National Health Act 1953 - Declaration under subsections 85(2) and 85(2AA) - Determinations under subsection 85(2A) (No. PB 88 of 2007)

Patients with diabetes mellitus not otherwise included

total cholesterol greater than 5.5 mmol per L

Aboriginal or Torres Strait Islander patients;

Patients with hypertension

total cholesterol greater than 6.5 mmol per L;

or

total cholesterol greater than 5.5 mmol per L and high density lipoprotein cholesterol less than 1 mmol per L

Patients with high density lipoprotein cholesterol less than 1 mmol per L

total cholesterol greater than 6.5 mmol per L

Patients with familial hypercholesterolaemia identified by:

 (1) DNA mutation; or

 (2) tendon xanthomas in the patient or their first or second degree relative

Patients with:

 (1) family history of coronary heart disease which has become symptomatic before the age of 60 years in one or more first degree relatives; or

 (2) family history of coronary heart disease which has become symptomatic before the age of 50 years in one or more second degree relatives

If aged 18 years or less at treatment initiation:

low density lipoprotein cholesterol greater than 4 mmol per L

If aged more than 18 years at treatment initiation:

low density lipoprotein cholesterol greater than 5 mmol per L;

or

total cholesterol greater than 6.5 mmol per L;

or

total cholesterol greater than 5.5 mmol per L and high density lipoprotein cholesterol less than 1 mmol per L

Patients not eligible under the above:

 (1) men over 34 but less than 76 years of age; or

 (2) post‑menopausal women less than 76 years of age

total cholesterol greater than 7.5 mmol per L;

or

triglyceride greater than 4 mmol per L

Patients not otherwise included

total cholesterol greater than 9 mmol per L;

or

triglyceride greater than 8 mmol per L

Abciximab

In compliance with authority procedures set out in subparagraph 14 (d):

1716

 Patients undergoing percutaneous coronary balloon angioplasty

1717

 Patients undergoing percutaneous coronary atherectomy

1718

 Patients undergoing percutaneous coronary stent placement

Acamprosate

In compliance with authority procedures set out in subparagraph 14 (d):

2665

 For use within a comprehensive treatment program for alcohol dependence with the goal of maintaining abstinence

Acarbose

—

Acetazolamide

—

Acetylcysteine

Bronchiectasis

Cystic fibrosis

Aciclovir

In respect of the tablet 200 mg:

In compliance with authority procedures set out in subparagraph 14 (d):

Moderate to severe initial genital herpes

Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis

In respect of the tablet 800 mg:

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment of patients with herpes zoster within 72 hours of the onset of the rash

Herpes zoster ophthalmicus

Patients with advanced human immunodeficiency virus disease (CD4 cell counts of less than 150 million per L)

In respect of the eye ointment 30 mg per g, 4.5 g:

Herpes simplex keratitis

Acitretin

In compliance with authority procedures set out in subparagraph 14 (d):

1366

 Severe intractable psoriasis

1363

 Severe forms of disorders of keratinisation

Adalimumab

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment commencing a biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:

(a) have severe active rheumatoid arthritis; and

(b) have not previously received PBS-subsidised treatment with a bDMARD for this condition, or, where the patient has previously received PBS-subsidised treatment with a bDMARD for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised bDMARD treatment for this condition was approved; and

(c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months’ treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and

where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and

where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

failure to achieve an adequate response to the treatment regimens specified at (c) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:

— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or

— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

all tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;

if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;

if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;

if intolerance to treatment with the regimens specified at (c) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;

the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient’s ESR and CRP measurements, and an assessment of the patient’s active joint count, conducted no earlier than 1 month prior to the date of application, and a signed patient acknowledgment;

a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

 Continuation of initial treatment in a bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment, or recommencement of treatment, with adalimumab within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:

(a) have a documented history of severe active rheumatoid arthritis; and

(b) have received prior PBS-subsidised treatment with a bDMARD for this condition in this Treatment Cycle and are eligible to receive further bDMARD therapy within this Treatment Cycle; and

(c) have not failed previous PBS-subsidised treatment with adalimumab during this Treatment Cycle; and

where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and

where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD Treatment Cycle with that therapy;

patients are eligible to receive further bDMARD therapy within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this Treatment Cycle;

patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with adalimumab within this bDMARD Treatment Cycle are eligible to recommence therapy with this drug within this same cycle provided that:

(i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment of rheumatoid arthritis, to their most recent course of PBS-subsidised adalimumab treatment; and

(ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and

(iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and

(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;

patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with adalimumab are not eligible to commence treatment with adalimumab until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;

the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and, in the case of patients recommencing therapy with adalimumab in this Treatment Cycle, evidence of the patient’s response to their most recent course of PBS-subsidised adalimumab therapy;

a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

 Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Continuing treatment with adalimumab within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:

(a) who have a documented history of severe active rheumatoid arthritis; and

(b) who have demonstrated an adequate response to treatment with adalimumab; and

(c) whose most recent course of PBS-subsidised bDMARD treatment in this bDMARD Treatment Cycle was with adalimumab; and

where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and

where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply

patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy;

an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:

— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or

— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;

a patient will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:

(a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and

(b) if the course of therapy is a 16-week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment;

the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;

if the most recent course of adalimumab therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;

the patient has not failed to demonstrate response to a course of PBS-subsidised adalimumab in this Treatment Cycle;

a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

 Continuing treatment within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:

(1) have severe active psoriatic arthritis; and

(2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and

(3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with methotrexate or sulfasalazine or leflunomide, at an adequate dose, for a minimum of 3 months; and

(4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and

(5) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and

where biological agent means adalimumab or etanercept or infliximab; and

where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:

— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or

— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;

if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;

if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;

the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient’s ESR and CRP measurements, and an assessment of the patient’s active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form;

a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

 Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment, or recommencement of treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:

(1) have a documented history of severe active psoriatic arthritis; and

(2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and

(3) have not failed treatment with adalimumab during the current Treatment Cycle; and

where biological agent means adalimumab or etanercept or infliximab; and

where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle;

patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with adalimumab within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if:

(i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with adalimumab, to their most recent course of PBS-subsidised adalimumab treatment; and

(ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and

(iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and

(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;

the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form;

a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

 Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:

(1) have a documented history of severe active psoriatic arthritis; and

(2) were receiving treatment with adalimumab prior to 16 March 2006; and

(3) have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab; and

(4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and

where biological agent means adalimumab or etanercept or infliximab; and

where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgment form;

the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight;

patients are eligible for PBS-subsidised treatment under the above criteria once only

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

 Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults:

(1) who have a documented history of severe active psoriatic arthritis; and

(2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with adalimumab; and

(3) who, at the time of application, demonstrate an adequate response to treatment with adalimumab; and

where biological agent means adalimumab or etanercept or infliximab; and

where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

where the following conditions apply:

an adequate response to treatment with adalimumab is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:

— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or

— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;

the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;

if the most recent course of adalimumab therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;

a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

 Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:

(a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with one of these drugs, has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and

(b) who has at least 2 of the following:

(i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or

(ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or

(iii) limitation of chest expansion relative to normal values for age and gender; and

(c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised therapy with adalimumab, etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and

(d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and

where the following conditions apply:

failure to achieve an adequate response is demonstrated by:

(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and

(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L;

both ESR and CRP measurements are included in the authority application and are no more than 1 month old;

if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied;

the authority application includes details of the NSAIDs trialled, their doses and duration of treatment;

if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reason why a higher dose cannot be used;

if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication;

if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance;

an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week;

if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed;

the application for authorisation includes:

(a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:

(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and

(ii) a completed BASDAI Assessment Form; and

(iii) a signed patient acknowledgment form; and

(iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed;

a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

 Continuation of initial treatment in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS-subsidised therapy with adalimumab; and

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and

where the following conditions apply:

a patient who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;

the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment;

the application is accompanied by the results of the patient’s most recent course of PBS-subsidised adalimumab, etanercept or infliximab therapy, where:

(a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and

(b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or

(ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment;

if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment;

a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

 Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who was receiving treatment with adalimumab prior to 1 November 2006; and

(a) who is receiving treatment with adalimumab at the time of application; and

(b) who has not received prior PBS-subsidised treatment with infliximab or etanercept; and

(c) whose current Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score is either less than or equal to 5 on a 0-10 scale or improved by at least 2 from baseline; and

(d) who has:

(i) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or

(ii) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or

(iii) an ESR or CRP measurement reduced by at least 20% from pre-treatment baseline; and

(e) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and

where the following conditions apply:

the BASDAI assessment and the ESR and CRP measurements provided are no more than 1 month old at the time of application;

the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:

(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and

(ii) a completed BASDAI Assessment Form; and

(iii) a signed patient acknowledgment form;

the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight;

patients are eligible for PBS-subsidised treatment under the above criteria once only

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

 Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who was receiving non-PBS-subsidised treatment with adalimumab prior to 1 November 2006 and at the time of the initial application for PBS-subsidised therapy and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with adalimumab, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with adalimumab; and

where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and

where the following conditions apply:

a patient who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;

response is defined as an improvement from baseline of at least 2 in the patient’s Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following:

(a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or

(b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or

(c) an ESR or CRP measurement reduced by at least 20% from baseline;

if the patient commenced treatment with adalimumab prior to 1 November 2006, was subsequently commenced on PBS-subsidised treatment and is continuing to receive PBS-subsidised treatment in their first treatment cycle, and where pre-treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, or no greater than 2, and 1 of the following:

(a) an ESR measurement no greater than 25 mm per hour; or

(b) a CRP measurement no greater than 10 mg per L;

all measurements provided are no more than 1 month old at the time of application;

the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient;

patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:

(a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and

(b) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment;

the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment;

a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

 Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight

Adrenaline

In respect of the injection 1 mg (as acid tartrate) in 1 mL (1 in 1,000):

—

In respect of the I.M. injection 150 micrograms in 0.3 mL single dose syringe auto‑injector and I.M. injection 300 micrograms in 0.3 mL single dose syringe auto‑injector:

In compliance with authority procedures set out in subparagraph 14 (d):

Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient who has been assessed to be at significant risk of anaphylaxis by, or in consultation with, a clinical immunologist, allergist, paediatrician or respiratory physician, where the name of the specialist consulted is included in the authority application

Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient who has been discharged from hospital or an emergency department after treatment with adrenaline for acute allergic reaction with anaphylaxis

Continuing supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis, where the patient has previously been issued with an authority prescription for this drug

Albendazole

In respect of the tablet 200 mg:

In compliance with authority procedures set out in subparagraph 14 (d):

2446

 Treatment of whipworm infestation in an Aboriginal or a Torres Strait Islander person

1525

 Treatment of tapeworm infestation

In respect of the tablet 400 mg:

In compliance with authority procedures set out in subparagraph 14 (d):

1496

 For the treatment of hydatid disease in conjunction with surgery or when a surgical cure cannot be achieved or where surgery cannot be used

Alendronic Acid

In respect of the tablet 70 mg (as alendronate sodium):

In compliance with authority procedures set out in subparagraph 14 (d):

2645

 Treatment as the sole PBS‑subsidised anti‑resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T‑score of ‑3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient’s medical records when treatment is initiated

2646

 Treatment as the sole PBS‑subsidised anti‑resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x‑ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient’s medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body

In respect of the tablet 40 mg (as alendronate sodium):

In compliance with authority procedures set out in subparagraph 14 (d):

1392

 Symptomatic Paget’s disease of bone

Alendronic Acid with Colecalciferol

In compliance with authority procedures set out in subparagraph 14 (d):

2645

 Treatment as the sole PBS‑subsidised anti‑resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T‑score of ‑3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient’s medical records when treatment is initiated

2646

 Treatment as the sole PBS‑subsidised anti‑resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x‑ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient’s medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body

Alginic acid with calcium carbonate and sodium bicarbonate

—

Allopurinol

—

Alprazolam

In compliance with authority procedures set out in subparagraph 14 (d):

Panic disorder where other treatments have failed or are inappropriate

Aluminium Hydroxide with Magnesium Hydroxide

—

Aluminium Hydroxide with Magnesium Trisilicate and Magnesium Hydroxide

—

Amantadine

Parkinson’s disease which is not drug induced

Amiloride

—

Amino acid formula without methionine, threonine and valine and low in isoleucine

Methylmalonic acidaemia

Propionic acidaemia

Amino acid formula without phenylalanine

Phenylketonuria

Amino acid formula without phenylalanine, and vitamins with minerals

Phenylketonuria

Amino acid formula without phenylalanine, tyrosine and methionine

Tyrosinaemia

Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine

Phenylketonuria

Amino acid formula with vitamins and minerals without lysine and low in tryptophan

In respect of the oral powder 400 g (XLYS, LOW TRY Analog):

An infant or young child with proven glutaric aciduria type 1

In respect of the oral powder 500 g (XLYS, LOW TRY Maxamaid):

A child aged less than 7 years with proven glutaric aciduria type 1

Amino acid formula with vitamins and minerals without methionine

In respect of the oral powder 400 g (XMET Analog):

For infants and very young children with pyridoxine non‑responsive homocystinuria

In respect of the sachets containing oral powder 20 g, 30 (HCU gel), sachets containing oral powder 25 g, 30 (HCU express), oral powder 500 g (XMET Maxamaid), oral powder 500 g (XMET Maxamum) and oral liquid 130 mL, 30 (HCU Cooler):

Pyridoxine non‑responsive homocystinuria

Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine

Methylmalonic acidaemia

Propionic acidaemia

Amino acid formula with vitamins and minerals without phenylalanine

Phenylketonuria

Amino acid formula with vitamins and minerals without phenylalanine and tyrosine

Tyrosinaemia

Amino acid formula with vitamins and minerals without valine, leucine and isoleucine

Maple syrup urine disease

Amino acids — synthetic, formula

In respect of the oral powder 400 g (EleCare):

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows’ milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where combined intolerance is demonstrated when the child has failed to respond to a strict cows’ milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula, and where the date of birth of the patient is included in the authority application

Initial treatment, in consultation with a paediatric gastroenterologist or specialist allergist, for up to 3 months, of a child up to the age of 2 years with severe intolerance (not infant colic) to cows’ milk protein, and where the date of birth of the patient is included in the authority application

Continuing treatment for combined intolerance (not infant colic) to cows’ milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application

Treatment for combined intolerance (not infant colic) to cows’ milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application

Continuing treatment for severe intolerance (not infant colic) to cows’ milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application

Treatment for severe intolerance (not infant colic) to cows’ milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application

Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed

Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition

Initial treatment for up to 3 months, by a clinical immunologist, suitably qualified allergist or gastroenterologist in a patient 18 years of age or less with eosinophilic oesophagitis who requires an amino acid based formula as a component of a dietary elimination programme, and where:

 eosinophilic oesophagitis is demonstrated by the following criteria:

 (i) chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and

 (ii) a lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and

 (iii) eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy specimen had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies;

 the date of birth of the patient is included in the authority application;

 treatment with oral steroids is not commenced during the period of initial treatment

Continuing treatment by a clinical immunologist, suitably qualified allergist or gastroenterologist in a patient 18 years of age or less with eosinophilic oesophagitis who has responded to an initial course of PBS-subsidised treatment, and where:

 response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy specimen has 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies;

 the response criteria will be deemed to have been not met if the patient commenced oral steroids during initial treatment

In respect of the oral powder 400 g (Neocate), oral powder 400 g (Neocate Advance) and oral powder 400 g (Neocate Advance Tropical Flavour):

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows’ milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where combined intolerance is demonstrated when the child has failed to respond to a strict cows’ milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula, and where the date of birth of the patient is included in the authority application

Initial treatment, in consultation with a paediatric gastroenterologist or specialist allergist, for up to 3 months, of a child up to the age of 2 years with severe intolerance (not infant colic) to cows’ milk protein, and where the date of birth of the patient is included in the authority application

Continuing treatment for combined intolerance (not infant colic) to cows’ milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application

Treatment for combined intolerance (not infant colic) to cows’ milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application

Continuing treatment for severe intolerance (not infant colic) to cows’ milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application

Treatment for severe intolerance (not infant colic) to cows’ milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application

Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed

Severe intestinal malabsorption including short bowel syndrome where the
patient has been receiving parenteral nutrition

Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows’ milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where combined intolerance is demonstrated when the child has failed to respond to a strict cows’ milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula, and where the date of birth of the patient is included in the authority application

Initial treatment, in consultation with a paediatric gastroenterologist or specialist allergist, for up to 3 months, of a child up to the age of 2 years with severe intolerance (not infant colic) to cows’ milk protein, and where the date of birth of the patient is included in the authority application

Continuing treatment for combined intolerance (not infant colic) to cows’ milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application

Treatment for combined intolerance (not infant colic) to cows’ milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application

Continuing treatment for severe intolerance (not infant colic) to cows’ milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application

Treatment for severe intolerance (not infant colic) to cows’ milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application

Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed

Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition

Aminoglutethimide

—

Amiodarone

Severe cardiac arrhythmias

Amisulpride

In compliance with authority procedures set out in subparagraph 14 (d):

1589

 Schizophrenia

Amitriptyline

—

Amlodipine

—

Amlodipine with Atorvastatin

For use in accordance with paragraph 16 in patients who have hypertension and/or angina, and who are currently receiving treatment with a dihydropyridine calcium channel blocker

For use in accordance with paragraph 16 in patients who have hypertension and/or angina, and whose blood pressure and/or angina is inadequately controlled with other classes of antihypertensive and/or anti‑anginal agent, and in whom adjunctive therapy with a dihydropyridine calcium channel blocker would be appropriate

For use in accordance with paragraph 16 in patients who have hypertension and/or angina, and who are intolerant of the side effects of other classes of antihypertensive and/or anti‑anginal agent, and in whom replacement therapy with a dihydropyridine calcium channel blocker would be appropriate

Amoxycillin

In respect of the tablet, chewable, 250 mg (as trihydrate), capsule 250 mg (as trihydrate), capsule 500 mg (as trihydrate), sachet containing oral powder 3 g (as trihydrate), powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL, powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL, powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL and powder for oral suspension 500 mg (as trihydrate) per 5 mL, 100 mL:

—

In respect of the tablet 1 g (as trihydrate):

Acute exacerbations of chronic bronchitis

Amoxycillin with Clavulanic Acid

Infections where resistance to amoxycillin trihydrate is suspected

Infections where resistance to amoxycillin trihydrate is proven

Amphotericin

—

Ampicillin

—

Anakinra

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment commencing a biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:

 (a) have severe active rheumatoid arthritis; and

 (b) have not previously received PBS-subsidised treatment with a bDMARD for this condition, or, where the patient has previously received PBS-subsidised treatment with a bDMARD for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised bDMARD treatment for this condition was approved; and

 (c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months’ treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and

 where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and

 where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

 where the following conditions apply:

 the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;

 failure to achieve an adequate response to the treatment regimens specified at (c) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:

 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or

 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

 all tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;

 if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;

 if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;

 if intolerance to treatment with the regimens specified at (c) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;

 the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient’s ESR and CRP measurements, and an assessment of the patient’s active joint count, conducted no earlier than 1 month prior to the date of application, and a signed patient acknowledgment;

 a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment

 In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

 Continuation of initial treatment in a bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment, or recommencement of treatment, with anakinra within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:

 (a) have a documented history of severe active rheumatoid arthritis; and

 (b) have received prior PBS-subsidised treatment with a bDMARD for this condition in this Treatment Cycle and are eligible to receive further bDMARD therapy within this Treatment Cycle; and

 (c) have not failed previous PBS-subsidised treatment with anakinra during this Treatment Cycle; and

 where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and

 where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

 where the following conditions apply:

 the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;

 patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD Treatment Cycle with that therapy;

 patients are eligible to receive further bDMARD therapy within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this Treatment Cycle;

 patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with anakinra within this bDMARD Treatment Cycle are eligible to recommence therapy with this drug within this same cycle provided that:

 (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment of rheumatoid arthritis, to their most recent course of PBS-subsidised anakinra treatment; and

 (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and

 (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and

 (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;

 patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with anakinra are not eligible to commence treatment with anakinra until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;

 the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and, in the case of patients recommencing therapy with anakinra in this Treatment Cycle, evidence of the patient’s response to their most recent course of PBS-subsidised anakinra therapy;

 a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment

 In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

 Continuation of initial treatment, or of a course which recommences treatment, with anakinra within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Continuing treatment with anakinra within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:

 (a) who have a documented history of severe active rheumatoid arthritis; and

 (b) who have demonstrated an adequate response to treatment with anakinra; and

 (c) whose most recent course of PBS-subsidised bDMARD treatment in this bDMARD Treatment Cycle was with anakinra; and

 where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and

 where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

 where the following conditions apply:

 the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;

 patients who commenced PBS-subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy;

 an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:

 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or

 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);

 the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;

 a patient will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:

 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and

 (b) if the course of therapy is a 16-week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment;

 the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with anakinra, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;

 if the most recent course of anakinra therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;

 the patient has not failed to demonstrate response to a course of PBS-subsidised anakinra in this Treatment Cycle;

 a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment

 In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

 Continuing treatment within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total

Anastrozole

Treatment of hormone‑dependent breast cancer in post‑menopausal women

Anecortave

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial treatment by an ophthalmologist, as the sole PBS‑subsidised therapy, of predominantly (greater than or equal to 50%) classic, subfoveal choroidal neovascularisation (CNV) due to age‑related macular degeneration, as diagnosed by fluorescein angiography, in a patient with a baseline visual acuity equal to or better than 6/60 (20/200), where the patient has not previously received PBS‑subsidised treatment with anecortave acetate in the eye for which treatment is being sought, and where the authority application includes a completed copy of the appropriate Subfoveal Choroidal Neovascularisation (CNV) ‑ PBS Supporting Information Form and a copy of the fluorescein angiogram demonstrating that the CNV is predominantly (greater than or equal to 50%) classic

 In compliance with authority procedures set out in subsubparagraph 14 (d) (ii):

 Initial treatment by an ophthalmologist, as the sole PBS‑subsidised therapy, of predominantly (greater than or equal to 50%) classic, subfoveal choroidal neovascularisation (CNV) due to age‑related macular degeneration, as diagnosed by fluorescein angiography, in a patient with a baseline visual acuity equal to or better than 6/60 (20/200), where the patient has not previously received PBS‑subsidised treatment with anecortave acetate in the eye for which treatment is being sought, and where the authority application includes a completed copy of the appropriate Subfoveal Choroidal Neovascularisation (CNV) ‑ PBS Supporting Information Form and a copy of the fluorescein angiogram demonstrating that the CNV is predominantly (greater than or equal to 50%) classic, is submitted to the Medicare Australia CEO by facsimile prior to contact by telephone and is resubmitted to the Medicare Australia CEO by post after the application has been authorised

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

 Continuing treatment by an ophthalmologist, as the sole PBS‑subsidised therapy, of predominantly (greater than or equal to 50%) classic, subfoveal choroidal neovascularisation due to age‑related macular degeneration, where the patient has previously been granted at least 1, but not more than 9, authority prescriptions for anecortave acetate for treatment of the same eye

Apraclonidine

Short‑term reduction of intra‑ocular pressure in patients already on maximally tolerated anti‑glaucoma therapy

Aprepitant

In compliance with authority procedures set out in subparagraph 14 (d):

Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy, when aprepitant is used in combination with a 5‑hydroxytryptamine type 3 receptor antagonist and dexamethasone, where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy, and where the cytotoxic chemotherapy to be administered to the patient includes any of the following agents:

 altretamine;

 carmustine;

 cisplatin, when a single dose constitutes a cycle of chemotherapy;

 cyclophosphamide, at a dose of 1500 mg per square metre per day or greater;

 dacarbazine;

 procarbazine, when a single dose constitutes a cycle of chemotherapy;

 streptozocin

Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat breast cancer where cyclophosphamide and an anthracycline are to be co‑administered, when aprepitant is used in combination with a 5‑hydroxytryptamine type 3 receptor antagonist and dexamethasone, and where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy

Aripiprazole

In compliance with authority procedures set out in subparagraph 14 (d):

1589

 Schizophrenia

Aspirin

—

Atenolol

—

Atomoxetine

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment of attention‑deficit hyperactivity disorder (ADHD) diagnosed between the ages of 6 and 18 years inclusive, by a paediatrician or psychiatrist according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM‑IV) criteria, where treatment with dexamphetamine sulfate or methylphenidate hydrochloride poses an unacceptable medical risk due to the following contraindications as specified in the Therapeutic Goods Administration‑approved Product Information:

 (1) the patient has a history of substance abuse or misuse (other than alcohol); and/or

 (2) the patient has comorbid motor tics or Tourette’s Syndrome; and/or

 (3) the patient has comorbid severe anxiety diagnosed according to the DSM‑IV

Initial treatment of attention‑deficit hyperactivity disorder (ADHD) diagnosed between the ages of 6 and 18 years inclusive, by a paediatrician or psychiatrist according to the DSM‑IV criteria, where treatment with dexamphetamine sulfate or methylphenidate hydrochloride has resulted in the development or worsening of a comorbid mood disorder (that is, anxiety disorder, obsessive compulsive disorder or depressive disorder, diagnosed according to the DSM‑IV criteria) of a severity necessitating permanent stimulant treatment withdrawal, or where the combination of stimulant treatment with another agent would pose an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal

Initial treatment of attention‑deficit hyperactivity disorder (ADHD) diagnosed between the ages of 6 and 18 years inclusive, by a paediatrician or psychiatrist according to the DSM‑IV criteria, where treatment with dexamphetamine sulfate and methylphenidate hydrochloride has resulted in the development of adverse reactions of a severity necessitating permanent treatment withdrawal:

 (1) Adverse effects on growth and weight; and/or

 (2) Adverse effects on sleep including insomnia; and/or

 (3) Adverse effects on appetite including anorexia

Continuing treatment where the patient has previously been issued with an authority prescription for this drug

Atorvastatin

For use in accordance with paragraph 16

Atovaquone

In compliance with authority procedures set out in subparagraph 14 (d):

1433

 Treatment of mild to moderate Pneumocystis carinii pneumonia in adult patients who are intolerant of trimethoprim with sulfamethoxazole therapy

Atropine

—

Auranofin

—

Aurothiomalate

—

Azathioprine

—

Azithromycin

In respect of the tablet 500 mg (as dihydrate):

Uncomplicated urethritis due to Chlamydia trachomatis

Uncomplicated cervicitis due to Chlamydia trachomatis

Trachoma

In respect of the powder for oral suspension 200 mg (as dihydrate) per 5 mL, 15 mL:

Trachoma

Baclofen

—

Balsalazide

In compliance with authority procedures set out in subparagraph 14 (d):

1708

 Ulcerative colitis where hypersensitivity to sulfonamides exists

1709

 Ulcerative colitis where intolerance to sulfasalazine exists

"BCG Immunotherapeutic" (Bacillus Calmette‑Guérin/ Connaught strain)

Treatment of carcinoma in situ of the urinary bladder

"BCG‑Tice" (Bacillus Calmette‑Guérin/ Tice strain)

Primary and relapsing superficial urothelial carcinoma of the bladder

Beclomethasone

In respect of the pressurised inhalation containing beclomethasone dipropionate 50 micrograms per dose, 200 doses (CFC‑free formulation) and pressurised inhalation containing beclomethasone dipropionate 100 micrograms per dose, 200 doses (CFC‑free formulation):

—

In respect of the pressurised inhalation in breath actuated device containing beclomethasone dipropionate 50 micrograms per dose, 200 doses (CFC‑free formulation) and pressurised inhalation in breath actuated device containing beclomethasone dipropionate 100 micrograms per dose, 200 doses (CFC‑free formulation):

Patients unable to achieve co‑ordinated use of other metered dose inhalers containing this drug

Benzathine benzylpenicillin

—

Benzathine Penicillin

—

Benzhexol

—

Benztropine

—

Benzydamine

Radiation induced mucositis

Benzylpenicillin

—

Betamethasone

In respect of the injection containing betamethasone acetate 3 mg with betamethasone sodium phosphate 3.9 mg in 1 mL:

Alopecia areata

For local intra‑articular or peri‑articular infiltration

Granulomata, dermal

Keloid

Lichen planus hypertrophic

Lichen simplex chronicus

Lupus erythematosus, chronic discoid

Necrobiosis lipoidica

Uveitis

In respect of the cream 500 micrograms (as dipropionate) per g, 15 g, cream 200 micrograms (as valerate) per g, 100 g, ointment 500 micrograms (as dipropionate) per g, 15 g, cream 500 micrograms (as valerate) per g, 15 g, ointment 200 micrograms (as valerate) per g, 100 g and ointment 500 micrograms (as valerate) per g, 15 g:

Treatment of corticosteroid‑responsive dermatoses

Betaxolol

—

Bethanechol

—

Bicalutamide

In compliance with authority procedures set out in subparagraph 14 (d):

Metastatic (equivalent to stage D) prostatic carcinoma, when used in combination with gonadotrophin‑releasing hormone (luteinising hormone‑releasing hormone) agonist therapy

Bifonazole

In compliance with authority procedures set out in subparagraph 14 (d):

2354

 Treatment of a fungal or a yeast infection in an Aboriginal or a Torres Strait Islander person

Bimatoprost

—

Biperiden

—

Bisacodyl

Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function

Patients who are receiving long‑term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities

For use by a patient who is receiving long‑term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult

Patients receiving palliative care

Terminal malignant neoplasia

Anorectal congenital abnormalities

Megacolon

Bisoprolol

In compliance with authority procedures set out in subparagraph 14 (d):

1734

 Moderate to severe heart failure in patients stabilised on conventional therapy which must include an angiotensin‑converting enzyme inhibitor if tolerated

Bivalirudin

In compliance with authority procedures set out in subparagraph 14 (d):

2147

 Patients undergoing non‑emergency percutaneous coronary intervention

Bleomycin

Germ cell neoplasms

Lymphoma

Bortezomib

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Continuing PBS‑subsidised treatment, as monotherapy or in combination with a corticosteroid, of multiple myeloma in a patient who has previously received 8 treatment cycles with bortezomib and who, at the time of application, has demonstrated at least a partial response to bortezomib but who has not received 2 treatment cycles after first achieving a confirmed complete response; and

 where the following conditions apply:

 if serum M protein and urine Bence‑Jones protein levels are measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as:

 (a)  at least a 50% reduction in the level of serum M protein (monoclonal protein); or

 (b)  at least a 90% reduction in 24‑hour urinary light chain M protein excretion or to less than 200 mg per 24 hours;

 if serum M protein and urine Bence‑Jones protein levels are unmeasurable as in non‑secretory/oligo‑secretory multiple myeloma, partial response compared with baseline is defined as:

 (c)  the difference between involved and uninvolved serum free light chain (FLC) levels, with at least a 50% reduction in this value;

 if serum M protein and urine Bence‑Jones protein levels and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:

 (d)  at least a 50% reduction in bone marrow plasma cells; or

 (e)  normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L; or

 (f)  no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or

 (g)  at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. magnetic resonance imaging or computed tomography scan);

 the same parameters provided for the diagnosis of progressive disease are used to demonstrate at least a partial response to treatment;

 a patient is eligible for continuing PBS‑subsidised bortezomib treatment beyond 8 cycles if they have achieved at least a partial response at the completion of cycle 8, and the results of the response assessment are included in the application for authorisation of further treatment;

 a patient will be deemed to have failed to respond to 8 cycles of treatment with bortezomib, despite demonstrating a partial response, if the response assessment is not submitted to the Medicare Australia CEO prior to cycle 9;

 the authority application is made not later than 10 months after the application for initial treatment and includes:

 (1)  a completed copy of the appropriate Multiple Myeloma Authority Application ‑ Supporting Information Form; and

 (2)  diagnostic reports, which are no more than 1 month old at the time of application, demonstrating that the patient has achieved at least a partial response;

 a patient is eligible to receive no more than 2 cycles of treatment beyond the cycle at which a complete response, confirmed by 2 determinations a minimum of 6 weeks apart, was first achieved;

 PBS‑subsidised treatment with bortezomib is limited to a maximum of 11 cycles

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial PBS‑subsidised treatment of multiple myeloma in patients receiving treatment with bortezomib prior to 1 November 2007; and

 where the following conditions apply:

 patients who fail to demonstrate at least a partial response after 4 cycles are not eligible to receive further PBS‑subsidised treatment with bortezomib;

 patients who qualify for PBS‑subsidised treatment under this restriction may receive a maximum of 3 cycles, after which the patient must qualify under the continuing treatment criteria to receive further treatment;

 the authority application includes:

 (1)  a completed copy of the appropriate Multiple Myeloma Authority Application ‑ Supporting Information Form; and

 (2)  a signed patient acknowledgment; and

 (3)  details including relevant reports of the basis of the diagnosis of progressive disease and nomination of which disease activity parameters will be used to assess response; and

 (4)  if relevant, details including relevant reports for patients who have demonstrated a partial response and who have received 4 or more cycles;

 diagnostic reports demonstrating at least a partial response are within 1 month of the date of application

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Initial PBS‑subsidised treatment, as monotherapy or in combination with a corticosteroid, of multiple myeloma in a patient with a World Health Organisation (WHO) performance status of 2 or less, who has progressive disease, who has received at least 1 prior therapy (other than thalidomide), who has undergone or is ineligible for a primary stem cell transplant and who has experienced treatment failure after a trial of at least 4 weeks of thalidomide at a dose of at least 100 mg daily; and

 where the following conditions apply:

 if the dosing requirement for thalidomide cannot be met, the authority application states the reasons why this criterion cannot be satisfied;

 thalidomide treatment failure is defined as:

 (1)  confirmed disease progression during or within 6 months of discontinuing thalidomide treatment; or

 (2)  severe intolerance or toxicity unresponsive to clinically appropriate dose adjustment;

 progressive disease is defined as at least 1 of the following:

 (a)  at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or

 (b)  at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or

 (c)  at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or

 (d)  an increase in the size or number of lytic bone lesions (not including compression fractures); or

 (e)  at least a 25% increase in the size of an existing, or the development of a new, soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or

 (f)  development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause);

 severe intolerance due to thalidomide is defined as unacceptable somnolence or sedation interfering with activities of daily living;

 toxicity from thalidomide is defined as peripheral neuropathy (Grade 2 or greater, interfering with function), drug‑related seizures, serious Grade 3 or Grade 4 drug‑related dermatological reactions, such as Stevens‑Johnson Syndrome, or other Grade 3 or 4 toxicity;

 the authority application includes:

 (1)  a completed copy of the appropriate Multiple Myeloma Authority Application ‑ Supporting Information Form, which includes details of prior treatments including names of drugs and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; the patient’s WHO performance status; details of thalidomide treatment failure; details of the basis of the diagnosis of progressive disease; nomination of which disease activity parameters will be used to assess response; and the results of current diagnostic reports as detailed below; and

 (2)  duration of thalidomide and daily dose prescribed; and

 (3)  a signed patient acknowledgment;

 to enable the Medicare Australia CEO to confirm response, current diagnostic reports of the following are required to establish baseline:

 (a)  the level of serum M protein (monoclonal protein); and

 (b)  if Bence‑Jones proteinuria is present, the results of 24‑hour urinary light chain M protein excretion;

 if neither serum M protein nor urine Bence‑Jones protein is present in measurable quantities, additional diagnostic reports are required, including:

 (c)  bone marrow aspirate and trephine; and

 (d)  if present, the size and location of lytic bone lesions (not including compression fractures); or

 (e)  if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination, i.e. magnetic resonance imaging or computed tomography scan; or

 (f)  if present, the level of hypercalcaemia, corrected for albumin concentration; or

 (g)  if present, the serum free light chain levels;

 to enable assessment of response, baseline values for the above parameters must be provided with the authority application as follows:

 (i)  for all patients, results for (a) and (b) must be provided;

 (ii)  where the patient has oligo‑secretory or non‑secretory multiple myeloma, results for (c) and if relevant (d), (e) or (f) must be provided;

 (iii)  where the prescriber plans to assess response in patients with oligo‑secretory or non‑secretory multiple myeloma with free light chain assays, results for (g) must be provided;

 where baseline values for 1 or more of the specified parameters cannot be provided, the authority application states the reason or reasons these cannot be provided

In compliance with authority procedures set out in subsubparagraph 14 (d) (i):

Continuing PBS‑subsidised treatment, as monotherapy or in combination with a corticosteroid, of multiple myeloma in a patient who has previously received 4 treatment cycles of bortezomib and who, at the time of application, has demonstrated at least a partial response to bortezomib; and

 where the following conditions apply:

 if serum M protein and urine Bence‑Jones protein levels are measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as:

 (a)  at least a 50% reduction in the level of serum M protein (monoclonal protein); or

 (b)  at least a 90% reduction in 24‑hour urinary light chain M protein excretion or to less than 200 mg per 24 hours;

 if serum M protein and urine Bence‑Jones protein levels are unmeasurable as in non‑secretory/oligo‑secretory multiple myeloma, partial response compared with baseline is defined as:

 (c)  at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels;

 if serum M protein and urine Bence‑Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:

 (d)  at least a 50% reduction in bone marrow plasma cells; or

 (e)  normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L; or

 (f)  no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or

 (g)  at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. magnetic resonance imaging or computed tomography scan);

 the same parameters provided for the diagnosis of progressive disease are used to demonstrate at least a partial response to treatment;

 a patient is eligible for continuing PBS‑subsidised bortezomib treatment beyond 4 cycles if they have achieved at least a partial response at the completion of cycle 4, and the results of the response assessment are included in the application for authorisation of further treatment;

 a patient will be deemed to have failed to respond to 4 cycles of treatment with bortezomib, despite demonstrating a partial response, if the response assessment is not submitted to the Medicare Australia CEO prior to cycle 5;

 the authority application is made not later than 6 months after the application for initial treatment and includes:

 (1)  a completed copy of the appropriate Multiple Myeloma Authority Application ‑ Supporting Information Form; and

 (2)  diagnostic reports, which are no more than 1 month old at the time of application, demonstrating that the patient has achieved at least a partial response;

 patients who fail to demonstrate at least a partial response after 8 cycles are not eligible to receive further PBS‑subsidised treatment with bortezomib;

 a patient is eligible to receive no more than 2 cycles of treatment beyond the cycle at which a complete response, confirmed by 2 determinations a minimum of 6 weeks apart, was first achieved

Brimonidine

—

Brimonidine with Timolol

Reduction of elevated intra‑ocular pressure in patients with open‑angle glaucoma who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL

Reduction of elevated intra‑ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL

Brinzolamide

—

Bromocriptine

In respect of the tablet 2.5 mg (as mesylate):

Prevention of the onset of lactation in the puerperium for medical reasons

Acromegaly

Parkinson’s disease

Pathological hyperprolactinaemia where surgery is not indicated

Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution

Pathological hyperprolactinaemia where radiotherapy is not indicated

Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution

In respect of the capsule 5 mg (as mesylate) and capsule 10 mg (as mesylate):

Acromegaly

Parkinson’s disease

Pathological hyperprolactinaemia where surgery is not indicated

Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution

Pathological hyperprolactinaemia where radiotherapy is not indicated

Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution

Budesonide

In respect of the nebuliser suspension 500 micrograms in 2 mL single dose units, 30 and nebuliser suspension 1 mg in 2 mL single dose units, 30:

In compliance with authority procedures set out in subparagraph 14 (d):

1351

 Severe chronic asthma in patients who require long‑term steroid therapy and who are unable to use other forms of inhaled steroid therapy

In respect of the powder for oral inhalation in breath actuated device 100 micrograms per dose, 200 doses, powder for oral inhalation in breath actuated device 200 micrograms per dose, 200 doses and powder for oral inhalation in breath actuated device 400 micrograms per dose, 200 doses:

—

Budesonide with Eformoterol

In respect of the powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses and powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses:

Patients who previously had frequent episodes of asthma while receiving treatment with oral corticosteroids and who have been stabilised on concomitant inhaled eformoterol fumarate dihydrate and budesonide

Patients who previously had frequent episodes of asthma while receiving treatment with optimal doses of inhaled corticosteroids and who have been stabilised on concomitant inhaled eformoterol fumarate dihydrate and budesonide

For single maintenance and reliever therapy in a patient who experiences frequent asthma symptoms while receiving treatment with oral corticosteroids

For single maintenance and reliever therapy in a patient who experiences frequent asthma symptoms while receiving treatment with inhaled corticosteroids

For maintenance and reliever therapy in a patient who experiences frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and a long‑acting beta‑2 agonist

In respect of the powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2:

Patients who previously had frequent episodes of asthma while receiving treatment with oral corticosteroids and who have been stabilised on concomitant inhaled eformoterol fumarate dihydrate and budesonide

Patients who previously had frequent episodes of asthma while receiving treatment with optimal doses of inhaled corticosteroids and who have been stabilised on concomitant inhaled eformoterol fumarate dihydrate and budesonide

Buprenorphine

Chronic severe disabling pain not responding to non‑narcotic analgesics

Bupropion

In compliance with authority procedures set out in subparagraph 14 (d):

Commencement of short-term, sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who has entered a comprehensive support and counselling program, and where details of the program are specified in the authority application

Commencement of short-term, sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who is entering a comprehensive support and counselling program during the same consultation at which the authority application is made, and where details of the program are specified in the authority application

Completion of short-term, sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has previously been issued with an authority prescription for this drug and who is enrolled in a comprehensive support and counselling program

Busulfan

—

Cabergoline

In respect of the tablet 500 micrograms:

Prevention of the onset of lactation in the puerperium for medical reasons

In compliance with authority procedures set out in subparagraph 14 (d):

2659

 Pathological hyperprolactinaemia where surgery is not indicated

2660

 Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution

2661

 Pathological hyperprolactinaemia where radiotherapy is not indicated

2662

 Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution

In respect of the tablet 1 mg, tablet 2 mg and tablet 4 mg:

Parkinson’s disease

Calcipotriol

In respect of the ointment 50 micrograms per g, 30g and cream 50 micrograms (as monohydrate) per g, 30 g

Chronic stable plaque type psoriasis vulgaris

In respect of the scalp solution 50 micrograms (as monohydrate) per mL, 30 mL:

Chronic stable plaque type psoriasis vulgaris of the scalp

Calcitriol

In compliance with authority procedures set out in subparagraph 14 (d):

1165

 Hypocalcaemia due to renal disease

1166

 Hypoparathyroidism

1167

 Hypophosphataemic rickets

1467

 Vitamin D‑resistant rickets

2636

 Treatment for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x‑ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient’s medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body

Calcium

In compliance with authority procedures set out in subparagraph 14 (d):

2212

 Hyperphosphataemia associated with chronic renal failure

Candesartan

—

Candesartan with Hydrochlorothiazide

Hypertension in patients who are not adequately controlled with 16 mg candesartan cilexetil

Capecitabine

In compliance with authority procedures set out in subparagraph 14 (d):

Advanced breast cancer after failure of prior therapy which includes a taxane and an anthracycline

Advanced breast cancer where therapy with a taxane or an anthracycline is contraindicated

Advanced breast cancer in combination with docetaxel after failure of prior anthracycline‑containing chemotherapy

Treatment of advanced or metastatic colorectal cancer

Adjuvant treatment of stage III (Dukes C) colon cancer, following complete resection of the primary tumour

Captopril

In respect of the tablet 12.5 mg, tablet 25 mg and tablet 50 mg:

—

In respect of the oral solution 5 mg per mL, 95 mL:

For patients unable to take a solid dose form of an angiotensin‑converting enzyme inhibitor

Carbamazepine

—

Carbimazole

—

Carbohydrate, fat, vitamins, minerals and trace elements

Patients with proven inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae

Carbomer 974

In compliance with authority procedures set out in subparagraph 14 (d):

1359

 Severe dry eye syndrome in patients who are sensitive to preservatives in multi‑dose eye drops

Carbomer 980

In respect of the ocular lubricating gel 2 mg per g, 10 g:

Severe dry eye syndrome, including Sjogren’s syndrome

In respect of the eye drops 2 mg per g, single dose units 0.6 mL, 30:

In compliance with authority procedures set out in subparagraph 14 (d):

1359

 Severe dry eye syndrome in patients who are sensitive to preservatives in multi‑dose eye drops

Carboplatin

—

Carmellose

In respect of the eye drops containing carmellose sodium 5 mg per mL, 15 mL and eye drops containing carmellose sodium 10 mg per mL, 15 mL:

Severe dry eye syndrome, including Sjogren’s syndrome

In respect of the eye drops containing carmellose sodium 2.5 mg per mL, single dose units 0.6 mL, 24, eye drops containing carmellose sodium 5 mg per mL, single dose units 0.4 mL, 30, eye drops containing carmellose sodium 10 mg per mL, single dose units 0.4 mL, 30 and ocular lubricating gel containing carmellose sodium 10 mg per mL, single dose units 0.6 mL, 28: