National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 11) (PB 100 of 2016) (Cth)

Case

PB 100 of 2016

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 11)

National Health Act 1953

___________________________________________________________________________

I, PENNY SHAKESPEARE, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.

Dated 28 November 2016

Penny Shakespeare

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

___________________________________________________________________________

Part 1        Preliminary

1                  Name of Instrument

(1)This instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 11).

(2)This instrument may also be cited as PB 100 of 2016.

2              Commencement

This instrument commences on 1 December 2016.

3              Amendment

The Schedule amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).

Schedule – Amendments

Schedule

National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)

  1. Schedule 1, after entry for Apomorphine, in the form, ‘Injection containing apomorphine hydrochloride 50 mg in 5 mL’ and brand ‘ Movapo’

Insert:

Solution for subcutaneous infusion containing apomorphine hydrochloride 50 mg in 10 mL pre-filled syringe Injection Movapo PFS TD EMP

 C4833 C4860 180 5 D

  1. Schedule 1, entry for Entecavir       Substitute:

Entecavir Tablet 0.5 mg (as monohydrate) Oral Baraclude BQ EMP C4993 C5036 60 5 D
Entecavir  Amneal EA EMP C4993 C5036 60 5 D
Entecavir APOTEX TX EMP C4993 C5036 60 5 D
Entecavir  Mylan AF EMP C4993 C5036 60 5 D
ENTECAVIR RBX RA EMP C4993 C5036 60 5 D
Entecavir  Sandoz SZ EMP C4993 C5036 60 5 D
ENTECLUDE RW EMP C4993 C5036 60 5 D
Tablet 1 mg (as monohydrate) Oral Baraclude BQ EMP C5037 C5044 60 5 D
Entecavir  Amneal EA EMP C5037 C5044 60 5 D
Entecavir APOTEX TX EMP C5037 C5044 60 5 D
Entecavir Mylan AF EMP C5037 C5044 60 5 D
ENTECAVIR RBX RA EMP C5037 C5044 60 5 D
Entecavir  Sandoz SZ EMP C5037 C5044 60 5 D
ENTECLUDE RW EMP C5037 C5044 60 5 D

  1. Schedule 1, entry for Infliximab, in the form ‘Powder for I.V infusion 100 mg’ and brands ‘Inflectra’ and ‘Remicade’ [Maximum Quantity: 1;    Number of Repeats: 0]   a)  Omit from the column headed ‘Circumstances’: C5079 C5111 C5112 C5120 C5570       

    Insert in numerical order: C6584 C6590 C6595 C6607 C6616

    b)  Omit from the column headed ‘Purposes’: P5079 P5111 P5112 P5120 P5570

Insert in numerical order: P6584 P6590 P6595 P6607 P6616

[4]      Schedule 1, entry for Omalizumab                Substitute:

Omalizumab Injection 75 mg in 0.5 mL single dose pre-filled syringe Injection Xolair NV EMP C4875 C4879 C4880 C6142 C6563 C6569 C6596 C6603 1 0 D
Injection 150 mg in 1 mL single dose pre-filled syringe Injection Xolair NV EMP C4875 C4879 C4880 C6142 C6563 C6569 C6596 C6603 1 0 D

  1. Schedule 1, after entry for Tenofovir with emtricitabine, in the form ‘Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine    200 mg’ and brand ‘Truvada’

Insert:

Tablet containing tenofovir alafenamide 10 mg with emtricitabine 200 mg Oral Descovy 10/200 GI EMP

 C4454 C4512 60 5 D
Tablet containing tenofovir alafenamide 25 mg with emtricitabine 200 mg Oral Descovy 25/200 GI EMP C4454 C4512 60 5 D

  1. Schedule 1, entry for Vedolizumab      Omit from the column headed ‘Circumstances’: C5072 C5073 C5096 C5107 C5591

Insert in numerical order: C6583 C6589 C6612 C6617

  1. Schedule 3, entry for Infliximab

Omit entry for: C5079 C5111 C5112 C5120 C5570

Substitute:

C6584 P6584

Where a patient is receiving treatment at/from a private or public hospital

Moderate to severe ulcerative colitis

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug for this condition; AND

Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR

Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years.

Must be treated by a gastroenterologist (code 87); OR

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR

Must be treated by a paediatrician; OR

Must be treated by a specialist paediatric gastroenterologist.

Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.

Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.

At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg.

Up to a maximum of 2 repeats will be authorised.

 Compliance with modified Authority Required procedures
C6590 P6590

Where a patient is receiving treatment at/from a private or public hospital

Moderate to severe ulcerative colitis

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug for this condition; AND

Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR

Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years.

Must be treated by a gastroenterologist (code 87); OR

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR

Must be treated by a paediatrician; OR

Must be treated by a specialist paediatric gastroenterologist.

Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.

Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.

At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg.

Up to a maximum of 2 repeats will be authorised.

 Compliance with modified Authority Required procedures
C6595 P6595

Where the patient is receiving treatment at/from a private or public hospital

Moderate to severe ulcerative colitis

Balance of supply

Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete the 3 doses (i.e. the initial infusion regimen at 0, 2 and 6 weeks); OR

Patient must have received insufficient therapy with this drug under the Initial 2 (Change or Recommencement of treatment after a break in therapy) restriction to complete the 3 doses (i.e. the initial infusion regimen at 0, 2 and 6 weeks); OR

Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; AND

The treatment must provide no more than the balance of up to 3 doses (Initial 1 and Initial 2 restrictions) or 2 repeats (Continuing restriction).

Patient must be 6 years of age or older.

Must be treated by a gastroenterologist (code 87); OR

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR

Must be treated by a paediatrician; OR

Must be treated by a specialist paediatric gastroenterologist.

Authority approval for sufficient therapy to complete a maximum of 3 initial doses or 2 repeats may be requested by telephone by contacting the Department of Human Services.

 Compliance with modified Authority Required procedures
C6607 P6607

Where the patient is receiving treatment at/from a private or public hospital

Moderate to severe ulcerative colitis

Change or Re-commencement of treatment after a break in therapy (Initial 2)

Patient must have previously been issued with an authority prescription for adalimumab, infliximab or vedolizumab for this condition in this treatment cycle; AND

Patient must not have failed PBS-subsidised therapy with infliximab for this condition more than once in the current treatment cycle.

Must be treated by a gastroenterologist (code 87); OR

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR

Must be treated by a paediatrician; OR

Must be treated by a specialist paediatric gastroenterologist.

To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of this drug within the timelines specified in the relevant restriction. If the response assessment to the previous course of this drug is not submitted as detailed in the relevant restriction, the patient will be deemed to have failed therapy with this drug.

A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.

At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg.

Up to a maximum of 2 repeats will be authorised.

Authority approval for sufficient therapy to complete a maximum of 3 initial doses or 2 repeats may be requested by telephone by contacting the Department of Human Services.

 Compliance with modified Authority Required procedures
C6616 P6616

Where the patient is receiving treatment at/from a private or public hospital

Moderate to severe ulcerative colitis

Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1) Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more months or have intolerance necessitating permanent treatment withdrawal; AND

Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more months or have intolerance necessitating permanent treatment withdrawal; OR

Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months or have intolerance necessitating permanent treatment withdrawal; OR

Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg (for a child, 1 to 2 mg/kg up to 40 mg) prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more months of treatment of an appropriately dosed thiopurine agent; AND

Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; OR

Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); OR

Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years; OR

Patient must have previously received induction therapy with this drug for an acute severe episode of ulcerative colitis in the last 4 months and demonstrated an adequate response to induction therapy by achieving and maintaining a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a PUCAI score less than 10 (if aged 6 to 17 years).

Patient must be 6 years of age or older.

Must be treated by a gastroenterologist (code 87); OR

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR

Must be treated by a paediatrician; OR

Must be treated by a specialist paediatric gastroenterologist.

Applications for authorisation of initial treatment must be in writing and must include:

(a) a completed authority prescription form; and

(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:

(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and

(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and

(iii) the signed patient acknowledgement or guardian acknowledgement.

A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, or to be administered at 8-weekly intervals for patients who have received prior treatment for an acute severe episode, will be authorised.

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 conventional treatment.

The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 1 month old at the time of application.

Where treatment for an acute severe episode has occurred, an adequate response to induction therapy needs to be demonstrated by achieving and maintaining a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 (if aged 6 to 17 years), within the first 12 weeks of receiving this drug for acute severe ulcerative colitis.

Patients who fail to achieve a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 within the first 12 weeks of receiving this drug for ulcerative colitis, or have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or have failed to maintain a PUCAI score less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.

A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose for patients administered doses at weeks 0, 2 and 6 (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.

The patient or guardian (required if patient is aged 6 to 17 years) must have signed a patient acknowledgement indicating that he or she understands and acknowledges that the PBS-subsidised treatment will cease if he or she does not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.

If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.

If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.

Details of the accepted toxicities including severity can be found on the Department of Human Services website.

 Compliance with modified Authority Required procedures

  1. Schedule 3, entry for Omalizumab

Insert:

C6563

Where the patient is receiving treatment at/from a private or public hospital

Uncontrolled severe allergic asthma

Continuing treatment

Patient must have a documented history of severe allergic asthma; AND

Patient must have demonstrated or sustained an adequate response to treatment with this drug; AND

Patient must not receive more than 24 weeks of treatment under this restriction.

Must be treated by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.

An adequate response to omalizumab treatment is defined as:

(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or ACQ-IA score of at least 0.5 from baseline, OR

(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 or ACQ-IA score from baseline, OR

(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.

All applications for continuing treatment with omalizumab must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient's response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate must be made at around 18 to 22 weeks after the first dose of PBS-subsidised omalizumab so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.

The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with omalizumab.

A patient who fails to respond to a course of PBS-subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS-subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased.

At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks of therapy.

The authority application must be made in writing and must include:

(a) a completed authority prescription form; and

(b) a completed Paediatric Severe Allergic Asthma Continuing PBS Authority Application - Supporting Information form which includes details of maintenance oral corticosteroid dose; and

(c) a completed Asthma Control Questionnaire (ACQ-5) or the Asthma Control Questionnaire interviewer administered version (ACQ-IA) calculation sheet including the date of assessment of the patient's symptoms and is endorsed with the signature of the prescriber.

 Compliance with modified Authority Required procedures
C6569

Where the patient is receiving treatment at/from a private or public hospital

Uncontrolled severe allergic asthma

Initial treatment - Grandfather patients

Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2016; AND

Patient must be receiving treatment with this drug for this condition at the time of application; AND

Patient must have had, prior to commencement of omalizumab, a diagnosis of asthma confirmed and documented by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician, defined by the following standard clinical features: forced expiratory volume (FEV1) reversibility or airway hyperresponsiveness or peak expiratory flow (PEF) variability; AND

Patient must have had a duration of asthma of at least 1 year prior to commencement of omalizumab; AND

Patient must have past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE; AND

Patient must have failed to achieve adequate control with optimised asthma therapy prior to omalizumab therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND

Patient must not receive more than 24 weeks of treatment under this restriction; AND

Patient must have demonstrated an adequate response to treatment; AND

Patient must be under the care of the same physician for at least 6 months.

Patient must be aged 6 to less than 12 years.

Must be treated by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.

Optimised asthma therapy includes:

(i) Adherence to optimal inhaled therapy, including high dose inhaled corticosteroid (ICS) and long-acting beta-2 agonist (LABA) therapy for at least six months. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative;

AND

(ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3-5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated.

If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications (including those specified in the relevant TGA-approved Product Information) and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.

A review of the patient's records should be conducted to extract pre- and post-omalizumab data on symptoms, quality of life, medication doses, exacerbations and hospitalisations. Examples of parameters to establish response include:

(i) a reduction in Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire Interviewer Administered (ACQ-IA) score of at least 0.5;

(ii) maintenance oral corticosteroid dose reduced by at least 25% from baseline; and/or

(iii) a reduction in the number of hospitalisations or severe exacerbations requiring use of systemic corticosteroids, compared to the 12 months prior to commencement of omalizumab.

The assessment of the patient's response to the initial PBS subsidised course of treatment must be made at around 18 to 22 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed. The same parameters used to establish response to non-PBS-subsidised therapy with omalizumab should be used for the assessment.

This assessment, which will be used to determine eligibility for continuing treatment, must be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with omalizumab.

Patients will be eligible to receive continuing courses of omalizumab treatment of up to 24 weeks providing they continue to demonstrate an adequate response to treatment.

Patients may qualify for PBS-subsidised treatment under this restriction once only.

A patient who fails to respond to a course of PBS-subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS-subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased.

At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for an initial course of omalizumab of up to 24 weeks, consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks.

The authority application must be made in writing and must include:

(a) a completed authority prescription form; and

(b) a completed Paediatric Grandfather Severe Allergic Asthma PBS Authority Application - Supporting Information Form,

which includes the following:

(i) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and

(ii) details of pre- and post-omalizumab data on symptoms, quality of life, medication doses, exacerbations and hospitalisations; and

(iii) acknowledgement signed by a parent or authorised guardian.

 Compliance with modified Authority Required procedures
C6596

Where the patient is receiving treatment at/from a private or public hospital

Uncontrolled severe allergic asthma

Initial and continuing treatment - balance of supply

Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete 28 weeks treatment; OR

Patient must have received insufficient therapy with this drug under the Continuing treatment restriction or Grandfather treatment restriction to complete 24 weeks treatment; AND

The treatment must provide no more than the balance of up to 28 weeks treatment available under the Initial restriction or up to 24 weeks treatment available under the Continuing or Grandfather restrictions.

Must be treated by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.

 Compliance with modified Authority Required procedures
C6603

Where the patient is receiving treatment at/from a private or public hospital

Uncontrolled severe allergic asthma

Initial treatment

Patient must have a diagnosis of asthma confirmed and documented by a paediatric respiratory physician, clinical immunologist, or allergist; or paediatrician or general physician experienced in the management of patients with severe asthma in consultation with a respiratory physician, defined by the following standard clinical features: forced expiratory volume (FEV1) reversibility or airway hyperresponsiveness or peak expiratory flow (PEF) variability; AND

Patient must have a duration of asthma of at least 1 year; AND

Patient must have past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE; AND

Patient must have total serum human immunoglobulin E greater than or equal to 30 IU/mL; AND

Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND

Patient must not receive more than 28 weeks of treatment under this restriction; AND

Patient must be under the care of the same physician for at least 6 months.

Patient must be aged 6 to less than 12 years.

Must be treated by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.

Optimised asthma therapy includes:

(i) Adherence to optimal inhaled therapy, including high dose inhaled corticosteroid (ICS) and long-acting beta-2 agonist (LABA) therapy for at least six months. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative;

AND

(ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3-5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated.

If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications (including those specified in the relevant TGA-approved Product Information) and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.

The initial IgE assessment must be no more than 12 months old at the time of application.

The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:

(a) An Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month (for children aged 6 to 10 years it is recommended that the Interviewer Administered version - the ACQ-IA be used),

AND

(b) while receiving optimised asthma therapy in the previous 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.

The Asthma Control Questionnaire (5 item version) or ACQ-IA assessment of the patient's response to this initial course of treatment, the assessment of oral corticosteroid dose, and the assessment of exacerbation rate must be made at around 22 to 26 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.

This assessment, which will be used to determine eligibility for continuing treatment, must be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with omalizumab.

A patient who fails to respond to a course of PBS-subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS-subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased.

At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab of up to 28 weeks, consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks.

The authority application must be made in writing and must include:

(a) a completed authority prescription form; and

(b) a completed Paediatric Severe Allergic Asthma Initial PBS Authority Application - Supporting Information form,

which includes the following:

(i) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and

(ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and

(iii) acknowledgement signed by a parent or authorised guardian; and

(c) a copy of the IgE pathology report; and

(d) a completed Asthma Control Questionnaire (ACQ-5) or the Asthma Control Questionnaire interviewer administered version (ACQ-IA) calculation sheet including the date of assessment of the patient's symptoms and is endorsed with the prescriber's signature.

 Compliance with modified Authority Required procedures

  1. Schedule 3, entry for Vedolizumab       Omit entry for: C5072 C5073 C5096 C5107 C5591         Substitute:

C6583

Where the patient is receiving treatment at/from a private or public hospital

Moderate to severe ulcerative colitis

Change or Re-commencement of treatment after a break in therapy (Initial 2)

Patient must have previously been issued with an authority prescription for adalimumab, infliximab or vedolizumab for this condition in this treatment cycle; AND

Patient must not have failed PBS-subsidised therapy with vedolizumab for this condition more than once in the current treatment cycle; AND

Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.

Patient must be aged 18 years or older.

Must be treated by a gastroenterologist (code 87); OR

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].

To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of this drug within the timelines specified in the relevant restriction. If the response assessment to the previous course of this drug is not submitted as detailed in the relevant restriction, the patient will be deemed to have failed therapy with this drug.

A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.

At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose.

Up to a maximum of 2 repeats will be authorised.

Authority approval for sufficient therapy to complete a maximum of 3 initial doses of treatment may be requested by telephone by contacting the Department of Human Services.

 Compliance with modified Authority Required procedures
C6589

Where the patient is receiving treatment at/from a private or public hospital

Moderate to severe ulcerative colitis

Balance of supply

Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete the 3 doses (i.e. the initial infusion regimen at 0, 2 and 6 weeks); OR

Patient must have received insufficient therapy with this drug under the Initial 2 (Change or Recommencement of treatment after a break in therapy) restriction to complete the 3 doses (i.e. the initial infusion regimen at 0, 2 and 6 weeks); OR

Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; AND

The treatment must provide no more than the balance of up to 3 doses (Initial 1 and Initial 2 restrictions) or 2 repeats (Continuing restriction); AND

Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.

Patient must be aged 18 years or older.

Must be treated by a gastroenterologist (code 87); OR

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].

Authority approval for sufficient therapy to complete a maximum of 3 initial doses or 2 repeats may be requested by telephone by contacting the Department of Human Services.

 Compliance with modified Authority Required procedures
C6612

Where the patient is receiving treatment at/from a private or public hospital

Moderate to severe ulcerative colitis

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug for this condition; AND

Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND

Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.

Must be treated by a gastroenterologist (code 87); OR

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].

Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.

Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.

At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose.

Up to a maximum of 2 repeats will be authorised.

 Compliance with modified Authority Required procedures
C6617

Where the patient is receiving treatment at/from a private or public hospital

Moderate to severe ulcerative colitis

Initial treatment (new patient – Initial 1)

Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more months or have intolerance necessitating permanent treatment withdrawal; AND

Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more months or have intolerance necessitating permanent treatment withdrawal; OR

Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months or have intolerance necessitating permanent treatment withdrawal; OR

Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more months of treatment of an appropriately dosed thiopurine agent; AND

Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; OR

Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND

Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.

Patient must be aged 18 years or older.

Must be treated by a gastroenterologist (code 87); OR

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].

Applications for authorisation of initial treatment must be in writing and must include:

(a) a completed authority prescription form; and

(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:

(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and

(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and

(iii) the signed patient acknowledgement.

A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.

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 conventional treatment.

The most recent Mayo clinic or partial Mayo clinic score must be no more than 1 month old at the time of application.

Patients who fail to achieve a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 or have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.

A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose for patients administered doses at weeks 0, 2 and 6 (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.

Patients must have signed a patient acknowledgement indicating they understand and acknowledge that the PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.

If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.

If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.

 Compliance with modified Authority Required procedures

  1. Schedule 4 – Patient Contributions       Substitute:

Listed Drug Form (strength, type, size, etc.) Manner of Administration Brand Pack Quantity Approved Ex‑manufacturer Price or Proportional Ex‑manufacturer Price
$ 		Claimed price
$
Lamivudine Tablet 100 mg Oral Zeffix 28 $55.34 $56.30
Valaciclovir Tablet 500 mg (as hydrochloride) Oral Valtrex 100 $63.70 $64.33
Actions
Download as PDF Download as Word Document
Cases Citing This Decision

0

Cases Cited

0

Statutory Material Cited

0