National Health Act 1953 Amendment declaration under subsections 85(2) and 85(2AA) Amendment determination under subsection 85(2A) drugs and medicinal preparations (No. PB 97 of 2008) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 97 of 2008

Amendment declaration under subsections 85(2) and 85(2AA) of the National Health Act 1953

Amendment determination under subsection 85(2A) of the National Health Act 1953

I, DIANA MACDONELL, Acting Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsections 85(2), 85(2A) and 85(2AA) of the National Health Act 1953.

Dated 2nd OCTOBER 2008

DIANA MACDONELL

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment declaration and determination — drugs and medicinal preparations

1 Commencement

This instrument commences on 1 November 2008.

2 Amendment of PB 74 of 2008

Schedule 1 amends PB 74 of 2008.

Schedule 1 Amendments

Paragraph 3, after the entry “extemporaneously-prepared pharmaceutical benefit” means a pharmaceutical benefit other than a ready-prepared pharmaceutical benefit;

insert:

“GP Management Plan” means a comprehensive written plan for the treatment of a patient, prepared by a medical practitioner, that includes a description of the patient’s health care needs, management goals, actions to be taken by the patient and treatment and services the patient is likely to need;

Paragraph 3, for the entry “Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960.

omit the “fullstop” and substitute with a “semi-colon”

Paragraph 3, after the entry “Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960;

insert:

“Team Care Arrangements” means a document prepared by a medical practitioner, following consultation with collaborating providers, that includes a description of the treatment and service goals for the patient, the treatment and services that all collaborating providers will provide and the actions to be taken by the patient.

Schedule 1, item dealing with Atomoxetine

omit all text from “Column 3”and substitute:

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

Initial sole PBS-subsidised 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 sole PBS-subsidised 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

(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 sole PBS-subsidised treatment where the patient has previously been issued with an authority prescription for this drug

Schedule 1, item dealing with Bortezomib

omit all text from “Column 3”and substitute:

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

Continuing PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid and/or cyclophosphamide, 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 and/or cyclophosphamide, 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:

(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 and/or cyclophosphamide, 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:

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

Schedule 1, item dealing with Cabergoline

omit from “Column 3”:

, tablet 2 mg and tablet 4 mg:

and substitute:

and tablet 2 mg:

Schedule 1, item dealing with Carbomer 980 in respect of the ocular lubricating gel 2 mg per g, 10 g

insert in “Column 3” as next paragraph after “Severe dry eye syndrome, including Sjogren’s syndrome”:

For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

Schedule 1, item dealing with 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

insert in “Column 3” as next paragraph after “Severe dry eye syndrome, including Sjogren’s syndrome”:

Schedule 1, item dealing with Dasatinib for the treatment of Chronic myeloid leukaemia

omit text from “Column 3” under the heading Chronic myeloid leukaemia (first occurring) and substitute:

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

Initial treatment, as the sole PBS-subsidised therapy, of a patient with chronic myeloid leukaemia in any disease phase bearing the Philadelphia chromosome or expressing the transcript BCR-ABL, and who:

(a) has active leukaemia (as defined by the presence on current pathology assessments of either the Philadelphia chromosome on cytogenetic or fluorescence in situ hybridisation (FISH) analysis, or the presence of the transcript BCR-ABL greater than 1% on the international scale); and

(b) has failed an adequate trial of imatinib, where failure of an adequate trial of imatinib is defined as:

(i) lack of response to initial imatinib therapy, defined as either:

— failure to achieve a haematological response after a minimum of 3 months of therapy with imatinib, for patients initially treated in chronic phase; or

— failure to achieve any cytogenetic response after a minimum of 6 months of therapy with imatinib, for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or

— failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months of therapy with imatinib; or

(ii) loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Philadelphia positive cells on bone marrow biopsy), during ongoing imatinib therapy; or

(iii) loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing in value by at least 5 fold to a level of greater than 1% confirmed on a subsequent test); or

(iv) development of accelerated phase or blast crisis in a patient previously prescribed imatinib for any phase of chronic myeloid leukaemia, where:

(1) accelerated phase is defined by the presence of 1 or more of the following:

— percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or

— percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%; or

— peripheral basophils greater than or equal to 20%; or

— progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or

— karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); and

(2) blast crisis is defined as either:

— percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or

— extramedullary involvement other than spleen and liver; or

(v) disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia; or

(vi) grade 3 or 4 non-haematological toxicity that is imatinib related and necessitates permanent cessation of imatinib; and

where the authority application includes:

(a) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib/Nilotinib PBS Authority Application - Supporting Information Form; and

(b) a signed patient acknowledgement; and

(c) a bone marrow biopsy pathology report demonstrating that the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 1% on the international scale, and the date of the relevant pathology report; and

(d)(1) where there has been a loss of response to imatinib, a copy of the current confirming pathology report, or reports, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement; or

(2) details of Grade 3 or 4 non-haematological imatinib related toxicity;

for patients with imatinib related toxicities, leukaemia activity does not need to be demonstrated

Schedule 1, item dealing with Dasatinib for the treatment of Chronic myeloid leukaemia

omit text from “Column 3” under the heading Chronic myeloid leukaemia (second occurring) and substitute:

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

Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial treatment with dasatinib as a pharmaceutical benefit for chronic myeloid leukaemia, and who has demonstrated either a major cytogenetic response to dasatinib, or less than 1% BCR-ABL level in the blood, within 18 months of the commencement of treatment and at 12 monthly intervals thereafter; and

where the following conditions apply:

a major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells;

a bone marrow or peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) indicates a response, at least the biological equivalent of a major cytogenetic response;

response to PBS-subsidised treatment with dasatinib is assessed by:

(1) cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or, in the case where standard karyotyping is not informative for technical reasons, cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe; or

(2) quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale;

the cytogenetic or peripheral blood quantitative PCR analyses demonstrating response are submitted as follows:

(i) between 10 and 18 months of the commencement of treatment with dasatinib, at which time patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been demonstrated are eligible for a further 12 months of treatment; and

(ii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been sustained;

the authority application includes:

(1) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib/Nilotinib Authority Application Form for continuing treatment; and

(2) demonstration of continued response to treatment as evidenced by:

(a) a copy of the cytogenetic analysis showing a major cytogenetic response, unless the relevant pathology report has been supplied within the previous 12 months (or 18 months if the application is the first application for continuing treatment), in which case only the date of this report needs to be provided; or

(b) a copy of the quantitative PCR analysis showing a peripheral blood level of BCR-ABL of less than 1% on the international scale, unless the relevant pathology report has been supplied within the previous 12 months (or 18 months if the application is the first application for continuing treatment), in which case only the date of this report needs to be provided; and

(3) if the cytogenetic analysis submitted with the application was conducted using FISH with BCR-ABL specific probe because standard karyotyping was not informative, a copy of the non-informative standard karyotype analysis;

a patient who has previously received PBS-subsidised treatment with dasatinib and has at any time failed to meet the criteria for continuing treatment, is not eligible for PBS-subsidised re-treatment

Schedule 1, item dealing with Hypromellose

insert in “Column 3” as next paragraph after “Severe dry eye syndrome, including Sjogren’s syndrome”:

Schedule 1, item dealing with Hypromellose with Carbomer 980

insert in “Column 3” after “Severe dry eye syndrome, including Sjogren’s syndrome”:

Schedule 1, item dealing with Hypromellose with Dextran in respect of the eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL

insert in “Column 3” after “Severe dry eye syndrome, including Sjogren’s syndrome”:

Schedule 1, item dealing with Imatinib

omit text from “Column 3” under the heading Myelodysplastic or myeloproliferative disorder (second occurring only) and substitute:

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

Continuing PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with a PDGFRB fusion gene-positive myelodysplastic or myeloproliferative disorder who has previously been issued with an authority prescription for imatinib and who has demonstrated a complete haematological response, and where the application for authorisation includes:

(a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and

(b) a copy of the full blood examination report which demonstrates a complete haematological response; and

Schedule 1, item dealing with Imatinib

omit heading text from “Column 3” (where occurring):

Mastocytosis with eosinophilia

and substitute:

Systemic mastocytosis with eosinophilia

Schedule 1, item dealing with Imatinib

omit text from “Column 3” under the newly amended heading Systemic mastocytosis with eosinophilia (second occurring only) and substitute:

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

Continuing PBS-subsidised treatment (at a dose that does not exceed 400 mg per day) of a patient with aggressive systemic mastocytosis confirmed to carry the FIP1L1-PDGFRA fusion gene, who has previously been issued with an authority prescription for imatinib and who has demonstrated a complete haematological response, and where the application for authorisation includes:

(a) a completed copy of the appropriate Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and

(b) a copy of the full blood examination report which demonstrates a complete haematological response; and

Schedule 1, item dealing with Mesalazine

omit from “Column 3”:

In respect of the sachet containing granules, 500 mg per sachet and sachet containing granules, 1 g per sachet:

and substitute:

In respect of the sachet containing granules, 500 mg per sachet, sachet containing granules, 1 g per sachet and sachet containing granules, 1.5 g per sachet:

Schedule 1, item dealing with Nilotinib

omit all text from “Column 3”and substitute:

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

Initial treatment, as the sole PBS-subsidised therapy, of a patient with chronic myeloid leukaemia in chronic or accelerated phase bearing the Philadelphia chromosome or expressing the transcript BCR-ABL, and who:

(b) has failed an adequate trial of imatinib, where failure of an adequate trial of imatinib is defined as:

(i) lack of response to initial imatinib therapy, defined as either:

— failure to achieve a haematological response after a minimum of 3 months of therapy with imatinib, for patients initially treated in chronic phase; or

— failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months of therapy with imatinib; or

(iv) development of accelerated phase in a patient previously prescribed imatinib for the chronic phase of chronic myeloid leukaemia, where accelerated phase is defined by the presence of 1 or more of the following:

— percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or

— percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30% provided that blast count is less than 30%; or

— peripheral basophils greater than or equal to 20%; or

— karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); or

(vi) grade 3 or 4 non-haematological toxicity that is imatinib related and necessitates permanent cessation of imatinib; and

where the authority application includes:

(a) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib/Nilotinib PBS Authority Application - Supporting Information Form; and

(b) a signed patient acknowledgement; and

(d)(1) where there has been a loss of response to imatinib, a copy of the current confirming pathology report, or reports, from an Approved Pathology Authority; or

(2) details of Grade 3 or 4 non-haematological imatinib related toxicity;

for patients with imatinib related toxicities, leukaemia activity does not need to be demonstrated

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

Continuing treatment, as the sole PBS-subsidised therapy, of a patient who has received initial treatment with nilotinib as a pharmaceutical benefit for chronic myeloid leukaemia, and who has demonstrated either a major cytogenetic response to nilotinib, or less than 1% BCR-ABL level in the blood, within 18 months of the commencement of treatment and at 12 monthly intervals thereafter; and

where the following conditions apply:

a major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells;

response to PBS-subsidised treatment with nilotinib is assessed by:

(2) quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale;

the cytogenetic or peripheral blood quantitative PCR analyses demonstrating response are submitted as follows:

(i) between 10 and 18 months of the commencement of treatment with nilotinib, at which time patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been demonstrated are eligible for a further 12 months of treatment; and

(ii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been sustained;

the authority application includes:

(1) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib/Nilotinib Authority Application Form for continuing treatment; and

(2) demonstration of continued response to treatment as evidenced by:

a patient who has previously received PBS-subsidised treatment with nilotinib and has at any time failed to meet the criteria for continuing treatment, is not eligible for PBS-subsidised re-treatment

Schedule 1, item dealing with Polyethylene Glycol 400 with Propylene Glycol in respect of the eye drops 4 mg-3 mg per mL,

15 mL

insert in “Column 3” after “Severe dry eye syndrome, including Sjogren’s syndrome”:

Schedule 1, item dealing with Polyethylene Glycol 400 with Propylene Glycol in respect of the eye drops 4 mg-3 mg per mL,

single dose units 0.7 mL, 28

omit from “Column 3”:

0.7 mL

and substitute:

0.8 mL

Schedule 1, item dealing with Polyvinyl Alcohol

insert in “Column 3” after “Severe dry eye syndrome, including Sjogren’s syndrome”:

Schedule 1, item dealing with Quetiapine

(a) insert in “Column 3” immediately before existing text:

In respect of the tablet 25 mg (as fumarate), tablet 100 mg (as fumarate), tablet 200 mg (as fumarate) and tablet 300 mg (as fumarate):

(b)insert in the columns in the order indicated immediately after existing text:

In respect of the tablet (modified release) 50 mg (as fumarate), tablet (modified release) 200 mg (as fumarate), tablet (modified release) 300 mg (as fumarate) and tablet (modified release) 400 mg (as fumarate):

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

1589

Schizophrenia

Schedule 1, item dealing with Rosiglitazone

omit from the columns in the order indicated:

2648	Treatment of type 2 diabetes, in combination with metformin hydrochloride and a sulfonylurea, in a patient:
(a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a thiazolidinedione (glitazone) is greater than 7%, despite treatment with maximally tolerated doses of metformin hydrochloride and a sulfonylurea; or
(b) in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of a thiazolidinedione (glitazone) shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with maximally tolerated doses of metformin hydrochloride and a sulfonylurea; and
where the HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstance, are documented in the patient's medical records, and are no more than 4 months old, at the time glitazone treatment is initiated

and substitute:

3037	Continuation of therapy in type 2 diabetes mellitus in a patient who has previously received and been stabilised on a PBS-subsidised regimen of oral anti-diabetic medicines which includes rosiglitazone maleate

Schedule 1, item dealing with Rosiglitazone with metformin

omit from the columns in the order indicated:

2634	Type 2 diabetes, in combination with a sulfonylurea, in a patient:
(a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a thiazolidinedione (glitazone) is greater than 7%, despite treatment with maximally tolerated doses of metformin hydrochloride and a sulfonylurea; or
(b) in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with maximally tolerated doses of metformin hydrochloride and a sulfonylurea; and
where the HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstance, are documented in the patient's medical records, and are no more than 4 months old, at the time glitazone treatment is initiated

and substitute:

3037	Continuation of therapy in type 2 diabetes mellitus in a patient who has previously received and been stabilised on a PBS-subsidised regimen of oral anti-diabetic medicines which includes rosiglitazone maleate

Schedule 1, item dealing with Thyrotropin Alfa

omit all text from “Column 3” and substitute:

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

Ablation of thyroid remnant tissue, in combination with radioactive iodine, in a post thyroidectomy patient without known metastatic disease

Schedule 1, item dealing with Tramadol

omit from “Column 3” the paragraph commencing “In respect of the tablet” and substitute:

In respect of the tablet (sustained release) containing tramadol hydrochloride 50 mg, tablet (sustained release) containing tramadol hydrochloride 100 mg, tablet (extended release) containing tramadol hydrochloride 100 mg, tablet (sustained release) containing tramadol hydrochloride 150 mg, tablet (sustained release) containing tramadol hydrochloride 200 mg, tablet (extended release) containing tramadol hydrochloride 200 mg, tablet (extended release) containing tramadol hydrochloride 300 mg and oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL:

Schedule 2, item dealing with Tramadol

omit from “Column 2” the paragraph commencing “In respect of the tablet” and substitute:

Schedule 2A, item dealing with Polyethylene Glycol 400 with Propylene Glycol in respect of the eye drops 4 mg-3 mg per mL,

single dose units 0.7 mL, 28

omit from “Column 2”:

0.7 mL

and substitute:

0.8 mL