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 54 of 2010) (Cth)
COMMONWEALTH OF AUSTRALIA
Instrument number PB 54 of 2010
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, FELICITY McNEILL, 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 3rd June 2010
FELICITY McNEILL
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 July 2010.
2 Amendment of PB 14 of 2010
Schedule 1 amends PB 14 of 2010.
Schedule 1 Amendments
Schedule 1, omit item dealing with Adrenaline
and substitute:
| 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 (EpiPen Jr.), I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector (Anapen Junior), I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector (EpiPen) and I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector (Anapen): In compliance with authority procedures set out in subparagraph 14 (d): | |
| Initial sole PBS-subsidised 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, and where the name of the specialist consulted is included in the authority application | |
| Initial sole PBS-subsidised 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 sole PBS-subsidised 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 |
Schedule 1, omit item dealing with Bevacizumab
and substitute:
| Bevacizumab | In compliance with authority procedures set out in subparagraph 14 (d): |
| Initial PBS-subsidised treatment, in combination with first-line chemotherapy, of a patient with previously untreated metastatic colorectal cancer with a World Health Organisation performance status of 0 or 1, and where the patient's dose of bevacizumab does not exceed 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks | |
| Continuing PBS-subsidised treatment, in combination with first-line chemotherapy, of a patient with metastatic colorectal cancer who has previously been issued with an authority prescription for bevacizumab and who does not have progressive disease and who remains on first-line chemotherapy, and where the patient's dose of bevacizumab does not exceed 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks |
Schedule 1, omit item dealing with Bimatoprost with timolol
and substitute:
| Bimatoprost with timolol | Reduction of elevated intra-ocular pressure in a patient with open-angle glaucoma that is not adequately controlled with monotherapy |
| Reduction of elevated intra-ocular pressure in a patient with ocular hypertension that is not adequately controlled with monotherapy |
Schedule 1, omit item dealing with Bisoprolol
and substitute:
| Bisoprolol | In compliance with authority procedures set out in subparagraph 14 (d): |
| 3234 | Moderate to severe heart failure in a patient stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor or angiotensin II antagonist, if tolerated |
Schedule 1, omit item dealing with Brimonidine with Timolol
and substitute:
| Brimonidine with Timolol | Reduction of elevated intra-ocular pressure in a patient with open-angle glaucoma that is not adequately controlled with monotherapy |
| Reduction of elevated intra-ocular pressure in a patient with ocular hypertension that is not adequately controlled with monotherapy |
Schedule 1, omit item dealing with Carvedilol
and substitute:
| Carvedilol | In compliance with authority procedures set out in subparagraph 14 (d): |
| 3234 | Moderate to severe heart failure in a patient stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor or angiotensin II antagonist, if tolerated |
| 1735 | Patients receiving this drug as a pharmaceutical benefit prior to 1 August 2002 |
Schedule 1, item dealing with Docetaxel
omit from the column headed “Circumstances”:
| Advanced breast cancer after failure of prior therapy which includes an anthracycline |
and substitute:
| Advanced breast cancer after failure of prior therapy |
Schedule 1, omit item dealing with Dorzolamide with Timolol
and substitute:
| Dorzolamide with Timolol | Reduction of elevated intra-ocular pressure in a patient with open-angle glaucoma that is not adequately controlled with monotherapy |
| Reduction of elevated intra-ocular pressure in a patient with ocular hypertension that is not adequately controlled with monotherapy |
Schedule 1, omit item dealing with Esomeprazole
and substitute:
| Esomeprazole | In respect of the tablet (enteric coated) 20 mg (as magnesium trihydrate): Initial treatment of gastric ulcer |
| Maintenance of healed gastro-oesophageal reflux disease | |
| Scleroderma oesophagus | |
| Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion | |
| In respect of the tablet (enteric coated) 40 mg (as magnesium trihydrate): Healing of gastro-oesophageal reflux disease | |
| In compliance with authority procedures set out in subparagraph 14 (d): | |
| Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion |
Schedule 1, omit item dealing with Lapatinib
and substitute:
| Lapatinib | In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment, in combination with capecitabine, of a patient with HER2 positive metastatic breast cancer (equivalent to Stage IIIC or Stage IV) who has received prior therapy with a taxane, for at least 3 cycles, and whose disease has progressed despite treatment with trastuzumab for metastatic disease, and where the authority application includes: (a) a pathology report demonstrating HER2 positivity has been demonstrated by in situ hybridisation (ISH); and (b) date of last treatment with a taxane and total number of cycles; and (c) a signed patient acknowledgment; and (d) dates of treatment with trastuzumab; and (e) date of demonstration of disease progression whilst on treatment with trastuzumab |
| In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Continuing treatment, in combination with capecitabine, of a patient with HER2 positive metastatic breast cancer who has previously received treatment with PBS-subsidised lapatinib and who does not have progressive disease, and where the authority application includes a statement from the prescribing doctor that the disease has not progressed |
Schedule 1, omit item dealing with Latanoprost with Timolol
and substitute:
| Latanoprost with Timolol | Reduction of elevated intra-ocular pressure in a patient with open-angle glaucoma that is not adequately controlled with monotherapy |
| Reduction of elevated intra-ocular pressure in a patient with ocular hypertension that is not adequately controlled with monotherapy |
Schedule 1, item dealing with Medroxyprogesterone
omit from the column headed “Circumstances”:
| In respect of the tablet containing medroxyprogesterone acetate 5 mg, tablet containing medroxyprogesterone acetate 10 mg, injection containing medroxyprogesterone acetate 50 mg in 1 mL and injection containing medroxyprogesterone acetate 150 mg in 1 mL: — |
and substitute:
| In respect of the tablet containing medroxyprogesterone acetate 5 mg, tablet containing medroxyprogesterone acetate 10 mg and injection containing medroxyprogesterone acetate 150 mg in 1 mL: — |
Schedule 1, item dealing with Mesalazine
omit from the column headed “Circumstances”:
suppositories 1 g, 28
and substitute:
suppository 1 g
Schedule 1, omit item dealing with Metoprolol succinate
and substitute:
| Metoprolol succinate | In compliance with authority procedures set out in subparagraph 14 (d): |
| 3234 | Moderate to severe heart failure in a patient stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor or angiotensin II antagonist, if tolerated |
Schedule 1, item dealing with Paclitaxel
omit from the column headed “Circumstances”:
| Advanced breast cancer after failure of prior therapy which includes an anthracycline |
and substitute:
| Advanced breast cancer after failure of prior therapy |
Schedule 1, item dealing with Paclitaxel, nanoparticle albumin-bound
omit from the column headed “Circumstances”:
| Metastatic breast cancer after failure of prior therapy which includes an anthracycline |
and substitute:
| Metastatic breast cancer after failure of prior therapy |
Schedule 1, omit item dealing with Pioglitazone
and substitute:
| Pioglitazone | In compliance with authority procedures set out in subparagraph 14 (d): |
| 3437 | Treatment of type 2 diabetes, in combination with either metformin or a sulfonylurea, in a patient in whom a combination of metformin and a sulfonylurea is contraindicated or not tolerated, and: (a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin) or a thiazolidinedione (glitazone) is greater than 7%, despite treatment with either metformin or a sulfonylurea; or (b) as an alternative to HbA1c level measurement 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 gliptin or a glitazone shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with either metformin or a sulfonylurea; and where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin or glitazone is initiated; and where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin or glitazone is initiated |
| 3438 | Treatment of type 2 diabetes, in combination with insulin, in a patient: (a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin) or a thiazolidinedione (glitazone) is greater than 7%, despite treatment with insulin and oral anti-diabetic agents, or with insulin alone where metformin is contraindicated; or (b) as an alternative to HbA1c level measurement 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 gliptin or a glitazone shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with insulin and oral anti-diabetic agents, or with insulin alone where metformin is contraindicated; and where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin or glitazone is initiated; and where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin or glitazone is initiated |
| 3439 | Treatment of type 2 diabetes, in combination with metformin and a sulfonylurea, in a patient: (a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin) or a thiazolidinedione (glitazone) is greater than 7%, despite treatment with maximally tolerated doses of metformin and a sulfonylurea; or (b) as an alternative to HbA1c level measurement 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 gliptin or a 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 and a sulfonylurea; and where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin or glitazone is initiated; and where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin or glitazone is initiated |
Schedule 1, omit item dealing with Rosiglitazone
and substitute:
| Rosiglitazone | In compliance with authority procedures set out in subparagraph 14 (d): |
| 3437 | Treatment of type 2 diabetes, in combination with either metformin or a sulfonylurea, in a patient in whom a combination of metformin and a sulfonylurea is contraindicated or not tolerated, and: (a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin) or a thiazolidinedione (glitazone) is greater than 7%, despite treatment with either metformin or a sulfonylurea; or (b) as an alternative to HbA1c level measurement 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 gliptin or a glitazone shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with either metformin or a sulfonylurea; and where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin or glitazone is initiated; and where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin or glitazone is initiated |
Schedule 1, omit item dealing with Rosiglitazone with Metformin
and substitute:
| Rosiglitazone with Metformin | In compliance with authority procedures set out in subparagraph 14 (d): |
| 3441 | Treatment of type 2 diabetes in a patient in whom a sulfonylurea is contraindicated or not tolerated, and: (a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin) or a thiazolidinedione (glitazone) is greater than 7%, despite treatment with metformin; or (b) as an alternative to HbA1c level measurement 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 gliptin or a glitazone shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with metformin; and where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin or glitazone is initiated; and where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin or glitazone is initiated |
Schedule 1, omit item dealing with Rosuvastatin
and substitute:
| Rosuvastatin | For use in accordance with paragraph 16 |
| For use in accordance with paragraph 16 in patients 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, omit item dealing with Sitagliptin
and substitute:
| Sitagliptin | In compliance with authority procedures set out in subparagraph 14 (d): |
| 3437 | Treatment of type 2 diabetes, in combination with either metformin or a sulfonylurea, in a patient in whom a combination of metformin and a sulfonylurea is contraindicated or not tolerated, and: (a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin) or a thiazolidinedione (glitazone) is greater than 7%, despite treatment with either metformin or a sulfonylurea; or (b) as an alternative to HbA1c level measurement in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemia 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 gliptin or a glitazone shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with either metformin or a sulfonylurea; and where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin or glitazone is initiated; and where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin or glitazone is initiated |
Schedule 1, omit item dealing with Sitagliptin with metformin
and substitute:
| Sitagliptin with metformin | In compliance with authority procedures set out in subparagraph 14 (d): |
| 3440 | Treatment of type 2 diabetes in a patient in whom a combination of metformin and a sulfonylurea is contraindicated or not tolerated, and: (a) whose glycosylated haemoglobin (HbA1c) prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin) or a thiazolidinedione (glitazone) is greater than 7%, despite treatment with metformin; or (b) as an alternative to HbA1c level measurement 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 gliptin or a glitazone shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with metformin; and where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstances, are documented in the patient's medical records at the time treatment with a gliptin or glitazone is initiated; and where the qualifying HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin or glitazone is initiated |
| 3149 | 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 diabetic medicines which includes metformin and sitagliptin |
Schedule 1, omit item dealing with Travoprost with Timolol
and substitute:
| Reduction of elevated intra-ocular pressure in a patient with open-angle glaucoma that is not adequately controlled with monotherapy |
| Reduction of elevated intra-ocular pressure in a patient with ocular hypertension that is not adequately controlled with monotherapy |
Schedule 2, after item dealing with Promethazine
insert in the columns in the order indicated:
| Roxithromycin | — |
Schedule 2A, omit item dealing with Bimatoprost with timolol
and substitute:
| Bimatoprost with timolol | Reduction of elevated intra-ocular pressure in a patient with open-angle glaucoma that is not adequately controlled with monotherapy |
| Reduction of elevated intra-ocular pressure in a patient with ocular hypertension that is not adequately controlled with monotherapy |
Schedule 2A, omit item dealing with Brimonidine with Timolol
and substitute:
| Brimonidine with Timolol | Reduction of elevated intra-ocular pressure in a patient with open-angle glaucoma that is not adequately controlled with monotherapy |
| Reduction of elevated intra-ocular pressure in a patient with ocular hypertension that is not adequately controlled with monotherapy |
Schedule 2A, omit item dealing with Dorzolamide with Timolol
and substitute:
| Dorzolamide with Timolol | Reduction of elevated intra-ocular pressure in a patient with open-angle glaucoma that is not adequately controlled with monotherapy |
| Reduction of elevated intra-ocular pressure in a patient with ocular hypertension that is not adequately controlled with monotherapy |
Schedule 2A, omit item dealing with Latanoprost with Timolol
and substitute:
| Latanoprost with Timolol | Reduction of elevated intra-ocular pressure in a patient with open-angle glaucoma that is not adequately controlled with monotherapy |
| Reduction of elevated intra-ocular pressure in a patient with ocular hypertension that is not adequately controlled with monotherapy |
Schedule 2A, omit item dealing with Travoprost with Timolol
and substitute:
| Travoprost with Timolol | Reduction of elevated intra-ocular pressure in a patient with open-angle glaucoma that is not adequately controlled with monotherapy |
| Reduction of elevated intra-ocular pressure in a patient with ocular hypertension that is not adequately controlled with monotherapy |
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