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 87 of 2010) (Cth)
COMMONWEALTH OF AUSTRALIA
Instrument number PB 87 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, DAVID LEARMONTH, Deputy Secretary, 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 17 September 2010
DAVID LEARMONTH
Deputy Secretary
Department of Health and Ageing
Amendment declaration and determination — drugs and medicinal preparations
1 Commencement
This instrument commences on 1 October 2010.
2 Amendment of PB 14 of 2010
Schedule 1 amends PB 14 of 2010.
Schedule 1 Amendments
[1]Schedule 1, after item dealing with Electrolyte Replacement, Solution
insert in the columns in the order indicated:
| Eletriptan | In compliance with authority procedures set out in subparagraph 14 (d): |
| 3233 | Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics |
[2]Schedule 1, omit item dealing with Exenatide
and substitute:
| Exenatide | In compliance with authority procedures set out in subparagraph 14 (d): |
| Initiation of therapy, in combination with either metformin or a sulfonylurea, in a patient with type 2 diabetes in whom a combination of metformin and a sulfonylurea is contraindicated or not tolerated, and: (a) who has a glycosylated haemoglobin (HbA1c) level greater than 7% prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1; 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, a glitazone or a glucagon-like peptide-1 shows blood glucose levels greater than 10 mmol per L in more than 20% of tests; and where the 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 therapy with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated; and where the HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated | |
| Continuation of therapy, in combination with either metformin or a sulfonylurea, in a patient with type 2 diabetes where the patient has previously been issued with an authority prescription for exenatide | |
| Initiation of therapy, in combination with metformin and a sulfonylurea, in a patient with type 2 diabetes who, despite maximally tolerated doses of metformin and a sulfonylurea, has: (a) a glycosylated haemoglobin (HbA1c) level greater than 7% prior to initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or a glucagon-like peptide-1; 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 — blood glucose levels greater than 10 mmol per L in more than 20% of tests conducted during blood glucose monitoring over a 2 week period prior to initiation of a gliptin, a glitazone or a glucagon-like peptide-1; and where the 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 therapy with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated; and where the HbA1c level and the results of the blood glucose monitoring are no more than 4 months old at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is initiated | |
| Continuation of therapy, in combination with metformin and a sulfonylurea, in a patient with type 2 diabetes where the patient has previously been issued with an authority prescription for exenatide |
[3]Schedule 1, omit item dealing with Pioglitazone
and substitute:
| Pioglitazone | In compliance with authority procedures set out in subparagraph 14 (d): |
| 3540 | 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), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 is initiated |
| 3541 | 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), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 is initiated |
| 3542 | 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), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 is initiated |
[4]Schedule 1, omit item dealing with Roziglitazone
and substitute:
| Rosiglitazone | In compliance with authority procedures set out in subparagraph 14 (d): |
| 3540 | 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), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 is initiated |
[5]Schedule 1, omit item dealing with Roziglitazone with Metformin
and substitute:
| Rosiglitazone with Metformin | In compliance with authority procedures set out in subparagraph 14 (d): |
| 3544 | 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), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 is initiated |
[6]Schedule 1, omit item dealing with Sitagliptin
and substitute:
| Sitagliptin | In compliance with authority procedures set out in subparagraph 14 (d): |
| 3540 | 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), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 is initiated |
[7]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): |
| 3543 | 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), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 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 |
[8]Schedule 1, omit item dealing with Vildagliptin
and substitute:
| Vildagliptin | In compliance with authority procedures set out in subparagraph 14 (d): |
| 3540 | 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), a thiazolidinedione (glitazone) or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 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, a glitazone or a glucagon-like peptide-1 is initiated |
Note
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