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National Health (Pharmaceutical Benefits - Therapeutic Groups) Determination 2010 (No. PB 1 of 2010)

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National Health (Pharmaceutical Benefits — Therapeutic Groups) Determination 20101
Instrument Number PB 1 of 2010
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 Determination under subsection 84AG (1) of the National Health Act 1953.
Dated 19 January 2010
 
Felicity McNeill
Assistant Secretary, Pharmaceutical Evaluation Branch
Department of Health and Ageing
Contents
                        1     Name of Determination                                                                         2
                        2     Commencement                                                                                  2
                        3     Revocation                                                                                          2
                        4     Definitions                                                                                           2
                        5     Therapeutic groups                                                                              3
                        6     Drugs in therapeutic groups                                                                  3
Schedule 1             Therapeutic groups and listed drugs                                                 4
Part 1                      ACE inhibitor group                                                                              4
Part 2                      ATRA group                                                                                        4
Part 3                      CCB group                                                                                          4
Part 4                      H2RA group                                                                                        4
Part 5                      PPI group                                                                                           5
Part 6                      Statins group                                                                                      5
Part 7                      Statins-HP group                                                                                 5
Part 8                      Venlafaxine group                                                                                5
Part 9                      Bisphosphonates osteoporosis group                                                    5
Part 10                    Bisphosphonates Paget disease group                                                  6
 
 
 
1              Name of Determination
         (1)   This Determination is the National Health (Pharmaceutical Benefits — Therapeutic Groups) Determination 2010.
         (2)   This Determination may also be cited as PB 1 of 2010.
2              Commencement
                This Determination commences on the day after it is registered.
3              Revocation
                The Determination under subsection 84AG (1) of the Act made on 28 August 2009 (Instrument number PB 80 of 2009) is revoked.
4              Definitions
                In this Determination:
ACE inhibitor group means the Angiotensin converting enzyme inhibitor group.
Act means the National Health Act 1953.
ATRA group means the Angiotensin II receptor antagonist group.
Bisphosphonates osteoporosis group means the oral Bisphosphonates‑osteoporosis group.
Bisphosphonates Paget disease group means the oral Bisphosphonates‑Paget disease of bone group.
CCB group means the Dihydropyridine calcium-channel blocker group.
H2RA group means the H2 receptor antagonist group.
pharmaceutical benefits instrument means an instrument made under subsection 85 (2A) of the Act, as in force from time to time.
PPI group means the Proton pump inhibitor group.
Statins group means the HMG Co-A reductase inhibitor group.
Statins-HP group means the HMG Co-A reductase inhibitor higher potency group.
Venlafaxine group means the Venlafaxine and Venlafaxine derivative antidepressants group.
5              Therapeutic groups
                For paragraph 84AG (1) (a) of the Act, a therapeutic group is a group mentioned in a Part of Schedule 1.
6              Drugs in therapeutic groups
                For paragraph 84AG (1) (b) and subsection 84AG (2) of the Act, each listed drug mentioned in a Part of Schedule 1 is in the therapeutic group mentioned in the Part, in the circumstances (if any) mentioned in the Part.
Schedule 1        Therapeutic groups and listed drugs
(sections 5 and 6)
Part 1          ACE inhibitor group
Item
Listed drug

1
Captopril

2
Enalapril

3
Fosinopril

4
Lisinopril

5
Perindopril

6
Quinapril

7
Ramipril

8
Trandolapril

Part 2          ATRA group
Item
Listed drug

1
Candesartan

2
Eprosartan

3
Irbesartan

4
Olmesartan

5
Telmisartan

6
Valsartan

Part 3          CCB group
Item
Listed drug

1
Amlodipine

2
Felodipine

3
Lercanidipine

4
Nifedipine

Part 4          H2RA group
Item
Listed drug

1
Cimetidine

2
Famotidine

3
Nizatidine

4
Ranitidine

Part 5          PPI group
Item
Listed drug

1
Esomeprazole

2
Lansoprazole

3
Omeprazole

4
Pantoprazole

5
Rabeprazole

Part 6          Statins group
Item
Listed drug

1
Pravastatin

2
Simvastatin

Part 7          Statins-HP group
Item
Listed drug

1
Atorvastatin

2
Rosuvastatin

Part 8          Venlafaxine group
Item
Listed drug

1
Desvenlafaxine

2
Venlafaxine

Part 9          Bisphosphonates osteoporosis group
Item
Listed drug
Circumstances

1
Alendronic acid
   (a)  the manner of administration of the listed drug is oral administration; and
   (b)  the listed drug is in a pharmaceutical benefit in relation to which a pharmaceutical benefits instrument applies; and

2
Alendronic acid with colecalciferol

3
Risedronic acid

4
Risedronic acid and calcium

5
Risedronic acid and calcium with colecalciferol

 
 
   (c)  the circumstances, mentioned in the instrument, when a prescription for the supply of the pharmaceutical benefit may be written for the treatment of osteoporosis mentioned in the instrument

Part 10        Bisphosphonates Paget disease group
Item
Listed drug
Circumstances

1
Alendronic acid
   (a)  the manner of administration of the listed drug is oral administration; and
   (b)  the listed drug is in a pharmaceutical benefit in relation to which a pharmaceutical benefits instrument applies; and
   (c)  the circumstances, mentioned in the instrument, when a prescription for the supply of the pharmaceutical benefit may be written for the treatment of Paget disease of bone

2
Risedronic acid

3
Tiludronic acid

Note
1.       All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au.