National Health Act 1953 Amendment determinations under sections 85, 85A and 88 pharmaceutical benefits (No. PB 119 of 2009) (Cth)
COMMONWEALTH OF AUSTRALIA
Instrument number PB 119 of 2009
Amendment determinations under sections 85, 85A and 88 of the National Health Act 1953
I, LINDA JACKSON, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under sections 85, 85A and 88 of the National Health Act 1953.
Dated 4 December 2009
LINDA JACKSON
Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
Amendment determination — pharmaceutical benefits
1 Commencement
This instrument commences on 1 January 2010.
2 Amendment of PB 114 of 2008
Schedule 1 amends PB 114 of 2008.
Schedule 1 Amendments
Part 1 of Schedule 1, item dealing with Allopurinol in the forms Tablet 100 mg and Tablet 300 mg
omit from the column headed “Brand”: Allohexal
and substitute: Allopurinol Sandoz
Part 1 of Schedule 1, item dealing with Alprazolam in the form Tablet 500 micrograms
omit from the column headed “Brand”: Zamhexal 0.5mg
and insert in alphabetical order: Alprazolam Sandoz
Part 1 of Schedule 1, item dealing with Alprazolam in the form Tablet 1 mg
insert in alphabetical order in the column headed “Brand”: Alprazolam-GA
Part 1 of Schedule 1, item dealing with Alprazolam in the form Tablet 2 mg
omit from the column headed “Brand”: Alprazolam-DP
Part 1 of Schedule 1, item dealing with Amino acid formula without phenylalanine
omit from the columns in the order indicated:
| Bars 42 g, 20 (Phlexy-10) | Oral | 10 | 5 | Phlexy-10 |
Part 1 of Schedule 1, item dealing with Amino acid formula with vitamins and minerals without phenylalanine
omit from the columns in the order indicated:
| Oral powder 400 g (XP Analog) | Oral | 8 | 5 | XP Analog |
Part 1 of Schedule 1, item dealing with Captopril in the forms Tablet 12.5 mg, Tablet 25 mg and Tablet 50 mg
in the column headed “Brand” insert in alphabetical order: Zedace
Part 1 of Schedule 1, item dealing with Cephalexin in the forms Capsule 250 mg (anhydrous) and Capsule 500 mg (anhydrous)
omit from the column headed “Brand”: Cephalexin Max
Part 1 of Schedule 1, item dealing with Clomiphene
(a)omit from the column headed “Brand”: Clomhexal
(b)omit from the column headed “Brand”: Fermil
(c)omit from the column headed “Brand”: GenRx Clomiphene
Part 1 of Schedule 1, item dealing with Diazepam in the forms Tablet 2 mg and Tablet 5 mg
omit from the column headed “Brand”: Ducene
Part 1 of Schedule 1, item dealing with Glucose and Ketone Indicator―Urine
omit from the column headed “Form (strength, type, size, etc.)” the words: “Reagent strips” (two instances)
and substitute the words: “Test strips”
Part 1 of Schedule 1, omit item dealing with Glucose Indicator―Blood
and substitute:
| Glucose Indicator—Blood | Test strips, 25 (On-Call Plus) | For external use | 4 | 5 | On-Call Plus |
| Test strips, 50 (Accu-Chek Active) | For external use | 2 | 5 | Accu-Chek Active | |
| Test strips, 50 (Accu-Chek Go) | For external use | 2 | 5 | Accu-Chek Go | |
| Test strips, 51 (Accu-Chek Integra) | For external use | 2 | 5 | Accu-Chek Integra | |
| Test strips, 50 (Advantage II) | For external use | 2 | 5 | Advantage II | |
| Test strips, 50 (Betachek) | For external use | 2 | 5 | Betachek | |
| Test strips, 50 (Betachek G5) | For external use | 2 | 5 | Betachek G5 | |
| Test strips, 50 (CareSens) | For external use | 2 | 5 | CareSens | |
| Test strips, 50 (FreeStyle) | For external use | 2 | 5 | FreeStyle | |
| Test strips, 50 (Freestyle Papillon) | For external use | 2 | 5 | Freestyle Papillon | |
| Test strips, 50 (Glucoboy) | For external use | 2 | 5 | Glucoboy | |
| Test strips, 50 (Glucocard 01 Sensor) | For external use | 2 | 5 | Glucocard 01 Sensor | |
| Test strips, 50 (Glucoflex-R) | For external use | 2 | 5 | Glucoflex-R | |
| Test strips, 50 (GlucoOz) | For external use | 2 | 5 | GlucoOz | |
| Test strips, 50 (Glucostix) | For external use | 2 | 5 | Glucostix | |
| Test strips, 50 (Lifeline Attest) | For external use | 2 | 5 | Lifeline Attest | |
| Test strips, 50 (MWD Pen Sensor Strips) | For external use | 2 | 5 | MWD Pen Sensor Strips | |
| Test strips, 50 (MyGlucoHealth) | For external use | 2 | 5 | MyGlucoHealth | |
| Test strips, 50 (Omnitest EZ) | For external use | 2 | 5 | Omnitest EZ | |
| Test strips, 50 (Omnitest Plus) | For external use | 2 | 5 | Omnitest Plus | |
| Test strips, 50 (Optium Omega) | For external use | 2 | 5 | Optium Omega | |
| Test strips, 50 (SensoCard) | For external use | 2 | 5 | SensoCard | |
| Test strips, 50 (TrueTrack) | For external use | 2 | 5 | TrueTrack | |
| Test strips, 100 (Accu-Chek Performa) | For external use | 1 | 5 | Accu-Chek Performa | |
| Test strips, 100 (FreeStyle Lite) | For external use | 1 | 5 | FreeStyle Lite | |
| Test strips, 100 (Optium glucose) | For external use | 1 | 5 | Optium glucose | |
| Test strips, 100 (Precision Plus) | For external use | 1 | 5 | Precision Plus | |
| Test strips, 100 (SofTact) | For external use | 1 | 5 | SofTact |
Part 1 of Schedule 1, item dealing with Glucose Indicator―Urine
omit from the column headed “Form (strength, type, size, etc.)” the words: “Reagent strips” (two instances)
and substitute the words: “Test strips”
Part 1 of Schedule 1, item dealing with Paclitaxel in the form Solution concentrate for I.V. infusion 150 mg in 25 mL
omit from the column headed “Brand”: Taxol
Part 1 of Schedule 1, item dealing with Posaconazole
(a) omit from the column headed “Maximum quantity”: 1 and substitute: 6
(b) omit from the column headed “Maximum number of repeats”: 5 and substitute: 2
Part 1 of Schedule 1, item dealing with Sotalol in the form Tablet containing sotalol hydrochloride 80 mg
omit from the column headed “Brand”: Sotahexal
and substitute: Sotalol Sandoz
Part 1 of Schedule 1, item dealing with Voriconazole in the form Powder for oral suspension 40 mg per mL, 70 mL
(a) omit from the column headed “Maximum quantity”: 1 and substitute: 4
(b) omit from the column headed “Maximum number of repeats”: . . and substitute: 2
Part 2 of Schedule 1, item dealing with Adalimumab in the forms Injection 40 mg in 0.8 mL pre-filled syringe and Injection 40 mg in 0.8 mL pre-filled pen
omit from the column headed “Purposes” under the first instance of the heading “Rheumatoid arthritis”:
| (c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and |
and substitute:
| (c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide or cyclosporin, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and |
Part 2 of Schedule 1, item dealing with Cabergoline
insert in alphabetical order in the column headed “Brand”: Tinexa
Part 2 of Schedule 1, item dealing with Diazepam in the forms Tablet 2 mg and Tablet 5 mg
omit from the column headed “Brand”: Ducene
Part 2 of Schedule 1, item dealing with Etanercept in the forms Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL, Injections 50 mg in 1 mL single use pre-filled syringes, 4 and Injection 50 mg in 1 mL single use auto-injector, 4
a) omit from the column headed “Purposes” under the first instance of the heading “Rheumatoid arthritis”:
| (c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and |
and substitute:
| (c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide or cyclosporin, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and |
b) omit from the column headed “Purposes” under the third instance of the heading “Rheumatoid arthritis”:
| where the patient has failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, has failed to achieve an adequate response to methotrexate in combination with 2 other disease modifying anti-rheumatic drugs for a minimum of 3 months, and has subsequently failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or leflunomide in combination with methotrexate or cyclosporin alone, unless treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to the above treatment regimens; and |
and substitute:
| where the patient has failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, has failed to achieve an adequate response to methotrexate in combination with 2 other disease modifying anti-rheumatic drugs for a minimum of 3 months, and has subsequently failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide or cyclosporin, unless treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to the above treatment regimens; and |
Part 2 of Schedule 1, item dealing with Glucose and Ketone Indicator―Urine
omit from the column headed “Form (strength, type, size, etc.)” the words: “Reagent strips” (two instances)
and substitute the words: “Test strips”
Part 2 of Schedule 1, omit item dealing with Glucose Indicator―Blood
and substitute:
| Glucose Indicator—Blood | Test strips, 25 (On-Call Plus) | For use 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 | For external use | 4 | 11 | On-Call Plus |
| Test strips, 50 (Accu-Chek Active) | For use 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 | For external use | 2 | 11 | Accu-Chek Active | |
| Test strips, 50 (Accu-Chek Go) | For use 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 | For external use | 2 | 11 | Accu-Chek Go | |
| Test strips, 51 (Accu-Chek Integra) | For use 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 | For external use | 2 | 11 | Accu-Chek Integra | |
| Test strips, 50 (Advantage II) | For use 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 | For external use | 2 | 11 | Advantage II | |
| Test strips, 50 (Betachek) | For use 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 | For external use | 2 | 11 | Betachek | |
| Test strips, 50 (Betachek G5) | For use 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 | For external use | 2 | 11 | Betachek G5 | |
| Test strips, 50 (CareSens) | For use 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 | For external use | 2 | 11 | CareSens | |
| Test strips, 50 (FreeStyle) | For use 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 | For external use | 2 | 11 | FreeStyle | |
| Test strips, 50 (Freestyle Papillon) | For use 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 | For external use | 2 | 11 | Freestyle Papillon | |
| Test strips, 50 (Glucoboy) | For use 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 | For external use | 2 | 11 | Glucoboy | |
| Test strips, 50 (Glucocard 01 Sensor) | For use 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 | For external use | 2 | 11 | Glucocard 01 Sensor | |
| Test strips, 50 (Glucoflex-R) | For use 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 | For external use | 2 | 11 | Glucoflex-R | |
| Test strips, 50 (GlucoOz) | For use 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 | For external use | 2 | 11 | GlucoOz | |
| Test strips, 50 (Glucostix) | For use 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 | For external use | 2 | 11 | Glucostix | |
| Test strips, 50 (Lifeline Attest) | For use 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 | For external use | 2 | 11 | Lifeline Attest | |
| Test strips, 50 (MWD Pen Sensor Strips) | For use 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 | For external use | 2 | 11 | MWD Pen Sensor Strips | |
| Test strips, 50 (MyGlucoHealth) | For use 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 | For external use | 2 | 11 | MyGlucoHealth | |
| Test strips, 50 (Omnitest EZ) | For use 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 | For external use | 2 | 11 | Omnitest EZ | |
| Test strips, 50 (Omnitest Plus) | For use 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 | For external use | 2 | 11 | Omnitest Plus | |
| Test strips, 50 (Optium Omega) | For use 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 | For external use | 2 | 11 | Optium Omega | |
| Test strips, 50 (SensoCard) | For use 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 | For external use | 2 | 11 | SensoCard | |
| Test strips, 50 (TrueTrack) | For use 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 | For external use | 2 | 11 | TrueTrack | |
| Test strips, 100 (Accu-Chek Performa) | For use 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 | For external use | 1 | 11 | Accu-Chek Performa | |
| Test strips, 100 (FreeStyle Lite) | For use 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 | For external use | 1 | 11 | FreeStyle Lite | |
| Test strips, 100 (Optium glucose) | For use 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 | For external use | 1 | 11 | Optium glucose | |
| Test strips, 100 (SofTact) | For use 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 | For external use | 1 | 11 | SofTact |
Part 2 of Schedule 1, item dealing with Glucose Indicator―Urine
omit from the column headed “Form (strength, type, size, etc.)” the words: “Reagent strips” (two instances)
and substitute the words: “Test strips”
Part 1 of Schedule 2, item dealing with Diazepam in the forms Tablet 2 mg and Tablet 5 mg
omit from the column headed “Brand”: Ducene
Part 2 of Schedule 2, item dealing with Diazepam in the forms Tablet 2 mg and Tablet 5 mg
omit from the column headed “Brand”: Ducene
Part 1 of Schedule 3, item dealing with Cephalexin in the forms Capsule 250 mg (anhydrous) and Capsule 500 mg (anhydrous)
omit from the column headed “Brand”: Cephalexin Max
Part 1 of Schedule 3, item dealing with Diazepam in the forms Tablet 2 mg and Tablet 5 mg
omit from the column headed “Brand”: Ducene
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