EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 65 OF 2009
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER SECTION 85B
Purpose and operation
Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.
Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.
Drugs and medicinal preparations to which Part VII applies are (with the exception of some medicinal preparations with additives) declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1).
The Minister by legislative instrument can determine the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)); the manner of administration of the form of the listed drug so determined (subsection 85(5)); and a brand of the pharmaceutical item (defined in subsection 84(1)) that has the listed drug in that form with that manner of administration (subsection 85(6)). These determinations govern what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act. Under section 84AF, the Minister may determine a responsible person for a brand of a pharmaceutical item.
Subsection 85B(1) provides that the section applies if the Minister and the responsible person for a brand of pharmaceutical item have been unable to make a price agreement under section 85AD on an amount that is to be taken to be the appropriate maximum price for sales of the brand of pharmaceutical item to approved pharmacists.
Under subsection 85B(2), the Minister may by legislative instrument determine, by reference to a quantity or number of units of a pharmaceutical item, the amount that is taken to be the appropriated maximum price for sales of the brand of the pharmaceutical item to pharmacists.
Under subsection 85B(3), the Minister may by legislative instrument determine, by reference to a quantity or number of units, the amount that is taken to be the price claimed by the responsible person as the responsible person’s price for sales of the brand of the pharmaceutical item to approved pharmacists.
Subsection 85B(4) provides the special patient contribution for the brand of the pharmaceutical item is the difference between the “responsible person’s Commonwealth price” and the “Commonwealth price” for the brand of the pharmaceutical item. Subsection 85(6) defines these terms to the effect that the Special Patient Contribution is the difference between the Commonwealth price (worked out in accordance with the determination of the Pharmaceutical Benefits Remuneration Tribunal under subsection 98B(1)) based on the amount determined under subsection 85B(2) and what would be the Commonwealth price based on the amount determined under subsection 85B(3).
Under subsection 85B(5), the Minister having made a determination under subsection 85B(3) may by legislative instrument determine the circumstances in which the Commonwealth is to pay the special patient contribution for the brand of the pharmaceutical item.
This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends the determination under section 85B made by legislative instrument number PB 118 of 2008 which came into effect on 1 December 2008. The amendments are set out in the items of Schedule 1 to the instrument.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument, expressed to commence on 1 August 2009, was made on 6 July 2009.
Consultations
This instrument affects certain responsible persons with medicines listed on the PBS. If the Minister and responsible person cannot enter into a price agreement, consultation occurs between the responsible person and the Commonwealth and thereafter the Minister determines the price in relation to the relevant brand of pharmaceutical item and determines the price claimed by the responsible person as the responsible person's price for sales of the brand of pharmaceutical item to approved pharmacists.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 August 2009.
Paragraph 2: provides that Schedule 1 amends PB 118 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Brands with an increased brand premium | ||
Amlodipine | Tablet 10 mg (as besylate) | Norvasc |
Clomiphene | Tablet containing clomiphene citrate | Serophene |
Cyclosporin | Capsule 50 mg | Neoral 50 |
Indomethacin | Capsule 25 mg | Indocid |
Methyldopa | Tablet 250 mg | Aldomet |
Omeprazole | Tablet 20 mg (as magnesium) | Losec Tablets |
Brands with a decreased brand premium | ||
Alendronic Acid | Tablet 70 mg (as alendronate sodium) | Fosamax Once Weekly |
Aspirin | Tablet 100 mg | Astrix |
Betamethasone | Cream 200 micrograms (as valerate) per g, 100 g | Betnovate 1/5 |
Betamethasone | Cream 500 micrograms (as valerate) per g, 15 g | Betnovate 1/2 |
Betamethasone | Ointment 500 micrograms (as valerate) per g, 15 g | Betnovate 1/2 |
Betaxolol | Eye drops, solution, 5 mg (as hydrochloride) per mL, 5 mL | Betoptic |
Bisacodyl | Suppositories 10 mg, 10 | Dulcolax |
Brimonidine | Eye drops containing brimonidine tartrate 2 mg per mL, 5 mL | Alphagan |
Brinzolamide | Eye drops 10 mg per mL, 5 mL | Azopt |
Bupropion | Tablet containing bupropion hydrochloride 150 mg (sustained release) | Zyban |
Carbomer | Eye gel 2 mg per g, 10 g | Viscotears |
Cefotaxime | Powder for injection 1 g (as sodium) | Cefotaxime Sandoz |
Cefotaxime | Powder for injection 2 g (as sodium) | Cefotaxime Sandoz |
Clindamycin | Capsule 150 mg (as hydrochloride) | Dalacin C |
Colchicine | Tablet 500 micrograms | Colgout |
Cyclosporin | Capsule 25 mg | Neoral 25 |
Cyclosporin | Capsule 100 mg | Neoral 100 |
Dexamethasone with Framycetin and Gramicidin | Ear drops containing dexamethasone 500 micrograms (as sodium metasulfobenzoate), framycetin sulfate | Sofradex |
Digoxin | Tablet 62.5 micrograms | Lanoxin-PG |
Digoxin | Tablet 250 micrograms | Lanoxin |
Diphenoxylate with Atropine | Tablet containing diphenoxylate hydrochloride 2.5 mg with atropine sulfate 25 micrograms | Lomotil |
Escitalopram | Tablet 10 mg (as oxalate) | Lexapro |
Escitalopram | Tablet 20 mg (as oxalate) | Lexapro |
Felodipine | Tablet 2.5 mg (extended release) | Plendil ER |
Fluvastatin | Capsule 20 mg (as sodium) | Vastin |
Fluvastatin | Capsule 40 mg (as sodium) | Vastin |
Glibenclamide | Tablet 5 mg | Daonil |
Glipizide | Tablet 5 mg | Minidiab |
Glyceryl Trinitrate | Tablets 600 micrograms, 100 | Anginine Stabilised |
Hydrocortisone | Cream containing hydrocortisone acetate 10 mg per g, 30 g | Sigmacort |
Hydrocortisone | Cream containing hydrocortisone acetate 10 mg per g, 50 g | Cortef |
Hydrocortisone | Cream containing hydrocortisone acetate 10 mg per g, 50 g | Sigmacort |
Hydrocortisone | Ointment containing hydrocortisone acetate 10 mg per g, 30 g | Sigmacort |
Hydrocortisone | Ointment containing hydrocortisone acetate 10 mg per g, 50 g | Sigmacort |
Hypromellose | Eye drops 3 mg per mL, 15 mL | Genteal |
Hypromellose with Carbomer 980 | Ocular lubricating gel 3 mg-2 mg per g, 10 g | Genteal gel |
Hypromellose with Dextran | Eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL | Tears Naturale |
Imipramine | Tablet containing imipramine hydrochloride 10 mg | Tofranil 10 |
Imipramine | Tablet containing imipramine hydrochloride 25 mg | Tofranil 25 |
Isotretinoin | Capsule 20 mg | Roaccutane |
Ketoprofen | Capsule 200 mg (sustained release) | Orudis SR 200 |
Labetalol | Tablet containing labetalol hydrochloride 100 mg | Trandate |
Labetalol | Tablet containing labetalol hydrochloride 200 mg | Trandate |
Levodopa with Carbidopa | Tablet 100 mg-25 mg (anhydrous) | Sinemet 100/25 |
Levodopa with Carbidopa | Tablet 250 mg-25 mg (anhydrous) | Sinemet |
Levonorgestrel with Ethinyloestradiol | Tablets 150 micrograms-30 micrograms, 21 | Microgynon 30 |
Levonorgestrel with Ethinyloestradiol | Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets | Nordette 28 |
Levonorgestrel with Ethinyloestradiol | Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets | Microgynon 30 ED |
Levonorgestrel with Ethinyloestradiol | Pack containing 6 tablets 50 micrograms-30 micrograms, 5 tablets | Triphasil 28 |
Levonorgestrel with Ethinyloestradiol | Pack containing 6 tablets 50 micrograms-30 micrograms, 5 tablets | Triquilar ED |
Loperamide | Capsule containing loperamide hydrochloride 2 mg | Imodium |
Medroxyprogesterone | Tablet containing medroxyprogesterone acetate 5 mg | Provera |
Medroxyprogesterone | Tablet containing medroxyprogesterone acetate 10 mg | Provera |
Medroxyprogesterone | Injection containing medroxyprogesterone acetate 150 mg in 1 mL | Depo-Provera |
Meloxicam | Tablet 7.5 mg | Mobic |
Meloxicam | Tablet 15 mg | Mobic |
Methylprednisolone | Injection containing methylprednisolone acetate 40 mg in 1 mL | Depo-Medrol |
Mianserin | Tablet containing mianserin hydrochloride 10 mg | Tolvon |
Mianserin | Tablet containing mianserin hydrochloride 20 mg | Tolvon |
Norethisterone | Tablets 350 micrograms, 28 | Noriday 28 Day |
Norethisterone with Ethinyloestradiol | Tablets 500 micrograms-35 micrograms, 21 | Brevinor |
Norethisterone with Ethinyloestradiol | Pack containing 21 tablets 500 micrograms-35 micrograms and 7 inert tablets | Brevinor |
Norethisterone with Ethinyloestradiol | Tablets 1 mg-35 micrograms, 21 | Brevinor-1 |
Norethisterone with Ethinyloestradiol | Pack containing 21 tablets 1 mg- | Brevinor-1 |
Norethisterone with Ethinyloestradiol | Pack containing 12 tablets 500 micrograms-35 micrograms, 9 tablets | Synphasic |
Ondansetron | Tablet 4 mg (as hydrochloride dihydrate) | Zofran |
Ondansetron | Tablet 8 mg (as hydrochloride dihydrate) | Zofran |
Ondansetron | Wafer 4 mg | Zofran Zydis |
Ondansetron | Wafer 8 mg | Zofran Zydis |
Ondansetron | I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL | Zofran |
Ondansetron | I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL | Zofran |
Oxazepam | Tablet 15 mg | Serepax |
Oxazepam | Tablet 30 mg | Serepax |
Paraffin | Eye ointment, compound, containing white soft paraffin with liquid paraffin 3.5 g | Duratears |
Paraffin | Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g | Lacri-Lube |
Polyvinyl Alcohol | Eye drops 14 mg per mL, 15 mL | Liquifilm Tears |
Polyvinyl Alcohol | Eye drops 30 mg per mL, 15 mL | Liquifilm Forte |
Potassium Chloride | Tablet 600 mg (sustained release) | Slow-K |
Potassium Chloride with Potassium Bicarbonate | Tablet, effervescent, 14 mmol potassium and 8 mmol chloride | Chlorvescent |
Prednisone | Tablet 1 mg | Panafcort |
Prochlorperazine | Tablet containing prochlorperazine maleate 5 mg | Stemetil |
Quinine | Tablet containing quinine sulfate 300 mg | Quinate |
Sucralfate | Tablet equivalent to 1 g anhydrous sucralfate | Carafate |
Sulfasalazine | Tablet 500 mg (enteric coated) | Salazopyrin-EN |
Temazepam | Tablet 10 mg | Normison |
Thyroxine | Tablet containing 50 micrograms anhydrous thyroxine sodium | Oroxine |
Thyroxine | Tablet containing 75 micrograms anhydrous thyroxine sodium | Oroxine |
Thyroxine | Tablet containing 100 micrograms anhydrous thyroxine sodium | Oroxine |
Thyroxine | Tablet containing 200 micrograms anhydrous thyroxine sodium | Oroxine |
Tinidazole | Tablet 500 mg | Fasigyn |
Triamcinolone | Cream containing triamcinolone acetonide 200 micrograms per g, 100 g | Aristocort 0.02% |
Triamcinolone | Ointment containing triamcinolone acetonide 200 micrograms per g, 100 g | Aristocort 0.02% |
Triamcinolone with Neomycin, Gramicidin and Nystatin | Ear drops containing triamcinolone acetonide 1 mg with neomycin 2.5 mg (as sulfate), gramicidin 250 micrograms and nystatin 100,000 units per g, 7.5 mL | Kenacomb Otic |
Triamcinolone with Neomycin, Gramicidin and Nystatin | Ear ointment containing triamcinolone acetonide 1 mg with neomycin 2.5 mg (as sulfate), gramicidin 250 micrograms and nystatin 100,000 units per g, 5 g | Kenacomb Otic |
Valproic Acid | Tablet (enteric coated) containing sodium valproate 200 mg | Epilim EC |
Valproic Acid | Tablet (enteric coated) containing sodium valproate 500 mg | Epilim EC |
Brands with a price change but no change in brand premium | ||
Amlodipine | Tablet 5 mg (as besylate) | Norvasc |
Felodipine | Tablet 5 mg (extended release) | Plendil ER |
Felodipine | Tablet 10 mg (extended release) | Plendil ER |
Brands with an increased therapeutic group premium | ||
Lercanidipine | Tablet containing lercanidipine hydrochloride 10 mg | Zanidip |
Lercanidipine | Tablet containing lercanidipine hydrochloride 20 mg | Zanidip |
Brands with a decreased special patient contribution | ||
Bleomycin | Powder for injection containing bleomycin sulfate 15,000 I.U. (with any determined brand of sodium chloride injection as the required solvent) | Blenamax |
Bleomycin | Powder for injection containing bleomycin sulfate 15,000 I.U. (with any determined brand of sodium chloride injection as the required solvent) | Blenoxane |
Bleomycin | Powder for injection containing bleomycin sulfate 15,000 I.U. (with any determined brand of sodium chloride injection as the required solvent) | Hospira Pty Limited |