EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 72 OF 2010
NATIONAL HEALTH ACT 1953
DETERMINATION UNDER SECTION 85B
Summary
This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) revokes and replaces the determination under section 85B made by legislative instrument number PB 18 of 2010 which came into effect on
1 April 2010. The instrument determines prices of listed drugs or brands of listed drugs on the Pharmaceutical Benefits Scheme which are subject to a special patient contribution, therapeutic group premium or brand premium.
The changes made in this instrument since the last amendment to the previous instrument are set out in the Summary of Changes.
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.
A provision-by-provision description of this instrument is contained in Attachment 1.
This instrument (No. PB 72 of 2010) is made under section 85B of the Act and revokes the instrument previously made under section 85B of the Act (No. PB 18 of 2010). The previous instrument was made on 3 March 2010, commenced on 1 April 2010 and was the subject of regular amendments, the last of which commenced on 1 July 2010.
Many of the matters determined under this instrument are the same as under the previous instrument, as amended up to 1 July 2010. The changes made in this instrument to matters determined under section 85B of the Act since the last amendment to the previous instrument, are set out in Attachment 2 to this Explanatory Statement and is titled Summary of Changes.
This instrument, expressed to commence on 1 August 2010, was made on 5 July 2010.
Consultations
This instrument affects 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 to determine 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 1
Paragraph 1 provides that this instrument commences on 1 August 2010.
Paragraph 2 provides that instrument number PB 18 of 2010 is repealed.
Paragraph 3 defines the term “authority prescription”.
Paragraph 4 determines that the amount for the purposes of subsection 85B(2) is that for a brand of pharmaceutical item mentioned in the column under “Determined price” in
Schedule 1.
Paragraph 5 determines that the amount for the purposes of subsection 85B(3) is that mentioned for a brand of pharmaceutical item in the column under “Claimed price” in Schedule 1.
Paragraph 6 determines that the circumstances for the purposes of subsection 85B(5) in which the Commonwealth will pay the special contribution for a brand of pharmaceutical item mentioned in Schedule 2 is that it has been supplied on an authority prescription. The latter term is defined in paragraph 3 in terms of a prescription approved by the CEO of Medicare Australia in accordance with a determination under subsection 85A(2).
Schedule 1 to the determination lists those pharmaceutical benefits to which section 85B applies, the form (strength, type, size etc.), the brand, the pack size, the price to pharmacist that the Government is prepared to pay and the price to pharmacist that the manufacturer requires.
Schedule 2 to the determination lists those pharmaceutical benefits to which subsection 85B(5) applies, the form (strength, type, size etc.) and the brand.
ATTACHMENT 2
SUMMARY OF CHANGES
Brands with an increased brand premium | ||
Allopurinol | Tablet 100 mg | Zyloprim |
| Tablet 300 mg | Zyloprim |
Captopril | Tablet 25 mg | Capoten |
| Tablet 50 mg | Capoten |
Enalapril | Tablet containing enalapril maleate 5 mg | Renitec M |
| Tablet containing enalapril maleate 10 mg | Renitec |
| Tablet containing enalapril maleate 20 mg | Renitec |
Famotidine | Tablet 20 mg | Pepcidine M |
Lisinopril | Tablet 5 mg | Prinivil 5 |
| Tablet 10 mg | Prinivil 10 |
| Tablet 20 mg | Prinivil 20 |
Minocycline | Tablet 50 mg (as hydrochloride) | Minomycin-50 |
Norfloxacin | Tablet 400 mg | Noroxin |
Pravastatin | Tablet containing pravastatin sodium 10 mg | Pravachol |
| Tablet containing pravastatin sodium 20 mg | Pravachol |
| Tablet containing pravastatin sodium 40 mg | Pravachol |
| Tablet containing pravastatin sodium 80 mg | Pravachol |
Simvastatin | Tablet 5 mg | Zocor |
| Tablet 10 mg | Zocor |
| Tablet 10 mg | Lipex 10 |
| Tablet 20 mg | Zocor |
| Tablet 20 mg | Lipex 20 |
| Tablet 40 mg | Zocor |
| Tablet 40 mg | Lipex 40 |
| Tablet 80 mg | Zocor |
| Tablet 80 mg | Lipex 80 |
Temazepam | Tablet 10 mg | Normison |
Timolol | Eye drops 2.5 mg (as maleate) per mL, 5 mL | Timoptol |
| Eye drops 5 mg (as maleate) per mL, 5 mL | Timoptol |
Trimethoprim | Tablet 300 mg | Triprim |
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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 |
| Cream 500 micrograms (as valerate) per g, 15 g | Betnovate 1/2 |
| Ointment 500 micrograms (as valerate) per g, 15 g | Betnovate 1/2 |
Betaxolol | Eye drops, solution, 5 mg (as hydrochloride) per 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 |
Clindamycin | Capsule 150 mg (as hydrochloride) | Dalacin C |
Colchicine | Tablet 500 micrograms | Colgout |
Cyclosporin | Capsule 25 mg | Neoral 25 |
| Capsule 50 mg | Neoral 50 |
| Capsule 100 mg | Neoral 100 |
Dexamethasone with Framycetin and Gramicidin | Ear drops containing dexamethasone 500 micrograms (as sodium metasulfobenzoate), framycetin sulfate 5 mg and gramicidin 50 micrograms per mL, 8 mL | Sofradex |
Digoxin | Tablet 62.5 micrograms | Lanoxin-PG |
| 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 |
| Tablet 20 mg (as oxalate) | Lexapro |
Fluvastatin | Capsule 20 mg (as sodium) | Vastin |
| 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 | Sigamcort |
| Cream containing hydrocortisone acetate 10 mg per g, 50 g | Sigmacort |
| Ointment containing hydrocortisone acetate 10 mg per g, 30 g | Sigmacort |
| 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 |
| 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 |
| Tablet containing labetalol hydrochloride 200 mg | Trandate |
Levodopa with Carbidopa | Tablet 100 mg-25 mg (anhydrous) | Sinemet 100/25 |
| Tablet 250 mg-25 mg (anhydrous) | Sinemet |
Levonorgestrel with Ethinyloestradiol | Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets | Nordette 28 Microgynon 30 ED |
| Pack containing 6 tablets 50 micrograms-30 micrograms, 5 tablets 75 micrograms-40 micrograms, 10 tablets 125 micrograms-30 micrograms and 7 inert tablets | Triphasil 28 |
| Pack containing 6 tablets 50 micrograms-30 micrograms, 5 tablets 75 micrograms-40 micrograms, 10 tablets 125 micrograms-30 micrograms and 7 inert tablets | Triquilar ED |
Loperamide | Capsule containing loperamide hydrochloride 2 mg | Imodium |
Medroxyprogesterone | Tablet containing medroxyprogesterone acetate 5 mg | Provera |
| Tablet containing medroxyprogesterone acetate 10 mg | Provera |
| Injection containing medroxyprogesterone acetate 150 mg in 1 mL | Depo-Provera |
Meloxicam | Tablet 7.5 mg | Mobic |
| Tablet 15 mg | Mobic |
Methylprednisolone | Injection containing methylprednisolone acetate 40 mg in 1 mL | Depo-Medrol |
Mianserin | Tablet containing mianserin hydrochloride 10 mg | Tolvon |
| 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 |
| Pack containing 21 tablets 500 micrograms-35 micrograms and 7 inert tablets | Brevinor |
| Tablets 1 mg-35 micrograms, 21 | Brevinor-1 |
| Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets | Brevinor-1 |
| Pack containing 12 tablets 500 micrograms-35 micrograms, 9 tablets 1mg-35 micrograms and 7 inert tablets | Synphasic |
Oxazepam | Tablet 15 mg | Serepax |
| Tablet 30 mg | Serepax |
Paraffin | Eye ointment, compound, containing white soft paraffin with liquid paraffin 3.5 g | Duratears |
| 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 |
| Eye drops 30 mg per mL, 15 mL | Liquifilm Forte |
Potassium Chloride | Tablet 600 mg (sustained release) | Slow-K |
Prochlorperazine | Tablet containing prochlorperazine maleate 5 mg | Stemetil |
Sucralfate | Tablet equivalent to 1 g anhydrous sucralfate | Carafate |
Sulfasalazine | Tablet 500 mg (enteric coated) | Salazopyrin-EN |
Thyroxine | Tablet containing 50 micrograms anhydrous thyroxine sodium | Oroxine |
| Tablet containing 75 micrograms anhydrous thyroxine sodium | Oroxine |
| Tablet containing 100 micrograms anhydrous thyroxine sodium | Oroxine |
| 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% |
| 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, 7.5mL | Kenacomb Otic |
| 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 |
| Tablet (enteric coated) containing sodium valproate 400 mg | Epilim EC |
Brands with a price change but no change in brand premium | ||
Felodipine | Tablet 2.5 mg (extended release) | Plendil ER |
| Tablet 5 mg (extended release) | Plendil ER |
| Tablet 10 mg (extended release) | Plendil ER |
Hydrocortisone | Cream containing hydrocortisone acetate 10 mg per g, 50 g | Cortef |
Prednisone | Tablet 1 mg | Panafcort |
Brands with an increased therapeutic group premium | ||
Lercanidipine | Tablet containing lercanidipine hydrochloride 10 mg | Zanidip |
| 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 |
| Powder for injection containing bleomycin sulfate 15,000 I.U. (with any determined brand of sodium chloride injection as the required solvent) | Blenoxane |
| Powder for injection containing bleomycin sulfate 15,000 I.U. (with any determined brand of sodium chloride injection as the required solvent) | HH |
New brands with brand premiums | ||
Sotalol | Tablet containing sotalol hydrochloride 80 mg | Sotacor |
| Tablet containing sotalol hydrochloride 160 mg | Sotacor |
Colchicine | Tablets 500 micrograms, 30 | Colgout |
Deletion of brand | ||
Levonorgestrel with Ethinyloestradiol | Tablets 150 micrograms-30 micrograms, 21 | Microgynon 30 |