EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (PRICE AND SPECIAL PATIENT CONTRIBUTION) AMENDMENT DETERMINATION 2016 (No. 9)
PB 98 of 2016
Authority
This legislative instrument, made under section 85B of the National Health Act 1953 (the Act) amends the National Health (Price and Special Patient Contribution) Determination 2010 (PB 109 of 2010) (the Principal Determination).
Subsections 85B(2), (3) and (4) of the National Health Act 1953 (the Act) provide for the Minister to determine, respectively, determined prices, claimed prices and the circumstances in which the Commonwealth will pay a special patient contribution. The Principal Determination contains determinations of these matters.
Variation and revocation
Unless there is an express power to revoke or vary PB 109 of 2010 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 109 of 2010.
Purpose
The Act provides for the Minister and the responsible person to agree a price that is taken to be the appropriate maximum price of a brand of a pharmaceutical item for the purposes of Part VII of the Act (section 85AD). Section 85B of the Act applies if the Minister and the responsible person have been unable to reach an agreement on a price for the pricing quantity. Whether or not an agreement is made for the pricing quantity, section 85B also applies if the responsible person is dissatisfied with the proportional ex-manufacturer prices that will apply to other pack quantities.
Subsection 85B(2) provides that the Minister may determine, by reference to the pricing quantity of a brand of a pharmaceutical item, an amount that is taken to be the appropriate maximum price of the brand for the purposes of Part VII of the Act. This is termed the ‘Determined Price’ in this Determination.
Subsection 85B(3) provides that the Minister may determine, by reference to a pack quantity of a brand of the pharmaceutical item, an amount that is taken to be the price claimed by the responsible person for the pack quantity of the brand, for the purposes of Part VII of the Act. This is termed the ‘Claimed Price’ in this Determination.
The Determined Price is the approved ex-manufacturer price and is used as the basis for working out the Commonwealth price for the brand of the pharmaceutical item (section 98B of the Act); for pack quantities other than the pricing quantity, the proportional ex-manufacturer price is used as the basis. Approved pharmacists are entitled to payment from the Commonwealth equal to the Commonwealth price less the applicable patient co-payment (section 99 of the Act).
The difference between the responsible person’s Commonwealth price for a pack quantity (ie, the price that would be the Commonwealth price if the responsible person’s claimed price had become the approved ex-manufacturer price or the proportional ex-manufacturer price for that pack quantity) and the Commonwealth price for the pack quantity is defined in subsection 85B(5) of the Act as the special patient contribution. An approved pharmacist may charge a patient an amount equal to the special patient contribution, in addition to any other amount that may be charged (subsection 87(2A) of the Act).
Subsection 85B(4) of the Act provides that the Minister may determine the circumstances in which the Commonwealth is to pay the special patient contribution for a brand. In such cases, the Commonwealth payment to the pharmacist is increased by the amount of the special patient contribution (subsection 99(2AA) of the Act) and the pharmacist may not charge the patient this amount (subsection 87(2A) of the Act).
The purpose of making subsection 85B(4) determinations is to enable patients for whom the base-priced brands (the ones without a special patient contribution) are not suitable, to obtain the higher priced brand (the one with the special patient contribution) without the need to pay the higher price. In such cases the Commonwealth pays the special patient contribution.
This instrument (the Amending Determination) amends the Principal Determination by: adding a new brand premium to 29 brands of pharmaceutical items and increases, decreases or maintains brand premiums to other brands of pharmaceutical items. It also removes two brands of pharmaceutical items that no longer have a premium. In addition, two brands of pharmaceutical items are changing their premium status from a therapeutic group premium to a brand premium.
Consultation
This determination affects certain responsible persons with medicines listed on the PBS. Before a pharmaceutical benefit is listed on the PBS, and from time to time thereafter, price negotiations occur between the responsible person and the Minister for the purpose of reaching a price agreement for section 85AD of the Act. Consultation was considered unnecessary (or inappropriate) because this instrument essentially involves a price negotiation between the Minister (or delegate) and the responsible persons.
A provision by provision description of the Amending Determination is contained in the Attachment.
This Determination commences on 1 December 2016.
This Determination is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (PRICE AND SPECIAL PATIENT CONTRIBUTION) AMENDMENT DETERMINATION 2016 (No. 9)
(PB 98 of 2016)
Section 1 Name of Determination
This section provides that the Determination is the National Health (Price and Special Patient Contribution) Amendment Determination 2016 (No. 9) and may also be cited as PB 98 of 2016.
Section 2 Commencement
This section provides that the Determination commences on 1 December 2016.
Section 3 Amendment of the National Health (Price and Special Patient Contribution) Determination 2010 (PB 109 of 2010).
This section provides that Schedule 1 amends the National Health (Price and Special Patient Contribution) Determination 2010 (PB 109 of 2010).
Schedule 1 Amendments commencing 1 December 2016
Schedule 1 sets out the amendments to the Principal Determination which commence on 1 December 2016.
SUMMARY OF CHANGES
SCHEDULE 1
Brands with an increased brand premium
Alendronic acid with colecalciferol | Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol | Fosamax Plus |
| Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol | Fosamax Plus 70 mg/140 mcg |
Alendronic acid with colecalciferol and calcium | Pack containing 4 tablets containing alendronic acid 70 mg (as alendronate sodium) with 140 micrograms colecalciferol and 48 tablets calcium 500 mg (as carbonate) | Fosamax Plus D-Cal |
Betaxolol | Eye drops, solution, 5 mg (as hydrochloride) per ml, 5 mL | Betoptic |
Bisoprolol | Tablet containing bisoprolol fumarate 2.5 mg | Bicor |
| Tablet containing bisoprolol fumarate 5 mg | Bicor |
| Tablet containing bisoprolol fumarate 10 mg | Bicor |
Brinzolamide | Eye drops 10 mg per mL, 5 mL | Azopt |
Candesartan | Tablet containing candesartan cilexetil 4 mg | Atacand |
| Tablet containing candesartan cilexetil 8 mg | Atacand |
| Tablet containing candesartan cilexetil 16 mg | Atacand |
| Tablet containing candesartan cilexetil 32 mg | Atacand |
Candesartan with Hydrochlorothiazide | Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg | Atacand Plus 16/12.5 |
| Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg | Atacand Plus 32/12.5 |
| Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg | Atacand Plus 32/25 |
Captopril | Tablet 12.5 mg | Zedace |
| Tablet 25 mg | Capoten |
|
| Zedace |
| Tablet 50 mg | Capoten |
|
| Zedace |
Ciprofloxacin | Eye drops 3 mg (as hydrochloride) per mL, 5 mL | Ciloxan |
Citalopram | Tablet 20 mg (as hydrobromide) | Cipramil |
Clomipramine | Tablet containing clomipramine hydrochloride 25 mg | Anafranil 25 |
Diclofenac | Tablet (enteric coated) containing diclofenac sodium 25 mg | Voltaren 25 |
| Tablet (enteric coated) containing diclofenac sodium 50 mg | Voltaren 50 |
Enalapril | Tablet containing enalapril maleate 10 mg | Renitec |
| Tablet containing enalapril maleate 20 mg | Renitec 20 |
Escitalopram | Tablet 10 mg (as oxalate) | Lexapro |
| Tablet 20 mg (as oxalate) | Lexapro |
Glimepiride | Tablet 1 mg | Amaryl |
| Tablet 2 mg | Amaryl |
| Tablet 3 mg | Amaryl |
| Tablet 4 mg | Amaryl |
Hypromellose | Eye drops 3 mg per mL, 15 mL | Genteal |
Hypromellose with Carbomer 980 | Ocular lubricating gel 3 mg-2mg per g, 10 g | Genteal gel |
Indapamide | Tablet containing indapamide hemihydrate 2.5 mg | Natrilix |
Irbesartan | Tablet 75 mg | Avapro |
|
| Karvea |
| Tablet 150 mg | Avapro |
|
| Karvea |
| Tablet 300 mg | Avapro |
|
| Karvea |
Irbesartan with hydrochlorothiazide | Tablet 150 mg-12.5 mg | Avapro HCT 150/12.5 |
|
| Karvezide 150/12.5 |
| Tablet 300 mg-12.5 mg | Avapro HCT 300/12.5 |
|
| Karvezide 300/12.5 |
| Tablet 300 mg-25 mg | Avapro HCT 300/25 |
|
| Karvezide 300/25 |
Metformin | Tablet containing metformin hydrochloride 500 mg | Diabex |
| Tablet (extended release) containing metformin hydrochloride 500 mg | Diabex XR |
| Tablet containing metformin hydrochloride 850 mg | Diabex 850 |
| Tablet containing metformin hydrochloride 1 g | Diabex 1000 |
| Tablet (extended release) containing metformin hydrochloride 1 g | Diabex XR 1000 |
Metoprolol | Tablet containing metoprolol tartrate 50 mg | Betaloc |
| Tablet containing metoprolol tartrate 100 mg | Betaloc |
Mirtazapine | Tablet 15 mg (orally disintegrating) | Avanza SolTab |
| Tablet 30 mg (orally disintegrating) | Avanza SolTab |
| Tablet 45 mg (orally disintegrating) | Avanza SolTab |
Montelukast | Tablet, chewable, 4 mg (as sodium) | Singulair |
Nizatidine | Capsule 150 mg | Tazac |
| Capsule 300 mg | Tazac |
Paroxetine | Tablet 20 mg (as hydrochloride) | Aropax |
Perindopril | Tablet containing perindopril arginine 2.5 mg | Coversyl 2.5mg |
Perindopril with amlodipine | Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besylate) | Coveram 5/5 |
| Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besylate) | Coveram 5/10 |
| Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besylate) | Coveram 10/5 |
| Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besylate) | Coveram 10/10 |
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 80mg | Pravachol |
Prochlorperazine | Tablet containing prochlorperazine maleate 5 mg | Stemetil |
Simvastatin | Tablet 10 mg | Lipex 10 |
|
| Zocor |
| Tablet 20 mg | Lipex 20 |
|
| Zocor |
| Tablet 40 mg | Lipex 40 |
|
| Zocor |
| Tablet 80 mg | Lipex 80 |
|
| Zocor |
Sotalol | Tablet containing sotalol hydrochloride 80 mg | Sotacor |
| Tablet containing sotalol hydrochloride 160 mg | Sotacor |
Sumatriptan | Tablet 50 mg (as succinate) | Imigran |
| Tablet 50 mg (as succinate) | Imigran |
| Tablet (fast disintegrating) 50 mg (as succinate) (Pricing Quantity 2) | Imigran FDT |
| Tablet (fast disintegrating) 50 mg (as succinate) (Pack Quantity 4) | Imigran FDT |
Telmisartan | Tablet 40 mg | Micardis |
| Tablet 80 mg | Micardis |
Telmisartan with amlodipine | Tablet 40 mg-5 mg (as besylate) | Twynsta |
| Tablet 40 mg-10 mg (as besylate) | Twynsta |
| Tablet 80 mg-5 mg (as besylate) | Twynsta |
| Tablet 80 mg-10 mg (as besylate) | Twynsta |
Telmisartan with hydrochlorothiazide | Tablet 40 mg-12.5 mg | Micardis Plus 40/12.5 mg |
| Tablet 80 mg-12.5 mg | Micardis Plus 80/12.5 mg |
| Tablet 80 mg-25 mg | Micardis Plus 80/25 mg |
Trimethoprim | Tablet 300 mg | Triprim |
Trimethoprim with Sulfamethoxazole | Paediatric oral suspension 40 mg-200 mg per 5 mL, 100 mL | Septrin |
| Tablet 160 mg-800 mg | Septrin Forte |
Valproic Acid | Tablet (enteric coated) containing sodium valproate 200 mg | Epilim EC |
| Tablet (enteric coated) containing sodium valproate 500 mg | Epilim EC
|
Brands with a price change and no change to brand premium
| ||
Allopurinol | Tablet 100 mg (Pack Quantity 200) | Zyloprim |
| Tablet 300 mg | Zyloprim |
Amoxycillin | Capsule 250 mg (as trihydrate) | Amoxil |
| Capsule 500 mg (as trihydrate) | Amoxil |
| Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL | Amoxil |
| Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL | Amoxil Forte |
Amoxycillin with Clavulanic Acid | Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL | Augmentin |
| Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL | Augmentin Duo 400 |
| Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | Augmentin Duo |
Cefaclor | Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL | Ceclor |
| Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL | Ceclor |
Cephalexin | Capsule 250 mg (anhydrous) | Keflex |
| Capsule 500 mg (anhydrous) | Keflex |
| Granules for oral suspension 125 mg per 5 mL, 100 mL | Keflex |
| Granules for oral suspension 250 mg per 5 mL, 100 mL | Keflex |
Diazepam | Tablet 5 mg | Valium |
Doxycycline | Capsule 100 mg (as hydrochloride) (containing enteric coated pellets) (Pricing quantity 7) | Doryx |
|
| Mayne Pharma Doxycycline |
| Capsule 100 mg (as hydrochloride) (containing enteric coated pellets) (Pricing quantity 21) | Doryx |
|
| Mayne Pharma Doxycycline |
| Capsule 50 mg (as hydrochloride) (containing enteric coated pellets) | Doryx |
|
| Mayne Pharma Doxycycline |
Frusemide | Tablet 20 mg | Lasix-M |
| Tablet 40 mg | Lasix |
Isosorbide Mononitrate | Tablet 60 mg (sustained release) | Imdur Durule |
|
| Monodur 60 mg |
Labetalol | Tablet containing labetalol hydrochloride 100 mg | Trandate |
Lamotrigine | Tablet 5 mg | Lamictal |
Moclobemide | Tablet 150 mg | Aurorix |
| Tablet 300 mg | Aurorix 300 mg |
Roxithromycin | Tablet 150 mg | Rulide |
| Tablet 300 mg | Rulide |
Temazepam | Tablet 10 mg | Normison |
Tramadol | Capsule containing tramadol hydrochloride 50 mg | Tramal
|
|
|
|
Brands with a price change and an increase to brand premium
| ||
Amoxycillin | Tablet 1 g (as trihyrate) | Maxamox |
Carbamazepine | Tablet 100 mg | Tegretol 100 |
Codeine with Paracetamol | Tablet containing codeine phosphate 30 mg with paracetamol 500 mg | Panadeine Forte |
Salbutamol | Pressurised inhalation 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation) | Ventolin CFC-free |
Brand with a price change and a decrease to brand premium
| ||
Clarithromycin | Tablet 250 mg | Klacid |
|
|
|
Brands with a new brand premium
| ||
Alendronic acid with colecalciferol | Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol | Dronalen Plus |
Alendronic acid with colecalciferol and calcium | Pack containing 4 tablets containing alendronic acid 70 mg (as alendronate sodium) with 140 micrograms colecalciferol and 48 tablets calcium 500 mg (as carbonate) | Dronalen Plus D-Cal |
Diltiazem | Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg | Cardizem CD |
| Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg | Cardizem CD |
| Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg | Cardizem CD |
| Tablet containing diltiazem hydrochloride 60 mg | Cardizem |
|
| Vasocardol |
Enalapril with Hydrochlorothiazide | Tablet containing enalapril maleate 20 mg with hydrochlorothiazide 6 mg | Renitec Plus 20/6 |
Lamivudine | Tablet 100 mg | Zeffix |
Levonorgestrel with Ethinyloestradiol | Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets | Levlen ED |
Mirtazapine | Tablet 15 mg (orally disintegrating) | Remeron SolTab |
| Tablet 30 mg (orally disintegrating) | Remeron SolTab |
| Tablet 45 mg (orally disintegrating) | Remeron SolTab |
Nizatidine | Capsule 150 mg | Nizac |
| Capsule 300 mg | Nizac |
Ondansetron | Wafer 4 mg (Pricing quantity 4) | Zofran Zydis |
| Wafer 4 mg (Pack quantity 10) | Zofran Zydis |
| Wafer 8 mg (Pricing quantity 4) | Zofran Zydis |
| Wafer 8 mg (Pack quantity 10) | Zofran Zydis |
Perindopril | Tablet containing perindopril arginine 5 mg | Coversyl 5mg |
| Tablet containing perindopril arginine 10 mg | Coversyl 10mg |
Perindopril with Indapamide | Tablet containing perindopril arginine 5 mg with indapamide hemihydrate 1.25 mg | Coversyl Plus 5mg/1.25mg |
Potassium Chloride | Tablet 600 mg (sustained release) | Slow-K |
Propranolol | Tablet containing propranolol hydrochloride 10 mg | Deralin 10 |
| Tablet containing propranolol hydrochloride 40 mg | Deralin 40 |
Rabeprazole | Tablet containing rabeprazole sodium 10 mg (enteric coated) | Pariet |
| Tablet containing rabeprazole sodium 20 mg (enteric coated) | Pariet |
Valaciclovir | Tablet 500 mg (as hydrochloride) (Pricing quantity 10) | Valtrex |
| Tablet 500 mg (as hydrochloride) (Pack quantity 30) | Valtrex |
| Tablet 500 mg (as hydrochloride) (Pack quantity 42) | Valtrex |
| Tablet 500 mg (as hydrochloride) (Pack quantity 100) | Valtrex |
|
|
|
Brands changing their premium status from a therapeutic group premium to a brand premium | ||
|
|
|
Olmesartan | Tablet containing olmesartan medoxomil 20 mg | Olmetec |
| Tablet containing olmesartan medoxomil 40 mg | Olmetec |
|
|
|
Brand that no longer has a brand premium | ||
|
|
|
Codeine with Paracetamol | Tablet containing codeine phosphate 30 mg with paracetamol 500 mg | Codapane Forte |
Perindopril | Tablet containing perindopril arginine 2.5 mg | PREXUM 2.5 |
|
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Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Price and Special Patient Contribution) Amendment Determination 2016 (No. 9) (PB 98 of 2016)
This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Legislative Instrument
This legislative instrument, made under section 85B of the National Health Act 1953 (the Act), amends the National Health (Price and Special Patient Contribution) Determination 2010 (the Principal Determination), which provides for price determinations in relation to brands of pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS) for which the Minister and the responsible person have not been able to make a price agreement. It also provides for the circumstances in which the Commonwealth will pay the special patient contribution resulting from these price determinations. This instrument (the Amending Determination) amends the Principal Determination by: adding a new brand premium to 29 brands of pharmaceutical items and increases, decreases or maintains brand premiums to other brands of pharmaceutical items. It also removes two brands of pharmaceutical items that no longer have a premium. In addition, two brands of pharmaceutical items are changing their premium status from a therapeutic group premium to a brand premium.
Human rights implications
This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
The PBS is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based.
Conclusion
This Legislative Instrument is compatible with human rights because it advances the protection of human rights.
Penny Shakespeare
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health