EXPLANATORY STATEMENT
National Health Act 1953
National Health (Price and Special Patient Contribution)
Amendment Determination 2012 (No. 3)
PB 28 of 2012
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).
The Principal Determination provides for price determinations in relation to brands of pharmaceutical items 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.
Purpose
The Act provides for the Minister and the responsible person to agree a price that is taken to be the appropriate maximum price for sales of a brand of a pharmaceutical item to approved pharmacists (section 85AD). Section 85B of the Act applies if the Minister and the responsible person have been unable to reach an agreement.
Subsection 85B(2) provides that the Minister may determine an amount that is taken to be the appropriate maximum price for sales of a brand of a pharmaceutical item to approved pharmacists. This is termed the ‘Determined Price’.
Subsection 85B(3) provides that the Minister may determine an amount that is taken to be the price claimed by the responsible person as the appropriate maximum price for sales of the brand of the pharmaceutical item to approved pharmacists. This is termed the ‘Claimed Price’.
The Determined Price is the approved price to pharmacists (subsection 98B(3) of the Act) and is used as the basis for working out the Commonwealth price for the brand of the pharmaceutical item (subsection 98B(2) of the Act). 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 (ie, the price that would be the Commonwealth price if the responsible person’s claimed price had become the approved price to pharmacists) and the Commonwealth price for the brand is defined in subsection 85B(4) 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 applicable patient co-payment (subsection 87(2A) of the Act).
Subsection 85B(5) of the Act provides that the Minister may determine the circumstances in which the Commonwealth, rather than the patient, is to pay the special patient contribution for a brand of a pharmaceutical item.
This instrument (the Amending Determination) amends the Principal Determination by: adding one new brand premium and reflecting for plain English reasons the price change and decrease to multiple existing brand premiums which took legal effect on 1 April 2012 due to price disclosure reductions.
Consultation
The Amending 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. If the Minister and the responsible person cannot agree on a price, further consultation occurs with the responsible person, and thereafter the Minister determines the price that will be the approved price to pharmacists for the brand. The Minister also determines the corresponding price claimed by the responsible person which is used to calculate the special patient contribution that will apply to the brand.
A provision by provision description of the Amending Determination is contained in Attachment 1.
The Amending Determination commences on 1 May 2012.
This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT 1
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (PRICE AND SPECIAL PATIENT CONTRIBUTION) AMENDMENT DETERMINATION 2012 (No.3)
Section 1 Name of Instrument
This section provides that this Amending Determination is the National Health (Price and Special Patient Contribution) Amendment Determination 2012 (No. 3) and may also be cited as PB 28 of 2012.
Section 2 Commencement
This section provides that the Amendment Determination commences on 1 May 2012.
Section 3 Amendment of PB 109 of 2010
This section provides that Schedule 1 of the Amending Determination amend the determination under section 85B of the Act, the National Health (Price and Special Patient Contribution) Determination 2010 (PB 109 of 2010).
Schedule 1 Amendments commencing 1 May 2012
Schedule 1 sets out the amendments to the Principal Determination which commence on 1 May 2012 (Attachment 2).
ATTACHMENT 2
SUMMARY OF CHANGES
SCHEDULE 1
Brand with a new brand premium
Bleomycin | Powder for injection containing bleomycin sulphate 15,000 I.U. | Bleo 15K |
Brands with a price change and a decreased brand premium
Alendronic Acid | Tablet 70 mg (as alendronate sodium) | Fosamax Once Weekly |
Alprazolam | Tablet 250 micrograms | Xanax |
| Tablet 500 micrograms | Xanax |
| Tablet 1 mg | Xanax |
| Tablet 2 mg | Xanax Tri-Score |
Amlodipine | Tablet 5 mg (as besylate) | Norvasc |
| Tablet 10 mg (as besylate) | Norvasc |
Amoxycillin | Tablet 1 g (as trihydrate) | Maxamox |
| 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 | Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | Augmentin Duo |
| Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | Augmentin Duo forte |
| 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 clavulaante) per mL, 60 mL | Augmentin Duo 400 |
Atenolol | Tablet 50 mg | Tenormin |
Baclofen | Tablet 10 mg | Lioresal 10 |
| Tablet 25 mg | Lioresal 25 |
Captopril | Tablet 25 mg | Capoten |
| Tablet 50 mg` | Capoten |
Cefaclor | Tablet (sustained release) 375 mg (as monohydrate) | Ceclor CD |
| 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 |
Ciprofloxacin | Tablet 250 mg (as hydrochloride) | Ciproxin 250 |
| Tablet 500 mg (as hydrochloride) | Ciproxin 500 |
| Tablet 750 mg (as hydrochloride) | Ciproxin 750 |
Citalopram | Tablet 20 mg (as hydrobromide) | Cipramil |
Clarithromycin | Tablet 250 mg | Klacid |
Clomipramine | Tablet containing clomipramine hydrochloride 25 mg | Anafranil 25 |
Codeine with Paracetamol | Tablet containing codeine phosphate 30 mg with paracetamol 500 mg | Panadeine Forte |
Enalapril | Tablet containing enalapril maleate 5 mg | Renitec M |
| Tablet containing enalapril maleate 10 mg | Renitec |
| Tablet containing enalapril maleate 20 mg | Renitec 20 |
Famotidine | Tablet 40 mg | Pepcidine |
Felodipine | Tablet 2.5 mg (extended release) | Plendil ER |
| Tablet 5 mg (extended release) | Plendil ER |
| Tablet 10 mg (extended release) | Plendil ER |
Fluoxetine | Tablet, dispersible, 20 mg (as hydrochloride) | Prozac Tab |
| Capsule 20 mg (as hydrochloride) | Prozac 20 |
Fluvoxamine | Tablet containing fluvoxamine maleate 50 mg | Luvox |
| Tablet containing fluvoxamine maleate 100 mg | Luvox |
Gabapentin | Capsule 100 mg | Neurontin |
| Capsule 300 mg | Neurontin |
| Capsule 400 mg | Neurontin |
| Tablet 600 mg | Neurontin |
| Tablet 800 mg | Neurontin |
Gemfibrozil | Tablet 600 mg | Lopid |
Glimepiride | Tablet 1 mg | Amaryl |
| Tablet 2 mg | Amaryl |
| Tablet 3 mg | Amaryl |
| Tablet 4 mg | Amaryl |
Isosorbide Mononitrate | Tablet 60 mg (sustained release) | Imdur Durule |
| Tablet 120 mg (sustained release) | Imdur 120 mg |
Isotretinoin | Capsule 20 mg | Roaccutane |
Lactulose | Solution BP 3.34 g per 5 mL, 500 mL | Duphalac |
Lamotrigine | Tablet 5 mg | Lamictal |
| Tablet 25 mg | Lamictal |
| Tablet 50 mg | Lamictal |
| Tablet 100 mg | Lamictal |
| Tablet 200 mg | Lamictal |
Lercanidipine | Tablet containing lercanidipine hydrochloride 10 mg | Zanidip |
| Tablet containing lercanidipine hydrochloride 20 mg | Zanidip |
Lisinopril | Tablet 5 mg | Zestril |
|
| Prinivil 5 |
| Tablet 10 mg | Zestril |
|
| Prinivil 10 |
| Tablet 20 mg | Zestril |
|
| Prinivil 20 |
Metformin | Tablet containing metformin hydrochloride 500 mg | Glucophage |
|
| Diabex |
| Tablet containing metformin hydrochloride 850 mg | Glucophage |
|
| Diabex 850 |
| Tablet containing metformin hydrochloride 1 g | Diabex 1000 |
Metoprolol | Tablet containing metoprolol tartrate 50 mg | Lopresor 50 |
|
| Betaloc |
| Tablet containing metoprolol tartrate 100 mg | Lopresor 100 |
|
| Betaloc |
Mirtazapine | Tablet 30 mg | Avanza |
| Tablet 45 mg | Avanza |
Moclobemide | Tablet 150 mg | Aurorix |
| Tablet 300 mg | Aurorix 300 mg |
Nifedipine | Tablet 10 mg | Adalat 10 |
| Tablet 20 mg | Adalat 20 |
| Tablet 30 mg (controlled release) | Adalat Oros 30 |
| Tablet 60 mg (controlled release) | Adalat Oros 60 |
Norfloxacin | Tablet 400 mg | Noroxin |
Omeprazole | Tablet 20 mg (as magnesium) | Losec Tablets |
Paroxetine | Tablet 20 mg (as hydrochloride) | Aropax |
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 |
Quinapril | Tablet 5 mg (as hydrochloride) | Accupril |
| Tablet 10 mg (as hydrochloride) | Accupril |
| Tablet 20 mg (as hydrochloride) | Accupril |
Roxithromycin | Tablet 150 mg | Rulide |
| Tablet 300 mg | Rulide |
Sertraline | Tablet 50 mg (as hydrochloride) | Zoloft |
| Tablet 100 mg (as hydrochloride) | Zoloft |
Simvastatin | Tablet 5 mg | Zocor |
| 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 |
Temazepam | Tablet 10 mg | Normison |
Tramadol | Capsule containing tramadol hydrochloride 50 mg | Tramal |
| Tablet (sustained release) containing tramadol hydrochloride 100 mg | Tramal SR 100 |
| Tablet (sustained release) containing tramadol hydrochloride 150 mg | Tramal SR 150 |
| Tablet (sustained release) containing tramadol hydrochloride 200 mg | Tramal SR 200 |
Trandolapril | Capsule 500 micrograms | Gopten |
| Capsule 1 mg | Gopten |
| Capsule 2 mg | Gopten |
| Capsule 4 mg | Gopten |