EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 69 OF 2017
NATIONAL HEALTH ACT 1953
National Health (Weighted average disclosed price – October 2017 reduction day)
Amendment Determination 2017 (No.1)
Authority
This legislative instrument is made pursuant to subsection 99ADB(4) of the National Health Act 1953 (the Act), which provides that the Minister may, by legislative instrument, determine the weighted average disclosed price (WADP) of a brand of a pharmaceutical item (listed brand) in accordance with the National Health (Pharmaceutical Benefits) Regulations 2017 (the Regulations).
Subsection 99ADB(7) of the Act further provides that a subsection 99ADB(4) determination for a listed brand may include the adjusted approved ex-manufacturer price (AAEMP) for the listed brand.
Purpose
This legislative instrument amends the National Health (Weighted average disclosed price – October 2017 reduction day) Determination 2017 (PB 44 of 2017) (the Principal Instrument) by:
- amending the WADPs for brands of pharmaceutical items containing perindopril for oral administration (perindopril), perindopril with amlodipine for oral administration (perindopril with amlodipine), perindopril with indapamide for oral administration (perindopril with indapamide) and topotecan for administration by injection (topotecan);
- revoking the WADPs for all brands of pharmaceutical items containing carboplatin for administration by injection (carboplatin), docetaxel for administration by injection (docetaxel), gemcitabine for administration by injection (gemcitabine), oxaliplatin for administration by injection (oxaliplatin) and methotrexate for administration by injection (methotrexate);
- amending the WADPs for all brands of the following 13 pharmaceutical items that no longer meet the no reduction criteria under regulation 82:
- Filgrastim, Injection 120 micrograms in 0.2 mL single use pre-filled syringe (Nivestim), Injection;
- Filgrastim, Injection 300 micrograms in 1 mL, Injection ;
- Filgrastim, Injection 480 micrograms in 0.8 mL single use pre-filled syringe (TevaGrastim), Injection;
- Filgrastim, Injection 480 micrograms in 1.6 mL, Injection;
- Olanzapine, Tablet 10 mg (as benzoate), Oral;
- Olanzapine, Tablet 5 mg (as benzoate), Oral;
- Olanzapine, Tablet 7.5 mg (as benzoate), Oral;
- Ondansetron, Wafer 8 mg, Oral;
- Pramipexole, Tablet (extended release) containing pramipexole hydrochloride 375 micrograms, Oral;
- Pramipexole, Tablet (extended release) containing pramipexole hydrochloride 750 micrograms, Oral;
- Tamoxifen, Tablet 10 mg (as citrate), Oral;
- Topiramate, Capsule 25 mg, Oral; and
- Topiramate, Capsule 50 mg, Oral;
- inserting a WADP for the first new brand of the following new pharmaceutical item:
- Ursodeoxycholic acid, Tablet 500 mg, Oral.
The Principal Instrument was made pursuant to subsection 99ADB(4) and paragraph 99ADH(1)(aa) of the Act for brands of pharmaceutical items with a data collection period ending 31 March 2017 (2017 October cycle).
Amendments
Perindopril, Perindopril with Amlodipine, Perindopril with Indapamide and Topotecan
Amendments are being made following consideration of matters raised by responsible persons concerning the determinations in the Principal Instrument for brands of pharmaceutical items containing perindopril, perindopril with amlodipine, perindopril with indapamide and topotecan. A review of determinations in response to matters raised by responsible persons revealed that incorrect data had been submitted by some responsible persons. Corrected data was submitted by some responsible persons for certain brands containing the drugs set out above. New calculations for the WADPs set out in this amending determination were completed in accordance with the Act and Regulations.
This amending instrument removes the previous WADPs for brands of perindopril, perindopril with amlodipine, perindopril with indapamide and topotecan. Revised WADPs for brands of perindopril are inserted in the appropriate column in Schedule 1 and revised WADPs for brands of perindopril with amlodipine, perindopril with indapamide and topotecan are inserted in Schedule 2.
Listed brands of perindopril are included in Schedule 1 of the Principal Instrument because they continue to have an unadjusted price reduction of at least 10 per cent. Listed brands of perindopril with amlodipine, perindopril with indapamide and topotecan are inserted in Schedule 2 of the Principal Instrument because their unadjusted price reduction following determination of the amended WADP is less than 10%.
For those brands with a WADP re-inserted in Schedule 1, the same amount is also determined as the AAEMP for the brands due to the operation of section 7 of the Principal instrument.
A Responsible Person for a listed brand appearing in Schedule 1 of the Principal Instrument will receive a price disclosure reduction on and from 1 October 2017, provided that, on that date, the ‘approved ex-manufacturer price’ for the listed brand is more than the determined ‘AAEMP’ for that brand.
Revocation of WADPs
This amending instrument revokes the WADPs in the Principal Instrument for:
- all brands of carboplatin, docetaxel, gemcitabine and oxaliplatin because brands of these drugs received a price increase on 1 December 2016, during the data collection period for the Cycle; and
- for methotrexate to support sustainable pricing and continued access to this drug/MoA for Australian patients.
As a result of the amending instrument no price disclosure reduction will apply to any brand of carboplatin, docetaxel, gemcitabine, oxaliplatin or methotrexate on 1 October 2017.
Amending the WADP for brands that no longer meet Regulation 82
WADPs/AAEMPs are being determined for all brands of 13 pharmaceutical items that no longer meet the criteria under regulation 82. The applicable PBS price that was determined as the WADP for these brands is being omitted and a new reduced price for each brand is being inserted into Schedule 1 because the unadjusted price reduction for these brands is now 10% or greater.
Insertion of WADP determinations for New Brands of New Pharmaceutical Items
A WADP is required to be determined for new brands of pharmaceutical items listing between 1 July 2017 and 1 September 2017 that have no other existing brand of the same pharmaceutical item (including a single brand pharmaceutical item where the brand or pharmaceutical item changes, or where all existing brands change).
There is one brands of one new pharmaceutical item that is included in this amending instrument, as follows:
- the Ursofalk® brand of ‘ursodeoxycholic acid, tablet 500 mg, oral’.
Basis for amendments
Subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to vary or revoke the determination made under subsection 99ADB(4) for the medicines affected by this amending instrument.
Consultation
This instrument affects companies that are Responsible Persons for brands of pharmaceutical items containing perindopril, perindopril with amlodipine, perindopril with indapamide, topotecan, carboplatin, docetaxel, gemcitabine, oxaliplatin and methotrexate.
Further, it affects companies that are Responsible Persons for brands of the following pharmaceutical items:
- Filgrastim, Injection 120 micrograms in 0.2 mL single use pre-filled syringe (Nivestim), Injection;
- Filgrastim, Injection 300 micrograms in 1 mL, Injection ;
- Filgrastim, Injection 480 micrograms in 0.8 mL single use pre-filled syringe (TevaGrastim), Injection;
- Filgrastim, Injection 480 micrograms in 1.6 mL, Injection;
- Olanzapine, Tablet 10 mg (as benzoate), Oral;
- Olanzapine, Tablet 5 mg (as benzoate), Oral;
- Olanzapine, Tablet 7.5 mg (as benzoate), Oral;
- Ondansetron, Wafer 8 mg, Oral;
- Pramipexole, Tablet (extended release) containing pramipexole hydrochloride 375 micrograms, Oral;
- Pramipexole, Tablet (extended release) containing pramipexole hydrochloride 750 micrograms, Oral;
- Tamoxifen, Tablet 10 mg (as citrate), Oral;
- Topiramate, Capsule 25 mg, Oral;
- Topiramate, Capsule 50 mg, Oral; and
- Ursodeoxycholic acid, Tablet 500 mg, Oral.
All of the affected companies were consulted about the amendments. No concerns were expressed.
This instrument commences on the day after it is registered on the Federal Register of Legislation. This instrument is a legislative instrument for the purposes of the Legislation Act 2003.