EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 9 OF 2015
NATIONAL HEALTH ACT 1953
National Health (Weighted average disclosed price – April 2015 reduction day)
Amendment Determination 2015 (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 1960 (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 – April 2015 reduction day) Determination 2014 (PB 97 of 2014) (the Principal Instrument) by:
- amending the WADP for all brands of pharmaceutical items containing the drugs aspirin for oral administration (aspirin oral), exemestane for oral administration (exemestane oral) and nevirapine for oral administration (nevirapine oral) and amending the AAEMP for brands of exemestane oral and nevirapine oral;
- amending the form of the Macrogol 3350, Oral liquid 13.125 g in 25 mL with electrolytes, 500 mL pharmaceutical item and the Sodium chloride, I.V. infusion 154 mmol per L, 1 L, Injection pharmaceutical item; and
- revoking the determination of the WADP for the Tramal SR 50® brand of the Tramadol, Tablet (sustained release) containing tramadol hydrochloride 50 mg, Oral pharmaceutical item.
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 30 September 2014 (2015 April cycle).
Amendments
Aspirin oral, exemestane oral and nevirapine oral
Amendments are being made following consideration of matters raised by certain responsible persons concerning the determinations in the Principal Instrument for brands containing aspirin oral, exemestane oral and nevirapine oral. 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 aspirin oral, exemestane oral and nevirapine oral brands for the 2015 April cycle and new calculation for the WADPs set out in this amending determination were completed under the Act and Regulations.
Schedule 1 of the Principal Instrument includes a WADP and AAEMP for brands of the aspirin oral, exemestane oral and nevirapine oral pharmaceutical items. This amending instrument removes the previous WADPs for brands of all three drugs and inserts the revised WADPs for brands of exemestane oral and nevirapine oral in the appropriate column in Schedule 1 and for aspirin oral in Schedule 2.
Listed brands of aspirin oral are included in Schedule 2 of the Principal Instrument because their unadjusted price reduction following determination of the amended WADP is less than 10%. Listed brands of exemestane oral and nevirapine oral are included in Schedule 1 because they have an unadjusted price reduction of at least 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 April 2015, provided that, on that date, the ‘approved ex-manufacturer price’ for the listed brand is more than the determined ‘AAEMP’ for that brand.
Amended forms
In January 2015, after the Principal Instrument was made, brands of two pharmaceutical items had technical amendments to their form determined in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) (the Main Listing Instrument). The Principal Instrument is being amended to reflect the forms as currently determined in the Main Listing Instrument. This is being done for the avoidance of doubt regarding brands of pharmaceutical items taking a reduction on the reduction day.
The form for brands of the following pharmaceutical items are amended: Macrogol 3350, Oral liquid 13.125 g in 25 mL with electrolytes, 500 mL and Sodium chloride, I.V. infusion 154 mmol per L, 1 L, Injection.
Revocation of WADP
This amending instrument revokes the WADP determination in the Principal Instrument for the Tramal SR 50® brand of the Tramadol, Tablet (sustained release) containing tramadol hydrochloride 50 mg, Oral pharmaceutical item based on the particular circumstances that exist in this case. As a result of the amending instrument no price disclosure reduction would apply to the brand of the relevant pharmaceutical item containing tramadol for oral administration on 1 April 2015.
In the case of Tramal SR 50®: a) it is the only brand of the pharmaceutical item; b) there is a high clinical need for the pharmaceutical item; c) there was no discounting across the pharmaceutical item during the data collection period ending 30 September 2014; d) the product received a recent price increase, effective from 1 December 2014; e) if the revocation is not made, the pricing delegate will be asked to agree to an increased price for the brand with effect from 1 May 2015, only 1 month after the reduction occurs, which would cause considerable inconvenience to a range of stakeholders; and f) the responsible person, bioCSL has requested that the price increase that took effect 1 December 2014 be maintained.
No other medicine that was granted a price increase on 1 December 2014, and subject to a 1 April 2015 price disclosure reduction, fits these criteria.
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 a responsible person for brands of pharmaceutical items containing aspirin oral, exemestane oral, nevirapine oral and the Tramal SR 50® brand of the Tramadol, Tablet (sustained release) containing tramadol hydrochloride 50 mg, Oral pharmaceutical item. Each of the affected companies were consulted concerning the amendments. No concerns were expressed about the amendments.
Responsible persons with brands of the relevant macrogol 3350 and sodium chloride pharmaceutical items were not consulted because the amendments made to their form descriptions were technical in nature, aligning them with their descriptions in the current PBS listing instrument.
This instrument commences on the day after it is registered on the Federal Register of Legislative Instruments.
This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.