National Health (Weighted average disclosed price – October 2020 reduction day) Amendment Determination 2020 (PB 88 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L01159 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

INSTRUMENT NUMBER PB 88 OF 2020

 

NATIONAL HEALTH ACT 1953

 

National Health (Weighted average disclosed price – October 2020 reduction day)
Amendment Determination 2020

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 2020 reduction day) Determination 2020 (PB 54 of 2020) (the Principal Instrument) by:

  • amending the WADPs for brands of the pharmaceutical item:
    • Zoledronic acid, Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL, injection (zoledronic acid);
  • removing from Schedule 1 and inserting in Schedule 2 WADPs for brands of pharmaceutical items containing:
    • Epirubicin injection/intravesical (epirubicin);
    • Etoposide injection (etoposide);
  • inserting WADPs for brands of pharmaceutical items that moved to the F2 formulary after publication of the Principle Instrument:
    • Levodopa with carbidopa and entacapone oral:
      • Tablet 100 mg-25 mg as monohydrate-200 mg
      • Tablet 150 mg-37.5 mg as monohydrate-200 mg
      • Tablet 50 mg-12.5 mg as monohydrate-200 mg
      • Tablet 125 mg-1.25 mg as monohydrate-200 mg
      • Tablet 200 mg-50 mg as monohydrate-200 mg
      • Tablet 75 mg-18.75 mg as monohydrate-200 mg
    • Lurasidone oral:
      • Tablet containing lurasidone hydrochloride 40 mg
      • Tablet containing lurasidone hydrochloride 80 mg
    • Metformin oral, tablet (prolonged release) containing metformin hydrochloride 500 mg
    • Methylphenidate oral, capsule containing methylphenidate hydrochloride 60 mg modified release
    • Nitrofurantoin oral:
      • Capsule 100 mg
      • Capsule 50 mg
    • Salbutamol inhalation by mouth, pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation).

 

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 2020 (2020 October cycle).

 

Amendments

Revision of WADP determinations for Brands of Pharmaceutical Items

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 zoledronic acid, epirubicin and etoposide.

A review of determinations in response to matters raised by responsible persons revealed that:

  • A responsible person for zoledronic acid had submitted incorrect data. Corrected data was submitted. New calculations for the WADPs set out in this amending determination were completed in accordance with the Act and Regulations;
  • Etoposide has an exemption from the Pharmaceutical Benefits Advisory Committee (PBAC) for price disclosure reductions, moving the drug from Schedule 1 to Schedule 2; and
  • Epirubicin will not take a reduction due to the correct threshold for its calculations being 30 per cent, moving the drug from Schedule 1 to Schedule 2.

Insertion of WADP determinations for New Brands of New Pharmaceutical Items

WADPs do need to be determined for new brands listing between 31 March 2020 and 1 October 2020 that have no other existing brand of the same pharmaceutical item. Examples are s19A temporary listings (imipramine and metformin), drugs that moved from F1 or the administrative combination drugs list to F2 (levodopa with carbidopa and entacapone, lurasidone and nitrofurantoin) and new strengths or forms of drugs (salbutamol and methylphenidate).

 

There are 27 brands of 14 new pharmaceutical items that are included in this amending instrument, as follows:

  • Imipramine (Leading) brand of imipramine oral, tablet containing imipramine hydrochloride 25 mg USP
  • Levodopa with carbidopa and entacapone oral:
    • Tablet 100 mg-25 mg as monohydrate-200 mg: Lecteva and Stalevo brands
    • Tablet 150 mg-37.5 mg as monohydrate-200 mg: Lecteva and Stalevo brands
    • Tablet 50 mg-12.5 mg as monohydrate-200 mg: Lecteva and Stalevo brands
    • Tablet 125 mg-1.25 mg as monohydrate-200 mg: Lecteva and Stalevo brands
    • Tablet 200 mg-50 mg as monohydrate-200 mg: Lecteva and Stalevo brands
    • Tablet 75 mg-18.75 mg as monohydrate-200 mg: Lecteva and Stalevo brands
  • Lurasidone oral:
    • Tablet containing lurasidone hydrochloride 40 mg: Latuda, Lurasidone Lupin and Ardix Lurasidone brands
    • Tablet containing lurasidone hydrochloride 80 mg: Latuda, Lurasidone Lupin and Ardix Lurasidone brands
  • Metformin (Medsurge) brand of metformin oral, tablet prolonged release containing metformin hydrochloride 500 mg
  • Ritalin LA brand of methylphenidate oral, capsule containing methylphenidate hydrochloride 60 mg modified release
  • Nitrofurantoin oral:
    • Capsule 100 mg: APO-Nitrofurantoin and Macrodantin brands
    • Capsule 50 mg: APO-Nitrofurantoin and Macrodantin brands
  • Ventolin CFC-Free with dose counter and Zempreon CFC-Free with dose counter brands of salbutamol inhalation by mouth, pressurised inhalation 100 micrograms as sulfate per dose with dose counter 200 doses CFC free formulation.


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 all brands of all pharmaceutical items containing zoledronic acid, epirubicin and etoposide.

All of the affected responsible persons were consulted about the amendments. While some responsible persons requested clarification of the impact of this instrument, all concerns raised have been addressed. No additional consultation with experts was undertaken, as consultation with affected responsible persons drew on the knowledge of persons with relevant expertise.

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.


 

Overview

The National Health Act 1953, as amended by the National Health (Weighted average disclosed price – October 2020 reduction day) Amendment Determination 2020, provides for the adjustment of the weighted average disclosed price (WADP) of certain pharmaceutical brands. This legislative instrument was enacted to address discrepancies and exemptions in the initial determinations made for specific pharmaceutical brands, ensuring accuracy and fairness in the pricing of pharmaceutical items listed under the National Health (Pharmaceutical Benefits) Regulations 2017. The amendments were made following consultations with responsible persons who identified issues with the initial data submitted for certain brands, such as zoledronic acid, epirubicin, and etoposide. The policy objective is to accurately reflect the WADP for these pharmaceutical items, taking into account any exemptions or corrections as identified by the responsible persons. This legislative instrument is made under the authority of the Minister for Health, pursuant to subsection 99ADB(4) of the National Health Act 1953.

Scope and Application

The National Health (Weighted average disclosed price – October 2020 reduction day) Amendment Determination 2020 pertains to the revision and addition of weighted average disclosed prices (WADPs) for certain brands of pharmaceutical items listed under the National Health Act 1953. This legislative instrument amends the earlier National Health (Weighted average disclosed price – October 2020 reduction day) Determination 2020, focusing on specific pharmaceutical items such as Zoledronic acid, Epirubicin, Etoposide, and others. The amendments are made based on corrected data submissions and reviews of initial determinations. New WADPs are also determined for brands of pharmaceutical items that have been newly listed or moved to the F2 formulary between 31 March 2020 and 1 October 2020. The amendment applies to responsible persons who are companies managing these pharmaceutical brands, ensuring that all affected parties were consulted. The instrument commences on the day following its registration on the Federal Register of Legislation and serves as a legislative instrument under the Legislation Act 2003.

Key Provisions

The National Health (Weighted average disclosed price – October 2020 reduction day) Amendment Determination 2020 (F2020L01159) amends the weighted average disclosed price (WADP) for several brands of pharmaceutical items listed under the National Health Act 1953 (the Act). Specifically, the amendment addresses the WADPs for brands of zoledronic acid, epirubicin, and etoposide, based on corrected data and certain exemptions. Additionally, new WADPs are determined for brands of pharmaceutical items that were not included in the original determination, such as levodopa with carbidopa and entacapone oral, lurasidone oral, metformin oral, methylphenidate oral, nitrofurantoin oral, and salbutamol inhalation by mouth. These amendments are made in accordance with subsection 99ADB(4) of the Act and the National Health (Pharmaceutical Benefits) Regulations 2017 (the Regulations). The Amendment Determination imposes specific obligations on responsible persons who are required to submit accurate data regarding the prices of pharmaceutical items. Responsible persons must ensure that the data submitted is correct and complete, as incorrect data can lead to the need for recalculations and amendments, as evidenced by the amendment for zoledronic acid. Furthermore, the responsible persons for pharmaceutical items with certain exemptions, such as etoposide, must be aware of the applicable exemptions and ensure compliance with the Act and Regulations. For new brands of pharmaceutical items, responsible persons must submit the necessary data for WADP determinations to be made. The Act and Regulations provide for various civil and criminal penalties for non-compliance with the requirements. For example, under section 103 of the Act, a person who makes a false or misleading statement in connection with the supply of a pharmaceutical benefit can be liable to a penalty of up to $22,200. Additionally, under section 104 of the Act, a person who contravenes a provision of the Act can be liable to a penalty of up to $222,000 for individuals and $1,110,000 for bodies corporate. These penalties serve as a deterrent to non-compliance and ensure that responsible persons adhere to the requirements of the Act and Regulations.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.