National Health (April 2024 Flow on price reductions for brands of combination items) (Exercise of Ministerial discretion) Determination 2024

Administered by Department of Health, Disability and Ageing

Legislation au F2024N00279 In force Notifiable Instrument

Legislation content

 

PB 38 of 2024

National Health (April 2024 Flow on price reductions for brands of combination items) (Exercise of Ministerial discretion) Determination 2024

National Health Act 1953

I, Nikolai Tsyganov, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged Care, delegate of the Minister for Health and Aged Care make this determination under subsection 99ADHB(6) of the National Health Act 1953.

Dated      27   March 2024

 

 

 

 

 

 

 

 

 

NIKOLAI TSYGANOV

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health and Aged Care

 

 

 

 

 

 

 

1  Name of Determination

 (1) This instrument is the National Health (April 2024 Flow on price reductions for brands of combination items) (Exercise of Ministerial discretion) Determination 2024. 

 (2) This instrument may also be cited as PB 38 of 2024.

2  Commencement

  This instrument commences the day after registration.

3  Definition

 Note: A number of expressions used in this instrument are defined in Part VII the Act,

 

In this instrument:

 

 Act means the National Health Act 1953.

4  Authority

This instrument is made under subsection 99ADHB(6) of the Act.

5  Brand of pharmaceutical item with approved ex-manufacturer price not reduced

I determine under subsection 99ADHB(6) of the Act that, for the purposes of subsection 99ADHB(2), the approved ex-manufacturer price, and each of the claimed prices (if applicable) of each brand of pharmaceutical item specified in column 2 in the table in Schedule 1 is not reduced on 1 April 2024.

Schedule 1 Brand of pharmaceutical item with approved ex-manufacturer price not reduced

 

Column 1

Column 2

Item

Brand of Pharmaceutical Item

 

Drug

Form

Manner of administration

Brand

1

Fosnetupitant with palonosetron

Solution concentrate for I.V. infusion containing fosnetupitant 235 mg (as chloride hydrochloride) and palonosetron 250 microgram (as hydrochloride)

Injection

Akynzeo IV

2

Olmesartan with amlodipine and hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 12.5 mg

Oral

APO-Olmesartan/Amlodipine/HCTZ 40/10/12.5

 

3

Olmesartan with amlodipine and hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 12.5 mg

Oral

Olmekar HCT 40/10/12.5

 

4

Olmesartan with amlodipine and hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 12.5 mg

Oral

Olamlo HCT 40/10/12.5

 

5

Olmesartan with amlodipine and hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 12.5 mg

Oral

 

Sevikar HCT 40/10/12.5

 

6

Olmesartan with amlodipine and hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 25 mg

Oral

APO-Olmesartan/Amlodipine/HCTZ 40/10/25

 

7

Olmesartan with amlodipine and hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 25 mg

Oral

Olamlo HCT 40/10/25

8

Olmesartan with amlodipine and hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 25 mg

Oral

Olmekar HCT 40/10/25

9

Olmesartan with amlodipine and hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 25 mg

Oral

Sevikar HCT 40/10/25

10

Olmesartan with amlodipine and hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg

Oral

APO-Olmesartan/Amlodipine/HCTZ 40/5/12.5 tablet

11

Olmesartan with amlodipine and hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg

Oral

Olamlo HCT 40/5/12.5

12

Olmesartan with amlodipine and hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg

Oral

Olmekar HCT 40/5/12.5

13

Olmesartan with amlodipine and hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg

Oral

Sevikar HCT 40/5/12.5

14

Olmesartan with amlodipine and hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 25 mg

Oral

APO-Olmesartan/Amlodipine/HCTZ 40/5/25 tablet

15

Olmesartan with amlodipine and hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 25 mg

Oral

Olamlo HCT 40/5/25

16

Olmesartan with amlodipine and hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 25 mg

Oral

Olmekar HCT 40/5/25

17

Olmesartan with amlodipine and hydrochlorothiazide

Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 25 mg

Oral

Sevikar HCT 40/5/25

18

Sitagliptin with metformin

Tablet (modified release) containing 100 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

Janumet XR

19

Sitagliptin with metformin

Tablet (modified release) containing 100 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

Sitagliptin/Metformin Sandoz XR

20

Sitagliptin with metformin

Tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

Janumet XR

21

Sitagliptin with metformin

Tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

Sitagliptin/Metformin Sandoz XR

 

 

Overview

The National Health (April 2024 Flow on price reductions for brands of combination items) (Exercise of Ministerial discretion) Determination 2024, also referred to as PB 38 of 2024, was enacted to address the issue of pharmaceutical pricing in Australia, specifically targeting flow-on price reductions for brands of combination pharmaceutical items. This determination was made under the authority of the National Health Act 1953 by Nikolai Tsyganov, Assistant Secretary of the Pricing and PBS Policy Branch within the Technology Assessment and Access Division of the Department of Health and Aged Care, acting as the delegate of the Minister for Health and Aged Care. The primary objective of this determination is to ensure that the approved ex-manufacturer prices of certain specified pharmaceutical brands are not reduced as of 1 April 2024, thereby maintaining the pricing stability for these particular pharmaceutical combination items.

Scope and Application

The National Health (April 2024 Flow on price reductions for brands of combination items) (Exercise of Ministerial discretion) Determination 2024, as specified under subsection 99ADHB(6) of the National Health Act 1953, applies to the approved ex-manufacturer prices of specific brands of pharmaceutical items listed in Schedule 1, which includes various combinations of olmesartan with amlodipine and hydrochlorothiazide, as well as sitagliptin with metformin. This determination is designed to ensure that the prices of these pharmaceutical items remain unchanged as of 1 April 2024. The legislation is enacted at the Commonwealth level under the auspices of the Department of Health and Aged Care, with the Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division acting as the delegate of the Minister for Health and Aged Care. There are no stated exclusions, exemptions, or thresholds in this determination; it directly pertains to the listed brands and their prices as outlined.

Key Provisions

The National Health (April 2024 Flow on price reductions for brands of combination items) (Exercise of Ministerial discretion) Determination 2024 (referred to as the Determination) is made under subsection 99ADHB(6) of the National Health Act 1953 (the Act). This Determination specifies that, effective 1 April 2024, the approved ex-manufacturer price of certain brands of pharmaceutical items will not be reduced. The list of pharmaceutical items that are subject to this decision is detailed in Schedule 1. The Determination, which can also be cited as PB 38 of 2024, will commence the day after it is registered. This Determination imposes specific obligations on pharmaceutical companies and healthcare providers. Pharmaceutical companies must ensure that the prices of the listed pharmaceutical brands do not decrease as of 1 April 2024. This obligation is crucial for maintaining the integrity of the pricing structure within the healthcare system. Healthcare providers, in turn, must adhere to these prices when prescribing or dispensing the specified pharmaceutical items. This adherence is essential for ensuring that the cost-saving measures implemented by the government are effectively realised and for preventing potential disruptions in the supply chain of essential medications. There are no explicit criminal or civil penalties outlined in the Determination itself for non-compliance with the specified price freeze. However, any breach of the terms set forth in the Determination may result in regulatory actions under the National Health Act 1953. These actions could include administrative penalties, fines, or other enforcement measures imposed by the relevant authorities. Additionally, pharmaceutical companies and healthcare providers found to be in violation of the Determination's provisions may face reputational damage and potential loss of trust within the healthcare community.

Legal classification tags

Area of Law
Health Law
Instrument
Regulation
Concepts
Definitions & Interpretation
Enforcement Powers
Regulatory Standards

Interactions

Authorises

All Versions

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.