Seeking feedback on funding criteria for rosuvastatin

Medicines Consultation Closed

We are seeking feedback on a proposed Special Authority criteria for rosuvastatin

What we are proposing

As part of PHARMAC’s annual tender process, PHARMAC is considering the listing of a new cholesterol-lowering medicine – rosuvastatin – on the Pharmaceutical Schedule. To ensure this medicine is targeted to people most likely to benefit, within the available funds, we propose to apply Special Authority criteria for access to this medicine.

Usually when we consult on funding a new medicine we would communicate information such as brand names, pricing and timing. However, as the Tender process is still in progress, these details are not available. Instead, we are seeking your feedback on the appropriateness of the proposed Special Authority criteria for rosuvastatin.

We welcome your feedback on this proposal. Consultation closes at 5 pm on 19th February 2021 and feedback can be emailed to consult@pharmac.govt.nz.

What would the effect be?

For patients

This proposal would mean patients who meet the Special Authority criteria (or equivalent Hospital Restrictions) who have high cholesterol and who have not responded to atorvastatin or simvastatin (with or without ezetimibe), would have access to another funded option.

For prescribers, pharmacies and DHBs

Prescribers would have the option to prescribe rosuvastatin for patients with high cardiovascular risk and high cholesterol who have not responded adequately to atorvastatin or simvastatin (with or without ezetimibe). Any relevant practitioner would be able to submit a Special Authority application. To help minimise the potential administrative burden on prescribers and dispensing pharmacists the proposed renewal approval period would be valid without further renewal.

Who we think will be interested

  • People with high cholesterol who have not responded to other cholesterol lowering medicines, and their whānau
  • Cardiologists and Internal Medicine Specialists
  • Cardiac Society of Australia & New Zealand
  • Primary Care Prescribers
  • Community and Hospital Pharmacies
  • Pharmaceutical suppliers and wholesalers

About rosuvastatin

Rosuvastatin is a potent lipid-modifying agent, known as a statin. Statins help reduce the levels of total cholesterol, LDL-cholesterol, and triglycerides. Rosuvastatin is used to prevent cardiovascular events in high-risk patients and reduce cholesterol in patients with high cholesterol. Rosuvastatin would provide an alternative treatment option for patients at high-risk of cardiovascular disease who have not been able to reduce their cholesterol levels adequately with the currently funded treatments.

Why we’re proposing this

Rosuvastatin was reviewed by the Cardiovascular Subcommittee of PTAC in 2017 and the Pharmacology and Therapeutics Advisory Committee (PTAC) in 2018. PTAC has recommended that rosuvastatin be funded as a third-line cholesterol lowering agent after treatment failure with maximum tolerated doses of both atorvastatin or simvastatin with or without ezetimibe, with a medium priority. The funding of rosuvastatin also received further support from the Cardiovascular Subcommittee of PTAC in 2019.

Further details can be found on PHARMAC application tracker.(external link)

This proposal supports PHARMAC’s goal to make more medicines available to more New Zealanders and aligns with PHARMAC’s Hauora Arotahi, Manawa Ora as one of the PHARMAC’s Māori health areas of focus.

Details about our proposal

As part of PHARMAC’s annual multi-product Tender, PHARMAC sought proposals for the supply of a number of medicines that are not currently listed on the Pharmaceutical Schedule, including rosuvastatin (included during the 2012/20 Invitation to Tender).

The listing of these products would occur through the Tender, therefore the brands to be made available, the pricing of these products, and the dates of listing are still to be confirmed. Any products listed through the Tender would have Sole Supply Status and Hospital Supply Status until 30 June 2023.

PHARMAC is seeking feedback on the following proposed Special Authority criteria that would apply to the listing of rosuvastatin in Section B and Part II of Section H of the Pharmaceutical Schedule if the Tender is progressed:

Special Authority for Subsidy

Initial application from any relevant practitioner. Approvals valid for 2 years.

All of the following:

  1. Patient has Familial Hypercholesterolemia; and / or
    Patient has a calculated risk of cardiovascular disease of at least 15% over 5 years; and
  2. The patient has not reduced their LDL cholesterol to less than 2.0 mmol/litre with the use of the maximal tolerated dose of atorvastatin or simvastatin (with or without ezetimibe).

Renewal – from any relevant practitioner. Approvals valid without further renewal unless notified if treatment remains appropriate and the patient is benefitting from treatment.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 5 pm Monday 22 February 2021.

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

Your feedback may be shared

Feedback we receive is subject to the Official Information Act 1982 (OIA). Please be aware that we may need to share your feedback, including your identity, in response to an OIA request. This applies to anyone providing feedback, whether they are providing feedback themselves or for an organisation, in a personal or professional capacity.

We can only keep feedback confidential as allowed under the OIA and other related laws. If you want any part of your feedback treated as confidential, you need to tell us. Please let us know if you want to keep part of your feedback confidential, and why. Is it commercially sensitive, confidential or proprietary, or personal information? Clearly state this and tell us which parts of your feedback you want to keep confidential for these reasons. We will consider your request under our OIA requirements.