Consultation on candesartan removal of restrictions

CONSULTATION

Proposal to remove the funding restrictions for candesartan 9 April 2018

What we’re proposing Following assessment of bids in PHARMAC’s 2017/18 annual Invitation to Tender, PHARMAC is proposing to remove the Special Authority and hospital restrictions that currently apply to all strengths of candesartan.

PHARMAC has not yet made a decision on the presentations in the tender, so the brand names, pricing and timing for these changes, if they were to be implemented, is still to be determined. PHARMAC is seeking your feedback on the proposal to remove the funding restrictions for candesartan.

Consultation closes at 5 pm on Monday, 23 April 2018 and feedback can be emailed to Alexander Rodgers at alexander.rodgers@pharmac.govt.nz.

What would the effect be?

The proposal would result in candesartan tablets being available fully funded without restriction.

Clinicians would no longer be required to apply for a Special Authority approval for each patient starting on candesartan, reducing the administrative workload of prescribing candesartan.

Who we think will be interested  Patients taking treatment for hypertension  Clinicians who manage treatment of hypertension and other cardiovascular issues, including general practitioners 

Community and hospital pharmacies and pharmacists

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Suppliers and wholesalers

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Ministry of Health

About candesartan Candesartan is an angiotensin II antagonist. The other funded agent in this class is losartan which is already funded without any Special Authority restrictions.

Candesartan is mainly used for the treatment of high blood pressure (hypertension) or heart failure. It is currently funded only for patients who have A1128827

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had an inadequate response to an ACE inhibitor (a similar class of medicines), a persistent ACE inhibitor-induced cough, or who have a history of angioedema.

Why we’re proposing this In September 2017, the Cardiovascular Subcommittee of PTAC recommended that restrictions on candesartan be removed. This recommendation was considered by PTAC in February 2018; the minutes of this meeting are not yet published. The full history of the proposal, including minutes of the clinical reviews, can be found here.

Candesartan was included in PHARMAC’s latest tender, seeking bids both for current access and open access.

This proposal would mean that both funded angiotensin II antagonists would be funded without restriction.

Details about our proposal The Special Authority criteria (as below) for candesartan tablets 4 mg, 8 mg, 16 mg and 32 mg in Section B of the Pharmaceutical Schedule would be removed.

Special Authority for Subsidy Initial application — (ACE inhibitor intolerance) from any relevant practitioner.

Approvals valid without further renewal unless notified for applications meeting the following criteria: Either: 1 Patient has persistent ACE inhibitor induced cough that is not resolved by ACE inhibitor retrial (same or new ACE inhibitor); or 2 Patient has a history of angioedema.

Initial application – (Unsatisfactory response to ACE inhibitor) from any relevant practitioner. Approvals valid without further renewal unless notified where patient is not adequately controlled on maximum tolerated dose of an ACE inhibitor.

The hospital restrictions for candesartan tablets 4 mg, 8 mg, 16 mg and 32 mg in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines list; HML) would also be removed.

This would remove all restrictions for the subsidy of candesartan.

As part of this proposal, PHARMAC would also accept bids made in the 2017/18 Initiation to Tender relating to candesartan. Depending on which bids are accepted, this may or may not necessitate a brand switch.

The date of these changes is yet to be determined.

To provide feedback Send us an email: alexander.rodgers@pharmac.govt.nz by 5 pm 23 April 2018.

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.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our

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obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld.

PHARMAC will give due consideration to any such request.

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