Proposal to list eplerenone for the treatment of heart failure in patients intolerant to spironolactone
To provide feedback
Send us an email: alexander.rodgers@pharmac.govt.nz by 5 pm on Thursday, 8 February 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 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.
What we’re proposing
Following assessment of bids in PHARMAC’s 2017/18 annual Invitation to Tender, PHARMAC is proposing to fund eplerenone for the treatment of heart failure in patients intolerant to spironolactone.
A decision has not been made on a preferred tender bid so the brand names, pricing and timing for these changes, if they were to be implemented, is still to be determined. However, PHARMAC is seeking your feedback on the proposed new investment and funding criteria.
Consultation closes at 5 pm on Thursday, 8 February 2018 and feedback can be emailed to Alexander Rodgers at alexander.rodgers@pharmac.govt.nz.
What would the effect be?
Eplerenone is a treatment for heart failure. It offers similar cardiovascular protection as funded spironolactone, but with reduced rates of adverse effects such as gynaecomastia.
Funding eplerenone would allow patients who are experiencing adverse events from spironolactone to try another medicine with the same heart benefits that may reduce or eliminate the adverse events.
Unlike spironolactone, which is open listed, funding for eplerenone would be restricted by Special Authority criteria. Eplerenone does not offer better protection for heart failure – its benefits lie only in lower adverse events – so we propose restricting funding to patients for whom spironolactone use has caused problems.
Who we think will be interested
- Cardiovascular specialists
- GPs and clinicians involved in managing heart failure
- Patients taking spironolactone experiencing adverse effects or those who have discontinued treatment due to adverse effects
- Organisations with an interest in cardiovascular health
Details about our proposal
PHARMAC is proposing to accept one of the bids received in the 2017/18 Invitation to Tender and list it in Section B (community) of the Pharmaceutical Schedule, with the following Special Authority criteria:
Special Authority for Subsidy
Initial application from a cardiologist or on the recommendation of a cardiologist. Approvals valid without further renewal for applications meeting the following criteria:
Both:
- Patient has heart failure with ejection fraction less than 40%; and
- Either:
- Patient is intolerant to optimal dosing of spironolactone; or
- Patient has experienced a clinically significant adverse effect while on optimal dosing of spironolactone.
Similar restrictions would apply in Section H (hospital).
The specific brand of eplerenone, formulations, pricing, and timing of the listing are still to be determined.