Decision to list eplerenone for the treatment of heart failure

Medicines

Decision

We’re pleased to announce a decision to fund eplerenone (Inspra), subject to certain clinical criteria being met, in conjunction with the awarding of eplerenone bids as part of PHARMAC’s 2017/18 annual Invitation to Tender.

What we’re doing

We’re pleased to announce a decision to fund eplerenone (Inspra), subject to certain clinical criteria being met, in conjunction with the awarding of eplerenone bids as part of PHARMAC’s 2017/18 annual Invitation to Tender.

The 25 mg tablet form will be listed from 1 July 2018, and the 50 mg tablet form will be listed from 1 October 2018.

Sole Subsidised Supply Status and Hospital Supply Status will apply to both strengths of Pfizer’s Inspra brand of eplerenone tablets until 30 June 2021.

This was the subject to a consultation letter dated 24 January 2018.

What would the effect be?

Having considered consultation feedback, we have amended the applicant restrictions to allow any medical practitioner to apply.

Who we think will be most interested

  • Cardiovascular specialists
  • GPs and clinicians involved in managing heart failure
  • Patients with heart failure
  • Organisations with an interest in cardiovascular health
  • Community and hospital pharmacists, and pharmacy wholesalers

Details about this decision

Through the 2017/18 Invitation to Tender, PHARMAC has entered into a sole supply arrangement with Pfizer to list its brand of eplerenone (Inspra).

  • From 1 July 2018 eplerenone (Inspra) tab 25 mg will be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule at the following prices and subsidies (ex-manufacturer, excluding GST):
    Chemical Presentation Brand Pack Size Price and subsidy
    (ex-man., ex. GST)
    Eplerenone Tab 25 mg Inspra 30 $11.87
  • Inspra tab 25 mg will have Sole Supply Status from 1 October 2018 until 30 June 2021, and will have Hospital Supply Status, with a DV Limit of 1%, from 1 September 2018 until 30 June 2021.
  • From 1 October 2018, eplerenone (Inspra) tab 50 mg will be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule at the following prices and subsidies (ex-manufacturer, excluding GST):
    Chemical Presentation Brand Pack Size Price and subsidy(ex-man., ex. GST)
    Eplerenone Tab 50 mg Inspra 30 $17.00
  • Inspra tab 50 mg will have Sole Supply Status from 1 January 2019 until 30 June 2021, and will have Hospital Supply Status, with a DV Limit of 1%, from 1 December 2018 until 30 June 2021.
  • Eplerenone will be listed in Section B of the Pharmaceutical Schedule subject to the following Special Authority criteria:

    Special Authority for Subsidy

    Initial application from any relevant practitioner. Approvals valid without further renewal for applications meeting the following criteria:

    Both:

    1. Patient has heart failure with ejection fraction less than 40%; and
    2. Either:

    2.1    Patient is intolerant to optimal dosing of spironolactone; or

    2.2    Patient has experienced a clinically significant adverse effect while on optimal dosing of spironolactone.

  • The same restrictions will apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML).

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. A summary of the main themes raised in feedback, our responses to the feedback received, and changes we have made after listening to you, is below.

For more information on advice we received from our clinical committees, please see the links in our Application Tracker.

Theme Response
Fully supportive Noted.
Requests to amend the restriction on who can apply for Special Authorities for eplerenone, including widening cardiac nurse practitioners, consultant endocrinologists, nephrologists, and internal medicine physicians with an interest in hypertension, as well as requests to remove all restrictions on who can apply. Following feedback, we have amended the restrictions to allow applications from “any relevant practitioner”. This fulfils all requests to widen access by applicant.
Requests to amend the proposed criteria to remove the requirement that the spironolactone trial be at “optimal dosing” The criteria are consistent with the advice from our clinical advisors that spironolactone is appropriately trialled at ‘optimal dosing’. We note that determining ‘optimal dosing’ requires clinical judgment by individual clinicians.
Requests to widen access to other patient groups including those with:
  • resistant hypertension where spironolactone is beneficial
  • hypertension secondary to hyperaldosteronism where surgery is not appropriate and mineralocorticoid receptor antagonism such as spironolactone is the optimal therapy
  • primary hyperaldosteronism for whom spironolactone is ineffective or not tolerated.
Our clinical advice has only reviewed and recommended funding for the group of patients with heart failure who are contraindicated to or experience adverse events on spironolactone.

We would welcome submissions, supported by published evidence, for widening access to eplerenone for these patient groups.
Queries as to whether ‘intolerant’ and ‘clinically significant adverse events’ needed definitions. We have chosen to leave the interpretation of these terms to the discretion of the applicant. This allows more scope for an application to determine if eplerenone would be appropriate.

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.