Proposal to list epoprostenol injection in Section H of the Pharmaceutical Schedule

Medicines

Consultation Closed

PHARMAC is seeking feedback on a proposal to list epoprostenol injection 0.5 mg vial and 1.5 mg vial in Part II of Section H (Hospital Medicines List) of the Pharmaceutical Schedule from 1 September 2015, through a provisional agreement with Actelion Pharmaceuticals Australia Pty Ltd.

In summary, this proposal would result in epoprostenol injection being listed on the Hospital Medicines List for patients with Pulmonary Arterial Hypertension (PAH) who are on the active waiting list for lung transplantation, subject to restriction criteria.

Full information on the proposal can be found below:

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Friday, 10 July 2015 to:

Chris Little
Therapeutic Group Manager
PHARMAC
PO Box 10254
Wellington 6143

Email: chris.little@pharmac.govt.nz
Fax:     04 460 4995

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 

Details of the proposal

PHARMAC and Actelion Pharmaceuticals Australia Pty Limited have entered into a provisional agreement relating to the listing of intravenous epoprostenol (Veletri) in the Pharmaceutical Schedule.

The intravenous epoprostenol would be listed in Part II of Section H of the Pharmaceutical Schedule from 1 September 2015 at the following price (ex-manufacturer, excluding GST):

Epoprostenol would be listed subject to the following restriction in Part II of Section H of the Pharmaceutical Schedule:

Epoprostenol – Restricted
Both:

  1. For use in patients with approval by the Pulmonary Arterial Hypertension Panel; and
  2. For use as a bridge to transplant for patients with Pulmonary Arterial Hypertension who are on the active waiting list for lung transplantation.

Background

Epoprostenol is a prostacyclin analogue delivered via a continuous infusion via an indwelling central venous line. An alternative IV prostacyclin analogue, iloprost injection, is currently listed in Section H of the Pharmaceutical Schedule.

PHARMAC’s Pharmacology and Therapeutics Advisory Committee (PTAC) considered an application from Actelion for the funding of intravenous epoprostenol at its meeting of 6 and 7 November 2014. In summary PTAC recommended epoprostenol be listed in Section H of the Pharmaceutical Schedule as a bridge to transplant for patients with PAH who are on the active waiting list for lung transplantation with a high priority. The proposed restriction is in line with this recommendation. This proposal is in line with the Committee’s recommendation.

Details of the funding application, including a reference to the relevant Committee meeting minutes can be found on the Application Tracker on PHARMAC website.

PHARMAC estimates that listing epoprostenol would provide savings of approximately $148,000 to DHBs over 5 years (NPV, discounted at 8% p.a.). This estimate is based on all patients requiring IV prostacyclin as a bridge to transplant gaining access to this therapy.

Chemical Formulation Brand Pack size Price
Epoprostenol Inj 0.5 mg vial Veletri 1 $36.61
Epoprostenol Inj 1.5 mg vial Veletri 1 $73.21