Proposal to list a range of Interventional Cardiology products supplied by Edwards Lifesciences (New Zealand) Limited

PHARMAC is seeking feedback on a proposal to list a range of Interventional Cardiology products supplied by Edwards Lifesciences (New Zealand) Limited (“Edwards”) in Part III of Section H of the Pharmaceutical Schedule from 1 August 2017.

The proposal is subject to approval by the PHARMAC Board or its delegate following this consultation.

In summary, this proposal would result in 15 transcatheter aortic valve devices which are already supplied to DHB Hospitals, being supplied under a proposed national agreement with Edwards, that all DHBs may purchase under. This agreement is not a sole supply agreement, and DHBs may continue to purchase other suppliers’ brands of transcatheter aortic valve devices.

The proposal will not increase the annual spend to those DHBs with Cardiac Catheterisation Laboratory (Cath Lab) services, currently using the Edwards devices.

Pricing for the devices in the agreement, subject to any prior termination of the agreement, would not be increased before 1 August 2020.

The PHARMAC Agreement would supersede any existing DHB contracts with Edwards for the devices listed in Schedule One of the Agreement. This would mean a device purchased by a DHB that is listed in the Agreement would have to be purchased at the Price as stated in the Agreement, effective from the date of listing on the Pharmaceutical Schedule.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Tuesday 4 July 2017 to:

Jacquie Pillay
Devices Category Manager
PHARMAC
PO Box 10254
Wellington 6143

Email: jacquie.pillay@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 decisions on these proposals.

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 has entered into a provisional agreement with Edwards for a range of interventional cardiology products. The exact product range and pricing in this proposal has not been included in this consultation, however we are making it available to Procurement Departments at DHBs. Brand ranges include:

• Sapien XT Transfemoral
• Sapien XT Transapical
• Sapien 3 Commander Transfemoral
• Sapien 3 Certitude Transapical

If the agreement is approved by PHARMAC’s Board or its delegate, Edwards range of interventional cardiology products would be listed in Part III of Section H of the Pharmaceutical Schedule, which contains products with national agreements that DHBs are able to purchase under.

The agreement includes terms for education services to be provided by Edwards to DHB personnel on appropriate use of its interventional cardiology products, which is to be provided at times as agreed with individual DHBs.

Background

In April 2014 PHARMAC issued a registration of interest (ROI) for interventional cardiology products, seeking proposals from suppliers for non-exclusive national agreements for a listing on the Pharmaceutical Schedule. Following closure of this request, PHARMAC has been working with a number of suppliers seeking to reach an agreement with them. The proposed agreement with Edwards is the thirteenth and final agreement arising from that process.