Proposal to award Principal Supply Status for permanent coronary drug-eluting stents to Boston Scientific New Zealand Limited

What we’re proposing

Pharmac is seeking feedback on a proposal to award Principal Supply Status for the supply of permanent coronary drug-eluting stents (“DES”) to Te Whatu Ora hospitals through a provisional agreement with Boston Scientific New Zealand Limited (“Boston”).

It is proposed that:

• from 1 November 2022 Boston’s brands of DES, Promus Elite, Synergy XD and Synergy Megatron, would be listed in Part III of Section H of the Pharmaceutical Schedule and available for Te Whatu Ora hospitals at reduced prices;
• a transition period would apply from 1 November 2022 to 28 February 2023; and
• Promus Elite, Synergy XD and Synergy Megatron would have Principal Supply Status from 1 March 2023 to 1 March 2026.

Other brands of DES would remain listed in the Pharmaceutical Schedule and would be available for use by Te Whatu Ora hospitals in accordance with the Alternative Brand Allowance.

Consultation closes at 4pm Friday 23 September 2022 and feedback can be emailed to alyssa.currie@pharmac.govt.nz.

What would the effect be?

Principal Supply Status

This proposal would result in awarding Principal Supply Status to Boston for the supply of DES to Te Whatu Ora hospitals with an Alternative Brand Allowance of 35% for a term of three years.

If this proposal is approved, this would mean that for the term of the Principal Supply Status Te Whatu Ora hospitals:

• must purchase a minimum of 65% of DES from Boston and
• can choose to purchase a maximum of 35% DES from suppliers other than Boston.

35% Alternative Brand Allowance

An Alternative Brand Allowance of 35% means that 35% of the DES purchased in Te Whatu Ora hospitals could be a brand that is not Promus Elite, Synergy XD and Synergy Megatron supplied by Boston.

Principal Supply Status Exemptions

DES purchased by Te Whatu Ora hospitals for the purpose of registered clinical trials would not be counted as Brand Allowance Medical Devices.

Timeline

Who we think will be interested

• Catherisation laboratory clinical personnel including but not limited to:
  • Interventional Cardiologists
  • Nurses
  • Radiography personnel
  • Technicians
• Procurement personnel
• Service/Funding Managers
• Suppliers

About the medical devices

Drug-eluting stents (DES)

A DES is a non-bioresorbable metal scaffold, coated with a pharmacological agent known to suppress restenosis, that is placed at the site of a major blockage in a coronary artery to hold the artery open and restore blood flow to the heart muscle.

Why we’re proposing this

Since 2017 Pharmac has sought advice from the Interventional Cardiology Advisory Group (“ICAG”) to assist with the development of market share Requests for Proposals (“RFPs”) and attain expert advice on the clinical suitability of different brands of DES.

In March 2022 Pharmac issued an RFP for DES under the Principal Supply Status model.

Pharmac had a similar market share arrangement that ended 30 June 2022. This process was undertaken to obtain quality product at competitive pricing.

Details about our proposal

The proposal would result in awarding Promus Elite, Synergy XD and Synergy Megatron Principal Supply Status, covering 140 product lines.

If new generations of Boston’s DES are launched during the Principal Supply Status period national pricing would be negotiated by Pharmac and Te Whatu Ora hospitals would be able to purchase the new DES as part of the Principal Supply Status.

Boston support

Boston would provide Te Whatu Ora personnel with training, education and clinical case support throughout the period of Principal Supply Status. Boston would also support the initial transition by working with each Te Whatu Ora hospital to establish the requirements of the hospital, including but not limited to:

• consignment stock levels
• transition timeframes
• in-service requirements, and
• product conversation support.

Pharmac support

Pharmac would contact nominated Te Whatu Ora personnel prior to 1 November 2022 to discuss their hospitals support needs and would also regularly liaise with them to work through any issues that arise during and after implementation. Nominated Te Whatu Ora personnel would be provided with an implementation pack to assist with the transition to the Principal Supply Status model for DES with Boston.

Further information, including pricing and contractual details, has been provided to Te Whatu Ora Procurement personnel as part of this consultation.

Monitoring compliance with Alternative Brand Allowance

Throughout the Principal Supply Status period the 35% Alternative Brand Allowance would apply. Pharmac would monitor compliance and if the use of Alternative Brand Medical Devices is within the 35% Alternative Brand Allowance at a national level, the contract requirement would be met. If Te Whatu Ora hospitals exceed the 35% Alternative Brand Allowance Boston would be entitled to seek compensation from Te Whatu Ora.

To provide feedback

Send us an email: alyssa.currie@pharmac.govt.nz by 4pm Friday 23 September 2022.

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.

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