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

Hospital devices Decision

We are pleased to announce the approval of a listing agreement for the supply of medical devices to Te Whatu Ora hospitals.

What we’re doing

We are pleased to announce the approval of a decision to award Principal Supply Status (“PSS”) to Boston Scientific New Zealand Limited (“Boston”) for the supply of permanent coronary drug-eluting stents (“DES”) to Te Whatu Ora hospitals, with a 35% Alternative Brand Allowance (“ABA”). The PSS will apply from 1 March 2023 until 28 February 2026.

In summary this will result in:

  • Boston’s brands of DES, Promus Elite, Synergy XD and Synergy Megatron, being listed in Part III of Section H of the Pharmaceutical Schedule and available for Te Whatu Ora hospitals at reduced prices from 1 November 2022;
  • A transition period from 1 November 2022 to 28 February 2023 will apply;
  • Promus Elite, Synergy XD and Synergy Megatron having Principal Supply Status from 1 March 2023 to 1 March 2026; and
  • Estimated annual savings of over $735,000 across all Te Whatu Ora hospitals.

What does this mean?

Principal Supply Status

For the term of PSS, Te Whatu Ora hospitals:

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

35% Alternative Brand Allowance

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

Principal Supply Status Exemptions

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

Timeline

List date

The date at which the Promus Elite, Synergy XD and Synergy Megatron DES would be available for purchase by Te Whatu Ora hospitals at the new Principal Supply Status price.

1 November 2022

Transition period

A four month period that would allow Te Whatu Ora hospitals time to undertake any training and education that may be required and make the necessary changes to consignment stock of DES, before the Principal Supply Status provisions are effective and compliance with the Alternative Brand Allowance is required.

1 November 2022 to 28 February 2023

Principal Supply Status start date

The date at which Te Whatu Ora hospitals must only purchase the Principal Supply Status of DES, with 35% allowance for alternative brands.

1 March 2023

Principal Supply Status

The date at which Principal Supply Status with Boston would end. The term of the Principal Supply Status agreement is three years.

28 February 2026

Any changes to the original proposal?

This decision was subject to a consultation letter dated 25 August 2022.

There have been no changes as a result of consultation feedback.

Who we think will most be interested

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

About this decision

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.

This decision results 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 has contacted Te Whatu Ora 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 will be provided with an implementation pack to assist with the transition to the Principal Supply Status model for DES with Boston.

Monitoring compliance with Alternative Brand Allowance

Throughout the Principal Supply Status period the 35% Alternative Brand Allowance will apply. Pharmac will 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 will be met. If Te Whatu Ora hospitals exceed the 35% Alternative Brand Allowance Boston will be entitled to seek compensation from Te Whatu Ora.

Our response to what you told us

We are really grateful for the time people took to respond to this consultation.

All consultation responses received by the closing date were considered in their entirety in making this decision. A summary of the main themes raised in feedback and our responses to the feedback received are set out below.    

Theme

Comment

Support for the proposal.

Noted.

Concern that if new technology is available globally from Boston during the term of market share that it is not introduced in New Zealand.

If a next generation DES was made available globally by Boston during the term of market share Pharmac would work proactively to make this available to Te Whatu Ora hospitals taking account of the costs and benefits of the technology.

No technical or resource impacts anticipated as a result of the proposal.

Noted.

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 660 050.