Proposal to award Principal Supply Status for permanent coronary drug-eluting stents to Boston Scientific New Zealand Limited
Pharmac is seeking feedback on a proposal to list a range of medical devices in Part III of Section H of the Pharmaceutical Schedule.
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 firstname.lastname@example.org.
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.
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
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
Who we think will be interested
- Catherisation laboratory clinical personnel including but not limited to:
- Interventional Cardiologists
- Radiography personnel
- Procurement personnel
- Service/Funding Managers
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 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 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: email@example.com 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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