Decision to list medical devices supplied by Cubro Limited

Source: Pharmac

19 October 2020

What we’re doing

We are pleased to announce the approval of a listing agreement with Cubro Limited (“Cubro”) for the supply of medical devices in the following categories:

In summary this will result in:

  • NIV products and rehabilitation products being listed in Part III of Section H of the Pharmaceutical Schedule from 1 December 2020 under a national agreement that all DHBs may purchase under (“Agreement”); and
  • DHBs being able to continue to purchase other suppliers’ brands of NIV products and rehabilitation products as the Agreement is not for sole supply.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 15 September 2020.

No changes have been made as a result of consultation feedback.

Who we think will be most interested

  • DHB clinical staff in a range of clinical settings including:
    • Clinical engineers and maintenance services
    • Clinical staff in a range of inpatient, outpatient and community settings where NIV Products are used

    • DHB procurement and supply chain

    • Geriatricians

    • Neurologists and Neurosurgeons

    • Nurses

    • Occupational therapists

    • Orthopaedic surgeons

    • Orthotists

    • Paediatricians

    • Physiotherapists

    • Podiatrists

    • Pulmonary rehabilitation specialists

    • Rehabilitation physicians (including spinal units)

    • Respiratory and sleep clinic specialists and support personnel

    • Speech-language therapists

  • Suppliers and wholesalers

Details about this decision

In 2018 PHARMAC issued requests for proposals (RFPs) for:

The RFPs requested proposals for non-exclusive national agreements for listing on the Pharmaceutical Schedule.

After completing the evaluation process, and consulting of the provisional Agreement reached with Cubro, PHARMAC has decided to list Cubro’s NIV products and rehabilitation products in Part III of Section H of the Pharmaceutical Schedule from 1 December 2020.

The list of products will be available on PHARMAC’s website from 1 December 2020, in both a PDF document and an Excel spreadsheet.

DHBs can continue to choose which NIV products and rehabilitation products they purchase, including those from other suppliers. DHBs that purchase NIV products or rehabilitation products must do so under the terms and conditions, including pricing, in the Agreement from 1 December 2020.

The Agreement includes terms and conditions for training and education to be provided by Cubro on the appropriate use of its NIV products and rehabilitation products, which is to be provided at times and in formats as agreed with individual DHBs.

Our response to what you told us

We appreciate the time people took to respond to this consultation.

All consultation responses received by 6 October 2020 were considered in their entirety in making the decision to list NIV products and rehabilitation products supplied by Cubro.

A summary of the main themes raised in feedback and our responses to the feedback are set out below:

Theme

Comment

No technical or resourceimplications anticipated as a result of the proposal.

Noted

Feedback received from a DHB on additional products that would be useful to be included.

PHARMAC advised that the proposal does not limit who DHBs can purchase from and that alternative products can be sourced from other suppliers where they are not available from Cubro. 

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 66 00 50.

Last updated: 19 October 2020

Proposal to list haemodialysis equipment and products by Nipro Australia Pty Ltd

Source: Pharmac

What we’re proposing

PHARMAC is seeking feedback on a proposal to list a range of haemodialysis equipment and products in Part III of Section H of the Pharmaceutical Schedule from 1 December 2020 through a provisional Agreement with Nipro Australia Pty Ltd (“Nipro”).

Consultation closes 4pm Tuesday 3 November 2020 and feedback can be emailed to terry.odonnell@pharmac.govt.nz.

What would the effect be?

From 1 December 2020, Nipro’s range of haemodialysis equipment and products would be listed under the proposed national agreement (“Agreement”) that all DHBs may purchase under, subject to consultation and approval by PHARMAC’s Board or delegate.

The Agreement would not be for sole supply, with DHBs continuing to be able to purchase other suppliers’ brands of haemodialysis equipment and products.

The Agreement would supersede any existing DHB contract with the supplier for the devices listed in the Agreement, unless otherwise referenced in the Agreement. Any device listed in a PHARMAC Agreement and purchased by a DHB would be at the price, terms and conditions stated in the Agreement, effective from the date of listing on the Pharmaceutical Schedule.

Who we think will be interested

  • DHB staff
    • Renal dialysis staff
    • Procurement officers
  • Suppliers and wholesalers

About haemodialysis products

Haemodialysis is used to treat renal failure, both acute and chronic. The leading cause of renal failure is diabetes. Patients require treatments to be performed on average three times per week with each session lasting on average four hours.

Most treatment is provided in a DHB Hospital or DHB satellite centre, though some patients self-administer using equipment installed in their home. Acute dialysis may be required for patients in intensive care who have undergone significant trauma or illness. Acute treatment may result in the patient’s full recovery or may lead to long term chronic dialysis.

Chronic haemodialysis is usually required until either the patient changes to peritoneal dialysis, receives a kidney transplant or no longer gains benefit from treatment and enters palliative care.

Why we’re proposing this

In February 2018, PHARMAC issued a  Request for Proposal (“RFP”) for the supply of haemodialysis equipment and products

The RFP was for non-exclusive national agreements for listing on the Pharmaceutical Schedule.

PHARMAC has been working with suppliers in order to seek provisional agreements and this is the latest proposal to arise from that process. We intend to consult on proposed agreements with other suppliers over the next few months.

Details about our proposal

PHARMAC has entered into a provisional Agreement with Nipro for the supply of a range of haemodialysis related equipment, products and support services. This includes haemodialysis machines and associated consumables, maintenance and service options (including all spare parts for the equipment).

We are making the full product list and pricing options available to Procurement Managers at DHBs.

To provide feedback

Send us an email: terry.odonnell@pharmac.govt.nz by 4pm Tuesday 3 November 2020.

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.

Last updated: 13 October 2020

Proposal to list infusion devices supplied by Teleflex Medical New Zealand

Source: Pharmac

What we’re proposing

PHARMAC is seeking feedback on a proposal to list medical devices supplied by Teleflex Medical New Zealand in Part III of Section H of the Pharmaceutical Schedule from 1 December 2020.

We propose to list medical devices in the following categories:

Consultation closes at 4pm Monday 2 November 2020 and feedback can be emailed to tyson.edwards@pharmac.govt.nz.

What would the effect be?

From 1 December 2020, Infusion Devices supplied by Teleflex would be listed under a proposed national agreement for all DHB hospitals to purchase under, subject to consultation and approval by PHARMAC’s Board or delegate (“Agreement”).

The Agreement would not be for sole supply and DHBs could continue to purchase other suppliers’ brands of products in the Infusion Devices category.

The Agreement would supersede any existing DHB contracts with Teleflex for the products included in the Agreement. Any product listed in the Agreement and purchased by a DHB would be in accordance with the terms and conditions, including price, stated in the Agreement effective from the date of listing on the Pharmaceutical Schedule.

Teleflex would provide appropriate educational services that would be tailored to the individual needs of DHBs, in formats and at times as required by DHBs.

Pricing for the devices in this Agreement, subject to any prior termination of the Agreement, would not be increased without prior consultation and approval by PHARMAC.

Who we think will be interested

  • DHB clinical staff in a range of different clinical settings inluding:
    • Procurement officers and supply chain personnel
    • Clinical engineers and maintenance services
    • ICU, emergency, and critical care staff
    • Anaesthetists
    • Perioperative care staff
    • Surgeons
    • Oncologists
    • Nurses (both inpatient and community based)
    • Infection control
    • General medical ward staff
  • Suppliers and wholesalers

About the infusion devices

Infusion devices are medical devices used, or associated with devices used, in the infusion of fluids such as medications, intravenous solutions (such as saline, glucose, and electrolyte solutions), blood, total parenteral nutrition (TPN) solutions into the body. This includes medical devices used in intravenous therapy as well as other infusion therapies.

PHARMAC’s infusion devices category includes:

Why we’re proposing this

In 2018 PHARMAC issued a Request for Proposals for:

The RFP was for non-exclusive national agreements for listing on the Pharmaceutical Schedule.

PHARMAC has been working with suppliers who responded to the RFP, and proposals were progressed to contract negotiation, to seek provisional agreements. This proposal is the latest to arise from this process and we expect to consult on further provisional agreements with suppliers of Infusion Devices throughout 2020 and 2021.

Details about our proposal

PHARMAC has entered into a provisional agreement with Teleflex for the supply of infusion devices. The proposal would result in Pharmaceutical Schedule listings for:

  • 121 non-dedicated & consumable infusion devices supplied by Teleflex under the brand names Arrow, Arrow International, Arrow AutoFuser, Arrow EZ-IO, Arrowg+ard Blue, and Arrowg+ard Blue Plus

Further information, including pricing and contractual details, has been provided to DHB Procurement personnel. Clinicians interested in further detail on what this change means for their DHB should engage with their Procurement teams.

To provide feedback

Send us an email: tyson.edwards@pharmac.govt.nz by 4pm Monday 2 November 2020.

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.

Last updated: 12 October 2020

Proposal to list medical devices supplied by Protec Solutions limited

Source: Pharmac

What we’re proposing

PHARMAC is seeking feedback on a proposal to list medical devices supplied by Protec Solutions Limited (“Protec”) in Part III of Section H of the Pharmaceutical Schedule from 1 December 2020.

We propose to list medical devices supplied by Protec in the following category:

Consultation closes at 4pm Friday 23 October 2020 and feedback can be emailed to ruben.kunst-sopacua@pharmac.govt.nz.

What would the effect be?

From 1 December 2020, Protec’s ranges of medical devices in the category listed above would be listed under a national agreement for all DHBs to purchase under, subject to consultation and approval by PHARMAC’s Board or delegate (“Agreement”).

The Agreement would not be for sole supply, with DHBs continuing to be able to purchase other suppliers’ brands of surgical drapes, gowns and procedure packs.

The Agreement would supersede any existing DHB contracts with Protec for the medical devices included in the Agreement. Any device listed in the PHARMAC Agreement and purchased by a DHB would be at the price, terms and conditions stated in the Agreement, effective from the date of listing on the Pharmaceutical Schedule.

As part of the Agreement, Protec would provide appropriate training and education services that would be tailored to the needs of the individuals DHBs, in formats and at times as required by DHBs.

Pricing for the medical devices in the Agreement, subject to any prior termination of the Agreement, would not be increased without prior consultation and approval by PHARMAC.

Who we think will be interested

  • Suppliers and wholesalers
  • DHB  clinical staff in a range of clinical settings including:
    • inpatient, outpatient and community settings;
    • general wards;
    • perioperative;
    • infection control;
    • central sterile services personnel;
    • occupational health and safety.
  • DHB procurement and supply chain personnel

About surgical drapes, gowns and procedure packs

Single use sterile surgical drapes are used during surgery to reduce the risk of infection of the surgical site by isolating and protecting the surgical site from exposure to microorganisms that may be present in the patient’s own microbial flora, the operating theatre environment, or on members of the surgical team.

Single use sterile surgical gowns are personal protective garments intended to be worn over the scrub suit of the operating team during surgical procedures.

Procedure packs are customisable and made specifically to the DHB’s clinician’s needs. They include a variety of disposable items.

Why we’re proposing this

In 2018 PHARMAC issued a Request for Proposal (“RFP”) for the supply of single-use sterile surgical drapes, gowns and procedure packs

The RFP was for non-exclusive national agreements for listing on the Pharmaceutical Schedule.

PHARMAC is working with a range of suppliers to seek provisional agreements in this category, this proposal is the latest to arise from these processes. 

We expect to consult on further proposed agreements in the surgical drapes, gowns and procedure packs category over the coming months.

Details about our proposal

The proposal would result in Pharmaceutical Schedule listings for 3 surgical drapes and gowns supplied by Protec. The proposed surgical drapes, gowns and procedure packs are from p3 Medical and Sentry Medical’s brands.

A full product list with pricing has been made available to appropriate DHB personnel.

To provide feedback

Send us an email: ruben.kunst-sopacua@pharmac.govt.nz by 4pm Friday 23 October 2020.

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.

Last updated: 9 October 2020

Proposal to list medical devices supplied by Merit Medical New Zealand limited

Source: Pharmac

What we’re proposing

PHARMAC is seeking feedback on a proposal to list medical devices supplied by Merit Medical New Zealand Limited (“Merit”) in Part III of Section H of the Pharmaceutical Schedule from 1 December 2020.

We propose to list medical devices supplied by Merit in the following category:

Consultation closes at 4pm Friday 23 October 2020 and feedback can be emailed to ruben.kunst-sopacua@pharmac.govt.nz.

What would the effect be?

From 1 December 2020, Merit’s ranges of medical devices in the category listed above would be listed under a national agreement for all DHBs to purchase under, subject to consultation and approval by PHARMAC’s Board or delegate (“Agreement”).

The Agreement would not be for sole supply, with DHBs continuing to be able to purchase other suppliers’ brands of surgical drapes, gowns and procedure packs.

The Agreement would supersede any existing DHB contracts with Merit for the medical devices included in the Agreement. Any device listed in the PHARMAC Agreement and purchased by a DHB would be at the price, terms and conditions stated in the Agreement, effective from the date of listing on the Pharmaceutical Schedule.

As part of the Agreement, Merit would provide appropriate training and education services that would be tailored to the needs of the individuals DHBs, in formats and at times as required by DHBs.

Pricing for the medical devices in the Agreement, subject to any prior termination of the Agreement, would not be increased without prior consultation and approval by PHARMAC.

Who we think will be interested

  • Suppliers and wholesalers
  • DHB  clinical staff in a range of clinical settings including:
    • inpatient, outpatient and community settings;
    • general wards;
    • perioperative;
    • infection control;
    • central sterile services personnel;
    • occupational health and safety.
  • DHB procurement and supply chain personnel

About surgical drapes, gowns and procedure packs

Single use sterile surgical drapes are used during surgery to reduce the risk of infection of the surgical site by isolating and protecting the surgical site from exposure to microorganisms that may be present in the patient’s own microbial flora, the operating theatre environment, or on members of the surgical team.

Single use sterile surgical gowns are personal protective garments intended to be worn over the scrub suit of the operating team during surgical procedures.

Procedure packs are customisable and made specifically to the DHB’s clinician’s needs. They include a variety of disposable items.

Why we’re proposing this

In 2018 PHARMAC issued a Request for Proposal (“RFP”) for the supply of single-use sterile surgical drapes, gowns and procedure packs

The RFP was for non-exclusive national agreements for listing on the Pharmaceutical Schedule.

PHARMAC is working with a range of suppliers to seek provisional agreements in this category, this proposal is the latest to arise from these processes. 

We expect to consult on further proposed agreements in the surgical drapes, gowns and procedure packs category over the coming months.

Details about our proposal

The proposal would result in Pharmaceutical Schedule listings for 54 surgical drapes and gowns supplied by Merit. The proposed surgical drapes, gowns and procedure packs are from the Merit brand.

A full product list with pricing has been made available to appropriate DHB personnel.

To provide feedback

Send us an email: ruben.kunst-sopacua@pharmac.govt.nz by 4pm Friday 23 October 2020.

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.

Last updated: 9 October 2020

Decision to list medical devices supplied by Jackson Allison Medical & Surgical Limited

Source: Pharmac

What we’re doing

We are pleased to announce the approval of the amendment to the non-exclusive listing amendment with Jackson Allison Medical & Surgical Limited for the supply of obstetrics and gynaecology products, and rehabilitation equipment.

In summary this will result in:

  • 91 of Jackson Allison’s products being listed in Part III of Section H of the Pharmaceutical Schedule from 1 November 2020 under a national agreement that all DHBs may purchase under (“Agreement”); and
  • DHBs being able to continue to purchase other suppliers’ brands of obstetrics and gynaecology products, and rehabilitation equipment.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 10 September 2020.

No changes were made to the agreement following consultation feedback.

Who we think will be most interested

  • DHB clinical staff in a range of clinical settings including:
    • Clinical engineers and maintenance services
    • DHB procurement and supply chain
    • Geriatricians
    • Perioperative staff
    • Theatre staff
    • Surgical, gynaecology and general ward staff
    • Central sterile services personnel
    • Delivery suite staff
    • Midwives
    • Obstetricians and Gynaecologists
    • Neurologists and Neurosurgeons
    • Nurses
    • Occupational therapists
    • Orthopaedic surgeons
    • Orthotists
    • Paediatricians
    • Physiotherapists
    • Podiatrists
    • Rehabilitation physicians (including spinal units)
    • Speech-language therapists
  • Suppliers and wholesalers

Details about this decision

In 2018 PHARMAC issued requests for proposals (RFPs) for:

The RFPs requested proposals for non-exclusive national agreements for listing on the Pharmaceutical Schedule.

After completing the RFP evaluation processes, and consulting on the provisional agreement reached with Jackson Allison, PHARMAC has decided to list Jackson Allison’s medical devices, in the categories listed above, in Part III of Section H of the Pharmaceutical Schedule from 1 November 2020.

The list of products will be available on PHARMAC’s website from 1 November 2020, in both a PDF document and an Excel spreadsheet.

DHBs can continue to choose which obstetrics and gynaecology, and Rehabilitation Products they purchase, including those from other suppliers. DHBs that purchase obstetrics and gynaecology, and Rehabilitation Products from Jackson Allison must do so under the terms and conditions, including pricing, in the Agreement, from 1 November 2020.

The Agreement includes terms and conditions for training and education to be provided by Jackson Allison on the appropriate use of its products, which is to be provided at times as agreed with individual DHBs. 

Our response to what you told us

We appreciate the time people took to respond to this consultation.

A summary of the main themes raised in feedback and our responses to the feedback are set out below:

Theme

Comment

No technical or resource impacts are expected

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 66 00 50.

Last updated: 8 October 2020

Inaugural Chief Advisor, Māori appointed to PHARMAC

Source: Pharmac

8 October 2020

PHARMAC is committed to upholding the articles of te Tiriti o Waitangi across all areas of our work. It is for this reason we are delighted to announce the development of a new role – Chief Advisor, Maori, and the appointment of Trevor Simpson (Tuhoe, Ngāti Awa).

Trevor comes to PHARMAC after more than eight years with the Health Promotion Forum, where he holds the role of Deputy Executive Director and Senior Health Promotion Strategist (Māori portfolio). Prior to this he worked in a number of vocations including Crown Land administration, Treaty Settlements, Maori social work and special youth projects. His interests are in raising the profile of Māori issues particularly in the areas of health and matters of social importance. Trevor is committed to health promotion as a fundamental approach to improving Māori health status and believes that strong Māori leadership in this field is an essential facet if we are to contemplate success.

“Trevor, as our Chief Advisor Māori, will ensure we receive robust Māori advice at a senior leadership level to inform and shape how we give effect to our commitment to Te Tiriti o Waitangi, including equity for Māori, into all of our work.

Trevor’s wealth of understanding of Māori health needs and experience in Māori health promotion will be invaluable at PHARMAC and we look forward to him starting at the end of the month.

Last updated: 8 October 2020

Decision to change PHARMAC’s approach to competitive procurement

Source: Pharmac

What we’re doing

We’re pleased to announce the decision to start offering and awarding Principal Supply Status in our competitive procurement processes.

This will create a consistent approach between the community and DHB hospital markets, improving the methods that we have used for many years.

Any changes to the original proposal?

This decision was subject to consultation on 4 August 2020 which was sent to suppliers,  healthcare professionals, patient advocacy groups and on PHARMAC’s website for anyone else wanting to have their say, as well as an earlier consultation to pharmaceutical suppliers on 10 July 2020.

The Principal Supply Status approach will be implemented, largely as proposed, in the annual Invitation to Tender (ITT) that will be issued in November 2020 for contracts that will commence from 1 July 2021.  It may also be utilised in other competitive procurement processes that we undertake going forward.

We received useful feedback on the proposed contract terms for the principal supplier relating to audit provisions, and we are currently considering these suggestions prior to finalising the terms and conditions for the 2020/21 ITT.

Who we think will be most interested

  • Pharmaceutical suppliers
  • Health professionals, including prescribers and pharmacists
  • Patient advocacy groups

Detail about this decision

Starting with the 2020/21 Invitation to Tender, PHARMAC will replace the use of Sole Supply Status (in the community) and Hospital Supply Status (in DHB hospitals) with Principal Supply Status. This change will give PHARMAC greater flexibility to fund alternative brands for those who may experience, or are at heightened risk of, adverse clinical outcomes due to a brand change.

In the case of community pharmaceuticals, this means that alternative brands might be listed in the Schedule (under Special Authority criteria) or funded through our exceptional circumstances framework, under specified criteria for patients who:

  • are experiencing adverse clinical outcomes following a brand change, and wish to change back to their previous brand, or
  • have unique clinical circumstances that would put them at heightened risk of adverse clinical outcomes, and their prescriber wishes to avoid a brand change, or
  • have circumstances that mean they require a temporary delay to a brand change (eg pregnancy or pending surgery).

In the case of hospital medicines, Principal Supply Status would operate essentially the same as Hospital Supply Status does now.

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. A summary of the main themes raised in feedback and our responses to the feedback received are set out below. 

Theme

Comment

Responders provided feedback on potential categories of patients and classes of medicines that would particularly benefit from alternative brands being available.

We appreciate the information provided and will be considering this in further detail as we make decisions about individual products.

Some responders noted that this change would not have a material impact on reducing risks associated with supply disruptions.

This change is not intended to address supply chain risks, and we agree that it will be unlikely to have an impact in that regard.

Some responders were concerned that this would result in multiple brands being funded for every pharmaceutical, and that this would result in additional cost to the supply chain.

Brand changes are generally well-tolerated, and we expect that funding of alternative brands will not be required for most products.

It was noted that prescribers often prescribe by brand, including for brands that are no longer funded, which can make it difficult for a pharmacist to ascertain whether or not they specifically intend for an alternative brand to be dispensed.

We agree that generic prescribing is preferable when a specific brand is not required and we note that Medical Council prescribing guidelines in this regard.(external link)

Where a specific brand is intended, prescribing by brand with ‘no substitution’ specified, as per the Medicines Regulations 1984, Regulation 42 (4), provides clarity to the dispensing pharmacist.

Suppliers provided some feedback about draft contract terms relevant to Principal Supply Status, particularly in relation to auditing usage relative to the alternative brand allowance limit.

We will be carefully considering these suggestions as we finalise the 2020/21 ITT terms and conditions in the coming weeks.

Suppliers noted that the contractual arrangements for alternative brands would not be managed through the ITT and were keen to better understand what the contractual arrangements would be for any alternative brands.

Our intention at this stage is to enter into new agreements with suppliers for medicines that we wish to fund as alternative brands through the Schedule.

Some responders had concerns about the potential for creating niche markets, particularly in relation to commercial viability and regulatory consents.

We agree that these are important considerations, and we will be working with suppliers of alternative brands in the future to ensure viable ongoing supply of registered products.

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 66 00 50.

Last updated: 7 October 2020

Decision to list medical devices supplied by Apex Medical NZ Limited

Source: Pharmac

What we are doing

We’re pleased to announce the approval of a non-exclusive listing agreement with Apex Medical NZ Limited (“Apex Medical”) for the supply of respiratory equipment and consumables.

In summary this will result in 13 of Apex Medical’s products being listed in Part III of Section H of the Pharmaceutical Schedule from 1 November 2020 under a national agreement that all DHBs may purchase under (“Agreement”). 

DHBs would continue to be able to purchase other suppliers’ brands of respiratory equipment and consumable products as the agreement is not for sole supply.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 10 September 2020.

No changes were made to the agreement following consultation feedback.

Who we think will be most interested

  • Clinical and non-clinical DHB staff:
    • Clinical/biomedical engineers
    • Anaesthetists and anaesthetic technicians
    • Clinical staff involved with airway management and emergency respiratory resuscitation
    • Respiratory clinicians
    • Respiratory therapists
    • Pulmonary function specialists
    • Pulmonary rehabilitation specialists
    • Procurement and supply chain personnel
  • Suppliers and Wholesalers

Details about this decision

In 2017 PHARMAC issued a Request for Proposals (“RFP”) for respiratory equipment and consumables.

The RFP was for non-exclusive national agreements for listing in the Pharmaceutical Schedule.

After completing the RFP evaluation process, and consulting on the provisional agreement reached with Apex Medical, PHARMAC has decided to list Apex Medical’s medical sevices in Part III of Section H of the Pharmaceutical Schedule from 1 November 2020.

The list of products will be available on PHARMAC’s website from 1 November 2020 in both PDF and Excel spreadsheet formats.

DHBs can continue to choose which respiratory equipment and consumables they purchase, including those from other suppliers. DHBs that purchase respiratory equipment and consumables from Apex Medical must do so under the terms and conditions, including pricing, in the Agreement, from 1 November 2020.

The Agreement includes terms and conditions for training and education to be provided by Apex Medical on the appropriate use of its products, which is to be provided at times as agreed with individual DHBs.

Our response to what you told us

We appreciate the time people took to respond to this consultation.

A summary of the main themes raised in feedback and our responses to the feedback received, are set out below: 

Theme

Comment

No technical or resource impacts are 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 66 00 50.

Last updated: 7 October 2020

Proposal to list medical devices supplied by Clinect NZ Pty Limited and Terumo Australia Pty Limited

Source: Pharmac

What we’re proposing

PHARMAC is seeking feedback on a proposal to list medical devices supplied by Clinect NZ Pty Limited and Terumo Australia Pty Limited in Part III of Section H of the Pharmaceutical Schedule from 1 December 2020.

We propose to list medical devices in the following categories:

  • a range of non-dedicated and consumable infusion devices (“infusion devices”) and non-dedicated feeding devices (“feeding devices”), through a non-exclusive provisional agreement with Terumo Australia Pty Limited (“Terumo”); and
  • a range of non-dedicated and consumable infusion devices through a non-exclusive provisional agreement with Clinect NZ Pty Limited (“Clinect”)

Consultation closes at 4pm Tuesday 27 October 2020 and feedback can be emailed to tyson.edwards@pharmac.govt.nz.

What would the effect be?

From 1 December 2020, infusion devices supplied by Clinect and infusion and feeding devices supplied by Terumo would be listed under a proposed national agreement for all DHB hospitals to purchase under, subject to consultation and approval by PHARMAC’s Board or delegate (“Agreement”).

The Agreement would not be for sole supply and DHBs could continue to purchase other suppliers’ brands of products in these categories of devices.

The Agreement would supersede any existing DHB contracts with Clinect and Terumo for the products included in the Agreement. Any product listed in the Agreement and purchased by a DHB would be in accordance with the terms and conditions, including price, stated in the Agreement effective from the date of listing on the Pharmaceutical Schedule.

Clinect and Terumo would provide appropriate educational services that would be tailored to the individual needs of DHBs, in formats and at times as required by DHBs.

Pricing for the devices in this Agreement, subject to any prior termination of the Agreement, would not be increased without prior consultation and approval by PHARMAC.

Who we think will be interested

  • DHB clinical staff in a range of different clinical settings inluding:
    • Procurement officers and supply chain personnel
    • Clinical engineers and maintenance services
    • ICU, emergency, and critical care staff
    • Anaesthetists
    • Perioperative care staff
    • Surgeons
    • Dietitians
    • Nurses (both inpatient and community based)
    • Geriatricians
    • Neurologists
    • Gastroenterologists
    • Paediatricians
  • Suppliers and wholesalers

About the medical devices

Infusion devices

Infusion devices are medical devices used, or associated with devices used, in the infusion of fluids such as medications, intravenous solutions (such as saline, glucose, and electrolyte solutions), blood, total parenteral nutrition (TPN) solutions into the body. This includes medical devices used in intravenous therapy as well as other infusion therapies.

PHARMAC’s infusion devices category includes:

Feeding devices

Feeding devices are medical devices used to deliver nutrition and hydration into the body through the gastrointestinal tract (enteral nutrition). Devices that supply nutrition via the circulatory system (parenteral nutrition) are contracted under the Infusion devices category.

Providing nutrition to patients who cannot consume adequate food and/or fluids orally is important to optimise healing, reduce recovery times, and lower complication rates. Feeding devices are used by patients with a wide variety of clinical conditions and across both acute and community-based settings.

PHARMAC’s feeding devices category includes:

  • Feeding equipment and associated devices
  • Non-dedicated feeding devices

Why we’re proposing this

In 2018 PHARMAC issued Requests for Proposals for:

The RFPs were for non-exclusive national agreements for listing on the Pharmaceutical Schedule.

PHARMAC has been working with suppliers who responded to the RFPs, and proposals were progressed to contract negotiation to seek provisional agreements. These proposals are the latest to arise from this process and we expect to consult on further provisional agreements with suppliers of infusion and feeding devices throughout 2020 and 2021.

Details about our proposal

PHARMAC has entered into provisional agreements with Clinect and Terumo for the supply of infusion and feeding devices. The proposal would result in Pharmaceutical Schedule listings for:

  • 3 non-dedicated & consumable infusion devices supplied by Clinect under the brand names Neria and Insuflon;
  • 34 non-dedicated & consumable infusion devices supplied by Terumo under the brand names Surflo. SurFlash, Safeed, and Surshield; and
  • 7 non-dedicated feeding devices supplied by Terumo under the brand name VR Medical

Further information, including pricing and contractual details, has been provided to DHB Procurement personnel. Clinicians interested in further detail on what this change means for their DHB should engage with their Procurement teams.

To provide feedback

Send us an email: tyson.edwards@pharmac.govt.nz by 4pm Tuesday 27 October 2020.

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.

Last updated: 6 October 2020