Decision to award Principal Supply Status for dasatinib tablets
What we’re doing
Dasatinib is currently funded for people with chronic myeloid leukaemia (CML) and Philadelphia chromosome-positive acute lymphoid leukaemia (Ph+ ALL), subject to eligibility criteria [PDF](external link).
As part of our Annual Invitation to Tender process, a decision has been made to award Principal Supply Status (PSS) of dasatinib tablets to Dasatinib-Teva, supplied by Teva Pharma (New Zealand) Limited (Teva). This means that there will be a be a change in the funded brand of dasatinib.
Dasatinib-Teva will be listed on the Pharmaceutical Schedule from 1 October 2024 and it will be the principal funded brand of dasatinib from 1 March 2025 until 30 June 2027.
Who we think will be most interested
- People with leukaemia and their family, whānau and caregivers
- Prescribers of dasatinib and pharmacists
- Groups who advocate for and support people with leukaemia
- Pharmaceutical suppliers and wholesalers
What this means for people and prescribers
When considering a potential competitive process for dasatinib, our clinical advisors noted the success of previous brand changes for imatinib. They considered that the Annual Invitation to Tender would be an appropriate way to compete this market, due to the limited clinical risk and appropriateness of the usual transition period.
April 2023 Cancer Treatments Advisory Commttee meeting record [PDF, 1.1 MB]
Principal Supply Status means that Dasatinib-Teva will be guaranteed at least 95% of the funded dasatinib market, with any alternative brand requiring approval through Pharmac’s Exceptional Circumstances Framework.
From 1 October 2024
Dasatinib-Teva will be listed on the Pharmaceutical Schedule alongside the current brand (Sprycel). People currently receiving dasatinib tablets will need to change from the Sprycel brand to the Dasatinib-Teva brand between 1 October 2024 and 1 March 2025.
From 1 March 2025
Sprycel will be delisted and Dasatinib-Teva will be the only brand of dasatinib tablets listed on the Pharmaceutical Schedule. Everyone needs to have transitioned to the Dasatinib-Teva brand.
Support for the transition
We will have a dedicated page on the Pharmac website with information about the change for individuals as well as health care professionals.
Support for healthcare professionals
We intend to communicate directly with recent prescribers of dasatinib and provide clear information regarding this brand change to ensure a smooth transition for all patients.
Information to support the change will also be made available on the New Zealand Formulary and Health Pathways.
Support for people taking dasatinib
We want everyone to have the information they need to understand the change and what it means for them.
We understand that some people may be uncertain about moving to a generic brand of dasatinib. A generic medicine has the same active ingredients and works in the same way as the original brand. You can find more information about generic medicines on our website.
Pharmac will work with consumer groups and the supplier to inform people directly impacted by the brand change. This will include:
- any differences between the Sprycel brand and Dasatinib-Teva, such as packaging or tablet shape or colour
- pictures of the new brand
- information on generic medicines
- where to find more information.
The information on the Pharmac website will be provided to patient support groups to share with people affected by this change. This information will be downloadable in PDF format in a range of languages to help inform population groups affected by this change.
Details about this decision
From 1 October 2024 Teva’s brand of dasatinib tablets 20 mg, 50 mg and 70 mg will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule as follows.
| Chemical and Presentation | Brand | Pack Size | Current Price and Subsidy (ex-man., ex. GST) | New Price and Subsidy (ex-man., ex. GST) |
|---|---|---|---|---|
| Dasatinib Tab 20 mg | Dasatinib-Teva | 60 | $3,774.06 | $132.88 |
| Dasatinib Tab 50 mg | Dasatinib-Teva | 60 | $6,214.20 | $304.13 |
| Dasatinib Tab 70 mg | Dasatinib-Teva | 60 | $7,692.58 | $415.75 |
The Sprycel brand of dasatinib will be delisted from Section B and Part II of Section H of the Pharmaceutical Schedule from 1 March 2025.
A Brand Switch Fee will be payable to Pharmacies from 1 March 2025 until 31 May 2025. Only one Brand switch Fee will be payable per patient.
Minor amendments have been made to the Special Authority criteria for all brands from 1 October 2024. The criteria related to maximum dose restrictions and enrolment in the KISS trial have been removed as they are no longer needed.
Dasatinib will be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria.
Special Authority for Subsidy
Initial application only from a haematologist or Practitioner on the recommendation of a haematologist. Approvals valid for 6 months for applications meeting the following criteria:
Any of the following:
- The patient has a diagnosis of chronic myeloid leukaemia (CML) in blast crisis or accelerated phase; or
- The patient has a diagnosis of Philadelphia chromosome-positive acute lymphoid leukaemia (Ph+ ALL); or
- Both
- The patient has a diagnosis of CML in chronic phase; and
- Any of the following:
- Patient has documented treatment failure* with imatinib; or
- Patient has experienced treatment-limiting toxicity with imatinib precluding further treatment with imatinib; or
- Patient has high-risk chronic-phase CML defined by the Sokal or EURO scoring system.
Renewal only from a haematologist or Practitioner on the recommendation of a haematologist. Approvals valid for 6 months for applications meeting the following criteria:
Both:
- Lack of treatment failure while on dasatinib*; and
- Dasatinib treatment remains appropriate and the patient is benefiting from treatment.
Note:
* treatment failure for CML as defined by Leukaemia Net Guidelines.
Similar eligibility criteria will apply in Part II of Section H of the Pharmaceutical Schedule from 1 October 2024.
Our response to what you told us
Dasatinib was included in the draft 2023/24 Invitation to Tender which was open for consultation in July 2023. No consultation feedback was received in relation to the inclusion of dasatinib in the 2023/24 Invitation to Tender.
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.