Decision to amend the distribution and access criteria for dasatinib (Sprycel)

Medicines

Decision

PHARMAC has a made a decision to change the distribution arrangements and access criteria for the funding of dasatinib (Sprycel) tablets for chronic myeloid leukaemia (CML) and acute lymphoid leukaemia (ALL) from 1 June 2019.

What we are doing

PHARMAC has a made a decision to change the distribution arrangements and access criteria for the funding of dasatinib (Sprycel) tablets for chronic myeloid leukaemia (CML) and acute lymphoid leukaemia (ALL) from 1 June 2019.

In summary the changes mean:

  • dasatinib will be funded subject to a standard Special Authority managed by the Ministry of Health and there will no longer be a requirement for individual patient applications to be made to the CML coordinator at PHARMAC;
  • direct distribution of dasatinib to patients or their nominated collection point will cease and dasatinib will instead need to be collected from community pharmacies in the same way as other funded medicines;
  • dasatinib will be funded in the first-line treatment setting only for patients with Philadelphia chromosome-positive acute lymphoid leukaemia (Ph+ ALL) or for patients with CML in blast crisis, accelerated phase or those considered to have ‘high-risk’ disease. Funded access in the first-line setting will also be permitted for patients who are enrolled and receiving treatment in the non-industry funded Kinase Inhibition with Sprycel Start up (KISS) trial(external link);
  • for all other patients with CML, dasatinib will be funded as a second-line treatment for those who experience treatment failure or adverse events on imatinib.

Dasatinib will continue to be funded for existing patients who started on funded dasatinib treatment prior to 1 June 2019, including participants in the KISS trial who have already started funded treatment, providing that renewal criteria continue to be met.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 18 December 2018.

Three changes were made to the original proposal:

  • Making wastage claimable on dispensings by community pharmacies.
  • Allowing Special Authority applications from any Practitioner on the recommendation of a haematologist.
  • Amending the commencement date from 1 May 2019 to 1 June 2019.  

We want to thank everyone who provided all their thoughtful feedback to this consultation, which has fed into this decision.

Who we think will be most interested

  • People currently receiving treatment with dasatinib (for distribution changes).
  • Health practitioners and other groups involved in the treatment of CML.
  • Hospital and community pharmacists, DHBs, suppliers and wholesalers.
  • Ministry of Health Sector Operations and pharmacy software vendors.

What will the effect be?

For people taking dasatinib

From 1 June 2019, people taking dasatinib will need to get their funded dasatinib tablets from their usual community pharmacy and pay the standard prescription co-payment, in the same way as they do for most other funded medicines.

All people taking funded dasatinib before 1 June 2019 will receive their usual, scheduled four-week supply of dasatinib tablets delivered to their address of choice on 16 May 2019. An extra four-week supply of dasatinib tablets will be sent with this delivery to give a total of eight weeks’ supply.

This will give all people who are already taking dasatinib at least four weeks to obtain a prescription from their haematologist or GP for ongoing supplies of dasatinib and to have it dispensed from their usual community pharmacy from 1 June 2019.

Changes will be made to the Special Authority criteria for funding of dasatinib for people starting dasatinib after 1 June 2019

For Community Pharmacies

Community pharmacies will access dasatinib though their usual supply channels. Any community pharmacy dispensing funded dasatinib can claim reimbursement for it. The wastage rule will apply.

For Prescribers

Funded access to dasatinib will require Special Authority approval via the Ministry of Health’s Sector Operations in the same way as other treatments that are subject to Special Authority restrictions.

Individual applications for a Special Authority for patients will no longer be made to the CML coordinator at PHARMAC, meaning that the coordinator will no longer inform Sector Operations of the Special Authority approval.

PHARMAC will ensure that existing patients will have their current approvals transferred to the new Special Authority and a new Special Authority approval number will be issued by the Ministry of Health. The new number will be valid for at least three months past 1 June 2019 to ensure that all patients have time to arrange for a new prescription and for the first dispensing to be claimed. For new patients from 1 June, an initial Special Authority approval will be needed.

Initial and renewal Special Authority applications will need to be made by a haematologist or any other Practitioner on the recommendation of a haematologist; however, any registered medical practitioner (including GPs) could then prescribe the medication.

Direct distribution will cease so there will no longer be a requirement to submit applications/prescriptions to PHARMAC for dispensing. Patients will need to arrange their own prescriptions and present the prescription to their community pharmacy for dispensing.

Changes have been made to the Special Authority criteria for funding of dasatinib for newly diagnosed patients

For DHBs

The proposal will incur distribution costs for dasatinib that are not currently payable due to direct distribution arranged by PHARMAC. However, due to the changes to the criteria that will limit access to dasatinib for most people to second-line treatment after the significantly lower-cost imatinib, there will likely be longer-term savings to the health sector as a result of this proposal.

Detail about this decision

From 1 June 2019, the following changes will occur:

  • the 100 mg tab of dasatinib (Sprycel) will be delisted from Section B and Part II Section H of the Pharmaceutical Schedule. This strength is not currently being used in New Zealand.
  • the Xpharm rule will be removed from the listing of dasatinib (Sprycel) tab 20 mg, 50 mg and 70 mg in the Pharmaceutical Schedule. There will be no change to the price or subsidy of dasatinib and a confidential rebate will continue to apply to Sprycel.
  • the following Special Authority criteria will apply to dasatinib (Sprycel) tablets 20 mg, 50 mg and 70 mg in Section B of the Pharmaceutical Schedule:

DASATINIB – Special Authority for Subsidy – Retail pharmacy

Initial application from a haematologist or any Practitioner on the recommendation of a haematologist. Approvals valid for 6 months for applications meeting the following criteria:

Any of the following:

Renewal only from a haematologist or any Practitioner on the recommendation of a haematologist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

  1. Lack of treatment failure while on dasatinib*; and
  2. Dasatinib treatment remains appropriate and the patient is benefiting from treatment; and
  3. Maximum dasatinib dose of 140 mg/day for accelerated or blast phase CML and Ph+ ALL, and 100 mg/day for chronic phase CML.

The same criteria will apply to dasatinib (Sprycel) tablets 20 mg, 50 mg and 70 mg in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML).

Note:

*treatment failure for CML as defined by Leukaemia Net Guidelines.

Our response to what you told us

We’re grateful for the time people took to respond to the consultation. All consultation responses received by 30 January 2019 were considered in their entirety when making a decision.

The table below summarises the main issues raised in feedback, any changes we have made after listening to you, and other comments on the feedback.

Theme

PHARMAC response

Distribution changes

Some responders had some concerns about patients having to visit the pharmacy to collect their medication.

 

Our data show that most patients taking dasatinib are regularly visiting (or having someone visit for them) the pharmacy to collect other medications.

Further, approximately 70% of patients who currently receive dasatinib have it delivered to a community pharmacy or medical centre and so are already travelling (or having someone travel for them) to pick up the medicine.

This change aligns the distribution mechanisms with other medicines, including other funded CML treatments, where patients are required to collect their medication from a community pharmacy. Patients should contact their preferred pharmacy to make arrangements.

Some responders had concerns regarding additional GP fees, prescription charges and pharmacy co-payment costs.

The move will align distribution mechanisms with other funded CML treatments, where patients are required to obtain prescriptions from their prescriber and collect their medication from the pharmacy.

Patients may request their next prescription when they see their haematologist or GP (depending on who is managing their condition).

Some responders had concerns that requiring patients to arrange for their repeat prescriptions may result in a reduction in adherence.

Patients on other funded CML treatments are currently managing both their supply through a community pharmacy and their adherence with medication. The change to dasatinib distribution will align with the other funded medicines, including other CML treatments, where patients are required to collect their medication from the pharmacy.

PHARMAC will contact haematologists to alert them to the changes and request they make arrangements for prescriptions to be written and Special Authority applications applied for.

A group response noted that community pharmacists may need to make prior arrangements with patients to avoid unexpected delays, noting that the pharmacy is likely to procure medicine only once a prescription has been presented.

The response noted support for community pharmacy distribution as pharmacies can provide advice and clinical checks at the same time as supply.

We will ensure that patients are sent an eight- week supply of tablets on 16 May 2019. This means that patients will have at least 6 weeks from 1 June to arrange their ongoing prescription and supply.

PHARMAC will contact patients to alert them to the changes and request they make arrangements for prescriptions and remind them to present their prescription to a pharmacy well before their stock runs out.

Some responders noted that the consultation has not considered the risk of stock wastage and expiry.

We have amended the proposal to allow wastage to be claimable by community pharmacy. This should avoid financial loss in the rare event that packs are required to be broken and the remaining stock is unable to be used.

Given that dasatinib is an expensive medicine, we expect that pharmacies will communicate with patients that they will only order it once a valid prescription is presented. Patients will need to present a prescription or request a repeat well before their stock runs out.

A DHB hospital group response supported the simplified distribution process, but noted the potential cost to DHBs in terms of clinician and support services time to manage the change.

Currently, haematologists must submit a manual renewal application to PHARMAC on a six-monthly basis. The new Special Authority number could be applied for through the electronic Special Authority process. The change also allows for delegation of both the submission of Special Authority applications and prescription writing to other clinicians on the recommendation of a haematologist. The change is therefore likely to result in a reduction in time taken in the management of dasatinib patients for DHB support services.

Addition of prescriber type

Some responders were concerned that specialist care would not be required.

A clinician response did not agree with the proposal that GPs could prescribe this medication for patients with a Special Authority approval.

Another responder considered that the haematologist specialist’s view is important in ensuring the appropriate and timely clinical management of the patient to reduce the risk of clinical deterioration and ensure the optimal treatment strategy.

Decisions on who is responsible for a patient’s care is a clinical management issue outside of PHARMAC’s responsibility. PHARMAC will contact haematologists to alert them to the changes and request they make arrangements for prescriptions to be written and Special Authority applications applied for (either themselves or delegated to a GP or other Practitioner on their recommendation).

Any registered medical practitioner within their scope of practice can prescribe dasatinib, and these changes will mean that the prescription is now able to be eligible for funding for patients who have a Special Authority approval. This may be particularly beneficial for patients living in rural locations and others who cannot easily access specialist services.

We note that a number of consultation responses were supportive of the proposed changes in relation to the writing of prescriptions by either haematologists or GPs.

Comments regarding the scoring system in the Special Authority

Responses proposed that alternative scoring systems could be used instead of Sokal and EURO to define high-risk patients, for example EUTOS. 

The Cancer Treatments Subcommittee of the Pharmacology and Therapeutics Advisory Committee (PTAC) specifically recommended the Sokal or EURO scoring systems. The Subcommittee considered that the EUTOS scoring system would result in a higher proportion of newly diagnosed CML cases being classified as high-risk patients.

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.