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

Medicines

Consultation Closed

PHARMAC is seeking feedback on a proposal to amend the distribution arrangements and access criteria for the funding of dasatinib (Sprycel) tablets for chronic myeloid leukaemia (CML).

PHARMAC is seeking feedback on a proposal to amend the distribution arrangements and access criteria for the funding of dasatinib (Sprycel) tablets for chronic myeloid leukaemia (CML) from 1 May 2019.

In summary:

  1. Dasatinib would be funded subject to a standard Special Authority managed by the Ministry of Health and there would no longer be a requirement for individual patient applications to be made to the CML coordinator at PHARMAC. Direct distribution to patients or their nominated collection point would cease and dasatinib would instead need to be collected from community pharmacies in the same way as other funded medicines.
  2. Dasatinib would be funded in the first-line treatment setting only for patients with Philadelphia chromosome-positive acute lymphoid leukaemia (Ph+ ALL) or CML in blast crisis, accelerated phase or those considered to have ‘high-risk’ disease. Funded access in the first-line setting would 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).
  3. For all other patients with CML, dasatinib would be funded as a second-line treatment for those who experience treatment failure or adverse events on imatinib.
  4. Dasatinib would continue to be funded for existing patients who started on funded dasatinib treatment prior to 1 May 2019, including participants in the KISS trial who have already started funded treatment, providing that renewal criteria continue to be met.

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5pm on Wednesday, 30 January 2019 to:

Andrew Park, Senior Therapeutic Manager, PHARMAC

Email: andrew.park@pharmac.govt.nz

What would the effect be?

For Patients

Patients would need to obtain their funded dasatinib tablets through their usual community pharmacy and pay the standard prescription co-payment, in the same way as they do for most other funded medicines.

All existing patients (those who started on funded dasatinib prior to 1 May 2019) would receive their usual four-week supply of dasatinib tablets, as scheduled, in March 2019 from the current distribution model. In addition, an extra four-week supply of dasatinib tablets would be sent in March 2019 to give a total of eight weeks’ supply. This would give all patients 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 May 2019.

All new patients from 1 May 2019 would need to obtain a Special Authority approval via their doctor and a prescription to take to their community pharmacy for dispensing. Although the Special Authority application would need to be made by the patient’s haematologist, ongoing prescriptions could be written by any registered medical practitioner, including the patient’s GP.

Changes are proposed to the access criteria for funding of dasatinib for newly diagnosed patients (further detailed below).

For Community Pharmacies

Community pharmacies would access dasatinib though their usual supply channels. Any community pharmacy dispensing funded dasatinib could claim reimbursement for it.

For Prescribers

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

Individual patient applications made to the CML coordinator at PHARMAC for a Special Authority would no longer be required and the coordinator would no longer inform Sector Services of the Special Authority approval.

Existing patients would have their current approvals transferred to the new Special Authority and renewal applications would be needed in order for the patient to have ongoing access to funded treatment from 1 May 2019. For new patients, an initial Special Authority approval would be needed.

Initial and renewal Special Authority applications would need to be made by a haematologist; however, any registered medical practitioner (including GPs) could then prescribe the medication.

Direct distribution would cease so there would no longer be a requirement to submit applications/prescriptions to PHARMAC for dispensing. Patients would need to request the prescriptions from their prescriber and then present the prescription to their community pharmacy for dispensing.

Changes are proposed to the access criteria for funding of dasatinib for newly diagnosed patients (further detailed below). 

For DHBs

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

Who we think will be interested

  • Patients 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.

Why we’re proposing this

Background

Dasatinib was funded from 1 August 2009 for the treatment of all patients with CML in chronic phase, accelerated phase and blast crisis. A direct distribution system was implemented by PHARMAC at the time of dasatinib listing, to minimise wastage of this high-cost treatment.

At the time of listing, the commercial arrangements negotiated with the supplier allowed PHARMAC to fund dasatinib for all CML patients, not just those who experienced treatment failure or adverse events on imatinib. In making this decision it was assumed that imatinib would remain the first-line treatment in most newly diagnosed patients with chronic-phase CML.

Multiple price reductions as a result of generic competition for imatinib have dramatically altered the comparative pricing of dasatinib and imatinib. The proposed changes to restrict dasatinib access to second-line treatment following the less expensive imatinib for some patients with chronic phase CML could result in a reduction in the overall cost of this class of treatments.

Clinical advice

The Cancer Treatments Subcommittee of the Pharmacology and Therapeutics Advisory Committee (CaTSoP) considered the access to dasatinib in March 2017 [PDF, 276 KB] and August 2017 [PDF, 423 KB].

At the March 2017 meeting, the Subcommittee recommended transitioning to the standard Special Authority and retail pharmacy distribution system.

The Subcommittee advised that as nearly all patients with Ph+ ALL were currently accessing funded dasatinib under the CML blast crisis criterion. Therefore, amending the Special Authority to specifically include this group of patients would have a small or negligible financial impact.

At the August 2017 meeting, the Subcommittee considered that it was appropriate to:

  • continue funding for all existing patients
  • restrict funded access to the second-line setting for patients with diagnosed with chronic-phase CML
  • continue funding in the first-line setting for patients diagnosed with high-risk chronic phase CML (defined by SOCAL or EURO scoring systems)
  • continue funding in the first-line setting for patients diagnosed with CML who are enrolled in the investigator-led KISS study.

Details about our proposal

From 1 May 2019, the Xpharm rule would be removed from the listing of dasatinib (Sprycel) tab 20 mg, 50 mg and 70 mg in the Pharmaceutical Schedule. There would be no change to the price or subsidy of dasatinib.

From 1 May 2019, the following Special Authority criteria would 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 only from a haematologist. Approvals valid for 6 months for applications meeting the following criteria:

Any of the following:

  1. Both:

1.1.    The patient has a diagnosis of chronic myeloid leukaemia (CML) in blast crisis or accelerated phase; and

1.2.    Maximum dose of 140 mg/day; or

  1. Both:

2.1.    The patient has a diagnosis of Philadelphia chromosome-positive acute lymphoid leukaemia (Ph+ ALL); and

2.2.    Maximum dose of 140 mg/day; or

  1. All of the following:

3.1.    The patient has a diagnosis of CML in chronic phase; and

3.2.    Maximum dose of 100 mg/day; and

3.3.    Any of the following:

3.3.1. Patient has documented treatment failure* with imatinib; or

3.3.2. Patient has experienced treatment-limiting toxicity with imatinib precluding further treatment with imatinib; or

3.3.3. Patient has high-risk chronic-phase CML defined by the SOCAL or EURO scoring system; or

3.3.4. Patients is enrolled in the KISS study[1] and requires dasatinib treatment according to the study protocol.

Renewal only from 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.

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

The same restrictions for dasatinib would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicines List; HML).

[1] Kinase-Inhibition Study with Sprycel Start-up https://www.cancertrialsnz.ac.nz/kiss/(external link)

To provide feedback

Send us an email to andrew.park@pharmac.govt.nz by 5pm on Wednesday, 30 January 2019.

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.