Proposal for sole supply of imatinib for indications other than Gastro Intestinal Stromal Tumours (GIST)

• List AFT’s brand of imatinib mesilate 100 mg capsules (Imatinib-AFT) in Section B, and Part II of Section H, of the Pharmaceutical Schedule from 1 April 2014; and
• Award Imatinib-AFT’ brand of imatinib mesilate Sole Subsidised Supply status in the community and DHB hospitals for all indications, other than Gastro Intestinal Stromal Tumours (GIST), from 1 July 2014 to 30 June 2017; and
• Amend the Special Authority restriction applying to imatinib mesilate 100 mg tablet (Glivec) in Section B of the Pharmaceutical Schedule from 1 July 2014.

The effect of this proposal, if approved, would be that:

1. The Glivec brand of imatinib mesilate tablets would no longer be funded for patients with Chronic Myeloid Leukaemia (CML) and any other indications approved under Exceptional Circumstances (EC)/Named Patient Pharmaceutical Assessment (NPPA); instead the Imatinib-AFT brand of imatinib mesilate capsules would be fully funded for these patients.
2. The direct distribution of imatinib mesilate (Glivec) to patients with CML would cease; these patients would need to obtain their supply of imatinib mesilate (Imatinib-AFT) through their usual retail pharmacy. Imatinib-AFT would be listed without restriction. (Special Authority criteria or otherwise).
3. Glivec would remain fully funded, but only for patients with unresectable and/or metastatic malignant GIST. Funding of Glivec for GIST would be widened to include patients with c-kit negative disease. GIST patients would continue to receive Glivec by direct distribution.

Further details of this proposal, including how to provide feedback and background information including proposed transition timelines and how the brand switch and change in distribution arrangements would be managed for non-GIST patients, can be found on the following pages.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5 pm, Tuesday 12 November 2014 to:

All feedback received before the closing date will be considered by PHARMAC’s Board (or Chief Executive acting under delegated authority) prior to making a decision on this proposal.