Pharmacology Advisory Committee Meeting

Part (Item 25.4) of the Record of the

Pharmacology and Therapeutics Advisory Committee Meeting
held on 15 & 16 November 2006

25.4 Cancer Treatments Subcommittee (CaTSoP) – 26 / 27 October 2006

24.5.1 PTAC noted and accepted the minutes of the Cancer Treatments Sub-Committee of PTAC (CaTSoP) meeting held on 26 / 27 October 2006, with the following comments:

24.5.2 PTAC was cognisant of the promising preliminary data for trastuzumab and the need for more effective treatment options in this patient population.

24.5.3 However, PTAC reiterated that there was still uncertainty about the best way of administering trastuzumab in terms of optimal treatment duration, dose and schedule (sequential to, or concurrent with, chemotherapy), minimising cardiovascular toxicity and long-term clinical outcomes.

24.5.4 PTAC noted CaTSoP’s discussion and recommendations regarding trastuzumab. The Committee noted that PHARMAC’s amended base-case cost-utility analysis resulted in an indicative cost/QALY of $12,300-$29,200 for 9 weeks trastuzumab treatment as equivalent to the FinHer trial regimen; however, the Committee noted that this did not include the additional cost of docetaxel that was used in FinHer. PTAC noted that the absolute disease-free survival for trastuzumab-treated patients in the FinHer trial was 89% at three years, whereas the published absolute disease free survival in the HERA trial was 86% (95% confidence interval 83%-89%) at a median duration of one year.

24.5.5 The Committee considered that more clinical research was needed and that a study comparing 12 months trastuzumab with 9 weeks trastuzumab should be performed.

24.5.6 The Committee noted CaTSoP’s view that, in the absence of availability of funding for 12 months trastuzumab treatment, 9 weeks treatment would be reasonable. PTAC recommended that, subject to an acceptable cost/QALY, including the cost of docetaxel, 9 weeks treatment with trastuzumab should be funded and gave this recommendation a high priority.

24.5.7 The Committee considered that the relevant decision criteria in favour of this recommendation were (i) the health needs of all eligible people within New Zealand, (ii) The particular health needs of Maori and Pacific peoples

(iii) the availability and suitability of existing medicines, therapeutic medical devices and related products and related things, (iv) The clinical benefits and risks of pharmaceuticals, (vi) The budgetary impact (in terms of the pharmaceutical budget and the Government’s overall health budget) of any changes to the Pharmaceutical Schedule and (viii) the Government’s priorities for health funding.

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