This is the text extract for Proposal to amend special authorities for trastuzumab (Herceptin) and sunitinib (Sutent); Closing Date: Closed; Contact: Jackie Evans, browse documents here.

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2 August 2011

Proposal to Amend Special Authorities for trastuzumab (Herceptin) and sunitinib (Sutent)

PHARMAC is seeking feedback on a proposal to make minor amendments to the Special Authority criteria applying to trastuzumab and sunitinib from 1 October 2011. The proposed changes, based on recommendations from the Cancer Treatments Subcommittee of PTAC, are not intended to materially change the funding of either of these pharmaceuticals. Details of the proposed changes are provided below. Feedback sought PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5 pm Wednesday, 17 August 2011 to: Jackie Evans Senior Therapeutic Group Manager PHARMAC Email: jackie.evans@pharmac.govt.nz Fax: 04 460 4995 Post PO Box 10 254, Wellington 6143

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. Details of the proposal Trastuzumab

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From 1 October 2011, the Special Authority criteria applying to the funding of trastuzumab (150 mg and 440 mg vials and 1 mg injection for extemporaneous compounding (ECP)) would be amended as follows (changes in bold deletions, in strikethrough):

Trastuzumab – PCT only – Specialist – Special Authority Initial application — (metastatic breast cancer) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria: where Both: 1 Tthe patient has metastatic breast cancer expressing HER-2 IHC 3+ or FISH+ (including FISH or other current technology); and 2 Trastuzumab to be discontinued at disease progression. Renewal — (metastatic breast cancer) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria: Both: 1 The patient has metastatic breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology); and 2 The cancer has not progressed at any time point during the previous 12 months.

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Initial application — (early breast cancer) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 15 months for applications meeting the following criteria: All of the following: 1 The patient has early breast cancer expressing HER 2 IHC 3+ or ISH + (including FISH or other current technology); and 2 Maximum cumulative dose of 106 mg/kg (12 months’ treatment); and 3 Any of the following: 3.1 9 weeks’ concurrent treatment with adjuvant chemotherapy is planned; or 3.2 12 months’ concurrent treatment with adjuvant chemotherapy is planned; or 3.3 12 months’ sequential treatment following adjuvant chemotherapy is planned; or 3.4 Other treatment regimen, in association with adjuvant chemotherapy, is planned. Note: For patients with previous Special Authority approvals for a maximum cumulative dose of 20 mg/kg (9 weeks treatment) granted after 1 April 2009 the approval period has been extended to allow claims for a maximum cumulative dose of 106 mg/kg (12 months treatment). Renewal — (early breast cancer) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria: 1 The patient has metastatic breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology); and 2 Either: 2.1 Both: 2.2.1 The patient received prior adjuvant trastuzumab treatment for early breast cancer; and 2.2.2 Trastuzumab to be discontinued at disease progression; or 2.2 The cancer has not progressed at any time point during the previous 12 months.

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PHARMAC does not believe the proposed changes above would make the funding for trastuzumab any more, or less, restrictive; the proposed changes are intended to clarify the intent of existing funding and enable Special Authorities to be processed for patients presenting with HER 2 positive metastatic disease following prior adjuvant trastuzumab treatment for HER 2 positive early breast cancer.

Sunitinib

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From 1 October 2011, the Special Authority criteria applying to the funding of sunitinib (12.5 mg, 25 mg and 50 mg capsules) would be amended as follows (changes in bold deletions in strikethrough):

Initial application only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 3 months for applications meeting the following criteria: All of the following: 1 The patient has metastatic renal cell carcinoma; and 2 Either 2.1 The patient is sunitinib treatment naive; or 2.2 The patient received sunitinib prior to 1 November 2010 and disease has not progressed; and 3 The patient has good performance status (WHO/ECOG grade 0-12); and 4 The disease is of predominant clear cell histology; and

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The patient has intermediate or poor prognosis based on the NCCN clinical practice guidelines for kidney cancer defined as: Any of the following: 5.1 Lactate dehydrogenase level > 1.5 times upper limit of normal; or 5.2 Haemoglobin level < lower limit of normal; or 5.3 Corrected serum calcium level > 10 mg/dL (2.5 mmol/L) ; or 5.4 Interval of < 1 year from original diagnosis to the start of systemic therapy; or 5.5 Karnofsky performance score of ≤ 70; or 5.6 ≥ 2 sites of organ metastasis; and Sunitinib to be used for a maximum of 2 cycles.

Renewal only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 3 months for applications meeting the following criteria: Both: 1 No evidence of disease progression; and 2 The treatment remains appropriate and the patient is benefiting from treatment. Notes: Sunitinib treatment should be stopped if disease progresses. NCCN c l i n i c a l practice guidelines for kidney cancer are http://www.nccn.org/professionals/physician_gls/f_guidelines.asp

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PHARMAC does not believe the proposed changes above would make the funding for sunitinib any more, or less, restrictive; the proposed changes clarify the relevant prognostic factors for diagnosing intermediate or poor prognosis rather than requiring clinicians to refer to the NCCN website and navigate through the clinical practice guidelines for kidney cancer each time they make an application.

Background The proposed Special Authority changes are based on the recommendations for trastuzumab and sunitinib made by the Cancer Treatments Subcommittee of PTAC (CaTSoP) at its November 2010 meeting. Details regarding CaTSoP’s discussion and recommendations can be found in the relevant minutes available on the PHARMAC website: www.pharmac.govt.nz/PTACSCMinutes

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