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23 December 2009

Approval of proposal relating to reference pricing exemestane (Aromasin)

PHARMAC is pleased to announce the approval of a proposal to reference price the subsidised aromatase inhibitor exemestane. In summary from 1 February 2010:

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The subsidy for exemestane will be reference priced to letrozole; Repeat dispensings for exemestane will be fully subsidised where the initial dispensing was before 1 February 2010; and Full subsidy will be available, via Special Authority, for patients receiving funded exemestane prior to 1 February 2010 and for patients with advanced breast cancer who have progressed following treatment with, or who are intolerant to, anastrozole or letrozole.

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Detail of the decision From 1 February 2010 the subsidy for exemestane will be reduced to the level of the subsidy for letrozole ($26.55 per pack) through the application of reference pricing. Existing patients and some new patients will be able to continue to receive full subsidy via a new Special Authority for an alternate higher subsidy as follows:

Subsidy (Manufacturer’s Price) $ Per EXEMESTANE Tab 25 mg – Higher subsidy of $175.00 per 30 with Special Authority see SAXXX below ……..……… 26.55 (175.00) 30 Aromasin

Brand

SAXXX Special Authority for Alternate Subsidy Initial Application – from any relevant practitioner. Approvals valid for 5 years for applications meeting the following criteria: All of the following: 1. Patient is a postmenopausal woman; and 2. Patient has hormone receptor positive breast cancer; and 3. Any of the following 3.1 the patient was receiving funded exemestane prior to 1 February 2010; or 3.2 the patient has advanced breast cancer and a very clear history of intolerance to anastrozole or letrozole; or 3.2 the patient has advanced breast cancer and disease has progressed following treatment with anastrozole or letrozole. Renewal from any relevant practitioner. Approvals valid without further renewal unless notified where the treatment remains appropriate and the patient is benefitting from treatment.

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PHARMAC will not change or remove the Special Authority applying to Aromasin prior to 1 February 2011. In order to allow more time for existing patients to obtain the necessary Special Authority approvals to maintain full subsidy existing repeat prescriptions will be fully subsidised. The following Note will be applied to Aromasin from 1 February 2010: Note: Repeat dispensings for Aromasin tab 25 mg will be fully subsidised where the initial dispensing was before 1 February 2010. From 1 February 2010 the current rebate applying to Aromasin will be increased such that the net effective price of Aromasin would be less than $146.46 per pack. Feedback Received We appreciate all of the feedback we received during consultation and acknowledge the time people took to respond. All consultation responses received by the closing date were considered in their entirety in making a decision on the proposed changes. Consultation responses from clinicians were supportive. Pharmacists raised some questions about the proposal, the key issues raised and PHARMAC's view is set out below:

Response One responder asked why it was necessary for existing patients to have to get a Special Authority approval to maintain full subsidy. They suggested that a pharmacist endorsement should suffice and considered that a Special Authority created more work for no need. PHARMAC Comment Due to database limitations it is not possible for an endorsement and a Special Authority rule to apply to the same chemical. PHARMAC explored a number of alternative options to maintain funding for existing patients without them having to get a new Special Authority including auto generating approvals for existing patients, however, this is not feasible in this case. We note that the proposal was changed following this feedback such that repeat prescriptions will now be fully subsidised, therefore, existing patients would have the remainder of their current prescription (up to 3 months) to obtain a Special Authority for ongoing full subsidy. One responder was concerned that pharmacists would be responsible for determining whether a patient has advanced breast cancer. They also questioned if exemestane would become a Stat medicine. Pharmacists will not be required to check any patients breast cancer stage. Full subsidy will only be available for all patients with Special Authority approval and those with a repeat prescription issued prior to 1 February 2010. The patient’s doctor is responsible for completing the necessary Special Authority approvals. No decision regarding exemestane becoming a Stat medicine has been made.

More information If you have any queries about these changes please contact the PHARMAC helpline on 0800 66 00 50 (9 am to 5 pm weekdays).

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