This is the text extract for Proposal to amend the Special Authority for cabergoline. Closed, browse documents here.

17 June 2010

Proposal to amend the Special Authority for cabergoline

PHARMAC is seeking feedback on a proposal to amend the Special Authority relating to funded cabergoline. In summary, this proposal would result in the Special Authority applying to cabergoline being amended to allow funded therapy without further Special Authority renewals where the patient has pathological hyperprolactinemia from 1 August 2010. Feedback sought PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Friday, 2 July 2010 to: Greg Williams Therapeutic Group Manager PHARMAC PO Box 10 254 Wellington 6143 Email: greg.williams@pharmac.govt.nz Fax: 04 460 4995

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 The Special Authority applying to cabergoline would be amended from 1 August 2010 as follows (additions in bold, deletions in strikethrough): Cabergoline Tab 0.5 mg – Maximum of 2 tab per prescription; can be waived by Special Authority see SAXXXX below: Special Authority for Waiver of Rule - Form SAXXXX Initial application only from an obstetrician, endocrinologist or gynaecologist. Approvals valid without further renewal, unless notified, for applications for 2 years where the patient has pathological hyperprolactinemia. Renewal only from an obstetrician, endocrinologist or gynaecologist. Approvals valid for 2 years without further renewal, unless notified, for applications where the patient has previously held a valid Special Authority which has expired and the treatment remains appropriate and the patient is benefiting from treatment. The renewal is in place to allow those patients whose Special Authority has expired within the previous two years to allow re-initiation of therapy.

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PHARMAC notes that there is a current consultation open regarding amendment of the applicant type to Vocational registered medical practitioners in the field of obstetrics and gynaecology or internal medicine1 for cabergoline. This proposal is independent of the consultation to amend the applicant type. Background PTAC considered cabergoline and the Special Authority form at its November 2007 meeting and the relevant excerpt of the minute is below:

Members considered that the data supported regular review of continuation of cabergoline treatment (in its view, at least once every two years) which the Special Authority criteria as they are currently written would prompt. However, members considered that in general Special Authority criteria were not designed to prompt or dictate good clinical practice in terms of frequency of patient treatment reviews. Members noted that application for a Special Authority could only come from obstetricians, gynaecologists or endocrinologists, and members considered that these experts should be able to adequately determine appropriate review periods for their patients. The Committee considered that given that the current Special Authority renewal criteria were fairly open, that is, ‘treatment remains appropriate and the patient is benefiting from treatment’ and the patients would be under the care of an expert who would review treatment on an ongoing basis, there would be no financial risk to the community pharmaceuticals budget by making the renewal period longer. The Committee recommended that the Special Authority Renewal period for cabergoline be amended to Lifetime where the treatment remains appropriate and the patient is benefiting from treatment. The Committee noted that cardiac valvulopathy (CAV) in Parkinson’s patients treated with pergolide and cabergoline has raised concerns about the long-term safety of ergoline dopamine agonists. However, members noted that the dosing in Parkinson’s patients associated with CAV was at least 3 mg cabergoline daily, which is 10 to 20 times higher than the dose used in the treatment of prolactinomas. Members noted that there is a current study looking at the effects of cabergoline on cardiac valves in patients with prolactinomas. Members requested that PHARMAC staff be vigilant about the results of this study to determine any possible adverse cardio toxicity associated with lower doses.

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http://www.pharmac.govt.nz/2010/06/03?q=prescriber

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