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PTAC MEMBER: CALL FOR NOMINATIONS AUGUST 2003

Assessment of nominees / applicants

The following criteria will be used to assess the suitability of people nominated, or who apply for, positions on the Pharmacology and Therapeutics Advisory Committee (PTAC): The following experience is ideally sought: Applicants/nominees should: • • • • • • be in active clinical practice; be generalists; demonstrate a good general knowledge of medicine and pharmaceuticals; have an understanding of the particular health needs of Maori and of Pacific peoples have experience of greater than five years in their vocational field; have demonstrated status and credibility within the medical profession.

They should also be able to demonstrate the following essential skills and abilities: • • • • • • critical appraisal; the ability to work constructively in a group and accept consensus decision-making; the ability to think analytically; excellent presentation skills; the ability to differentiate between an individual and societal perspective on issues; and the ability to work with a budget and make decisions under pressure.

Relevant association with other Ministerial Committees, such as MAAC or MARC, may also be considered. The balance of skills and experience on the Committee are an important consideration and, in addition, some consideration may be given to geographical balance.

Time commitment

The position requires a considerable commitment in time and energy. There are four main, oneday meetings per year. We estimate up to 25 hours of preparation for each meeting. In addition, during each year there are additional sub-committee meetings, monthly teleconferences and other tasks required of members.

Remuneration

Remuneration for PTAC members is $95 per hour for preparation and attendance up to $600 for attendance of a full-day meeting. Travel and accommodation expenses are either refunded by PHARMAC or booked through, and paid for by, PHARMAC.

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TITLE: LOCATION : REPORTS TO: DATE:

Member of the Pharmacology and Therapeutics Advisory Committee (PTAC) PTAC meetings are usually held in Wellington. PTAC Chair July 2003

1. PHARMAC’S OBJECTIVE PHARMAC’s objective is to secure for eligible people in need of pharmaceuticals the best health outcomes that are reasonably achievable from pharmaceutical treatment and from within the amount of funding provided.

2. PURPOSE OF PTAC

PTAC is a committee of vocationally registered medical practitioners with expertise in clinical pharmacology, internal medicine and general practice. The primary purpose of PTAC is to provide PHARMAC with objective advice on pharmaceuticals and their benefits. More detail on the role of PTAC can be found in the Guidelines for the Pharmacology and Therapeutics Advisory Committee (PTAC) and its Sub-committees 2002. 3. PURPOSE OF THE POSITION To provide objective advice on pharmaceuticals and their benefits to enable PTAC to fulfil its advisory role to PHARMAC. 4. PTAC FUNCTIONS 4.1. To perform its primary purpose, PTAC is to: 4.1.1. Consider and make recommendations to PHARMAC on applications for the listing and delisting, restricting and de-restricting of pharmaceuticals on the Pharmaceutical Schedule that have been referred to it by PHARMAC. When requested by PHARMAC, consider and make recommendations to PHARMAC on proposals for defining, removing or amending a therapeutic group or sub-group of pharmaceuticals on the Pharmaceutical Schedule. Review, monitor and from time to time make recommendations to PHARMAC in relation to the management of the Pharmaceutical Schedule. Subject to the prior agreement of PHARMAC, initiate its own reviews of any policy adopted by PHARMAC in relation to the management of the Pharmaceutical Schedule, and provide reports or make recommendations to PHARMAC arising from those reviews. Make recommendations to PHARMAC on the information that should be provided by pharmaceutical suppliers in support of applications for the listing of pharmaceuticals on the Pharmaceutical Schedule. Consider and report, or make recommendations, to PHARMAC on any other matters that may be referred to it by PHARMAC.

4.1.2.

4.1.3. 4.1.4.

4.1.5.

4.1.6.

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4.2. When PTAC is to consider applications for new listings, normally the drug should have already gained registration and all consents for marketing in New Zealand by Medsafe. 4.3. PTAC’s meetings are usually held in Wellington at least four times a year.

Decision criteria

4.4. In performing its functions, PTAC is to take into account, where applicable, the following: 4.4.1. 4.4.2. 4.4.3. 4.4.4. 4.4.5. 4.4.6. 4.4.7. 4.4.8. 4.4.9. The health needs of all eligible people within New Zealand; The particular health needs of Maori and Pacific peoples; The availability and suitability of existing medicines, therapeutic medical devices and related products and related things; The clinical benefits and risks of pharmaceuticals; The cost-effectiveness of meeting health needs by funding pharmaceuticals rather than using other publicly funded health and disability support services; The budgetary impact (in terms of the pharmaceutical budget and the Government’s overall health budget) of any changes to the Pharmaceutical Schedule; The direct cost to health service users; the Government’s priorities for health funding, as set out in any objectives notified by the Crown to PHARMAC, or in PHARMAC’s Funding Agreement, or elsewhere; and Such other criteria as PTAC thinks fit.

5. ACOUNTABILITY PTAC and its sub-committees are to be accountable at all times to PHARMAC. 6. RELATIONSHIPS Members of PTAC are expected to actively foster relationships with the following groups of people: § § § § § § § § The PTAC Chair All other PTAC members PTAC Sub-committee members PHARMAC Medical Director PHARMAC CEO The PTAC Secretary PHARMAC staff The PHARMAC Board

7. PERSON SPECIFICATION 7.1. The member should be in active clinical practice and ideally have: § § § § § excellent critical appraisal skills; a good general knowledge of medicine and pharmaceuticals; at least five years experience in their vocational field; good presentation skills; the ability to work constructively in a group and accept consensus decision-making;

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§ § §

the ability to work with a budget and make decisions under pressure; the ability to differentiate between an individual and societal perspective on issues; and a good understanding of evidence-based medicine in clinical practice.

7.2. Relevant association with other Ministerial Committees, such as MAAC or MARC may also be considered. 8. DUTIES

Review of applications/submissions:

8.1. Members of PTAC are expected, prior to the meeting, to have: 8.1.1. 8.1.2. critically appraised all the papers and information provided in the applications /submissions to be considered by the committee; and analysed the subject and formed a professional view of the strengths and weaknesses of the application.

8.2. All members are required during meetings to provide their view on each subject under consideration based on the available scientific evidence. They are also required during meetings to be prepared to discuss issues related to these subjects with other members in a professional and constructive manner, to enable the committee to reach its recommendations to PHARMAC. 8.3. Following the meeting members contribute to the minute finalisation process.

9. CONFIDENTIALITY

9.1. Members of PTAC will be required to comply with comprehensive statements of confidentiality obligations in the form required by PHARMAC's Board. Members will be prohibited from speaking to the media in relation to the activities of PTAC and any matters discussed at, or considered by, PTAC meetings. 9.2. Members will be required to store material relating to any pharmaceutical in a secure place, until a final recommendation has been made by PTAC for consideration by PHARMAC's Board. 9.3. After PTAC has made a final recommendation, members must either return the information about that pharmaceutical to PHARMAC or undertake to destroy that information. 9.4. Members will endeavour to use all opportunities available to them to gain information from colleagues so as to enable PTAC to make the most informed judgement possible. Although the material on the agenda is confidential (as are the proceedings of the PTAC), members may reveal their interest in a product to gain information from colleagues on its use, efficacy, adverse effects etc. 9.5. Once minutes of meetings are finalised, members may discuss with colleagues matters considered at the meeting but only on a general basis and only to the extent of the contents of the official minutes. Any invitation from the media to comment on matters considered by PTAC must be previously discussed with the PTAC Chairman, PHARMAC’s Medical Director and PHARMAC’s media liaison advisers.

10. REMUNERATION

Members are to be paid for their reasonable costs incurred for attendance at meetings and time spent preparing for meetings. The current rate for PTAC members is $95 per hour or $600 for a full day.

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