This is the text extract for Having Your Say in our Decisions, browse documents here.

---

Pharmaceutical Management Agency

Having your say in our decisions

---

PHARMAC’s decision-making

PHARMAC is the Government agency that decides which medicines are funded for New Zealanders. We welcome input from people into our decision-making processes. There are a number of ways you can get involved in PHARMAC’s decision-making. The information you provide can help us to make medicine funding decisions. Here we give you general information on how to get involved in PHARMAC’s processes, and what we look for in our funding assessments and consultations. You can find more detailed information, like how we measure costeffectiveness, PHARMAC’s Operating Policies and Procedures, or guidance for people looking to make funding applications, on our website: www.pharmac.govt.nz.

PHARMAC uses nine criteria to inform its decisions and these provide a guide to the sort of information we are looking for. The decision criteria are:

• The health needs of all eligible people; • The particular health needs of Māori 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 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 PHARMAC thinks fit.

---

Opportunities for involvement

The Pharmaceutical Schedule is the list of funded medicines. We use a defined process when looking at adding a medicine to the Schedule. This process is illustrated in the flow chart on the next page. There are three different places where you could get involved: 1 2 3

Making a funding application Consultation Notification

We are also happy to talk to you about funding applications at any stage in the process. You can call us on (04) 460 4990, or 0800 66 00 50.

---

The PHARMAC decision making process

The process set out in this diagram is intended to be indicative of the process that may follow where a supplier or other applicant wishes a pharmaceutical to be funded on the Pharmaceutical Schedule. PHARMAC may, at its discretion, adopt a different process or variations of the process (for example, decisions on whether or not it is appropriate to undertake consultation are made on a case-by-case basis). Considering evidence

Receipt proposal Receipt ofof proposal Listed on PHARMAC website Listed on PHARMAC website Summary of proposal Preliminary economic assessment and questions for PTAC Request more specialised advice from Subcommittee / Experts as required

Negative Negative recommendation recommendation

1

Review of proposal by PTAC

Recommendation to PHARMAC Some minutes published on PHARMAC website

Assessing Relative Value

Positive Positive Recommendation Recommendation

Economic Assessment

Prioritisation of all proposals

Review by PTAC

Negotiation with supplier(s)

2 Reaching a Decision

Consultation on Preliminary agreement Summary of all relevant information prepared for board

PHARMAC Board PHARMAC Board Decision Decision

3

Implementation

---

1

Making a funding application

What sort of information is PHARMAC interested in?

We will want to know what the medicine is and what it’s for, and information on any clinical trials involving the medicine. PHARMAC’s decision criteria provide a guide for the type of questions we want answers to. For example: • Is there a particular health need that this medicine will meet? Who is this medicine likely to benefit? And, is there any other medicine or treatment available that meets their needs? • Does the condition the medicine treats have a particular impact on Māori or Pacific people? • What other products and services (including medicines) are currently available to treat the condition? • How effective is the medicine? What are its side-effects? Has it been shown to be better than existing treatments? • What is the cost-effectiveness of the medicine, compared to other treatments? • How much does the medicine cost, and what would the total cost of treating all eligible patients be? • Is the condition this medicine treats a Government health priority?

Listing on the Pharmaceutical Schedule

Most pharmaceutical funding applications come from pharmaceutical companies, but anyone can make an application – including patients and consumers, doctors, or health officials. In addition to the information we get from funding applicants, we regularly conduct our own research to ensure we have as much relevant information as possible for making our decisions. We also carry out a careful economic analysis of the medicine. So don’t worry if you feel you can’t supply full information – we can usually help supplement the information you provide us with. If you want to apply for funding, a good first step is to first contact us to talk through a potential application. The people at PHARMAC who manage funding applications are called Therapeutic Group Managers. To contact them, call PHARMAC on (04) 460 4990, or 0800 66 00 50. There are some practical issues that may need to be worked through: • Is the medicine registered for use in New Zealand? We won’t usually consider a medicine for funding unless it is first registered by Medsafe, the Government’s medicines regulatory agency. You can check if a medicine is registered on Medsafe’s website, www.medsafe.govt.nz. • Is there a company prepared to supply the medicine in New Zealand? If we are to fund a medicine we need to know that there will be a secure and ongoing supply, to meet the needs of patients.

Exceptional Circumstances

Through your doctor, you can apply to have a medicine funded through the Exceptional Circumstances scheme, which is administered by PHARMAC. This is mainly for conditions that are very rare (usually fewer than 10 cases nationally), or for people with unusual clinical circumstances. If you think you might qualify for funding under the Exceptional Circumstances scheme, talk to your doctor.

---

2

Consultation

How to make a consultation submission

We prefer that your submission is made in writing, because these all go to the PHARMAC Board, which makes decisions on medicine funding. It may also be possible for you to discuss your submission with us face to face. All consultation documents have a PHARMAC staff member’s name as a point of contact, or you can email us your views at consultation@ pharmac.govt.nz. You can get in touch with the named contact person on the consultation letter if you need further information.

We regularly ask people for their views on proposals to fund or change access to medicines. We would like to hear from you. The main ways you can be involved in our consultations are:

• Join our consultation database – this will mean you receive all of our consultation documents. Contact consultation@pharmac.govt.nz • Sign up to electronic web feeds on the PHARMAC website.

Our usual consultation period is for at least two weeks, and may sometimes be longer.

How long should my submission be?

There is no limit to how long your submission can be, and we don’t ask that it be provided in a particular format or template. Some of our consultations, however, generate a lot of responses, so to get your view heard it would be useful to make your submission as concise as you can.

What sort of information should I provide in my submission?

PHARMAC’s decision criteria, outlined on page 1, provide a guide to the sort of information that is most useful to us. This doesn’t necessarily limit the information you can provide to us, but indicates the framework we work within.

3

Notification

This is the final step in our decision-making process. If you made a consultation submission, we will include you on the distribution list for the letter notifying of the PHARMAC Board’s decision. Our notification letters include a summary of the submissions we received and our responses to them. With some decisions, however, it may not be possible to respond to every point raised in consultation, because of issues like privacy or commercial confidentiality.

---

Getting even more involved in PHARMAC

Funding medicine is just a part of PHARMAC’s work and there are other ways of keeping in touch, and getting involved, with PHARMAC. We welcome your interest.

• Write to us – we respond to all the emails and letters we receive • Call us – PHARMAC operates a freephone line (0800 66 00 50), and calls are answered by PHARMAC employees. The freephone line operates 9am to 5pm Monday to Friday. • Visit our website: www.pharmac.govt.nz This is the main window into PHARMAC. You can sign up to electronic updates for a range of information including media releases, notification letters, and consultations. • Consultation – As well as consulting people about medicine funding, we seek the public’s views on policy changes, such as our recent consultation on changing our clinical advisory committee’s Terms of Reference.

---

Pharmaceutical Management Agency Level 9, Cigna House, 40 Mercer Street, PO Box 10-254, Wellington 6143, New Zealand Phone: 64 4 460 4990 - Fax: 64 4 460 4995 - www.pharmac.govt.nz Freephone Information line (9am-5pm weekdays) 0800 66 00 50 PHARMAC is the Government agency responsible for deciding which medicines are subsidised for New Zealanders. It manages spending on pharmaceuticals for the District Health Boards, and ensures that a comprehensive list of medicines (the Pharmaceutical Schedule) is subsidised for New Zealanders, and that the list of medicines continues to grow to meet the needs of patients.