Getting your patients the medicines they need: Pharmac’s Exceptional Circumstances Framework

As clinicians, all people you treat are unique, and sometimes people are so unique that usual funding mechanisms for medicines don’t quite fit for them. At Pharmac, we ensure all people can be considered for funding.

We usually do that through the Pharmaceutical Schedule, which provides the bulk of medicines New Zealanders need that we can fund from our fixed budget – but there are exceptions.

Clinicians consistently and clearly tell us that living with some health conditions can be a unique experience, and they don’t always fit into the box of what we think they would look, feel or be like.

Pharmac can’t fund everything, but we know there are times when a person has exceptional clinical needs and there is a medicine they can’t access through the schedule.

Our exceptional circumstances framework can help, but it’s not a shortcut to accessing the newest or best treatments.

The framework is intended to meet the needs of individuals with exceptional circumstances, which are unlikely to be considered through our normal funding process. This may be due to the urgent or unusual clinical nature of their circumstances.

We have several pathways that sit alongside our usual funding process to assess whether we can fund what your patient needs, including:

• funding for individuals with exceptional clinical circumstances through our Named Patient Pharmaceutical Assessment (NPPA)
• waivers for people who meet the intent of the Special Authority (SA) criteria
• applications for alternative brands of funded medicines, usually when Pharmac has made a brand change

The processes for each of these pathways are outlined below, and more details are available on our website: Exceptional Circumstances Framework

Named Patient Pharmaceutical Assessment

The Named Patient Pharmaceutical Assessment (NPPA) pathway allows us to consider funding medicines for individuals with exceptional clinical circumstances. These people usually don’t fit within the population groups that our national funding covers, and need access to a different medicine.

While hospital specialists usually make applications, it’s useful for specialist GPs to understand how this pathway works as an avenue for access to treatment.

The NPPA pathway is like our usual funding process – but on a smaller scale and for an individual.

Before we accept an application, we make sure it meets our NPPA policy principles.

This includes considering whether a person has exceptional clinical circumstances, has tried all of the available funded treatments, and whether Pharmac has previously considered the treatment for funding.

If the application doesn’t meet these principles, we will inform you that the requirements of the NPPA policy are not met and we aren’t able to assess it further.

If the principles are met, we’ll assess the application.

Our team of Exceptions Advisors will review the information provided, seek clinical advice, and consider the application using our Factors for Consideration. We will then approve or decline the application, and we’ll let you know the outcome.

Our website has information about the outcomes of NPPA applications over the past four years: NPPA outcome data. This provides you with information on the treatments and indications that have been previously assessed through this pathway.

We know that NPPA applications are for people in difficult situations. We must make sure that NPPA is complementary to our national funding process and doesn’t bypass it.

Special Authority waivers

We use eligibility criteria to ensure funding is targeted to those most likely to benefit and those with the greatest health need. Doctors must make sure these criteria are met and fill out a form giving their patient an SA approval before the medicine is funded.

If a person’s clinical circumstances align with our intended group for funding but not the exact requirements, you can ask us to waive certain access criteria with an SA waiver.

An example of us waiving criteria would be if someone is wanting access to a medicine that requires a different treatment to be tried first but is unable to do so. For example, if an SA requires a person to have trialled methotrexate, but the person is pregnant, and methotrexate is contraindicated. In this case, they may be eligible for the waiver.

You can apply for a waiver using the PDF version of the SA form available on the Pharmaceutical Schedule. Please note on the form or in your email why the person meets the criteria’s intent and why specific criteria aren’t appropriate for them.

Email this to waivers@pharmac.govt.nz and we’ll assess it as soon as possible. We’ll come back to you to advise whether the waiver has been approved or declined, so you can keep your patient updated.

Accessing alternative brands or types of treatment

Sometimes, we change the funded brand of medicine (or device) as part of a funding process to free up funds in our budget or to help ensure continuity of supply. When we do this, we know the change may not be suitable for everyone.

To address this, we can consider applications for access to an alternative brand of the funded medicine – usually the one the patient was using before the change.

Some of the medicines that have alternative brands available have a specific form on our website under: Other Exceptional Circumstances forms. Like the Special Authority Waivers, we need to hear from you why your patient needs an alternative brand or type of the funded treatment.

If you are seeking an alternative brand for a medicine that does not have a specific Exceptional Circumstances form, you can apply for this using our standard NPPA application form.

Email this to NPPA@pharmac.govt.nz and we’ll assess it as soon as possible, so you can let your patient know if it’s been approved or declined.

Who’s involved?

Any health care professional working within their scope of practice can apply through our Exceptional Circumstance’s Framework.

If you’re unsure about submitting an application, our Exceptions team can help. You can phone them at 0800 660 050 (option 2) or by emailing waivers@pharmac.govt.nz or nppa@pharmac.govt.nz

The Exceptions team works with a range of people to consider your application including our Therapeutic Group Managers, Health Economists, and health care professionals on our Specialist Advisory Committees.

When considering a NPPA application they seek advice from our NPPA Advisory Panel which is made up of over 15 clinicians, including specialists across all areas of health who have expertise and training in the NPPA policy.

Medicines, vaccines, and related products funded through the framework come from the same fixed budget as all other medicines funded on the Pharmaceutical Schedule. This means we must make careful decisions to fund medicines that will improve New Zealanders’ health outcomes.

If you have any questions about the framework, please get in touch.