Frequently Asked Questions about the Exceptional Circumstances Framework and Current Review

Exceptional Circumstances Framework Review

What are the next steps for the Framework review?

We are currently carefully considering the submissions and feedback that we received. This feedback will be used to develop potential changes to the way we consider Exceptions.

A second phase of consultation is expected to begin in late November 2026 and run for at least two months. This phase will include publication of a document outlining what we heard during the initial consultation and how feedback has informed the proposed changes.

Why has the timeline for the Exceptional Circumstances Framework review changed?

We received a significant amount of feedback through the first phase of the consultation process.

We want to make sure that all submissions are carefully considered and that any proposed changes are thoroughly developed.

We have moved the expected release of the second consultation from October to November. This additional time will help us better reflect the feedback we received.

How can I get involved in the Exceptional Circumstances Framework review?

There will be opportunities for people to share their views on proposed changes to the Framework.

During the first phase of consultation, we got feedback through public webinars, hospital visits, our online feedback tool (Citizen Space), and email submissions. We'll post updates about future opportunities to get involved on this web page.

In the meantime, if you have any queries about the review, you can contact the us at ECFreview@pharmac.govt.nz.

About the Exceptional Circumstances Framework

What is Pharmac’s Exceptional Circumstances Framework?

The Exceptional Circumstances Framework is how Pharmac considers funding medicines for people with exceptional circumstances that not covered by Pharmac’s standard funding process. 

It includes the Named Patient Pharmaceutical Assessment (NPPA) Policy and other processes.

Who is Pharmac’s Exceptional Circumstances Framework for?

The Exceptional Circumstances Framework is for people whose health needs cannot be met through the standard medicine funding process. It provides a way for Pharmac to consider funding medicines for individuals with unusual, complex, or exceptional clinical circumstances

Who can make an application under the Exceptional Circumstances Framework?

• Applications made under the Framework must come from an authorised prescriber.
• Any authorised prescriber can apply if the request is within their scope of practice.

How is an application assessed?

All applications made under the Exceptional Circumstances Framework are individually assessed by a member of Pharmac's Exceptions team. Each application is assessed:

• on the person's specific circumstances and needs
• based on the information available at the time
• in line with the policy.

 This means outcomes for one person do not guarantee the same outcome for others.

How is equity considered when assessing applications under the framework?

• We take equity into account through our Factors for Consideration (FFC), which are used in all funding decisions, including Exceptional Circumstances.
• The Factors include health need, health benefit, cost and savings, and suitability, at both individual and population levels.
• As part of any policy review, Pharmac would consider how populations with the greatest health needs could be better reflected at a policy level.

Does Pharmac report on, or publish, the outcomes of Exceptional Circumstances applications?

• To protect patient privacy, we do not publish the full details of individual applications.
• We publish high level outcome data for initial NPPA applications for the last four financial years on our website.
• Pharmac does not report outcomes where there are fewer than seven similar requests, this is to protect patient privacy.

Where does the funding come from for treatments approved under the Exceptional Circumstances framework?

• The medicines budget funds treatments approved through the Exceptional Circumstances Framework.
• There is no fixed or ring‑fenced fund for treatments funded under the Framework.

Named Patient Pharmaceutical Assessment Pathway (NPPA)

What is the Named Patient Pharmaceutical Assessment Pathway (NPPA)

The NPPA pathway is Pharmac’s process to consider funding a medicine for an individual patient whose circumstances are exceptional and whose needs cannot be met through Pharmac’s normal funding process.

When should I apply for funding for a medicine under the NPPA pathway?

In general, you may want to consider a NPPA application when all funded treatment options have either been tried without success, are not tolerated, or are not clinically appropriate for the person and their clinical circumstances are considered exceptional.

If you are unsure whether an NPPA application is appropriate, please feel free to contact our Exceptions Team on 0800 66 00 50 (option 2).

How many people with the same circumstances would make a situation exceptional?

• There is no fixed patient number. Guided by clinical advice, Pharmac looks at the principles of the NPPA policy and considers whether a patient group could be funded through the normal funding process or if an exceptions pathway is needed.
• Patient numbers are not the only reason that someone is or isn’t clinically exceptional.

Does Pharmac stop funding a medicine through NPPA after receiving an application to fund the medicine for a wider population group?

• Anyone with a current NPPA approval will continue to receive funded access to the medicine, provided they continue to meet any ongoing funding criteria associated with their approval.
• For any new patients, if their clinical circumstances are similar to a previously approved NPPA application (and the other principles are met), Pharmac may continue to fund treatment through NPPA.
• On occasion, we start funding a treatment for a small number of people because we have had advice that their circumstances are exceptional.
• We can then discover that a larger group of people with similar circumstances could benefit, usually because we have received a lot of applications. If this happens, Pharmac will seek new clinical advice.
• If that advice shows that circumstances are no longer exceptional, Pharmac may consider that the medicine is better funded through the Schedule. If this is the case, we will stop accepting new applications through NPPA.
• People with existing NPPA approvals will continue to get funded access to the medicine, provided they continue to meet any ongoing funding criteria associated with their approval.

What is the difference between a 'Decline' and 'Principles not met' outcome for an application?

• While the outcome for the patient is the same (that the medicine is not funded) the reason differs.
• There are two stages to our consideration of a NPPA application
  • First, are the principles of the NPPA policy met?
  • If yes, the application is assessed against the Factors for Consideration(1).
• If an application does not meet the principles of the NPPA policy, it does not go to the assessment stage. This is reported as “principles not met”
• A “Decline” only occurs if, after assessing an application against the Factors for Consideration, Pharmac decides not to fund the medicine.
• Declining applications is rare. We have declined fewer than 1% of applications.

(1). The Factors for Consideration is the framework Pharmac uses when making funding decisions.

Can Pharmac apply discretion when assessing NPPA applications?

Under the current Framework, Pharmac can apply discretion to fund treatments for people, even where the circumstances do not fully meet the core principles of the NPPA policy.

• We may use discretion when a funded alternative is more expensive than the treatment being sought through a NPPA application and all other principles are met. The person would still need to have exceptional clinical circumstances.
• As part of the review, Pharmac will develop clearer guidance for consumers, prescribers, and Pharmac staff. We want to reduce our reliance on discretion and improve transparency about when and how it is applied.

Does Pharmac consider every application in isolation?

• We consider every NPPA application individually, based on the person's specific circumstances and needs.
• NPPA decisions are informed by, not determined by, earlier decisions. A single application doesn’t set a precedent or provide access for everyone with similar circumstances.
• Where we have considered earlier NPPA applications with similar clinical circumstances, you can expect similar funding decisions.
• However, evidence can change over time, which may lead to a different decision. Where there is new evidence to support a treatment, a different recommendation may be made.
• As such, Pharmac considers every application individually, but not in isolation.

How does Pharmac get the right clinical advice?

• Pharmac’s main source of clinical advice for NPPA applications is the NPPA Advisory Panel. The Panel is made up of 13 expert clinicians, covering 10 specialities.
• Three members of the Advisory Panel provide advice three times a week, on a rostered basis.
• All three members give advice on each application individually, and Pharmac considers this as a collective clinical view.
• When more specialist input is needed, we seek advice from members of our existing Special Advisory Committees.
• If we still can’t find a suitable expert, we work with the applicant to make sure we get appropriate specialist advice. We have strengthened this collaborative approach in response to feedback.
• When communicating the outcome of an application, Pharmac explains where the advice came from and provides a summary. This helps applicants understand the basis of the decision and raise any concerns if needed.

Are the Principles of the NPPA policy up for review through this process?

Yes, the NPPA policy, including the NPPA Principles are in scope of the review.

If Pharmac has flexibility to consider exceptional circumstances and wider impacts, why is it still hard for medicines for rare disorders to be funded?

• Under the current NPPA policy, we can fund applications for rare disorders where the principles are met, and the application has been successfully considered against the Factors for Consideration.
• As part of this review, Pharmac wants to explore whether we need more pathways to better meet our legislative responsibilities under the Healthy Futures (Pae Ora) Act.
• This could include specific pathways within the Exceptional Circumstances Framework for rare disorders, cancer treatments, or other defined exceptional circumstances.
• The budget and how medicines are funded are out of scope of this review.

Why are there renewals each year, are renewals only given for one year?

• Renewal criteria help Pharmac assess whether the intended benefits of treatment are being achieved, similar to Special Authority criteria(2).
• Approval durations vary depending on the treatment and condition. Durations can vary anywhere from 1 month to lifetime. Where a patient is stable and their condition is unlikely to change, we may consider approvals for several years or for the person’s lifetime.

(2). Pharmac sets specific criteria that must be met before some medicines will be funded. We do this to ensure medicines are targeted to those who would benefit most from treatment.

Urgent Assessments

When should a NPPA Rapid Application be submitted to Pharmac for assessment?

A NPPA Rapid Application should be considered when the person receiving the treatment is an in-patient at a Health New Zealand hospital and treatment is needed within five working days due to clinical urgency.

Pharmac (rather than your hospital) must assess any rapid assessment applications for any treatment that is PCT claimable(3) (Rules of the Schedule), this includes:

• rituximab
• infliximab
• tocilizumab
• any pharmaceutical cancer treatment

(3). PCT means a Pharmaceutical listed in Section B of the Schedule that a Health NZ Hospital Contractor may claim a subsidy payment for, and identified therein as a "PCT" or "PCT only" Pharmaceutical.

When should a Health New Zealand Hospital undertake its own NPPA Rapid Assessment?

Generally, Pharmac can process NPPA Rapid Assessment applications for in hospital treatments within the time-period requested by the applicant.

However, there may be times when a patient needs a decision before Pharmac can assess the application.

NPPA Rapid Assessments considered within a Health New Zealand hospital are for those hospital pharmaceutical applications that are so urgent that it is not feasible for Pharmac to consider and decide on the application within a clinically appropriate time frame. 

If you are unsure whether your hospital should undertake its own NPPA Rapid Assessment, contact the Exceptions Advisors team first, on 0800 66 00 50 option 2. The Exceptions Advisors team can provide guidance on whether Pharmac is able to make a decision within the timeframe required for the patient.

Do Health New Zealand Hospitals need to assess applications against the Principles of the NPPA policy?

Yes, Health New Zealand hospitals must follow the same process as Pharmac in considering NPPA Rapid Assessments.

This includes determining whether the core principles of the NPPA policy are met.

What is the Emergency Use Rule and how does this differ from a NPPA Rapid Assessment?

The Emergency Use Rule and a NPPA Rapid Assessment considered within the Health New Zealand hospital are both used in urgent situations, but they are for different circumstances.

The Emergency Use Rule applies when there is an immediate life-threatening need, the medicine is not listed in the Hospital Medicines List for that indication, and the medicine is already available in the hospital. In these situations, clinicians can use their usual hospital protocols to access treatment and notify Pharmac afterward.

The Emergency Use Rule is not part of the Framework and therefore the NPPA principles do not apply. It is intended to enable access to treatment in an immediate life-threatening situation, rather than requiring an assessment against NPPA criteria before treatment can proceed.

Special Authority Waivers

What is a Special Authority Waiver?

A Special Authority waiver is an exception to a Special Authority criteria. It allows Pharmac to consider funded access for a patient who does not meet the exact criteria but whose clinical circumstances are consistent with the intent of the funding rules.

When and how should I apply for a Special Authority Waiver?

A Special Authority waiver may be requested when a patient does not meet one or more of the eligibility criteria for a medicine funded through Special Authority, but their circumstances are consistent with the intent of the Special Authority and there is a clinical rationale for funded access.

To apply for a Special Authority waiver, complete the relevant Special Authority form and explain which criteria the patient does not meet and why an exception is being requested. Include any supporting clinical information, such as clinic letters, and email the request to waivers@pharmac.govt.nz.

Special Authority forms can be downloaded from the Hospital Medicines (HML) Schedule on Pharmac's website. Special Authority waiver applications cannot be submitted through the electronic Special Authority system.

Exceptional Circumstances Applications for Alternative Brands

Does Pharmac have a specific EC pathway for considering alternative brands of funded medicines?

Sometimes Pharmac needs to change the funded brand of a medicine. When this happens, Pharmac recognises that the new funded brand may not be suitable for everyone.

In some cases, an alternative brand may be funded through a bespoke pathway. This allows people to remain on their current treatment when it is not clinically appropriate for them to switch to the new funded brand.

These pathways are developed for specific medicines and have their own application forms and assessment criteria. There is currently no single pathway for considering access to alternative brands of funded medicines.

Requests for alternative brands that do not have a bespoke form available can be submitted via NPPA.

Where do I find information on what EC pathways are currently available for accessing alternative brands?

Application forms and information for currently available alternative brand pathways are available on Pharmac's website under Other Exceptional Circumstances Forms.

What do I do if my medicine has changed and I am unable to use the currently funded brand?

There is currently no single pathway for considering access to alternative brands of funded medicines. In some cases, Pharmac may establish a bespoke alternative brand pathway for a specific medicine.

If a bespoke pathway is available, applications should be made through that pathway. If there is no alternative brand pathway available, a Named Patient Pharmaceutical Assessment (NPPA) application may be submitted for consideration.

Any NPPA application will be assessed against the NPPA policy, including the core principles of the policy and Pharmac's Factors for Consideration.

Who to contact

If you have any further questions that were not answered here, email ECFReview@pharmac.govt.nz