Proposal to decline inactive funding applications
Final decision made
On 7 November 2023 we announced our decision as a result of this consultation.
What we’re proposing
To help make our decision-making process clearer, we are seeking feedback on a proposal to decline the 27 funding applications detailed in the tables below.
These are all inactive applications, meaning that Pharmac is not currently working on progressing these applications for funding.
Your feedback will help us make decisions on whether the funding applications for the medicines detailed in this consultation should be declined.
Further information about this proposal, including details of each application and how to provide feedback follows below.
Consultation closes at 5 pm on Friday 1 September 2023 and feedback can be emailed to applicationfeedback@pharmac.govt.nz
Why we’re proposing this
Pharmac’s role is to decide which medicines are funded to get the best health outcomes from within a fixed budget, and we know that the decisions we make impact nearly every New Zealander. All funded medicines are listed on the Pharmaceutical Schedule(external link).
We are committed to making our decision-making process faster and easier for people to understand. We want to ensure that people can easily see what is happening with funding applications, including what stage applications are at, and why we make our decisions.
We’ve heard from New Zealanders that they want Pharmac to reach decisions on funding applications so they can have some certainty about whether a medicine is, or is not, being actively considered, even if our decision is to decline funding.
In line with this, Pharmac is considering declining funding for a number of inactive applications.
There are a range of reasons a funding application may be inactive, including:
- our expert clinical advisors have recommended that the funding application be declined
- other medicines for the same condition are now funded making the funding application no longer relevant
- our expert clinical advisors have recommended that the medicine would provide no additional benefits over other treatments we already fund, or it may be harmful
- no company is willing to supply the medicine in New Zealand.
Details about our proposal
We have identified inactive funding applications for 27 different medicines that we are proposing to decline. For each of these funding applications, we have provided our rationale as to why we are considering declining the application. For the majority, it is because we understand no company is willing to supply the medicine in New Zealand. Alternatively, it is because, since we received the application, we have funded a clinically appropriate alternative medicine.
It is important to note that Pharmac has not yet made a decision about these funding applications. We want to consider all relevant information before any final decisions are made.
We therefore want to hear from people and communities about whether it would be appropriate to decline funding for these medicines for the use requested, or whether we should reconsider our proposal to decline funding.
A decline decision would mean the medicine would not be funded for the use requested. However, it would not prevent Pharmac from reconsidering funding for these medicines in the future. For example, if new evidence, or other relevant information, became available which addresses the reasons for the decline decision. The availability of a supply of Medsafe approved medicine is one example. In addition, Pharmac retains the discretion to consider the funding of applications for individual patients through the wider Exceptional Circumstances Framework.
All consultation responses will be considered before making a final decision on any of these funding applications. These decisions would be made by the Pharmac Board or its delegate using Pharmac’s Factors for Consideration. We expect to make these decisions over the next few months, depending on the feedback we receive.
Information about how Pharmac decides which medicines to fund is explained on our website.
Common terms used when describing our funding application assessment and decision-making process are explained in the following table.
|
Term |
What does it mean? |
|---|---|
|
Application |
A funding application received from a supplier, clinician, consumer or generated by Pharmac staff. |
|
Inactive application |
Following consideration of expert clinical advice, Pharmac is not working on progressing the medicines for funding for the use requested |
|
The Factors for Consideration are the framework Pharmac uses when making funding decisions. The Factors are not weighted or applied rigidly, and not every factor is relevant for every funding decision Pharmac makes. This is because the situation for one assessment may require quite different considerations compared with another. Funding decisions are made relative to other options, and the context within which decisions are made is constantly changing. |
|
|
Medsafe-approved |
Medsafe(external link) is responsible for the regulation of medicines and medical devices in New Zealand, ensuring they have acceptable quality, efficacy and safety. |
|
Pharmac’s statutory clinical advisory committee, the Pharmacology and Therapeutics Advisory Committee, is made up of senior health practitioners from a range of specialities. PTAC considers clinical evidence for funding applications and takes into account all of Pharmac's Factors for Consideration before making recommendations to Pharmac. PTAC’s role is to provide objective clinical advice to Pharmac. |
|
|
Specialist Advisory Committees (previously known as Subcommittees) |
Pharmac’s specialist advisory committees provide Pharmac with objective specialist knowledge and expertise within specific clinical areas, such as diabetes, cancer, and mental health. They meet as needed to discuss issues within their clinical areas. The specialist advisory committees have a different, but complementary, role to that of PTAC. Their expertise and perspectives can differ from PTAC. |
|
Recommended for decline |
A recommendation to Pharmac from PTAC or a specialist advisory committee to decline the funding application. A recommendation is not a decision by Pharmac. |
|
Cost neutral recommendation |
A recommendation to Pharmac from PTAC or a specialist advisory committee to only fund a medicine if it costs the same or less than another comparable medicine (ie one that is already funded which provides the same or similar health benefits). |
|
Proposing to decline |
A proposal from Pharmac to decline funding for a medicine. This is issued before a final decision is made. |
|
Decline decision |
A decision by Pharmac (the Board or its delegate), using the Factors for Consideration, to decline funding for a medicine. Pharmac decides which medicines will be funded, comparing all the options, to ensure we are getting the best possible health outcomes for New Zealanders from a fixed budget set by the Minister of Health. |
Applications that we are proposing to decline
In the table below you can find information on each of the applications that we are proposing to decline. For ease of navigation, the applications have been categorised by therapeutic group. The reason why we are proposing that the application is declined can be found in the 3rd column in the table (the column is titled “Why we are proposing this application be declined”).
Please note that if you don’t want to click on the hyperlinks in the table below, you can search for the pharmaceutical directly from the main Application Tracker(external link) on the Pharmac website and then select the relevant indication.
Applications that we are proposing to decline
Alimentary and metabolism
|
Pharmaceutical and indication |
Applicant |
Why we are proposing this application be declined |
Additional information |
|---|---|---|---|
|
Calcitriol liquid - Chronic kidney disease |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information. |
|
|
Phentermine Hydrochloride (37.5mg immediate-release tablet) - Obesity |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information. |
|
|
Calcium acetate - Phosphate binder |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information. |
Blood and Blood Forming Organs
|
Pharmaceutical and indication |
Applicant |
Why we are proposing this application be declined |
Additional information |
|---|---|---|---|
|
Folic Acid 0.4 mg tablets - Folic acid supplementation in pregnancy |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information. |
|
|
Prasugrel, Ticagrelor - Amending access post-ACS in clopidogrel non-responders using CYP2C19 genotyping |
Since this application was received we have funded ticagrelor(external link) for the treatment of post - acute coronary syndromes for all patients without the requirement to demonstrate clopidogrel non-response |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information. |
Cardiovascular System
|
Pharmaceutical and indication |
Applicant |
Why we are proposing this application be declined |
Additional information |
|---|---|---|---|
|
Dronedarone - Atrial fibrillation (AF) - permanent and non-permanent |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information. |
|
|
Vernakalant - Atrial fibrillation (AF) - chemical conversion |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information. |
|
|
Tafamidis – Cardiac amyloidosis |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information. |
Dermatology
|
Pharmaceutical and indication |
Applicant |
Why we are proposing this application be declined |
Additional information |
|---|---|---|---|
|
Dithranol powder - Dermatology |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information. |
|
|
Lassar's paste -Dermatology |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information. |
|
|
Doxycycline (low-dose) - Dermatological indications |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information. |
|
|
Hydrocortisone ointment 1% proprietary/premade product- Dermatology |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information. Please note that extemporaneously compounded hydrocortisone 1% ointment is funded if compounded in accordance with the Pharmaceutical Schedule Rules – Part 7 – Compounds and Mixtures. Further information about Dermatological extemporaneously compounded products and galenicals is available here |
|
|
Coal tar shampoo 4% - Psoriasis |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please clickhere(external link) for a link through to the Application Tracker entry for this application and further information. |
|
|
Cetrimide shampoo - Psoriasis and eczema |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please clickhere(external link) for a link through to the Application Tracker entry for this application and further information. |
Musculoskeletal System
|
Pharmaceutical and indication |
Applicant |
Why we are proposing this application be declined |
Additional information |
|---|---|---|---|
|
Naproxen oral liquid - Inflammation and pain |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please clickhere(external link) for a link through to the Application Tracker entry for this application and further information.
|
|
|
Meloxicam - Osteoarthritis and rheumatoid arthritis |
Since this application was received we have funded an alternative medicine, celecoxib for the treatment of osteoarthritis and rheumatoid arthritis |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information.
|
Nervous System
|
Pharmaceutical and indication |
Applicant |
Why we are proposing this application be declined |
Additional information |
|---|---|---|---|
|
Amifampridine (3,4-diaminopyridine) - Lambert Eaton myasthenic syndrome |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information. Please note that we currently consider applications for amifampridine via the Named Patient Pharmaceutical Assessment (NPPA) Policy. Pharmac retains the discretion to consider the funding of applications for individual patients through the wider Exceptional Circumstances Framework(external link). |
|
|
Pimozide - Schizophrenia |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information. |
|
|
Levomilnacipran - major depressive disorder |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information.
|
Oncology Agents and Immunosuppressants
|
Pharmaceutical and indication |
Applicant |
Why we are proposing this application be declined |
Additional information |
|---|---|---|---|
|
Carboxypeptidase G2 - Methotrexate overdose |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information. |
|
|
Levamisole - Frequently relapsing steroid sensitive nephrotic syndrome |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information. |
|
|
Mitotane –Adrenocortical carcinoma |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information. Please note that we currently consider applications for mitotane via the Named Patient Pharmaceutical Assessment (NPPA) Policy. Pharmac retains the discretion to consider the funding of applications for individual patients through the wider Exceptional Circumstances Framework(external link). |
Respiratory System and Allergies
|
Pharmaceutical and indication |
Applicant and brand name (if relevant/ specified) |
Why we are proposing this application be declined |
Additional information |
|---|---|---|---|
|
Lumacaftor/ivacaftor (Orkambi) - Cystic Fibrosis Patients with F508del gene mutations |
Since this application was received we have funded an alternative medicine elexacaftor with tezacaftor and ivacaftor triple therapy (Trikafta(external link)) for cystic fibrosis in people aged 6 years and over with F508del gene mutations |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information. |
Sensory Organs
|
Pharmaceutical and indication |
Applicant |
Why we are proposing this application be declined |
Additional information |
|---|---|---|---|
|
Cevimeline - Dry mouth incl. Sjogren's syndrome |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information. |
|
|
Iodine crystals 1%, Ether liquid 16%, magnesium carbonate light powder 1%, boric acid powder 82% - Otitis externa - ear inflammation |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information. |
|
|
Loteprednol - Eye inflammation in those with intraocular pressure rise |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information. |
|
|
Cefuroxime 1 mg per 0.1 ml injection- endophthalmitis prophylaxis post cataract surgery |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe registration. We note that there are Medsafe registered cefuroxime powder for injection(external link)s in various strengths. However, this medicine has a special warning and precaution against intracameral use (ie into the anterior chamber of the eyeball) |
Please click here(external link) for a link through to the Application Tracker entry for this application and further information. |
To provide feedback
Please send us an email: applicationfeedback@pharmac.govt.nz by 5pm on Friday 1 September 2023.
All feedback received before the closing date will be considered by Pharmac’s Board (or its delegate) prior to making a decision on this proposal.
Your feedback may be shared
Feedback we receive is subject to the Official Information Act 1982 (OIA). Please be aware that we may need to share your feedback, including your identity, in response to an OIA request. This applies to anyone providing feedback, whether they are providing feedback themselves or for an organisation, in a personal or professional capacity.
We can only keep feedback confidential as allowed under the OIA and other related laws. If you want any part of your feedback treated as confidential, you need to tell us. Please let us know if you want to keep part of your feedback confidential, and why. Is it commercially sensitive, confidential or proprietary, or personal information? Clearly state this and tell us which parts of your feedback you want to keep confidential for these reasons. We will consider your request under our OIA requirements.