Proposal to decline inactive funding applications

What we’re proposing

To provide clarity about which medicines we’re actively considering for funding, we’re proposing to decline 94 funding applications.

All of these applications are inactive which means Pharmac is not currently progressing them.

We want your feedback to help us understand whether the funding applications in this consultation should be declined.

Consultation closes at 5 pm on Friday 9 February 2024 and feedback can be emailed to applicationfeedback@pharmac.govt.nz

Why we’re proposing this

Pharmac’s role is to secure the best health outcomes possible for New Zealanders through medicines and related products within the available funding. Because we work within a fixed budget, this requires us to make difficult choices about what can be funded. Medicines funded by Pharmac are listed on the Pharmaceutical Schedule(external link).

We are committed to making our decision-making process clearer and easier for people to understand. We want to ensure people can easily see what is happening with funding applications, including what stage applications are at, and why we make our decisions.

We know people want to see us reach decisions on funding applications so they have certainty about whether a medicine is, or is not, being considered, even if our decision is to decline funding. 

Because of this, we’re considering declining a number of inactive applications. These applications may be inactive for a number of reasons, 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 94 inactive funding applications that we are proposing to decline. We will not make a decision on these until we have considered all of the information made available to us.

At the bottom of this document we have noted all 94 applications and the reason we are proposing to decline them. We are interested to hear from you whether this reason is appropriate or if we should reconsider declining the application. 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.

Declining the application would mean the medicine would not be funded for the use requested at this time. This would not prevent Pharmac from reconsidering funding for the medicines in the future if information became available that addresses the reason for the decline. For example, if new evidence, or other relevant information, became available which addresses the reasons for the decline decision.

We will consider all of the feedback we receive before we make any decisions on these funding applications. The final decisions would be made in line with Pharmac’s Factors for Consideration, and by the Pharmac Board or its delegate We expect to make these decisions over the next few months.

If we decided to decline a funding application, we can still consider funding the medicine for individuals with exceptional circumstances through the wider Exceptional Circumstances Framework.

More information about how medicines are funded is available on the Pharmac website. 

Share your feedback with us

If you have information to share about any of the applications in the table at the end of this proposal, or a reason we should not progress declining the application please let us know.


Send us an email with this information to applicationfeedback@pharmac.govt.nz by 5pm on Friday 9 February 2024.

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 

Any feedback you provide to us is subject to the Official Information Act 1982 (OIA). Please be aware we may need to share your feedback, including your identity, in response to an OIA request. This applies to anyone, in any capacity, for example providing feedback as an individual or for an organisation, or in a personal or professional capacity.

If you would like your feedback treated as confidential, let us know and provide the reason. Reasons for confidentiality may include commercial sensitivity, confidentiality, proprietary, or inclusion of personal information. This will help us understand if it could be kept confidential within our OIA requirements.

Glossary of words and terms

To help you understand the words and terms in the table at the bottom of this page, outlining the applications we are proposing to decline, we have explained what some of these mean below.

Term

What does it mean?

Application

A funding application is a request to fund a specific medicine, or related product, for a specific condition or under specific clinical circumstances. It is usually received from a supplier, clinician, consumer or generated by Pharmac staff.

Inactive application

Following consideration of expert clinical advice, we are not working on progressing the medicines for funding for the use requested.

Factors for Consideration

The Factors for Consideration are the framework we use 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. The context within which decisions are made is constantly changing.

Medsafe

Medsafe(external link) is the Government body responsible for the regulation of medicines and medical devices in New Zealand, ensuring they have acceptable quality, efficacy and safety.

The Pharmacology and Therapeutics Advisory Committee - PTAC

 

Pharmac’s statutory clinical advisory committee, the Pharmacology and Therapeutics Advisory Committee, PTAC, is made up of senior health practitioners from a range of specialities. It considers evidence for funding applications and takes into account all of the Factors for Consideration before making objective clinical recommendations 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 those of 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 or combination of medicines (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 publicly consulted on 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 we’re proposing to decline

In the tables below you can find information on each of the applications that we are proposing to decline and the reasons why. For ease of navigation, the applications have been categorised by therapeutic area.

All of the applications are available to view on the Application Tracker(external link) on the Pharmac website.

Alimentary

Pharmaceutical and indication

Applicant

Why we are proposing this application be declined

Additional information

Multivitamin and mineral boost – individuals with burns patients (community use)

Clinician application(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined (May 2014). [PDF, 286 KB]

Please click here for a link through to the Application Tracker entry for this application and further information.

Note: Multivitamin and Mineral Boost is funded for use in hospital(external link)

Tacrolimus suppository - Rectal inflammation due to inflammatory bowel disease

Clinician application(external link)

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.

 

Anaesthetics, analgesics and anti-nausea

Pharmaceutical and indication

Applicant

Why we are proposing this application be declined

Additional information

Paracetamol 500mg with codeine 30mg - Pain

Pharmac initiated(external link)

The Analgesic Subcommittee of PTAC recommended that this application be declined (March 2008).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Capsaicin 0.075% cream - Cannabinoid hyperemesis syndrome

Clinician application(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined (November 2021). [PDF, 528 KB]

Please clickhere(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

Enoxaparin - patients with lower leg immobilisation

Clinician application(external link)

The Haematology Subcommittee of PTAC recommended that this application be declined [PDF, 157 KB] (January 2019).

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Prasugrel - Percutaneous coronary intervention - immediate PCI for STEMI patients

Eli Lilly(external link)

This application has been superseded. An alternative application for prasugrel for acute coronary syndrome, STEMI or non-STEMI, is being progressed for consideration.(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Peginterferon alfa-2a - myeloproliferative neoplasms

Clinician application(external link)

The Cancer Treatments Subcommittee of PTAC recommended that this application be declined (April 2021).(external link)

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

Aluminium hydrochloride 35% suspension- Compounding ingredient, for haemostasis in the setting of post shave biopsies

Specialist Advisory Committee recommendation(external link)

The Dermatology Subcommittee of PTAC recommended that this application be declined (November 2015) [PDF, 103 KB]. In summary, the Subcommittee considered that funding of compounded aluminium hydroxide 35% suspension was no longer required as there was a 20% proprietary aluminium chloride liquid listed on the HML(external link) which is available under restriction for use as a haemostasis agent(external link).

Please clickhere(external link) for a link through to the Application Tracker entry for this application and further information.

Sirolimus ointment (compounded) - Facial angiofibromas secondary to tuberous sclerosis complex

Pharmac initiated (NPPA)(external link)

This application has been superseded. An alternative application for a proprietary sirolimus ointment (Pascomer) is now being progressed(external link) for consideration.

 

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Note that applications for individual patients could still be submitted through the Exceptional Circumstances Framework even if this funding application were to be declined.

 

Diabetes

Pharmaceutical and indication

Applicant

Why we are proposing this application be declined

Additional information

Glucose solution (with or without complex carbohydrate biscuit) - Hypoglycemia

AJW Enterprises Ltd(external link)

The Diabetes Subcommittee of PTAC indicated that this medicine should only be funded if it is cost neutral ie costs the same, or less, than the funded comparable medicine. The Diabetes Subcommittee recommended that glucose solution plus complex carbohydrate, brand name HypoPak be funded only if cost-neutral to the glucose with sucrose and fructose gel, 18 g sachet currently listed on the Hospital Medicines List (HML) [PDF, 328 KB]. We understand that this pricing is not achievable.

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Linagliptin - Diabetes - type 2

Boehringer Ingelheim(external link)

This application has been overtaken by events. Pharmac ran a Request for Proposals (RFP) in January 2020 for the supply of diabetes agents: SGLT-2 inhibitors, GLP-1 agonists and DPP-4 inhibitors. Linagliptin is a DPP-4 inhibitor. However, as a result, this proposal (linagliptin for diabetes-type 2) was not progressed for funding at that time. A range of alternative medicines are now funded for people with diabetes(external link). These listings are in line with our clinical advice which recommended funding of at least one chemical from two of the three classes of anti-diabetic agents, DDP4s, GLP-1s or SGLT2s. [PDF, 94 KB]

Although Pharmac is proposing to decline this proposal, we would still retain the discretion to reconsider this proposal for funding at a future date.

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Dapagliflozin - Diabetes - type 2

Astra Zeneca(external link)

This application has been overtaken by events. Pharmac ran a Request for Proposals (RFP) in January 2020 for the supply of diabetes agents: SGLT-2 inhibitors, GLP-1 agonists and DPP-4 inhibitors. Dapagliflozin is an SGLT-2 inhibitor. However, as a result, this proposal (dapagliflozin for diabetes-type 2) was not progressed for funding at that time. A range of alternative medicines are now funded for people with diabetes(external link). These listings are in line with our clinical advice which recommended funding of at least one chemical from two of the three classes of anti-diabetic agents, DDP4s, GLP-1s or SGLT2s. [PDF, 94 KB]

Although Pharmac is proposing to decline this proposal, we would still retain the discretion to reconsider this proposal for funding at a future date.

Please click here(external link) for a link through to the Application Tracker entry for this application and further information

Canagliflozin - Diabetes - type 2

Janssen(external link)

This application has been overtaken by events. Pharmac ran a Request for Proposals (RFP) in January 2020 for the supply of diabetes agents: SGLT-2 inhibitors, GLP-1 agonists and DPP-4 inhibitors. Canagliflozin is a SGLT-2 inhibitor. However, as a result, this proposal (canagliflozin for diabetes-type 2) was not progressed for funding at that time. A range of alternative medicines are now funded for people with diabetes(external link). These listings are in line with our clinical advice which recommended funding of at least one chemical from two of the three classes of anti-diabetic agents, DDP4s, GLP-1s or SGLT2s. [PDF, 94 KB]

Although Pharmac is proposing to decline this proposal, we would still retain the discretion to reconsider this proposal for funding at a future date.

Please clickhere(external link) for a link through to the Application Tracker entry for this application and further information

Lixisenatide - Type 2 diabetes, with established cardiovascular disease

Sanofi(external link)

This application has been overtaken by events. Pharmac ran a Request for Proposals (RFP) in January 2020 for the supply of diabetes agents: SGLT-2 inhibitors, GLP-1 agonists and DPP-4 inhibitors. Lixisenatide is a GLP-1 inhibitor. However, as a result, this proposal (lixisenatide for diabetes-type 2, with established cardiovascular disease) was not progressed for funding at that time. A range of alternative medicines are now funded for people with diabetes(external link). These listings are in line with our clinical advice which recommended funding of at least one chemical from two of the three classes of anti-diabetic agents, DDP4s, GLP-1s or SGLT2s. [PDF, 94 KB]

Although Pharmac is proposing to decline this proposal, we would still retain the discretion to reconsider this proposal for funding at a future date.

Please click here(external link) for a link through to the Application Tracker entry for this application and further information

Exenatide - Type 2 diabetes, with established cardiovascular disease

Astra Zeneca(external link)

This application has been overtaken by events. Pharmac ran a Request for Proposals (RFP) in January 2020 for the supply of diabetes agents: SGLT-2 inhibitors, GLP-1 agonists and DPP-4 inhibitors. Exenatide is a GLP-1 inhibitor. However, as a result, this proposal (exenatide for diabetes-type 2, with established cardiovascular disease) was not progressed for funding at that time. A range of alternative medicines are now funded for people with diabetes(external link). These listings are in line with our clinical advice which recommended funding of at least one chemical from two of the three classes of anti-diabetic agents, DDP4s, GLP-1s or SGLT2s. [PDF, 94 KB]

Although Pharmac is proposing to decline this proposal, we would still retain the discretion to reconsider this proposal for funding at a future date.

Please click here(external link) for a link through to the Application Tracker entry for this application and further information

 

Hormone Preparations – Systemic excluding contraceptive hormones

Pharmaceutical and indication

Applicant

Why we are proposing this application be declined

Additional information

Whole Thyroid Extract, Normal Release T3 and Extended Release T3 - Hypothyroidism

Clinician application(external link)

The Endocrinology Advisory Committee recommended that this application be declined(external link) (August 2022).

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

We have previously consulted on declining this application. However, during consultation, we received additional information to support the application. The application was not progressed to a decline and the additional information was taken to the Endocrinology Advisory Committee for consideration. However, upon consideration, our clinical advisors recommended that this application be declined. 

Levothyroxine oral liquid - Congenital hypothyroidism

Clinician application(external link)

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.

 

 

Immunosuppressants

Pharmaceutical and indication

Applicant

Why we are proposing this application be declined

Additional information

Tocilizumab - Grade 3 or 4 cytokine release syndrome

Clinician application(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined [PDF, 295 KB] (November 2016).

 

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Please note that tocilizumab is currently funded via Special Authority for individuals who are enrolled in the Children’s Oncology Group AALL1731 trial(external link). This funding would be unaffected should this application be progressed to a decline decision.

Note that applications for individual patients could still be submitted through the Exceptional Circumstances Framework even if this funding application were to be declined.

Biosimilar Etanercept - Multiple Indications

Celltrion Healthcare New Zealand Limited(external link)

This application has been overtaken by events. This pharmaceutical was included in a Request for Proposals (RFP) for the supply of etanercept in November 2018. However, as a result, this proposal was not progressed at that time. We are now proposing to decline this proposal; however we note that Pharmac would still retain the discretion to reconsider this proposal for funding at a future date.

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

 

Everolimus – Angiomyolipoma associated with tuberous sclerosis complex

Clinician application(external link)

This application has been superseded. A clinical alternative medicine, sirolimus(external link), has now been funded via Special Authority(external link) for people with angiomyolipoma associated with tuberous sclerosis complex.

 

Please clickhere(external link) for a link through to the Application Tracker entry for this application and further information.

Everolimus – Tuberous sclerosis (TSC) 2 years & older with refractory epilepsy

Clinician application(external link)

This application has been superseded. A clinical alternative medicine, sirolimus(external link), has now been funded via Special Authority(external link) for people two years and older with tuberous sclerosis complex with refractory epilepsy.

 

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Note that applications for individual patients could still be submitted through the Exceptional Circumstances Framework(external link) even if this funding application were to be declined.

Rituximab Biosimilar – Multiple indications

Celltrion Healthcare New Zealand Limited(external link)

This application has been overtaken by events. This pharmaceutical was included in the July 2019 Request for Proposals (RFP) on the supply of rituximab.(external link) However, as a result, this proposal not progressed. We are now proposing to decline this proposal; however we note that Pharmac would still retain the discretion to reconsider this proposal for funding at a future date.

Please clickhere(external link) for a link through to the Application Tracker entry for this application and further information.

 

Infections – Agents for Systemic Use

Pharmaceutical and indication

Applicant

Why we are proposing this application be declined

Additional information

Azithromycin - Bronchiectasis - prevention of exacerbations in non-cystic fibrosis in adults

Clinician application(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined (August 2015).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Ledipasvir with sofosbuvir - Chronic hepatitis C, lower-risk groups, genotype 1

Gilead Sciences(external link)

Since this application was received we have funded an alternative medicine, glecaprevir/pibrentasvir (Marivet)(external link) for the treatment of chronic hepatitis C, lower-risk groups, genotype 1.

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Elbasvir with grazoprevir - Chronic hepatitis C, genotype 1

Merck Sharp and Dohme(external link)

Since this application was received we have funded an alternative medicine, glecaprevir/pibrentasvir (Marivet)(external link) for the treatment of chronic hepatitis C, genotype 1.

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Ceftolozane and tazobactam - Complicated intra -abdominal infections, complicated urinary tract infections

Merck Sharp and Dohme(external link)

The Anti-Infective Subcommittee of PTAC recommended that this application be declined (October 2016).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Ceftolozane with tazobactam - Significant infections due to multi-drug resistant aerobic Gram-negative organisms

Clinician application(external link)

The Anti-Infective Subcommittee of PTAC recommended that this application be declined (May 2019).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Oseltamivir - Influenza prevention (Community use)

Pharmac initiated(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined (May 2013).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Note: Oseltamivir is funded for use in hospital(external link)

Zanamivir - Influenza (community use)

Pharmac initiated(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined (May 2013).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Note: Zanamivir is funded for use inhospital(external link)

Palivizumab - Respiratory syncytial virus (RSV) - prevention of infection in high risk infants

Abbott(external link)

This application has been superseded. An alternative proposal, Palivizumab – extension of funding for RSV,(external link) is now being progressed for consideration instead of this application.

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Oseltamivir - treatment and prophylaxis of influenza during influenza outbreaks in long-term care facilities

Clinician application(external link)

The Anti-Infective Subcommittee of PTAC recommended that this application be declined (May 2019).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Note: Oseltamivir is funded for use in hospital(external link)

Albendazole - Giardiasis

Te Arai Biofarma(external link)

The Anti-Infective Subcommittee of PTAC recommended that this application be declined (November 2017).(external link)

In addition, we understand there is currently no Medsafe approved product available in New Zealand and no supplier is willing to progress an application for Medsafe registration for this product.

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Tenofovir Alafenamide - Chronic Hepatitis B adults

Gilead Sciences(external link)

Our clinical advisors, the Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this medicine should only be funded if it was cost neutral i.e. cost the same, or less, than the funded comparable medicine (August 2018).(external link)

The advice we received recommended that tenofovir alafenamide be listed if it was cost neutral to tenofovir disoproxil salts.(external link) We understand that this pricing is not achievable

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

 

Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol - fixed dose combinations - Tuberculosis

Clinician application(external link)

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.

Ivermectin - For prevention and/or treatment of COVID-19

Consumer application(external link)

The COVID-19 Treatments Advisory Group recommended that this application be declined (February 2022).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

 

Mental Health

Pharmaceutical and indication

Applicant

Why we are proposing this application be declined

Additional information

Esketamine hydrochloride - Major depressive disorder with active suicidal ideation with intent (MDSI).

Janssen NZ Ltd(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined (November 2020).(external link)

.

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Note: Esketamine for treatment resistant depression, post augmentation is being progressed for consideration. You can read information about this application on the application tracker(external link)

Esketamine - Treatment-resistant depression

Janssen NZ Ltd(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined (February 2021).(external link)

 

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Note: Esketamine for treatment resistant depression, post augmentation is being progressed for consideration. You can read information about this application on the application tracker(external link)

 

Metabolic Agents

Pharmaceutical and indication

Applicant

Why we are proposing this application be declined

Additional information

Miglustat - Niemann Pick Type C

Te Arai Biofarma(external link)

The Rare Disorders Subcommittee of PTAC recommended that this application be declined (November 2018).(external link)

 

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Note that applications for individual patients could still be submitted through the Exceptional Circumstances Framework(external link) even if this funding application were to be declined.

Miglustat - Gaucher disease - type 1 (mild to moderate)

Actelion(external link)

This application has been superseded. An alternative application for miglustat for Gaucher Disease(external link) is being progressed for consideration.

 

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Note that applications for individual patients could still be submitted through the Exceptional Circumstances Framework(external link) even if this funding application were to be declined.

Alglucosidase alfa - Late onset Pompe disease

Sanofi Genzyme(external link)

The Rare Disorders Subcommittee of PTAC recommended that this application be declined (November 2018).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

 

Miglustat - Gaucher disease

Te Arai Biofarma(external link)

The Rare Disorders Subcommittee of PTAC recommended that this application be declined (November 2018).(external link)

 

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Note that applications for individual patients could still be submitted through the Exceptional Circumstances Framework(external link) even if this funding application were to be declined.

Laronidase - Hurlers disease (Mucopolysaccharidosis 1 or MPS 1)

Clinician application(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined (November 2011).(external link)

Please clickhere(external link) for a link through to the Application Tracker entry for this application and further information.

 

Sapropterin - Hyperphenylalaninaemia due to phenylketonuria (PKU) in non-pregnant PKU patients

Te Arai Biofarma(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined (May 2016).(external link)

 

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Note that applications for individual patients could still be submitted through the Exceptional Circumstances Framework(external link) even if this funding application were to be declined.

 

Musculoskeletal System

Pharmaceutical and indication

Applicant

Why we are proposing this application be declined

Additional information

Quinacrine - Systemic Lupus Erythematosus (SLE)

Clinician application(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined (May 2021).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Adalimumab/etanercept - Rheumatoid arthritis - amendment to SA criteria to include patient-reported outcomes

AbbVie Ltd(external link)

The Rheumatology Subcommittee of PTAC recommended that this application be declined (May 2021).(external link)

Please clickhere(external link) for a link through to the Application Tracker entry for this application and further information.

Denosumab - Osteoporosis, removing definition of contraindicated to zoledronic acid

Amgen(external link)

This application has been superseded. Two alternative applications for people with osteoporosis are being progressed for consideration. These are denosumab for osteoporosis in patients contraindicated or unable to tolerate bisphosphates(external link); and denosumab for osteoporosis, contraindicated to bisphosphonates(external link).

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Etoricoxib - Osteoarthritis and rheumatoid arthritis

Merck Sharp and Dohme(external link)

Since this application was received we have funded an alternative medicine, celecoxib(external link), as a treatment option for osteoarthritis and rheumatoid arthritis.

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

 

Neurology

Pharmaceutical and indication

Applicant

Why we are proposing this application be declined

Additional information

Multiple Sclerosis (MS) treatments - Fingolimod, Glatiramer Acetate, Interferon Beta 1A, Interferon Beta 1B, Natalizumab - clinically isolated syndrome fulfilling the McDonald 2010 diagnostic criteria

Subcommittee recommendation(external link)

Since this application was received we have widened access to these treatments for people with MS as detailed in our decision June 2022(external link).

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Multiple Sclerosis treatments - interferon beta-1-alpha, interferon beta-1-beta, glatiramer acetate - Multiple sclerosis (MS) - amending entry criteria

Clinician application, Multiple Sclerosis Treatment Assessment Committee recommendation(external link)

Since this application was received we have widened access to natalizumab, fingolimod, glatiramer acetate, interferon beta-1-alpha, interferon beta-1-beta, natalizumab and teriflunomide(external link). These changes allow earlier access to treatments than that requested in this application.

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Cannabidiol with tetrahydrocannabinol - Multiple sclerosis spasticity, epilepsy, pain and spasticity

To be determined(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined (August 2015).(external link)

Please click her(external link)e for a link through to the Application Tracker entry for this application and further information.

Multiple Sclerosis (MS) treatments - Amending access criteria to include an additional measurement scale

Clinician application(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined (November 2018).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Multiple Sclerosis (MS) treatments - Amending definition of Significant Relapse to 24 hr duration

Clinician application(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined (November 2018).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Multiple Sclerosis (MS) treatments - interferon beta-1-alpha, interferon beta-1-beta, glatiramer acetate - Removal of exit criteria

Clinician application, Multiple Sclerosis Treatment Assessment Committee recommendation(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined (February 2010).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Multiple Sclerosis (MS) treatments - Amending entry criteria to include CIS

Clinician application(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined (November 2019).(external link)

Since this application was received we have widened access to these treatments for people with MS as detailed in our decision June 2022(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Zolmitriptan - Migraine - acute migraine with or without aura  

AstraZeneca(external link)

This application has been superseded. An alternative application for the listing of additional triptans has been progressed for consideration.(external link) This alternative application was recommended for decline by the Neurological Subcommittee of PTAC in 2013.(external link)It then went on to be declined(external link).

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

 

Oncology Agents

Pharmaceutical and indication

Applicant

Why we are proposing this application be declined

Additional information

Amifostine - Cisplatin-related ototoxicity

Clinician application(external link)

The Cancer Treatments Subcommittee of PTAC recommended that this application be declined (March 2015).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Please note, although this medicine was recommended for decline for the broader affected group, our advisors did recommend that it should be made available for individuals taking part In the St Jude’s Children’s Research Hospital SJMB12 clinical trial. In this case, amifostine can be accessed via Schedule Rule 8.1b(external link) which applies to pharmaceuticals used within a Paediatric Oncology/Haematology service for the treatment of cancer.

Nivolumab with ipilimumab - Melanoma, unresectable or metastatic

Bristol Myers Squibb(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined (May 2016).(external link)

We note that this PTAC recommendation was based on immaturity of the data at that time, the significant adverse effect profile, and the extremely high price being sought by the supplier.

Pharmac staff would welcome consultation feedback on whether publication of longer-term survival and toxicity data is now available for review.

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Everolimus - Breast cancer, advanced, hormone receptor positive, HER-2 negative

Consumer application(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined (May 2019).(external link)

Please clickhere(external link) for a link through to the Application Tracker entry for this application and further information.

Sorafenib - Hepatocellular carcinoma, advanced

Bayer(external link)

The Cancer Treatments Subcommittee of PTAC recommended that this application be declined (September 2013).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Ibritumomab tiuexetan - Patients with CD20 positive indolent B-cell non-Hodgkin's lymphoma who have experienced failure of rituximab therapy

Schering(external link)

The Cancer Treatments Subcommittee of PTAC recommended that this application be declined (May 2005).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Methyl 5-Aminolevulinate Hydrochloride - Actinic keratoses and basal cell carcinoma

Galderma(external link)

The Cancer Treatments Subcommittee of PTAC recommended that this application be declined (February 2005).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Sorafenib - Renal Cell Carcinoma

Bayer(external link)

The Cancer Treatments Subcommittee of PTAC recommended that this application be declined (November 2011).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Teniposide - Primary CNS lymphoma

Clinician application(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined (August 2014).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Please note, although this medicine was recommended for decline for the broader affected group, our advisors did recommend that it should be made available for individuals taking part In the HOVON 105 PCNSL/ALLG NHL 24 study. In this case, teniposide can be accessed via Schedule Rule 8.1b(external link) which applies to pharmaceuticals used within a Paediatric Oncology/Haematology service for the treatment of cancer.

Pertuzumab - Breast cancer; HER2 positive, metastatic, previously-treated

Pharmac initiated(external link)

The Cancer Treatments Subcommittee of PTAC recommended that this application be declined (September 2018).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Ipilimumab - Melanoma - previously treated unresectable stage IIIC or IV

Bristol-Myers Squibb(external link)

This application has been superseded. Alternative medicines, Programmed Cell Death-1 (PD-1) Inhibitors, have now been funded for this patient population.(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Ibrutinib - Chronic lymphocytic leukaemia, relapsed/refractory Del 11q

Janssen(external link)

The Cancer Treatments Subcommittee of PTAC recommended that this application be declined (July 2020).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Denosumab - Hypercalcemia (associated with malignant bone disease) in patients with renal impairment, first line

Clinician application(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined ( Nov 2018).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Lenalidomide - in combination with dexamethasone for the first-line treatment of transplant eligible patients with multiple myeloma

Clinician application(external link)

The Cancer Treatments Subcommittee of PTAC recommended that this application be declined (April 2021).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Pembrolizumab - combination with chemotherapy for those with recurrent or metastatic head and neck squamous cell carcinoma irrespective of Combined Positive Score (ie. an ‘all-comers’ population)

Merck Sharp and Dohme(external link)

The Cancer Treatments Subcommittee of PTAC recommended that this application be declined (November 2021).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Bevacizumab - Second-line treatment of high-risk advanced ovarian cancer

Roche(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined (May 2022).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Peptide Receptor Radionuclide Therapy - neuroendocrine tumours

Clinician application(external link)

This application has been overtaken by events. Peptide Receptor Radionuclide Therapy for neuroendocrine tumours is now funded by Te Whatu Ora.(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Enzalutamide - Prostate cancer, metastatic, castration resistant

Sequiris(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this medicine should only be funded if it was cost neutral i.e. cost the same, or less, than the funded comparable medicine (August 2016).(external link)

The Committee recommended that enzalutamide be funded for the treatment of people with metastatic castration-resistant prostate cancer (mCRPC), but only if cost-neutral compared with the comparator treatment option abiraterone.(external link)

We understand that pricing is not achievable.

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

 

Obinutuzumab - Follicular lymphoma, 1st line

Roche(external link)

The Cancer Treatments Subcommittee of PTAC recommended that this medicine should only be funded if it was cost neutral ie cost the same, or less, than the funded comparable medicine (November 2021).(external link)

The Subcommittee recommended that obinutuzumab for the treatment of follicular lymphoma be listed if cost neutral to rituximab(external link) within the context treatment of malignancy.

We understand that pricing is not achievable.

Please clickhere(external link) for a link through to the Application Tracker entry for this application and further information.

 

 

Respiratory System and Allergies

Pharmaceutical and indication

Applicant and brand name (if relevant/ specified)

Why we are proposing this application be declined

Additional information

Tobramycin Podhaler (TOBI) - Cystic fibrosis

Clinician application(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this medicine should only be funded if it was cost neutral ie cost the same, or less, than the funded comparable medicine (February 2020).(external link)

The advice we received recommended that TOBI Podhaler be listed if it was cost neutral to tobramycin inhalation solution.(external link)

We understand that cost neutral pricing for TOBI is not achievable.

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

Dexamethasone implant - Diabetic macular oedema, first-line

Allergan(external link)

The Ophthalmology Subcommittee of PTAC recommended that this application be declined(external link) (February 2016).

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Isopropyl alcohol 95% and anhydrous glycerin 5% - Swimmer's ear

 

Wilson Consumer Products(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined(external link) (February 2010).

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Verteporfin - Small subfoveal choroidal neovascularisation due to age-related macular degeneration

Novartis(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined(external link) (May 2006).

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Ranibizumab - Diabetic macular oedema – 2nd line treatment and 3rd line treatment

Pharmac initiated(external link)

Since this application was received, we have funded an alternative medicine, aflibercept, as the second line treatment option for diabetic macular oedema.

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that ranibizumab as the third line treatment for diabetic macular oedema be declined(external link) (May 2017).

 

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Note that applications for individual patients could still be submitted through the Exceptional Circumstances Framework(external link) even if this funding application were to be declined.

Atropine - 0.01% eye drops - myopia

Clinician application(external link)

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.

Atropine - 0.5% eye drops Congenital cataract surgery - paediatric patients

Pharmac initiated(external link)

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.

Ketotifen fumarate - Ocular allergy

Novartis(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this medicine should only be funded if it was cost neutral ie cost the same, or less, than the funded comparable medicine (May 2008).(external link)

The advice we received recommended that ketotifen fumarate multidose eyedrops be listed only if they are cost neutral to levocabastine eye drops(external link).

We understand that this pricing is not achievable.

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

 

 

Special Foods

Pharmaceutical and indication

Applicant

Why we are proposing this application be declined

Additional information

Amino Acid plus carbs, vits, mins (PKU Synergy) - Phenylketonuria (PKU)

Nutricia(external link)

This application has been superseded. An alternative application for a range of nutritional supplements for people with phenylketonuria is being progressed(external link) for consideration.

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Oral supplement 1 Kcal/ml – Complan - Nutrition supplementation

Heinz(external link)

The Special Foods Subcommittee of PTAC recommended that this application be declined (August 2007).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Adult enteral feed with fibre and increased protein – Promote - Adult enteral feed with fibre 1Kcal/ml and increased protein

Abbott(external link)

The Special Foods Subcommittee of PTAC recommended that this application be declined (October 2006).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Oral Supplement – Prosure - Oral supplementation for use in cancer

Abbott(external link)

The Special Foods Subcommittee of PTAC recommended that this application be declined (October 2006).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Multivitamins (Fruit-Vits and Phlexy-Vits) - Ketogenic dietary treatment for children with epilepsy

Nutricia LTD and clinician application(external link)

This application has been superseded. An alternative application for

Phlexy-Vits for people with intractable epilepsy, pyruvate dehydrogenase, glucose transporter Type 1 deficiency, people with other inborn errors of metabolism, requiring a ketogenic diet or taking a protein supplement without micronutrients(external link) is being progressed for consideration.

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

PKU Cooler - Phenylketonuria (PKU)

Vitaflo(external link)

This application has been superseded. An alternative application for a range of nutritional supplements for people with phenylketonuria is being progressed(external link) for consideration.

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

PKU Gel - Phenylketonuria (PKU)

Vitaflo(external link)

This application has been superseded. An alternative application for a range of nutritional supplements for people with phenylketonuria is being progressed(external link) for consideration.

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

PKU supplementation (Add-ins) - Phenylketonuria (PKU)

Nutricia(external link)

This application has been superseded. An alternative application for a range of nutritional supplements for people with phenylketonuria is being progressed(external link) for consideration.

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

 

Vaccines

Pharmaceutical and indication

Applicant

Why we are proposing this application be declined

Additional information

Hepatitis A vaccine - Immunisation of people living with HIV

Clinician application(external link)

The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined (February 2015).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Influenza vaccine - ring protection for high risk groups, Māori from an age earlier than 65 years, Pacific peoples from an age earlier than 65 years

Clinician application(external link)

The Immunisation Subcommittee of PTAC recommended that this application be declined (May 2018).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Pneumococcal polysaccharide vaccine - Immunisation of those aged over-65 years

Merck, Sharp and Dohme(external link)

The Immunisation Subcommittee of PTAC recommended that this application be declined (August 2021).(external link)

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

Adjuvanted inactivated quadrivalent influenza vaccine - influenza vaccination for people aged 65 years and over

Seqirus(external link)

This application has been overtaken by events. This vaccine was included in the November 2022 Request for Proposals (RFP) – Supply of various vaccines and a diagnostic agent(external link). However, as a result, this proposal was not progressed at that time(external link). We are now proposing to decline this proposal, however we note that Pharmac would still retain the discretion to reconsider this proposal for funding at a future date.

Please click here(external link) for a link through to the Application Tracker entry for this application and further information.

 

Various

Pharmaceutical and indication

Applicant

Why we are proposing this application be declined

Additional information

Dimercaptosuccinic acid – Lead poisoning – (Community listing)

Pharmac initiated(external link)

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.

Dimercaptosuccinic acid is available via the Hospital Medicines List(external link) and funded for any brand that the hospital can source.