Proposal to decline inactive funding applications

Hospital devices Medicines Consultation Closed

To help make our decision-making process clearer, we are seeking feedback on a proposal for PHARMAC to make decisions to decline specified inactive funding applications.

A decision has been made 

Read the notification of PHARMAC's decision – published 20 March 2020

What we’re proposing 

To help make our decision-making process clearer, we are seeking feedback on a proposal for PHARMAC to make decisions to decline the following funding applications:

  • Naltrexone hydrochloride (low-dose) for Henoch-Schonlein purpura
  • Dipyridamole 200mg for stroke prophylaxis
  • Dipyridamole 200mg + aspirin for stroke prophylaxis
  • Niacin (nicotinic acid) + laropiprant (extended release) for hypercholesterolaemia and mixed dyslipidaemia
  • Prasugrel for percutaneous coronary intervention (PCI) procedure in patients with diabetes
  • Aliskiren for hypertension
  • Fenofibrate for hyperlipidemia
  • Clindamycin for prophylaxis of haematogenous infection of prosthetic joints during dental interventions
  • Clodronate for osteoradionecrosis
  • Golimumab as a second-line TNF inhibitor in ankylosing spondylitis
  • Golimumab as a second-line TNF inhibitor in psoriatic arthritis
  • Omega-3 fatty acids for augmentation of antipsychotics in schizophrenia
  • Certolizumab for rheumatoid arthritis
  • Everolimus as second line therapy in metastatic renal cell carcinoma
  • Octreotide (long-acting) for small intestinal neuroendocrine tumours (SI-NETs), metastatic or unresectable
  • Bovine lipid extract surfactant for pulmonary distress
  • Fluticasone in combination with salmeterol (high dose) for asthma and chronic obstructive pulmonary disease
  • Ciprofloxacin and hydrocortisone ear drops for chronic suppurative otitis media
  • Paediatric oral feed (Neocate Nutra) for food allergies
  • Oral supplement 1 Kcal/ml to 2 Kcal/ml (Enprocal) for nutrition supplementation

These applications are inactive, meaning that PHARMAC is not currently actively undertaking any work to progress these applications for funding.

Further information about this proposal, including details of each application and how to provide feedback follows below.

Consultation closes at 5 pm on Friday 31 January 2020 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.

We are committed to making our decision-making process faster, and clearer and simpler for people to understand. We want to ensure that people can easily see what is happening with funding applications. This includes making it clearer what stage applications are at in our processes, 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, even if our decision is to decline funding.

To give people more clarity about what we may – and may not – fund, we’re looking to make decisions to decline funding for a number of inactive applications. This will make it clearer to everyone whether a medicine is, or is not, being actively considered for funding.

There are a range of reasons a funding application may be inactive, including:

  • our expert clinical advisors recommended that the funding application be declined more than two years ago
  • other more clinically preferred medicines for the same condition are now funded, making the funding application no longer relevant
  • the medicine would provide no additional benefits over other treatments we already fund, or may be harmful
  • no company is willing to supply the medicine in New Zealand.

Earlier this year we consulted on a proposal to decline inactive funding applications for eight medicines. At the time, we sought feedback on our approach and indicated that we planned to consult on more proposals to decline other inactive funding applications. We subsequently notified our decision to decline those funding applications and shared the feedback we received.

> Read the April 2019 consultation to decline 8 inactive funding applications

> Read the July 2019 notification on the April consultation

This consultation follows from our earlier work and we expect to continue to consult on proposals to decline other inactive funding applications in the future.

Feedback from this consultation will help us make decisions on the funding applications for the medicines detailed in this consultation.

Details about our proposal

We have identified inactive funding applications for twenty different medicines that we are proposing to decline. For each of these funding applications, we received advice from our clinical advisors to decline the applications more than two years ago.

PHARMAC has not yet made a decision about these funding applications.

Before we do, we want to hear from people and communities about whether it would be appropriate to decline funding for these medicines for the use requested. We want to ensure any final decisions are made having considered all relevant information, so we are also interested in receiving any information about the twenty medicines and indications we’re consulting on that would lead us to reconsider our proposal to decline funding for them.

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 if, for instance, new evidence or other relevant information that addresses the reasons for the decline decision became available.

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 currently actively undertaking any work to progress the medicine for funding for the use requested.

Factors for Consideration

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.

> Read the Factors for Consideration

Medsafe-approved

Medsafe is responsible for the regulation of medicines and medical devices in New Zealand, ensuring they are acceptably safe.

> Learn more about Medsafe on their website(external link)

PTAC

PHARMAC’s primary 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.

> Read about PTAC

Subcommittee

PTAC has over 20 expert subcommittees which provide clinical evaluations in specialist areas. PTAC subcommittees meet as required to discuss issues referred to them by PTAC or PHARMAC.

> Read about the PTAC subcommittees

CaTSoP

Cancer Treatments Subcommittee of PTAC – the expert Subcommittee relating to cancer treatments.

Recommended for decline

A recommendation to PHARMAC from PTAC or a Subcommittee to decline the funding application.

A recommendation is not a decision by PHARMAC.

Cost neutral recommendation

A recommendation to PHARMAC from a clinical advisory committee (PTAC or a Subcommittee) to only fund a medicine if it costs the same or less than another comparable medicine (i.e. one that is already funded which provides the same or similar health benefits).

Proposing to decline

A proposal from PHARMAC to make a decision 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 Zealander from a fixed budget set by the Minister of Health.

> Read more about the Combined Pharamaceutical Budget

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. We are proposing to decline these applications as we have received advice from our clinical advisors that they should be declined. In every case, this advice to decline the application was received over two years ago.

Note that if you don’t want to click on the hyperlinks in the table below that you can search for the pharmaceutical directly from the main Application Tracker on the PHARMAC website and then select the correct indication. 

Pharmaceutical and indication Applicant and brand name (if relevant/ specified) Primary reason for clinical advisors recommending declining proposal

Clinical advice summary 

* You can find the committee minute under the Seeking Expert Advice tab.
Naltrexone hydrochloride (low-dose) for Henoch-Schonlein purpura A consumer application Lack of evidence Find more information in Application Tracker *(external link)
Dipyridamole 200mg for stroke prophylaxis Boehringer Ingelheim for Persantin Weak evidence Find more information in Application Tracker *(external link)
Dipyridamole 200mg + aspirin for stroke prophylaxis Boehringer Ingelheim for Asasantin Weak evidence Find more information in Application Tracker *(external link)
Niacin (nicotinic acid) + laropiprant (extended release) for hypercholesterolaemia and mixed dyslipidaemia Merck Sharp & Dohme for Tredaptive Lack of long-term efficacy and safety data Find more information in Application Tracker *(external link)
Prasugrel for percutaneous coronary intervention (PCI) procedure in patients with diabetes Eli Lilly for Effient Lack of evidence Find more information in Application Tracker *(external link)
Aliskiren for hypertension Novartis for Rasilez Lack of long-term efficacy and safety data Find more information in Application Tracker *(external link)
Fenofibrate for hyperlipidemia A clinician application for Lipidil / Lipantil / Supralip No unmet need Find more information in Application Tracker *(external link)
Clindamycin for prophylaxis of haematogenous infection of prosthetic joints during dental interventions A clinician application for Dalacin C No unmet need Find more information in Application Tracker *(external link)
Clodronate for osteoradionecrosis A clinician application for Ostac No evidence of health benefit Find more information in Application Tracker *(external link)
Golimumab as a second-line tumour necrosis factor (TNF) inhibitor in ankylosing spondylitis Merck Sharp & Dohme for Simponi Lack of evidence Find more information in Application Tracker *(external link)
Golimumab as a second-line tumour necrosis factor (TNF) inhibitor in psoriatic arthritis Merck Sharp & Dohme for Simponi Lack of evidence Find more information in Application Tracker *(external link)
Omega-3 fatty acids for augmentation of antipsychotics in schizophrenia Clinician application for Fish oils Insufficient evidence Find more information in Application Tracker *(external link)
Certolizumab pegol as a first-line tumour necrosis factor (TNF) inhibitor for rheumatoid arthritis UCB Pharma for Cimzia Only short-term evidence available. Little clinical need and limited benefit to be gained from funding a third TNF inhibitor for this setting. Find more information in Application Tracker *(external link)
Everolimus as second line therapy in metastatic renal cell carcinoma Novartis for Afinitor Poor quality evidence. Find more information in Application Tracker *(external link)
Octreotide (long-acting) for small intestinal neuroendocrine tumours (SI-NETs), metastatic or unresectable A clinician application The evidence for the use of long-acting octreotide in this setting to be low to moderate. Short-acting octreotide is currently available for use in this patient group and if patients develop carcinoid syndrome octreotide (long-acting) is available for symptom relief. Find more information in Application Tracker *(external link)
Bovine lipid extract surfactant for pulmonary distress Rex Medical for BLES Evidence is of low/moderate quality. There is no comparison against Curosurf, the product that is almost exclusively used in New Zealand. In was noted that desaturation can occur when treating infants with surfactants and ideally the required volume should be minimised. Twice the volume of BLES is used per kilogram compared to the volume of Curosurf. Find more information in Application Tracker *(external link)
Fluticasone in combination with salmeterol (high dose) for asthma and chronic obstructive pulmonary disease GlaxoSmithKlein for Seretide and Seretide Accuhaler Concern about the high dose of corticosteroid in this combination product that could cause significant side effects.  If high-dose inhaled steroids are warranted, such regimens could be achieved by combining existing inhalers. Find more information in Application Tracker *(external link)
Ciprofloxacin and hydrocortisone ear drops for chronic suppurative otitis media A clinician application for Ciproxin HC Insufficient evidence to suggest that ciprofloxacin and hydrocortisone ear drops are more efficacious than currently funded ear drops or were safer to use in the presence of a non-intact tympanic membrane. Find more information in Application Tracker *(external link)
Paediatric Oral Feed (Neocate Nutra) for food allergies Nutricia for Neocate Nutra No unmet health need. Find more information in Application Tracker *(external link)
Oral supplement 1 Kcal/ml to 2 Kcal/ml (Enprocal) for nutrition supplementation Warrnabrool for Enprocal Limited evidence supporting its use. Not nutritionally complete and a reasonable range of alternatives are available. Find more information in Application Tracker *(external link)

To provide feedback

Send us an email: applicationfeedback@pharmac.govt.nz by 5 pm Friday 31 January 2020.

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.

Feedback we receive is subject to the Official Information Act 1982 (OIA). Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.