Decision to decline inactive medicines funding applications

Medicines

Decision

To give people more clarity about what medicines we are, or are not, actively considering for funding, we will be making more decisions on inactive applications.

Following public consultation, PHARMAC has made a decision 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
  • 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
  • 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
  • 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 have been ‘inactive’, meaning that PHARMAC has not been actively undertaking any work to progress the applications for funding.

A decline decision means the medicine will not be funded for the use requested. However, this does not prevent PHARMAC from reconsidering funding for these medicines for the conditions listed above in the future if, for instance, new evidence or other relevant information that addresses the reasons for the decline decision became available.

In the future, we plan to consult on more proposals to decline other inactive funding applications.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 17 December 2019

We consulted on declining 19 medicines for use in 20 different conditions. However, following consideration of consultation feedback, we have elected not to progress the following applications to a decline decision at this point:

  • Clodronate for osteoradionecrosis
  • Certolizumab for rheumatoid arthritis
  • Fluticasone in combination with salmeterol (high dose) for asthma and chronic obstructive pulmonary disease

Further details of the consultation responses received, and our response to this feedback, can be found in Table 1

No changes to the proposal were made other than those noted above.

Who we think will be most interested

  • Medicines suppliers
  • Clinicians who treat people with these conditions
  • Patients who have these conditions, and their whānau

Details about this decision

This decision relates to 17 funding applications that we identified as being ‘inactive’ (these applications are listed above). For each of these funding applications, we received advice from our specialist clinical advisors to decline the applications and this advice was received more than two years ago. A decision has now been made to decline these 17 funding applications. This means the medicine will not be funded for the conditions identified. However, this does not prevent PHARMAC from reconsidering funding for these medicines for these conditions in the future if, for instance, new evidence or other relevant information became available.

Further details about each of the individual applications that have been progressed to a decline, including the applicant, brand name of the medicine, and details of the clinical advice we received can be found in the consultation document

Our response to what you told us

We appreciate the time people took to respond to this consultation.

All consultation responses were considered in their entirety when making the decision. Most responses were fully supportive or considered that there were no issues associated with the proposal. However, responses were received in relation to three of the funding applications that, after considering the issues raised, have meant that these three funding applications were not be progressed for a decline decision at this time. A summary of the responses in relation to these three applications, and our comments on this feedback, is provided in the table below.

Table 1

Response summary

Comment

Clodronate for osteoradionecrosis

A responder considered that there is some evidence that clodronate may provide some benefit as part of the PENTOCLO protocol in a very specific clinical setting for osteoradionecrosis.

PHARMAC has decided not to progress clodronate for osteoradionecrosis to a decline decision at this time pending further clinical advice.

Certolizumab pegol as a first-line tumour necrosis factor (TNF) inhibitor for rheumatoid arthritis

A responder noted that long term efficacy data on the use of certolizumab pegol for rheumatoid arthritis is now available. In addition, they noted that certolizumab is the  only anti-TNF inhibitor that does not cross the placenta and therefore can be safely used throughout pregnancy by women with rheumatoid arthritis.

PHARMAC has decided not to progress certolizumab as a first-line tumour necrosis factor (TNF) inhibitor for rheumatoid arthritis to a decline decision at this time pending further clinical advice.

Fluticasone in combination with salmeterol (high dose) for asthma and chronic obstructive pulmonary disease

A responder noted that the Special Authority for omalizumab requires an inhaled corticosteroid dose of 1000 mcg fluticasone per day or equivalent. Currently, it is not possible to reach this threshold without prescribing two inhalers, one containing the combination fluticasone/salmeterol and another containing fluticasone only. The responder considered that fluticasone in combination with salmeterol (high dose) would resolve the need for two inhalers to satisfy this Special Authority criterion for this population.

PHARMAC has decided not to progress fluticasone in combination with salmeterol (high dose) to a decline at this time pending further clinical advice.

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.