Decision to decline inactive applications for the funding of some medicines

Medicines Decision

What we’re doing

We are providing more clarity about which treatments we are actively considering for funding by making decisions on applications that are inactive. 'Inactive’ means that we are not actively undertaking any work to progress the application.

A decline decision means it will not be funded for the use requested. This does not prevent Pharmac from reconsidering the treatment in the future if the appropriate information is provided.

This decision is a part of a wider piece of work Pharmac is undertaking to be more transparent and open about our decision making processes. We plan to consult on more proposals to decline other inactive funding applications in the future.

This decision was subject to a consultation letter dated 1 August 2023. As a result, we are declining the 24 applications listed below, out of the 27 applications that we originally consulted on. The links for the treatments in this list will direct you to the consultation feedback we received.

Alimentary tract and metabolism

  • Calcitriol liquid - Chronic kidney disease
  • Phentermine Hydrochloride (37.5mg immediate-release tablet) – Obesity
  • Calcium acetate - Phosphate binder 

Blood and blood forming organs

Cardiovascular system

  • Dronedarone - Atrial fibrillation (AF) - permanent and non-permanent
  • Vernakalant - Atrial fibrillation (AF) - chemical conversion 

Dermatologicals

 Musculoskeletal system

Nervous system

  • Amifampridine (3,4-diaminopyridine) - Lambert Eaton myasthenic syndrome
  • Pimozide - Schizophrenia
  • Levomilnacipran - major depressive disorder

Oncology Agents and Immunosuppressants

  • Levamisole - Frequently relapsing steroid sensitive nephrotic syndrome
  • Mitotane –Adrenocortical carcinoma

Respiratory system and allergies

  • Lumacaftor/ivacaftor (Orkambi) - Cystic Fibrosis Patients with F508del gene mutations

Sensory organs

Any changes to the original proposal?

This decision was subject to a consultation letter dated 1 August 2023

Following consideration of consultation feedback, we have chosen not to decline three applications. We have explained the reasons for making these changes in the summary of feedback table below.

Who we think will be most interested

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

Detail about this decision

This decision relates to 24 funding applications that we identified as being ‘inactive’ that we are declining. For a number of these treatments, we are not aware of any suppliers willing to seek consent for distribution in New Zealand (as required by the Medicines Act 1981 and Regulations 1984(external link)).

When a treatment is approved for distribution under the Act, it means that medicines have met quality standards of safety, quality and efficacy and that the benefits outweigh the risks of harm in the intended treatment population. Medsafe(external link) is the medicines regulator who makes recommendations on whether medicines can be approved.

Usually, for Pharmac to consider a funding application we require the product to have this approval. Should treatments gaining this approval become available in the future, a decline decision would not prevent these applications from being reconsidered for funding.

Details about 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.

Our response to what you told us

We’re grateful for the time people took to respond to this consultation. All consultation responses were considered in their entirety when making the decision.

We have summarised the themes of this feedback and Pharmac’s response for the applications that will continue to be active and those that we are declining below.

Table 1 – Response themes and Pharmac’s response for the applications that will remain active.

Theme

Pharmac Comment

Tafamidis – Cardiac amyloidosis

Feedback from a supplier indicates that tafamidis may be Medsafe approved and available in New Zealand soon.

We are not declining this application as we note that there may be a product with regulatory approval in the near future.

Carboxypeptidase G2 - Methotrexate overdose

Carboxypeptidase G2 is required for emergency use in hospitals for high dose methotrexate toxicity. Concerns were highlighted about the time it can take to source this product from Australia when it is needed.

We are not declining this application as from the feedback received, we understand there is a need for treatment options for methotrexate toxicity. We intend to seek further information relating to the need for this medicine and the potential options we have for progressing this application.

Cefuroxime 1 mg per 0.1 ml injection- endophthalmitis prophylaxis post cataract surgery

Feedback from a supplier indicates that cefuroxime suitable for this indication may be Medsafe approved and available in New Zealand soon.

We are not declining this application as we note that there may be a product with regulatory approval in the near future.

Table 2 - Response themes and Pharmac’s response for the applications that have been declined.

Theme

Pharmac Comment

Prasugrel and Ticagrelor - Amending access post- acute coronary syndrome (ACS) in clopidogrel non-responders using CYP2C19 genotyping

Feedback highlighted that Māori and Pacific people are more likely than non-Māori and non-Pacific people to be non-responders to clopidogrel. There is an unmet health need for an effective treatment for stroke prevention and management of heart disease for Māori and Pacific peoples.

We acknowledge that, while ticagrelor is funded for people with ACS, prasugrel is currently unfunded.

We have received an application for prasugrel for acute coronary syndrome (without the requirement to demonstrate clopidogrel non-response)(external link).

Our Cardiology Advisory Committee recommended funding for this application [PDF, 409 KB] with a high priority. This application is currently active and includes the patient group that has been declined as part of this notification.

The next step in our process is to assess the application and rank it on our options for investment list. The unmet health need for Māori and Pacific people will be considered as part of our assessment of this application.

Dithranol powder - Dermatology

There is low demand for this item.

We appreciate receiving confirmation that the health need for this product is low.

Doxycycline (low-dose) - Dermatological indications

Considered that should a low dose product be available it would be better for antimicrobial stewardship.

We are aware that there is a clinical desire to have access to this treatment, however there is no product with regulatory approval in New Zealand. Should this change, we could reconsider a funding application.

Hydrocortisone ointment 1% proprietary/premade product - Dermatology

This product can be extemporaneously compounded but considered that it was disappointing to not have access to a premade product.

Hydrocortisone ointment is funded as an extemporaneous product. We are not aware of a proprietary/premade product with regulatory approval available in New Zealand. Should this change, we could reconsider a funding application.

Coal tar shampoo 4% - Psoriasis

Feedback stated that coal tar shampoo can be purchased over the counter (OTC) without a prescription.

We note that this is an OTC pharmaceutical and understand that there are a number of coal tar shampoos available with <4% coal tar.

However, we are not aware of any that specifically contain 4% available coal tar.

We would consider funding of a 4% coal tar shampoo formulation should one become available.

Cetrimide shampoo – Psoriasis and eczema

Feedback stated that alternative treatment options are available.

We appreciate receiving confirmation that there are clinical alternatives to this treatment.

Naproxen oral liquid - Inflammation and pain

There may be benefits associated with naproxen liquid being a funded treatment option in addition to the currently available nonsteroidal anti-inflammatory drugs (NSAIDs).

We are aware that there is a clinical desire to have access to this treatment, however there is no product with regulatory approval in New Zealand. Should this change, we could reconsider a funding application.

Loteprednol - Eye inflammation in those with intraocular pressure rise

There is an unmet health need for people where treatment with topical corticosteroids causes a significant elevation in intraocular pressure. This treatment could be cost saving and may cause less complications when compared to other treatment options.

The responder queried why Medsafe approval is necessary.

We have attempted to source a product, however there is no product with regulatory approval in New Zealand. Should this change, we could reconsider a funding application.

The role of Medsafe(external link) is to ensure treatments meet quality standards and that the benefits of use outweigh the risks of harm in the intended treatment population. Regulatory approval is important when Pharmac considers a treatment for funding.

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 660 050.