Decision to decline inactive applications for the funding of some medicines

Clindamycin vaginal cream - Bacterial vaginosis and desquamative inflammatory vaginitis

Not supportive.

The feedback detailed the unmet health need for people with bacterial vaginosis or desquamative vaginitis.

The feedback informed us that several pharmacies compound an unfunded clindamycin vaginal cream.

Based on the feedback received we have decided not to decline this application. We plan to explore the availability/suitability of a compounded pharmacy product.

Eribulin - Locally advanced or metastatic breast cancer (following progression on chemotherapy)

Not supportive.

One submitter made a number of comments in relation to the earlier clinical advice provided by both PTAC (Nov 22, May 23) and the Cancer Treatments Advisory Committee (CTAC) (Jul 23). They supplied newly published evidence to support the use of eribulin for locally advanced or metastatic breast cancer (following progression on chemotherapy) and discussed the changing treatment paradigm. They requested that the new evidence be considered by CTAC.

Concerns were also raised that if this application was declined that a full application for eribulin would be required to get the application reconsidered in the future.

Based on the feedback received we have decided not to decline this application. Given the further evidence that has been provided in support of the application, we plan to seek further clinical advice on the application from our Cancer Treatments Advisory Committee.

We would like to reassure people that, although we have decided not to decline this specific application, declining an application does not prevent us from reconsidering funding for that medicine in the future. A decline is intended to provide clarity that the medicine will not be funded for the use requested at this time.

In addition, information relating to an application always remains available to us. Therefore, a full application would not be required to get the application reconsidered. All the previously collated information, including any clinical advice we received, would still be available. Unless data and circumstances were to change substantially, or there was additional information that was important to be included, it would be unlikely that a full application would be necessary.

Fluticasone with vilanterol, 200/25, high dose, severe asthma - Asthma

Not supportive.

The feedback requested that this funding application remain active. Submitters noted that having access to this inhaler would mean that people needing a higher inhaled corticosteroid dose would be able to use this without the need for an additional inhaler. This would be more convenient and provide better adherence.

Further feedback stated that this medicine would be useful for those people who don’t meet the criteria for funded anti-IL5 therapy. It was questioned whether this medicine would provide benefit for some people, reducing oral corticosteroid use, preventing hospital admissions, and preventing morbidity and mortality.

We received consultation feedback from the supplier noting that this medicine had received a medium priority recommendation from the Respiratory Advisory Committee and the supplier considered this information should be added to the tables in the consultation document.

Based on the feedback received we have decided not to decline this application. We intend to get further information from clinicians on the feedback provided relating to the health benefit from a high dose inhaler.

We note that the table in the consultation document detailed the reasons why we were proposing the application be declined. It did not detail all the information relating to the applications. This can be found by following the ‘additional information’ link.

We acknowledge the medium priority recommendation from the Respiratory Advisory Committee in October 2020. However, PTAC considered this recommendation along with the application at its May 2021 meeting where it again recommended decline.

Record of the October 2020 Respiratory Advisory Committee meeting [PDF, 661 KB]

Record of the May 2021 PTAC meeting [PDF, 747 KB]

PTAC based this recommendation on evidence that high dose fluticasone with vilanterol (200/25) provided little health benefit over and above that of currently funded treatments. The Committee noted its previous considerations regarding the availability of funded alternatives and the risk associated with high dose inhaled corticosteroid (pneumonia).

Inactivated quadrivalent influenza vaccine, split virion (high dose) - for people aged 60 years and over who meet the criteria

Not supportive.

Evidence, that has not previously been considered, was provided that inactivated quadrivalent influenza vaccine, split virion (high dose) has additional health benefits over Influvac Tetra for elderly people, particularly for frail elderly people.

Based on the feedback received we have decided not to decline this application. We will be seeking further clinical advice from our Immunisation Advisory Committee on the additional evidence that has been provided for this application.

Quadrivalent Influenza virus haemagglutinin, surface antigen, inactivated, prepared in cell cultures - Prevention of influenza caused by Influenza Virus Types A and B

Not supportive.

Feedback was received noting that new information on this medicine was submitted in July 2024 and is awaiting clinical review.

One submitter considered that, as this vaccine is produced using cell technology, it is more sustainable and has fewer environmental impacts when compared to a standard vaccine.

Based on the feedback received we have decided not to decline this application. We will be seeking further clinical advice from our Immunisation Advisory Committee.

Mirabegron - Open listing; and Mirabegron - Overactive bladder, 2nd line

Feedback was strongly opposed to declining this application. A request was made that Pharmac not wait for Medsafe approval before funding a medicine, that Pharmac agree to fund mirabegron, and that Pharmac work with Medsafe to simplify Medsafe processes.

A request that Pharmac pursue an application for an alternative beta-3 agonist medicine.

Based on the feedback received we have decided not to decline this application at this time. We understand the unmet health need for people with an overactive bladder. We will be engaging with the correspondents to discuss potential alternative treatments that could be considered for funding to address the unmet health need for overactive bladder, in the absence of a supplier of a Medsafe approved mirabegron product.

The role of Medsafe(external link) is to make sure treatments meet quality and safety 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.  We are aware that legislation is being considered by the Government to implement a quicker approval pathway for medicines that have been approved by two recognised overseas regulators through the Medicines Amendment Bill. This will help result in earlier approvals in New Zealand. The changes are under consideration at present. More details about the proposed changes are available on the Ministry of Health website(external link).

We would also welcome a funding application for an alternative Medsafe approved beta-3 agonist and plan to discuss this further with the correspondents.

Ixekizumab - Inflammatory conditions

Feedback was received expressing disappointment at the proposal to decline this medicine. Feedback stated that there is a need for more biologic options for severe psoriasis and a preference for an anti-IL-23 inhibitor was expressed.

We understand people with severe psoriasis have a high health need and that there is a need for more biologic options for them.

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

We have received two applications for IL-23 inhibitors for plaque psoriasis, risankizumab(external link) and guselkumab(external link). We also have an application for the IL-23 and IL-12 inhibitor ustekinumab.(external link) All of these medicines have received positive recommendations from our clinical advisors and have been ranked as options for investment(external link), meaning it is something we would like to consider for funding if we have budget available

Cyproterone acetate 10mg tablets - Testosterone Suppression

Feedback stated that a 10mg tablet would be useful for anti-androgen therapy. The submission noted that cyproterone should be prescribed in the lowest possible dose to limit long term cumulative adverse effects. The smallest current strength available is a 50mg tablet, a number of people receive a dose of 25 mg (1/2 x 50mg tablet). A 10mg tablet would allow titration to the lowest effective dose.

A request was made that PTAC minutes discussing this treatment be made available on the Application Tracker.

We are aware that there is a clinical desire to have access to this treatment, however there is no 10mg product with regulatory approval in New Zealand. Should this change, we could reconsider a funding application.

As there is no Medsafe approved product available and we have been unable to find a supplier who is able to supply cyproterone 10mg into New Zealand, we were unable to progress the application forward to seek clinical advice.

As we haven’t requested clinical advice on the application, there are no discussion minutes that could be made available on the Application Tracker.

Buprenorphine sublingual tablets - Acute pain

Feedback suggested that buprenorphine sublingual tablets would benefit some people. Particularly those with acute pain and end-stage renal disease.

Feedback also suggested that buprenorphine sublingual tablets could decrease nursing workloads by providing an option for people unable to take medicines orally following gastrointestinal surgery.

Feedback noted that they were aware of a potential supplier interested in sponsoring buprenorphine sublingual tablet through the Medsafe process.

We appreciate the feedback and summary of potential health benefits from the use of a sublingual form of buprenorphine.

As there is currently no Medsafe approved product available, we have decided to decline this application. We will continue to work with suppliers who are interested in getting regulatory approval for buprenorphine sublingual tablets.

Declining this application does not prevent it being reconsidered in the future if a supplier was found who was seeking Medsafe approval for buprenorphine sublingual tablet.

Atezolizumab – Advanced non-small cell lung cancer first-line (NSCLC 1L) combination therapy with platinum chemotherapy

Atezolizumab – Non-small cell lung cancer, locally advanced or metastatic, high (>50%) PD-L1 expression, 1st line monotherapy

Feedback from a supplier noted that the current treatments for non-small cell lung cancer were awarded for a specific time period (until 31 March 2026).

Once this time period was up, other treatments (including atezolizumab) could then be reconsidered as the funded checkpoint inhibitor for the treatment of people with advanced NSCLC.

The supplier noted that these other treatments could be considered as first-line treatment for NSCLC in less than 2 years’ time.

They were concerned about the resources needed to resubmit a full application to have atezolizumab reconsidered for funding in the future.

Since these applications were received, we have funded a clinically appropriate alternative treatment for this condition.

Declining an application does not prevent us from reconsidering funding for that medicine in the future. A decline is intended to provide clarity that the medicine will not be funded for the use requested at this time.

In addition, information relating to an application remains available to us. Therefore, if we were to reconsider an application in the future, all the previously collated information, including any clinical advice we received, will still be available. Unless data and circumstances have changed substantially, or there was additional information that was important to be included, it would be unlikely that another full application would be necessary.

Atezolizumab for NSCLC, nivolumab for NSCLC, pembrolizumab for NSCLC, tislelizumab for NSCLC

No concerns with the decline of the lung cancer immunotherapy applications.

A question why declining these applications had not been done at the conclusion of the lung cancer immunotherapy RFP (request for proposals) process.

In future, we intend to decline unsuccessful RFP bids as part of the RFP process.

Moxifloxacin ophthalmic (0.5% USP) - Prophylaxis of post-operative endophthalmitis (POE) following intra-ocular surgery.

Feedback noted that moxifloxacin ophthalmic (0.5% USP) is available in generic form in the USA and Canada.

Feedback also suggested that the current funded alternative medicine (cefuroxime) is more expensive and not as good as moxifloxacin ophthalmic (0.5% USP).

It was requested that Pharmac pursue the funding of moxifloxacin ophthalmic (0.5% USP).

We are aware that clinicians want to have access to this treatment, however there is no product with regulatory approval in New Zealand.

We regularly discuss potential funding applications with suppliers and will continue to raise the possibility of a funding application for a moxifloxacin ophthalmic product.

As there is currently no Medsafe approved product available at this time, we have decided to decline the application.

Declining this application does not prevent it being reconsidered in the future if a supplier was found who was seeking Medsafe approval for a moxifloxacin ophthalmic product.