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.

What we’re doing

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:

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 in these uses 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.

In our public consultation we also asked for feedback on our approach to making decisions on inactive applications. The responses we received are summarised at the end of this document.

Details about the declined applications

We proposed to decline inactive funding applications for eight different medicines. A decision to decline the applications has now been made. The reasons underlying these decisions are explained below.

Refer to the consultation document for further background on the applications and the process.

Cisapride for gastrointestinal motility disorders

Cisapride background

PHARMAC has declined the funding application for cisapride for gastrointestinal motility disorders primarily because there is no company willing to supply the medicine in New Zealand.

Who we think will be interested

People with severe reflux oesophagitis or gastroparesis and carers or family/whānau of these individuals, gastroenterologists and general practitioners.

More information, including links to the record of advice from Pharmacology and Therapeutics Advisory Committee (PTAC) and relevant Subcommittees, can be found in the Application Tracker record for cisapride(external link).

Melatonin (Circadin) widened access for primary insomnia in individuals aged 55 years and older and for secondary insomnia associated with dementia

Melatonin background

PHARMAC has declined the funding applications for melatonin for primary insomnia in individuals aged 55 years and older and for secondary insomnia associated with dementia. These applications were recommended for decline by our expert clinical advisors more than two years ago and no additional information has been provided since then to change this recommendation.

Who we think will be interested?

People with insomnia and/or dementia and carers or family/whānau of these individuals, suppliers of melatonin, psychiatrists, psychologists, geriatricians, general practitioners, nurses and pharmacists.

What will this mean?

Any future consideration of melatonin for these populations will require new information to be submitted to PHARMAC that addresses the reasons for the decline decision.

There is no change to the current funding of melatonin for children and adolescents with neurodevelopmental or psychiatric comorbidities with secondary insomnia.

More information, including links to the record of advice from the Pharmacology and Therapeutics Advisory Committee (PTAC) and relevant Subcommittees, can be found in the Application Tracker records for melatonin for primary insomnia in individuals aged 55 years and older(external link) and for secondary insomnia associated with dementia(external link).

Methylphenidate hydrochloride widened access for depression and traumatic brain injury

Methylphenidate background

PHARMAC has declined the funding applications to widen access for methylphenidate for treatment-resistant depression; depression in terminally ill individuals; and individuals with traumatic brain injury. These applications were recommended for decline by our expert clinical advisors more than two years ago due to poor evidence of clinical benefit and the large range of alternative funded options. 

In addition, PHARMAC staff note that under the Misuse of Drugs Regulations 1977 methylphenidate cannot be prescribed for treatment-resistant depression or traumatic brain injury except in the context of palliative care treatment(external link).

Who we think will be interested?

People with treatment-resistant depression, terminally ill individuals with depression and people with traumatic brain injury and carers or family/whānau of these individuals, suppliers of methylphenidate, psychiatrists, psychologists, neurologists, palliative care physicians, general practitioners, nurses and pharmacists.

What will this mean?

Any future consideration of funding of methylphenidate for these patient populations will require new information to be submitted to PHARMAC that addresses the reasons for the decline decision.

There is no change to the current funding of methylphenidate for ADHD or narcolepsy.

More information, including links to the record of advice from the Pharmacology and Therapeutics Advisory Committee (PTAC) and relevant Subcommittees, can be found in the Application Tracker records for methylphenidate for treatment-resistant depression(external link), depression in terminally ill individuals(external link) and traumatic brain injury(external link).

Paracetamol sustained release (Panadol Osteo) for pain

Paracetamol sustained release background

PHARMAC has declined the application for paracetamol sustained-release tablets as this form of the medicine would provide no significant health benefits over other medicines we already fund and would cost more than those other medicines. 

Who we think will be interested

People who use paracetamol and carers or family/whānau of these individuals, suppliers of paracetamol sustained release and immediate release formulations, general practitioners, pain specialists, nurses and pharmacists.

What will this mean?

Any future consideration of funding for paracetamol sustained-release tablets will likely require new information to be submitted to PHARMAC that addresses the reasons for the decline decision.

There is no change to the current funding of other paracetamol formulations.

More information, including links to the record of advice from the Pharmacology and Therapeutics Advisory Committee (PTAC) and relevant Subcommittee, can be found in the Application Tracker record for paracetamol sustained release tablets(external link).

Sibutramine hydrochloride (Reductil) for severe obesity

Sibutramine background

PHARMAC has declined the funding application for sibutramine for severe obesity as it was recommended for decline by our expert clinical advisors more than two years ago and as there are significant safety concerns with its use.     

Who we think will be interested

Individuals with severe obesity and carers or family/whānau of these individuals, suppliers of sibutramine, gastroenterologists, general practitioners, nurses and pharmacists.

What will this mean?

Any future consideration of funding for sibutramine will likely require new information to be submitted to PHARMAC that addresses the reasons for the decline decision.

More information, including links to the record of advice from the Pharmacology and Therapeutics Advisory Committee (PTAC) and relevant Subcommittees, can be found in the Application Tracker record for sibutramine(external link).

Simeprevir (Olysio) for chronic hepatitis C genotype 1

Simeprevir background

PHARMAC has declined the funding application for simeprevir for chronic hepatitis C genotype 1 infection as our clinical advisors recommended that simeprevir be funded only if cost-neutral to boceprevir. Treatment options for hepatitis C infections have now changed with the recent funding of direct acting antiviral medicines.

Who we think will be interested

People with chronic hepatitis C infection, carers or family/whānau of these individuals, the supplier of simeprevir, gastroenterologists, infectious disease specialists, general practitioners, pharmacists and organisations that support people at risk or chronic hepatitis C infection.

What will this mean?

The funding application for simeprevir for chronic hepatitis C genotype 1 infection would be declined. Any future consideration of funding for simeprevir would require a new submission that addresses the reasons for the decline decision, including supporting evidence (if relevant).

More information, including links to the record of advice from the Pharmacology and Therapeutics Advisory Committee (PTAC) and relevant Subcommittees, can be found in the Application Tracker record for simeprevir(external link).

Temozolomide widened access for glioma (brain tumour)

Temozolomide background

PHARMAC has declined the funding applications to widen access for temozolomide for:      

  • relapsed or recurrent grade 3 and 4 gliomas
  • gliomas where surgery and/or radiation is contraindicated
  • anaplastic oligodendroglioma and anaplastic oligoastrocytoma  

as they were recommended for decline by our expert clinical advisors more than two years ago and no additional information has been provided since then to change this recommendation.

Who we think will be interested

People who have or may develop gliomas, carers or family/whānau of these individuals, suppliers of temozolomide, oncologists, pharmacists and organisations with an interest in cancer treatment.

What will this mean?

Any future consideration of funding for temozolomide for these indications will require a new submission that addresses the reasons for the decline decision, including supporting evidence (if relevant).

There is no change to the current funding of temozolomide for individuals with high grade gliomas who meet the Special Authority criteria or individuals with neuroendocrine tumours or Ewing’s sarcoma.

More information, including links to the record of advice from the Pharmacology and Therapeutics Advisory Committee (PTAC) and relevant Subcommittees, can be found in the Application Tracker records for temozolomide:

Trastuzumab (Herceptin) for HER2-positive advanced gastric cancer

Trastuzumab background

PHARMAC has declined the funding application for trastuzumab for HER2‑positive locally advanced or metastatic (advanced) gastric cancer as it was recommended for decline by our expert clinical advisors more than two years ago and no additional information has been provided to change this recommendation.

Who we think will be interested

People who have or may develop gastric cancer, carers or family/whānau of these individuals, oncologists, general surgeons, pharmacists, organisations with an interest in cancer treatment and suppliers of trastuzumab.

What will this mean?

Any future consideration of funding of trastuzumab for HER2-positive advanced gastric cancer will require a new submission that addresses the reasons for the decline decision, including supporting evidence (if relevant).

There is no change to the current funding of trastuzumab for people with breast cancer.

More information, including links to the record of advice from the Pharmacology and Therapeutics Advisory Committee (PTAC) and Subcommittee meetings, can be found in the Application Tracker records for trastuzumab(external link).

Our response to what you told us

We’re grateful for the time people took to respond to this consultation. All consultation responses received by 21 May 2019 were considered when making a decision. Most responses were fully supportive of the proposal.  A summary of the main themes raised in feedback and our responses are set out below. We note that some applications in the consultation did not receive any responses.

Theme

PHARMAC comment

Cisapride for gastrointestinal motility disorders

Cisapride is rarely used but that it has been useful at times.

There is no supplier willing to supply cisapride in NZ. The product was discontinued worldwide 2004.

Melatonin (Circadin) widened access for primary insomnia in individuals aged 55 years and older and for secondary insomnia associated with dementia

Not supportive as removing melatonin would result in more falls for older people and reduce the likelihood of an older person with insomnia being able to be treated with a safe effective medication.

Melatonin is not currently funded for people aged 55 years or older with primary insomnia or to treat secondary insomnia associated with dementia.  Unfunded melatonin will remain available for private purchase and use in NZ.

Methylphenidate hydrochloride widened access for depression and traumatic brain injury

For treatment-resistant depression

Mixed support to decline the application.

One responder noted the lack of evidence to support such use and the ample evidence of oversupply with attendant harms.

One responder noted methylphenidate is a good second- or third- line antidepressant (no evidence provided).

We consider there is poor evidence of benefit to support the use of methylphenidate for treatment-resistant depression.

Our expert clinical advisors considered there was a high risk of abuse and diversion if methylphenidate was funded for treatment-resistant depression, poor evidence of effectiveness and that there is a large range of alternative funded treatment options for this indication.

On balance, we made no change to the proposal and the funding application has been declined.

For depression in terminally ill individuals

One responder considered methylphenidate is used only rarely in terminally ill individuals with significant depression as other antidepressants take several weeks to act. Commented that such use did not result in high levels of diversion or illicit use. Agreed that there is poor evidence of therapeutic benefit.

We consider there is poor evidence of benefit to support the use of methylphenidate for treating depression in the terminally ill.

Our expert clinical advisors considered there was a high risk of abuse and diversion if methylphenidate was funded for depression in the terminally ill, poor evidence of clinical benefit, and that there is a large range of alternative funded treatment options for this indication.

On balance, we made no change to the proposal and the funding application has been declined.

For individuals with traumatic brain injury

Some responders considered there is good evidence that methylphenidate helps with post head injury fatigue and cognitive abilities, the same effects as in Chronic Fatigue Syndrome.

Several articles to support the use of methylphenidate in traumatic brain injury were provided.

Our expert clinical advisors recommended that the application for patients with traumatic brain injury and acquired brain injury be declined, noting the difficulties in defining the patient group, dose and duration of treatment, the lack of evidence of longer-term benefit, the risk of abuse and diversion and the financial risk and the legal issues.

We also note that methylphenidate cannot be prescribed for traumatic brain injury in NZ (Misuse of Drugs Regulations 1977) except in the context of palliative care.

On balance, we made no change to the proposal and the funding application has been declined.

Temozolomide widened access for glioma (brain tumour)

One responder noted the price of temozolomide has reduced significantly since the PTAC recommendations.

We note that the application was declined due to poor quality evidence in the groups compared to other funded treatments.

Trastuzumab (Herceptin) for HER2-positive advanced gastric cancer

Responders acknowledged the lack of new data but considered that trastuzumab treatment is effective.

One responder provided some new evidence but noted that while the new information might possibly improve the proposal's priority (given these patients’ high health need), it would unlikely change the PTAC recommendation to decline. Considered overall that it may still be appropriate to decline the application and only widen access if more competition were available.

We do not consider that there was any new information provided during consultation that warrants reconsideration of the application at this time.

On balance, we made no change to the proposal and the funding application has been declined.

Responses regarding our approach to making decline decisions

We received some responses from members and representatives of the pharmaceutical industry that they considered that PHARMAC should spend its time on making positive funding decisions rather than on declining applications.

However, we did also receive a similar number of responses from clinicians and clinical groups that were supportive of our approach.

We have heard from New Zealanders that they want us to reach decisions so that they can have more certainty, even if our decision is to decline funding.

The process of making decisions to decline inactive funding applications does not impact PHARMAC’s assessment process to consider the funding of new medicines.

If you have any questions, 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.