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Source: Pharmac

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.

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 and for secondary insomnia associated with dementia.

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 methylphenidatecannot 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, depression in terminally ill individuals and traumatic brain injury.

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
.

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
.

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
.

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:

  • relapsed or recurrent grade 3 and 4 gliomas: 20072016
  • gliomas where surgery and/or radiation is contraindicated: 20072016
  • anaplastic oligodendroglioma and anaplastic oligoastrocytoma: 2012.

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
.

MIL OSI