Proposal to decline inactive applications

What we’re proposing

To help make our decision-making process clearer, we are seeking feedback on a proposal for PHARMAC to make decisions to decline funding applications as detailed below. 

• Cisapride for gastrointestinal motility disorders
• Melatonin widened access for primary insomnia in patients aged 55 years and older and secondary insomnia associated with dementia
• Methylphenidate widened access for depression and traumatic brain injury
• Paracetamol sustained release for pain
• Sibutramine hydrochloride for severe obesity
• Simeprevir for chronic hepatitis C genotype 1
• Temozolomide widened access for glioma (brain tumour)
• Trastuzumab for HER2-positive advanced gastric cancer

These applications are inactive, meaning that PHARMAC is not currently actively undertaking any work to progress the application for funding.

Further information about this proposal, including details of each application and how to provide feedback follows below.

Consultation closes at 5 pm on Tuesday, 21 May 2019 and feedback can be emailed to applicationfeedback@pharmac.govt.nz.

Why we are proposing this

PHARMAC’s role is to decide which medicines are funded to get the best health outcomes from within a fixed budget, and we know that the decisions we make impact nearly every New Zealander. All funded medicines are listed on the Pharmaceutical Schedule(external link).

We are committed to making our decision-making process faster, and clearer and simpler for people to understand. We want to ensure that people can easily see what is happening with funding applications. This includes making it clearer what stage applications are at in our processes, and why we make our decisions.

We’ve heard from New Zealanders that they want PHARMAC to reach decisions on funding applications so they can have some certainty, even if our decision is to decline funding.  

To give people more clarity about what we may – and may not – fund, we’re looking to make decisions to decline funding for a number of inactive applications. This will make it clearer to everyone whether a medicine is, or is not, being actively considered for funding.

There are a range of reasons a funding application may be inactive, including:

• our expert clinical advisors recommended that the funding application be declined more than two years ago;
• other more clinically preferred medicines for the same condition are now funded, making the funding application no longer relevant;
• the medicine would provide no additional benefits over other treatments we already fund, or may be harmful;
• no company is willing to supply the medicine in New Zealand.

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

Feedback from this consultation will help us make decisions on the medicines detailed in this consultation; it will also help us determine if this consultation approach works for people who are interested in and want to contribute to our decision-making. We want to know if this approach works and, if not, how we can make it better and easier to understand.

Details about our proposal

We have identified inactive funding applications for eight different medicines that we are proposing to decline, for reasons that are explained in detail below.

PHARMAC has not yet made a decision about these funding applications.

Before we do, we want to hear from people and communities about whether it would be appropriate to decline funding for these medicines for the use requested. We want to ensure any final decisions are made having considered all relevant information, so we are also interested in receiving any information about the eight medicines and indications we’re consulting on that would lead us to reconsider our proposal to decline funding for them.

A decline decision would mean the medicine would not be funded for the use requested. However, it would not prevent PHARMAC from reconsidering funding for these medicines in the future if, for instance, new evidence or other relevant information that addresses the reasons for the decline decision became available.

All consultation responses will be considered before making a final decision on any of these funding applications. These decisions would be made by the PHARMAC Board or its delegate using PHARMAC’s Factors for consideration.  We expect to make these decisions over the next few months, depending on the feedback we receive.

Information about how PHARMAC decides which medicines to fund is explained on our website.  See the following links:

• How medicines are funded (diagram of process); and
• Making funding decisions. 

Common terms used when describing our funding application assessment and decision-making process are explained in the following table.

Cisapride for gastrointestinal motility disorders

Cisapride background

PHARMAC is proposing to decline a funding application for cisapride for gastrointestinal motility disorders as there is no company willing to supply the medicine in New Zealand.

Cisapride is a serotonin receptor agonist that increases motility of the gastrointestinal tract. Cisapride was previously listed on the Pharmaceutical Schedule for the treatment of severe reflux oesophagitis and gastroparesis. Cisapride was delisted from the Pharmaceutical Schedule in 2004 after the supplier, Janssen-Cilag, discontinued the medicine worldwide due to cardiovascular safety concerns. This was due to cisapride causing QT-prolongation with the potential to worsen life-threatening arrhythmia (torsade de pointes).

A proposal to fund cisapride was initiated by PHARMAC in January 2011 following feedback from clinicians during the development of the list of medicines used in DHB hospitals. In 2011/2012, our clinical advisers recommended that cisapride should be available for use in DHB hospitals and funded in the community for a small subgroup of patients with gut motility disorders, provided that an electrocardiogram was performed prior to prescribing.

The funding application had not been progressed as there is no supplier with a Medsafe-approved brand of cisapride willing to supply cisapride in New Zealand.

What will this mean?

The funding application for cisapride would be declined. Any future consideration of funding for cisapride would likely require new information to be submitted to PHARMAC that addresses the reasons for the decline decision.

Who we think will be interested

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

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 is proposing to decline 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.

Melatonin is a naturally occurring hormone that aids sleep. Funding applications for melatonin were received in August 2012 and September 2012 for three groups of people:

• children and adolescents with neurodevelopmental or psychiatric comorbidities with secondary insomnia
• individuals aged 55 years or older with primary insomnia
• individuals with secondary insomnia associated with dementia.

The applications were reviewed by PTAC in November 2012.

PTAC recommended that melatonin be funded for children and adolescents with neurodevelopmental or psychiatric comorbidities with secondary insomnia and, in 2017, PHARMAC made a decision to fund melatonin for this patient group.

PTAC also recommended that the applications for melatonin be declined for individuals with primary insomnia aged 55 years or older and declined for individuals with secondary insomnia associated with dementia. PTAC considered that melatonin was similar in efficacy to zopiclone and other medicines that aid sleep in individuals 55 years and older with primary insomnia. PTAC considered that the evidence for the use of melatonin for secondary insomnia in individuals with dementia was weak and of poor quality. PHARMAC has previously indicated that funding of melatonin for these patient groups could be reconsidered if additional evidence was provided.

What will this mean?

The funding applications for melatonin for the treatment of primary insomnia in individuals aged 55 years or older and for the treatment of secondary insomnia associated with dementia would be declined. Any future consideration of melatonin for these populations would likely require new information to be submitted to PHARMAC that addresses the reasons for the decline decision.

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

Who we think will be interested

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

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 is proposing to decline a funding application to widen access for methylphenidate for treatment-resistant depression; depression in terminally ill individuals; and individuals with traumatic brain injury. This application was recommended for decline by our expert clinical advisors more than two years ago.

Methylphenidate is a mild central nervous system stimulant that is Medsafe-approved for the treatment of attention deficit/hyperactivity disorder (ADHD) and narcolepsy. Methylphenidate is subject to restrictions under the Misuse of Drugs Regulations 1977: permitted uses are ADHD, narcolepsy and use in palliative care treatment(external link).

Methylphenidate is currently funded for the treatment of ADHD and narcolepsy subject to Special Authority criteria.

In June 2013, PHARMAC received a funding application to widen access for methylphenidate for three groups of people:

• individuals with treatment-resistant depression
• depression in terminally ill individuals
• individuals with traumatic brain injury.

Individuals with treatment-resistant depression

In July 2013, the Mental Health Subcommittee deferred making a funding recommendation for methylphenidate for treatment-resistant depression pending publication of the new Royal Australian New Zealand College of Psychiatry (RANZCP) guidelines for the treatment of depression. In November 2015, PTAC considered the application along with the (then) draft RANZCP guidelines and recommended the application be declined, noting the high risk of diversion and illicit use of methylphenidate, poor evidence of effectiveness for treatment-resistant depression, and the availability of alternative treatment options.

Under the Misuse of Drugs Regulations 1977 methylphenidate cannot be prescribed for treatment-resistant depression except by a medical practitioner with a vocational scope of palliative medicine, in the context of palliative care treatment (see below).

Depression in terminally ill individuals

In July 2013, the Mental Health Subcommittee recommended that the funding application for methylphenidate for depression in terminally ill individuals be declined, given the high risk for diversion and illicit use of methylphenidate, and due to poor evidence of clinical benefit. In November 2013, the Pharmacology and Therapeutics Advisory Committee (PTAC) agreed with the Subcommittee’s recommendation to decline the application.

Individuals with traumatic brain injury

In July 2013, the Mental Health Subcommittee deferred making a funding recommendation for methylphenidate in individuals with traumatic brain injury, instead recommending that PHARMAC seek additional expert advice. Additional advice was sought, and in November 2015, the Neurological Subcommittee recommended that the application be declined for a number of reasons including unclear information about who would benefit most, dosing and duration, the lack of evidence of long-term benefit, the high risk for diversion and illicit use of methylphenidate and legal issues. In February 2016, the Pharmacology and Therapeutics Advisory Committee (PTAC) agreed with the Subcommittee’s recommendation.

Under the Misuse of Drugs Regulations 1977 methylphenidate can’t be prescribed for traumatic brain injury except in the context of palliative care (see above).

What will this mean?

The funding application to widen access to methylphenidate for:

• treatment-resistant depression
• depression in terminally ill individuals, and
• individuals with traumatic brain injury

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

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

Who we think will be interested

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

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 is proposing to decline the application for paracetamol sustained release tablets as this form of the medicine would provide no significant health benefits over other treatments we already fund, and would cost more.

Paracetamol is a medicine used to treat pain and fever, usually taken up to four times a day. A funding application for paracetamol sustained release 665 mg tablets was received in March 2010. This medicine would need to be taken three times a day.

In April 2010, the Analgesic Subcommittee recommended that paracetamol sustained release tablets be funded only if the daily cost per patient was no greater than the daily cost of paracetamol immediate release 500 mg tablets. The Subcommittee considered that there was no unmet clinical need for paracetamol sustained release tablets and that the medicine would not provide any significant benefit over paracetamol immediate release tablets.

The Pharmacology and Therapeutics Advisory Committee (PTAC) accepted the Subcommittee’s recommendation in August 2010.

To our knowledge, there is currently no available brand of paracetamol sustained release tablets that would be the same cost per day (“cost neutral”) as the paracetamol immediate release tablets that PHARMAC currently funds.       

What will this mean?

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

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

Who we think will be interested

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

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 is proposing to decline 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.

Sibutramine induces weight loss by reducing appetite and increasing the feeling of fullness. PHARMAC received a funding application for sibutramine for the treatment of severe obesity in individuals who had not adequately responded to an appropriate weight-reducing regimen in March 2007.

In May 2007, the Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that the application for sibutramine be declined as there was insufficient evidence to determine the long-term benefits and risks associated with treatment.

In 2010, Medsafe withdrew consent to distribute sibutramine in New Zealand following the publication of a study that reported that individuals treated with sibutramine had an increased risk of non-fatal cardiovascular events (Medsafe; Withdrawal of sibutramine; 2010(external link)).       

What will this mean?

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

Who we think will be interested

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

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 is proposing to decline the funding application for simeprevir for chronic hepatitis C genotype 1 infection as simeprevir would provide no additional benefits over other treatments now funded for hepatitis C.

Simeprevir is a protease inhibitor that prevents the replication of the hepatitis C virus. PHARMAC received a funding application for simeprevir for the treatment of chronic hepatitis C genotype 1 infection in adults in May 2015.

The Pharmacology and Therapeutics Advisory Committee (PTAC) reviewed the application in February 2016 and in August 2016. PTAC recommended that simeprevir should be funded for the treatment of hepatitis C genotype 1 infection if cost-neutral to boceprevir (funded since September 2013).

The treatment options for hepatitis C infection have now changed, with the recent funding of safer, simpler, and more effective direct acting antiviral medicines. In July 2016, Viekira Pak and Viekira Pak-RBV were funded for the treatment of hepatitis C genotype 1a and 1b, and Harvoni was funded for individuals with hepatitis C and severe liver disease (Notification 10 June 2016). In February 2019 Maviret was funded for all genotypes of hepatitis C (Notification 17 December 2018).

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).

Who we think will be interested

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

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 is proposing to decline funding applications to widen access for temozolomide as they were recommended for decline by our expert clinical advisors more than two years ago for:

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

Temozolomide is a chemotherapy medicine used for the treatment of certain types of cancer. Temozolomide is currently funded in combination with radiotherapy for newly diagnosed high grade gliomas: glioblastoma multiforme (grade 4 glioma) and anaplastic astrocytoma (grade 3 glioma), for metastatic or unresectable well-differentiated neuroendocrine tumours, and Ewing’s sarcoma, subject to Special Authority criteria.

PHARMAC has received several applications for widening access to temozolomide for the treatment of gliomas for three groups of people with gliomas.

Relapsed/recurrent grade 3 and 4 gliomas

In November 2007, PHARMAC received an application to widen access to temozolomide for relapsed or recurrent grade 3 or grade 4 gliomas. In December 2007, the Cancer Treatment Subcommittee of the Pharmacology and Therapeutics Advisory Committee (CaTSoP) recommended that the application to widen funded access to this patient group be declined due to the absence of comparative evidence.

In August 2016, PHARMAC received another application to widen access to temozolomide to include relapsed/recurrent grade 3 or 4 glioma. In November 2016, the Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined, noting that the evidence was of low strength and poor quality, and that the appropriate comparator and dosing regimen was unclear.

Gliomas where surgery and/or radiation is contraindicated

In November 2007, PHARMAC received an application to widen access to temozolomide for grade 3 or grade 4 gliomas where surgery and/or radiation is contraindicated. In December 2007, CaTSoP recommended that the application to widen funded access to this patient group be declined due to the absence of comparative evidence.

In August 2016, PHARMAC received another application for individuals with newly diagnosed grade 3 or grade 4 glioma without concomitant radiation for patients who are older than 60 years and/or have poor performance status. In November 2016, PTAC recommended that this application be declined, noting that the evidence was of reasonable strength but low quality being generally from studies for different population groups to those requested.

Anaplastic oligodendroglioma and anaplastic oligoastrocytoma

In February 2012, PHARMAC received an application to widen funded access to temozolomide to include all individuals with grade 3 glioma, including anaplastic oligodendroglioma and anaplastic oligoastrocytoma. In May 2012, PTAC recommended this application be declined noting that the evidence regarding the health gains of temozolomide was weak compared to other funded treatments for this population.

What will this mean?

The funding applications for the widening of access to temozolomide above would be declined. Any future consideration of funding for temozolomide for these indications would require a new submission that addresses the reasons for the decline decision, including supporting evidence (if relevant).

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

Who we think will be interested

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

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(external link):

• relapsed or recurrent grade 3 and 4 gliomas: 2007, 2016
• gliomas where surgery and/or radiation is contraindicated: 2007, 2016
• anaplastic oligodendroglioma and anaplastic oligoastrocytoma: 2012.

Trastuzumab (Herceptin) for HER2-positive advanced gastric cancer

Trastuzumab background

PHARMAC is proposing to decline 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.

Trastuzumab is a monoclonal antibody that targets human epidermal growth factor receptor 2 (HER2), which is overexpressed in some cancers. Trastuzumab is Medsafe-approved for the treatment of early breast cancer, metastatic breast cancer and gastric cancer. Trastuzumab is funded for the treatment of early and metastatic breast cancer subject to Special Authority criteria(external link).

PHARMAC received a funding application for trastuzumab for HER2-positive advanced gastric cancer in November 2010.

In February 2011, Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that trastuzumab be funded with a low priority noting a modest benefit in patients with HER2-positive advanced gastric cancer.

In April 2011, the Cancer Treatment Subcommittee of PTAC (CaTSoP) recommended that the application be declined.  CaTSoP noted the modest benefit but questioned whether it was clinically relevant and considered that further evidence was required to determine the benefit of trastuzumab in this setting.

In August 2011, CaTSoP considered additional information from the supplier and again recommended trastuzumab for HER2-positive advanced gastric cancer be declined. In November 2011 PTAC agreed with this recommendation. 

What will this mean?

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

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

Who we think will be interested

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

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).

Feedback about this consultation process

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

We want to know if the approach we’ve taken to this consultation works for people who are interested in and want to contribute to our decision-making and, if not, how we can make it better.

We would appreciate feedback on:

• whether this consultation is clear about what we’re proposing
• whether there is enough information and context
• whether the format works and, if not, how it could be improved
• how you think we should consult in the future.

Please note that we may contact people who respond to this consultation to get further information.

To provide feedback

Send us an email: applicationfeedback@pharmac.govt.nz by 21 May 2019.

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

Feedback we receive is subject to the Official Information Act 1982 (OIA). Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.