Proposal to fund treatments for gynaecological cancers, respiratory disorders, infectious diseases and vasculitis

What we’re proposing 

We’re seeking feedback on a proposal to fund three new treatments and widen access to two others, through a provisional agreement with GlaxoSmithKline New Zealand Limited (GSK).

The proposal would result in three new treatments being funded from 1 May 2024:

• niraparib (branded as Zejula) for the maintenance treatment of advanced, high-grade, platinum sensitive ovarian, fallopian tube or primary peritoneal cancer.
• fluticasone furoate with umeclidinium and vilanterol (branded as Trelegy Ellipta), a single inhaler triple-therapy for the treatment of chronic obstructive pulmonary disease (COPD).
• dolutegravir with lamivudine combination tablets (branded as Dovato) for the treatment of human immunodeficiency virus (HIV).

The proposal would also result in widened access for two currently funded treatments:

• mepolizumab (branded as Nucala) for treatment of a form of vasculitis called eosinophilic granulomatosis with polyangiitis (EGPA) from 1 May 2024.
• recombinant varicella zoster virus vaccine (branded as Shingrix) for prevention of shingles in immunocompromised people from 1 July 2024.

The provisional agreement with GSK also includes amendments to the contractual terms for vilanterol with umeclidinium dual therapy inhaler (brand name Anoro Ellipta), currently funded for COPD, dolutegravir (brand name Tivicay) funded for HIV and lamotrigine (brand name Lamictal), used for the treatment of epilepsy and mood disorders.

• vilanterol with umeclidinium (branded as Anoro Ellipta). No changes would be made to the funding of vilanterol with umeclidinium, however the net price would reduce via a confidential rebate.
• dolutegravir tablets (branded as Tivicay). No changes would be made to the funding of dolutegravir, however the net price would reduce via a confidential rebate.
• lamotrigine 2mg and 5mg dispersible tablets (brand name Lamictal). No changes would be made to the funding of Lamictal tablets, however the net price would reduce via a confidential rebate.

Consultation closes at 4pm Thursday 29^th February. Feedback can be emailed to consult@pharmac.govt.nz

Niraparib for gynaecological cancers

What would the effect be? 

From 1 May 2024 niraparib capsules (branded as Zejula) would be funded for first-line and second line maintenance treatment of advanced, high-grade, platinum sensitive ovarian, fallopian tube or primary peritoneal cancer, subject to eligibility criteria. Niraparib would be funded for all people who meet eligibility criteria, irrespective of BReast CAncer (BRCA) gene mutational status or homologous recombination deficiency (HRD).

We anticipate that up to 111 people would benefit from niraparib in the first year of funding, increasing to 116 people per year by year 5.

Who we think will be interested

• People with gynaecological cancers, their whānau, friends and caregivers
• Healthcare professionals involved in the care of people with gynaecological cancers
• Te Whatu Ora hospitals and other organisations who deliver services and support for people, and their whānau who are affected by gynaecological cancers
• People or groups with an interest in treatments for gynaecological cancers
• Pharmacies and wholesalers
• Pharmaceutical suppliers of cancer treatments

About gynaecological cancers and niraparib (branded as Zejula)

Gynaecological cancers are a type of cancer that affects the female reproductive system. Ovarian cancer is the second most common gynaecological cancer in New Zealand after endometrial cancer. Around 370 people are diagnosed with ovarian cancer per year. Fallopian tube and primary peritoneal cancer are less common.

Ovarian cancer is associated with poor health outcomes and high mortality. Māori and Pacific people experience higher incidence of ovarian cancer, with worse outcomes compared with non-Māori, non-Pacific people. Pacific people are more likely to be impacted by ovarian cancer compared to other ethnicities.

Niraparib is a targeted oral cancer medicine. It targets a protein found in cells called Poly (ADP-ribose) polymerase (PARP). PARP helps damaged cells to repair themselves. Niraparib stops PARP from repairing cancer cells, so the cancer cells die.

Niraparib is used as a maintenance treatment for people with gynaecological cancers who have responded to chemotherapy. This means that people take it for an extended period after they have received treatment for their cancer to prevent its return. Niraparib has been shown to reduce the likelihood of progression and would likely improve survival in people with these cancers. It is taken at home as a once-daily capsule.

More information about niraparib dosing and administration is available from the Medsafe datasheet.(external link)

Another PARP inhibitor called olaparib is currently funded, however it is funded subject to eligibility criteria(external link) restricting use to people who have a particular gene mutation called a BRCA mutation. The funding of niraparib would not require testing to confirm mutational gene status.

Why we’re proposing this

Niraparib was considered by the Cancer Treatments Advisory Committee (CTAC) in July 2021 [PDF, 533 KB]. Our advisors recommended that niraparib be funded as a first and second line maintenance treatment for three gynaecological cancers irrespective of mutation status with a medium priority.

While consideration was also given to those with BRCA mutated or HRD status, we are proposing to fund niraparib irrespective of mutation status. Our advisors have told us that people without BRCA or HRD mutations are still likely to benefit from this treatment and that this would help improve equitable access to treatment.

Full details of the clinical advice we have received is available from the Application Tracker(external link)

Details about our proposal

Niraparib would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 May 2024 at the following price and subsidy (ex-manufacturer, excluding GST):

Chemical	Brand	Formulation	Pack size	Proposed price and subsidy
Niraparib	Zejula	Cap 100 mg	56	$8,929.84
Niraparib	Zejula	Cap 100 mg	84	$13,393.50

A confidential rebate would apply to Zejula that would reduce the net price and it would have protection from delisting and subsidy reduction until 30 June 2028.

We’re proposing that community pharmacies are able to claim wastage for any capsules that are not dispensed.

Niraparib would be listed in Section B of the Pharmaceutical Schedule subject to the following eligibility criteria:

Similar eligibility criteria would also apply in Part II of Section H of the Pharmaceutical Schedule.  

Fluticasone furoate with umeclidinium and vilanterol for chronic obstructive pulmonary disease (COPD)

What would the effect be?

From 1 May 2024 the single inhaler triple-therapy (inhaled corticosteroid/long-acting muscarinic antagonist/long-acting beta agonist [ICS/LAMA/LABA]), fluticasone furoate with umeclidinium and vilanterol inhaler (branded as Trelegy Ellipta) would be funded for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD).

We estimate that around 15,000 people would benefit from this inhaler in the first year of funding, and that this would increase to over 30,000 people after five years.

People can already receive the ICS/LABA/LAMA combination therapy from more than one inhaler. Funding this triple therapy combination in a single inhaler would mean people only need to use one inhaler instead of two or three. We expect this to reduce barriers for people to access treatment for their COPD.

Who we think will be interested

• People with COPD, their whānau and friends
• Healthcare professionals involved in the care of people with COPD
• Te Whatu Ora hospitals and other organisations who deliver services and support for people with COPD
• People or groups with an interest in treatments for COPD
• Pharmacies and wholesalers
• Pharmaceutical suppliers of respiratory treatments

About COPD and fluticasone furoate/umeclidinium/vilanterol (branded as Trelegy Ellipta)

COPD is a common lung disease that causes breathing problems. It is also known as emphysema and chronic bronchitis. COPD results from a blockage or damage to the lungs that causes restricted airflow, coughing, wheezing, breathing problems, and tiredness. Medicines for COPD work by opening and reducing swelling in the airways.

COPD is estimated to affect 15% of all New Zealanders aged over 45 years. It is the fourth leading cause of death in New Zealand behind cancer, heart disease and stroke. COPD is permanent, disabling and frequently progressive.

Respiratory health (Romaha Ora) is one of Pharmac’s Māori health areas of focus (Hauora Arotahi). The health burden of COPD is one of the most significant sources of healthcare disparity in New Zealand. Māori and Pacific peoples are more likely to experience and are more severely impacted by COPD compared to other ethnicities. Amongst New Zealanders aged 50 – 64 years, Māori are approximately five times more likely to die from COPD-related causes than non-Māori and are affected by COPD up to 20 years earlier. Māori and Pacific peoples are three to four times more likely to be admitted to hospital for COPD than people in other ethnic groups in New Zealand. *

COPD is more frequent in communities with higher levels of deprivation and higher smoking rates, over 85% of cases of COPD are estimated to be caused by inhalation of tobacco smoke.**

(*) Best Practice Advocacy Centre New Zealand (BPAC). Available from: bpac.org.nz

(**) The Asthma Foundation. COPD in New Zealand. Available from: www.asthmafoundation.org.nz

Trelegy Ellipta is a combination of three medicines in a single inhaler.

• Fluticasone furoate reduces inflammation and swelling the lungs.
• Umeclidinium is a bronchodilator that keeps airways open by blocking the tightening of smooth muscle around the airways.
• Vilanterol is also a bronchodilator that opens airways by relaxing the muscles around the airways in the lungs.

These three chemicals (fluticasone furoate, umeclidinium and vilanterol) and other types of ICS/LAMA/LABA medicines are administered by use of either a single or dual Inhaler. Trelegy Ellipta would be the first funded single inhaler, triple-therapy in New Zealand for COPD.

More information about fluticasone furoate with umeclidinium and vilanterol dosing and administration is available from the Medsafe datasheet(external link).

While fluticasone furoate/umeclidinium/vilanterol is Medsafe approved for the treatment of asthma as well as COPD Pharmac is yet to receive a funding application for this indication. 

Why we’re proposing this

The single inhaler triple-therapy, fluticasone furoate with umeclidinium and vilanterol was considered by the Pharmacology and Therapeutics Advisory Committee (PTAC) in May 2019 and by the Respiratory Advisory Committee in October 2020. PTAC and the Respiratory Advisory Committee both recommended that it be funded only if it was cost-neutral to the pricing of the same components received from multiple inhalers (fluticasone furoate/vilanterol trifenatate 100/25mg [Breo Ellipta] in combination with umeclidinium 62.5mg [Incruse Ellipta]), within the context of treatment of respiratory disease.

In summary, the advice we received was that there was equivalent benefit from multiple inhaler triple therapy to that of triple therapy from a single inhaler. The Committees considered there are, however suitability benefits from combining the treatment in a single inhaler. This may include better adherence to treatment, easier to use regimen (once daily), and reduced chances of errors when administering compared to triple therapy from multiple inhalers.

Funding a triple therapy single inhaler may also be equity enhancing by reducing barriers for people to access treatment with multiple single inhalers. The need to dispose of less inhalers and use less propellant could also reduce the impact on the environment.

Full details about the clinical advice we have received, and its status over time, is available in the Application Tracker(external link).

The application has been ranked on our Options for Investment list since June 2019. We are pleased to have now reached a provisional commercial agreement with the supplier to progress it.

Details about our proposal

Chemical	Brand	Formulation	Pack size	Proposed price and subsidy
Fluticasone furoate with umeclidinium and vilanterol	Trelegy Ellipta 100/62.5/25	Powder for inhalation fluticasone furoate 100 mcg with umeclidinium 62.5 mcg and vilanterol 25 mcg	1 inhaler - OP (30 doses per inhaler)	$104.24

A confidential rebate would apply to Trelegy Ellipta that would reduce the net price and it would have protection from delisting and subsidy reduction until 30 June 2028.

Trelegy Ellipta would be listed in Section B of the Pharmaceutical schedule subject to the following eligibility criteria:

Similar eligibility criteria would also apply in Part II of Section H of the Pharmaceutical Schedule.  

Dolutegravir with lamivudine for treatment of Human Immunodeficiency Virus (HIV)

What would the effect be?

From 1 May 2024 dolutegravir with lamivudine combination tablets (branded as Dovato) would be funded for people with HIV, subject to the existing eligibility criteria(external link) for HIV treatments.

We anticipate that 885 people would use Dovato in place of their current HIV treatment regimens or initiate treatment for HIV using Dovato, increasing to 1,950 people after 5 years. 

Who we think will be interested 

• People living with HIV, their whānau, friends and caregivers
• Healthcare professionals involved in the care of people with HIV
• Te Whatu Ora hospitals and other organisations who deliver services and support for people, and their whānau who are affected by HIV
• People or groups with an interest in treatments for HIV
• Pharmacies and wholesalers 

About HIV and dolutegravir with lamivudine (branded as Dovato)

Human immunodeficiency virus (HIV) is a virus that attacks the body’s immune system. If HIV is not treated, it can lead to AIDS (acquired immunodeficiency syndrome). Once a person is diagnosed with HIV, it stays in their system for life – as there is no cure available. However, with treatment people living with HIV can live long, healthy lives.

In New Zealand, inequities in HIV outcomes have been clearly identified. Gay, bisexual and other men who have sex with men (MSM) are the most disproportionately affected by HIV and are 348 times more likely to be diagnosed with HIV than the heterosexual population. There are further and intersecting inequities within this population group. Māori and Pacific gay, bisexual and other MSM are no more likely to be living with HIV than non-Māori gay, bisexual and other MSM, however, they are more than twice as likely to be diagnosed late and present with advanced HIV. *

(*) Saxton et al 2022(external link); https://pubmed.ncbi.nlm.nih.gov/34479989/(external link)

Dovato is a tablet which is a combination of two antiretroviral medicines, dolutegravir and lamivudine. Antiretrovirals work by stopping the virus replicating in the body, allowing the immune system to repair itself and preventing further damage. However, if treatment is interrupted the virus will return.

Both medicines which make up Dovato are currently funded for treatment of HIV as separate tablets which are each taken 1-2 times per day. Dovato combines the two medicines into a single, once per day HIV treatment.

More information about dosing and administration of dolutegravir with lamivudine for HIV infection is available from the Medsafe datasheet(external link). 

Why we’re proposing this 

The dolutegravir/lamivudine combination tablet, Dovato, was considered by the Anti-infective Advisory Committee in September 2022. The Committee recommended it be funded only if cost-neutral to the cost of other funded HIV medicine regimens.

Our clinical advisors have told us that Dovato is clinically equivalent to currently funded treatment regimens, but that it would be more convenient for people than receiving multi-tablet treatment regimens and it may help people better manage their HIV over time.

Advocacy groups for people living with HIV have highlighted that a crucial part of improving the lives of people living with HIV is reducing the stigma associated with the disease. Simplifying treatment as much as possible to allow people to receive effective treatment with minimal impact on their day to day lives would contribute to this endeavour.

Full details about the clinical advice we have received, and its status over time, is available in the Application Tracker(external link).

The application has been ranked on our Options for Investment list since January 2024. We are pleased to have now reached a provisional commercial agreement with the supplier to progress it.

Details about our proposal 

Dolutegravir with lamivudine would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 May 2024 at the following price and subsidy (ex-manufacturer, excluding GST):

Chemical	Brand	Formulation	Pack size	Proposed price and subsidy
Dolutegravir with lamivudine	Dovato 50/300	Tab dolutegravir 50 mg with lamivudine 300 mg	30	$1,090.00

A confidential rebate would apply to Dovato that would reduce the net price and it would have protection from delisting and subsidy reduction until 30 June 2028.

Dovato would be listed in section B subject to the existing antiretrovirals eligibility criteria(external link) and in Part II of Section H.

Mepolizumab for treatment of relapsed or refractory eosinophilic granulomatosis with polyangiitis (EGPA)

What would the effect be?

From 1 May 2024 access to mepolizumab (branded as Nucala) would be widened to include people with eosinophilic granulomatosis with polyangiitis (EGPA), a rare condition severely affecting small blood vessels.

We expect up to 15 people in New Zealand would be able to receive mepolizumab for EGPA in the first year increasing to 23 by year 5.

Who we think will be interested

• People with EGPA, their whānau and friends
• Healthcare professionals involved in the care of people with EGPA
• Te Whatu Ora hospitals and other organisations who deliver services and support for people with EGPA
• People or groups with an interest in treatments for EGPA
• Pharmacies and wholesalers
• Pharmaceutical suppliers of respiratory treatments

About EGPA and mepolizumab (branded as Nucala)

EGPA is a rare disease, formerly called Churg-Strauss syndrome. It is a form of vasculitis, characterised by inflammation of the blood vessels, which can restrict blood flow and damage vital organs and tissues.

We are unsure of the relative incidence and outcomes of EGPA on Māori and Pacific peoples.

Mepolizumab, currently funded for the treatment of severe eosinophilic asthma is a monoclonal antibody against a protein called interleukin-5 (IL-5). By blocking the action of IL-5 mepolizumab helps reduce the activity of specialised white blood cells called eosinophils.  

Mepolizumab is Medsafe approved for treatment to manage symptoms in patients aged 18 years and older that have EGPA. It is available as prefilled pen and is administered by subcutaneous injection every 4 weeks at a dose of 300 mg per 4 weeks. More information about dosing and administration of mepolizumab for EGPA is available from the Medsafe datasheet(external link).

Why we’re proposing this

Mepolizumab for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) was considered by the Respiratory Advisory Committee in April 2022. The Committee recommended it be funded with a high priority. Our clinical advisors told us there is a high health need for those people with relapsed or refractory EGPA. There is strong evidence of a benefit in using mepolizumab to sustain remission, in turn improving symptom-related quality of life, reducing the risk of organ damage and improve survival.

Full details about the clinical advice we have received, and its status over time, is available in the Application Tracker(external link).

Details about our proposal 

The eligibility criteria(external link) for mepolizumab (Nucala) inj 100 mg prefilled pen in Section B of the Pharmaceutical Schedule would be amended from 1 May 2024 to include the following indication:

Similar eligibility criteria would also apply in Part II of Section H of the Pharmaceutical Schedule. 

Recombinant varicella zoster virus vaccine for the prevention of shingles in immunocompromised people

What would the effect be? 

From 1 July 2024 access to the recombinant varicella zoster virus vaccine (branded as Shingrix) for the prevention of shingles would be widened to include immunocompromised people 18 years or older with the following illnesses:

• People who are pre- or post- haematopoietic stem cell transplant
• People who have had a solid organ transplant
• People with haematological malignancies
• People living with poorly controlled HIV infection
• People who are planned to or are receiving disease modifying anti-rheumatic drugs (DMARDs) for:
  • systemic lupus erythematosus
  • polymyalgia rheumatica
  • rheumatoid arthritis
• People with end stage kidney disease (CKD 4 or 5)
• People with primary immunodeficiency

There would be no other changes to age eligibility criteria for Shingrix at this time, meaning that it would remain funded for all other people aged 65 years.

We expect approximately 15,000 immunocompromised people would benefit from the shingles vaccine in the first two years as a result of this proposal and another 2000 people every year after that to a total of 21,000 after 5 years.

Who we think will be interested

• Immunocompromised people, their whānau and friends
• Healthcare professionals involved in the delivery of vaccines and the care of immunocompromised people
• Te Whatu Ora hospitals and other organisations who deliver services and support for immunocompromised people
• People or groups with an interest in treatments for Shingles
• Pharmacies and wholesalers
• Suppliers of vaccines

About shingles and recombinant varicella zoster virus vaccine (branded as Shingrix)

Herpes zoster, commonly known as shingles, is a painful blistering rash caused by the same virus that causes chickenpox. Anyone who has previously had chickenpox may subsequently develop shingles or post-herpetic neuralgia (prolonged nerve pain in the rash area) from reactivation of the virus later in life. Shingles is more common and more severe in people with poor immunity and the elderly.

One in every three people can expect to suffer at least one attack of shingles in their lifetime. Particularly for older people, shingles and post-herpetic neuralgia can be very painful, prolonged and debilitating and may affect their ability to carry out simple daily activities, such as dressing and bathing.

Shingrix is a recombinant vaccine indicated for the prevention of herpes zoster (shingles) and post-herpetic neuralgia. Recombinant vaccines use small proteins from of the virus or bacteria they are intended to protect against instead of the whole live attenuated or inactivated organisms in some vaccines.

More information about Shingrix is available from the Medsafe datasheet(external link).

Zoster vaccine (Shingrix) is currently funded for people who are 65 years of age. Shingrix requires two doses given 6 months apart. Both doses are funded if the person being vaccinated is 65 when they receive their first dose.

Why we’re proposing this

The Immunisation Advisory Committee considered Shingrix for people who are immunocompromised at its May 2022 and November 2023 meetings. At its November 2023 meeting, the Immunisation Advisory Committee told us that Shingrix is a safe and effective treatment for preventing shingles recommended that access be widened to specific groups of immunocompromised people with a high priority.

Excerpt of November 2023 meeting record [PDF, 271 KB]

Our clinical advisors have told us that the Shingrix vaccine is a safe and effective vaccine for preventing shingles and recommended that access should be widened to specific groups of immunocompromised people. They have told us that people who are immunocompromised are at much greater risk of shingles and its complications. They also told us that Shingrix is much better at preventing the complications of shingles than the current antiviral treatments available once the disease has begun.

People who receive the shingles vaccine have substantially lower rates of shingles and complications from the disease once acquired. As a recombinant vaccine, Shingrix can also be given to immunocompromised people where a live-attenuated vaccine is not suitable. Prevention of shingles cases also reduces the number of consultations required by community health nurses and general practitioners reducing the pressure on front-line healthcare services.

The Committee considered the impact that shingles may have on Māori and Pacific peoples and their whānau may be disproportionally greater compared to non-Māori, non-Pacific peoples due to the well documented barriers experienced by Māori within the healthcare system.

Full details about the clinical advice we have received for this application, and its status over time, is available in the Application Tracker.(external link)

We have received a number of funding applications for wider funding of the shingles vaccine. the status of each application can be viewed on our Application Tracker(external link):

• People from 50 to 64 years of age(external link).
• People over 65 years of age who have received Zostavax at least 5 years previously(external link).
• Māori and Pacific peoples 60 years of age and over.(external link)
• People with rheumatological conditions treated with a JAK Kinase inhibitor or rituximab.
• Catch-up programme for people aged over 65 years, due to COVID-19 pandemic disruption(external link).

Details about our proposal

The eligibility criteria for varicella zoster vaccine [shingles vaccine] inj 50 mcg per 0.5 ml vial plus vial in Section I(external link) and Part II of Section H of the Pharmaceutical Schedule would be amended as follows (additions in bold and deletions in strikethrough):

A confidential rebate would apply to Shingrix that would reduce the net price and it would have protection from delisting and subsidy reduction until 30 June 2027. 

Other contractual changes associated with this proposal

Dolutegravir

Dolutegravir (Tivicay) is funded for the treatment of HIV subject to eligibility criteria(external link). There would be no changes to the list price and subsidy, or current eligibility criteria for Tivicay as part of this proposal.

As part of the proposal, the net price for Tivicay would reduce via confidential rebate from 1 May 2024 and there would be subsidy and delisting protection for Tivicay until 30 April 2027. 

Umeclidinium/vilanterol

Umeclidinium/vilanterol (Anoro Ellipta) is funded for COPD subject to eligibility criteria(external link). There would be no changes to the list price and subsidy, or current eligibility criteria for Anoro Ellipta as part of this proposal.

As part of the proposal, the net price for Anoro would reduce via confidential rebate from 1 May 2024 and there would be subsidy and delisting protection for Anoro until 30 April 2027. 

Lamotrigine

There would be no changes to the list price and subsidy for the 2 mg and 5 mg strengths of lamotrigine (brand name Lamictal). As part of the proposal, the net price for Lamictal would reduce via confidential rebate from 1 May 2024. The net price of other strengths of the Lamictal brand lamotrigine accessed via Pharmac’s exceptional circumstances framework would also reduce via confidential rebate. 

To provide feedback 

Send us an email: consult@pharmac.govt.nz by 4pm Thursday 29^th February

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. 

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