Decision to fund treatments for ovarian cancer, respiratory disorders, infectious diseases and vasculitis

12 April 2024

Medicines Decision

We're funding three new treatments and widening access to another treatment and a vaccine, through an agreement with GlaxoSmithKline New Zealand Limited (GSK).

What we’re doing

Three new treatments will be 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).

Access to a currently funded treatment and a currently funded vaccine will be widened as follows:

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 18 years of age with certain conditions from 1 July 2024.

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

This decision was subject to a consultation letter dated 15 February 2024.

We’re grateful for the feedback we received in response to the consultation on this proposal. A summary of the main themes raised for each part of this proposal, and our responses to these are detailed at the end of each section.

Niraparib for ovarian cancer

What does this mean for people?

From 1 May 2024 niraparib capsules (branded as Zejula) will 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 will 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 approximately 110 people will benefit from niraparib in the first year of funding, increasing to about 160 people per year by year 5.

Any changes to the original proposal?

We received feedback from clinicians, advocacy groups, suppliers and health sector stakeholders. We want to thank everyone for their feedback.

Responses ranged from supportive of niraparib being funded to wanting different cancer medicines to be funded. Responders also requested clarification to the proposed funding criteria. In response to feedback received we have made some changes to the funding criteria for niraparib to:

Clarify that niraparib is funded for use as either first or later line treatment
Allow people receiving niraparib for this indication prior to 1 May 2024 to continue their treatment without the need to submit a request for a Special Authority waiver, if they met all remaining criteria prior to commencing treatment.

A summary of the feedback and our responses to this are detailed below.

Who we think will be interested

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

Details about this decision

Niraparib will 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 will apply to Zejula that will reduce the net price and it will have protection from delisting and subsidy reduction until 30 June 2028.

Community pharmacies will be able to claim wastage for any capsules that are not dispensed.

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

Special Authority for Subsidy

Initial application from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

Patient has advanced high-grade serous* epithelial ovarian, fallopian tube, or primary peritoneal cancer; and
Patient has received at least one line** of treatment with platinum-based chemotherapy; and
Patient has experienced a partial or complete response to the preceding treatment with platinum-based chemotherapy; and
Patient has not previously received funded treatment with a PARP inhibitor; and
Either:
1. Treatment will be commenced within 12 weeks of the patient’s last dose of the preceding platinum-based regimen; or
2. Patient commenced treatment with niraparib prior to 1 May 2024; and
Treatment to be administered as maintenance treatment; and
Treatment not to be administered in combination with other chemotherapy.

Renewal from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

No evidence of progressive disease; and
Treatment to be administered as maintenance treatment; and
Treatment not to be administered in combination with other chemotherapy; and
Either
1. Treatment with niraparib to cease after a total duration of 36 months from commencement; or
2. Treatment with niraparib is being used in the second-line or later maintenance setting.

Notes:

* “high-grade serous” includes tumours with high-grade serous features or a high-grade serous component.

**A line of chemotherapy treatment is considered to comprise a known standard therapeutic chemotherapy regimen and supportive treatments.

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

Our response to what you told us

We’re grateful to those who took the time to respond to our consultation. This is an important part of our decision-making process. It gives us the opportunity to listen to the voices of the community and acknowledge and respond to feedback. Responses were largely supportive of the proposal.

Theme	Pharmac comment
Supportive	We are pleased to be able to enable access to this medicine for people with ovarian cancer.
Request to add high-grade endometrioid carcinoma to the funded indications.	Thank you for providing this feedback and supporting evidence for this group. We understand there is a high health need for people with endometrioid cancer and it is valuable to hear that niraparib may be beneficial for this type of cancer. We intend to seek advice from the Cancer Treatments Advisory Committee regarding endometrioid carcinoma at a future meeting.
Requests to clarify whether funding is for first or second line treatment, as well as if this is once per patient lifetime.	We have amended the criteria to clarify that niraparib is funded for either first-line or later line maintenance treatment. Retreatment with niraparib is not part of the funded indication. This is in line with the clinical advice we received that the available evidence supported once-per-patient-lifetime access to a PARP inhibitor. Full details of the advice we received are available from the Application tracker(external link).
Unsupportive of niraparib being funded ahead of cancer treatments that were recommended by clinical advisors with a ‘high priority’.	The clinical advice we have received is that niraparib will reduce the likelihood of progression in people with ovarian cancer. There are other cancer treatments ranked on our options for investment list that have been recommended for funding with a high priority by our clinical advisors that we would also like to fund when we have available budget. Funding for niraparib has been made possible due to successful negotiations with the supplier GSK and through the amendments to the contractual arrangements and net pricing for several other medicines supplied by GSK.
Funding niraparib would likely increase the time that people remain under the care of medical oncology and will have an impact on clinic capacity and resource required to monitor treatment and manage side effects.	We appreciate the feedback regarding sector impacts. Niraparib is an oral medicine and funding criteria will not require testing to confirm mutational gene status. We understand that there will be increased monitoring and toxicity/side effect management associated with its use. We have incorporated this into our assessment. We intend to share this with Health New Zealand and the Cancer Control Agency - Te Aho o Te Kahu to inform the extent of this increase in requirements from the Sector.
Funding niraparib may result in a small increase in people developing acute leukaemia which will impact haematology services.	We appreciate the feedback regarding sector impacts and specifically side effect management. Side effects of treatment with cytotoxic pharmaceuticals are common. We have included the risk of development of leukaemia in our assessment.
Request to add wastage claimable to niraparib.	We have enabled wastage to be claimed on this medicine.

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

What does this mean for people?

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) will be funded for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD).

We estimate that around 15,000 people will benefit from this inhaler in the first year of funding, and that this will 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 means 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.

Any changes to the original proposal?

We received feedback from clinicians, clinical groups, advocacy groups and suppliers. We want to thank everyone for their feedback. Overall we received supportive feedback. In response to feedback received we have made some changes to the funding criteria for fluticasone furoate with umeclidinium and vilanterol to:

Enable access for people who try but are unable to complete a spirometry assessment.
Enable access for those currently receiving multiple inhaler triple therapy if they met the intent of the criteria prior to starting triple therapy.
Enable access for people with a history of 1 exacerbation requiring hospitalisation in the previous 12 months, or 2 or more exacerbations in the previous 12 months.

A summary of the feedback and our responses to this are detailed below.

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

Details about this decision

Fluticasone furoate with umeclidinium and vilanterol will 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
Fluticasone furoate with umeclidinium and vilanterol	Trelegy Ellipta	Powder for inhalation fluticasone furoate 100 mcg with umeclidinium 62.5 mcg and vilanterol 25 mcg	30 dose OP	$104.24

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

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

Special Authority for Subsidy

Initial application from any relevant practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria:

All of the following

Patient has a diagnosis of COPD confirmed by spirometry or spirometry has been attempted and technically acceptable results are not possible; and
Either:
1. Both:
  1. Patient is currently receiving an inhaled corticosteroid with long acting beta-2 agonist (ICS/LABA), or a long acting muscarinic antagonist with long acting beta-2 agonist (LAMA/LABA); and
    1. Any of the following:
      Clinical criteria:
    2. Patient has a COPD Assessment Test (CAT) score greater than 10; or
    3. Patient has had 2 or more exacerbations in the previous 12 months; or
    4. Patient has had one exacerbation requiring hospitalisation in the previous 12 months; or
    5. Patient has had an eosinophil count greater than or equal to 0.3 x 10ˆ9 cells/L in the previous 12 months; or
2. Patient is currently receiving multiple inhaler triple therapy (inhaled corticosteroid with long acting muscarinic antagonist and long acting beta-2 agonist – ICS/LAMA/LABA) and met at least one of the clinical criteria above prior to commencing multiple inhaler triple therapy.

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

Our response to what you told us

Theme	Pharmac comment
Supportive. A single inhaler for triple therapy will help with adherence and assist with management of COPD, which is a big driver of health inequity currently.	We are pleased to enable access to a single inhaler for triple therapy that could improve both adherence and support improvements in health equity.
Requested amendments to Special Authority criteria to enable access for people who have had a severe exacerbation requiring hospitalisation, or two exacerbations (not >2), to align with clinical guidelines.	We have amended the Special Authority criteria for fluticasone furoate with umeclidinium and vilanterol to enable access for people with a history of one exacerbation requiring hospitalisation in the previous 12 months, or at least two (not "more than 2”) exacerbations in the last 12 months.
Request that Special Authority criteria be modified to remove the requirement for spirometry, or not apply in instances where spirometry is attempted but technically acceptable results are not possible.	We have amended the Special Authority criteria for fluticasone furoate with umeclidinium and vilanterol to enable access for people who try but are unable to complete a spirometry assessment. Our clinical advisors have told us that spirometry is a necessary diagnostic tool for people with COPD, and that relying on clinical diagnosis alone would lead to overdiagnosis and the triple therapy inhaler being used by people who are unlikely to benefit from it. Based on this advice we have not removed the requirement that ensures spirometry is attempted.
Request that we enable all people currently receiving multiple inhaler triple therapy, or those who receive multiple inhaler triple therapy, to transition to single inhaler triple therapy without the need to meet the remaining criteria.	We have amended the Special Authority Criteria to enable people currently receiving multiple inhaler triple therapy (ICS/LABA/LAMA) and who can provide evidence of having met the severity criteria prior to receiving multiple inhaler triple therapy to transition to single inhaler therapy.
Request for wider access (not just COPD) to single inhaler triple therapy where clinically appropriate.	The Respiratory Advisory Committee considered an application for the funding of single inhaler triple therapy for people with COPD. The eligibility criteria are based on the clinical advice we received about the group of people with COPD who are most likely to benefit. We appreciate there is a desire for access to single inhaler triple therapy for other indications. We welcome an application to support consideration of broader access to single inhaler triple therapy. Information on how to submit a funding application is on the Pharmac website.

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

What does this mean for people?

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

We anticipate that about 900 people will use Dovato in place of their current HIV treatment regimens or initiate treatment for HIV using Dovato in year 1, increasing to 1,950 people after 5 years.

People can already receive dolutegravir with lamivudine combination therapy from more than one tablet. We expect funding a combination tablet to reduce barriers for people to receive treatment for their HIV.

Any changes to the original proposal?

We received feedback from clinicians, advocacy groups and health sector stakeholders. We want to thank everyone for their feedback. We received supportive feedback and have not made any changes to the original proposal.

A summary of the feedback and our responses to this are detailed below.

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

Details about this decision

Dolutegravir with lamivudine will 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	Tab dolutegravir 50 mg with lamivudine 300 mg	30	$1,090.00

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

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

Our response to what you told us

Theme	Pharmac comment
Supportive moving from a three-drug to two-drug regimen can be beneficial in older people or people with impaired kidney function polypharmacy and ‘pill burden’ for some people living with HIV can be substantial due to co-morbid diseases and the requirement for multiple prescriptions.	We are pleased to be able to fund a combination dolutegravir/lamivudine tablet for people with HIV that will support people with moving to clinically appropriate regimens and reduce their pill burden and medicine administration difficulties.
Limited concern with taking two tablets once daily for some people.	The advantages of a single combination tablet compared to two to three tablet regimens was considered by the Anti-infective Advisory Committee at its September 2022 Meeting. The Committee recommended funding a single tablet provided it was no more expensive than a two or three tablet regimen. The recommendation was based on the clinical need and suitability benefits of a single tablet regimen compared with other funded, two or three tablet regimens. We are pleased to be able to fund a combination tablet for people with HIV as an alternative option to two or three tablet regimens. Full details of the clinical advice we received is available from the Application tracker(external link).
Other HIV medicines including tenofovir alafenamide and injectable cabotegravir would also be beneficial for an increasingly complex and ageing group of people living with HIV.	Pharmac is considering two applications for medicines containing tenofovir alafenamide for HIV. Bictegravir with emtricitabine and tenofovir alafenamide. We received an application for funding this medicine in 2019. The most recent clinical advice we received on this funding app was in 2020 and was to fund if it was no more expensive than the cost of other HIV medicines. However, based on feedback provided by the supplier we plan to seek additional clinical advice on this application at the next Anti-Infective Advisory Committee meeting in 2024. You can find further details on the Application tracker(external link)) Emtricitabine with tenofovir alafenamide. Our clinical advisors recommended funding emtricitabine with tenofovir alafenamide if it was no more expensive that the funded alternatives containing tenofovir disoproxil. Emtricitabine with tenofovir alafenamide is currently more expensive than the funded alternatives and we are not able to progress funding for it at this time. You can find further details on the Application tracker(external link)) We have not recieved an application for cabotegravir. We understand this is not Medsafe approved. We would be happy to receive an application for funding should cabotegravir be submitted to Medsafe for regulatory approval. Information on how to submit a funding application is on the Pharmac website.

Theme

Pharmac comment

Supportive

moving from a three-drug to two-drug regimen can be beneficial in older people or people with impaired kidney function
polypharmacy and ‘pill burden’ for some people living with HIV can be substantial due to co-morbid diseases and the requirement for multiple prescriptions.

We are pleased to be able to fund a combination dolutegravir/lamivudine tablet for people with HIV that will support people with moving to clinically appropriate regimens and reduce their pill burden and medicine administration difficulties.

Limited concern with taking two tablets once daily for some people.

The advantages of a single combination tablet compared to two to three tablet regimens was considered by the Anti-infective Advisory Committee at its September 2022 Meeting.

The Committee recommended funding a single tablet provided it was no more expensive than a two or three tablet regimen. The recommendation was based on the clinical need and suitability benefits of a single tablet regimen compared with other funded, two or three tablet regimens.

We are pleased to be able to fund a combination tablet for people with HIV as an alternative option to two or three tablet regimens. Full details of the clinical advice we received is available from the Application tracker(external link).

Other HIV medicines including tenofovir alafenamide and injectable cabotegravir would also be beneficial for an increasingly complex and ageing group of people living with HIV.

Pharmac is considering two applications for medicines containing tenofovir alafenamide for HIV.

Bictegravir with emtricitabine and tenofovir alafenamide. We received an application for funding this medicine in 2019. The most recent clinical advice we received on this funding app was in 2020 and was to fund if it was no more expensive than the cost of other HIV medicines. However, based on feedback provided by the supplier we plan to seek additional clinical advice on this application at the next Anti-Infective Advisory Committee meeting in 2024. You can find further details on the Application tracker(external link))
Emtricitabine with tenofovir alafenamide. Our clinical advisors recommended funding emtricitabine with tenofovir alafenamide if it was no more expensive that the funded alternatives containing tenofovir disoproxil. Emtricitabine with tenofovir alafenamide is currently more expensive than the funded alternatives and we are not able to progress funding for it at this time. You can find further details on the Application tracker(external link))

We have not recieved an application for cabotegravir. We understand this is not Medsafe approved. We would be happy to receive an application for funding should cabotegravir be submitted to Medsafe for regulatory approval. Information on how to submit a funding application is on the Pharmac website.

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

What does this mean for people?

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

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

Any changes to the original proposal?

We received feedback from clinicians, clinical groups, advocacy groups, other health sector stakeholders and suppliers. We want to thank everyone for their feedback. Overall we received supportive feedback. In response to feedback received we have made a change to the funding criteria for mepolizumab to clarify that people are not required to trial maximum tolerated doses of one of the other funded treatments for at least three months, but that these would need to be trialled for at least three months (unless contraindicated).

A summary of the feedback and our responses to this are detailed below.

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

Details about this decision

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

Special Authority for Subsidy

Initial application – (eosinophilic granulomatosis with polyangiitis) from any relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

The patient has eosinophilic granulomatosis with polyangiitis; and
The patient has trialled and not received adequate benefit from at least one of the following for at least three months (unless contraindicated to all): azathioprine, cyclophosphamide, leflunomide, methotrexate, mycophenolate, or rituximab; and
Either:
1. The patient has trialled prednisone for a minimum of three months and is unable to maintain disease control at doses below 7.5 mg per day; or
2. Corticosteroids are contraindicated.

Renewal application – (eosinophilic granulomatosis with polyangiitis) from any relevant specialist or any relevant practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months where patient has no evidence of clinical disease progression.

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

Our response to what you told us

Theme	Pharmac comment
Supportive	We are pleased to be able to enable access to mepolizumab for people with relapsed or refractory EGPA.
Request for amendments to the Special Authority criteria to allow first line use of mepolizumab.	The application, we received and assessed was for mepolizumab for people with relapsed or refractory EGPA. We have not included first line use of mepolizumab in the funding criteria as we would require more information to assess treatment in this setting. We would welcome an application to support consideration of the use of mepolizumab in the first line setting. Information on how to submit a funding application is on the Pharmac website.
Request that the Special Authority for mepolizumab be amended to remove: the requirement that the person trial the listed alternative treatments for at least three months the requirement that the person trial the listed alternative treatments at the maximum tolerated dose	The intent of the criteria is to ensure that people trial other funded alternatives prior to receiving mepolizumab. To aid with clarity, we have amended the criteria to remove the requirement for people to trial a maximal tolerated dose of other funded immunosuppressive medicines for 3 months. We intend to seek advice from the Respiratory Advisory Committee at a future meeting regarding the request to remove the requirement for people to trial the listed funded alternatives for the three month time period. In the meantime, we would be happy to consider a waiver for someone who meets the intent of this criteria, but is unable to trial funded alternatives for three months due to intolerance. Information about how to submit a Special Authority waiver is located on the Pharmac website.
Request to fund the provision of syringes and needles for use with community mepolizumab administration.	Mepolizumab is currently primarily supplied as a prefilled pen which is a complete administration system and does not require needles or syringes. The vial presentation is being discontinued and will be de-listed from the Pharmaceutical schedule from 1 August 2024.

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

What does this mean for people?

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

People who are pre- and post- haematopoietic stem cell transplant or cellular therapy
People who are pre- or post- 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 - targeted synthetic, biologic or conventional synthetic) for:
- polymyalgia rheumatica
- systemic lupus erythematosus
- rheumatoid arthritis
People with end stage kidney disease (CKD 4 or 5)
People with primary immunodeficiency

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

We anticipate approximately 15,000 immunocompromised people will benefit from the shingles vaccine in the first two years as a result of this proposal and another 2000 people each year after this.

Any changes to the original proposal?

We received feedback from consumers, clinicians, advocacy groups, health sector stakeholders and suppliers. We want to thank everyone for their feedback. Overall we received supportive feedback on this proposal.

We did however receive a large number of requests for inclusion of further groups in the eligible population. These further groups have not been included in the eligible population at this time as we need to do further assessments on the requests.

In response to the feedback we have sought further clinical advice regarding the requested inclusions from the Immunisation Advisory Committee at its meeting in late March 2024. More detail on the requested changes and our response is found below in the response to consultation feedback.

In response to feedback received we have made some changes to the funding criteria for recombinant zoster vaccine from the original proposal:

To include both pre and post haematopoietic stem cell transplant (not or) and to include cellular therapy such as CAR-T cell recipients.
To clarify that targeted synthetic, biologic and conventional synthetic disease modifying anti-rheumatic drugs (DMARDs) are included in the criteria.

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 preventing and treating shingles
Pharmacies and wholesalers
Suppliers of vaccines

Details about this decision

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

Section I eligibility criteria

VARICELLA ZOSTER VACCINE [SHINGLES VACCINE]

a) Only on a prescription

b) No patient co-payment payable

A) Funded for patients meeting the following criteria:

1.~~Two doses for all people aged 65 years~~

Either:

Two doses for all people aged 65 years; or
Two doses for people 18 years of age or older with any of the following:

a. pre- or post-haematopoietic stem cell transplant; or
b. solid organ transplant; or
c. haematological malignancies; or
d, people living with poorly controlled HIV infection; or
e. planned or receiving disease modifying anti-rheumatic drugs (DMARDs) for polymyalgia rheumatica, systemic lupus erythematosus or rheumatoid arthritis; or
f. end stage kidney disease (CKD 4 or 5); or
g. primary immunodeficiency

B) Contractors will be entitled to claim payment from the Funder for the supply of Varicella zoster vaccine (Shingles vaccine) to patients eligible under the above criteria pursuant to their contract with Te Whatu Ora Health New Zealand for subsidised immunisation, and they may only do so in respect of the Varicella zoster vaccine [Shingles vaccine] listed in the Pharmaceutical Schedule.

C) Contractors may only claim for patient populations within the criteria that are covered by their contract, which may be a sub-set of the population described in paragraph A above.

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

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

Our response to what you told us

Theme	Pharmac comment
Supportive	We are pleased to be able to enable access to shingles vaccine for immunocompromised people.
Supportive, but requested further widened access for people aged over 65 years and a catch-up programme for people who missed immunisation at age 65 due to COVID-19 pandemic restrictions.	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. A number of these are on our Options for Investment list. This means we would like to fund them, subject to budget availability: 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) We are also seeking clinical advice or assessing other applications: People with rheumatological conditions treated with a JAK inhibitor or with rituximab(external link) Catch-up programme for people aged over 65 years, due to COVID-19 pandemic disruption(external link) All people over 65 years of age(external link) We are unable to progress funding for these applications at this time from our current available budget.
Request for people to be eligible for vaccination both pre and post haematopoietic stem cell transplant (re-vaccination)	We have amended the proposed eligibility criteria to enable vaccination both pre and post haematopoietic stem cell transplantation. We understand previously vaccinated people will likely require revaccination post transplantation as their previous immunity will be lost post-transplant..
Request to amend eligibility criteria to include those who have received cellular therapy such as CAR T-cell therapies	We have amended the eligibility criteria to include cellular therapies such as CAR T-cell therapy, as part of the criterion that includes pre- and post-haematopoietic stem cell transplant.
Request for multiple indications to be included in the immunocompromised eligibility criteria including (but not limited to): All people living with HIV over 40/50/65 years of age All people receiving high-dose prednisone for extended periods. Bullous disorders (including pemphigoid) Cutaneous lupus Dermatomyositis Eczema (atopic dermatitis) Giant cell arteritis Inflammatory bowel disease (IBD) Multiple sclerosis (MS) Mycosis fungoides Pemphigus Plaque psoriasis Psoriatic arthritis (PsA) Systemic sclerosis Vasculitis	We appreciate the feedback received on other possible inclusions in the immunocompromised criteria. We have not made any changes to include these groups in the criteria at this time. The immunocompromised groups included in the eligibility criteria have been identified based on available clinical evidence as having the same or greater risk of shingles infection as the currently eligible 65-year age group. More information about this is available in the Immunisation Advisory Committee November 2023 record(external link). There were many additional indications requested to be included in the eligibility criteria. The number of people in the requested groups is large and may have a significant budget impact. This means we need to do further assessment on the requested groups. We intend to assess all groups requested for inclusion and sought further clinical advice from the Immunisation Advisory Committee at its meeting in late March 2024. Consultation responses were considered by the Committee and the record of this meeting will be available on our website when published. This advice will inform assessment for this wider population for funding as per Pharmac’s standard process. Read more about Pharmac’s funding process.
The current proposed criterion of “people living with poorly controlled HIV infection” involves clinician judgment and interpretation of the criteria, and that specific measures to assess immunosuppression in people living with HIV may be more appropriate.	We appreciate the feedback and have not made any changes to the proposed criteria at this time. We appreciate the desire for absolute clarity regarding what ‘poorly controlled’ means. Our understanding is that treating clinicians will be able to assess the individual clinical circumstances and proceed with vaccination if appropriate.
Requests to specify the medicines considered in the immunosuppressed criteria (e.g specify a list of DMARD’s, systemic corticosteroids, biologics, JAK inhibitors).	We have amended the criteria to clarify that targeted synthetic (eg. JAK inhibitors), biologic, or conventional synthetic DMARDS are included in the criteria. The intent at this time is not to include corticosteroids. The immunocompromised groups included in the eligibility criteria have been identified, informed by available clinical evidence, as having the same or greater risk of shingles infection as the currently eligible 65-year age group. We intend to assess all groups requested for inclusion, including people receiving systemic corticosteroids, and sought further clinical advice from the Immunisation Advisory Committee at its meeting in late March 2024. Consultation responses were considered by the Committee and the record of this meeting will be available on our website when published. This advice will inform assessment for this wider population for funding as per Pharmac’s standard process. Read more about Pharmac’s funding process.
Request for pharmacists to be able to administer shingles vaccine to eligible immunocompromised people.	The Xpharm restriction was removed from shingles vaccine from 1 June 2023, so pharmacists can currently administer this vaccine to eligible people 50 years of age and over. The medicine classification for shingles vaccine would need to be amended before pharmacists could administer it to people under 50 years of age. We have shared this feedback with Health NZ.

Other contractual changes associated with this proposal

Umeclidinium with vilanterol

Umeclidinium/vilanterol (branded as Anoro Ellipta) is funded for COPD subject to eligibility criteria(external link). There will 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 will reduce via confidential rebate from 1 May 2024 and there will be subsidy and delisting protection for Anoro until 30 April 2027.

Dolutegravir

Dolutegravir (branded as Tivicay) is funded for the treatment of HIV subject to eligibility criteria(external link). There will 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 will reduce via confidential rebate from 1 May 2024 and there will be subsidy and delisting protection for Tivicay until 30 April 2027.

Lamotrigine

There will be no changes to the list price and subsidy for the 2 mg and 5 mg strengths of lamotrigine (branded as Lamictal). As part of the proposal, the net price for Lamictal will 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 will also reduce via confidential rebate.

If you have any questions about this decision, 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 660 050.