Decision to fund treatments for cancer and asthma

Medicines Decision

What we’re doing

We are pleased to announce a decision to fund new treatments for cancer and asthma.  We will also be amending the pricing and exclusivity arrangements for three currently funded treatments through an agreement with AstraZeneca Pty Ltd. (AstraZeneca).

What this decision means

New listings

Widening of access

The agreement with AstraZeneca includes amendments to the contractual arrangements for budesonide with eformoterol powder for inhalation (Symbicort Turbuhaler), fulvestrant (Faslodex) and gefitinib (Iressa). These products will remain fully funded, but the price to the funder will change and these products will have protection from delisting and subsidy reduction until 31 March 2025.

Durvalumab for stage III non-small cell lung cancer

What does this mean for people?

Durvalumab will be funded subject to eligibility criteria from 1 August 2022, for maintenance treatment (for up to 12 months) of people with locally advanced (Stage III), unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy. Durvalumab targets a disease with a high unmet need, which particularly affects Māori and Pacific populations.

We estimate that approximately 80-100 people will benefit from this treatment each year.

Who we think will be most interested

  • People with lung cancer and their whānau, and caregivers
  • Oncologists, specialist nurses, and other health professionals involved in the care of people with lung cancer
  • Hospital and community pharmacists, DHBs and wholesalers
  • Pharmaceutical suppliers
  • Other organisations/groups with an interest in lung cancer and its treatment

About durvalumab

Durvalumab can be administered at a dose of 10 mg/kg every 2 weeks, or a flat dose of 1500 mg every four weeks. Administering every four weeks reduces the treatment burden for those who find accessing treatment administration services difficult. Detailed information about durvalumab dosing and administration can be found in the Medsafe datasheet(external link).

Reducing barriers

We are funding durvalumab for all people with locally advanced, unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy:

  • irrespective of PD-L1 expression
  • enabling the ability to commence treatment 8 weeks rather than 6 weeks after prior radiation therapy to allow flexibility for patients and clinicians
  • enabling a flat dose of 1500 mg every 4 weeks to help reduce the treatment burden for those who may find it difficult to access administration services fortnightly

We work hard to enable access for people with the highest health need, expected to achieve the most benefit, and reduce barriers where possible.

Remaining unmet need for lung cancer

We appreciate that an unmet need remains for effective treatment for people with Stage IV lung cancer, and that this decision will enable treatment of a fraction of people with NSCLC.

Funding of durvalumab for locally advanced (stage III), unresectable NSCLC will not prevent the progression of a proposal for the treatment of patients with Stage IV lung cancer. We have assessed and continue to consider the use of immunotherapy for people with Stage IV NSCLC as an option for investment(external link).

Any changes to the proposal

This decision was subject to a consultation letter dated 16 December 2021. There have been no changes as a result of consultation feedback. All consultation feedback received has been summarised at the end of this notification letter.

Details about this decision

Durvalumab (Imfinzi) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 August 2022 at the following prices and subsidies (ex-manufacturer, excluding GST):

Chemical

Formulation

Brand

Pack size

Price and subsidy

Durvalumab

Inj 50 mg per ml, 2.4 vial

Imfinzi

1

$1128.00

Durvalumab

Inj 50 mg per ml, 10 ml vial

Imfinzi

1

$4700.00

Durvalumab

Inj 1 mg for ECP

Baxter

1 mg

$9.59

A confidential rebate will apply to durvalumab (Imfinzi) that will reduce the net price to the Funder. Imfinzi will have protection from delisting and subsidy reduction until 31 July 2025.

Imfinzi will be listed as a PCT only - Specialist pharmaceutical in Section B of the Pharmaceutical Schedule, meaning that only DHB hospitals will be able to make a subsidy claim.

Imfinzi will be listed in Section B and Part II of Section H subject to the following eligibility criteria:

Special Authority for Subsidy

Initial application – only from a medical oncologist or on the recommendation of a medical oncologist. Approvals valid for 3 months for applications meeting the following criteria:

All of the following:

  1. Patient has histologically or cytologically documented stage III, locally advanced, unresectable non-small cell lung cancer (NSCLC); and
  2. Patient has received two or more cycles of platinum-based chemotherapy concurrently with definitive radiation therapy; and
  3. Patient has no disease progression following the second or subsequent cycle of platinum-based chemotherapy with definitive radiation therapy treatment; and
  4. Patient has a ECOG performance status of 0 or 1; and
  5. Patient has completed last radiation dose within 8 weeks of starting treatment with durvalumab; and
  6. Patient must not have received prior PD-1 or PD-L1 inhibitor therapy for this condition; and
  7. Either
    1. Durvalumab is to be used at a maximum dose of no greater than 10 mg/kg every 2 weeks; or
    2. Durvalumab is to be used at a flat dose of 1500 mg every 4 weeks; and
  8. Treatment with durvalumab to cease upon signs of disease progression. 

Renewal – only from a medical oncologist or on the recommendation of a medical oncologist. Approvals valid for 3 months for applications meeting the following criteria:

All of the following:

  1. The treatment remains clinically appropriate and the patient is benefitting from treatment; and
  2. Either:
    1. Durvalumab is to be used at a maximum dose of no greater than 10 mg/kg every 2 weeks; or
    2. Durvalumab is to be used at a flat dose of 1500 mg every 4 weeks; and
  3. Treatment with durvalumab to cease upon signs of disease progression; and
  4. Total continuous treatment duration must not exceed 12 months.

Benralizumab for severe refractory eosinophilic asthma

What does this mean for people?

Benralizumab will be listed for the treatment of people with severe refractory eosinophilic asthma subject to eligibility criteria. Funding is subject to Medsafe approval of the prefilled pen presentation. Benralizumab, targets a disease which particularly affects Māori and Pacific populations.

We estimate approximately 50 people will benefit in the first full year of funding, increasing to up to approximately 140 patients each year after five years.

Who we think will be most interested

  • People with severe eosinophilic asthma and their whānau and caregivers
  • Respiratory physicians, respiratory nurses, clinical immunologists, and other clinicians involved in the management of severe eosinophilic asthma
  • Hospital and community pharmacists, DHBs and wholesalers
  • Pharmaceutical suppliers
  • Other organisations/groups with an interest in the treatment of asthma

About benralizumab

Benralizumab comes in a prefilled pen presentation, which is not yet Medsafe approved (other presentations are Medsafe approved). The prefilled pen can be self-administered and will be funded should it receive Medsafe approval. The first three doses are administered every four weeks and then doses are administered every eight weeks. Detailed information about benralizumab dosing and administration can be found in the Medsafe datasheet(external link).

Reducing barriers

This proposal will provide an additional option for people with severe refractory eosinophilic asthma, and will provide an option for people who are intolerant of, or refractory, to the other funded treatment for severe refractory eosinophilic asthma (mepolizumab).

Any changes to the proposal

This decision was subject to a consultation letter dated 16 December 2021. Following consultation feedback, we have extended the timeframe to confirm intolerance or lack of response to prior anti-IL5 therapy. This now aligns better with clinical practice and the approval period for prior anti-IL5 therapy.

All consultation feedback received has been summarised at the end of this notification letter.

Details about this decision

Benralizumab (Fasenra) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule once Medsafe approval is granted for the prefilled pen presentation at the following prices and subsidies (ex-manufacturer, excluding GST):

Chemical

Formulation

Brand

Pack size

Price and subsidy

Benralizumab

Inj 30 mg per ml, 1 ml prefilled pen

Fasenra

1

$3,539.00

A confidential rebate will apply to benralizumab (Fasenra) that will reduce the net price to the Funder. Fasenra will have protection from delisting and subsidy reduction until 31 March 2025.

Fasenra will be listed in Section B and Part II of Section H subject to the following eligibility criteria (changes in response to consultation shown – additions in bold and deletions in strikethrough):

Special Authority for Subsidy

Initial application — (Severe eosinophilic asthma) only from a respiratory physician or clinical immunologist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

  1. Patient must be aged 12 years or older; and
  2. Patient must have a diagnosis of severe eosinophilic asthma documented by a respiratory physician or clinical immunologist; and
  3. Conditions that mimic asthma eg. vocal cord dysfunction, central airway obstruction, bronchiolitis etc. have been excluded; and
  4. Patient has a blood eosinophil count of greater than 0.5 × 10ˆ9 cells/L in the last 12 months; and
  5. Patient must be adherent to optimised asthma therapy including inhaled corticosteroids (equivalent to at least 1000 mcg per day of fluticasone propionate) plus long-acting beta-2 agonist, or budesonide/formoterol as part of the anti-inflammatory reliever therapy plus maintenance regimen, unless contraindicated or not tolerated; and
  6. Either:
    1. Patient has had at least 4 exacerbations needing systemic corticosteroids in the previous 12 months, where an exacerbation is defined as either documented use of oral corticosteroids for at least 3 days or parenteral corticosteroids; or
    2. Patient has received continuous oral corticosteroids of at least the equivalent of 10 mg per day over the previous 3 months; and
  7. Treatment is not to be used in combination with subsidised mepolizumab; and
  8. Patient has an Asthma Control Test (ACT) score of 10 or less. Baseline measurements of the patient’s asthma control using the ACT and oral corticosteroid dose must be made at the time of application, and again at around 52 weeks after the first dose to assess response to treatment; and
  9. Either
    1. Patient has not previously received an anti-IL5 biological therapy for their severe eosinophilic asthma; or
    2. Both:
      1. Patient was refractory or intolerant to previous anti-IL5 biological therapy; and
        9.2.2  Discontinued within 3 months of commencing treatment with previous anti-IL5 biological therapy
      2. Patient was not eligible to continue treatment with previous anti-IL5 biological therapy and discontinued within 12 months of commencing treatment

Renewal — (Severe eosinophilic asthma) only from a respiratory physician or clinical immunologist. Approvals valid for 2 years for applications meeting the following criteria:

Both:

  1. An increase in the Asthma Control Test (ACT) score of at least 5 from baseline; and
  2. Either:
    1. Exacerbations have been reduced from baseline by 50% as a result of treatment with benralizumab; or
    2. Reduction in continuous oral corticosteroid use by 50% or by 10 mg/day while maintaining or improving asthma control.

Olaparib for the first line treatment of high-grade ovarian cancers

What does this mean for people?

Access to olaparib will be widened to include first line maintenance treatment for people with high-grade serous ovarian cancers with a germline mutation in breast cancer susceptibility gene 1 or 2 (BRCAm).

We estimate that approximately 20 additional people will benefit from earlier, first-line treatment with olaparib in the first year. After five years we expect that most of the use of olaparib will be in this first line setting.

Who we think will be most interested

  • People with ovarian cancer and their whānau and caregivers
  • Oncologists, specialist nurses, and other health professionals involved in the care of people with ovarian cancer
  • Hospital and community pharmacists, DHBs and wholesalers
  • Pharmaceutical suppliers
  • Other organisations/groups with an interest in ovarian cancer and its treatment

About olaparib

Olaparib is Medsafe approved as monotherapy for the:

  • maintenance treatment of adult patients with newly diagnosed advanced BRCAm high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to first-line platinum-based chemotherapy; and 
  • maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) after platinum-based chemotherapy.

Olaparib is currently funded for the treatment of adult patients with platinum-sensitive BRCAm relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) after platinum-based chemotherapy(external link)

Detailed information about olaparib dosing and administration can be found in the Medsafe datasheet(external link).

Reducing barriers

Funding olaparib for patients earlier in their disease is expected to reduce barriers to access and enable access to an effective treatment earlier in the disease course.

Any changes to the proposal

This decision was subject to a consultation letter dated 16 December 2021. Following consultation feedback, we have extended the timeframe to commence olaparib after platinum-based chemotherapy from 8 weeks to 12 weeks to reduce barriers that may present in access to olaparib.

This extension is expected to extend the timeframe to establish germline BRCA mutation status acknowledging the current capacity constraints impacting timely genetic testing results. However, if people are unable to initiate treatment within 12 weeks of prior platinum-based chemotherapy due to unexpected delays in confirming BRCA mutation status we would be happy to consider a Special Authority waiver application. Details on how to submit a Special Authority waiver application are available on our website.

All consultation feedback received has been summarised at the end of this notification letter.

Details about this decision

Access to olaparib (Lynparza) will be widened in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 August 2022 at the following prices and subsidies (ex-manufacturer, excluding GST):

Chemical

Formulation

Brand

Pack size

Price and subsidy

Olaparib

Tab 100 mg

Lynparza

56

$3701.00

Olaparib

Tab 150 mg

Lynparza

56

$3701.00

A confidential rebate will apply to olaparib (Lynparza) that will reduce the net price to the Funder. Lynparza will have protection from delisting and subsidy reduction until 31 July 2025.

Lynparza will be listed in Section B and Part II of Section H subject to the following eligibility criteria (changes in response to consultation shown – additions in bold and deletions in strikethrough):

Special Authority for Subsidy

Initial application - only from a medical oncologist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

  1. Patient has a high-grade serous* epithelial ovarian, fallopian tube, or primary peritoneal cancer; and
  2. There is documentation confirming pathogenic germline BRCA1 or BRCA2 gene mutation; and
  3. Either:
    1. All of the following:
      1. Patient has newly diagnosed, advanced disease; and
      2. Patient has received one line of previous treatment with platinum-based chemotherapy; and
      3. Patient’s disease must have experienced a partial or complete response to the first-line platinum-based regimen; or
    2. All of the following:
      1. Patient has received at least two lines of previous treatment with platinum-based chemotherapy; and
      2. Patient has platinum sensitive disease defined as disease progression occurring at least 6 months after the last dose of the penultimate line of platinum-based chemotherapy; and
      3. Patient’s disease must have experienced a partial or complete response to treatment with the immediately preceding platinum-based regimen; and
      4. Patient has not previously received funded olaparib treatment; and
  1. Treatment will be commenced within 8 12 weeks of the patient’s last dose of the immediately preceding platinum-based regimen; and
  2. Treatment to be administered as maintenance treatment; and
  3. Treatment not to be administered in combination with other chemotherapy. 

Renewal - only from a medical oncologist or medical practitioner on the recommendation of a medical oncologist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

  1. Treatment remains clinically appropriate and patient is benefitting from treatment; and
  2. Either:
    1. No evidence of progressive disease; or
    2. Evidence of residual (not progressive) disease and the patient would continue to benefit from treatment in the clinician’s opinion; and
  3. Treatment to be administered as maintenance treatment; and
  4. Treatment not to be administered in combination with other chemotherapy; and
  5. Either:
    1. Both:
      1. Patient has received one line of previous treatment with platinum-based chemotherapy; and
      2. Documentation confirming that the patient has been informed and acknowledges that the funded treatment period of olaparib will not be continued beyond 2 years if the patient experiences a complete response to treatment and there is no radiological evidence of disease at 2 years; or
    2. Patient has received at least two lines of previous treatment with platinum-based chemotherapy.

Note: *Note “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.

Other changes associated with this decision

Budesonide with eformoterol powder for inhalation

Budesonide with eformoterol dry powder inhalers are funded without restriction. They are used to relieve and/or control symptoms in people with asthma and chronic obstructive pulmonary disease (COPD).

The list price of the following strengths of budesonide with eformoterol will reduce from 1 August 2022 to the following prices and subsidies (ex-manufacturer, excluding GST): 

Chemical

Formulation

Brand

Pack size

Price and subsidy

Budesonide with eformoterol

Powder for inhalation 200 mcg budesonide with 6 mcg eformoterol per dose

Symbicort Turbuhaler

120 dose OP

(1 inhaler)

$33.74

Budesonide with eformoterol

Powder for inhalation 400 mcg budesonide with 12 mcg eformoterol per dose

Symbicort Turbuhaler

60 dose OP

(1 Inhaler)

$33.74

The net price for the above strengths and formulations of budesonide with eformoterol (Symbicort Turbuhaler) will also reduce via confidential rebate from 1 April 2022. There will be protection from delisting and subsidy reduction until 31 March 2025.

There are no other changes to Symbicort Turbuhaler listings as part of this proposal. 

Fulvestrant

Fulvestrant is funded for people with locally advanced or metastatic oestrogen-receptor positive breast cancer whose disease has progressed following previous treatment.

The net price for fulvestrant (Faslodex) will reduce via confidential rebate from 1 April 2022 and there will be protection from delisting and subsidy reduction until 31 March 2025.

There are no changes to the current eligibility criteria for Faslodex as part of this proposal. 

Gefitinib

Gefitinib is funded for the first-line treatment people with advanced or metastatic NSCLC with activating epithelial growth factor receptor (EGFR) tyrosine kinase mutations.

As part of this proposal, the list price of gefitinib (Iressa) will reduce from 1 August 2022 to the following price and subsidy (ex-manufacturer, excluding GST): 

Chemical

Formulation

Brand

Pack size

Price and subsidy

Gefitinib

Tab 250 mg

Iressa

30

$918.00

The net price for gefitinib (Iressa) will reduce via confidential rebate from 1 April 2022 and there will be protection from delisting and subsidy reduction until 31 March 2025.

There are no changes to the current eligibility criteria for Iressa as part of this proposal.

Our response to what you told us

We’re really grateful for the time people took to respond to consultation. A summary of the main themes raised in feedback and our responses to the feedback received are set out below. 

Theme

Comment

Responders were supportive of this proposal, highlighting that:

  • a funding date of 1 August 2022 for immunotherapy for Stage III lung cancer could have some capacity planning benefits for the sector
  • supportive of flexibility in dosing to reduce the burden on people with lung cancer, whānau and the health system
  • durvalumab offers improved progression free survival, and an expected overall survival benefit
  • health outcomes in New Zealand are currently far worse than many comparable countries and this represents a step to improving the care of people with NSCLC
  • alignment of the criteria with that of mepolizumab, in particular, the requirement for an eosinophil count greater than 500 cells/ul
  • funding benralizumab will help to further reduce the burden of disease for those with severe asthma who represent a large percentage of hospital admissions and prednisone prescriptions for asthma nationally

Pharmac is pleased to be funding a proposal that will improve the health outcomes of New Zealanders.

Patients who have commenced self-funded treatment prior to the list date should be able to switch to publicly funded treatment for the remainder of their treatment course.

Where it can be demonstrated that the initial funding criteria were met prior to commencing self-funded treatment and that any relevant renewal criteria are currently met, patients would be eligible to access funded treatment.

An individual application will need to be made by the treating clinician via a Special Authority waiver(external link) application. These can be made from the date of funding onwards.

Durvalumab

There may be some patients who may not be able to proceed with two cycles of chemotherapy due to toxicity and consider it would be appropriate for patients who experienced significant toxicity after the first cycle to still be eligible for durvalumab.

We consider it important that these patients remain eligible for treatment with durvalumab, however the definitive radiation component of their treatment would need to have been completed. We consider that instances such as these would best be managed via Pharmac’s exceptional circumstances framework. An individual application would need to be made by the treating clinician via a Special Authority waiver(external link) application.

The funding of durvalumab will add to the already competing demands for infusion services.

We acknowledge that this proposal to fund durvalumab will increase demand for infusion services. However, we note that treatment is for a finite duration and expected to be for less than 100 patients per year. Furthermore, it will be listed from 1 August 2022, which we hope will provide sufficient time for the sector to prepare for any unexpected impact on resource demands.

Considered that the impact of the funding of durvalumab on Māori and Pacific peoples could have been clearer and that this made an equity assessment of the proposal difficult.

 

 

We note that there are a range of factors relating to medicines access equity that are outside of the direct control of Pharmac. Those things that are in our control, when we are also considering managing a fixed pharmaceutical budget, have been considered and addressed by enabling a more permissive dosing regimen for durvalumab and by removing any requirement for PD-L1 expression testing.

We consider that the proportion of patients that we expect to be eligible for this treatment would be suitably represented by Māori and Pacific ethnicities as has been inferred from the Te Aho o Te Kahu lung cancer quality improvement monitoring report(external link), and a recent study (Lawrenson et al. N Z J Med. 2018;131(1479):13-23(external link)).  

However, we know the journey for any patient is variable and influenced by many factors, therefore we will endeavour to monitor uptake of this medicine and would intend to revisit the criteria should there be any unexpected uptake of this medicine and share this information with Te Aho o Te Kahu. We will use this information to inform on future funding decisions for lung cancer, as we work to ensure that this and other proposals are pro-equity.

Concern regarding the funding of an immunotherapy for a small subsection of lung cancer.

Considered that the evidence would support a wider role for durvalumab than contained within this proposal, with very good evidence for immunotherapies for wider indications including in stage 4 disease. However, noted that the proposed special authority criteria are reasonable within the proposed indication.

We note that this application is positioned earlier in the treatment paradigm than applications for other PD-1/PD-L1 inhibitors for advanced NSCLC.

We appreciate that there remains a significant unmet need for patients with stage IV NSCLC and that this proposal will result in treatment for a small number of patients with NSCLC.

The funding of this proposal will not limit the progression of a proposal for the treatment of patients with stage IV NSCLC. We have received multiple applications for this indication and have ranked these proposals as Options for Investment(external link). We appreciate that an unmet need remains for effective treatment for people with Stage IV lung cancer, and that this decision will enable treatment of a fraction of people with NSCLC. Funding of durvalumab for locally advanced (stage III), unresectable NSCLC will not prevent the progression of a proposal for the treatment of the large group of patients with Stage IV lung cancer.

Benralizumab

Considers it appropriate to have one common anti-IL-5 Special Authority form for access to both mepolizumab and to benralizumab

We intend to explore the possibility of harmonising the criteria for these treatments.

Widening access:

  • for people with blood eosinophil count of greater 0.3x10^9 cells/L; and
  • removal of the requirement for ACT to confirm eligibility and ongoing access.

The Special Authority criteria relating to these requests are in line with the clinical advice [PDF, 397 KB] that has been received previously.

Pharmac staff note that the Respiratory Subcommittee recommended that access to anti-IL5 therapy be widened to include those patients with a blood eosinophil count greater than 0.3x10^9 cells/L with a high priority in October 2020 [PDF, 661 KB]. This application to widen access has been ranked as an Option for Investment(external link)

In addition, in October 2020 [PDF, 661 KB] the Respiratory Subcommittee recommended that the ACT criterion be removed from the Special Authority criteria for anti-IL5 treatments with a medium priority. This application to widen access has also been ranked as an Option for Investment(external link).

Widened access (both blood eosinophil count and ACT score) to both benralizumab and mepolizumab cannot be progressed at this time as part of this proposal, but both remain as possible future Options for Investment.

Concern regarding the requirement for a patient to have discontinued treatment within 3 months of commencing treatment with previous anti-IL5 biological therapy, as most doctors would give a trial of more than 3 months before identifying that mepolizumab was not effective.

Pharmac staff note this concern and consider that the intent of the criteria is to ensure that waning efficacy would not be a rationale for switching but rather intolerance and/or lack of response. However, the intent of the eligibility criteria is to ensure that the decision to remain on therapy is based on a clinical decision regarding response to and tolerance of prior treatment.

The proposed criteria have thus been amended to enable patients to switch at the end of the initial approval period for prior anti-IL-5 therapy (after 12 months).

Olaparib

Concern regarding equitable access to timely genetic testing across the country which would be exacerbated by the widening of access to olaparib.

Provision of a rapid access clinic for all advanced high grade serous ovarian cancer patients referred to the service will be supported by the supplier (Astra Zeneca) over the next 12 months as short-term assistance to manage the expected increase in testing requirements for this patient group. In addition, implementation of mainstreaming within all DHBs is being explored as a potential solution by the supplier and Genetics Health Services NZ as a longer-term solution.

We have and will continue to engage with both Genetics Health Services NZ and Te Aho o Te Kahu to ensure that there is sufficient capacity and resource to ensure equitable access to olaparib for New Zealanders.

We have amended the criteria to enable a longer timeframe to access appropriate testing. Furthermore, we will consider applications for patients via the Special Authority waiver mechanism for people who are unable to start within the required 12 week period following platinum-based chemotherapy due to unexpected delayed access to genetic testing results.  

We will endeavour to monitor uptake of this medicine and would revisit the eligibility criteria should there be any unexpected uptake of this medicine. We will also use this information to inform on future funding decisions for proposals that require germline testing and how to ensure that this and other proposals are pro-equity.

There is good evidence for patients without a germline BRCA mutation deriving benefit from PARP inhibition. These patients continue to miss out and there remains an unmet clinical need here.

Pharmac has not received an application for olaparib funding in any population other than those patients with a germline BRCA mutation. We would encourage an application for the broader use of olaparib, should there be evidence supporting benefit for the wider group than that included in this proposal.

The eligibility criteria are in line with the clinical advice we have received from CaTSoP. CaTSoP considered that while it was likely that the clinical utility of PARP inhibitor treatment in ovarian cancer patients with somatic mutations would be similar to those with germline, at the time of review there was insufficient evidence to support the use of olaparib for ovarian cancer patients with somatic BRCA mutation. Further details on the clinical advice we have received is available on the application tracker(external link).

An application for another PARP inhibitor (niraparib) for use in both those with and without germline BRCA mutations has been received and considered by Pharmac. Niraparib has received positive recommendations (Medium priority for funding) from the Cancer Treatments Advisory Committee in the first and second line maintenance settings irrespective of mutation status. The next step in our funding process is to rank the application on our options for investment list.(external link)

The funding of olaparib for patients with a germline BRCA mutation would not prevent or limit the funding of a PARP inhibitor where there is evidence supporting its use irrespective of mutation status.

Other aspects of the proposal

Considered that this proposal could have a detrimental impact on wholesalers with the change in list price(s)

A price support provision has been included in the contract for the products for which there is a change in list price.

Support for a procurement process for:

  • Fulvestrant
  • Gefitinib
  • Budesonide with eformoterol dry powder inhalers 

Noted the lack of generic interest in the New Zealand market and that the proposed period of subsidy and delisting protection until 31 March 2025 would disincentivise generic entry for these markets.

We note the subsidy and delisting protection period of these products as part of this multiproduct proposal and the intention to compete these markets at a time that is appropriate.

We carefully consider the available options when making decisions. When making our decision, we considered this proposal would support New Zealanders in achieving the best health outcomes. This decision does not mean we would not consider a competitive procurement process in future.

For budesonide with eformoterol, we have issued a contract awarded notice on Government Electronic Tenders Service (GETS). This notification forms part of our communication regarding a contract award.

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.