Proposal to fund treatments for cancer and asthma

16 December 2021

Medicines Consultation Closed

We are seeking feedback on a proposal to fund new treatments for lung cancer and severe refractory eosinophilic asthma, and widen access to a treatment for ovarian cancer.

On this page

What we’re proposing

We are seeking feedback on a proposal to fund new treatments for lung cancer and severe refractory eosinophilic asthma, as well as widen access to a treatment for ovarian cancer. As part of this proposal we would also amend the contractual arrangements for three currently funded treatments through a provisional agreement with AstraZeneca Pty Ltd. (AstraZeneca).

This proposal would result in the following changes:

New treatments:

Widened access:

From 1 August 2022, olaparib (brand name Lynparza) would be funded for the first line treatment of people with high-grade ovarian cancers with a mutation in breast cancer susceptibility gene 1 or 2 (BRCAm)(external link)

The agreement with AstraZeneca would also include amendments to the contractual arrangements for budesonide with eformoterol powder for inhalation (Symbicort Turbuhaler), fulvestrant (Faslodex) and gefitinib (Iressa). No changes would be made to the funding of these products, but the cost would reduce and these products would have protection from delisting and subsidy reduction until 31 March 2025.

Further details on this proposal, including how to provide feedback, can be found below.

We welcome your feedback on this proposal. Consultation closes at 5 pm on Friday 28 January 2022 and feedback can be emailed to consult@pharmac.govt.nz.

Durvalumab for non-small cell lung cancer

What would the effect be?

From 1 August 2022, durvalumab would be funded 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 subject to eligibility criteria.

Our clinical advisors have told us that evidence suggests that durvalumab offers substantial progression free and an expected overall survival benefit compared to currently available treatments and could be a potentially curative treatment for some patients.

We estimate that approximately 80 people would benefit in the first year increasing to up to 100 people each year, after a few years.

Who we think will be 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 with an interest in lung cancer and its treatment

About non-small cell lung cancer

There are two main types of lung cancer; NSCLC and small cell lung cancer (SCLC). NSCLC accounts for about 80% of all lung cancers. The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.

People with NSCLC typically have a poor quality of life and don’t live for as long. We understand that Māori and Pacific people have a higher rate of NSCLC, are diagnosed at a younger age and experience worse outcomes from NSCLC compared to non-Māori, non-Pacific people.

We estimate that approximately one third of people with NSCLC have Stage III disease at diagnosis. Staging describes where the cancer is located, if or where it has spread, and whether it is affecting other parts of the body. When lung cancer has been diagnosed at Stage III it has not spread to other parts of the body. In comparison, Stage IV lung cancer means that it has spread to other parts of the body.

Stage III lung cancers are defined as either stage IIIA, IIIB, or IIIC. For most stage IIIA and stage IIIB cancers, the tumour may be difficult or sometimes impossible to remove with surgery. Stage IIIC cancers cannot be removed with surgery.

We appreciate that there remains an unmet need for more effective treatment for people with Stage IV lung cancer. The progression of this proposal would not limit the progression of a proposal for the treatment of patients with Stage IV lung cancer.

About durvalumab

Durvalumab is a monoclonal antibody that blocks programmed-death ligand 1 (PD-L1) from binding to programmed death 1 (PD-1) and CD80 receptors on the cell membrane, enhancing T-cell anti-tumour immune responses.

Durvalumab is Medsafe approved for the treatment of people with:

locally advanced or metastatic urothelial carcinoma;
locally advanced, unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy;
extensive-stage small cell lung cancer (ES-SCLC) in combination with etoposide and either carboplatin or cisplatin

Durvalumab can be administered at a dose of 10 mg/kg every 2 weeks, or at a flat dose of 1500 mg every four weeks to reduce the treatment burden for people who need it and the requirement for fortnightly infusions.

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

Why we’re proposing this

A funding application for durvalumab for people with locally advanced, unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy was reviewed by:

Reducing barriers

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

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

We are proposing this approach to ensure there are no unnecessary barriers in access and so the people our advisors indicated would benefit from durvalumab would be able to access it.

Details about our proposal

Durvalumab (Imfinzi) would 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	120 mg per 2.4 ml	Imfinzi	1	$1128.00
Durvalumab	500 mg per 10 ml	Imfinzi	1	$4700.00
Durvalumab	Inj 1 mg for ECP	Baxter	1 mg	$9.59

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

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

Imfinzi would 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:

Patient has histologically or cytologically documented stage III, locally advanced, unresectable non-small cell lung cancer (NSCLC); and
Patient has received two or more cycles of platinum-based chemotherapy concurrently with definitive radiation therapy; and
Patient has no disease progression following the second or subsequent cycle of platinum-based chemotherapy with definitive radiation therapy treatment; and
Patient has a ECOG performance status of 0 or 1; and
Patient has completed last radiation dose within 8 weeks of starting treatment with durvalumab; and
Patient must not have received prior PD-1 or PD-L1 inhibitor therapy for this condition; and
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
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:

The treatment remains clinically appropriate and the patient is benefitting from treatment; and
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
Treatment with durvalumab to cease upon signs of disease progression; and
Total continuous treatment duration must not exceed 12 months.

Benralizumab for severe refractory eosinophilic asthma

What would the effect be?

Benralizumab would be listed for the treatment of people with severe refractory eosinophilic asthma subject to eligibility criteria. The timing of funding is subject to Medsafe approval of the prefilled pen presentation and no sooner than 1 April 2022.

Evidence suggests that treatment with benralizumab reduces the number of severe exacerbations and hospitalisations for people with severe eosinophilic asthma.

We estimate approximately 40 people would benefit in the first year increasing to up to approximately 110 patients each year, after five years.

Who we think will be 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 with an interest in the treatment of asthma

About severe eosinophilic asthma

Eosinophilic asthma is a type of severe asthma, characterised by high levels of white blood cells. In eosinophilic asthma, these white blood cells (called eosinophils) can cause swelling and inflammation in the airways and respiratory system resulting in symptoms like wheezing and trouble breathing. The higher the levels of eosinophils in the blood, the more severe the symptoms of asthma can be.

In April 2020, mepolizumab was funded for the treatment of people with severe refractory eosinophilic asthma.

About benralizumab

Benralizumab, like mepolizumab, targets a disease with a high unmet health need which particularly affects Māori and Pacific populations. Benralizumab is a monoclonal antibody that binds to the human interleukin-5 (IL-5) receptor, preventing IL-5 from binding to its target which results in a reduction in the number of eosinophils produced by the body.

Benralizumab is currently Medsafe approved as a solution for injection, to be used alongside other standard asthma treatments in patients aged 12 years and over with severe eosinophilic asthma.

Benralizumab can be self-administered as a 30 mg injection every four weeks for the first three doses and then every eight weeks.

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

Benralizumab would be funded in a prefilled pen presentation following any Medsafe approval of this presentation and no earlier than 1 April 2022.

Why we’re proposing this

A funding application for benralizumab as an add-on treatment for people with severe refractory eosinophilic asthma was reviewed by:

Previously mepolizumab was recommended for funding with a high priority by both the RAC and PTAC(external link)

Reducing barriers

This proposal would provide an additional option for people with severe refractory eosinophilic asthma, and would provide an option for people who are intolerant of or refractory to the other funded treatment for severe refractory eosinophilic asthma (mepolizumab). The funding of benralizumab could provide an additional benefit to Māori and Pacific people, who experience higher rates of and poorer outcomes from asthma.

Details about our proposal

Benralizumab (Fasenra) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule if 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	Fasenra	1	$3539.00

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

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

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:

Patient must be aged 12 years or older; and
Patient must have a diagnosis of severe eosinophilic asthma documented by a respiratory physician or clinical immunologist; and
Conditions that mimic asthma eg. vocal cord dysfunction, central airway obstruction, bronchiolitis etc. have been excluded; and
Patient has a blood eosinophil count of greater than 0.5 × 10ˆ9 cells/L in the last 12 months; and
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
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
Treatment is not to be used in combination with subsidised mepolizumab; and
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
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
  2. Discontinued within 3 months of commencing treatment with previous anti-IL5 biological therapy

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

Both:

An increase in the Asthma Control Test (ACT) score of at least 5 from baseline; and
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 would the effect be?

From 1 August 2022 olaparib would be funded for the first line maintenance treatment of people with high-grade serous ovarian cancers with a germline mutation in breast cancer susceptibility gene 1 or 2 (BRCAm).

Our clinical advisors have told us that evidence suggests that treatment with olaparib in this setting provides a significant progression-free survival benefit, and a likely overall survival benefit for people with ovarian, fallopian tube or primary peritoneal cancers.

In January 2020 olaparib was funded for the treatment of people with relapsed BRCAm ovarian, fallopian tube or primary peritoneal cancer.

We estimate that approximately 20 people would benefit in the first year. After five years we expect that most of the use of olaparib would be in the first line setting.

Who we think will be 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 with an interest in ovarian cancer and its treatment

About BRCAm high grade ovarian cancer

BRCA1 and BRCA2 are genes that produce proteins that help repair DNA. Many people inherit two functioning copies of each gene from their parents but in some cases, a person may inherit or develop a harmful variant of one of, or both of these genes which can be referred to as mutation in the BRCA gene. People with BRCA mutated ovarian cancers are more likely to develop or present with a higher grade cancer that is associated with a worse prognosis. People with BRCA gene mutations can also develop ovarian cancer at an earlier age and have an increased risk of other types of cancer such as breast cancer.

The majority of patients with ovarian cancer relapse following platinum-based chemotherapy and can experience a lower response rate to subsequent lines of treatment. Providing access to effective treatments in an earlier line is expected to improve the likelihood of response, providing people with greater benefit through increased time without disease and improved survival.

Ovarian cancer is associated with poor outcomes and high mortality. Māori and Pacific people experience higher incidence of ovarian cancer, with worse outcomes and higher mortality rates compared with non-Māori, non-Pacific people. However, it is uncertain if this applies to the same extent for Māori and Pacific people with BRCAm high grade serous ovarian cancers.

Funding olaparib earlier in the treatment of ovarian cancer may help reduce inequities for these people.

About olaparib

Olaparib is an inhibitor of human poly-(ADP-ribose) polymerase (PARP) enzymes. PARP is a protein that helps damaged cells to repair themselves. Olaparib stops PARP from repairing cells with DNA damage and the cancer cells die.

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. Prior treatment must have included at least 2 courses of platinum-based regimens.

The recommended dose of olaparib is 300 mg (two 150 mg tablets) taken twice daily, equivalent to a total daily dose of 600 mg. People with newly diagnosed advanced BRCAm ovarian cancers can continue first line maintenance treatment with olaparib until disease progression, or for a maximum of 2 years.

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

Why we’re proposing this

A funding application for olaparib for the treatment of people with newly diagnosed BRCAm ovarian, fallopian tube or primary peritoneal cancer, platinum sensitive was reviewed by:

Reducing barriers

We think this proposal to fund olaparib for patients earlier in the disease would reduce barriers to access and enable access to more effective treatment earlier in the disease course. This proposal could be expected to benefit Māori and Pacific people who experience higher incidence of ovarian cancer and mortality, compared with non-Māori, non-Pacific people.

Details about our proposal

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

Lynparza would 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 medical practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

Patient has a high-grade serous* epithelial ovarian, fallopian tube, or primary peritoneal cancer; and
There is documentation confirming pathogenic germline BRCA1 or BRCA2 gene mutation; and
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; andEither:
Treatment will be commenced within 8 weeks of the patient’s last dose of the immediately preceding platinum-based regimen; and
Treatment to be administered as maintenance treatment; and
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:

Treatment remains clinically appropriate and patient is benefitting from treatment; and
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
Treatment to be administered as maintenance treatment; and
Treatment not to be administered in combination with other chemotherapy; and
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 proposal

Budesonide with eformoterol powder for inhalation

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

As part of this proposal, the list price of the following strengths of budesonide with eformoterol would reduce from 1 August 2022 to the following prices and subsidies (ex-manufacturer, excluding GST):

Chemical	Formulation	Brand	Strength	Pack size	Price and subsidy
Budesonide with eformoterol	Powder for inhalation	Symbicort Turbuhaler	200 mcg budesonide with 6 mcg eformoterol per dose	120 dose (1 inhaler)	$33.74
Budesonide with eformoterol	Powder for inhalation	Symbicort Turbuhaler	400 mcg budesonide with 12 mcg eformoterol per dose	60 dose (1 Inhaler)	$33.74

Chemical

Formulation

Brand

Strength

Pack size

Price and subsidy

Budesonide with eformoterol

Powder for inhalation

Symbicort Turbuhaler

200 mcg budesonide with 6 mcg eformoterol per dose

120 dose

(1 inhaler)

$33.74

Budesonide with eformoterol

Powder for inhalation

Symbicort Turbuhaler

400 mcg budesonide with 12 mcg eformoterol per dose

60 dose

(1 Inhaler)

$33.74

The net price for the above strengths of budesonide with eformoterol would reduce via confidential rebate from 1 April 2022 and there would be protection from delisting and subsidy reduction until 31 March 2025.

There would be no other changes to Symbicort 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.

As part of this proposal, the net price for fulvestrant (Faslodex) would reduce via confidential rebate from 1 April 2022 and there would be protection from delisting and subsidy reduction until 31 March 2025.

There would be 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) would 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 Iressa would reduce via confidential rebate from 1 April 2022 and there would be protection from delisting and subsidy reduction until 31 March 2025.

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

To provide feedback

Send us an email: consult@pharmac.govt.nz by 5pm on Friday 28 January 2022.

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