Proposal to fund treatments for cancer and asthma

Medicines Consultation Closes 28 Jan

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:

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 Tuesday 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:

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:

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:

 

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

Both:

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:

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:

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

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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