Proposal to fund two new cancer treatments: olaparib and fulvestrant

1 September 2019

Medicines Consultation Closed

We are seeking feedback on a proposal to fund two new cancer treatments and amend the contractual arrangements to one currently funded treatment through a provisional agreement with AstraZeneca Pty Ltd.

A decision has been made

Read PHARMAC's decision to fund two new cancer treatments: olaparib and fulvestrant – published 5 December 2019

What we’re proposing

In summary, this proposal would result in the funding of two new treatments for cancer as follows:

Further details of the proposal for these two treatments, including how to provide feedback and background information, can be found below.

The agreement with AstraZeneca would also include an amendment to the contractual arrangements for gefitinib (Iressa), which is currently funded for EGFR positive advanced lung cancer. No changes would be made to the funding of Iressa, but the net price would reduce via a confidential rebate and Iressa would have subsidy and delisting protection until 31 January 2023. This component of the proposal is not discussed further below as there would be no changes for patients or prescribers and there would be no changes to the listing of Iressa in the Pharmaceutical Schedule.

Consultation closes at 5 pm on Monday, 16 September 2019 and feedback can be emailed to consult@pharmac.govt.nz.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 5pm, 16 September 2019.

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

Feedback we receive is subject to the Official Information Act 1982 (OIA). Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.

Olaparib (Lynparza) for BRCA-mutated relapsed ovarian cancer

What would the effect be?

Olaparib (Lynparza) would be funded for the treatment of BRCA-mutated platinum-sensitive relapsed ovarian, fallopian tube or primary peritoneal cancer with high-grade serous features or a high-grade serous component.

Our clinical advice is that olaparib increases the interval between disease relapses, delaying the time to subsequent rounds of chemotherapy without a reduction in quality of life.

We estimate that 15%-17% of patients with high-grade serous ovarian cancer would have a germline BRCA mutation. We estimate that around 30-40 patients per year would be eligible for treatment under the proposed criteria.

There would be an increase in genetic testing and counselling services, to provide testing for BRCA mutations to determine eligibility for funded olaparib and to support patients and affected families. Clinical advice indicates that up to 300 patients per year would require testing for BRCA mutations.

Olaparib is an orally administered treatment, so there may be a reduction in compounding and infusion service requirements associated with current treatments for this patient group if this proposal was progressed.

Who we think will be interested

People who have or may develop ovarian cancer and their whānau
Oncologists
Community and hospital pharmacies
DHBs and genetic testing service providers
Organisations with an interest in cancer treatment

About olaparib and BRCA mutated ovarian cancer

Olaparib is an inhibitor of human poly-(ADP-ribose) polymerase (PARP) enzymes. PARP is a protein that helps damaged cells to repair themselves. In the BRCA mutated setting, 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 patients with platinum-sensitive relapsed BRCA-mutated (germline or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial response) after platinum-based chemotherapy.

Olaparib is currently available in capsule form. A tablet presentation is also registered and would be made available in the coming months.

The majority of patients with ovarian cancers are diagnosed with advanced disease. People with BRCA-mutated ovarian cancers are more likely to be of higher grade (usually worse prognosis). Women with BRCA gene mutations typically develop ovarian cancer at an earlier age and have an increased risk of ovarian and breast cancer. The majority of patients with ovarian cancer relapse following platinum-based chemotherapy and have a lower response rate to each subsequent line of platinum-based chemotherapy treatment.

Pacific and Māori women experience higher incidence of ovarian cancer and mortality, compared with non-Māori, non-Pacific women.

Information regarding olaparib dosing and administration can be found in the Medsafe datasheet(external link).

Why we're proposing this

A funding application for olaparib treatment of BRCA-mutated platinum-sensitive relapsed ovarian, fallopian tube, or primary peritoneal cancer with high-grade serous features or a high-grade serous component was considered by the Pharmacology and Therapeutics Advisory Committee (PTAC) in May 2017 and November 2018 and the Cancer Treatments Subcommittee of PTAC (CaTSoP) in April 2018 and April 2019.

PTAC recommended olaparib for funding with medium priority and CaTSoP recommended funding with a high priority for patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer, subject to certain clinical criteria being met.

More information including links to the PTAC and Subcommittee minutes can be found in the Application Tracker record for Olaparib for relapsed, BRCA mutated, platinum-sensitive ovarian cancer(external link).

Details about our proposal

Olaparib would be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 February 2020 at the following price (ex-manufacturer, excluding GST):

Chemical	Formulation	Brand	Pack size	Proposed price and subsidy
Olaparib	Cap 50 mg	Lynparza	448	$7,402.00
Olaparib	Tab 100 mg	Lynparza	56	$3,701.00
Olaparib	Tab 150 mg	Lynparza	56	$3,701.00

A confidential rebate would apply to Lynparza that would reduce the net price to the Funder.

Olaparib would be listed in Section B of the Pharmaceutical Schedule subject to the following Special Authority criteria:

Special Authority for Subsidy – Retail Pharmacy - Specialist

Initial application - 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:

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
Patient has received at least two lines of previous treatment with platinum-based chemotherapy; and
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
Patient’s disease must have achieved partial or complete response to treatment with the immediately preceding platinum-based regimen; and
Patient’s disease has not progressed following prior treatment with olaparib; and
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
No evidence of progressive disease; and
Treatment to be administered as maintenance treatment; and
Treatment not to be administered in combination with other chemotherapy.

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

The same restrictions would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML).

Lynparza would have protection from delisting and subsidy reduction until 31 January 2023.

Fulvestrant (Faslodex) for locally advanced or metastatic oestrogen-receptor positive advanced breast cancer

What would the effect be?

Fulvestrant (Faslodex) would be funded for post-menopausal (either naturally or induced) women with locally advanced or metastatic (advanced) oestrogen-receptor positive breast cancer whose disease has progressed following previous treatment with either an aromatase inhibitor (letrozole, anastrozole, exemestane) or tamoxifen.

Treatment with fulvestrant would provide another line of hormonal treatment that would extend the time patients respond to hormonal therapy, delay the time to disease progression and delay the need for treatment with chemotherapy. There is also a reduced risk of venous thromboembolism with use of fulvestrant as compared with tamoxifen.

We estimate that up to 1750 patients in the first year, and up to 630 patients per year in subsequent years, would be eligible to receive treatment with fulvestrant.

Fulvestrant is a monthly intramuscular injection. Patients would likely need to have this treatment administered by a healthcare professional.

Who we think will be interested

People who have or may develop breast cancer and their whānau
Oncologists
Community and hospital pharmacies
DHBs
Organisations with an interest in cancer treatment

About fulvestrant and oestrogen-receptor positive advanced breast cancer

Fulvestrant is an antioestrogen that stops oestrogen getting to the cancer cells by blocking oestrogen receptors and reducing the number of receptors the cancer cells have. This slows or stops the growth of breast cancer cells.

There is currently no Medsafe approved fulvestrant product currently available in New Zealand; however, Faslodex has previously held provisional Medsafe approval (now lapsed) for a 250 mg monthly dose. Updated published evidence (see below) indicates that a 500 mg monthly dose is more effective. Listing is proposed as soon as practicable following Medsafe approval.

The currently recommended dose of fulvestrant is 500 mg monthly (based on the CONFIRM(external link) and FALCON(external link) studies), administered as an intramuscular injection. Our clinical advice indicates that this would likely be administered by a healthcare professional.

Around 1800 people are diagnosed with hormone-receptor positive breast cancer each year, the majority of which is oestrogen-receptor positive. The incidence of breast cancer is higher in Māori as compared to non-Māori; and there are significant ethnic disparities in survival with poorer outcomes for Māori and Pacific peoples than other ethnic groups.

Information regarding fulvestrant dosing and administration can be found in the Australian TGA datasheet(external link). A New Zealand datasheet would be available following any Medsafe approval.

Why we're proposing this

A funding application for fulvestrant for the treatment of locally advanced or metastatic breast cancer has been considered by both the Pharmacology and Therapeutics Advisory Committee (PTAC) and the Cancer Treatments Subcommittee of PTAC (CaTSoP) on a number of occasions, most recently in February 2019 and September 2018 respectively.

PTAC and CaTSoP recommended funding with medium priority as a second or third-line treatment of locally advanced or metastatic breast cancer subject to certain clinical criteria being met. PTAC and CaTSoP also recommended that funding of fulvestrant for this population as a first-line treatment be declined.

More information including links to the PTAC and Subcommittee minutes can be found in the Application Tracker record for:

This proposal is for fulvestrant as a second-line (or later) treatment, in line with the recommendations from our clinical advisors.

Details about our proposal

Fulvestrant would be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule as soon as practicable following Medsafe approval at the following price (ex-manufacturer, excluding GST):

Chemical	Formulation	Brand	Pack size	Proposed price and subsidy
Fulvestrant	Inj 50 mg per ml, 5 ml prefilled syringe	Faslodex	2	$1,068.00

A confidential rebate would apply to Faslodex that would reduce the net price to the Funder.

Fulvestrant would be listed in Section B of the Pharmaceutical Schedule subject to the following Special Authority criteria:

Special Authority for Subsidy – Retail Pharmacy - Specialist

Initial application - only from a medical oncologist or medical practitioner on the recommendation of a medical oncologist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

Patient has oestrogen-receptor positive locally advanced or metastatic breast cancer; and
Patient has disease progression following prior treatment with an aromatase inhibitor or tamoxifen for their locally advanced or metastatic disease; and
Patient is amenorrhoeic for 12 months or greater, either naturally or induced, with endocrine levels consistent with a postmenopausal state; and
Treatment to be given at a dose of 500 mg monthly following loading doses; and
Treatment to be discontinued at disease progression.

Renewal – only from a medical oncologist or medical practitioner on the recommendation of a medical oncologist. Approvals valid for 6 months for applications meeting the following criteria:

All of the following:

Treatment remains appropriate and patient is benefitting from treatment; and
Treatment to be given at a dose of 500 mg monthly; and
No evidence of disease progression.

The same restrictions would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML).

Faslodex would have protection from delisting and subsidy reduction until 30 June 2021.