Decision to fund two new cancer treatments: olaparib and fulvestrant

Medicines

Decision

PHARMAC is pleased to announce a decision to fund two new cancer treatments and amend the contractual arrangements for one currently funded treatment through an agreement with AstraZeneca Pty Ltd.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 1 September 2019

The proposal was approved as consulted on without any changes except that, as a result of consultation feedback, we have applied the wastage rule to olaparib (Lynparza) cap 50 mg in Section B of the Pharmaceutical Schedule from 1 February 2020.

Who we think will be most interested

  • People who have or may develop ovarian cancer and their whānau

  • Oncologists and primary care clinicians

  • Community and hospital pharmacies

  • DHBs and genetic testing service providers

  • Organisations with an interest in cancer treatment

Our response to what you told us

We’re grateful for the time people took to respond to this consultation. A summary of the main themes raised in feedback, our responses to the feedback received and changes we have made after listening to you, are set out below. 

Feedback theme

Comment

Olaparib (Lynparza) for BRCA-mutated relapsed ovarian cancer

Widened access

Requests for patients with somatic BRCA mutations to be eligible.

 

The criteria are in line with the clinical advice we have received from our experts.

The Cancer Treatments Subcommittee (CaTSoP) considered that while it was likely that the clinical utility of PARP inhibitors (the class of treatments to which olaparib belongs) in patients with ovarian cancer with somatic mutations would be similar to those with germline mutations, there was currently insufficient evidence to support the use of olaparib for ovarian cancer patients with somatic BRCA mutations.

Further details on the clinical advice we have received are available from the application tracker.(external link)

We would further consider the funding of olaparib in patients with somatic BRCA mutations should new evidence become available to support this use.

Requests for use of olaparib in the first-line maintenance setting for patients who have responded to one line of platinum chemotherapy.

As noted above, the criteria are in line with the clinical advice we have received from our experts.

The funding application that was received from the supplier and considered by PHARMAC was for use in a relapsed setting (after two lines of prior platinum chemotherapy), and this was the setting recommended for funding by our clinical advisors.

We also note that first-line use would be outside the current Medsafe registered indication, which is for patients with platinum-sensitive disease (defined as > 6 months elapsed between the completion of the initial (first-line) adjuvant platinum-based chemotherapy and detection of relapse).

We would welcome an application, with supporting evidence, for funding of olaparib for the treatment of newly diagnosed ovarian cancer patients.

System impacts

Request that the wastage rule be applied to all strengths of olaparib, because there could be dose adjustments due to adverse effects such that community pharmacy could be left with a part pack and at risk of financial burden.

 

Given possible dosage reductions, the pack size of the capsules and the high cost of treatment, an amendment was made to allow for the claiming of wastage by community pharmacies for the 50 mg capsule pack.

Given the smaller pack size of the tablet presentations we have not applied the wastage or Original Pack (OP) rules to olaparib tablet presentations.

Suggestion that primary care (both GPs and pharmacy) would require training and support in terms of administration and monitoring requirements.

We will provide implementation support to ensure all relevant parties are informed of these listings.

We will provide primary care with education on administration. However, feedback we have received is that these patients would continue to be monitored by medical oncologists. 

Grandparenting

Request to clarify the process for patients who have been self-funding olaparib to access funded treatment.

 

Where clinicians can demonstrate that the initial funding criteria were met prior to a patient commencing self-funded treatment, and that any relevant renewal criteria are currently met, the patient will be eligible to commence funded treatment from 1 February 2020.

Individual applications would need to be made by the treating clinician via the Special Authority waiver mechanism

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

Widened access

Concern that the criteria require patients to be postmenopausal and request for premenopausal women treated with ovarian suppression and/or ablation in combination with endocrine therapy to be eligible for funded treatment with fulvestrant, by amending criterion 3 from:

“Patient is amenorrhoeic for 12 months or greater, either naturally or induced, with endocrine levels consistent with a postmenopausal state”

to the following:

‘Patient is postmenopausal, or if premenopausal is also being treated with ovarian suppression or ablation” 

The criteria do not specify that patients must be postmenopausal. Criterion 3 is phrased to define patients who have endocrine levels consistent with a postmenopausal state either naturally or induced. We consider that premenopausal patients, particularly those with ovarian suppression or ablation, may fulfil this criterion and be eligible for funded treatment.

No changes have been made to the criteria for fulvestrant based on this feedback.

 

 

Earlier funding

Requests for fulvestrant to be funded as soon as possible prior to Medsafe approval.

 

We understand the desire for patients to access funded treatment as early as possible, However, we consider it is important for products to be Medsafe approved prior to listing wherever possible to ensure the safety of medicines supplied and used in New Zealand.

Medsafe’s assessment of the fulvestrant registration application is underway and the application has been granted priority assessment status.

You can follow the progress of the registration application here(external link)

Fulvestrant will be funded as soon as possible following Medsafe approval.

System impacts

Responders considered that fulvestrant could be administered in primary care, but primary care (both GPs and pharmacy) would require training and support in terms of administration and monitoring requirements.

We will provide implementation support to ensure all relevant parties are informed of this listing.  Specifically, we intend to commission a simple, instructional video on intramuscular injections to help educate all required parties on how to administer fulvestrant.

Advice will also be provided on any monitoring requirements to DHBs.

Requests that the wastage rule be applied, noting that while fulvestrant is usually given as a 500 mg monthly injection and comes in a pack size of two 250 mg injections, if the prescribed dose differed from the recommended dose there is a risk of financial burden for pharmacy from excess stock.

The Special Authority criteria specify that fulvestrant is to be given at a dose of 500 mg monthly, which is based on the dose used in the key clinical studies.

We note from the Australian TGA datasheet that no dose adjustments are recommended for patients with renal or hepatic insufficiency, or for elderly patients(external link)

Given this, we consider that fulvestrant should always be prescribed and administered at a dose of 500 mg, meaning only full packs would be dispensed. Therefore, we do not consider it appropriate or necessary to apply wastage to fulvestrant at this time.

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 66 00 50.