Proposal to list pemetrexed for the treatment of mesothelioma and non-small cell lung cancer

Medicines Consultation Closed

Following assessment of bids in PHARMAC’s 2015/16 annual Invitation to Tender, PHARMAC is proposing to fund pemetrexed for the treatment of mesothelioma and non-small cell lung cancer (NSCLC). 

A decision has not been made on the presentations in the tender so the brand names, pricing and timing for these changes, if they were to be implemented, is still to be determined. However, PHARMAC is seeking your feedback on the proposed new investment and funding criteria.

In summary, PHARMAC is seeking feedback on proposed Special Authority criteria that would apply to pemetrexed:

  • as first-line treatment for patients with mesothelioma.
  • as first-line or second-line treatment for patients with locally advanced or metastatic non-squamous NSCLC.

Details of the proposal and background information can be found below.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5 pm on Friday, 26 May 2017 to:

Danae Staples-Moon
Therapeutic Group Manager
PHARMAC
PO Box 10254
Wellington 6143

Email: danae.staples-moon@pharmac.govt.nz

Fax: 04 460 4995

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) and we will consider any request to have information withheld in accordance with our obligations under the 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.

Details of the proposal

PHARMAC is seeking feedback on a proposal to list pemetrexed subject to the below Special Authority criteria in conjunction with the awarding of pemetrexed tender bids as part of PHARMAC’s 2015/16 annual Invitation to Tender. 

The proposed funding criteria are as follows:

Special Authority for Subsidy

Initial application – (mesothelioma) only from a relevant specialist. Approvals valid for 8 months for applications meeting the following criteria:

Both:

  1. Patient has been diagnosed with mesothelioma; and
  2. Pemetrexed to be administered at a dose of 500 mg/m2 every 21 days in combination with cisplatin for a maximum of 6 cycles.

Renewal – (mesothelioma) only from a relevant specialist. Approvals valid for 8 months for applications meeting the following criteria:

All of the following:

  1. No evidence of disease progression; and
  2. The treatment remains appropriate and the patient is benefitting from treatment; and
  3. Pemetrexed to be administered at a dose of 500mg/m2 every 21 days for a maximum of 6 cycles.

Initial application – (non-small cell lung carcinoma) only from a relevant specialist. Approvals valid for 8 months for applications meeting the following criteria:

All of the following

  1. Patient has locally advanced or metastatic non-squamous non-small cell lung carcinoma; and
  2. Either:
    1. Both:
      1. Patient has treatment naïve disease; and
      2. Pemetrexed is to be administered at a dose of 500 mg/m2 every 21 days in combination with cisplatin for a maximum of 6 cycles, or
    2. All of the following:
      1. Patient has had first-line treatment with platinum based chemotherapy; and
      2. Patient has not received prior funded treatment with pemetrexed; and
    3. Pemetrexed is to be administered at a dose of 500 mg/m2 every 21 days for a maximum of 6 cycles.

Background

In PHARMAC’s 2015/16 annual Invitation to Tender, bids were sought for the supply of a number of medicines including pemetrexed. As the proposed listing would be implemented through the tender, brand names, pricing and timing for these changes, are still to be determined.

Pemetrexed is an antineoplastic chemotherapy medicine which inhibits enzymes involved in DNA replication and repair.

Pemetrexed is approved by Medsafe for the treatment of patients with:

  • malignant pleural mesothelioma in combination with cisplatin.
  • in combination with cisplatin for initial treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology.
  • as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology after prior platinum-based chemotherapy.

The recommended dose of pemetrexed is 500 mg/m2 administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle. When given in combination, the recommended dose of cisplatin is 75 mg/m2 infused over 2 hours approximately 30 minutes after completion of the pemetrexed infusion.

The Pharmacology and Therapeutics Advisory Committee (PTAC) and the Cancer Treatments Subcommittee of PTAC (CaTSoP) have considered the funding of pemetrexed on a number of occasions, most recently by PTAC in August 2015 and CaTSoP in September 2016.

The proposed criteria are in line with the advice received, which can be found on PHARMAC’s website.

Mesothelioma

Mesothelioma is an aggressive form of cancer, arising from the mesothelial surfaces of pleural and peritoneal cavities.  The disease is caused primarily by inhalation of asbestos fibers.

We estimate there would be 40-50 patients with mesothelioma per year who may be eligible for treatment with pemetrexed.

NSCLC

NSCLC is the most common type of lung cancer in New Zealand with the majority of patients presenting with advanced disease at diagnosis. Around 75% of NSCLC are classified as non-squamous, and includes adenocarcinoma and large cell histologies.

We estimate there would be up to 400 first-line and up to 50 second-line patients with NSCLC that would be eligible for pemetrexed if it were funded in these settings. Our clinical advice indicates that all currently diagnosed patients would likely receive second-line treatment within 12-18 months of listing and new patients would access funded pemetrexed following diagnosis as a first-line treatment.