Approval of funding for pemetrexed for the treatment of mesothelioma and non-small cell lung cancer

Medicines

Decision

PHARMAC is pleased to announce the approval of a proposal to fund pemetrexed for the treatment of mesothelioma and non-small cell lung cancer (NSCLC) in conjunction with the awarding of pemetrexed tender bids as part of PHARMAC’s 2015/16 annual Invitation to Tender.

This was the subject of a consultation letter dated 8 May 2017.

In summary, the effect of the decision is that:

  • Pemetrexed will be listed on the Pharmaceutical Schedule from 1 November 2017 for the treatment of patients with mesothelioma and locally advanced or metastatic non-squamous NSCLC who meet certain clinical criteria.
  • Juno Pharmaceutical NZ Limited’s brand of pemetrexed, Juno Pemetrexed, will have Hospital Supply Status within DHB hospitals, with a DV Limit of 1%, from 1 January 2018 until 30 June 2019.

Having carefully considered consultation feedback, we have made changes to the proposed access criteria to:

  • clarify eligibility for chemotherapy-naïve NSCLC patients,
  • include maintenance treatment for NSCLC patients,
  • allow for administration in combination with carboplatin, and
  • allow applications by medical practitioners on the recommendation of relevant specialists (rather than applications by relevant specialists only).

We note that the funding of pemetrexed provides another treatment option, for patients with mesothelioma and NSCLC, which has improved tolerability compared to current treatments and, at the listed price and subsidy, would be a cost saving for DHB Hospital services in terms of reduced adverse event management and infusion service requirements. We estimate that, over a 5 year period, nationally the costs offsets for DHB hospital budgets from the listing of pemetrexed could be up to $1 million.

Details of the decision

  • Pemetrexed (Juno Pemetrexed) will be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 November 2017 at the following prices and subsidies (ex-manufacturer, excluding GST):

Presentation

Brand

Pack size

Price and subsidy

Inj 100 mg vial

Juno Pemetrexed

1

$60.89

Inj 500 mg vial

Juno Pemetrexed

1

$217.77

Inj 1 mg for ECP

Baxter

1 mg

$0.55*

* note – not being listed in Part II of Section H of the Pharmaceutical Schedule.

  • Juno Pemetrexed inj 100 mg and 500 mg vial will have Hospital Supply Status, with a DV Limit of 1%, from 1 January 2018 until 30 June 2019.
  • Pemetrexed will be listed in the Pharmaceutical Schedule as a Pharmaceutical Cancer Treatment only (PCT-only Specialist), meaning that only DHB hospitals will be able to claim for its use.
  • Pemetrexed will be listed in Section B of the Pharmaceutical Schedule, for claiming purposes only, subject to the following Special Authority criteria:

Special Authority for Subsidy

Initial application – (mesothelioma) only from a relevant specialist or medical practitioner on the recommendation of 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 or carboplatin for a maximum of 6 cycles.

Renewal – (mesothelioma) only from a relevant specialist or medical practitioner on the recommendation of 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 or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 8 months for applications meeting the following criteria:

Both:

  1. Patient has locally advanced or metastatic non-squamous non-small cell lung carcinoma; and
  2. Either:

2.1.    Both:

2.1.1.  Patient has chemotherapy-naïve disease; and
2.1.2.  Pemetrexed is to be administered at a dose of 500 mg/m2 every 21 days in combination with cisplatin or carboplatin for a maximum of 6 cycles, or

2.2.    All of the following:

2.2.1.  Patient has had first-line treatment with platinum based chemotherapy; and
2.2.2.  Patient has not received prior funded treatment with pemetrexed; and
2.2.3.  Pemetrexed is to be administered at a dose of 500 mg/m2 every 21 days for a maximum of 6 cycles.

Renewal application - (non-small cell lung carcinoma) only from a relevant specialist. or medical practitioner on the recommendation of 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 is to be administered at a dose of 500mg/m2 every 21 days.
  • The same restrictions will apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML).

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 2 June 2017 were considered in their entirety in making a decision on the proposed changes. All responses were supportive of the proposal, and the following issues were raised in relation to specific aspects of the proposal:

Theme

Comment

Support for the proposal as this is the international standard of care supported by evidence of efficacy and improved tolerability in these settings.

Noted.

Requests for the access criteria be amended:

  • to allow combination treatment with either cisplatin or carboplatin as this is established standard clinical practice due to its increased tolerability with similar efficacy and provides a safer treatment option for patients with impaired hearing or renal function. Noting that cisplatin infusion appointments are around 2-3 hours longer than carboplatin appointments due to premeds and fluids before and after.
  • to allow application by ‘any other medical practitioner on the recommendation of a relevant specialist’.
  • to allow access for ‘chemotherapy naïve’ patients who have received targeted or immunotherapy first-line.
  • to allow maintenance treatment for responding NSCLC patients until disease progression, as there is a demonstrated survival advantage.
  • to remove ongoing use as maintenance in mesothelioma as there is no data supporting benefit from this use.
  • to allow rechallenge with combination treatment for mesothelioma patients who progress after a treatment-free interval of at least six months, for up to 6 cycles, based on clinical experience.
  • Some of the access criteria have been amended following consideration of this feedback.
  • We note that patients who were chemotherapy-naïve were eligible for the Scagliotti et al. trial (JCO 2007:26;3543-51).
  • We note that in the EMPHACIS trial (Vogelzang et al. JCO 2003:21:2636-44) treatment was administered up to 6 cycles with additional cycles permitted for patients with mesothelioma who were receiving benefit and that some patients received up to 12 cycles of treatment. The duration of pemetrexed treatment, as with any other treatment, is a clinical decision made by each patient’s clinician.
  • Pemetrexed retreatment for patients with mesothelioma has not been previously considered by PHARMAC for funding. We would welcome a funding application supplying appropriate evidence for the use of pemetrexed in this setting.

Comment that

  • additional DHB resources will be required including for additional clinic visits (physician and nursing resource) and radiology services.
  • the proposal would likely increase manufacturing requirements due to additional step for reconstitution of pemetrexed powder (as compared to current treatments).
  • adjuvant B12 is administered 1 week prior and during therapy which is usually administered by hospital nurses given difficulty in administration by GPs particularly due to cost to patients in this setting.

PHARMAC’s assessment of the proposal includes the impact on DHB services.

We estimate that the reduced infusion duration of pemetrexed compared to current treatments and its improved tolerability would be resource sparing for DHB hospital services. We estimate that over a 5 year period, nationally the costs offsets for DHB hospital budgets from the listing of pemetrexed could be valued at $1 million.

One responder noted that ACC currently funds mesothelioma patients and queried whether these patients would be transferred to PHARMAC funded treatment.

Our analysis assumes that ACC patients being treated with pemetrexed for mesothelioma would receive treatment funded via the Combined Pharmaceutical Budget managed by PHARMAC.

More information

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.