Proposal to fund cetuximab for head and neck cancer

Medicines

Consultation Closed

What we’re proposing

We propose to fund cetuximab (Erbitux) from 1 February 2018 for the treatment of patients with locally advanced, non-metastatic, squamous cell cancer of the head and neck subject to certain clinical criteria being met.

Consultation closes at 5 pm on Thursday, 30 November 2017 and feedback can be emailed to danae.staples-moon@pharmac.govt.nz.

What would the effect be?

Certain patients with locally advanced, non-metastatic, squamous cell cancer of the head and neck would be eligible for a funded course of treatment with cetuximab in combination with radiotherapy.  We estimate there would be around 40-50 patients per year who may be eligible for treatment with cetuximab under this proposal.

This treatment is given by intravenous infusion in tandem with radiation therapy and provides improved disease control and survival.

We estimate that the impacts to DHB services, if this proposal was progressed, would be:

  FYE 2018 # FYE 2019 FYE 2020 FYE 2021 FYE 2022
Eligible patients 18 43 43 43 43
Additional infusions 129 345 349 352 356
Additional infusion (hours) 405 1079 1090 1101 1112

# A listing from 1 February 2018 would result in 5 months usage during the 2017/18 Financial Year.  The above estimated impacts assume a 4 hour first infusion and seven 3 hour subsequent infusions, including premedication and observation time.

Who we think will be interested

  • Oncologists
  • Patients who have or may develop head and neck cancer and their supporters
  • Hospital pharmacists
  • Organisations with an interest in cancer treatment

About cetuximab

Cetuximab is a monoclonal antibody that competes for epidermal growth factor receptor (EGFR) binding sites on the external surface of the cell membrane which slows and stops the growth of cancer cells.

Cetuximab, in combination with radiotherapy, is licensed for the treatment of locally advanced squamous cell cancer of the head and neck.

The presentation of cetuximab (Erbitux) that is proposed for funding is inj 5 mg per ml, and it would be available in either a 20 ml or 100 ml vial.  It is started one week before radiation therapy and administered until the end of the radiotherapy course.

The initial dose is 400 mg/m2 followed by subsequent weekly doses of 250 mg/m2 each, generally for 7 weeks. The recommended initial infusion duration is 120 minutes, with 60 minutes for the subsequent doses. Further information can be found in the Medsafe datasheet(external link).

Why we’re proposing this

PHARMAC received an application from Merck Serono to fund cetuximab for the treatment of patients with locally advanced squamous cell carcinomas of the head and neck. The application has been reviewed by the Pharmacology and Therapeutics Advisory Committee (PTAC) as well as by PTAC’s Cancer Treatments Subcommittee, CaTSoP.

PTAC and CaTSoP recommended that cetuximab, in combination with radiation therapy, be funded with a high priority for patients with locally advanced, non-metastatic, squamous cell cancer of the head and neck who have a significant contraindication to both cisplatin and carboplatin.(external link)

We note that the proposed funding criteria differ slightly to the above recommendation from our clinical advisors, in that a requirement for contraindication to carboplatin would not be required. This is because subsequent informal advice from CaTSoP members indicated that carboplatin is not the current standard of care in New Zealand for patients with head and neck cancer.

Details about our proposal

  • Cetuximab (Erbitux) would be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 February 2018 at the following prices and subsidies (ex-manufacturer, excluding GST): 

Presentation

Pack size

Proposed price and subsidy

Inj 5 mg per ml, 20 ml vial

1

$364.00

Inj 5 mg per ml, 100 ml vial

1

$1,820.00

Inj 1 mg for ECP

1 mg

$3.82

*The proposed price and subsidy for the 1 mg for ECP presentation assumes 5% wastage based on the expected average dose, dosing schedule and number of patients treated.
  •  A confidential rebate would apply to Erbitux that would reduce its net price to the Funder.
  • Erbitux would be listed in the Pharmaceutical Schedule as a Pharmaceutical Cancer Treatment only (PCT only – Specialist), meaning that only DHB hospitals would be able to claim for its use.
  • Erbitux would be listed in Section B of the Pharmaceutical Schedule, for claiming purposes only, subject to the following Special Authority criteria: