2 The technologies

2 The technologies

Cetuximab

Panitumumab

Description of the technologies

Cetuximab (Erbitux, Merck Serono) is a chimeric monoclonal IgG1 antibody that is specifically directed against epidermal growth factor receptor (EGFR).

Panitumumab (Vectibix, Amgen) is a recombinant, fully human IgG2 monoclonal antibody that binds with high affinity and specificity to human EGFR.

Marketing authorisations

Cetuximab has a marketing authorisation in the UK for treating 'patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer:

  • in combination with irinotecan-based chemotherapy,

  • in first-line in combination with FOLFOX,

  • as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan'.

Panitumumab has a marketing authorisation in the UK for treating 'adult patients with wild-type RAS metastatic colorectal cancer (mCRC):

  • in first-line in combination with FOLFOX or FOLFIRI [folinic acid, fluorouracil and irinotecan].

  • in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).

  • as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens'.

Please note this appraisal considered the previously untreated population only.

Monotherapy for previously treated mCRC was not within the scope of the appraisal.

Adverse reactions

The most frequently reported adverse reactions are skin reactions, hypomagnesaemia and infusion-related reactions. For full details of adverse reactions and contraindications, see the summary of product characteristics.

The most frequently reported adverse reactions are skin reactions and gastrointestinal disorders. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended doses and schedules

Cetuximab is given by intravenous infusion once a week. The first dose of cetuximab is 400 mg/m2 body surface area. All further doses are 250 mg/m2 of cetuximab given weekly.

Panitumumab is given by intravenous infusion once every 2 weeks at a dose of 6 mg/kg of body weight.

Prices

Cetuximab costs £178.10 per 20‑ml vial and £890.50 per 100‑ml vial (excluding VAT, 'British national formulary' [BNF] online, October 2015).

The pricing arrangement considered during guidance development was that Merck had agreed a patient access scheme with the Department of Health. This scheme provided a simple discount to the list price of cetuximab with the discount applied at the point of purchase or invoice. After guidance publication in March 2017, the company agreed a commercial access agreement with NHS England that replaces the patient access scheme on equivalent terms. The financial terms of the agreement are commercial in confidence.

Panitumumab costs £379.29 per 5‑ml vial and £1,517.16 per 20‑ml vial (excluding VAT, BNF online, October 2015).

The company has agreed a patient access scheme with the Department of Health, providing a simple discount to the list price of panitumumab with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence. The Department of Health considered that this patient access scheme would not constitute an excessive administrative burden on the NHS.

  • National Institute for Health and Care Excellence (NICE)