2 The technology

2 The technology

Description of the technology

Radium‑223 dichloride (Xofigo, Bayer) is a radiopharmaceutical agent designed to deliver alpha radiation to bone metastases without affecting normal bone marrow.

Marketing authorisation

The marketing authorisation for radium‑223 dichloride (hereafter referred to as radium‑223) is 'for the treatment of adults with castration‑resistant prostate cancer, symptomatic bone metastases and no known visceral metastases'.

Adverse reactions

The summary of product characteristics lists the following adverse reactions for radium‑223: thrombocytopenia, diarrhoea, vomiting, nausea, neutropenia, pancytopenia, leukopenia, injection-site reactions and lymphopenia. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

Radium‑223 dichloride is administered by intravenous injection at a recommended dose of 55 kBq/kg body weight every 4 weeks for 6 injections.

Price

The company's submission states that radium‑223 is available at a radioactivity of 6.6 MBq in a 6‑ml vial at a list price of £4,040 (excluding VAT). The company estimates the cost of a full course of treatment to be £24,240. The company (Bayer's) that holds the marketing authorisation for radium‑223 has agreed a patient access scheme with the Department of Health that makes radium‑223 available with a discount applied to all invoices. The level of the discount is commercial in confidence. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS. Costs may vary in different settings because of negotiated procurement discounts.

  • National Institute for Health and Care Excellence (NICE)