Beta interferons and glatiramer acetate for treating multiple sclerosis

Marketing authorisation indications

Avonex (interferon beta‑1a; Biogen Idec Ltd) is licensed for the treatment of 'patients diagnosed with relapsing multiple sclerosis'. In clinical trials, 'this was characterised by two or more acute exacerbations (relapses) in the previous three years without evidence of continuous progression between relapses'. It is also licensed for the treatment of 'patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis'.

Rebif (interferon beta‑1a; Merck Serono Ltd) is licensed for the treatment of 'patients with relapsing multiple sclerosis'. In clinical trials, 'this was characterised by two or more acute exacerbations in the previous two years'. It is also licensed for the treatment of 'patients with a single demyelinating event with an active inflammatory process, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis'.

Betaferon (interferon beta‑1b; Bayer Plc) and Extavia (interferon beta‑1b; Novartis Pharmaceuticals UK Ltd) are licensed for the treatment of 'patients with relapsing–remitting multiple sclerosis and two or more relapses within the last two years'. They are also licensed for the treatment of 'patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis'. They are also licensed for the treatment of 'patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses'.

Copaxone (glatiramer acetate; Teva UK Ltd) is licensed for 'the treatment of relapsing forms of multiple sclerosis'. Generic versions (such as Brabio, Mylan) are also available in the UK.

Dosages in the marketing authorisations

Avonex is given by intramuscular injection weekly at a dose of 30 micrograms.

Rebif is given by subcutaneous injection 3 times per week at a dose of 44 or 22 micrograms.

Betaferon and Extavia are given by subcutaneous injection every other day at a dose of 250 micrograms.

Glatiramer acetate is given by subcutaneous injection once daily at a dose of 20 mg or 3 times a week at a dose of 40 mg.

See the summaries of product characteristics for full dosage schedules.

Prices

The list price for Avonex is £163.60 per pre‑filled pen containing 30 micrograms (excluding VAT, British National Formulary [BNF] online, March 2017).

The list price for Rebif is £51.13 per pre‑filled syringe containing 22 micrograms or £67.77 per pre‑filled syringe containing 44 micrograms (excluding VAT, BNF online, March 2017).

The list price for Betaferon and Extavia is £39.78 per vial containing 300 micrograms (excluding VAT, BNF online, March 2017).

The list price for Copaxone is £18.36 per pre‑filled syringe containing 20 mg or £42.83 per pre‑filled syringe containing 40 mg (excluding VAT, BNF online, March 2017). The list price for Brabio is £16.52 per pre‑filled syringe containing 20 mg or £38.55 per pre‑filled syringe containing 40 mg (excluding VAT, BNF online, June 2018).

Costs may vary in different settings because of negotiated procurement discounts.

Four companies have commercial arrangements. These make Avonex, Copaxone, Extavia and Rebif available to the NHS with a discount. The size of each discount is commercial in confidence. It is the companies' responsibility to let relevant NHS organisations know details of each discount.