2 Information about the beta interferons and glatiramer acetate

Marketing authorisation indications

2.1

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'.

2.2

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'.

2.3

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'.

2.4

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.

Dosage in the marketing authorisation

Price

2.6

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 accessed March 2017).

2.7

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

2.8

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 accessed 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 accessed June 2018).

2.9

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.