The National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012

PART 10 Standing rules: funding of therapies for Multiple Sclerosis

Scheme for the funding of certain disease modifying therapies for Multiples Sclerosis

56.—(1) A relevant body must, in exercising its functions under or by virtue of section 3(1), 3A(1) or 3B of the 2006 Act, ensure that—

(a) a scheme product is supplied or administered in accordance with the scheme to a scheme patient,

(b) a scheme product continues to be supplied or administered in accordance with the scheme to a scheme patient where such a patient was receiving such a course of treatment immediately before the relevant date unless the patient’s consultant has determined, in consultation with the scheme patient, that the scheme product is no longer clinically appropriate;

(c) a scheme product is supplied or administered to a patient with multiple sclerosis for the purpose of that person’s treatment for that condition where that patient—

(i) is not a scheme patient, but

(ii) was, on 4th February 2002, and is, immediately before the relevant date, receiving such a course of treatment for that condition.

(2) In this Part—

“scheme” means the arrangement between the Department of Health (England), the National Assembly for Wales, the Scottish Ministers, the Northern Ireland Department of Health, Social Security and Public Safety, Biogen Idec Inc., Bayer PLC, Merck Serono Limited, and Teva Pharmaceutical Industries Limited together with Aventis Pharma Limited, dated 1st February 2002, for the supply and administration of products for the treatment of multiple sclerosis(1);

“scheme patient” means a patient with multiple sclerosis who is eligible to receive treatment under the scheme and who consents to receive such treatment;

“scheme product” means—

(a)

Interferon beta-1a: Avonex and Rebif (22mg and 44mg);

(b)

Interferon beta – 1b: Betaferon; or

(c)

Glatiramer acetate: Copaxone,

which is given for the treatment of multiple sclerosis and which is manufactured by a company that is a party to the scheme.

(1)

The arrangement can be found at www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/ Healthservicecirculars/DH_4004332 – see Annex A.