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SMC ISSUES ADVICE ON NEW DRUGS

The Scottish Medicines Consortium (SMC) today (Monday) accepted the following new drug for use within NHSScotland:

• raltegravir (Isentress) is accepted in combination with other antiretroviral medicinal products agents for the treatment of Human Immunodeficiency Virus (HIV-1) infection (restricted)

Further Details:

RALTEGRAVIR (ISENTRESS)

• Raltegravir (Isentress) is accepted for restricted use in combination with other antiretroviral medicinal products/agents for the treatment of Human Immunodeficiency Virus (HIV-1) infection in treatment experienced adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. It is restricted to patients with triple class resistant HIV-1 infection.
• Addition of raltegravir to optimised background therapy in treatment experienced patients with documented resistance to at least one drug in each of the three HIV antiviral classes, significantly increased the number of patients achieving clinically significant reductions in viral load.
• The manufacturer estimated a gross drug cost of £235,041 in year 1, rising to £325,773 by year 5, based upon 30 patients in year 1 rising to 41 patients by year 5. Advice from clinical experts suggests that these patient numbers may be an underestimate, with the likely budget impact increasing as a result.

Notes for editors – Glossary:

1. Human Immunodeficiency Virus (HIV-1) - HIV, or human immunodeficiency virus, is the virus that is responsible for AIDS. HIV-1 is the more virulent form of HIV.

2. Triple-class antretroviral resistance - Resistance to three widely used classes of antiretroviral drugs.

Notes for editors – About SMC:

1. The SMC advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) in Scotland about the use of all newly licensed medicines, all new formulations of existing medicines and any major new indications for established products. It does this after new medicines have been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) / European Medicines Evaluation Agency (EMEA).

2. The SMC process encourages pharmaceutical manufacturers to make a submission before a product is launched. The aim is to issue advice as soon as possible after the launch of a product.

3. Membership of the SMC has been derived from NHS Boards across Scotland. Membership is wide ranging across multi-disciplines of NHS Scotland and also includes members of the Association of British Pharmaceutical Industry (ABPI), and patient and voluntary group representatives.

4. This advice represents the views of the Scottish Medicines Consortium and was arrived at after careful consideration of the available evidence. Health professionals are expected to take due account of this recommendation when exercising their clinical judgement. This recommendation does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

For further information, contact Stephen Ferguson on 07779 329 689 or Colin McAllister on 07813 095930