Decision

Early access to medicines scheme (EAMS) scientific opinion: Pembrolizumab (MK-3475)

Information on the EAMS scientific opinion given to pembrolizumab (MK-3475), including the public assessment report.

This publication was withdrawn on

This scientific opinion has expired.

Documents

Pembrolizumab (MK-3475) EAMS public assessment report

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Treatment protocol for patients

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Treatment protocol for healthcare professionals

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Treatment protocol on the pharmacovigilance system

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Details

This positive scientific opinion was issued to Merck Sharp & Dohme Limited on 9 March 2015 for pembrolizumab, in treatment of advanced melanoma (a type of skin cancer affecting cells called melanocytes), which has spread or cannot be removed by surgery and has progressed after other treatments.

The scientific opinion includes:

  • a public assessment report
  • a treatment protocol:
    • for healthcare professionals
    • for patients
    • on the pharmacovigilance system

Contact

Information and details regarding patient access

For new patients wishing to access EAMS medicines in England, trusts must submit an application form to england.eams@nhs.net to register the patient with NHS England. The form itself can be requested from the same dedicated EAMS email address. Plans are underway to introduce a web based application form as soon as possible. Trusts will be informed when this is available.

For information about access in Northern Ireland, contact Mark Timoney, Chief Pharmaceutical Officer at Mark.Timoney@dhsspsni.gsi.gov.uk and Joe Magee, Secondary Care Directorate at Joe.Magee@dhsspsni.gov.uk.

For information about access in Scotland contact the Scottish Government Directorate General Health & Social Care. Please email John.Hannah@scotland.gsi.gov.uk and Kathryn.Fergusson@scotland.gsi.gov.uk.

For information about access in Wales, contact the Welsh Government Department of Health and Social Services by e-mailing Roger Walker Chief Pharmaceutical Officer at Roger.Walker@wales.gsi.gov.uk and Karen Eveleigh, Head of Pharmacy & Prescribing policy at Karen.Eveleigh@wales.gsi.gov.uk.

Published 11 March 2015