Decision

Early access to medicines scheme (EAMS) scientific opinion: Volanesorsen as a treatment of adult patients with familial chylomicronaemia syndrome

EAMS scientific opinion given to Akcea Therapeutics UK Ltd to treat, as an adjunct to diet, adult patients with familial chylomicronaemia syndrome including the public assessment report.

Documents

Volanesorsen - 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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Volanesorsen - background information for medical directors

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Details

Details

This positive scientific opinion was issued to Akcea Therapeutics UK Ltd to treat as, an adjunct to diet adult patients with familial chylomicronaemia syndrome The scientific opinion includes:

  • a public assessment report
  • a treatment protocol:
    • for healthcare professionals
    • for patients
    • on the pharmacovigilance system
    • EAMs scientific opinion – background information for Medical Directors

Contact

Information and details regarding patient access

For new patients wishing to access EAMS medicines in England, trusts must register patients on the NHS England web based registration system. Queries to NHS England regarding the scheme can be submitted to england.eams@nhs.net.

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 at John.Hannah@gov.scot and Rosemarie.parr@gov.scot

For information about access in Wales, contact the Welsh Government Department of Health and Social Services by emailing Andrew Evans, Interim Chief Pharmaceutical Officer at Andrew.Evans@wales.gsi.gov.uk and Karen Eveleigh, Head of Pharmacy and Prescribing policy at Karen.Eveleigh@wales.gsi.gov.uk.

Published 20 March 2018
Last updated 4 June 2018 + show all updates
  1. Changed text under Contact
  2. First published.