Decision

Early access to medicines scheme (EAMS) scientific opinion: tafamidis for the treatment of transthyretin amyloidosis in adult patients with wild type or hereditary cardiomyopathy to reduce all-cause mortality and cardiovascular-related hospitalisation

EAMS scientific opinion given to Pfizer Ltd for the treatment of transthyretin amyloidosis in adult patients with wild type or hereditary cardiomyopathy to reduce all-cause mortality and cardiovascular-related hospitalisation.

From:
Medicines and Healthcare products Regulatory Agency
Published
29 May 2019
Last updated
13 March 2020 — See all updates

Documents

Tafamidis - Public Assessment Report (PAR)

PDF, 694 KB, 3 pages

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Treatment protocol for patients

PDF, 217 KB, 6 pages

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Treatment protocol for healthcare professionals

PDF, 300 KB, 16 pages

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Treatment protocol on the pharmacovigilance system

PDF, 167 KB, 3 pages

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Tafamidis - background information for medical directors

PDF, 59.1 KB, 2 pages

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Details

This positive scientific opinion was issued to Pfizer Limited for tafamidis for the treatment of transthyretin amyloidosis in adult patients with wild type or hereditary cardiomyopathy to reduce all-cause mortality and cardiovascular-related hospitalisation.

The scientific opinion includes:

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

Contacts

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 Chief Pharmaceutical Officer 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 medicines.policy@gov.scot.

For information about access in Wales, contact the Welsh Government Health and Social Services Group by emailing Andrew Evans, Chief Pharmaceutical Officer or Lynne Schofield, Head of Pharmacy and Prescribing policy at pharmacyand.prescribingbranch@gov.wales.

Published 29 May 2019
Last updated 13 March 2020 + show all updates

  1. Replaced PAR with withdrawn PDF version

  2. Changes of multiple contacts in Contacts section.

  3. Updated contact details for information and details regarding patient access

  4. First published.