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About VYNDAQEL

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Study DesignEfficacySafety ProfileDosingReal-world evidenceSupporting Resources Supporting ResourcesGuidelines and ReimbursementLong Term Extension StudyModels of care MaterialsVideosContact us

Click here for VYNDAQEL®▼ (tafamidis) Prescribing Information. 

Guidelines and Reimbursement 

NICE Recommendation

Availability in Scotland

2021 ESC Heart Failure Guidelines

As of 19th June 2024, NICE recommends Vyndaqel (tafamidis) as an option for treating wild-type or hereditary transthyretin amyloidosis with cardiomyopathy (ATTR-CM) in adults. Tafamidis is only recommended if the company provides it according to the commercial arrangement.1

This advice applies in England and Wales.

To view the advice in full, visit the NICE Website.

Access to Vyndaqel on the NHS in England 

Initially Vyndaqel will be prescribed to eligible adult patients with ATTR-CM by the National Amyloidosis Centre (NAC). To learn more about how you can refer your patients for treatment consideration, download the materials below.

PDFNAC Referral guidance for suspected or confirmed ATTR-CM

This referral guidance has been developed & funded by Pfizer and co-created with the National Amyloidosis Centre and offers helpful information on how to refer a suspected or confirmed case of ATTR-CM to the NAC. This will enable the NAC to organise further diagnostic follow-up for suspected cases and initiate VYNDAQEL for eligible adult patients with confirmed ATTR-CM. 

 

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PDFNAC Referral Template for suspected or confirmed ATTR-CM

This referral guidance has been developed & funded by Pfizer and co-created with the National Amyloidosis Centre and offers clinicians a downloadable template to complete with patient information if you have a suspected or confirmed case of ATTR-CM. Sending the completed template to the NAC will enable further diagnostic follow-up for suspected cases and initiation of VYNDAQEL for eligible adult patients with confirmed ATTR-CM. 

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NICE = National Institute of Health and Care Excellence ; NHS = National Health Service

References:

NICE. [TA984]. Tafamidis for treating transthyretin amyloidosis with cardiomyopathy. Available at: Overview | Tafamidis for treating transthyretin amyloidosis with cardiomyopathy | Guidance | NICE  (Accessed January 2025)

Scottish Medicines Consortium (SMC) Advice:1
Advice: Following a second resubmission assessed under the end of life and orphan medicine process - VYNDAQEL (tafamidis) is accepted for use within NHS Scotland.

Indication under review: for the treatment of wild-type and hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).

This advice applies only in the context of an approved NHS Scotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

To view the advice in full, visit the SMC Website

If you are a healthcare professional based in Scotland and would like to learn more about how to access VYNDAQEL, get in touch with Pfizer here.

References:

Scottish Medicines Consortium (SMC). Vyndaqel. [SMC2585] Available at: 
https://www.scottishmedicines.org.uk/medicines-advice/tafamidis-vyndaqel-2nd-resubmission-smc2585/ (Accessed January 2025)

The European Society of Cardiology (ESC) is non profit organisation formed of healthcare professionals working in all different fields of cardiology.1

Adapted from McDonagh TA, et al. Eur Heart J. 2021
*Class of recommendation. Class I: conditions for which there is evidence and/or general agreement that a given procedure or treatment is useful and effective. 
†Level of evidence. Level of evidence B: recommendation based on evidence from a single randomised trial or non-randomised studies

CV= cardivascular ;ESC=European Society of Cardiology ;hTTR-CA=hereditary transthyretin amyloid cardiac amyloidosis ;NYHA=New York Heart Association ;wTTR-CA=wild-type transthyretin cardiac amyloidosis

References: Who We Are. European Society of Cardiology (ESC). Available at: Who is the European Society of Cardiology? (escardio.org) [Accessed: January 2025] McDonagh TA, et al. Eur Heart J 2021;42(36):3599–3726.
PP-VYN-GBR-2015 January 2025

Learn about the efficacy of VYNDAQEL in patients with ATTR-CM

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Learn more about Vyndaqel

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Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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