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14 September 2021

Announcement of the outcome of appraisals undertaken at this AWMSG meeting;

In line with the AWMSG appraisal process, there is a requirement for the Chair to announce the outcome of the appraisals held at each AWMSG meeting. Because we have had to adapt to the current circumstances and the AWMSG meeting has been held ‘virtually’, the advice that will be forwarded to Welsh Government for ratification is below:

Nitisinone (Orfadin®) is recommended for use within NHS Wales for the treatment of adult patients with alkaptonuria.

This recommendation applies only in circumstances where the approved Wales Patient Access Scheme (WPAS) is utilised or where the list/contract price is equivalent or lower than the WPAS price.

Everolimus (Votubia®) is recommended as an option for use within NHS Wales for the adjunctive treatment of patients aged 2 years and older whose refractory partial-onset seizures, with or without secondary generalisation, are associated with tuberous sclerosis complex (TSC).

This recommendation applies only in circumstances where the approved Patient Access Scheme (PAS) is utilised or where the list/contract price is equivalent or lower than the PAS price.

Amikacin liposomal (Arikayce®) is recommended as an option for use within NHS Wales for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis.

This recommendation applies only in circumstances where the approved Wales Patient Access Scheme (WPAS) is utilised or where the list/contract price is equivalent or lower than the WPAS price.

Dolutegravir (Tivicay®) is recommended as an option for use within NHS Wales in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.

This recommendation applies only in circumstances where the approved Wales Patient Access Scheme (WPAS) is utilised or where the list/contract price is equivalent or lower than the WPAS price.
Etravirine (Intelence®) is recommended as an option for use within NHS Wales, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adults and in antiretroviral treatment-experienced paediatric patients from 2 years of age.
The Final Appraisal Recommendation (FAR) will be finalised and emailed to the applicant company within five working days of the AWMSG meeting at which the appraisal was undertaken.
 
The applicant company has ten working days from the date of the AWMSG meeting at which the appraisal of their medicine was undertaken to accept the recommendation or lodge a request for an independent review, the grounds for which should be submitted in writing to the Chairman via awttc@wales.nhs.uk.  The process will not be delayed if the applicant company fails to respond within this ten day deadline. 
 
At the end of the ten-day period, and unless a request is made for an independent review, AWMSG’s recommendation/s will be forwarded to Welsh Government for ratification. AWTTC will contact the applicant company when Ministerial ratification has been confirmed.
 
AWTTC will disseminate confirmation of Ministerial ratification to the Service and will publish the Final Appraisal Recommendations on the AWMSG website for implementation within NHS Wales.