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riociguat (Adempas®)


Reference No. 558

Publication date:
13/10/2015


Appraisal information

riociguat (Adempas®) 0.5 mg film-coated tablet
riociguat (Adempas®) 1 mg film-coated tablet
riociguat (Adempas®) 1.5 mg film-coated tablet
riociguat (Adempas®) 2 mg film-coated tablet
riociguat (Adempas®) 2.5 mg film-coated tablet


Company: Bayer Healthcare Pharmaceuticals
BNF category: Cardiovascular system
NMG meeting date: 22/07/2015
AWMSG meeting date: 16/09/2015
   
   
Submission Type: Full Submission
Status: Recommended with restrictions
Advice No: 2515
Ministerial ratification: 09/10/2015

Current Progress


Submission
received
NMG
meeting
AWMSG
meeting
Ministerial
Ratification

AWMSG advice

Riociguat (Adempas®) is recommended as an option for restricted use within NHS Wales for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO functional class II to III to improve exercise capacity. This recommendation applies only in circumstances where the approved Wales Patient Access Scheme is utilised. Riociguat (Adempas®) should be restricted for use as a PAH-specific monotherapy as an alternative treatment option to endothelin receptor antagonist (ERA) monotherapy in adult patients with PAH of WHO functional class II to III. Riociguat (Adempas®) is not recommended for use within NHS Wales outside of this subpopulation.
Final Appraisal Recommendation (FAR)
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AWMSG Secretariat Appraisal Report (ASAR)
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Clinical Expert (CE) Summary
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