Pharmacoeconomic review report : Riociguat (Adempas) / Canadian Agency for Drugs and Technologies in Health.

Format:

Book

Author/Creator:

Canadian Agency for Drugs and Technologies in Health, author, issuing body.

Series:

Common drug review clinical review report.

Common drug review clinical review report

Language:

English

Subjects (All):

Cost effectiveness.

Physical Description:

1 online resource (ii, 17 pages).

Other Title:

Pharmacoeconomic review report Riociguat

Place of Publication:

[Ottawa, Ontario] : Canadian Agency for Drugs and Technologies in Health, 2015.

Summary:

Riociguat (Adempas) is a soluble guanylate cyclase (sGC) stimulator indicated for the treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1), as monotherapy or in combination with endothelin receptor antagonists (ERAs) in adult patients (≥ 18 years of age) with WHO functional class II or III pulmonary hypertension. It is available in 0.5 mg, 1 mg, 1.5 mg, 2 mg, and 2.5 mg oral tablets, with a recommended dose of 1 to 2.5 mg three times daily, based on a 0.5 mg incremental titration phase. The manufacturer submitted a price of 42.75 dollar per tablet for all dosage strengths based on its current list price, which corresponds to a cost of 128.25 dollar daily per patient or 46,811 annually per patient. The manufacturer is requesting riociguat to be listed for patients who are unable to achieve disease control with another PAH therapy. Riociguat is also indicated for the treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) and persistent or recurrent CTEPH after surgical treatment in adult patients (≥ 18 years of age) with WHO functional class II or III pulmonary hypertension. Riociguat was previously reviewed for this indication (at the same submitted price) and received a "list with conditions" recommendation by the CADTH Canadian Drug Expert Committee (CDEC) in July 2014, one of which was the requirement of a substantial reduction in price.

Contents:

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Abbreviations

Summary

Background

Summary of the economic analysis submitted by the manufacturer

Key limitations

Issues for consideration

Results and conclusions

APPENDIX 1. Cost Comparison

APPENDIX 2. Price Reduction Analysis

APPENDIX 3. Reviewer Worksheets

APPENDIX 4. Treatment Pathway Diagrams

References.

Notes:

Description based on publisher supplied metadata and other sources.

Includes bibliographical references.