Limited coverage criteria – riociguat

Last updated on May 1, 2025

 

Return to Special Authority drug list

Generic name

riociguat

Strength & form

0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg tablets

Special Authority criteria

Approval period

For the treatment of chronic thromboembolic pulmonary hypertension (CTEPH)1 in adult patients 18 years of age who meet the following criteria:

  • The patient is diagnosed with inoperable CTEPH2 (World Health Organization [WHO] Group 4) with Functional Class (FC) II or III pulmonary hypertension

OR

  • The patient has persistent or recurrent CTEPH after surgical treatment with WHO FC II or III pulmonary hypertension

AND

  • Requests must be submitted by a cardiologist or respirologist with experience in the diagnosis and treatment of CTEPH

1 year

Practitioner exemptions

  • None

Special notes

  • 1The diagnosis of CTEPH should be confirmed by right heart catheterization
  • 2For patients who are diagnosed with inoperable CTEPH, details of patient-specific contraindications must be specified

Special Authority requests