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Limited coverage criteria – sotatercept

Last updated on March 11, 2026

 

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Generic name

sotatercept

Strength & form

45 mg and 60 mg kit containing single-use vial(s) of lyophilized powder for subcutaneous injection

Special Authority criteria

Approval period

Initial

For the treatment of adults 18 years of age or older with confirmed World Health Organization (WHO) Group 1 pulmonary hypertension (PAH) and Functional Class (FC) II or III when ALL the following criteria are met:

  • PAH WHO Group 1 is confirmed based on guidelines-approved diagnostic procedure including right heart catheterization

AND

  • When used as add-on therapy in patients who are currently treated with all the following optimal background therapy for PAH for at least 3 months:
    • A phosphodiesterase type 5 inhibitor (PDE5i), and
    • An endothelial receptor antagonist (ERA), and
    • A prostacyclin receptor/prostacyclin analogue

AND

  • Patient is not considered low risk1 based on COMPERA 2.0 risk score or Simplified French Score completed within the last 3 months

AND

  • Special Authority is requested by a cardiologist or respirologist with experience in the diagnosis and treatment of PAH

12 months

Renewal

Renewals will be considered when ALL of the following criteria are met: 

  • Renewal is requested by a cardiologist or respirologist with experience in the diagnosis and treatment of PAH

AND

  • The patient's risk status is stable or has improved compared to the initial submission, as shown by improvement in the COMPERA 2.0 risk score or the Simplified French Score
 12 months

Practitioner exemptions

  • None

Special notes

  • 1Low risk is assessed by meeting a COMPERA 2.0 risk score of 1, or meeting all the low-risk criteria included in the Simplified French Score:
    • FC I or II
    • 6-Minute Walk Test Distance > 440 m
    • N-terminal pro-B-type natriuretic peptide (NT-proBNP) < 300 ng/L or BNP < 50 ng/L
  • Coverage will not be provided if the patient has undergone a lung transplant
  • PharmaCare will consider coverage for patients who are medically contraindicated to the required background therapy on an exceptional, case-by-case basis. Details of medical contraindications must be submitted to assist with consideration of coverage
  • PharmaCare covers up to 120 mg (kit containing 2 vials of 60 mg) per fill per 21-day period

Special Authority requests