SUMMARY OF RECOMMENDATIONS

1. The Canadian Drug Expert Committee (CDEC) recommends that sildenafil or tadalafil be the preferred initial therapy for adult patients with functional class (FC) II and III pulmonary arterial hypertension (PAH).
2. CDEC recommends that add-on therapy should be used in adult PAH patients who are unable to achieve disease control with a single drug.
3. CDEC could not make a specific recommendation pertaining to subgroups of patients (based on disease severity or other disease characteristics) who may benefit more from specific drugs or combinations of drugs based on the evidence reviewed.

Contents

• ABBREVIATIONS
• BACKGROUND
• PREAMBLE TO THE RECOMMENDATIONS
• ADDRESSING STAKEHOLDER FEEDBACK TO THE DRAFT RECOMMENDATIONS
• SUMMARY OF RECOMMENDATIONS
  • CANADIAN DRUG EXPERT COMMITTEE VALUES AND PREFERENCES
• RECOMMENDATIONS
  • Reasons for Recommendation 1
  • Reason for Recommendation 2
  • Reason for Recommendation 3
• PATIENT GROUP INPUT
• SUMMARY OF THE EVIDENCE
  • Clinical Evidence
  • Monotherapy (Treatment-Naive Population)
  • Combination Therapy (Add-on)
  • Other Efficacy Outcomes
  • Subgroup Analyses
  • Safety
  • Economic Evidence
  • Limitations of the Evidence
• DISCUSSION POINTS
  • Efficacy and Cost-Effectiveness
  • Other Discussion Points
• RESEARCH GAPS
• REFERENCES

Committee Members:: Dr. Lindsay Nicolle (Chair), Dr. James Silvius (Vice Chair), Dr. Ahmed Bayoumi, Dr. Bruce Carleton, Mr. Frank Gavin, Mr. Allen Lefebvre, Dr. Peter Jamieson, Dr. Kerry Mansell, Dr. Irvin Mayers, Dr. Silvia Alessi-Severini, Dr. Yvonne Shevchuk, and Dr. Adil Virani.

About This Document:: The Therapeutic Review Recommendations or Advice are formulated following a comprehensive evidence-based review of the medication’s efficacy or effectiveness and safety and an assessment of its cost-effectiveness. Therapeutic Review clinical and economic reports are based on published information available up to the time that CDEC made its recommendation. Input from stakeholders, such as drug manufacturers, patient groups, and health-related professional associations or organizations, is considered in the preparation of this recommendation document.

CDEC is a committee of the Canadian Agency for Drugs and Technologies in Health (CADTH). It makes recommendations and provides advice to Canadian jurisdictions to use in making informed decisions. It is made up of experts in drug evaluation and drug therapy, and public members.

The Therapeutic Review Framework describes the Therapeutic Review process in detail.⁴¹

Regrets:

Conflicts of Interest: None.

One external clinical expert attended the meeting and participated in the discussion, but did not vote on the recommendations.

The Final CDEC Therapeutic Review Recommendations or Advice neither takes the place of a medical professional providing care to a particular patient nor is it intended to replace professional advice.

CADTH is not legally responsible for any damages arising from the use or misuse of any information contained in or implied by the contents of this document. The statements, conclusions, and views expressed herein do not necessarily represent the view of Health Canada or any provincial, territorial, or federal government, or the manufacturer.