Limited coverage criteria – tadalafil
Last updated on March 24, 2025
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Generic name |
tadalafil |
|---|---|
Strength & form |
20 mg tablet |
Special Authority criteria |
Approval period |
|---|---|
|
As monotherapy for the treatment of World Health Organization (WHO) / New York Heart Association (NYHA) functional class III or IV pulmonary arterial hypertension (PAH). |
1 year |
Practitioner exemptions
- Designated specialist physicians experienced in the diagnosis and treatment of PAH have been invited to apply for individual specialist exemption by entering into a Collaborative Prescribing Agreement
Special notes
- The usual dose of tadalafil should be limited to a maximum of 40 mg (2 x 20 mg) once daily
- The diagnosis of PAH should be confirmed by right heart catheterization
- Conventional therapy (including calcium channel blockers, anticoagulation with warfarin to maintain INR 1.5-2.5, loop diuretics, digoxin, supplemental oxygen) is considered first-line therapy for select patients with PAH. An inadequate response to maximal appropriate conventional therapy is required for these patients prior to consideration of any other treatment for PAH
- For patients who do not meet established criteria, exceptional cases may be considered where the physician provides additional documentation in a supporting letter. For example, exceptional case requests for combination therapy with two PAH drugs should be accompanied by details of inadequate response and duration of monotherapy. These exceptional case requests will be reviewed by the PAH drug benefit adjudication advisory committee