Limited Coverage Drugs - Sildenafil
|Special Authority Criteria||Approval Period|
|A monotherapy for the treatment of World Health Organization (WHO)/New York Heart Association (NYHA) functional class III or IV pulmonary arterial hypertension (PAH). The usual dose of sildenafil should be limited to a maximum of 25 mg 3 times a day.||1 year|
- A Collaborative Prescribing Agreement (CPA) is available to a limited number of specialist practitioners experienced in the diagnosis and treatment of PAH. These practitioners are not required to submit a Special Authority request form for coverage.
- Important: PharmaCare coverage covers sildenafil for patients who meet the Limited Coverage criteria and whose prescription has been written by specialist experienced in the diagnosis and treatment of PAH who has entered into a CPA.
- PharmaCare coverage is subject to the patient's PharmaCare plan rules, including any annual deductible requirement.
- Practitioners who have not signed a CPA may submit a Special Authority request if the patient meets the criteria above. These prescriptions will not be covered automatically.
- 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. 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.