Limited coverage criteria – treprostinil sodium
Last updated on March 24, 2025
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Generic name |
treprostinil sodium |
Strength & form |
1 mg/mL, 2.5 mg/mL, 5 mg/mL, 10 mg/mL vial |
Special Authority criteria |
Approval period |
|---|---|
|
As monotherapy, for the treatment of World Health Organization (WHO)/New York Heart Association (NYHA) functional class IV pulmonary arterial hypertension (PAH), in patients who: Have had an inadequate response and/or a contraindication to the non-prostanoid therapies AND Are not candidates for epoprostenol |
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 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
- Patients may not be candidates for epoprostenol because of: Prior recurrent complications with central line access (e.g., infection, thrombosis); an inability to operate the complicated delivery system of epoprostenol; or residence in an area without ready access to medical care, which could complicate problems associated with an abrupt interruption of epoprostenol therapy
- Both intravenous and subcutaneous formulations of treprostinil are options for coverage
- 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