Limited Coverage Drugs - selexipag

Generic Name:

selexipag

Strength:

200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,000 mcg, 1,200 mcg, 1,400 mcg, 1,600 mcg

Form:

tablet

Special Authority Criteria

Approval Period

For the long-term treatment of idiopathic pulmonary arterial hypertension (PAH), heritable PAH, PAH associated with connective tissue disorders, and PAH associated with congenital heart disease in adult patients:

  • with World Health Organization/New York Heart Association functional class III PAH,
  • whose symptoms are inadequately controlled with a phosphodiesterase-type 5 inhibitor and endothelin receptor antagonist, and
  • when prescribed by a specialist physician experienced in the diagnosis and treatment of PAH.

(Combination therapy with a prostacyclin, such as epoprostenol, or prostacyclin analog therapies, such as treprostinil, are not covered by PharmaCare.)

1 year

Practitioner Exemptions

  • Designated specialist physicians experienced in the diagnosis and treatment of PAH can enter into a Collaborative Prescribing Agreement to be exempt from completing SA forms.

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, and 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. These exceptional case requests will be reviewed by the PAH Drug Benefit Adjudication Advisory Committee.

Special Authority Request Form(s)