Flolan — Medical Mutual

Initial criteria

• The patient has World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH); AND
• The agent is prescribed by, or in consultation with, a cardiologist or a pulmonologist; AND
• The patient has had a right heart catheterization [documentation required]; AND
• The results of the right heart catheterization confirm the diagnosis of WHO Group 1 PAH; AND
• The patient is in Functional Class III or IV; OR the patient is in Functional Class II AND has tried or is currently receiving one oral agent for PAH (e.g., Tracleer [bosentan], Letairis [ambrisentan], Opsumit [macitentan], Adempas [riociguat], Revatio [sildenafil], Adcirca [tadalafil], Orenitram [treprostinil ER], Alyq [tadalafil], Tadliq [tadalafil], Uptravi [selexipag]); OR has tried one inhaled or parenteral prostacyclin product for PAH (e.g., Ventavis [iloprost], Tyvaso [treprostinil inhalation], Remodulin [treprostinil injection], Tyvaso DPI, or epoprostenol injection); AND
• For idiopathic PAH: patient had an acute response to vasodilator testing AND has tried one oral calcium channel blocker (e.g., amlodipine, nifedipine ER); OR patient did not have an acute response per prescriber; OR patient cannot undergo vasodilator test; OR patient cannot take CCB (e.g., right heart failure, decreased cardiac output); OR has tried one CCB (e.g., amlodipine, nifedipine ER); AND
• If brand Veletri or Flolan is prescribed, the patient has failed or is intolerant to generic epoprostenol; OR brand is required due to a formulation difference in inactive ingredient(s) leading to significant allergy or adverse reaction [documentation required].

Reauthorization criteria

• Patient is benefiting from the agent as determined by the prescriber (e.g., improving in functional class, quality of life, or other hemodynamic/clinical parameters).
• If brand Veletri or Flolan is prescribed, patient has failed or is intolerant to generic epoprostenol; OR brand is required due to a formulation difference in inactive ingredient(s) leading to significant allergy or adverse reaction [documentation required].
• Short-term approval (≤14 days) may be authorized if insufficient information is available and coverage determination cannot be made, with referral to medical director review.

Approval duration

initial 6 months; reauth 6 months; short-term 14 days allowed; indefinite duration if patient is responding/benefiting