Remodulin — Medical Mutual

Initial criteria

• Diagnosis of WHO Group 1 pulmonary arterial hypertension (PAH); AND
• Prescribed by or in consultation with a cardiologist or a pulmonologist; AND
• Right heart catheterization performed AND results confirm the diagnosis of WHO Group 1 PAH; AND
• Functional Class III or IV OR Functional Class II AND (has tried or is receiving one oral agent for PAH (e.g., Tracleer [bosentan], Letairis [ambrisentan], Opsumit [macitentan], Adempas [riociguat], Revatio [sildenafil], Adcirca [tadalafil], Orenitram [treprostinil ER], Uptravi [selexipag]) OR has tried one inhaled or parenteral prostacyclin product (e.g., Ventavis [iloprost], Tyvaso [treprostinil inhalation], epoprostenol injection)); AND
• For idiopathic PAH, ONE of: acute vasodilator response with trial of a calcium channel blocker (e.g., amlodipine, nifedipine ER) OR no acute response to vasodilator OR cannot undergo vasodilator testing OR cannot take CCB therapy OR has tried one CCB; AND
• If brand Remodulin requested, must have tried and failed or contraindicated/intolerant to generic treprostinil

Reauthorization criteria

• Prescribed by or in consultation with a cardiologist or pulmonologist; AND
• Diagnosis WHO Group 1 PAH confirmed by right heart catheterization; AND
• If brand Remodulin requested, must have tried and failed or contraindicated/intolerant to generic treprostinil; AND
• Patient is benefiting from therapy (e.g., improved functional class, quality of life, hemodynamic or clinical parameters)

Approval duration

initial 6 months, reauth 6 months