Yutrepia — Blue Cross Blue Shield of Kansas

Initial criteria

• Therapy will consist of 1 agent from 2 of the following therapeutic classes: an endothelin receptor antagonist (ERA), phosphodiesterase 5 inhibitor (PDE5i) and prostanoid OR therapy will consist of an ERA plus a soluble guanylate cyclase inhibitor (sGC) (Adempas) AND the patient has had an unacceptable response to therapy with an ERA plus a PDE5i OR therapy will be part of triple therapy meeting all specific outlined criteria for high risk or inadequate response situations OR quadruple therapy meeting all criteria for high risk and inadequate response with 3 or more classes.
• For PH-ILD, the requested agent must be Tyvaso or Yutrepia AND diagnosis confirmed by right heart catheterization (medical records required) AND mean pulmonary arterial pressure >20 mmHg AND pulmonary capillary wedge pressure ≤15 mmHg AND pulmonary vascular resistance >2 Wood units AND PH-ILD assessed using multiple clinical and diagnostic parameters AND patient has extensive parenchymal changes on CT AND patient is currently treated with and will continue standard of care therapy for ILD (e.g., Ofev).
• If the patient has another FDA labeled indication, eligibility is based on patient meeting age labeling or supported age use for the agent and indication.
• If the request is for a listed brand agent with an available generic equivalent (Revatio/sildenafil, Adcirca/tadalafil, Tracleer/bosentan, Letairis/ambrisentan) then ONE of the following must apply: intolerance or hypersensitivity to generic not expected with brand, FDA labeled contraindication to generic not expected with brand, or clinical support for use of brand.
• If the request is for Tadliq, then patient has tried and had inadequate response to generic tadalafil tablets OR intolerance/hypersensitivity to generic tadalafil not expected with requested agent OR FDA labeled contraindication to generic tadalafil not expected with requested agent.
• If the request is for Liqrev, then patient has tried and had inadequate response to generic sildenafil oral suspension OR intolerance/hypersensitivity to generic sildenafil oral suspension not expected with requested agent OR FDA labeled contraindication to generic sildenafil oral suspension not expected with requested agent.
• Prescriber is a specialist in the area of the patient’s diagnosis (e.g., cardiologist, pulmonologist) or has consulted with a specialist.
• Patient does NOT have any FDA labeled contraindications to the requested agent.

Reauthorization criteria

• Patient has been previously approved for the requested agent through the plan’s prior authorization process AND patient has had clinical benefit with the requested agent (e.g., stabilization, decreased disease progression) AND if Tyvaso for PH-ILD, patient will continue standard of care therapy for ILD (e.g., Ofev).
• For renewals of brand agents with generic equivalents, applicable brand/generic criteria continue to apply (Revatio/sildenafil, Adcirca/tadalafil, Tracleer/bosentan, Letairis/ambrisentan, Tadliq/tadalafil, Liqrev/sildenafil).
• Prescriber remains a specialist or has consulted with a specialist AND patient does not have any FDA labeled contraindications.

Approval duration

12 months