Adcirca — Blue Cross Blue Shield of Alabama

Initial criteria

• ONE of the following:
• 1. The patient has an FDA labeled indication for the requested agent and route of administration
• OR
• 2. The patient has CTEPH, WHO Group 4 AND ALL of the following:
• • Requested agent is Adempas
• • Diagnosis confirmed by ventilation-perfusion scan and selective pulmonary angiography
• • Mean pulmonary artery pressure > 20 mmHg
• • Pulmonary capillary wedge pressure ≤ 15 mmHg
• • Pulmonary vascular resistance > 2 Wood units
• • ONE of the following: patient not a candidate for surgery OR patient has had pulmonary endarterectomy and has persistent or recurrent disease
• • Patient will NOT use the requested agent with a PDE5 inhibitor (e.g., tadalafil, sildenafil)
• OR
• 3. The patient has PAH, WHO Group 1 AND ALL of the following:
• • Diagnosis confirmed by right heart catheterization (medical records required)
• • Mean pulmonary arterial pressure > 20 mmHg
• • Pulmonary capillary wedge pressure ≤ 15 mmHg
• • Pulmonary vascular resistance > 2 Wood units
• • If requested agent is Winrevair, patient is not pregnant or planning to become pregnant while on therapy
• • If requested agent is Adcirca, Adempas, Liqrev, Opsynvi, Revatio, sildenafil, Tadliq, or tadalafil, patient will NOT use with another PDE5 inhibitor
• • ONE of the following therapy descriptions:
• – Requested agent not Winrevair and used as monotherapy, OR
• – Dual therapy: 1 agent from 2 of the following classes (ERA, PDE5i, prostanoid), OR
• – ERA + soluble guanylate cyclase stimulator (Adempas) with inadequate response to ERA + PDE5i, OR
• – Triple therapy: ERA + PDE5i + prostanoid for high risk (WHO class IV) OR inadequate response to ≥2 prior classes, OR
• – Quadruple therapy: high risk (WHO class IV), 4 different classes, inadequate response to ≥3 prior classes, AND one of the following — prostanoid started, or intolerance/contraindication/hypersensitivity to all prostanoids
• OR
• 4. The patient has PH-ILD (WHO Group 3) AND ALL of the following:
• • Requested agent is Tyvaso or Yutrepia
• • Diagnosis confirmed by right heart catheterization (medical records required)
• • Mean pulmonary arterial pressure > 20 mmHg
• • Pulmonary capillary wedge pressure ≤ 15 mmHg
• • Pulmonary vascular resistance > 2 Wood units
• • PH-ILD assessed using risk factors, clinical features, PFTs, BNP/NT-proBNP, imaging, echocardiography
• • Extensive parenchymal changes on CT
• • Patient is currently treated with standard of care ILD therapy (e.g., Ofev) AND will continue standard of care therapy
• OR
• 5. The patient has another FDA labeled indication for the requested agent and route
• AND if FDA labeled indication: patient's age within labeling OR supported by literature
• AND if request is for brand with available generic equivalent (Revatio, Adcirca, Tracleer, Letairis) then ONE of the following:
• • Intolerance or hypersensitivity to generic equivalent not expected with brand
• • FDA labeled contraindication to generic not expected with brand
• • Support for use of brand over generic
• AND if request is for Tadliq then ONE of the following:
• • Tried and inadequate response to generic tadalafil tablets
• • Intolerance or hypersensitivity to generic tadalafil tablets not expected with requested agent
• • FDA labeled contraindication to generic tadalafil tablets not expected with requested agent
• AND if request is for Liqrev then ONE of the following:
• • Tried and inadequate response to generic sildenafil oral suspension
• • Intolerance or hypersensitivity to generic sildenafil oral suspension not expected with requested agent
• • FDA labeled contraindication to generic sildenafil oral suspension not expected with requested agent
• AND prescriber is a specialist (e.g., cardiologist, pulmonologist) or has consulted with one
• AND patient does NOT have any FDA labeled contraindications to requested agent

Reauthorization criteria

• The requested agent is eligible for continuation of therapy AND ONE of the following:
• • Patient treated with requested agent within past 90 days (not samples)
• OR • Prescriber states patient treated with requested agent within past 90 days (not samples) and is at risk if therapy changed

Approval duration

12 months