Opsynvi — Blue Cross Blue Shield of Texas

Initial criteria

• ONE of the following:
• A. BOTH of the following: 1. The requested agent is eligible for continuation of therapy AND the prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed AND 2. The patient has an FDA labeled indication for the requested agent and route of administration OR
• B. The patient has chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) AND ALL of: 1. Requested agent is Adempas; 2. Diagnosis confirmed by ventilation-perfusion scan and selective pulmonary angiography; 3. Mean pulmonary artery pressure >20 mmHg; 4. Pulmonary capillary wedge pressure ≤15 mmHg; 5. Pulmonary vascular resistance >2 Wood units; 6. ONE of: not a surgical candidate OR had pulmonary endarterectomy with persistent/recurrent disease; 7. Will NOT use with PDE5 inhibitor (e.g., tadalafil or sildenafil) OR
• C. The patient has pulmonary arterial hypertension (PAH, WHO Group 1) AND ALL of the following: 1. Diagnosis confirmed by right heart catheterization (medical records required); 2. Mean pulmonary arterial pressure >20 mmHg; 3. Pulmonary capillary wedge pressure ≤15 mmHg; 4. Pulmonary vascular resistance >2 Wood units; 5. If Winrevair requested, patient is not pregnant or planning pregnancy while on therapy; 6. If PDE5 inhibitor (Adcirca, Adempas, Liqrev, Opsynvi, Revatio, sildenafil, Tadliq, tadalafil) requested, not in combination with another PDE5 inhibitor; 7. ONE of: A. Monotherapy if agent not Winrevair OR B. Dual therapy of 2 of 3 PAH classes (ERA, PDE5i, prostanoid) OR ERA + sGC inhibitor after inadequate response to ERA + PDE5i OR C. Triple therapy (ERA + PDE5i + prostanoid) for WHO Class IV or high-risk or inadequate response to 2 or more PAH classes OR D. Quadruple therapy (4 different classes) if high-risk/WHO Class IV and inadequate response to 3+ PAH drug classes and ONE of: prostanoid started OR intolerance/contraindication/hypersensitivity to all prostanoids
• D. The patient has PH-ILD (WHO Group 3) AND ALL of: 1. Requested agent is Tyvaso or Yutrepia; 2. Diagnosis confirmed by right heart catheterization; 3. Mean pulmonary arterial pressure >20 mmHg; 4. Pulmonary capillary wedge pressure ≤15 mmHg; 5. Pulmonary vascular resistance >2 Wood units; 6. PH-ILD assessed using key factors (risk factors, clinical features, PFT, BNP/NT-proBNP, imaging, echocardiography); 7. Extensive parenchymal changes on CT; 8. BOTH: A. Currently treated with standard of care for ILD (e.g., Ofev) AND B. Will continue standard of care for ILD
• E. The patient has Raynaud’s phenomenon AND ALL of: 1. Requested agent is Adcirca or Revatio; 2. NOT concurrently taking erectile dysfunction agents or guanylate cyclase stimulators; 3. ONE of: A. Tried dihydropyridine calcium channel blocker (e.g., amlodipine, felodipine, nifedipine) OR B. Intolerance/hypersensitivity to calcium channel blocker OR C. Contraindication to all such agents
• F. The patient has another FDA labeled indication for the requested agent and route AND ALL of: 1. Age within FDA labeling or supported for patient’s age for the requested indication; 2. If brand listed below requested (Revatio tablet, Adcirca, Tadliq, Tracleer, Letairis, Revatio oral suspension, Liqrev), then ONE of: A. Stage IV metastatic cancer use for cancer or associated condition AND consistent with best practices and FDA approval OR B. Currently stable on requested agent OR C. Tried and inadequate response to corresponding generic OR D. Generic discontinued due to lack of efficacy/adverse event OR E. Intolerance/hypersensitivity to generic OR F. Contraindication to generic OR G. Generic expected to be ineffective/adherence barrier/worsen comorbidity/harm OR H. Generic not in best interest based on medical necessity OR I. Tried another agent in same pharmacologic class discontinued for lack of efficacy/adverse event OR J. Support for use of requested brand over generic
• The prescriber is a specialist or consulted with specialist in patient’s diagnosis AND Patient has no FDA labeled contraindications to requested agent

Approval duration

12 months