Letairis — Blue Cross Blue Shield of Montana

Initial criteria

• ONE of the following:
• A. BOTH of the following: The requested agent is eligible for continuation of therapy AND prescriber states the patient has been treated with the requested agent within the past 90 days (excluding samples) AND patient is at risk if therapy is changed AND the patient has an FDA labeled indication for the requested agent and route of administration
• B. chronic thromboembolic pulmonary hypertension (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 candidate for surgery OR had pulmonary endarterectomy and persistent/recurrent disease; and patient will NOT use with a PDE5 inhibitor (e.g., tadalafil or sildenafil)
• C. pulmonary arterial hypertension (PAH, WHO Group 1) AND ALL of the following: diagnosis confirmed by right heart catheterization; mean pulmonary arterial pressure > 20 mmHg; pulmonary capillary wedge pressure ≤ 15 mmHg; pulmonary vascular resistance > 2 Wood units; if Winrevair requested, patient not pregnant or planning to become pregnant; if Adcirca, Adempas, Liqrev, Opsynvi, Revatio, sildenafil, Tadliq, or tadalafil requested, will NOT be used with another PDE5 inhibitor; ONE of the following therapy structures:
•   1. Monotherapy (agent not Winrevair) OR
•   2. Dual therapy: ONE of the following: (a) 1 agent from two of ERA, PDE5i, prostanoid classes OR (b) ERA + sGC inhibitor (Adempas) after unacceptable response to ERA + PDE5i OR
•   3. Triple therapy: ONE of the following: (a) ERA + PDE5i + prostanoid with high risk/WHO IV OR (b) ERA + PDE5i + activin‑signaling inhibitor (Winrevair) or prostanoid after inadequate response with ≥2 prior classes (ERA, PDE5i, prostacyclin analogue/receptor agonist) OR
•   4. Quadruple therapy: high risk or WHO IV; four agents each from distinct classes; inadequate response to ≥3 prior drug classes (ERA, PDE5i, activin‑signaling inhibitor, prostacyclin analogue/receptor agonist) AND ONE of: prostanoid started OR prostanoid intolerance/FDA contraindication/hypersensitivity to ALL prostanoids
• D. pulmonary hypertension associated with interstitial lung disease (PH‑ILD, WHO Group 3) AND ALL: requested agent is Tyvaso or Yutrepia; diagnosis confirmed by right heart catheterization; mean pulmonary arterial pressure > 20 mmHg; pulmonary capillary wedge pressure ≤ 15 mmHg; pulmonary vascular resistance > 2 Wood units; PH‑ILD assessment includes risk factors, clinical features, PFT, BNP/NT‑proBNP, imaging, echocardiography; extensive parenchymal changes on CT; BOTH: currently treated with and will continue standard ILD therapy (e.g., Ofev)
• E. Raynaud’s phenomenon AND ALL: requested agent is Adcirca or Revatio; patient not concurrently taking an oral erectile dysfunction agent or guanylate cyclase stimulator; ONE of: tried dihydropyridine calcium channel blocker (e.g., amlodipine, felodipine, nifedipine) OR intolerance/hypersensitivity OR FDA contraindication to all dihydropyridine CCBs
• F. Patient has another FDA labeled indication for the requested agent and route of administration
• AND if FDA labeled indication present, ONE of: patient’s age within FDA labeling OR support exists for use in patient’s age
• If requested brand is Revatio tablet, Adcirca, Tadliq, Tracleer, Letairis, Revatio oral suspension, or Liqrev, then ONE of the following additional applies:
• A. Stage 4 advanced/metastatic cancer treated with or related to cancer; consistent with best practices, evidence‑based, FDA approved 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/effectiveness or adverse event OR
• E. Intolerance/hypersensitivity to generic not expected with brand OR
• F. FDA labeled contraindication to generic not expected with brand OR
• G. Generic expected to be ineffective or barrier to adherence, worsen comorbid condition, or decrease functional ability, or cause harm OR
• H. Generic not in best interest based on medical necessity OR
• I. Tried another drug in same pharmacologic class/MOA discontinued due to adverse event or inefficacy OR
• J. Support for use of requested brand over generic
• Prescriber is specialist in or has consulted specialist in area of diagnosis (e.g., cardiologist, pulmonologist)
• Patient does NOT have any FDA labeled contraindications to the requested agent
• For BCBS MT Fully Insured or MT HIM member: approve if patient age < 18 years

Approval duration

12 months