tadalafil — Blue Cross Blue Shield of Illinois

Initial criteria

• ALL of the following must be met:
• 1. ONE of the following:
• A. The requested agent is eligible for continuation of therapy AND the patient has been treated with the requested agent within the past 90 days (samples not accepted) AND is at risk if therapy is changed AND the patient has an FDA labeled indication for the requested agent and route of administration OR
• B. Diagnosis = CTEPH (WHO Group 4) AND the requested agent is Adempas AND diagnosis confirmed by ventilation-perfusion scan and selective pulmonary angiography AND mean pulmonary artery pressure > 20 mmHg AND pulmonary capillary wedge pressure ≤ 15 mmHg AND pulmonary vascular resistance > 2 Wood units AND (NOT a surgical candidate OR has persistent/recurrent disease after pulmonary endarterectomy) AND the agent will NOT be used with any PDE5 inhibitor (e.g., tadalafil, sildenafil) OR
• C. Diagnosis = PAH (WHO Group 1) AND 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
• • If the agent is Winrevair, patient is not pregnant or planning pregnancy while on therapy
• • If agent is Adcirca, Adempas, Liqrev, Opsynvi, Revatio, sildenafil, Tadliq, or tadalafil, it will NOT be used in combination with another PDE5 inhibitor
• • ONE of the following therapy configurations:
• – Monotherapy if agent is not Winrevair OR
• – Dual therapy: 1 agent from 2 of classes (ERA, PDE5i, prostanoid) OR ERA + sGC (Adempas) if inadequate response to ERA + PDE5i OR
• – Triple therapy: ERA + PDE5i + prostanoid (high-risk or WHO class IV) OR ERA + PDE5i + Winrevair or prostanoid after inadequate response to ≥2 drug classes (ERA, PDE5i, prostacyclin analogue/receptor agonist) OR
• – Quadruple therapy: all 4 agents from different classes AND high risk (PAH risk tool or WHO class IV) AND inadequate response to ≥3 classes (ERA, PDE5i, activin-signaling inhibitor, prostacyclin analogue/receptor agonist) AND (prostanoid started OR intolerance/contraindication/hypersensitivity to all prostanoids)
• D. Diagnosis = PH-ILD (WHO Group 3) AND requested agent is Tyvaso or Yutrepia AND confirmed by right heart catheterization AND mean pulmonary artery pressure > 20 mmHg AND pulmonary capillary wedge pressure ≤ 15 mmHg AND pulmonary vascular resistance > 2 Wood units AND PH-ILD assessment includes risk factors, clinical features, PFT, BNP/NT-proBNP, imaging, echocardiography AND extensive parenchymal changes on CT AND currently treated with and will continue standard ILD therapy (e.g., Ofev) OR
• E. Diagnosis = Raynaud’s phenomenon AND requested agent is Adcirca or Revatio AND NOT concurrently taking an erectile dysfunction agent or guanylate cyclase stimulator (e.g., Adempas) AND (trial of or intolerance/contraindication to dihydropyridine calcium channel blocker) OR
• F. Other FDA labeled indication for the agent and route of administration AND
• 2. Age requirement: within FDA labeling or supported for age for the requested indication AND
• 3. If the requested brand agent is Revatio, Adcirca, Tadliq, Tracleer, Letairis, Revatio oral suspension, or Liqrev THEN must meet ONE of the following:
• – Patient with stage IV metastatic cancer using for cancer or related condition with use consistent with best practices FDA-supported OR
• – Currently stable on requested agent OR
• – Tried and inadequate response to corresponding generic OR
• – Generic discontinued due to lack of efficacy/diminished effect/adverse event OR
• – Intolerance or hypersensitivity to generic not expected with brand OR
• – FDA labeled contraindication to generic not expected with brand OR
• – Generic expected to be ineffective or inappropriate due to patient characteristics or adherence issues or comorbidities or adverse effects OR
• – Generic not in best interest of patient (medical necessity) OR
• – Tried another drug in same class discontinued due to inefficacy/adverse event OR
• – Supported use for requested brand over generic
• 4. Prescriber is a specialist (e.g., cardiologist, pulmonologist) or has consulted with one AND
• 5. No FDA labeled contraindications to requested agent.

Approval duration

12 months