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Opsynvi — Blue Cross Blue Shield of New Mexico

Raynaud’s phenomenon

Initial criteria

  • 1. The requested agent is eligible for continuation of therapy (patient treated with requested agent within past 90 days and at risk if changed) AND the patient has an FDA labeled indication for the requested agent OR
  • 2. The patient has chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) AND ALL of: 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; NOT used with PDE5 inhibitor; and EITHER not a surgical candidate OR has persistent/recurrent disease post-endarterectomy.
  • 3. The patient has pulmonary arterial hypertension (PAH, WHO Group 1) AND ALL of: diagnosis confirmed by right heart catheterization; mean pulmonary artery pressure >20 mmHg; pulmonary capillary wedge pressure ≤15 mmHg; pulmonary vascular resistance >2 Wood units; if Winrevair, patient not pregnant or planning pregnancy; if PDE5i/sGC agents, not in combination with another PDE5i; and one of the following therapy conditions:
  • • Monotherapy if not Winrevair, OR
  • • Dual therapy with one agent from two different classes (ERA, PDE5i, prostanoid) OR ERA + sGC after inadequate response to ERA + PDE5i, OR
  • • Triple therapy (ERA + PDE5i + prostanoid) when high risk or WHO class IV OR after inadequate response to at least two of ERA, PDE5i, prostanoid/receptor agonist, OR
  • • Quadruple therapy if high risk or WHO class IV, all four agents from different classes, inadequate response to at least three of ERA, PDE5i, activin-signaling inhibitor, prostacyclin analogue/receptor agonist, AND either prostanoid included OR intolerance/contraindication to all prostanoids.
  • 4. The patient has pulmonary hypertension associated with interstitial lung disease (PH-ILD, WHO Group 3) AND ALL of: requested agent is Tyvaso or Yutrepia; diagnosis confirmed by right heart catheterization; mean pulmonary artery pressure >20 mmHg; pulmonary capillary wedge pressure ≤15 mmHg; pulmonary vascular resistance >2 Wood units; PH-ILD evaluated using risk factors, PFTs, BNP/NT-proBNP, imaging, echocardiography; extensive parenchymal changes on CT; and patient is on and will continue standard of care ILD therapy (e.g., Ofev).
  • 5. The patient has Raynaud’s phenomenon AND ALL of: requested agent is Adcirca or Revatio; not taking oral ED agents or guanylate cyclase stimulators; and has tried, or has intolerance/hypersensitivity/contraindication to, dihydropyridine calcium channel blockers.
  • 6. The patient has another FDA labeled indication for the requested agent, and patient’s age is within labeling or supported by evidence.
  • 7. For brand agents (Revatio tablet, Adcirca, Tadliq, Tracleer, Letairis, Revatio oral suspension, Liqrev), ONE of: treated/stable on brand; inadequate response, intolerance, contraindication, or adverse outcome with generic; generic ineffective or not in best interest based on patient characteristics; or use consistent with metastatic cancer indications and best practices.
  • 8. Prescriber is a specialist (e.g., cardiologist, pulmonologist) or has consulted with a specialist.
  • 9. Patient does not have any FDA labeled contraindications to the requested agent.

Approval duration

12 months