Prior Authorization — Pulmonary Hypertension Agents (PAH, CTEPH, PH-ILD)
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Policy governs prior authorization and reauthorization requirements for specified pulmonary hypertension medications (PAH agents) under the pharmacy benefit for Colorado Rocky Mountain Health Plans members.
No material clinical or coverage changes in this revision.
Coverage Criteria for PAH Agents
Initial Authorization — Pulmonary Arterial Hypertension (PAH)
Covered when ALL of the following are met:
Authorization issued for 12 months
Reauthorization — Pulmonary Arterial Hypertension (PAH)
Covered when ALL of the following are met:
Authorization issued for 12 months
Initial Authorization — CTEPH (Adempas)
Covered when ALL of the following are met:
Authorization issued for 12 months
Initial Authorization — Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
Covered when ALL of the following are met:
Authorization issued for 12 months
Certain brand formulations are handled specially under this policy. Adcirca, Letairis, Liqrev oral suspension, Opsynvi, and Revatio oral powder for suspension have historically been typically excluded from coverage or may be subject to plan-specific exclusion or tried/failed requirements; consult the member's benefit plan for current exclusion status and any step-edit requirements. The policy language and reference history also note changes over time to which formulations are excluded (see plan-specific details for the most current status).
Be aware of contraindicated combinations: administration of oral PDE-5 inhibitors with any form of organic nitrate (regularly or intermittently) is contraindicated. In addition, concomitant use of oral PDE-5 inhibitors with Adempas (riociguat) is contraindicated. Use of these combinations is clinically inappropriate and may result in denial of authorization.
Covered Products and Authorization Duration
| Adcirca | tadalafil (brand) |
| Adempas | riociguat |
| Alyq | tadalafil |
| Letairis | ambrisentan |
| Liqrev | sildenafil oral suspension |
| Opsumit | macitentan |
| Opsynvi | macitentan/tadalafil combination |
| Orenitram | treprostinil oral |
| Revatio | sildenafil oral powder for suspension |
| Tadliq | tadalafil oral suspension |
Prior Authorization, Documentation, and Prescribing Notes
Prior authorization required for listed PAH agents and formulations
Prior authorization is required for the listed PAH agents and the specified oral suspension/powder formulations. Initial approvals are issued for 12 months when diagnosis criteria are met. State mandates, federal requirements, and member-specific benefit plan coverage may affect coverage and other utilization management programs may apply.
- Applies to: Adcirca, Adempas, Alyq, Letairis, Liqrev oral suspension, Opsumit, Opsynvi, Orenitram, Revatio oral powder for suspension, Tadliq oral suspension, Tracleer, Tyvaso, Tyvaso DPI, Uptravi, Ventavis, and Yutrepia.
- Initial authorization duration: 12 months.
Exclusion / step-edit — check member plan
Some brand formulations are typically excluded from coverage or may be subject to tried/failed (step) criteria per the member's plan; refer to the member's benefit plan to determine exclusion status and any plan-specific step edits.
- Brand products typically excluded: Adcirca, Letairis, Liqrev oral suspension, Opsynvi, Revatio oral powder for suspension.
- Tried/Failed criteria or other plan-specific step edits may apply — check member plan specifics.
Reauthorization requires documentation of positive clinical response
For reauthorization of PAH agents (including Adempas and Tyvaso products), the provider must submit documentation demonstrating a positive clinical response to the therapy to support continued coverage.
- PAH reauthorization: "Documentation of positive clinical response to therapy" is required.
- Adempas reauthorization: "Documentation of positive clinical response to Adempas therapy" is required.
- Tyvaso/Tyvaso DPI/Yutrepia reauthorization: "Documentation of positive clinical response to Tyvaso, Tyvaso DPI, or Yutrepia therapy" is required.
Initial authorization requires symptomatic diagnosis
Initial authorization requires documentation of a symptomatic diagnosis of the applicable condition (symptomatic PAH for PAH agents; symptomatic inoperable or persistent/recurrent CTEPH for Adempas; symptomatic PH-ILD for Tyvaso/Tyvaso DPI/Yutrepia).
- PAH initial auth: "Diagnosis of pulmonary arterial hypertension which is symptomatic."
- Adempas initial auth (CTEPH): "Diagnosis of inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) which is symptomatic."
- PH-ILD initial auth (Tyvaso products, Yutrepia): "Diagnosis of pulmonary hypertension associated with interstitial lung disease which is symptomatic."
Contraindicated combinations — avoid oral PDE‑5 + nitrates or oral PDE‑5 + Adempas
Concomitant use that is contraindicated must be avoided: administration of oral PDE-5 inhibitors with any form of organic nitrate, and concomitant administration of oral PDE-5 inhibitors with Adempas are contraindicated and clinically inappropriate.
- "Administration of the oral PDE-5 inhibitors to patients taking any form of organic nitrate, either regularly or intermittently, is contraindicated."
- "The concomitant administration of oral PDE-5 inhibitors with Adempas is contraindicated."
- Combination use may lead to denial of coverage.
Clinical Definitions and Indication Groups
Background
Pulmonary arterial hypertension (PAH) is a progressive disease characterized by elevated pulmonary vascular pressures that reduce exercise capacity and can lead to right‑sided heart dysfunction. Multiple drug classes target the pathophysiologic pathways in PAH, including endothelin receptor antagonists, phosphodiesterase type‑5 (PDE‑5) inhibitors, prostacyclin analogs and receptor agonists, and soluble guanylate cyclase stimulators. Several agents included in this policy also have indications for related conditions such as chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary hypertension associated with interstitial lung disease (PH‑ILD).
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