Selexipag (Uptravi) coverage
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Defines medical necessity and prior authorization criteria for selexipag (Uptravi) for treatment of pulmonary arterial hypertension (PAH) and related coverage rules for Ambetter Georgia lines of business.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy - Pulmonary Arterial Hypertension
Covered when ALL of the following are met:
From Initial Approval Criteria: item 1.
From Initial Approval Criteria: item 2.
From Initial Approval Criteria: item 3 and Appendix B reference.
From Initial Approval Criteria: item 4 and Quantity Limits.
Continuation Therapy - Pulmonary Arterial Hypertension
Continued therapy covered when ALL of the following are met:
From Continued Therapy: item 1.
From Continued Therapy: item 2 and policy history adding an efficacy statement.
From Continued Therapy: item 3 and Quantity Limits.
Other Indications
Other diagnoses/indications (not PAH):
From Initial Approval Criteria B and cross-reference to off-label policies.
From Continued Therapy Other indications: approval duration guidance.
Coverage for indications not specifically listed in this policy is limited. Non‑FDA approved indications that are not addressed in this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy: CP.CPA.09 (Commercial), HIM.PA.154 (Marketplace), or CP.PMN.53 (Medicaid). Requests for such non‑FDA uses should include the clinical evidence required by those off‑label policies to be considered for approval.
Routine policy‑level safety checks previously included in older versions of this policy have been removed except where they remain necessary for safe use. Safety criteria are retained only if they: 1) constitute a documented contraindication or a black‑box warning not covered by a REMS program, or 2) require specific laboratory or imaging parameters that must be met prior to initiation of therapy. Absence of required REMS, contraindication, or pre‑initiation lab/imaging documentation may be a basis for denial.
Coverage decisions for selexipag are driven by the specific criteria for pulmonary arterial hypertension (PAH) and limited allowances for other indications. For Initial Therapy — PAH, coverage is authorized only when ALL of the following are met: a documented diagnosis of PAH (WHO Group 1); the drug is prescribed by or in consultation with a cardiologist or pulmonologist; failure of a trial of a calcium channel blocker has been documented unless there was an inadequate response to acute vasodilator testing or a contraindication/intolerable adverse effect to calcium channel blockers; and the requested dose does not exceed the maximum daily dose of 3,200 mcg/day. If the request is for ongoing titration, the provider must submit a titration plan. Initial approval durations were historically increased to 6 months in prior revisions.
For Continuation Therapy — PAH, continued coverage requires that the member is currently receiving selexipag through the Centene benefit or previously met all initial approval criteria, and that there is documentation the member is responding positively to therapy. Dose increases must not exceed 3,200 mcg/day, and titration requests require submission of a titration plan. Continuation approval durations were historically increased to 12 months, and an efficacy statement was added to the continuation criteria.
For Other Indications (diagnoses not PAH), coverage is limited and may be allowed only when either: 1) the request aligns with the off‑label use policy criteria described above with adequate documentation of efficacy and safety, or 2) the member is already receiving the medication under the Centene benefit with documentation of a positive response — in which case approval duration will be the lesser of the requested duration or 6 months.
Initial Therapy
Continued Therapy
Step Therapy Requirements
| Step | Requirement | Notes |
|---|---|---|
| 1 | ||
| Failure of a calcium channel blocker prior to approval | ||
| See Appendix B for listed calcium channel blocker agents and dosing (e.g., nifedipine, diltiazem, amlodipine); exceptions include inadequate response to acute vasodilator testing or contraindication/clinically significant adverse effects to calcium channel blockers. |
| Step | Policy Revision Note | Implication for Step Therapy |
|---|---|---|
| 1 | ||
| Functional class II (FC II) was added to the prostanoid class of pulmonary hypertension drugs during policy revisions. | ||
| Addition of FC II may affect placement/sequencing of prostanoid agents within step therapy and is reflected in reorganized appendices and historical step placement guidance. |
Quantity Limits
Coding
Provider Actions and Requirements
Prior authorization required: confirm PAH diagnosis and specialist involvement
Prior authorization is required. The provider must demonstrate the member has a diagnosis of pulmonary arterial hypertension (PAH) and that the drug is prescribed by or in consultation with a cardiologist or pulmonologist as part of the PAH approval criteria.
- Diagnosis of PAH must be documented
- Prescribed by or in consultation with a cardiologist or pulmonologist
Submit titration plan with prior authorization for titration requests
When the request is for titration, the prior authorization must include a titration plan and supporting clinical documentation as noted in the policy updates.
- Include a titration schedule when requesting dose titration
- Provide supporting clinical documentation per policy (office notes, labs, etc.)
Document calcium channel blocker trial or valid exception
Prior to approval, the provider must document failure of a calcium channel blocker trial unless the member had an inadequate response to acute vasodilator testing or has a contraindication or clinically significant adverse effects to calcium channel blockers.
- If trialed, document agent, dose, and duration (see Appendix B for agents/dosing)
- If exempt, document inadequate response to acute vasodilator testing or specific contraindication/intolerable adverse effects
Note: Functional class II added historically—document FC and therapy sequence
The prostanoid class of pulmonary hypertension drugs was updated historically to include WHO functional class II; this affects step placement and sequencing—ensure documentation reflects current functional class and prior step therapy where applicable.
- Document member functional class (WHO/NYHA) if relevant
- Reflect prior therapeutic sequencing per appendices
Submit clinical documentation (office notes, labs, prior therapy)
Provider must submit office chart notes, laboratory results, or other clinical information that support the member meets all approval criteria (diagnosis, specialist involvement, prior therapy or exceptions, dosing limits).
- Include documentation of PAH diagnosis
- Include specialist consultation/prescription notes
- Include prior therapy trials, labs, and any acute vasodilator testing results
Titration plan must be provided for titration requests (added 1Q2020)
A titration plan is required to be submitted for requests that involve dose titration; this requirement was added in the 1Q 2020 annual review.
- Provide planned dosing increments and schedule for titration requests
- Reference: policy update adding titration plan requirement (1Q 2020)
Non‑FDA indications: denial risk without off‑label documentation
Requests for non‑FDA approved indications not addressed in this policy will be denied unless there is sufficient documentation of efficacy and safety per the off‑label use policies referenced (CP.CPA.09, HIM.PA.154, CP.PMN.53).
- If requesting off‑label use, include documentation meeting the referenced off‑label use policy criteria
- If previously receiving therapy via Centene and evidence of benefit exists, include documentation supporting positive response
Safety criteria removal: document contraindications/REMS or required labs/imaging
Safety criteria were removed from the policy except where they represent contraindications, black box warnings not covered by a REMS, or specific lab/imaging parameters required prior to initiation; absence of documentation for these required safety items could result in denial.
- If a contraindication, black box warning, or REMS applies, include documentation
- If the policy specifies lab or imaging parameters, provide results showing criteria met prior to initiation
Definitions
Background
Selexipag is an oral prostacyclin (IP) receptor agonist indicated to delay disease progression and reduce the risk of hospitalization in patients with pulmonary arterial hypertension (PAH, WHO Group 1). Efficacy was demonstrated in long‑term studies enrolling patients with WHO functional class II–III PAH (including idiopathic/heritable PAH, connective tissue disease–associated PAH, and PAH with repaired congenital shunts). Initiation typically begins at 200 mcg PO twice daily with weekly increases to the highest tolerated dose up to a maximum of 3,200 mcg/day; therapy is intended to be prescribed by or in consultation with a cardiologist or pulmonologist and requires prior authorization per policy criteria.
Revision History
Age restriction removed; WHO FC II was added to the prostanoid class of pulmonary hypertension drugs; safety criteria were removed except when representing contraindications/black box warnings not covered by REMS or when specific lab/imaging parameters are required; appendices reorganized; initial and continuation durations increased (to 6 and 12 months respectively); an efficacy statement was added to the continuation criteria.
Appendices covering PH groups, functional class, and therapies reorganized.
Policies combined for commercial, HIM and Medicaid; Medicaid removed WHO/NYHA classifications from initial criteria when specialist is involved in care; references reviewed and updated.
1Q2019 annual review noted no significant clinical changes; references reviewed and updated.
1Q2020 annual review (noted in history) — statement added requiring submission of a titration plan and continued references review/updates.
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