Selexipag (Uptravi) — Coverage Criteria
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Defines medical necessity and prior authorization criteria for selexipag (Uptravi) for treatment of pulmonary arterial hypertension (PAH) across Health Net lines of business including Commercial, HIM, and Medicaid.
Added IV Uptravi 1800 mcg/10 mL formulation and criteria for use per prescribing information.
Clarified that concomitant administration with CYP2C8 inducers may require higher doses.
Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less.
Coverage Criteria for Selexipag (Uptravi)
inv-01: Initial Therapy — Covered when ALL of the following are met:
Covered when ALL of the following are met:
inv-02: Continuation Therapy — Covered when ALL of the following are met:
Covered when ALL of the following are met:
inv-03: Initial and dosing requirements — Coverage aligned to Uptravi prescribing information and policy updates
Coverage aligned to Uptravi prescribing information and policy updates
Formulations listed in Product Availability section
Requests for use of selexipag (Uptravi) for non‑FDA approved indications that are not specifically addressed by this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or other evidence of coverage documents.
Appendix B was updated to remove commercially unavailable branded products per Clinical Pharmacology review; these removed brands are no longer considered as therapeutic alternatives for coverage decisions and have been excluded from the policy appendices.
Use of selexipag for diagnoses or indications that are not listed in this policy is considered not authorized unless the provider supplies adequate off‑label documentation in accordance with the referenced off‑label use policies (see CP.CPA.09, HIM.PA.154, CP.PMN.53 or evidence of coverage documents).
There are no additional explicit not medically necessary conditions specified beyond the standard exclusions and off‑label limitations already described in this policy and its appendices; policy updates have focused on formulation availability and dosing clarifications rather than adding new NMN statements.
Coding, Dosing, and Formulations
| NDC | Not listed in this document |
| NDC | IV single-dose vial 1800 mcg/10 mL; multiple tablet strengths 200 mcg–1600 mcg |
Prior Authorization, Documentation, and Prescribing Requirements
Obtain prior authorization and meet approval durations
Prior authorization is required and will only be granted when the member meets the policy's initial or continuation criteria; approvals are issued for specified durations by line of business (Medicaid/HIM initial 6 months; Commercial initial 12 months or duration of request, whichever is less).
Specify dose, formulation, and clinical rationale
When requesting prior authorization, include the specific dose, formulation (oral tablet strengths or IV single‑dose vial 1800 mcg/10 mL), and clinical rationale consistent with the Uptravi prescribing information.
Confirm failure of calcium channel blocker prior to approval
Document that the member has had failure of a calcium channel blocker unless there is a documented contraindication or clinically significant adverse effect to calcium channel blockers; therapeutic alternatives are listed in Appendix B.
- Failure of a calcium channel blocker is required unless contraindicated or intolerant
- Appendix B lists therapeutic alternatives (e.g., nifedipine, diltiazem, amlodipine)
No explicit step sequence beyond CCB failure
No additional step therapy sequencing is specified by this policy beyond the requirement to document failure of a calcium channel blocker when applicable.
Provide clinical documentation and titration plan as required
Submit supporting clinical documentation such as office chart notes, titration plans (if request is for titration), and relevant lab or clinical data demonstrating the diagnosis of PAH and that approval criteria are met.
- Provide a titration plan if the request is for titration
- For IV requests, document temporary inability to take oral therapy
Align documentation with Uptravi prescribing information
Ensure submitted documentation aligns with the Uptravi prescribing information for formulation and dosing—specifically IV Uptravi 1800 mcg/10 mL when used, and note that concomitant administration with CYP2C8 inducers may require higher doses.
Off‑label indication requests must meet off‑label policies
Requests for non‑FDA approved (off‑label) indications not addressed in this policy may be denied unless adequate off‑label use documentation is provided per the referenced off‑label use policies.
- Follow off‑label documentation requirements in CP.CPA.09 (Commercial), HIM.PA.154 (HIM), or CP.PMN.53 (Medicaid) as applicable
Avoid documentation/dosing mismatches with IV formulation and CYP2C8 guidance
Coverage and authorization may be affected or denied if submitted documentation does not reflect the updated IV formulation criteria (IV 1800 mcg/10 mL) or dosing adjustments when selexipag is coadministered with CYP2C8 inducers.
- Ensure IV requests document use of the single‑dose 1800 mcg/10 mL vial and rationale for IV use (temporary inability to take oral therapy)
- Document consideration of higher doses when coadministered with CYP2C8 inducers (e.g., rifampin)
Definitions and Drug Class
Background
Selexipag (Uptravi) is a prostacyclin pathway agent — a non‑prostanoid prostacyclin (IP) receptor agonist — developed to reduce pulmonary arterial pressure through vasodilation in patients with pulmonary arterial hypertension (WHO Group 1). Clinical intent of therapy is to delay disease progression and reduce the risk of hospitalization; recent policy updates added an IV formulation (single‑dose vial 1800 mcg/10 mL) and clarified dosing considerations when coadministered with CYP2C8 inducers.
Policy Revision History and Material Changes
1Q 2024 annual review added IV Uptravi 1800 mcg/10 mL formulation and incorporated criteria for IV use per prescribing information; clarified dosing adjustments when coadministered with CYP2C8 inducers.
Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less; template changes applied to other diagnoses/continued therapy sections.
1Q 2021 annual review: references revised (HIMPHAR.21 updated to HIM.PA.154) and references reviewed and updated.
1Q 2022 annual review: no significant changes; references reviewed and updated.
1Q 2023 annual review: no significant changes; references reviewed and updated.
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