ModifiedmhnPolicy CP.PHAR.196

Selexipag (Uptravi)

Policy governs medical necessity criteria, dosing limits, and prior authorization requirements for selexipag (Uptravi) for treatment of WHO Group 1 pulmonary arterial hypertension for members of the payer's lines of business.

Policy Summary

Payermhn

PolicySelexipag (Uptravi) for pulmonary arterial hypertension

Policy CodePolicy CP.PHAR.196

Change TypeMaterial changes: new IV formulation addedCommercial approval duration revised

Effective Date03.16

Next Review Date

Key ActionSubmit prior authorization with diagnosis, specialist involvement, dosing at or below limits (oral 3,200 mcg/day; IV 3,600 mcg/day) and titration plan when applicable.

SourceLink

POLICY UPDATE CHANGES

Added IV Uptravi 1800 mcg/10 mL formulation and criteria for use per PI.

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less.

Removed commercially unavailable branded products from Appendix B.

Updated dosing regimens and clarified drugs used for off-label indications in Appendix B.

3,200 mcg/dayoral maximum dose

3,600 mcg/dayIV maximum dose

12 moCommercial approval

6 mo

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Medicaid/HIM approval

1800 mcg/10 mLIV vial strength

Coverage and Medical Necessity Criteria

Initial Therapy (PAH)

Covered when ALL of the following are met

Initial PAH criteria: 1. Diagnosis of pulmonary arterial hypertension (PAH).

Initial PAH criteria: 2. Prescribed by or in consultation with a cardiologist or pulmonologist.

Initial PAH criteria: 3. Failure of a calcium channel blocker (see Appendix B), unless the member has either (a) an inadequate response or contraindication to acute vasodilator testing, OR (b) a contraindication to or clinically significant adverse effects from calcium channel blockers.

Initial PAH criteria: 4. If the request is for intravenous (IV) Uptravi, the member is temporarily unable to take oral therapy.

Initial PAH criteria: 5. Proposed dose does not exceed one of the following: (a) 3,200 mcg per day for oral formulation, OR (b) 3,600 mcg per day for IV formulation. Concomitant administration with CYP2C8 inducers (e.g., rifampin) may require higher doses.

Initial PAH criteria: 6. If the request is for titration, the provider has submitted a titration plan.

Continuation Therapy (PAH)

Continuation covered when ALL of the following are met

Continuation PAH criteria: 1. Member meets one of the following: (a) currently receiving the medication via the Centene benefit or previously met initial approval criteria; OR (b) member is currently receiving the medication and is enrolled in a state/product with continuity-of-care regulations.

Continuation PAH criteria: 2. Member is responding positively to therapy.

Continuation PAH criteria: 3. If the request is for intravenous (IV) Uptravi, the member is temporarily unable to take oral therapy.

Continuation PAH criteria: 4. If the request is for a dose increase, the new dose does not exceed one of the following: (a) 3,200 mcg per day for oral formulation, OR (b) 3,600 mcg per day for IV formulation. Concomitant administration with CYP2C8 inducers (e.g., rifampin) may require higher doses.

Dosing and formulation

Coverage guidance and criteria are not specified in this portion; clinical and dosing details included.

Dosing and formulation: Oral: initiate 200 mcg PO twice daily and increase at weekly intervals to the highest tolerated dose up to 1,600 mcg twice daily (oral maximum 3,200 mcg/day). Injection: IV given twice daily at a dose corresponding to the patient’s current oral dose (IV maximum 3,600 mcg/day).

IV single-dose vial available: 1800 mcg/10 mL (added in 1Q2024). Concomitant CYP2C8 inducers (e.g., rifampin) may require higher doses.

Requests for uses of selexipag that are for non‑FDA‑approved indications that are not specifically addressed in this policy are excluded unless the prescriber provides sufficient documentation of safety and efficacy consistent with the payer's off‑label use policies. See the referenced off‑label policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), and CP.PMN.53 (Medicaid) for required supporting evidence and documentation.

Per the most recent policy update, commercially unavailable branded products have been removed from Appendix B. These products should not be considered when evaluating coverage or submitting requests; providers should reference currently available formulations listed elsewhere in the policy when documenting therapy choices.

This document segment does not enumerate specific items judged to be not medically necessary. The policy is intended to guide medical necessity determinations but does not itself list explicit 'not medically necessary' conditions in this section; coverage decisions remain subject to the plan's coverage documents and applicable regulatory requirements.

Product Strengths, Dosing, and Maximums

Product strengths (informational)mixed

N/A	Document lists product strengths and formulation (tablets and single-dose vial) but contains no specific CPT/HCPCS/ICD-10 codes in this segment.

Tablet dosing

Tablet starting doseStart 200 mcg orally twice daily (PO BID)

Titration scheduleIncrease at weekly intervals to the highest tolerated dose

Tablet target per-dose maximumUp to 1,600 mcg twice daily (1,600 mcg BID)

Maximum dose (tablet)

Maximum oral daily dose3,200 mcg/day

ContextApplies to tablet (oral) formulation for PAH per dosage guidance

Related IV limit

Prior Authorization, Documentation, and Operational Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must document the diagnosis of pulmonary arterial hypertension (PAH) and that the prescriber is a cardiologist or pulmonologist or that the prescriber consulted with one. Prior authorization requests should include supporting clinical information (office notes, lab results, titration plan when applicable) demonstrating that the member meets all applicable approval criteria, including dosing limits and temporary inability to take oral therapy when IV formulation is requested.

Diagnosis of PAH documented in chart notes
Prescriber specialty: cardiology or pulmonology, or documented consultation
Include titration plan if request is for titration
Include office notes and lab results supporting criteria

Documentation Required

Documentation Standards

Providers must submit office chart notes, laboratory results, and other clinical documentation that support the member has met all approval criteria. Follow standard medical record practices and include any documentation referenced by state Medicaid manuals or plan coverage documents when applicable.

Clinical Background and Scope

Selexipag (Uptravi) is a selective prostacyclin (IP) receptor agonist indicated for treatment of pulmonary arterial hypertension (WHO Group 1) to delay disease progression and reduce the risk of hospitalization. Clinical trials demonstrated benefit in patients with WHO Functional Class II–III symptoms across multiple PAH etiologies. The agent is available in oral tablet strengths and as a single‑dose vial for IV administration; oral dosing begins at 200 mcg PO twice daily with weekly titration to the highest tolerated dose up to 1,600 mcg twice daily (oral maximum 3,200 mcg/day), and an IV single‑dose vial formulation (noted in the product availability) corresponds to IV dosing with a maximum of 3,600 mcg/day.

Key Terms and Classifications

Selexipag (Uptravi)

Drug classProstacyclin (IP) receptor agonist (non‑prostanoid)

IndicationTreatment of pulmonary arterial hypertension (WHO Group 1)

Primary goalDelay disease progression and reduce risk of hospitalization for PAH

WHO Functional Class (FC)

WHO Functional Class rangeClass I to IV

UseClassification of symptom severity used to guide treatment intensity for pulmonary hypertension

Examples

Policy Revision History

2024-10-03material_change

Added IV Uptravi 1800 mcg/10 mL formulation and criteria for IV use; clarified that concomitant administration with CYP2C8 inducers may require higher doses.

2024-11-08updateLatest

Removed commercially unavailable branded products from Appendix B and updated dosing regimens and clarification of drugs used for off-label indications.

2022-06-23policy_change

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less; applied template changes to other diagnoses/continued therapy sections.

Policy Summary

Payermhn

PolicySelexipag (Uptravi) for pulmonary arterial hypertension

Policy CodePolicy CP.PHAR.196

Change TypeMaterial changes: new IV formulation addedCommercial approval duration revised

Effective Date03.16

Next Review Date

Key ActionSubmit prior authorization with diagnosis, specialist involvement, dosing at or below limits (oral 3,200 mcg/day; IV 3,600 mcg/day) and titration plan when applicable.

SourceLink

On This Page

Continuation PAH criteria: 5. If the request is for titration, the provider has submitted a titration plan.

IV maximum is 3,600 mcg/day (see injection maximum)

Maximum dose (injection)

Maximum injection (IV) daily dose3,600 mcg/day

Dosing relationshipIV BID dose corresponds to the patient’s current oral Uptravi dose

Use caseIV recommended when patient temporarily unable to take oral therapy (per policy context)

Oral dosing titration

Oral titration starting doseStart 200 mcg PO BID

Titration frequencyIncrease at weekly intervals

Titration ceilingTitrate to highest tolerated dose up to 1,600 mcg BID

Office chart notes and progress notes
Relevant lab results and diagnostic test reports
Titration plan for dose escalation requests
State Medicaid manual documentation where applicable

Denial Risk

Non‑Covered Indications

Coverage is not authorized for non–FDA-approved indications unless sufficient documentation of efficacy and safety is provided in accordance with the plan's off-label use policies (CP.CPA.09 for commercial, HIM.PA.154 for Marketplace, CP.PMN.53 for Medicaid) or other applicable evidence of coverage documents.

Non‑FDA indications require strong supporting evidence per off‑label policies
Check evidence of coverage for plan‑specific rules

Step Therapy

There are no additional explicit step therapy requirements specified in this section beyond the requirement to document failure or intolerance to a calcium channel blocker for PAH initial approval (unless contraindicated or inadequate response to acute vasodilator testing).

Calcium channel blocker failure/intolerance requirement remains where applicable
No other step therapy sequences are specified here

Denial Risk

Denial Risk if Documentation Incomplete or Outdated

Requests lacking required documentation or that do not reflect current approval durations, dosing limits, or applicable off‑label policy support are at risk for denial. Examples include missing specialty consultation, absent titration plan for dose escalation, or requesting commercially unavailable products.

Missing specialty prescriber or consultation note
No titration plan for titration requests
Documentation not demonstrating failure/intolerance to required therapies
Requesting commercially unavailable branded products

FC I: no limitation of physical activity; FC IV: symptoms at rest

Selexipag / Uptravi — mechanism and formulation

Available formulationsOral tablets and single‑dose IV vial (1800 mcg/10 mL)

Mechanism noteProstacyclin receptor agonist that reduces pulmonary arterial pressure through vasodilation

Dosing relationshipIV dosing is administered BID at a dose corresponding to the patient’s current oral tablet dose

2020-10-12annual_review

1Q 2021 annual review: references revised (HIM.PHAR.21 to HIM.PA.154) and references reviewed/updated.