CurrentNeighborhood Health Plan of Rhode IslandPolicy 6216-A

Etrasimod (Velsipity) for Ulcerative Colitis — Coverage Criteria

Covers prior authorization, clinical criteria, and continuation requirements for etrasimod (Velsipity) when prescribed for moderately to severely active ulcerative colitis in adults; applies to members of Neighborhood Health Plan of Rhode Island using referenced pharmacy benefit products.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEtrasimod (Velsipity) for Ulcerative Colitis — Coverage Criteria

Policy CodePolicy 6216-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit required documentation demonstrating the member meets clinical criteria and has no exclusions.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

1FDA-approved indication

Gastroenterologistprescriber requirement

Yesconcomitant therapy prohibited

Coverage Criteria for Etrasimod (Velsipity)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEtrasimod (Velsipity) for Ulcerative Colitis — Coverage Criteria

Policy CodePolicy 6216-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit required documentation demonstrating the member meets clinical criteria and has no exclusions.

SourceLink

On This Page

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inv-01: Initial Authorization

Covered when ALL of the following are met

Primary indication: Member is an adult with moderately to severely active ulcerative colitis (FDA-approved indication).

Source: FDA-approved indication

Authorization duration: Authorization may be granted for up to 12 months.12 months

Initial approvals may be for 12 months.

inv-02: Continuation Therapy

Continuation therapy — Covered when ANY of the following improvement measures from baseline are met

Evidence of response or remission: Member demonstrates remission or positive clinical response as evidenced by improvement in stool frequency, rectal bleeding, urgency of defecation, C-reactive protein (CRP), fecal calprotectin (FC), appearance of the mucosa on endoscopy/CTE/MRE/intestinal ultrasound, or improvement on a disease activity scoring tool (e.g., UCEIS, Mayo).

Documentation (chart notes or medical records) required for continuation.

Authorization duration for continuation: Authorization may be granted for up to 12 months for members who achieve or maintain remission or demonstrate a positive clinical response.12 months

Continuation approvals may be for 12 months.

inv-03: Not Medically Necessary / Experimental Uses

Not covered indications: All indications other than treatment of moderately to severely active ulcerative colitis in adults are considered experimental/investigational and not medically necessary.

Requests for non‑approved indications may be denied.

Coverage for etrasimod (Velsipity) is limited such that the member must not receive the requested medication at the same time as immunomodulators, biologic drugs, or targeted synthetic drugs. Concurrent use with any of these agents may result in denial of the request.

Use of etrasimod (Velsipity) for any indication other than treatment of moderately to severely active ulcerative colitis in adults is considered experimental/investigational and not medically necessary and is not covered.

Referenced Covered Drugs / Codes

Covered drugs referencedNDCCovered

Velsipity

etrasimod (brand and generic; all dosage forms and strengths unless otherwise stated)

Provider Requirements and Prior Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required and will be reviewed; coverage is provided only if approval criteria are met and the member has no exclusions to the prescribed therapy.

Prior Authorization

Dosing Limits and Alignment

Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and evidence-based practice guidelines.

Documentation Required

Required Documentation

Submit required prior authorization documentation, including chart notes or medical record documentation. For continuation requests include documentation supporting positive clinical response to therapy or remission.

Denial Risk

Indication Not Approved

Requests for indications other than treatment of moderately to severely active ulcerative colitis in adults are considered experimental/investigational and not medically necessary.

Denial Risk

Prohibited Concomitant Therapy

The requested medication cannot be used concomitantly with immunomodulators, biologic drugs, or targeted synthetic drugs; presence of such concomitant therapy may result in denial of the request.

Background on Etrasimod (Velsipity)

Etrasimod (brand name Velsipity) is an oral sphingosine 1‑phosphate receptor modulator approved by the FDA for the treatment of moderately to severely active ulcerative colitis in adults. The policy requires documentation of clinical benefit for continuation, and approvals are tied to the FDA‑approved indication.

Clinical Response and Remission Measures

Clinical response / Remission evidence

Stool frequencyImprovement from baseline in stool frequency.

Rectal bleedingReduction or resolution of rectal bleeding compared with baseline.

Urgency of defecationDecreased urgency of defecation from baseline.

Inflammatory markers (CRP, fecal calprotectin)Improvement in C-reactive protein (CRP) or fecal calprotectin (FC) levels compared with baseline.

Mucosal appearance on imaging/endoscopyImproved appearance of the mucosa on endoscopy, CTE, MRE, or intestinal ultrasound compared with baseline.

Disease activity scoresImprovement on a disease activity scoring tool (e.g., UCEIS, Mayo score) from baseline.