CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Velsipity (etrasimod) — Coverage Criteria for Moderately to Severely Active Ulcerative Colitis

Covers authorization and coverage criteria for Velsipity (etrasimod) for treatment of moderately to severely active ulcerative colitis in adult members under Neighborhood Health Plan of Rhode Island Medicaid program.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVelsipity (etrasimod) — Coverage Criteria for Moderately to Severely Active Ulcerative Colitis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 24, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of baseline disease severity and evidence of required prior biologic trials.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration when criteria met

1 tab dailyquantity limit / dosing

18+minimum age for coverage

FDA-approved onlycoverage stance

Coverage Criteria for Velsipity (etrasimod)

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Initial therapy criteria

Covered when ALL of the following are met

Population: Member is 18 years of age or older with moderately to severely active ulcerative colitisage >= 18

FDA-approved indication

Prescriber: Velsipity must be prescribed by or in consultation with a gastroenterologist

Prior therapy: Member has had an inadequate response, intolerance, or contraindication to at least a 3-month trial of infliximab IV or adalimumab at maximum tolerated doses and a 6-month trial of ustekinumab biosimilar at maximum tolerated doses

step therapy requirement

Baseline assessment and safety: Member is free of any clinically important active infection; physician has assessed baseline disease severity with an objective measure/tool; member has obtained ECG to assess conduction abnormalities; member will not receive live vaccines during therapy

safety prerequisites

Concomitant therapy restriction: Velsipity will not be used concomitantly with an injectable biologic response modifier (e.g., TNF-inhibitors, IL-inhibitors) or specified oral non-biologic agents (examples listed in policy)

concomitant use exclusion

Continuation therapy criteria

Authorization renewal (12 months) may be granted when ALL of the following are met

Clinical response: Member achieves or maintains a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms from baseline

renewal requires response

Response measures: Improvement in one or more of: stool frequency, urgency of defecation, rectal bleeding, C-reactive protein (CRP), endoscopic mucosal appearance (CTE/MRE/intestinal ultrasound), fecal calprotectin (FC), or disease activity scoring tool (e.g., UCEIS/Mayo)

any listed measure

Coverage is limited to the FDA‑approved indication: moderately to severely active ulcerative colitis in adults. All other indications beyond this FDA‑approved use are considered experimental/investigational and are not a covered benefit.

Concomitant use of Velsipity (etrasimod) with injectable biologic response modifiers or certain specified oral non‑biologic immunomodulatory agents is prohibited. Examples of injectable biologic response modifiers include TNF‑inhibitors and IL‑inhibitors (e.g., adalimumab, infliximab, secukinumab, ustekinumab, guselkumab, risankizumab, mirikizumab), and prohibited oral agents include agents such as apremilast, tofacitinib, baricitinib, and upadacitinib.

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

Provider Requirements and Prior Authorization

Prior Authorization

Prior authorization required; authorization up to 12 months

Prior authorization is required for Velsipity (etrasimod). Authorization of up to 12 months may be granted when all specified criteria are met, including age, prescriber specialty, prior therapy failure/intolerance/contraindication, documented disease severity, and safety prerequisites.

Step Therapy

Required prior biologic trials before approval

Member must have had inadequate response, intolerance, or contraindication to at least a 3-month trial of infliximab IV or adalimumab at maximum tolerated doses and a 6-month trial of ustekinumab biosimilar at maximum tolerated doses.

Documentation Required

Submit medical records and baseline assessments

Submission of the member's chart or medical record is required to document medical necessity and that the applicable criteria are met; documentation must include baseline disease severity assessment using an objective measure/tool, evidence of prior trials or contraindications to specified biologics, and an ECG to assess conduction abnormalities.

Denial Risk

Indication exclusion — non‑UC uses not covered

Use of Velsipity for any indication other than moderately to severely active ulcerative colitis in adults is considered experimental/investigational and is not a covered benefit.

Definitions

Live vaccines — definition and guidance about withholding live vaccines during therapy

DefinitionLive vaccines: vaccines containing live organisms which members will not receive during therapy.

Therapy restrictionMember will not receive live vaccines during therapy with Velsipity.

Related safety requirementsMember must be free of any clinically important active infection prior to initiation.

Baseline assessmentPhysician must assess baseline disease severity using an objective measure/tool before starting therapy.

Injectable biologic response modifier — definition and examples

DefinitionInjectable biologic response modifiers: parenteral biologic agents that alter immune response (examples listed in policy).

Examples — TNF inhibitorsHumira (adalimumab), Remicade (infliximab), Enbrel (etanercept), Simponi (golimumab).

Examples — IL inhibitorsCosentyx (secukinumab), Stelara/Wezlana (ustekinumab), Tremfya (guselkumab), Ilumya (tildrakizumab), Skyrizi (risankizumab), Omvoh (mirikizumab).

Concomitant use prohibitionVelsipity will not be used concomitantly with an injectable biologic response modifier (including the TNF- and IL-inhibitors listed).

Related oral agentsPolicy also lists prohibited concomitant use with certain oral non-biologic immunomodulatory agents (e.g., Otezla, Xeljanz, Olumiant, Rinvoq).

OpenPayer

Velsipity (etrasimod) — Coverage Criteria for Moderately to Severely Active Ulcerative Colitis

Coverage Criteria for Velsipity (etrasimod)

Provider Requirements and Prior Authorization

Background

Definitions