CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Budesonide rectal foam (Uceris) — Coverage Criteria for Induction of Remission in Distal Ulcerative Colitis

This policy governs coverage and prior authorization criteria for budesonide rectal foam (Uceris) when used for induction of remission of active mild to moderate distal ulcerative colitis in Medicaid members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBudesonide rectal foam (Uceris) — Coverage Criteria for Induction of Remission in Distal Ulcerative Colitis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document age ≥18, diagnosis of active mild–moderate distal ulcerative colitis (≤40 cm), trial of oral aminosalicylate for 4 weeks, and failure/intolerance/contraindication to mesalamine or hydrocortisone enema.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+minimum member age for approval

up to 40 cmdisease extent (FDA)

2 monthscoverage duration

2 canisters/2 weeksinitial dosing limit

2 canisters/4 weeks

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Coverage and Medical Necessity Criteria

Initial approval criteria

Covered when ALL of the following are met:

Approval criteria: Member is 18 years of age or older

Approval criteria: Diagnosis of active, mild to moderate distal ulcerative colitis

disease extent up to 40 cm from the anal verge per FDA indication

Approval criteria: Requested for induction of remission only

Uceris is not approvable for chronic or maintenance use

Approval criteria: Failed a recent 4-week trial of an oral aminosalicylate (e.g., sulfasalazine, mesalamine)4 weeks

Approval criteria: Failed, intolerant to, or contraindicated to formulary mesalamine enema or hydrocortisone enema

Approval criteria: Dose does not exceed initial: 2 canisters for 2 weeks; maintenance: 2 canisters every 4 weeks

Maintenance use generally not approvable

Requests for use for any indication other than induction of remission of active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge are considered experimental/investigational and are not a covered benefit.

Uceris (budesonide rectal foam) is not approvable for chronic or maintenance therapy. The product is intended for induction of remission only and requests for ongoing maintenance use risk denial.

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for FDA‑approved induction use of budesonide rectal foam. Requests must document that the drug is prescribed for induction of remission of active mild to moderate distal ulcerative colitis (disease extent up to 40 cm from the anal verge) in members 18 years or older. Dose limits must be followed and chronic/maintenance use is not approvable.

Member age ≥ 18 years required
Indication: active mild to moderate distal ulcerative colitis (up to 40 cm)
Therapy intent: induction of remission only
Step therapy: failed recent 4‑week trial of an oral aminosalicylate (e.g., sulfasalazine, mesalamine) and failed/intolerant/contraindicated to mesalamine enema or hydrocortisone enema
Dose limits: Initial — up to 2 canisters for 2 weeks; Maintenance dosing not approved beyond induction (2 canisters every 4 weeks is a maximum dosing boundary)
Non‑FDA indications (any indication other than distal UC ≤40 cm) are excluded and considered not covered

Clinical Background

Budesonide rectal foam is a topical corticosteroid formulation indicated to induce remission of active mild to moderate distal ulcerative colitis when disease extends up to 40 cm from the anal verge. Approval is limited to induction use in adults and requires meeting the policy’s clinical criteria, including prior trials of oral aminosalicylates and enema therapies. The agent is not intended for long‑term maintenance therapy.

Definitions and Key Terms

Induction — Definition of induction of remission

DefinitionInduction of remission: use of medication to achieve clinical remission of active disease rather than long-term maintenance.

IntentTherapy is intended to achieve remission of active mild to moderate distal ulcerative colitis (induction), not for chronic or maintenance use.

Age requirementPolicy applies to members 18 years of age or older for induction therapy.

Distal ulcerative colitis — Definition (extent up to 40 cm from anal verge)

DefinitionDistal ulcerative colitis: disease involvement extending up to 40 cm from the anal verge.

FDA‑approved extentIndication applies to disease that extends up to 40 cm from the anal verge (rectum and sigmoid).