CurrentAvMedPolicy N/A

Ustekinumab (Selarsdi/Yesintek) prior authorization for Crohn's disease and Ulcerative colitis

Forms and clinical criteria governing pharmacy prior authorization and medical-benefit induction dosing for Selarsdi (ustekinumab-aekn) and Yesintek (ustekinumab-kfce) for members with moderate-to-severe Crohn's disease or ulcerative colitis; applies to AvMed providers and members.

Policy Summary

PayerAvMed

PolicyUstekinumab (Selarsdi/Yesintek) prior authorization for Crohn's disease and Ulcerative colitis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit pharmacy prior authorization for maintenance dosing and one-time medical-benefit authorization for IV induction with documentation of administering site and NPI/DEA.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2preferred ustekinumab product choices listed on form

90 mgmaintenance subcutaneous dose

260/390/520weight-based IV induction billable units

Proprium Rxspecialty pharmacy indicated

Coverage Criteria

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Maintenance Therapy (Pharmacy benefit)

Covered when ALL of the following are met

Maintenance Authorization: Member has a diagnosis of moderate-to-severe active Crohn's disease OR moderate-to-severe active ulcerative colitis; prescribed by or in consultation with a Gastroenterologist; member has tried and failed budesonide or high‑dose steroids unless contraindicated OR has tried and failed at least one DMARD therapy (e.g., 5‑aminosalicylates or oral mesalamine) unless contraindicated or intolerant; member has previously tried and failed at least one biologic medication other than the requested medication unless contraindicated or intolerant; maintenance dose to be 90 mg every 8 weeks beginning 8 weeks after IV induction dose.

All criteria lines must be documented; prior therapies will be verified through pharmacy paid claims or submitted chart notes.

Induction Therapy (Medical benefit, one-time)

Covered when ALL of the following are met

Induction Authorization: Medication will be used as induction therapy; member must meet all maintenance dose authorization criteria; medication will be provided under the medical benefit with documented location/site of administration and NPI or DEA number of administering location; member to receive a single weight‑based IV induction dose (≤55 kg = 260 mg; >55–85 kg = 390 mg; >85 kg = 520 mg).

Induction is a one‑time medical‑benefit authorization; billing requires Q9998 (Selarsdi) or Q5100 (Yesintek) as applicable.

The Health Plan considers concomitant use of more than one biologic immunomodulator for the same or different indications to be experimental and investigational. Such combinations have not had safety or efficacy established and will not be permitted.

Examples of biologic immunomodulators whose concomitant use is prohibited include, but are not limited to, Dupixent, Entyvio, Humira, Rinvoq, and Skyrizi. The policy states that safety and efficacy of these combination regimens have not been established and therefore use of more than one biologic immunomodulator concurrently will not be permitted.

Coding and Billing

Medical benefit IV induction HCPCS/Q-codesHCPCSCovered

Q9998	Selarsdi intravenous induction billing code (ustekinumab-aekn)
Q5100	Yesintek intravenous induction billing code (ustekinumab-kfce)

inv-06: Weight-based induction thresholds

Weight-based IV induction thresholds≤55 kg = 260 mg as a single dose (260 billable units); >55–85 kg = 390 mg as a single dose (390 billable units); >85 kg = 520 mg as a single dose (520 billable units)

Billing units equal mgInduction billable units are expressed in mg (e.g., 260 mg = 260 billable units)

One-time administrationIV induction is a single, weight-based dose provided under the medical benefit

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Maintenance subcutaneous therapy requires pharmacy prior authorization. Induction intravenous (IV) doses (Selarsdi Q9998 / Yesintek Q5100) for Crohn's disease and ulcerative colitis are billed under the medical benefit; IV induction dosing (260 mg, 390 mg, 520 mg) should be billed as the corresponding billable units (260, 390, 520).

Maintenance subcutaneous therapy: pharmacy prior authorization required
IV induction doses: bill under medical benefit; 260 mg = 260 billable units, 390 mg = 390 billable units, 520 mg = 520 billable units

Step Therapy

Step Therapy Requirements

Members must have tried and failed required corticosteroids or DMARD therapies unless there is a documented contraindication or intolerance. In addition, members must have previously tried and failed at least one biologic medication other than the requested medication unless contraindicated. Prescriptions should be by or in consultation with a Gastroenterologist when for Crohn's disease or Ulcerative colitis.

Try and fail budesonide or high‑dose steroids unless contraindicated
Try and fail at least one listed DMARD (e.g., mesalamine, balsalazide, olsalazine, sulfasalazine) unless contraindicated
Prior failure of at least one biologic other than the requested agent unless contraindicated

Documentation Required

Required Supporting Documentation

The provider must supply complete member and prescriber information and full drug details. Incomplete, incorrect, or illegible information can delay review or result in denial. All documentation supporting criteria checked (lab results, diagnostics, chart notes) must be provided.

Member name, AvMed ID, date of birth
Prescriber name, original signature (preprinted stamps not valid), date, NPI
Office contact name, phone and fax numbers
Drug name/form/strength, dosing schedule, length of therapy, diagnosis, ICD code if applicable, weight and date weight obtained
Attach lab results, diagnostics, and chart notes to support each criterion checked

Denial Risk

Form Completeness and Denial Risk

Authorization requests missing required fields, signatures, or supporting documentation may be delayed or denied. Use of samples to initiate therapy does not meet preauthorization/step edit criteria. The prescriber must indicate whether the member will discontinue a previously prescribed biologic if approved for the requested medication and provide effective dates.

Prescriber signature must be original and legible; preprinted stamps are not valid
Requests with missing/illegible/correct information may be delayed or denied
Samples do not satisfy step-edit/preauthorization requirements
If switching biologics, list medication discontinued and medication to be initiated with effective dates

Definitions

inv-12: IV induction

Medical-benefit billingSingle weight-based intravenous induction dose billed under the medical benefit using HCPCS/Q-codes Q9998 (Selarsdi) or Q5100 (Yesintek)

One-time doseInduction is a one-time IV administration; member to receive single weight-based dose within 2 months of initiating maintenance therapy

Site documentationLocation/site of drug administration and NPI or DEA number of administering location must be documented

inv-13: Subcutaneous maintenance

Maintenance dosing90 mg subcutaneous injection every 8 weeks beginning 8 weeks after the IV induction dose

FormulationSelarsdi/Yesintek SQ 90 mg/mL prefilled syringe

Pharmacy benefitMaintenance subcutaneous therapy is reviewed and authorized under the pharmacy benefit

Initial Therapy Criteria

Induction (Medical benefit)

Initial induction dosing under medical benefit

Initial Induction: Member will receive a single weight‑based IV induction dose within 2 months of initiating maintenance therapy; documented site of administration and administering location NPI/DEA required; induction dose based on weight: ≤55 kg = 260 mg as a single dose; >55–85 kg = 390 mg as a single dose; >85 kg = 520 mg as a single dose.≤55 kg = 260 mg; >55–85 kg = 390 mg; >85 kg = 520 mg

Induction is billed under the medical benefit as a one‑time dose; medication provided by an identified specialty pharmacy/location (Proprium Rx noted for supply).

Continuation and Maintenance Criteria

Maintenance/Continuation

Continuation/maintenance therapy

Continuation: Maintenance dosing of 90 mg subcutaneous injection every 8 weeks beginning 8 weeks after IV induction; member may need to discontinue a previously prescribed biologic if approved for the requested medication (provider must indicate discontinuation and supply dates).90 mg every 8 weeks

Provider must indicate if discontinuing prior biologic and supply dates; all documentation must be provided to support continuation.

Step Therapy Requirements

Step	Requirement	Notes
1	Trial and failure of budesonide or high‑dose systemic steroids unless contraindicated or intolerant	Document prior therapy and reason for failure or intolerance; supporting chart notes required
2	Trial and failure of at least one DMARD therapy (e.g., 5‑ASA or oral mesalamine) unless contraindicated or intolerant	Examples listed on form include balsalazide, olsalazine, sulfasalazine, and oral mesalamine formulations
3	Trial and failure of at least one biologic agent other than the requested ustekinumab product unless contraindicated or intolerant	Form lists example biologics (e.g., Humira, Rinvoq, Skyrizi, Tremfya); prior biologic use will be verified via pharmacy claims or chart notes

Policy Summary

PayerAvMed

PolicyUstekinumab (Selarsdi/Yesintek) prior authorization for Crohn's disease and Ulcerative colitis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit pharmacy prior authorization for maintenance dosing and one-time medical-benefit authorization for IV induction with documentation of administering site and NPI/DEA.

SourceLink

On This Page

OpenPayer

Ustekinumab (Selarsdi/Yesintek) prior authorization for Crohn's disease and Ulcerative colitis

Coverage Criteria

Coding and Billing

Provider Actions and Requirements

Background

Definitions

Initial Therapy Criteria

Continuation and Maintenance Criteria

Step Therapy Requirements

Quantity Limits

Site of Care Requirements