CurrentHawaii Medical Service Association (HMSA)Policy MR C18701-D, C12538-A

Stelara (ustekinumab) and biosimilars prior authorization criteria

A CVS Caremark prior authorization form and exception/coverage criteria for Stelara (ustekinumab) and listed biosimilars for multiple indications (plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, rheumatoid arthritis, immune checkpoint inhibitor-related colitis). It defines preferred products, step therapy / exception logic, and documentation requirements to obtain coverage.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyStelara (ustekinumab) and biosimilars prior authorization criteria

Policy CodePolicy MR C18701-D, C12538-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSend completed CVS Caremark Specialty Programs form with supporting documentation (including evidence of inadequate response/intolerance/contraindication to preferred products and TB testing results) to fax 1-866-237-5512.

POLICY UPDATE CHANGES

No material clinical/coverage changes

7Indications listed

multiplePreferred products listed

1-866-237-5512PA fax number

Coverage summary

This is a CVS Caremark prior authorization form used by HMSA to adjudicate coverage for Stelara (ustekinumab) and listed biosimilars across multiple immune-mediated indications (including plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, rheumatoid arthritis, and immune checkpoint inhibitor-related colitis). Coverage stance is mixed: preferred products are listed by indication and requests for non-preferred agents or biosimilars are evaluated through exception/step-therapy logic where approvals are driven by preferred-product status, documented failures/intolerance/contraindications, and additional form-based clinical evidence.

Thresholds and stats

Age for psoriasis>= 6 years

Plaque psoriasis BSA threshold>= 3% (or <3% with crucial body areas affected)

TB testing windowTB test (TST or IGRA) within 6 months of initiating therapy

Indications listed7

Preferred products listedmultiple

PA fax number1-866-237-5512

Authorization criteria

General Authorization / Exception Criteria

Coverage requires meeting indication-specific criteria and demonstrating inadequate response/intolerance/contraindication to preferred products; continuation requires positive clinical response.

Product selection: Requested product is being used for one of the covered indications: ankylosing spondylitis, Crohn's disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, immune checkpoint inhibitor-related diarrhea or colitis
Question F / #9 used to identify diagnosis
Non-preferred biosimilar / branded agent logic: If product is a non-preferred biosimilar or non-preferred branded agent (list in section E), exception criteria apply
Section E lists Humira/Remicade/non-preferred Stelara biosimilars
Indication-specific and preferred product failures required: Coverage requires meeting indication-specific criteria and documentation of inadequate response, intolerable adverse event, or contraindication to the preferred products listed for the patient’s indication (supporting documentation required)
Multiple sections (B, H, K, M, Q, T, W, X etc.) specify required failed/contraindicated preferred products by indication

Requested product matches listed Stelara/biosimilar options: Selections include Stelara IV, Stelara SC, and specified biosimilars (Otulfi, Selarsdi, Starjemza, Steqeyma, ustekinumab variants, Wezlana, Yesintek) with some selections directing to criteria questions

Product list in form

Preferred Product / Step Therapy

For many indications, coverage is provided for listed preferred products; request for non-preferred or exception requires documentation that patient cannot use preferred products or has failed them. This block represents step-therapy (step requirement) logic.

Switch to preferred product option: Can the patient's treatment be switched to a preferred product? If Yes, provider must obtain the preferred-product-specific form and submit for corresponding PA
Section C
Step therapy requirement by indication: For each indication, patient must have documented inadequate response, intolerable adverse event, or contraindication to ALL (or specified sets) of preferred products listed for that indication; supporting documentation required
Questions H, K, M, Q, T, W, X specify required failed/contraindicated preferred products by indication

Preserve AND logic across preferred product lists: Provider must document failure/intolerance/contraindication to the complete set(s) of preferred agents specified for the patient’s diagnosis (form enumerates sets per indication)

Indication-Specific Initial Therapy Criteria (Plaque Psoriasis example)

Initial therapy for plaque psoriasis requires age and prescriber criteria plus moderate-to-severe disease or involvement of crucial body areas or BSA threshold, and prior failure or contraindication to topical/systemic/phototherapy.

Indication-Specific Initial Therapy Criteria (Plaque Psoriasis)

Age and prescriber: Patient is >= 6 years of age for plaque psoriasis; requested product prescribed by or in consultation with a dermatologist
Questions 100-101
Disease severity / extent
- Moderate to severe diagnosis: Diagnosed with moderate to severe plaque psoriasis
  Question 102
- Crucial body areas affected (hands, feet, face, neck, scalp, genitals/groin, intertriginous)

Continuation of Therapy

Continuation requests require evidence of positive clinical response or maintained remission since starting therapy.

Remission question: Has the patient achieved or maintained remission?
Question 304/404/103 etc.
Disease-specific response measures: If not remission, document improvement in one or more of the listed measures appropriate to the disease: Psoriasis (BSA reduction; signs/symptoms improvement), Psoriatic arthritis (swollen/tender joint counts, dactylitis, enthesitis, skin/nail involvement, functional status, CRP), Crohn's disease (abdominal pain, diarrhea, weight, hematocrit, endoscopic appearance, CDAI), Ulcerative colitis (stool frequency, urgency, CRP, fecal calprotectin, endoscopic appearance, UCEIS/Mayo)
Questions 105-106, 205, 305, 405

Documentation requirement: Documented maintained remission or positive clinical response with the specific outcome measures per indication is required for continuation approvals

Provider actions and continuation sections

TB Screening Requirement

TB testing and assessment required prior to initiating biologic or targeted synthetic therapy associated with TB risk; positive results require documentation of latent/active TB and treatment status.

Prior biologic/targeted synthetic exposure: Has the patient ever received a biologic or targeted synthetic drug associated with increased risk of tuberculosis?
Question 2
Recent TB testing: Has the patient had a tuberculosis (TB) test (TST or IGRA) within 6 months of initiating therapy?6 months
Question 3
If TB test positive, document status and treatment: If TB test positive, document whether patient has latent TB and whether latent TB treatment has been initiated or completed, or if patient has active TB
Questions 4-5

Immune Checkpoint Inhibitor-Related Colitis

For immune checkpoint inhibitor-related diarrhea or colitis, specialist involvement and prior failure/intolerance/contraindication to infliximab or vedolizumab are required.

Specialist prescriber: Requested product prescribed by or in consultation with a gastroenterologist, hematologist, or oncologist
Question 500
Prior failure/intolerance/contraindication to infliximab or vedolizumab: Has the patient experienced inadequate response OR intolerance OR a contraindication to infliximab or vedolizumab?
Questions 501-503

Supporting documentation: If prior failure/intolerance/contraindication is indicated, supporting documentation must be available for review

Attestation and ACTION REQUIRED statements

Coding

ICD-10 diagnosis codesICD-10

Form asks "What is the ICD-10 code?" — specific codes not supplied in document text

Provider actions & documentation requirements

Prior Authorization

Submit prior authorization form

Send the completed CVS Caremark Specialty Programs prior authorization form with all required supporting documentation. Fax the form and any supporting records to 1-866-237-5512. Include documentation demonstrating inadequate response/intolerance/contraindication to preferred products as specified by the indication.

Documentation Required

Document inadequate response/intolerance/contraindication

Provide supporting documentation showing the patient has failed, is intolerant of, or has a contraindication to the preferred products listed for the specific diagnosis. The form indicates 'ACTION REQUIRED: Please submit supporting documentation' when documenting inadequate response, intolerance, or contraindication to all listed preferred agents for the indication.

Documentation Required

TB testing results

Document tuberculosis testing: record a TB test (tuberculin skin test [TST] or interferon-release assay [IGRA]) performed within 6 months of initiating therapy. If positive, document whether latent or active TB and whether latent TB treatment was initiated or completed as applicable.

Prior Authorization

Preferred product substitution

If the patient can be switched to a preferred product, obtain and complete the preferred-product-specific form and submit it for the corresponding prior authorization.

Documentation Required

Continuation evidence

For continuation requests, supply documentation demonstrating maintained remission or a positive clinical response since starting therapy. Use indication-specific outcome measures such as reduction in body surface area (BSA) and symptom improvement for psoriasis; swollen/tender joint counts, dactylitis/enthesitis, skin/nail involvement, functional status, or CRP for psoriatic arthritis; CDAI or symptom improvements and endoscopic findings for Crohn's disease; and stool frequency/urgency, CRP, fecal calprotectin, endoscopic appearance, or UCEIS/Mayo score for ulcerative colitis.

Background

This document is the CVS Caremark Specialty Programs prior authorization form used by HMSA to adjudicate coverage for Stelara (ustekinumab) and its biosimilars. The form lists preferred products by indication (e.g., adalimumab products, infliximab/Inflectra/unbranded infliximab, Entyvio, Cosentyx, Skyrizi, Taltz, Tremfya, Yesintek, and others) and asks whether treatment can be switched to a preferred product. For non-preferred branded agents or biosimilars the form requires providers to submit supporting documentation demonstrating inadequate response, intolerable adverse events, or contraindications to the listed preferred alternatives. The form also collects indication-specific clinical data (e.g., age, prescriber specialty, BSA, symptom improvement, CDAI, endoscopic appearance, CRP, fecal calprotectin, TB testing) to determine exception approvals and continuation of therapy.

Definitions

Preferred product: Products listed by indication for which coverage is provided without exception when appropriate (the form enumerates specific preferred agents by indication and asks if the patient can be switched to a preferred product).

Continuation of therapy: Requests for ongoing treatment which require evidence of maintained remission or clinical response (the form asks whether the patient has achieved or maintained remission or demonstrated improvement on indication-specific measures such as BSA, joint counts, CDAI, UCEIS/Mayo, CRP, or fecal calprotectin).

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyStelara (ustekinumab) and biosimilars prior authorization criteria

Policy CodePolicy MR C18701-D, C12538-A

Change TypeNo material change

Effective Date

Next Review Date

On This Page

Form lists preferred products by indication and asks that ALL listed products be failed/contraindicated

BSA threshold: Body surface area (BSA) affected >= 3%>= 3% (Question 111)

Question 111

Prior therapies: Inadequate response/intolerance/contraindication to phototherapy (UVB, PUVA) or systemic agents methotrexate, cyclosporine, or acitretin OR clinical reason to avoid those agents (alcohol use disorder, liver disease, pregnancy, breastfeeding, significant comorbidity, hypersensitivity)

Questions 112-114

Prior therapy documentation: If patient has not failed listed therapies, must document clinical reason to avoid methotrexate/cyclosporine/acitretin (e.g., pregnancy, liver disease, alcohol use disorder, significant comorbidity, hypersensitivity)

Questions 113-114

Proceed if negative or unknown: If TB test is negative or unknown, follow form logic to proceed with evaluation

Question 4

OpenPayer

Stelara (ustekinumab) and biosimilars prior authorization criteria

Coverage summary

Authorization criteria

Coding

Provider actions & documentation requirements

Background

Definitions

Revision history