Biologic & Immunologic Agents — Coverage and Authorization Criteria
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Coverage and authorization criteria for select biologic and immunologic agents (e.g., Actemra, Cosentyx, Entyvio, Orencia, Simponi Aria, Skyrizi, Stelara, Tremfya) for Aloha Care members, including Medicare-specific rules and prior authorization requirements.
Updated to include Starjema as the preferred Ustekinumab agent.
Coverage and Medical Necessity Criteria
General Biologic Use (applies to listed products)
Covered when ALL of the following are met
See policy drug/diagnosis list in source.
Ankylosing Spondylitis - Initial and Renewal
Initial covered when ALL of the following are met
Initial approval typically 6 months.
Renewal approval typically 1 year.
Crohn's Disease - Initial and Renewal
Initial covered when ALL of the following are met
Initial approval typically 6 months; Starjemza preferred for Medicaid (no PA); Steqeyma acceptable for Medicare (PA may be required).
See product-specific notes in source.
Renewal approval typically 1 year.
Initial therapy — Crohn's disease
Covered when ALL of the following are met:
Renewal — Crohn's disease
Covered when ALL of the following are met:
Initial therapy — Hidradenitis Suppurativa (Cosentyx referenced)
Covered when ALL of the following are met:
Initial therapy — Non-radiographic axial spondyloarthritis
Covered when ALL of the following are met:
Initial therapy — Plaque psoriasis
Covered when ALL of the following are met:
Initial therapy — Juvenile idiopathic arthritis
Covered when ALL of the following are met:
Initial therapy — Psoriatic arthritis
Covered when ALL of the following are met:
Initial Therapy - Psoriatic Arthritis
Psoriatic Arthritis — Covered when ALL of the following are met for the requested biologic:
See agent-specific sequencing in source.
See agent-specific sequencing in source.
Initial Therapy - Rheumatoid Arthritis
Rheumatoid Arthritis — Covered when ALL of the following are met:
Initial Therapy - Ulcerative Colitis
Ulcerative Colitis — Covered when ALL of the following are met:
See product-specific sequencing in source.
Initial Therapy - Enthesitis-Related Arthritis
Enthesitis-Related Arthritis — Covered when ALL of the following are met:
Initial Therapy - Systemic JIA
Systemic Juvenile Idiopathic Arthritis (sJIA) — Covered when ALL of the following are met:
Renewal Therapy Criteria
Renewal Criteria — Covered when ANY of the following are met (per indication):
Initial Therapy — Systemic Juvenile Idiopathic Arthritis
Initial criteria for Systemic Juvenile Idiopathic Arthritis
Initial and Renewal Therapy — Giant Cell Arteritis
Criteria for Giant Cell Arteritis (initial and renewal elements present)
Initial and Renewal Therapy — Cytokine Release Syndrome
Criteria for Cytokine Release Syndrome
Initial and Renewal Therapy — Systemic Sclerosis-Associated ILD
Criteria for Systemic Sclerosis-Associated Interstitial Lung Disease
Initial and maintenance dosing rules (partial)
Drug-specific dosing, administration, and discontinuation guidance (partial extract):
SC dosing to begin after at least two IV infusions; discontinue if no benefit by week 14.
Vial size and weight-based dosing provided in source.
May be given with or without methotrexate or other DMARDs.
Maintenance generally q8w; interval decreases described for relapse per source.
See source for indication-specific regimens and pediatric dosing.
Requests for a listed biologic or immunologic agent must not be for concurrent use with other targeted immune therapies. Specifically, combination use with other JAK inhibitors, with other biologic immunomodulators, or with potent immunosuppressants (examples listed in the policy include JAK inhibitors such as tofacitinib, upadacitinib, baricitinib; biologics such as adalimumab, etanercept, secukinumab, ustekinumab, dupilumab, abatacept, golimumab, risankizumab, ixekizumab, guselkumab; and immunosuppressants such as azathioprine, cyclosporine, tacrolimus, pimecrolimus, and 6-mercaptopurine) is not permitted for approvals under this policy.
The policy identifies payer- and program-preferred ustekinumab products that affect prior authorization handling: for Medicaid the preferred product is Starjemza (no PA required), while for Medicare the preferred product is Steqeyma (PA required). These preferences are referenced across Crohn's disease, plaque psoriasis, and psoriatic arthritis criteria and should be considered when submitting requests or selecting agents for covered indications.
Coverage for biologic agents generally requires documentation that specified prior-step therapies were tried and failed (or were intolerant/contraindicated). Examples include conventional immunomodulators (methotrexate, azathioprine/6-MP, corticosteroids, 5‑ASA agents), NSAIDs where indicated, and comparator biologics such as infliximab biosimilars or adalimumab products per the indication-specific sequences.
The policy explicitly excludes concurrent therapy with two biological or immunologic agents. Requests that propose the use of two biologic/immunologic agents at the same time (including many named combinations such as abatacept with TNF antagonists, IL‑17/IL‑23 inhibitors, vedolizumab, ustekinumab, IL‑1/IL‑6 inhibitors, rituximab, or natalizumab) will not meet the coverage criteria.
The policy notes certain off‑label management strategies as clinical considerations rather than mandated coverage actions. For example, decreasing a maintenance dosing interval (e.g., shortening to every 4 weeks for relapse) is described as an option to consider for patients who relapse on maintenance therapy, not as a required or automatically covered approach.
Requests for any listed biologic are not supported when there is no documentation of trial and failure, intolerance, or contraindication to the required prior conventional or biologic therapies specified for the indication; absence of such documented prior therapy may render the request not medically necessary.
The policy makes clear that requests for combination therapy (two biologic/immunologic agents) or for use without the required latency and prior‑therapy sequencing may be denied. In addition, initiation without required baseline testing (for example, tuberculin testing where indicated) or without documented prior trials may also trigger denial.
For Entyvio (vedolizumab), dosing guidance includes IV induction at 300 mg at weeks 0, 2, and 6 with maintenance IV every 8 weeks (or SC 108 mg q2w after at least two IV infusions). The policy specifies that therapy should be discontinued if there is no evidence of therapeutic benefit by week 14.
What Providers Must Do / Documentation & Prior Authorization
Authorization required for listed HCPCS/J-codes
Submit a medical-management prior authorization for any listed biologic billed with the HCPCS/J‑codes; initial approvals are typically for 6 months and renewals for 1 year.
- MM prior authorization required for listed HCPCS/J-codes for medical benefit.
- Initial request: 6 months; Renewal: 1 year.
Product- and payor-specific PA rules
Follow the product- and payor-specific prior‑authorization notes: Starjemza (ustekinumab / Starjemza) is preferred with no PA required for Medicaid, while Steqeyma is the preferred ustekinumab biosimilar for Medicare and may require PA.
- Medicaid: Starjemza preferred — no PA required for ustekinumab products.
- Medicare: Steqeyma preferred — PA may be required for ustekinumab products.
Prior authorization required
Obtain prior authorization (MM auths only) for the biologic or biosimilar requested; initial approvals are typically 6 months with renewals for 1 year.
- Medical‑management prior authorization is required (MM auths only).
- Typical initial approval length: 6 months; renewals: 1 year.
Dosing/indication must be provided
Include the indication and exact dosing regimen (induction and maintenance); note weight‑based calculations where applicable (e.g., Stelara weight‑based IV induction; Actemra IV dosing for CRS/GCA).
- Document induction and maintenance schedules (examples: Entyvio IV 300 mg at 0,2,6 weeks then q8w; Stelara weight‑based IV induction then 90 mg SC q8w).
- Provide weight‑based dose calculations when required (e.g., Stelara, Actemra).
Prior authorization requirements: include indication and dosing
Prior‑authorization submissions must state the specific indication and list the induction and maintenance dosing regimen, including weight‑based calculations and rationale for any non‑standard dosing.
- Include induction schedule, maintenance interval, and any calculated weight‑based dose.
- If an accelerated interval or switching strategy is requested, document the clinical rationale.
Medicare Part B step therapy
For Medicare Part B new starts, document step‑therapy compliance: show inadequate response, intolerance, or contraindication to the required alternatives (e.g., Avsola/Inflectra, preferred adalimumab products, or preferred ustekinumab products).
- Medicare Part B step therapy applies to Actemra, Cosentyx, Entyvio, Orencia, Simponi Aria, Skyrizi, Stelara, Tremfya (new starts).
- Provide chart evidence of inadequate response, intolerance, or contraindication to the listed alternatives (Avsola/Inflectra, preferred adalimumab products, Steqeyma where applicable).
Step therapy and required prior treatments
Demonstrate trial and failure, intolerance, or contraindication to the specified conventional therapies and/or preferred biologics required by indication before approval of the requested biologic.
- Examples: methotrexate, azathioprine/6‑MP, corticosteroids, NSAIDs, and specified infliximab or adalimumab products as listed per indication.
- Follow agent‑specific sequencing (e.g., Skyrizi, Cosentyx, ustekinumab) per policy guidance.
Step therapy requirements: trials to DMARDs/NSAIDs or comparators
Ensure documentation shows trial and failure, intolerance, or contraindication to required DMARDs/NSAIDs or comparator biologics per the indication-specific step‑therapy rules.
- Members must have tried and failed (or had intolerance/contraindication to) the listed conventional DMARDs/NSAIDs before biologic approval.
- Agent‑specific prior biologic trials (e.g., infliximab, adalimumab, Cimzia) are required where noted.
Biosimilar trial requirement for Actemra
For Actemra (tocilizumab) requests, document trial and failure, intolerance, or contraindication to the required biosimilar per line of business (Medicaid: Tyenne; Medicare: Avtozma or Tofidence).
- Actemra requires prior trial/failure of the listed biosimilars — Tyenne for Medicaid, Avtozma or Tofidence for Medicare.
- Cite the biosimilar trial evidence in chart notes submitted with PA.
Therapy switching and interval adjustment
When switching therapies or requesting interval adjustments, include clinical justification; earlier switching may be permitted for severe disease and decreasing the maintenance interval may be considered for relapse.
- Policy allows switching to an alternative agent sooner than 8–12 weeks for severe disease requiring symptom control.
- For relapse on maintenance, consider documenting rationale for decreasing interval to every 4 weeks.
Chart notes and prior therapy documentation required
Attach chart notes that document the diagnosis and detailed prior‑treatment history, including dates, agents tried, duration, and objective evidence of trial failure or intolerance.
- Include trial/failure/intolerance/contraindication details for required prior therapies (e.g., NSAIDs, methotrexate, azathioprine, infliximab/adalimumab products).
- Provide dates and clinical notes supporting the sequence of therapies.
Renewal response documentation
For renewals, provide documentation of active disease and objective improvement or stabilization (symptoms, labs such as ESR/CRP, functional measures, or mucosal healing) to demonstrate therapeutic benefit.
- Renewal evidence may include symptom improvement, lab improvements (ESR/CRP), mucosal healing, or reversal of high fecal output state for Crohn's.
- Renewal approvals are typically for 1 year when benefit is documented.
Required chart notes and clinical measures
Include required chart notes and clinical measures specific to the indication (e.g., CDAI >220, lesion counts, stool frequency >6/day, BSA for psoriasis, joint counts for JIA/RA) when submitting PA or renewal requests.
- Crohn's: CDAI >220, 10% weight loss, frequent diarrhea/abdominal pain, or abnormal CRP.
- Psoriasis: BSA ≥3% or severe site involvement; Hidradenitis: lesion counts as applicable; Ulcerative colitis: >6 stools/day or other objective findings.
Clinical documentation required (biomarkers / active systemic features)
Document objective clinical evidence where required (e.g., positive RA biomarkers for RA; at least one active systemic feature for sJIA) in chart notes to support initial authorization.
- RA: positive RF and/or anti‑CCP test results must be in the chart.
- sJIA: chart notes must confirm ≥1 active systemic feature (fever, evanescent rash, lymphadenopathy, hepatomegaly, splenomegaly, or serositis).
Document indication and dosing consistent with listed regimens
Providers must document that dosing matches the listed regimens (induction and maintenance), including weight‑based calculations where applicable (e.g., Stelara induction dosing), to support authorization.
- Show induction and maintenance schedules and any weight‑based dose calculations in the submission.
- If requesting altered dosing (interval decrease or weight‑based adjustment), include clinical rationale.
Step therapy noncompliance may trigger denial
Failure to document inadequate response, intolerance, or contraindication to required preferred or step‑therapy agents (e.g., Avsola/Inflectra, preferred adalimumab, preferred ustekinumab) for Medicare Part B step therapy may result in denial.
- Medicare Part B step therapy denials can result from missing documentation that required alternatives were tried and failed.
- Include explicit evidence of trial and reason for discontinuation or failure.
Ankylosing spondylitis prior therapy documentation required
For ankylosing spondylitis initial requests, include chart evidence of trial and failure/intolerance/contraindication to an NSAID, conventional DMARD(s), and specified anti‑TNF agents (infliximab and an adalimumab product); absence of this documentation may lead to denial.
- Required prior trials include an NSAID (celecoxib, diclofenac, ibuprofen, or indomethacin), a conventional DMARD (methotrexate, leflunomide, sulfasalazine, or cyclosporine), infliximab (Avsola/Inflectra), and an adalimumab product.
- Initial approval length: 6 months when criteria met.
Crohn's disease documentation required
For Crohn's disease initial requests, provide chart notes documenting required clinical features (e.g., frequent diarrhea/abdominal pain, 10% weight loss, complications, abnormal CRP, or CDAI >220) and evidence of trial and failure/intolerance/contraindication to listed conventional therapies and prior biologics as specified.
- Document one or more of: frequent diarrhea and abdominal pain; 10% weight loss; complications (obstruction, fever, abdominal mass); abnormal CRP; or CDAI >220.
- Show trial and failure/intolerance/contraindication to conventional therapies (methotrexate, 6‑MP, azathioprine, corticosteroids, 5‑ASA) and to required prior biologics (e.g., infliximab biosimilars).
Failure to document required trials may lead to denial
If the submission lacks documentation of required trials and failures (or intolerance/contraindication) to indication‑specific prior therapies, the request may be denied.
- Provide evidence of each prior agent tried, duration, and reason for discontinuation.
- Absence of these trial records is a common cause for denial.
Common denial triggers to avoid
Common denial triggers to review before submission include: requests for concurrent use of two biologic/immunologic agents, missing tuberculosis screening documentation when initiating therapy, and absent prior‑therapy evidence.
- Concurrent use of two biologic/immunologic agents is excluded and may be denied.
- If initiating therapy, document a TST or CDC‑recommended equivalent for latent tuberculosis evaluation unless switching with no new risk factors.
- Missing prior‑therapy evidence (trials/failures) commonly triggers denials.
Lack of documented therapeutic benefit may prompt discontinuation/denial
Document objective evidence of therapeutic benefit by the policy‑specific timepoints (for example, Entyvio requires discontinuation if no evidence of benefit by week 14); failure to document benefit within required timelines may result in termination or denial of continued therapy.
- Entyvio: discontinue if no therapeutic benefit by week 14 — include evidence of response by that time for continued coverage.
- For renewals generally, provide objective improvement or stabilization (labs, imaging, mucosal healing, or clinical measures).
Billing Codes and Clinical Measures
| J3262 | Actemra (tocilizumab) injection, 1mg |
| Q5135 | Tyenne (tocilizumab-aazg) injection, biosimilar, 1mg (preferred for Medicaid) |
| Q5156 | Avtozma (tocilizumab-anoh) injection, biosimilar, 1mg (preferred for Medicare) |
| Q5133 | Tofidence (tocilizumab-bavi) injection, biosimilar, 1mg (preferred for Medicare) |
| J3247 | Cosentyx (secukinumab) intravenous, 1mg |
| J3380 | Entyvio (vedolizumab) intravenous, 1mg |
| J0129 | Orencia (abatacept) injection, 10mg |
| J1602 | Simponi Aria (golimumab) intravenous, 1mg |
| J2327 | Skyrizi (risankizumab-rzaa) intravenous injection, 1mg |
| J3357 | Stelara (ustekinumab) subcutaneous injection, 1mg |
| Cosentyx | secukinumab |
| Orencia | abatacept |
| Simponi Aria | golimumab |
| Skyrizi | risankizumab |
| Tremfya | guselkumab |
| Stelara / ustekinumab | ustekinumab |
| Actemra | tocilizumab |
| Entyvio | vedolizumab |
| Avsola / Inflectra | infliximab products |
| adalimumab-aaty / adalimumab-fkjp / Hadlima / Simlandi | adalimumab products (examples) |
| Starjemza | preferred ustekinumab product for Medicaid (no PA required) |
| Steqeyma | preferred ustekinumab product for Medicare (PA required) |
Policy Scope and Background
Background: This policy governs authorization and coverage of selected biologic and immunologic agents across rheumatology, dermatology, and gastroenterology indications (examples include Actemra, Cosentyx, Entyvio, Orencia, Simponi/Simponi Aria, Skyrizi, Stelara and Tremfya and their biosimilars). It defines the scope of covered diagnoses, documents program‑specific product preferences (for example, Starjemza for Medicaid and Steqeyma for Medicare), and establishes general exclusions such as prohibiting combination use with other JAK inhibitors, other biologics, or potent immunosuppressants, and disallowing concurrent use of two biologic/immunologic agents.
Abbreviations and Clinical Definitions
Policy Revision History
Policy revised and published with effective/revision date 2025-12-23 (covers biologic and immunologic agents; standard initial approval: 6 months; renewal: 1 year).
Updated to designate Starjemza (ustekinumab-hmny) as the preferred ustekinumab agent for Medicaid (no prior authorization required).
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