Approval Criteria for Biologic and Immune Modulators
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Defines prior authorization, coverage, and renewal criteria for FDA‑approved biologic and immune‑modulator therapies for autoimmune and inflammatory diseases for AllCare Advantage members; applies to prescribers requesting coverage of these agents.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-01: Initial Therapy and Formulary-based Prior Treatment Requirements
Covered when the following sequence of criteria is met according to the policy flow:
Initial sequence
- Preferred agent branch: If requested agent is a preferred, lowest-cost formulary treatment for the submitted indication as listed in Table 1: there must be documented treatment failure with (or contraindication to) recommended prior treatment(s) as listed for the indication (Criteria #4).
If met -> Approve for clinically-appropriate duration; if not met -> Deny
- Non-preferred agent branch: If requested agent is a non-preferred formulary treatment for the submitted indication as listed in Table 1: there must be documented treatment failure with (or contraindication to) at least 2 preferred formulary agents (Criteria #6).
If met -> Approve for clinically-appropriate duration; if not met -> Deny
- Non-formulary agent branch: If requested agent is non-formulary: there must be documentation that the member has had treatment failure with (or contraindication to) preferred and non-preferred formulary agents AND there are no other formulary agents which, based on sound clinical and scientific evidence, could be used in place of the requested non-formulary medication (Criteria #7).
If met -> Approve for clinically-appropriate duration; if not met -> Deny
inv-02: Continuation / Renewal Therapy
Renewal requests are approved when ALL of the following are met:
If met -> Approve for clinically-appropriate duration; if not met -> Deny
Coverage of biologic and immune‑modulating agents is determined on an indication‑specific basis and requires prior authorization. Requests are reviewed only for the submitted indication and must align with FDA‑approved labeling (age, gender, indication, duration, and safety considerations) and applicable treatment guidelines. Approval is granted when the policy flow of sequential criteria is met, beginning with documentation that supports the submitted diagnosis and evidence of specialist involvement or a specialist consult. (See Table 1 for formulary status by indication.)
Determine the requested agent’s formulary status for the submitted indication. If the agent is listed as preferred, there must be documented treatment failure with (or contraindication to) the recommended prior treatment(s) for that indication to approve. If the agent is listed as non‑preferred, there must be documented failure with (or contraindication to) at least two preferred formulary agents for that indication to approve. For non‑formulary requests, documentation must show failure of formulary options and that no suitable formulary alternative exists based on clinical evidence.
Renewal requests are approved when the member continues to meet the original initiation criteria and the request includes documentation of clinical benefit and appropriate monitoring. Typical approval length for authorizations is up to 1 year.
Required documentation must clearly support the submitted indication or any relevant comorbid diagnosis and include evidence of prior treatments tried, treatment failures, or documented contraindications as applicable to the agent’s formulary status. Renewal requests must additionally include objective evidence of treatment efficacy and documentation of appropriate safety monitoring.
The prescribing provider should be a specialist for the requested indication or there must be documentation of a specialist consult. Requests where the prescriber is not a specialist and no consult or specialist documentation is provided are subject to denial. Insufficient or incomplete documentation of the indication, comorbid diagnosis, prior treatment history, or specialist involvement will result in the request not meeting approval criteria.
Initial Therapy Requirements
inv-11: Initial Therapy
Initial therapy requirements per Table 1
Approval granted for clinically-appropriate duration when criteria met
Continuation and Renewal
inv-12: Renewal
Renewal requirements
Approve for clinically-appropriate duration if met; if not met -> Deny
Step Therapy and Prior Treatment Table
| Indication / Setting | Agent (examples from Table 1) | Formulary status | Required prior treatment(s) |
|---|---|---|---|
| Plaque psoriasis | Infliximab; Adalimumab; Ustekinumab; Secukinumab; Apremilast; Brodalumab; Guselkumab | Preferred or Non-preferred (see Table 1 entry) | Preferred agents: documented failure of recommended prior treatment(s) (1st & 2nd line agents where listed); Non-preferred agents: documented failure of 2 preferred formulary immunobiologics |
| Psoriatic arthritis (prior treatments need not be concurrent) | Infliximab; Adalimumab; Ustekinumab | Preferred or Non-preferred (see Table 1 entry) | Documented failure of 1st & 2nd line agents as listed |
| Inflammatory bowel disease | Infliximab; Adalimumab; Ustekinumab; Infliximab-dyyb (biosimilar); Pen tofacitinib; Etrasimod; Zeposia | Preferred or Non-preferred (agent-specific per Table 1) | At least one 1st‑line agent (for some non‑preferred entries also require additional preferred agent failures; non‑preferred may require 1 JAKi + TNFi or two preferred agents as specified) |
Provider Actions and Requirements
Prior authorization must be obtained and is indication‑specific
Prior authorization is required for biologic and immune‑modulator requests and is evaluated by the submitted indication; non‑preferred formulary agents require a trial with one preferred agent prior to approval. For agents with an available biosimilar, refer to biosimilar criteria (UMCCOMED75.1). Approval length is up to 1 year and each request will be reviewed for the indication submitted.
Follow step therapy per Table 1 before non‑preferred or non‑formulary agents
Members must meet step therapy requirements per Table 1: preferred agents listed for the indication must be used first; non‑preferred formulary agents require documented failure of at least two preferred formulary agents in many cases; non‑formulary agents require documented failure of formulary options and demonstration that no other formulary agents are suitable.
- Preferred agent branch: documented failure with (or contraindication to) recommended prior treatment(s) → approve if met.
- Non‑preferred agent branch: documented failure with (or contraindication to) at least 2 preferred formulary agents → approve if met.
- Non‑formulary agent branch: documented failure with (or contraindication to) preferred/non‑preferred formulary agents and no suitable formulary alternatives → approve if met.
Provide full clinical documentation, specialist involvement, and prior treatment history
Submit documentation that supports the submitted indication or comorbid diagnosis, documents specialist involvement or a specialist consult, and details prior treatment history (failures or contraindications); renewal requests must include evidence of treatment efficacy and appropriate monitoring.
- Clinical documentation to support the diagnosis or comorbid indication submitted.
- Evidence that the prescribing provider is a specialist or documentation of a specialist consult.
- Prior treatment history showing failures or contraindications as required by formulary status.
- For renewals, objective evidence of clinical benefit and appropriate monitoring.
Denial triggers: missing indication, specialist consult, or prior failures
Requests will be denied if there is insufficient documentation of the submitted indication or comorbid diagnosis, if the prescribing provider is not a specialist and no specialist consult is documented, or if required prior treatment failures/contraindications per formulary branching are not documented.
- Insufficient documentation to support the submitted indication or comorbid diagnosis → Deny.
- Prescribing provider not a specialist and no specialist consult documented → Deny.
- Lack of documented prior treatment failures or contraindications required by formulary status (preferred, non‑preferred, non‑formulary) → Deny.
Site of Care
Coverage follows FDA labeling; site‑of‑care not specified
Coverage is aligned with FDA labeling and applicable OHA criteria; this policy does not specify site‑of‑care requirements within the document.
- Approved treatments must follow FDA‑approved labeling for age, gender, indication, duration, and safety concerns.
- Site‑of‑care specifics are not detailed in this policy.
Biosimilars Guidance
Refer to biosimilar criteria UMCCOMED75.1
When a reference product has an available biosimilar, follow the separate biosimilar criteria (UMCCOMED75.1) for coverage decisions.
- Policy directs reviewers to UMCCOMED75.1 for biosimilar handling.
Definitions and Formulary Status
Background
Biologic and immune‑modulating agents are used to treat autoimmune and inflammatory diseases and frequently have multiple FDA‑approved indications. Because a single agent may be preferred for one indication and non‑preferred for another, every prior authorization request is evaluated based on the specific indication submitted and the formulary status for that indication. Coverage decisions follow FDA labeling and recognized treatment guidelines, and where biosimilars are available, the separate biosimilar criteria (UMCCOMED75.1) apply.
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