Blue Cross MA Immunomodulator Prior Auth Policy Update

Medical Necessity and Coverage Criteria

Ankylosing Spondylitis - Initial Therapy

Preferred drugs listed on the drug coverage table for ankylosing spondylitis may be considered MEDICALLY NECESSARY and may be covered when ALL of the following criteria are met:

Ankylosing Spondylitis initial coverage criteria: 1. A documented diagnosis of active ankylosing spondylitis; AND 2. Age according to FDA approval; AND 3. The drug is prescribed by a board-certified or board-eligible rheumatologist; AND 4. Treatment failure with, or contraindication to, one prescription NSAID OR previous use and failure or clinical rationale for not using the preferred medication for ankylosing spondylitis; AND 5. Documented dose and frequency submitted and within FDA‑approved dosing and frequency; AND 6. For a Non‑Preferred Drug or Non‑Formulary, Non‑Covered, there has been previous use of preferred drugs and failure or clinical rationale for not using the preferred medication for Ankylosing Spondylitis (this criterion applies only to the Infliximab class).

Criterion 6 specified as only for Infliximab class in source.

Initial Therapy — Ankylosing Spondylitis

Preferred drugs for ankylosing spondylitis may be considered MEDICALLY NECESSARY and covered when ALL of the following are met:

Ankylosing Spondylitis initial criteria: 1. Documented diagnosis of active ankylosing spondylitis; 2. Age according to FDA approval; 3. Prescribed by a board-certified or board-eligible rheumatologist; 4. Treatment failure with, or contraindication to, one prescription NSAID OR previous use and failure or clinical rationale for not using the preferred medication; 5. Documented dose and frequency within FDA‑approved dosing; 6. For non‑preferred/non‑formulary drugs, previous use of preferred drugs and failure or clinical rationale for not using preferred medication (Infliximab class exception noted).

Criterion 6 applies to infliximab class only as noted.

Ilaris (CAPS) Coverage Criteria

Ilaris for CAPS and other FDA indications may be considered MEDICALLY NECESSARY when ALL of the following are met:

Ilaris (CAPS) criteria: 1. A documented diagnosis of CAPS (Familial Cold Autoinflammatory Syndrome, Muckle‑Wells Syndrome, or NOMID) OR another FDA‑approved indication for Ilaris (e.g., gout, FMF, MKD); AND 2. The drug is prescribed by a board‑certified or board‑eligible rheumatologist or dermatologist; AND 3. For a Non‑Preferred Drug, there has been previous use of preferred drugs and failure or clinical rationale for not using the preferred medication for CAPS (see drug coverage table for preferred drug failure requirements).

Giant Cell Arteritis

Preferred drugs for Giant Cell Arteritis may be considered MEDICALLY NECESSARY and covered when ALL of the following are met:

Giant Cell Arteritis criteria: 1. A documented diagnosis of Giant Cell Arteritis; AND 2. Age according to FDA approval; AND 3. The drug is prescribed by a board‑certified or board‑eligible rheumatologist or neurologist; AND 4. Treatment failure with, or contraindication to, one systemic corticosteroid; AND 5. Documented dose and frequency submitted and within FDA‑approved dosing and frequency; AND 6. For a Non‑Preferred Drug or Non‑Formulary, Non‑Covered, there has been previous use of preferred drugs and failure or clinical rationale for not using the preferred medication for Giant Cell Arteritis; AND 7. Criterion 7 applies only to Actemra (including biosimilars).

Criterion 7 applies only to Actemra/class as noted.

Non-radiographic Axial Spondylarthritis

Non-radiographic axial spondylarthritis therapies may be MEDICALLY NECESSARY when ALL of the following are met:

Non-radiographic Axial Spondylarthritis criteria: 1. A documented diagnosis of non‑radiographic axial spondylarthritis; AND 2. Age according to FDA approval; AND 3. The drug is prescribed by a board‑certified or board‑eligible rheumatologist; AND 4. Treatment failure or contraindication to a prescription NSAID OR previous use and failure or clinical rationale for not using the preferred medication for non‑radiographic axial spondylarthritis; AND 5. For a Non‑Preferred Drug, there has been previous use of preferred drugs and failure or clinical rationale for not using the preferred medication for NAS (see drug coverage table for NAS for preferred drug failure requirements).

Panuveitis / Uveitis

Panuveitis/Uveitis preferred drugs may be considered MEDICALLY NECESSARY when ALL of the following are met:

Panuveitis/Uveitis criteria: 1. A documented diagnosis of non‑infectious intermediate or posterior uveitis or panuveitis; AND 2. Age according to FDA approval; AND 3. Prior use of topical corticosteroids OR topical cycloplegics OR history of preferred systemic/local therapies OR presence of severe disease with profoundly limited vision or risk of significant vision loss (including macular edema) OR comorbid glaucoma precluding local glucocorticoid injections OR bilateral posterior uveitis OR certain systemic diseases (e.g., Behcet syndrome, serpiginous choroiditis); AND 4. For a Formulary Non‑Preferred Drug or Non‑Formulary, Non‑Covered, there has been previous use of preferred drugs and failure or clinical rationale for not using the preferred medication for panuveitis/uveitis (see drug table for preferred drug failure requirements).

Criteria include multiple acceptable prior/local therapy or severity conditions.

Polyarticular JIA

Polyarticular juvenile idiopathic arthritis therapies may be MEDICALLY NECESSARY when ALL of the following are met:

Polyarticular JIA criteria: 1. Documented diagnosis of moderate to severely active polyarticular juvenile idiopathic arthritis; AND 2. Age according to FDA approval; AND 3. The drug is prescribed by a board‑certified or board‑eligible rheumatologist; AND 4. Documented dose and frequency submitted and within FDA‑approved dosing and frequency; AND 5. For a Formulary Non‑Preferred Drug or Non‑Formulary, Non‑Covered, there has been previous use of preferred drugs and failure or clinical rationale for not using the preferred medication for JIA (see drug table for JIA for preferred drug failure requirements) — this criterion applies only to Actemra (including biosimilars) and Orencia.

Actemra and Orencia-specific criterion noted.

Psoriatic Arthritis

Psoriatic arthritis therapies may be MEDICALLY NECESSARY when ALL of the following are met:

Psoriatic Arthritis criteria: 1. A documented diagnosis of active psoriatic arthritis; AND 2. Age according to FDA approval; AND 3. Treatment failure with, or contraindication to, one oral or injectable DMARD OR previous use of one preferred medication for psoriatic arthritis; AND 4. The drug is prescribed by a board‑certified or board‑eligible rheumatologist; AND 5. Documented dose and frequency submitted and within FDA‑approved dosing and frequency; AND 6. For a Formulary Non‑Preferred Drug or Non‑Formulary, Non‑Covered, there has been previous use of preferred drugs and failure or clinical rationale for not using the preferred medication for psoriatic arthritis (see drug table for preferred drug failure requirements) — this criterion applies to the Infliximab class and Orencia as noted.

Infliximab class and Orencia-specific criteria noted.

Rheumatoid Arthritis

Rheumatoid arthritis therapies may be MEDICALLY NECESSARY when ALL of the following are met:

Rheumatoid Arthritis criteria: 1. A documented diagnosis of moderate to severely active rheumatoid arthritis; AND 2. Age 18 years or older; AND 3. The drug is prescribed by a board‑certified or board‑eligible rheumatologist; AND 4. Treatment failure with, or contraindication to, one conventional DMARD (azathioprine, cyclophosphamide, cyclosporine, hydroxychloroquine, leflunomide, methotrexate, mycophenolate, sulfasalazine) OR previous use of one of the preferred medications for rheumatoid arthritis; AND 5. Documented dose and frequency submitted and within FDA‑approved dosing and frequency; AND 6. For a Formulary Non‑Preferred Drug or Non‑Formulary, Non‑Covered, there has been previous use of preferred drugs and failure or clinical rationale for not using the preferred medication for RA (see drug coverage table for RA) — this criterion applies to the Infliximab class, Actemra (including biosimilars), and Orencia as noted.

Multiple drug-class specific exceptions noted.

Systemic JIA (Still's Disease)

Systemic juvenile idiopathic arthritis (Still's Disease) therapies may be MEDICALLY NECESSARY when ALL of the following are met:

Systemic JIA criteria: 1. A documented diagnosis of moderate to severely active systemic juvenile idiopathic arthritis (Still's Disease); AND 2. Age according to FDA approval; AND 3. The drug is prescribed by a board‑certified or board‑eligible rheumatologist; AND 4. Documented dose and frequency submitted and within FDA‑approved dosing and frequency; AND 5. For a Formulary Non‑Preferred Drug or Non‑Formulary, Non‑Covered, there has been previous use of preferred drugs and failure or clinical rationale for not using the preferred medication for systemic JIA (see drug table for JIA) — this criterion applies only to Actemra (including biosimilars).

Actemra-specific note.

Generalized Pustular Psoriasis (GPP)

Generalized pustular psoriasis (GPP) preferred drugs may be MEDICALLY NECESSARY when ALL of the following are met:

GPP criteria: 1. A documented diagnosis of generalized pustular psoriasis; AND 2. Age according to FDA approval; AND 3. For a Formulary Non‑Preferred Drug or Non‑Formulary, Non‑Covered, there has been previous use of preferred drugs and failure or clinical rationale for not using the preferred medication for GPP (see drug table for preferred failure requirements).

Alopecia Areata

Alopecia areata therapies may be MEDICALLY NECESSARY when ALL of the following are met:

Alopecia Areata criteria: 1. Age is equal to or greater than 12 years; AND 2. Confirmed diagnosis of alopecia areata; AND 3. Documentation of >= 25% scalp hair loss; AND 4. For a Formulary Non‑Preferred Drug or Non‑Formulary, Non‑Covered, there has been previous use of preferred drugs and failure or clinical rationale for not using the preferred medication (see drug table for preferred drug failure requirements).>= 25% scalp hair loss

Initial therapy — Generalized Pustular Psoriasis

Preferred drugs may be considered medically necessary and covered when ALL of the following are met:

GPP initial therapy criteria: 1) Documented diagnosis of Generalized Pustular Psoriasis; AND 2) Use consistent with FDA approval and age; AND 3) For formulary non‑preferred or non‑formulary agents, prior use of preferred drugs with documented failure or clinical rationale for not using preferred medication (see drug table for preferred failure requirements).

Initial therapy — Hidradenitis Suppurativa

MEDICALLY NECESSARY and may be covered when ALL of the following are met:

Hidradenitis Suppurativa criteria: 1) Documented diagnosis of moderate to severe hidradenitis suppurativa; AND 2) Age per FDA approval; AND 3) For formulary non‑preferred/non‑formulary agents, prior use of preferred drugs with failure or clinical rationale for not using preferred agents; AND 4) For non‑adalimumab agents: a trial and failure of an adalimumab product is required; AND 5) For adalimumab products: a trial and failure of a preferred adalimumab agent is required.

Initial therapy — Psoriasis

MEDICALLY NECESSARY and covered when ALL of the following are met:

Psoriasis criteria: 1) Documented diagnosis of chronic plaque psoriasis per FDA labeling; AND 2) Age per FDA approval; AND 3) Drug prescribed by a board‑certified or board‑eligible dermatologist; AND 4) Treatment failure with or contraindication to systemic therapy (e.g., methotrexate, azathioprine, acitretin, tacrolimus, cyclosporine, mycophenolate, 6‑thioguanine, sulfasalazine, hydroxyurea, oral methoxsalen, narrow‑band UVB, oral methoxsalen) OR previous use and failure or clinical rationale for not using the preferred medication for psoriasis; AND 5) Documented dose and frequency submitted and within FDA‑approved dosing and frequency; AND 6) For a Formulary Non‑Preferred Drug or Non‑Formulary, Non‑Covered, there has been previous use of preferred drugs and failure or clinical rationale for not using the preferred medication for psoriasis (this criterion applies only to the Infliximab class).

Criterion 5 noted as specific to infliximab class in one footnote.

Initial therapy — Crohn's Disease

Preferred drugs may be considered MEDICALLY NECESSARY and covered when ALL of the following are met:

Crohn's Disease criteria: 1) Documented diagnosis of moderate to severe Crohn's Disease; AND 2) Age per FDA approval; AND 3) Drug prescribed by a board‑certified or eligible gastroenterologist; AND 4) Not receiving in combination with specified potent immunosuppressives or integrin inhibitors; AND 5) Documented dose and frequency submitted and within FDA‑approved dosing and frequency; AND 6) Provide therapeutic drug monitoring (TDM) and antidrug antibody (ADA) testing results; AND 7) For formulary non‑preferred or non‑formulary agents, prior use of preferred drugs with documented failure or clinical rationale for not using preferred medication (see drug table) — dose escalation rules for infliximab/adalimumab: if low trough and low/absent ADA consider escalation; if high ADA consider switching class; if high trough and low/absent ADA consider different TNFi or different class of biologic.

Dose escalation rules for infliximab/adalimumab referenced.

Initial therapy — Ulcerative Colitis

Preferred drugs may be considered MEDICALLY NECESSARY and covered when ALL of the following are met:

Ulcerative Colitis criteria: 1) Documented diagnosis of moderate to severe ulcerative colitis; AND 2) Age per FDA approval; AND 3) Drug prescribed by a board‑certified or eligible gastroenterologist; AND 4) Documented history of failure, contraindication, or intolerance to at least one TNF blocker OR a DMARD OR systemic corticosteroid OR documented rationale for not using the preferred medication; AND 5) Documented dose and frequency submitted and within FDA‑approved dosing and frequency; AND 6) Not receiving specified combination immunosuppressives or integrin inhibitors; AND 7) For formulary non‑preferred/non‑formulary agents, prior use of preferred drugs with documented failure or clinical rationale for not using preferred medication (see drug table) — criterion 5 noted as specific to the Infliximab class in one footnote.

Criterion 5 noted as specific to infliximab class in one footnote.

This policy does not apply to Medicare Advantage members. Coverage criteria, prior authorization, step therapy and formulary sequencing described herein are intended for Commercial plan members of Blue Cross Blue Shield of Massachusetts and are not applicable to Medicare Advantage.

The extracted coverage criteria do not enumerate separate clinical exclusions beyond the requirement that requests meet formulary sequencing and prior authorization rules. In other words, the document focuses on conditions for coverage (diagnosis, prescriber specialty, age, prior trials or contraindications to preferred agents, dosing within FDA ranges) rather than listing additional explicit clinical exclusions.

Requests that are based solely on the use of drug samples are insufficient for an exception. Providers must submit supporting clinical documentation (e.g., chart notes, lab results) and, when applicable, the name/strength of formulary alternatives tried and specifics of treatment failure to support an individual consideration or exception request.

All requests must comply with the preferred → non-preferred sequence and prior authorization requirements. Requests that do not document required trials of preferred agents or justification for not using preferred medications may be considered not medically necessary and can be denied.

When a non-formulary or non-preferred medication is requested and formulary alternatives are available, the policy requires documented failure of, or contraindication to, the required number of covered formulary alternatives (often at least two alternatives where available) or a clinical rationale supporting why those alternatives cannot be used.

What the Prescriber Must Do

Prior Authorization

Prior Authorization Required

Prior authorization required for many immune modulators. Providers must submit a completed prior authorization/eForm and supporting clinical documentation (diagnosis, age, prescriber specialty, prior therapy tried including dates when available, dose and frequency). Failure to provide required documentation may result in denial.

PA required for pharmacy and/or medical benefit as listed on drug tables
Submit Massachusetts Standard Medication Prior Authorization eForm or MA PA form #434 (fax number and phone in header)
Include chart notes, lab results, TDM/ADA results when applicable

Documentation Required

Ilaris (CAPS) prior authorization

Ilaris (for CAPS and other FDA‑approved indications) requires: documented diagnosis (CAPS subtype or other FDA indication), prescriber specialty (board‑certified or board‑eligible rheumatologist or dermatologist), and evidence of prior use/failure of preferred drugs when applicable. For non‑preferred requests, document prior preferred drug trials or clinical rationale for not using them.

Coding, Thresholds, and Key Values

Scalp hair loss — Alopecia Areata

Threshold>= 25% scalp hair loss

Minimum age>= 12 years

Required documentationConfirmed diagnosis of alopecia areata and documentation of scalp hair loss percentage

Definitions and Abbreviations

SPBO — Pharmacy Benefit Note

DefinitionSPBO: This medication is covered ONLY under the pharmacy benefit.

ImplicationRequests must be submitted through pharmacy (Rx) channels per benefit design.

Related policy noteSee individual consideration section for atypical patient exceptions.

PA — Prior Authorization

AbbreviationPA = Prior Authorization

Use in policyPA is required for many immunomodulators described in this policy.

Typical approval duration

Background and Scope

This policy governs the use of immune‑modulating agents (including biologics and other specialty immunomodulators) across multiple autoimmune and inflammatory indications. It defines medical necessity criteria, prior authorization, step therapy and quantity‑limit expectations for covered therapies and describes provider documentation requirements and processes for individual consideration of atypical patients.

Policy History and Updates

2010-01-01policy_review

Reviewed by Medical Policy Group — Gastroenterology, Nutrition and Organ Transplantation; no changes to clinical policy statements recorded in this entry.

2010-09-01criteria_update

Policy updated to include coverage criteria for new FDA‑approved products (Actemra, Ilaris, Stelara) and specialty pharmacy contact updates per P&T Committee recommendations.

2010-01-01criteria_update

Policy updated to include coverage criteria for Simponi and to add an FDA‑approved diagnosis for Cimzia; additional coverage criteria added for certain Remicade indications.

OpenPayer

Immunomodulator Prior Authorization and Formulary Requirements