Premera Bluecross biologics Coverage & Prior Auth Update

Medical Necessity and Coverage Criteria

Medically Necessary criteria and site-of-service rules

Covered when ALL of the following are met for specified drug/indication/site:

General SOS medically necessary conditions: Drug is listed in the policy AND administration site meets medically necessary site criteria (physician's office, infusion center, or home infusion) OR hospital-based outpatient setting when initial course or re-initiation after ≥6 months, or no outpatient/home infusion available within 50 miles

High-risk conditions include specified cardiac or pulmonary disease, unstable renal function, difficult vascular access, acute cognitive impairment, or history of severe drug reactions/anaphylaxis; CRS grade 3–4 requires inpatient admission

CRS requiring inpatient care: CRS grade 3 or 4 as evidenced by ALL: temperature ≥38 °C; hypotension requiring ≥1 vasopressors; hypoxia requiring high-flow oxygen or positive pressure ventilation AND the individual will be admitted to an inpatient setting

Supports hospital-based site selection

Site-of-service medically necessary when clinical-risk present: Hospital-based outpatient site is considered medically necessary when the individual has a clinical condition that increases risk of complications from infusion or injection (e.g., symptomatic cardiac arrhythmia, significant respiratory disease or %FVC ≤ 40%, unstable renal function, difficult/unstable vascular access, acute mental status changes, or prior severe anaphylaxis)

Site selection must be documented in the medical record

Riabni/Ruxience/Truxima for rheumatoid arthritis (site review): Treating moderately to severely active RA (e.g., ≥8 swollen and ≥8 tender joints) AND administered in combination with methotrexate AND used as second-line after failure of one listed first-line therapyclinical severity as noted

First-line examples include Humira, etanercept, Avsola, Inflectra

Preferred site exception for Rituxan Hycela SC: Rituxan Hycela (SC) may have an exception for difficult venous access; documentation of difficult venous access required to support SC formulation instead of IV

Document venous access issues in chart

Entyvio (vedolizumab) SC — Crohn disease

Covered when ALL of the following are met

Vedolizumab SC for Crohn disease: The individual is aged ≥18 years AND has tried one corticosteroid OR one other conventional agent for Crohn's disease OR has enterocutaneous or rectovaginal fistulas OR has had ileocolonic resection AND has had a trial and treatment failure with 2 of the specified biologic/JAK agents (examples: Humira or biosimilars, Cimzia, Omvoh, Rinvoq, Stelara/Steqeyma) AND has received induction therapy with Entyvio (vedolizumab) IV or is currently undergoing IV induction AND Entyvio SC is prescribed by or in consultation with a gastroenterologist.age >= 18

Induction with IV vedolizumab required for SC formulation; specific prior agents listed in policy

Entyvio (vedolizumab) SC — Ulcerative colitis

Covered when ALL of the following are met

Vedolizumab SC for ulcerative colitis: The individual is aged ≥18 years AND has had a trial and treatment failure with 2 of the specified agents (examples: Humira or biosimilars, Omvoh, Rinvoq, Simponi, Skyrizi, Stelara/Steqeyma/Yesintek, Tremfya, Velsipity, Xeljanz/XR) AND has received induction therapy with Entyvio (vedolizumab) IV or is currently undergoing IV induction AND Entyvio SC is prescribed by or in consultation with a gastroenterologist.age >= 18

Induction with IV vedolizumab required for SC formulation; lists of acceptable prior agents provided in policy

Rituximab products — rheumatoid arthritis

Covered when ALL of the following are met

Rituxan (rituximab) IV or Rituxan Hycela SC for rheumatoid arthritis: Treating moderately to severely active RA (e.g., ≥8 swollen and ≥8 tender joints) AND administered in combination with methotrexate AND used as second-line therapy after trial/failure of at least one listed first-line therapy (examples: Humira or biosimilars, Enbrel, Avsola/Inflectra, Actemra, JAK inhibitors) OR when patient is not a suitable candidate for TNF inhibitors after inadequate response to conventional DMARDs; documentation of prior trials requiredclinical severity as noted

Exception may be granted for Rituxan Hycela SC with documentation of difficult venous access

Kineret (anakinra) — rheumatoid arthritis

Covered when ALL of the following are met

Kineret (anakinra) for moderate to severe rheumatoid arthritis: Individual aged ≥18 years AND not responsive or intolerant to hydroxychloroquine, leflunomide, methotrexate, or sulfasalazine AND has had an inadequate response or intolerance to 2 of the following agents (examples: tocilizumab/Avtozma/Tyenne SC, Enbrel, Humira or specified biosimilars, Rinvoq, Xeljanz/XR) AND medication is prescribed by or in consultation with a specialist (rheumatologist).age >= 18

Requires prior trials of conventional DMARDs and two additional biologic/JAK agents

Kevzara (sarilumab) — JIA and RA

Covered when ALL of the following are met

Kevzara (sarilumab) for polyarticular JIA: Individual weighs ≥63 kg AND has aggressive disease AND inadequate response or intolerance to leflunomide, methotrexate, or sulfasalazine AND inadequate response or intolerance to 2 specified drugs AND medication is prescribed by or in consultation with a rheumatologist.weight >= 63 kg

Weight requirement applies to PJIA; specialist involvement required

Kevzara (sarilumab) for moderate to severe RA: Individual aged ≥18 years AND has not responded to or does not tolerate hydroxychloroquine, leflunomide, methotrexate, or sulfasalazine AND has had an inadequate response or intolerance to 2 of the listed agents (examples: tocilizumab/Avtozma/Tyenne SC, Enbrel, Humira/biosimilars, Rinvoq, Xeljanz/XR) AND medication is prescribed by or in consultation with a rheumatologist.age >= 18

Standard RA step therapy and specialist consultation required

Bimzelx (bimekizumab) — multiple dermatologic/rheumatologic indications

Covered when ALL of the following are met (per indication)

Bimzelx for ankylosing spondylitis: Individual aged ≥18 years AND inadequate response or intolerance to 1 listed agent (examples: Enbrel, Humira or biosimilars, Taltz) AND medication prescribed by or in consultation with a rheumatologist.age >= 18

Single prior biologic required for AS

Bimzelx for hidradenitis suppurativa: Individual aged ≥18 years AND has tried at least 1 other therapy (e.g., intralesional/oral corticosteroids, systemic antibiotics) AND inadequate response or intolerance to 1 of specified agents (examples: adalimumab biosimilars, Cosentyx, Humira) AND prescribed by or in consultation with a dermatologist.age >= 18

Dermatologist involvement required

Bimzelx for moderate to severe plaque psoriasis: Individual aged ≥18 years AND chronic plaque psoriasis involving ≥10% BSA (exceptions for facial, genital, or pustular involvement) AND history of adequate trial and failure with ≥1 approved systemic therapy unless contraindicated AND inadequate response or intolerance to 1 of listed biologics/agents AND prescribed by or in consultation with a dermatologist.

Cosentyx (secukinumab) — multiple indications

Covered when ALL of the following are met (per indication)

Cosentyx for ankylosing spondylitis: Individual aged ≥12 years AND inadequate response or intolerance to 2 listed agents (examples: Enbrel, Humira/biosimilars, Rinvoq, Taltz, Xeljanz/XR) AND medication prescribed by or in consultation with a rheumatologist.age >= 12

Two prior agent failures required for AS

Cosentyx for moderate to severe plaque psoriasis: Individual aged ≥6 years AND chronic plaque psoriasis involving ≥10% BSA (exceptions for specified site involvement) AND history of adequate trial and treatment failure with at least 1 approved systemic therapy unless contraindicated AND inadequate response or intolerance to 2 listed agents AND prescribed by or in consultation with a dermatologist.age >= 6; BSA >= 10%

Pediatric and adult psoriasis criteria specified

Cosentyx for active psoriatic arthritis:

Siliq (brodalumab) — plaque psoriasis

Covered when ALL of the following are met

Siliq (brodalumab) for moderate to severe plaque psoriasis: Individual aged ≥18 years AND chronic plaque psoriasis involving ≥10% BSA (exceptions for site-specific severe disease) AND history of adequate trial and treatment failure with ≥1 approved systemic therapy unless contraindicated AND inadequate response or intolerance to 2 listed agents (examples include Enbrel) AND prescribed by or in consultation with a dermatologist.age >= 18; BSA >= 10%

Two prior agent failures required

Ilumya (tildrakizumab) — plaque psoriasis

Covered when ALL of the following are met

Ilumya (tildrakizumab) for moderate to severe plaque psoriasis: Individual aged ≥18 years AND chronic plaque psoriasis involving ≥10% BSA (exceptions listed) AND history of adequate trial and failure with ≥1 approved systemic therapy unless contraindicated AND prescribed by or in consultation with a dermatologist.age >= 18; BSA >= 10%

Standard plaque psoriasis criteria applied

Olumiant (baricitinib) — rheumatoid arthritis (and cosmetic exclusion)

Covered when ALL of the following are met

Olumiant (baricitinib) for moderate to severe rheumatoid arthritis: Individual aged ≥18 years AND has not responded to or does not tolerate hydroxychloroquine, leflunomide, methotrexate, or sulfasalazine AND has had an inadequate response or intolerance to 2 of the listed agents (examples: Actemra, Enbrel, Humira/biosimilars, Rinvoq, Xeljanz/XR) AND medication is prescribed by or in consultation with a rheumatologist AND quantity limits apply where noted (30 tablets/30 days may be specified elsewhere).age >= 18

Use in alopecia is considered cosmetic and not covered by this policy

Zeposia (ozanimod) — ulcerative colitis

Covered when ALL of the following are met

Zeposia (ozanimod) for ulcerative colitis: Individual aged ≥18 years AND trial and treatment failure with 2 of the specified agents (examples: Humira/biosimilars, Omvoh, Rinvoq, Simponi, Skyrizi, Stelara/Steqeyma/Yesintek, Tremfya, Velsipity, Xeljanz/XR) AND prescribed by or in consultation with a gastroenterologist AND dose limited to 0.92 mg per day AND quantity limits as specified (30 tablets/30 days where applicable).age >= 18; dose <= 0.92 mg/day

Specialist prescriber and dose/quantity limits required

Orencia (abatacept) — multiple indications

Covered when ALL of the following are met

Orencia (abatacept) for polyarticular JIA: Individual aged ≥2 years AND has aggressive disease AND inadequate response or intolerance to leflunomide, methotrexate, or sulfasalazine AND inadequate response or intolerance to 2 listed drugs AND prescribed by or in consultation with a rheumatologist.age >= 2

Specialist involvement required

Orencia for adults with active psoriatic arthritis: Individual aged ≥18 years AND inadequate response or intolerance to 2 of listed agents (examples: Humira/biosimilars, Otezla, Rinvoq, Skyrizi, Sotyktu, Stelara/Steqeyma/Yesintek, Taltz, Tremfya, Xeljanz/XR) AND comorbidity considerations (heart failure, lymphoproliferative disorder, serious infection, demyelinating disorder) noted AND prescribed by or in consultation with a dermatologist or rheumatologist.age >= 18

Comorbidity considerations may affect suitability

Orencia for moderate to severe RA:

TNF-α inhibitors — ankylosing spondylitis

Covered when ALL of the following are met

Adalimumab/related TNF-α products for ankylosing spondylitis: Individual aged ≥18 years AND inadequate response or intolerance to required prior adalimumab formulations/biosimilars (list includes multiple adalimumab brands/biosimilars) AND medication prescribed by or in consultation with a rheumatologist.age >= 18

Some criteria require failure of multiple specific adalimumab formulations prior to approval

Representative indication-specific requirements: Medication is prescribed by or in consultation with the appropriate specialist; patient meets indication-specific age/weight thresholds; has had inadequate response/intolerance to the listed prior therapies as required for the indication (counts and specific agents are indication-specific); disease-specific severity or objective measures (e.g., BSA ≥10% for psoriasis, Mayo score/Mayo-defined remission for UC, CDAI for Crohn's disease) are documented when required.Indication-specific

See individual product sections for exact prior agent lists and counts

Indication-specific medical necessity criteria (representative set)

Covered when ALL of the following indication-specific criteria are met (examples below for representative agents and indications):

General: Medication is prescribed by or in consultation with the appropriate specialist as specified per indication (e.g., rheumatologist, dermatologist, gastroenterologist, ophthalmologist).

See individual indication nodes for specialist requirements.

Age requirement: Patient meets the age threshold specified for the indication (ranges from ≥2 years to ≥18 years depending on disease and agent).Indication-specific (e.g., ≥2 years for pediatric uveitis, ≥5 or 6 years for some IBD, ≥12 for ankylosing spondylitis for Cosentyx).

Prior therapy / step requirements: Has had an inadequate response or intolerance to the listed prior agents as required for the indication (examples include trials of corticosteroids, immunosuppressives, conventional DMARDs, or specific biologics).Indication-specific counts (e.g., failed 1–2 or more agents; some indications require failure of multiple adalimumab products)

Benefit assignment

Products are assigned to medical, pharmacy, or both benefits; coverage/authorization follows assigned benefit

Medical benefit management: Listed products managed through the medical benefit include Actemra IV, Avsola, Avtozma IV, Cosentyx IV, Inflectra, Infliximab (Janssen unbranded), Orencia IV, Remicade, Renflexis, Riabni, Rituxan, Rituxan Hycela, Ruxience, Tofidence IV, Tyenne IV, and Truxima.

Medical benefit prior authorization/site-of-service review applies

Medical/Pharmacy dual management: Products managed through both pharmacy and medical benefits include Abrilada, Actemra SC, multiple adalimumab brands and biosimilars, Amjevita, Avtozma SC, Bimzelx, Cimzia, Cosentyx SC, Cyltezo, Entyvio SC, Hadlima, Hulio, Humira (specified NDCs), Hyrimoz, Ilumya, Kevzara, Kineret, Orencia SC, Siliq, Simlandi, Simponi, Tyenne SC, Yuflyma, and Yusimry.

Benefit routing determines which prior authorization workflow applies

Pharmacy benefit management: Olumiant (baricitinib) and Zeposia (ozanimod) are managed through the pharmacy benefit.

Pharmacy benefit prior authorization/quantity limits (e.g., Zeposia dose 0.92 mg/day, some orals limited to 30 tablets/30 days) apply

Coverage criteria for TNFα inhibitors

Coverage aligned with evidence of benefit demonstrated in randomized trials and standard treatment pathways; biologic TNFα inhibitors are covered when clinical criteria and prior therapy conditions are met

General coverage prerequisites: Documented diagnosis of an indicated immune-mediated disease (examples: moderate-to-severe plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, moderate-to-severe ulcerative colitis, Crohn's disease, pyoderma gangrenosum) AND documentation of prior conventional therapies or objective disease severity measures where required.

Evidence from RCTs (e.g., REVEAL, CHAMPION, UC trials) supports efficacy; document PASI, Mayo score, CDAI as applicable

Evidence of prior therapy or disease severity: Either failure, intolerance, or contraindication to appropriate conventional therapies (topical agents, NSAIDs, systemic corticosteroids, traditional DMARDs such as methotrexate or sulfasalazine) OR disease activity meeting trial-defined moderate-to-severe thresholds (e.g., PASI-75 context, Mayo score criteria for UC).

Document prior therapy trials and objective measures in the chart

Safety assessment before initiation: Documentation of baseline infection risk assessment including TB screening and discussion of infection/malignancy risks associated with TNFα inhibitors and other biologics.

Product-specific medical necessity criteria (summary)

Coverage criteria for individual biologic agents are added or updated and apply when product-specific FDA-approved indications and dosing are met.

Product-specific criteria: Individual biologic and biosimilar products have distinct coverage criteria; new or revised product-specific nodes (examples: rituximab products for RA; tocilizumab products for PJIA and RA; vedolizumab SC for IBD; multiple adalimumab biosimilars) apply when FDA-approved indications and dosing are satisfied and the policy's step/prior therapy requirements are met.N/A

See product-specific sections elsewhere in the policy for exact AND/OR logic, prior-agent lists, age/weight thresholds, and dosing limits.

This policy specifies that a requested outpatient infusion or injectable therapy site is not medically necessary when the site-of-service criteria are not met. Medically necessary hospital-based outpatient or infusion center administration is supported when the individual meets high-risk criteria (for example: symptomatic cardiac or significant respiratory disease, unstable renal function, difficult vascular access, acute cognitive impairment, or a history of severe drug reactions/anaphylaxis), or when cytokine release syndrome (CRS) grade 3–4 is present and inpatient admission is required. Conversely, if these site-specific safety conditions are absent and the site requested does not align with the policy criteria, the service should be considered not medically necessary.

Use of baricitinib (Olumiant) for the treatment of alopecia is expressly identified in the policy as a cosmetic exclusion and is not covered under this policy.

The policy states that all other uses of the listed agents, including combinations of the named biologics or use for conditions not specifically described in the policy, are considered investigational and therefore not covered / not medically necessary.

No additional explicit exclusions are listed in the excerpted coding and policy sections; the document instead focuses on indication- and product-specific criteria, site-of-service rules, and not medically necessary statements rather than an enumerated exclusion list.

Although there is no formal exclusion list for mild disease in the excerpt, the policy indicates that mild disease responsive to symptomatic therapy (for example managed with NSAIDs, corticosteroids, or sulfasalazine) is generally managed without biologic therapies and therefore may not meet the criteria for biologic treatment.

This medical policy does not apply to Medicare Advantage members; providers and reviewers should verify plan applicability and consult the member benefit booklet or customer service for Medicare Advantage considerations.

Requests for infusion or injectable therapy at non-preferred or non-approved sites of service that do not meet the site-of-service safety criteria described in the policy are considered not medically necessary.

The policy clarifies that, beyond the specific covered indications, other uses of the drugs for approved conditions listed in the policy are considered not medically necessary where policy-specific statements or criteria are not met.

No additional summary text was provided in the inventory for this placeholder. Refer to the policy sections above for product- and indication-specific coverage rules, site-of-service requirements, and not medically necessary statements.

The policy indicates that use of TNFα inhibitors in settings where evidence of benefit is limited (for example, mild disease responsive to non-biologic therapies) may be considered not medically necessary. When such agents are requested, the provider must document the clinical necessity, prior therapies tried, and rationale supporting use of a TNFα inhibitor.

Services that do not meet the policy’s medical necessity criteria, or that exceed applicable member benefit limits, are not supported. The policy requires that product-specific not medically necessary conditions be evaluated per the individual drug criteria and that plan benefit limits and applicability (including the Medicare Advantage exclusion) be confirmed prior to authorization.

Codes, Limits, and Key Clinical Thresholds

Formulary product identifiers and routesNDC

Humira (adalimumab) (Cordavis) [NDCs starting with 83457]	Subcutaneous
Hyrimoz (adalimumab-adaz) (Cordavis) [NDCs starting with 83457]	Subcutaneous
adalimumab-adbm [NDCs starting with 00597]	Subcutaneous
Humira (adalimumab) (AbbVie) [NDCs starting with 00074]	Subcutaneous

Listed NDC prefixes and referenced biologicsNDC

00074	Humira (adalimumab) (AbbVie)
00597	adalimumab-adbm (unbranded)
82009	adalimumab-adbm (alternate prefix)
83457	Humira and Hyrimoz (Cordavis) NDC prefix

Covered HCPCS CodesHCPCSCovered

J0129	Injection, abatacept (Orencia), 10 mg
J0139	Injection, adalimumab (Humira) 1 mg
J0717	Injection, certolizumab pegol (Cimzia), 1 mg
J1745	Injection, infliximab, excludes biosimilar, 10 mg
J3245	Injection, tildrakizumab (Ilumya), 1 mg
J3247	Injection, secukinumab (Cosentyx), IV, 1 mg
J3262	Injection, tocilizumab (Actemra), 1 mg
J3590	Unclassified biologics (use to report listed products)
J9311	Injection, rituximab 10 mg and hyaluronidase (Rituxan Hycela)
J9312	Injection, rituximab (Rituxan), 10 mg

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Covered HCPCS / Medical benefit injectables (partial list)HCPCSCovered

J0129	Orencia (abatacept)
J0139	Humira (adalimumab)
J0717	Cimzia (certolizumab pegol)
J1745	Infliximab (Remicade)
J9312	Rituxan (rituximab)
J9311	Rituxan Hycela
J3590	Unclassified biologics
J3247	Cosentyx (secukinumab)
J3262	Actemra (tocilizumab)
J3245	Ilumya (tildrakizumab)

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Biosimilar Q-codesHCPCSCovered

Q5104	Infliximab-abda (Renflexis), biosimilar, 10 mg
Q5115	Rituximab-abbs (Truxima), biosimilar, 10 mg
Q5119	Rituximab-pvvr (Ruxience), biosimilar, 10 mg
Q5121	Infliximab-axxq (Avsola), biosimilar, 10 mg
Q5123	Rituximab-arrx (Riabni), biosimilar, 10 mg
Q5133	Tocilizumab-bavi (Tofidence), biosimilar, 1 mg
Q5135	Tocilizumab-aazg (Tyenne), biosimilar, 1 mg
Q5140	Adalimumab-fkjp (Hulio), biosimilar, 1 mg
Q5141	Adalimumab-aaty (Yuflyma), biosimilar, 1 mg
Q5142	Adalimumab-ryvk (Simlandi), biosimilar, 1 mg

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HCPCS/J-code updates referenced in historyHCPCS

Q5119	Ruxience IV added
Q5115	Truxima IV added
J3262	Actemra added
Q5133	Tofidence IV added
Q5135	Tyenne added
J3247	Cosentyx added
J0129	Orencia added
J0717	Cimzia added
J3245	Ilumya added
Q5131	Administrative addition referenced

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inv-36: FVC — key clinical threshold (≤ 40%)

FVC<= 40%

inv-37: Zeposia (ozanimod) daily dose — 0.92 mg per day

Zeposia (ozanimod) daily dose0.92 mg per day

inv-38: Oral quantity limit — 30 tablets per 30 days

Oral quantity limit30 tablets per 30 days

inv-39: Crohn's Disease Activity Index (CDAI) — Moderate-severe defined as CDAI ≥220 and ≤450

Crohn's Disease Activity Index (CDAI)

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior authorization and step therapy required

Prior authorization and step therapy criteria apply for specific drugs in the plan's formulary. IV and other injectable agents are subject to medical-benefit review where applicable. Prior authorization and site-of-service review may be required; approvals can be granted for up to 12 months.

Formulary applicability: Formulary ID: 6062 — verify member plan booklet or ID card to determine applicability.
Many injectable biologics are managed through the medical benefit and require the medical benefit prior authorization process.
Approvals: initial and re-authorization approvals may be granted up to 12 months when drug-specific criteria are met and records show continued clinical benefit.

Documentation Required

Prior authorization requirements and required documentation

Document trials and failures of specified alternative agents, including any required induction with an IV product when the SC formulation requires it (e.g., vedolizumab/Entyvio). Include patient age to demonstrate age eligibility for the requested indication.

Clinical Background and Rationale

Background: This policy governs use of biologic and immunomodulatory agents administered IV, subcutaneously, or orally for autoimmune and inflammatory conditions such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and related disorders. It defines indication-specific medical necessity requirements (including age and weight thresholds, prior-conventional therapy trials, specialist involvement), site-of-service safety criteria for infusion/injectable administration, and documentation requirements to support prior authorization and medical necessity review.

Key Definitions and Trial Endpoints

inv-67: Site of service (SOS) — location where the drug is administered (hospital outpatient, infusion center, office, home)

DefinitionSite of service (SOS) = the location where the drug is administered (hospital-based outpatient setting, infusion center, physician's office, or at home)

Preferred medically necessary sitesPhysician's office, infusion center, and home infusion are listed as preferred medically necessary sites for specified drugs

Hospital-based outpatient useHospital-based outpatient setting may be medically necessary for initial course or re-initiation after ≥6 months, or when no outpatient/home infusion available within 50 miles

inv-68: Cytokine release syndrome (CRS) grade 3 or 4 — clinical definition (fever ≥38°C, vasopressor requirement, high-flow oxygen or ventilation)

CRS grade 3–4 criteriaCytokine release syndrome (CRS) grade 3 or 4 is defined by ALL of: temperature ≥38°C; hypotension requiring ≥1 vasopressors; and hypoxia requiring high-flow oxygen delivery or positive pressure ventilation

Coding and Billing Notes

Covered HCPCS codes listed in policy - duplicate grouping for billing teamsHCPCSCovered

J0129	Injection, abatacept (Orencia), 10 mg
J0139	Injection, adalimumab (Humira) 1 mg
J0717	Injection, certolizumab pegol (Cimzia), 1 mg
J1745	Injection, infliximab, excludes biosimilar (Remicade or Janssen unbranded), 10 mg
J3245	Injection, tildrakizumab (Ilumya), 1 mg
J3247	Injection, secukinumab (Cosentyx), IV, 1 mg
J3262	Injection, tocilizumab (Actemra), 1 mg
J3590	Unclassified biologics (use to report: Amjevita, Bimzelx, Cyltezo, Hadlima, Hulio, Hyrimoz, Kevzara, Kineret, Siliq, Simlandi, Yuflyma and Yusimry)
J9311	Injection, rituximab 10 mg and hyaluronidase (Rituxan Hycela)
J9312	Injection, rituximab (Rituxan), 10 mg

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Policy Changes and Effective Dates

2026-06-01policy_effective_dateLatest

Policy effective date updated to 2026-06-01 with material updates to product-specific criteria and operational provisions including re-authorization duration and preferred status changes.

2025-04-01annual_review

Annual review approved March 11, 2025 with updates to adalimumab product listings and NDC blocks.

2025-01-01

OpenPayer

Medical Necessity Criteria for Custom Open Formulary

Medical Necessity and Coverage Criteria

Codes, Limits, and Key Clinical Thresholds

Prior Authorization, Step Therapy, and Documentation Requirements

Clinical Background and Rationale

Key Definitions and Trial Endpoints

Coding and Billing Notes

Policy Changes and Effective Dates