Premera Bluecross Arthropathies Coverage Update

Initial and stepwise therapy coverage criteria — Covered when ALL of the following are met (examples by indication).

Covered when ALL of the following are met (step/line placement and examples by indication consolidated):

ALL of the following

Step therapy tier listings: Agents are organized into First Line and Second Line tiers by indication (refer to the Policy section for full formulary and step details). Tier placement examples for rheumatoid arthritis (RA) include: First Line - TNF-alpha inhibitors (eg, adalimumab biosimilars, etanercept, certolizumab, infliximab products including Inflectra/Remicade/Janssen infliximab, golimumab [Simponi Aria], and other listed TNF agents); IL-6 inhibitors (eg, tocilizumab IV/SC [Actemra], biosimilars); Janus kinase (JAK) inhibitors (eg, tofacitinib [Xeljanz/XR], upadacitinib [Rinvoq]); and selected other mechanism agents as listed in the Policy. Second Line - includes alternative TNF agents (specified biosimilars/unbranded adalimumab products), IL-6 inhibitors (second-line agents such as sarilumab [Kevzara] where indicated), T-cell costimulation modulators (abatacept [Orencia]), other mechanism-based agents, and additional JAK or non-JAK agents per the Policy.
Decision criteria common to RA step tiers: Medication must be prescribed by or in consultation with a rheumatologist; member age must meet indication-specific minimums (typically >=18 years for adult RA); prior inadequate response, intolerance, or contraindication to conventional synthetic DMARDs (eg, methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) is required before biologic or targeted synthetic agents unless otherwise specified; progression from First Line to Second Line generally requires documented inadequate response or intolerance to the required First Line agent(s) as defined in the Policy.
TNF-alpha antagonists — First Line (Rheumatoid arthritis): TNF-alpha inhibitors may be considered medically necessary as First Line biologic therapy for RA when ALL the following are met: (1) The individual is aged 18 years or older; (2) The individual has active moderate to severe RA and has not responded to or does not tolerate conventional synthetic DMARD therapy (eg, methotrexate); (3) Medication is prescribed by or in consultation with a rheumatologist. Representative First Line TNF agents include adalimumab products (Cyltezo, Simlandi, Hyrimoz, Cyltezo unbranded, others), etanercept (Enbrel), certolizumab (Cimzia), infliximab products (Inflectra, Remicade, Janssen infliximab), golimumab (Simponi Aria), and others listed in the Policy.
Infliximab products — Medical necessity (Rheumatoid arthritis): Infliximab formulations (Inflectra [infliximab-dyyb], Remicade [infliximab], and other Janssen infliximab) are subject to site-of-service review for IV administration. They may be considered medically necessary when RA criteria for a TNF inhibitor are met (age, rheumatologist involvement, inadequate response/intolerance to required DMARDs) and when administration meets Site-of-Service medical necessity rules (see SOS criteria).
TNF-alpha antagonists — Second Line (Rheumatoid arthritis): TNF-a antagonists designated as Second Line may be considered medically necessary when ALL the following are met: (1) The individual is aged 18 years or older; (2) The individual has had an inadequate response or intolerance to required First Line agents per the Policy; (3) Medication is prescribed by or in consultation with a rheumatologist; (4) For some Second Line TNF agents, documentation of failure of specific named First Line adalimumab products or other TNF agents may be required (see Policy for exact sequencing). Representative Second Line TNF agents include branded and biosimilar adalimumab products and other listed TNF agents identified as Second Line in the Policy.
IL-6 inhibitors — First and Second Line (Rheumatoid arthritis): IL-6 inhibitors (eg, tocilizumab IV/SC [Actemra], biosimilars such as Tofidence/Tyenne) may be First Line for some JIA or RA indications but are often used as Second Line in RA when there is inadequate response or intolerance to TNF inhibitors. Coverage requires: (1) Appropriate age per indication; (2) Inadequate response or intolerance to required prior agents (TNF inhibitors or conventional DMARDs) as specified for First vs Second Line use; (3) Rheumatologist involvement. Second Line IL-6 agents (eg, sarilumab [Kevzara]) require inadequate response to the specified prior biologic/JAK agents per Policy and consideration of comorbidities (eg, heart failure, lymphoproliferative disorder, prior serious infection) as noted in the Policy.
Janus kinase (JAK) inhibitors — First and Second Line (Rheumatoid arthritis): JAK inhibitors (eg, tofacitinib [Xeljanz/XR], upadacitinib [Rinvoq], baricitinib [Olumiant]) may be designated First Line or Second Line depending on indication and formulary. Coverage criteria include: (1) Age >=18 years for adult RA; (2) Inadequate response or intolerance to one or more TNF blockers for certain JAK approvals (per Policy); (3) Prescription by or in consultation with a rheumatologist. Note: Use of tofacitinib or baricitinib for alopecia is considered cosmetic and is not covered under this policy.
Non-radiographic axial spondyloarthritis (nr-axSpA) — First and Second Line: For nr-axSpA, IL-17 inhibitors (eg, ixekizumab [Taltz]) and JAK inhibitors (eg, upadacitinib [Rinvoq]) are included in First Line listings when objective signs of inflammation are present (CRP elevation or MRI sacroiliitis) and medication is prescribed by or in consultation with a rheumatologist. Rinvoq may be considered after inadequate response or intolerance to certolizumab (Cimzia) per Policy. Second Line IL-17 agents follow sequencing rules requiring failure of designated First Line agents as specified in the Policy.
Other mechanism-based agents (RA) — Criteria: Agents with different mechanisms (eg, T-cell costimulation modulators such as abatacept [Orencia]; IL-1 inhibitors; other non-TNF biologics) are covered when ALL the following are met: (1) The individual meets age and diagnosis criteria for RA; (2) The individual has had an inadequate response, intolerance, or contraindication to the required prior classes (eg, TNF inhibitors, IL-6 inhibitors, JAK inhibitors) per the Policy’s step sequence; (3) Medication is prescribed by or in consultation with a rheumatologist; (4) For IV formulations, site-of-service rules apply and administration at non-approved sites may be considered not medically necessary. Specific exceptions and sequencing requirements (including required failed agents and number of agents) are detailed in the main Policy section and apply to Custom Open and Preferred formularies (Formulary IDs noted).

Site-of-Service criteria — Site-of-Service Medical Necessity rules (applies to medical benefit reviews for IV/injectable drugs).

Site-of-Service criteria for IV/injectable drugs (applies to medical benefit reviews):

ALL of the following

Site-of-Service (SOS) Medical Necessity rules apply ONLY to medical benefit reviews and do NOT apply to specified Alaska fully-insured members (see Policy for exceptions).
SOS review applies to IV and injectable drugs administered in hospital-based outpatient settings, outpatient hospital IV infusion departments, and similar clinical levels of care; claims for IV-administered drugs must be processed through the medical benefit (not pharmacy).
Infusion/injection at a site that does not meet SOS criteria is considered not medically necessary for infusion and injectable therapy services. SOS may deem hospital-based administration medically necessary when no outpatient infusion center exists within 50 miles, no contracted home infusion agency will travel to the home, the patient has clinical risks that increase complication likelihood (eg, significant cardiac or pulmonary disease, unstable renal function, difficult vascular access, acute mental status changes, known history of severe infusion reactions), or when cytokine release syndrome grade and criteria are met.

Polyarticular JIA — TNF-alpha antagonists First Line (selected adalimumab biosimilars, Enbrel) — Covered when ALL of the following are met.

Polyarticular juvenile idiopathic arthritis — TNF-alpha antagonists First Line (selected agents) — Covered when ALL of the following are met:

ALL of the following

The individual is aged 2 years or older;
Has aggressive polyarticular JIA as defined in the Policy (Related Information);
Has had an inadequate response or intolerance to leflunomide, methotrexate, or sulfasalazine, OR is being started concurrently with one of those conventional agents;
Medication is prescribed by or in consultation with a rheumatologist;
Representative First Line TNF agents include adalimumab products (Cyltezo, Simlandi, Hyrimoz, and listed biosimilars) and etanercept (Enbrel).

Polyarticular JIA — IV TNF and JAK inhibitor criteria — Covered when ALL of the following are met.

Polyarticular juvenile idiopathic arthritis — IV TNF and JAK inhibitor criteria — Covered when ALL of the following are met:

ALL of the following

Simponi Aria (golimumab) IV and infliximab products (Inflectra, Remicade, Janssen infliximab) are subject to site-of-service review for IV administration; they may be considered medically necessary when JIA clinical criteria and SOS criteria are met (age >=2 years, aggressive disease, inadequate response to leflunomide/methotrexate/sulfasalazine, and rheumatologist involvement).
Janus Kinase inhibitors (eg, upadacitinib [Rinvoq], tofacitinib [Xeljanz/XR]) for polyarticular JIA may be considered medically necessary when the patient is aged 2 years or older, has had an inadequate response or intolerance to one or more TNF blockers, and the medication is prescribed by or in consultation with a rheumatologist.

IL-6 inhibitors — polyarticular and systemic JIA — Covered when ALL of the following are met.

IL-6 inhibitors — polyarticular and systemic JIA — Covered when ALL of the following are met:

ALL of the following

For polyarticular JIA: Actemra (tocilizumab) IV/SC and biosimilars (Tofidence, Tyenne) may be considered medically necessary when the individual is aged 2 years or older, has aggressive disease, has had an inadequate response or intolerance to leflunomide, methotrexate, or sulfasalazine, AND has had an inadequate response or intolerance to specified TNF blockers (eg, Cyltezo, Simlandi) or when comorbid conditions (heart failure, previously treated lymphoproliferative disorder) influence agent choice; medication must be prescribed by or in consultation with a rheumatologist. SOS rules apply to IV doses.
For systemic JIA: Actemra (tocilizumab) IV/SC and biosimilars may be considered medically necessary when the individual is aged 2 years or older, has had an inadequate response or intolerance to corticosteroids, leflunomide, methotrexate, NSAIDs or sulfasalazine, and medication is prescribed by or in consultation with a rheumatologist.
IL-6 Second Line (eg, sarilumab [Kevzara]) may be considered when there is inadequate response or intolerance to first-line IL-6 agents and other required prior therapies per the Policy, and when rheumatologist involvement is documented.

Second-line escalation: IL-6, T-cell modulators, TNF-a inhibitors — Covered when ALL of the following are met (examples for second-line agents).

Second-line escalation: IL-6, T-cell modulators, TNF-alpha inhibitors — Covered when ALL of the following are met (examples for second-line agents):

ALL of the following

Second-line agents (eg, sarilumab [Kevzara], abatacept [Orencia], alternative TNF biosimilars) are considered when the individual has had an inadequate response or intolerance to two or more prior agents as specified for the indication (eg, failed IL-6 + TNF or failed multiple TNF agents), and when medication is prescribed by or in consultation with a rheumatologist.
Orencia (abatacept) IV/SC may be considered medically necessary for polyarticular JIA when age and prior therapy failure requirements are met (inadequate response to two prior agents including relevant IL-6 or TNF agents), and SOS rules govern IV administration.

Rheumatoid arthritis — step/line placements (excerpt) — Covered when consistent with step therapy tier listed.

Rheumatoid arthritis — step/line placements (excerpt): Covered when consistent with step therapy tier listed and clinical sequencing below:

ALL of the following

RA First Line: TNF-alpha inhibitors (eg, adalimumab biosimilars, etanercept, certolizumab, infliximab products, golimumab), IL-6 inhibitors (eg, tocilizumab where indicated), and selected JAK inhibitors per formulary placement; requirements: age >=18 years, inadequate response or intolerance to conventional DMARDs unless otherwise specified, rheumatologist involvement.
RA Second Line: May include alternative TNF agents (specified biosimilars/unbranded adalimumab products), IL-6 second-line agents (eg, sarilumab), T-cell costimulation modulators (abatacept), JAK inhibitors (if designated second-line), IL-1 inhibitors, or other mechanism-based agents when there is inadequate response or intolerance to required First Line agents and documentation of failures is provided.
Infliximab products (Inflectra, Remicade, Janssen infliximab) for RA are subject to SOS review and considered medically necessary when RA criteria are met and administration meets site-of-service rules (documentation required).

Non-radiographic axial spondyloarthritis (nr-axSpA) — First and second line.

Non-radiographic axial spondyloarthritis (nr-axSpA) — First and second line:

ALL of the following

IL-17 inhibitors (eg, ixekizumab [Taltz]) First Line: Covered when the individual is aged 18 years or older, has objective signs of inflammation (elevated CRP or sacroiliitis on MRI), and medication is prescribed by or in consultation with a rheumatologist.
JAK inhibitor First Line (eg, upadacitinib [Rinvoq]): Covered when the individual is aged 18 years or older, has objective signs of inflammation (CRP elevation or MRI sacroiliitis), has had an inadequate response or intolerance to certolizumab (Cimzia), and medication is prescribed by or in consultation with a rheumatologist.
IL-17 Second Line: Applies when inadequate response or intolerance to First Line IL-17 agents or other required prior therapies per Policy; sequencing and required failed agents are detailed in the main Policy.

Prior Authorization, Documentation, and Step Therapy — Provider Responsibilities

Prior Authorization

Prior authorization and site-of-service review required

Specific biologic and injectable agents listed in this policy are subject to prior review for medical necessity and site-of-service determination; claims for drugs administered via an intravenous route must be processed through the medical benefit and will be reviewed for site-of-service appropriateness.

IV-administered drugs listed in the policy are subject to site-of-service review.
Claims for IV-administered drugs must be billed through the medical benefit (not pharmacy).

Prior Authorization

Medical necessity & rheumatologist prescriber

Prior authorization requests must document the member's age and that the medication is being prescribed by or in consultation with a rheumatologist; for polyarticular JIA also document aggressive disease and prior inadequate response or intolerance to leflunomide, methotrexate, or sulfasalazine as required by the criteria.

Document member age (e.g., >=2 years for many JIA indications or >=18 years for adult indications).
For polyarticular JIA: document aggressive disease and prior inadequate response/intolerance to specified csDMARDs.
Prescriber must be a rheumatologist or include rheumatology consultation.

Step Therapy

Step therapy prior authorization

Coverage for subcutaneous adalimumab products requires prior authorization that follows the policy's multi-tier step therapy sequence; providers must follow the listed step therapy tiers and consult the Policy section for tier-specific requirements.

Step therapy tiers for numerous SC adalimumab products are enumerated in the policy and govern coverage sequencing.
Refer to the Policy section for tier-specific prior authorization criteria and any required trial/failure documentation.

Step Therapy

Step therapy applies to listed adalimumab (SC) products

Step therapy tiers enumerated in the policy apply to the listed subcutaneous adalimumab products (branded and biosimilar); providers must reference the policy's tier listings when requesting authorization or step overrides.

The policy lists multiple SC adalimumab brands and biosimilars assigned to numbered tiers.
Providers should identify the exact adalimumab product and the corresponding tier when submitting requests.

Prior Authorization

Step therapy prior authorization

Prior authorization must follow the policy's step therapy structure: the document provides numbered tier assignments for many subcutaneous adalimumab products and PA decisions must align with those tier assignments.

Numerous sequential tier entries list the same set of SC adalimumab products across tier slots.
PA evaluators will use the policy's step therapy sequence to determine coverage eligibility.

Step Therapy

Step therapy tier assignments (adalimumab SC)

Step therapy tier assignments for individual subcutaneous adalimumab products are enumerated in the policy; providers must follow the Policy section to determine the correct tier and any required prior-trial evidence when requesting authorization.

Tier entries (example IDs 463–557) repeatedly list the same group of adalimumab products across slots.
Consult the Policy section for the specific tier mapping and PA evidence required for your product.

Prior Authorization

Adalimumab step therapy / prior authorization guidance

When seeking prior authorization for an adalimumab SC product, providers must follow the Policy section's tier requirements and supply any trial/failure documentation required for that numbered tier.

Providers must reference the numeric tier mapping listed in the policy to determine required prior therapies.
PA requests should include documentation that corresponds to the tier-specific prerequisites indicated in the Policy section.

Note

Step therapy tier listing — see Policy section

The policy enumerates step therapy tier numeric identifiers (many numbered entries are shown); providers should reference those numeric tier IDs in the Policy section to configure prior authorization and step-therapy controls.

Numeric tier IDs (examples shown across the document) map products to step therapy tiers.
The Policy section contains the operative mapping and PA requirements tied to these numeric IDs.

Prior Authorization

Prior authorization required per Policy section

Prior authorization is required for the listed subcutaneous adalimumab products and the Policy section specifies the exact PA criteria tied to those products and tiers; submitters must follow that Policy section to determine required documentation.

The document instructs providers to see the Policy section for exact PA criteria for listed adalimumab products.
Do not assume coverage without meeting the Policy section's tier- and PA-specific requirements.

Billing Rule

Step therapy tiers enumerated

The step therapy tier table in this document enumerates many numeric tier entries but does not list affected billing or HCPCS/CPT codes here; providers must use the Policy section to identify any billing implications and the applicable codes for PA requests.

This excerpt lists numeric tiers but does not include code-level billing information.
For affected billing codes and benefit processing details, consult the main Policy section.

Prior Authorization

Use tier mappings for prior authorization

Prior authorization and step-therapy determinations are made using the numeric tier mappings listed in the policy; providers should consult the Policy section to identify the tier number for a product and the corresponding PA rules.

Numeric tier mappings determine prior authorization/step therapy decisions.
Reference the main Policy section when configuring PA or when requesting tier overrides.

Note

Step therapy tier reference

This section of the document provides step therapy tier numeric IDs that must be referenced against the Policy section to configure prior authorization and step-therapy enforcement for listed products.

Step therapy tier numeric IDs are listed throughout the section.
Providers and PA staff must cross-reference these IDs with the Policy section for operational details.

Documentation Required

Step therapy tier listing

Providers must refer to the main Policy section for the operative step therapy requirements — this document repeatedly lists tier placeholders and product lists but delegates the exact PA rules and documentation needs to the Policy section.

Step therapy tiers are enumerated here but specific PA requirements and affected billing codes are specified in the Policy section.
Submit documentation per the criteria described in the Policy section for the product's tier.

Prior Authorization

Prior authorization and site-of-service review

Prior authorization for many agents requires evidence of prior trial and failure of conventional DMARDs and that the medication is prescribed by or in consultation with a rheumatologist; many IV agents are also subject to site-of-service review.

Document prior trials and inadequate response/intolerance to methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine where required.
IV agents listed are subject to site-of-service review and must be billed through the medical benefit.

Note

OpenPayer

Pharmacotherapy of Arthropathies (biologic and targeted therapies)

Coverage Criteria and Indication-specific Rules

Billing Codes, Products, and Key Numeric Parameters

Prior Authorization, Documentation, and Step Therapy — Provider Responsibilities

Background and Scope

Key Definitions

Policy Revision History