Prior authorization not specified in excerpt

This excerpt does not include explicit prior authorization rules for the policy as presented; the document is primarily cross-references and coverage criteria excerpts rather than a standalone prior authorization table.

Prior authorization — not present here

No discrete prior authorization steps or forms are stated in the provided excerpt; providers should not assume specific PA workflows are defined here.

Related policy listing (cross‑reference)

The policy lists numerous related Premera medical policies (e.g., 5.01.607, 5.01.645, 5.01.647) that are referenced for related indications and plan‑specific criteria; providers should consult those policies for cross‑references.

• Related policies include: 5.01.575, 5.01.607, 5.01.628, 5.01.629, 5.01.645, 5.01.647 (Medical Necessity Criteria for Custom Open Formulary).

Prior authorization referenced but not specified

The document references prior‑authorization–type policies and related pharmacotherapy policies but does not specify the PA requirements in this excerpt; providers should check the referenced policies for explicit PA rules.

• References to pharmacologic treatment of psoriatic arthritis and continuity of coverage appear but without PA detail.

Medical necessity and billing pathway

IV‑administered drugs described in this policy must be reviewed for medical necessity and billed through the medical benefit (not pharmacy); site‑of‑service medical necessity criteria apply for many IV agents.

• Claims for IV‑administered drugs should be processed under the medical benefit.
• Site‑of‑service review applies (age and clinical criteria described in policy).

Prior authorization required for listed agents

Many biologic and targeted therapies listed require prior authorization with documentation of prior therapy failures and that the medication is prescribed by or in consultation with a rheumatologist.

• Documentation of inadequate response or intolerance to specified prior agents is required per agent criteria.
• Prescriber specialty (rheumatology) is repeatedly required in agent criteria.

Prior authorization duration — approvals up to 12 months

When drug‑specific coverage criteria and required documentation are met, initial approvals and re‑authorizations may be granted for up to 12 months.

• Initial authorization: up to 12 months.
• Re-authorization: up to 12 months if criteria and documentation show continued clinical benefit.

Prior authorization for newly added agents (example)

The policy has historically added new agents (example: baricitinib/Olumiant in 2018) and such new agents may be subject to prior authorization per the policy when criteria were added.

• 2018 update added Olumiant (baricitinib) criteria — implying PA may apply to newly added agents.

Step/brand therapy and NDC grouping — preferred product trials required

Prior authorization and step/brand therapy require trials of preferred adalimumab and infliximab products per updated preferred/non‑preferred lists; NDC groupings are used to identify preferred products that must be tried first.

• Preferred adalimumab/infliximab products are identified by NDC groupings (e.g., NDCs starting with 00597).
• New‑start rules require trial/failure of preferred products before non‑preferred agents.

Prior authorization and plan verification — check custom formulary

Providers must verify the member's plan — members on a custom Open formulary (Formulary ID: 6062; Rx Plan F1) follow policy 5.01.647 rather than this policy for applicable agents.

• Check member Plan booklet or ID card to determine whether policy 5.01.647 applies.
• Failure to apply the correct formulary policy may affect PA decisions.

HCPCS/J-code additions and updates — use updated codes

The policy documents additions and updates to HCPCS/J‑codes and Q‑codes; providers must use the updated HCPCS/Q codes when submitting claims and authorization requests for affected biologics.

• New and updated codes include J0139, J1602, J1628, J1745, J3247, J3262 and multiple Q‑codes (e.g., Q5103, Q5156, Q5137).
• Coding table in the policy should be used to identify the correct billing code.

Prior authorization for updated biologic/HCPCS items

Certain newly added or updated biologic products and HCPCS‑coded services (for example Q5156 for Avtozma) were included in the policy and may require prior authorization consistent with the policy coverage criteria.

• Added HCPCS code Q5156 for Avtozma (tocilizumab-anoh).
• Providers should confirm PA requirements for these new codes when requesting authorization.

No step therapy rules included in provided text

No explicit step therapy rules are included in the provided text segment as standalone instructions; the excerpt contains references to step therapy tiers but not a separate step therapy rule table in this excerpt.

Step therapy reference — tiers and sequencing noted

The policy references step therapy tiers and sequencing (e.g., first‑line TNF‑α inhibitors, IL‑6, JAK inhibitors) across indications; providers should follow the agent‑ and indication‑specific sequencing in the policy sections.

• Step therapy tiers are listed per indication (RA, PJIA, AS, NRAS) in the policy.
• Refer to the specific agent section for exact sequencing and prior‑trial requirements.

Step therapy tiers — tiering by indication

Step therapy is tiered by indication — for example, TNF‑α inhibitors are first‑line for polyarticular JIA while IL‑6 inhibitors are first‑line for systemic JIA; providers must follow the indication‑specific sequencing described in each agent section.

• PJIA first‑line includes TNF‑α inhibitors and certain JAK/IL‑6 agents.
• sJIA first‑line lists IL‑6 inhibitors (Actemra, Avtozma, Tofidence, Tyenne).

Step therapy requirements — prior‑failure documentation required

The policy requires documented inadequate response or intolerance to specified prior agents before advancing to later‑line therapies; providers must include prior‑trial details in authorization requests per agent criteria.

• Many agents require failure of baseline csDMARDs (e.g., methotrexate) and specific biologics before approval.
• Baricitinib requires inadequate response to two specified agents and is quantity limited to 30 tablets per 30 days.

Preferred sequencing and combination therapy — start DMARDs early

Clinical guidance in the policy emphasizes initiating DMARD therapy early and using methotrexate in combination with biologics where indicated; this sequencing is reflected in the step therapy structure.

• Initiate DMARDs within three months of diagnosis when appropriate.
• Combination therapy with methotrexate is often recommended and more efficacious than TNF inhibitor monotherapy.

Brand step therapy and exceptions — clinical exceptions allowed

Brand‑level step therapy exceptions are specified for some agents (e.g., exceptions for heart failure, treated lymphoproliferative disorder, prior serious infection or demyelinating disorder) that allow bypassing brand step requirements; document the exception reason when applicable.

• Exceptions to brand step therapy exist for heart failure and previously treated lymphoproliferative disorder for several agents.
• Kevzara PJIA includes exceptions for prior serious infection or demyelinating disorder.

Step therapy and prior agent requirements — historical prerequisite trials

Historically the policy required trials of conventional DMARDs or TNF blockers prior to some agents; several updates retained prior‑trial logic for many agents.

• Policy history shows multiple edits enforcing prior trial/failure sequencing for new starts of biologics.

Step therapy / preferred product trials — adalimumab biosimilars required first

Recent edits require trials of preferred adalimumab biosimilars as required prior agents before non‑preferred adalimumab products; providers should document trials of the specified preferred adalimumab products.

• Preferred adalimumab products now include adalimumab-aaty, adalimumab-adaz, adalimumab-adbm (NDCs starting with 00597).
• Non‑preferred adalimumab products require documented failure of preferred alternatives for new starts.

Preferred adalimumab alternatives — updated preferred list

The policy lists specific preferred adalimumab products (e.g., adalimumab-aaty, adalimumab-adaz, adalimumab-adbm) as preferred alternatives that must be tried prior to certain non‑preferred agents.

• Preferred alternatives are identified by NDC groupings (NDCs starting with 00597).

Prescriber requirement — rheumatologist prescription/consultation

Many agents require prescription by or consultation with a rheumatologist; prescriber specialty is repeatedly added to coverage criteria for multiple indications and agents.

• Prescriber specialty requirement appears for ankylosing spondylitis, RA, PJIA, and other indications.
• Authorization requests should document rheumatologist prescription or consultation.

Required documentation — age, prior therapy, rheumatologist involvement

Authorization requests must include documentation supporting age eligibility, prior inadequate response or intolerance to specified prior therapies, and evidence of rheumatologist involvement.

• Include patient age, prior treatment trials and outcomes, and prescriber consultation notes.
• Office visit notes with diagnosis, relevant history, physical exam and medication history are required.

Required clinical documentation — product/NDC‑specific prior therapy

For certain NDC‑specific adalimumab and infliximab products, documentation must identify the exact product/NDCs tried (NDC groupings are referenced in the policy).

• Providers should document prior trials by product name and NDC grouping when required by the criteria.
• NDC groups referenced include those starting with 00597, 61314, 00074, 55513, etc.

Office visit notes required — diagnosis, history, exam, medication history

Office visit notes that include diagnosis, relevant history, physical evaluation and medication history must be submitted to document that medical necessity criteria are met.

• Ensure notes specifically document inadequate response or intolerance to prior therapies where required.

Age and site‑of‑service documentation — support SOS requests

When requesting site‑of‑service medical necessity (SOS), include documentation supporting the patient's age and the administration site because SOS criteria apply to individuals aged 13 and older.

• Site‑of‑service review is limited for pediatric individuals under age 13; SOS criteria apply for age ≥13.
• Document reasons for hospital‑based outpatient administration if applicable (distance, clinical risk factors).

Supporting clinical trial data — Kevzara evidence may support requests

Clinical trial evidence supporting Kevzara (sarilumab) indications (e.g., ACR20/DAS28‑CRP endpoints and sustained remission at 52 weeks for PMR) may be included as supporting rationale when requesting coverage for Kevzara.

• Kevzara demonstrated higher sustained remission at 52 weeks in PMR (28.3% vs 10.3% placebo).
• Kevzara Study 2 showed improved DAS28‑CRP outcomes in TNF‑refractory RA.

Prescriber specialty and prior therapy documentation — include specialty and history

Prescriber specialty and prior treatment history have been added historically as required documentation elements for multiple agents; include prescriber specialty and prior therapy details in requests.

• Policy history documents addition of prescriber specialty requirements across many agents and indications.
• Include prior treatment history chronologically with response details.

Non‑formulary exception duration and plan applicability — exceptions up to 12 months

Non‑formulary exception authorizations for drugs in this policy may be approved for up to 12 months; providers should check the member's plan booklet or ID card to determine applicability and duration.

• Non‑formulary exceptions: may be approved up to 12 months per 2025 updates.
• Verify member plan for custom formulary applicability.

Document prior therapy and response — include trial details and outcomes

Authorization requests must document prior use and inadequate response or intolerance to preferred alternatives when required by updated criteria (for example, required failures of preferred infliximab or adalimumab products for new starts).

• New starts of certain infliximab and adalimumab products require documentation of inadequate response/intolerance to preferred products.
• Include dates, dosages, and reasons for discontinuation of prior therapies.

Denial risk — site‑of‑service not meeting SOS criteria

Administrations billed at sites that do not meet the policy's site‑of‑service criteria are considered not medically necessary; lack of SOS documentation may trigger denial.

• Site‑of‑service criteria specify clinically supported reasons for hospital‑based outpatient administration (initial course, re‑initiation after ≥6 months, distance >50 miles, clinical risk factors).

Denial risk — missing rheumatologist prescription/consultation

Failure to document that the medication is being prescribed by or in consultation with a rheumatologist may lead to denial for many agents, as prescriber specialty is required across multiple criteria.

• Document rheumatologist prescription or consultation in the medical record submitted for review.

Denial risk — site‑of‑service review for specified IV agents

Requests for certain IV agents (e.g., infliximab products, Actemra IV, Orencia IV, Simponi Aria IV) are subject to site‑of‑service review; failure to justify the SOS or provide required SOS documentation may result in review or denial.

• Providers must document why IV administration in a hospital‑based outpatient setting is medically necessary when requested.
• Examples of agents subject to SOS review are listed in the policy's drugs‑subject table.

Denial risk — investigational or not medically necessary uses

Uses of agents for conditions or combinations not outlined in this policy are considered investigational or not medically necessary and may be denied.

• All other uses of the listed agents when used in combination or for conditions not in the policy are considered investigational/Not Medically Necessary.

Denial risk — site‑of‑service age trigger (under 13)

Site‑of‑service medical necessity requests for individuals under age 13 may be limited or denied because site‑of‑service review is restricted to individuals aged 13 years or older.

• Pediatric infusion care requires specialty training; SOS review is limited to age ≥13.

Denial risk — formulary applicability and wrong policy applied

If a member is covered under a custom Open formulary that follows policy 5.01.647, use of adalimumab products may be subject to different criteria; applying the wrong policy for that member may result in denial.

• Check member Plan booklet or ID card to confirm whether policy 5.01.647 applies.
• Applying this policy instead of the plan‑specific policy can affect coverage decisions.

Denial risk — SOS exception for Alaska fully‑insured members

SOS medical necessity criteria do not apply to Alaska fully‑insured members per Alaska HB 226; failing to account for this plan exception when requesting SOS coverage for Alaska fully‑insured members may affect authorization outcomes.

• For Alaska fully‑insured members, only the infusion drug medical necessity criteria applies per the referenced legislation.
• Verify member's state and insurance type before SOS requests.

Denial risk — formulary‑specific criteria may trigger denial

Members on the referenced custom Open formulary (Formulary ID: 6062; Rx Plan F1) follow policy 5.01.647; misapplying this policy instead of 5.01.647 may trigger denial because formulary‑specific criteria differ.

• Providers should verify member's formulary and follow the applicable policy for PA and coverage.

Re‑authorization duration — approvals limited to 12 months

Re‑authorization duration was updated to 12 months (reduced from 3 years); requests exceeding the authorized duration or lacking documentation of continued benefit may be denied.

• Re‑authorizations: up to 12 months when criteria are met and documentation shows continued clinical response.
• Ensure renewal requests include evidence of ongoing benefit.