Policy included in Premera pharmacotherapy set — PA may apply

This policy is part of Premera's pharmacotherapy policy set and may include prior authorization requirements; the excerpt contains no explicit PA instructions or affected billing codes — providers must refer to the related policy sections when submitting authorizations.

See referenced policies for prior authorization details

This excerpt does not list specific prior authorization rules; providers must consult the related policies referenced here (e.g., policies in the pharmacotherapy set) for the applicable PA criteria and submission instructions.

Related policy index — no PA rules shown here

This section functions as an index of related policies and does not itself contain prior authorization requirements; use the listed policy numbers/titles to find PA rules that apply to a given agent or indication.

Cross-reference to policy-specific prior authorization

This excerpt cross-references other policy numbers for agent- and indication-specific prior authorization criteria; providers must consult those policy-specific pages for PA rules before requesting authorization.

Site-of-service medical necessity review required for select IV/injectables

Select IV and other injectable biologics named in this policy are subject to a site-of-service medical necessity review prior to coverage; these include multiple infliximab and IV tocilizumab products and Simponi Aria IV.

• Examples: Actemra IV, Avsola, Avtozma IV, Cosentyx IV, Inflectra, Infliximab (Janssen), Orencia IV, Remicade, Renflexis, Simponi Aria IV, Tofidence IV, Tyenne IV

PA requires age, prior trials, and rheumatologist documentation

Prior authorization for listed agents often requires documentation of the patient's age, prior trials/failures or intolerance to specified therapies, and that the medication is prescribed by or in consultation with a rheumatologist; some IV agents will also trigger site-of-service review.

• Document age and prescriber (rheumatologist) involvement
• Document prior treatment trials, failures, or intolerances per agent
• Anticipate site-of-service review for select IV formulations

Prior authorization approvals commonly granted up to 12 months

When drug-specific criteria and documentation are met, initial authorizations (and re-authorizations) for many agents may be approved for up to 12 months; submit chart notes demonstrating continued positive clinical response for re-authorization.

• Initial and re-authorization approvals: up to 12 months
• Re-authorization requires chart notes showing clinical benefit

Site-of-service age requirement: age ≥13

Site-of-service medical necessity review for infusion/administration applies only to individuals aged 13 years or older — pediatric site-of-service reviews are limited due to specialized infusion needs.

• Site-of-service age threshold: ≥ 13 years

PA approvals aligned to 12‑month re-authorization duration

Prior authorization approvals and re-authorization durations have been aligned to the updated 12-month re-authorization period; ensure PA requests reflect the 12‑month authorization framework.

• Re-authorization period updated from 3 years to 12 months

Verify policy applicability (Enbrel/Simponi Aria Open formulary change)

Verify applicable policy and member plan before requesting prior authorization: previous note exempting a custom Open formulary (Formulary ID: 6062; Rx Plan F1) from these criteria was removed — members with that formulary now follow policy 5.01.647.

• Check member plan booklet or ID card to determine whether policy 5.01.550 or policy 5.01.647 applies

Use updated HCPCS/NDC coding when requesting authorizations

Prior authorization and authorization coding requirements were updated to include additional biosimilars and new HCPCS/Q-codes; providers must use the updated HCPCS/NDC codes (and J3590 where indicated) when submitting PA requests.

• Updated codes include J3590 and new Q-codes (examples: Q5156 added for Avtozma)

PA requirements updated for added agents and biosimilars

Prior authorization criteria and coverage lists were revised to add agents and biosimilars (e.g., additional tocilizumab products, tofacitinib additions) and to update PA rules; providers should submit PA requests per the revised product-specific criteria.

• Policy updates reflect added agents, biosimilars, and coding; follow the current drug-specific criteria when requesting PA

No step therapy specifics in this excerpt — refer to policy sections

The provided excerpt does not define specific step therapy rules here; see the policy sections referenced for complete step therapy tiers and required prior agent trials.

Step therapy tiers and disease-state prior trial requirements

Step therapy tiers are described elsewhere in the policy; tiers include first-line TNF inhibitors followed by IL-6, IL-17, JAKs, anti-CD20, IL-1, and T-cell costimulation modulators — providers must document required prior trials/failures per disease-state tiering.

• Disease-state tiering dictates required prior agents before later-line therapies
• Document prior trials/failures according to the tier applicable to the indication

Step therapy requiring trial of preferred adalimumab alternatives (NDCs 00597)

Step therapy rules require documented trials and inadequate response/intolerance to preferred adalimumab alternatives (specific NDCs starting with 00597) before initiating certain non-preferred adalimumab products.

• Preferred adalimumab alternatives: NDCs starting with 00597
• New starts of some adalimumab-related agents require failure of preferred adalimumab products

Concurrent csDMARD initiation allowed with Simponi Aria in PJIA

Simponi Aria IV for PJIA may be initiated concurrently with a csDMARD (leflunomide, methotrexate, or sulfasalazine) per the updated PJIA initiation criteria; document concurrent csDMARD use in the PA request.

• Concurrent initiation allowed: leflunomide, methotrexate, or sulfasalazine

Document rheumatologist involvement and prior-treatment trials

Providers must submit clinical documentation demonstrating prescriber specialty and prior-treatment history: many approvals require the medication be prescribed by or in consultation with a rheumatologist and include documented trials/failures of specified prior agents.

• Document rheumatologist prescribing or consultation
• Provide prior-treatment trial and failure history per agent-specific criteria

Required clinical documentation (office notes, diagnostics, prior response)

Submit office visit notes that include diagnosis, relevant history, physical exam, and medication history; for PMR, document history, exam, inflammatory markers (ESR/CRP), imaging if applicable, and response to a low‑dose glucocorticoid trial.

• Office visit notes with diagnosis, history, exam, medication history
• For PMR: ESR/CRP, MRI/ultrasound as applicable, and glucocorticoid trial response

Verify member plan/formulary before PA (Open formulary now follows policy 5.01.647)

Verify the member's plan booklet or member ID card before submitting authorizations: the prior open-formulary exception was removed and members with the custom Open formulary (Formulary ID: 6062; Rx Plan F1) now follow policy 5.01.647.

• Check member plan booklet/ID to determine whether policy 5.01.550 or policy 5.01.647 applies

Non‑formulary exception approvals may be up to 12 months — verify plan

Non-formulary exception approvals for drugs in this policy may be granted for up to 12 months; confirm plan applicability and document clinical justification when requesting non‑formulary exceptions.

• Non-formulary exception duration: up to 12 months
• Check member plan booklet/ID for custom formulary applicability

Document prior response/intolerance to preferred products for new starts

Document prior use and inadequate response or intolerance to preferred products when initiating certain non-preferred agents (for example, new starts of infliximab or Remicade require documented inadequate response/intolerance to preferred products).

• For new starts of infliximab (Janssen unbranded) and Remicade: document inadequate response/intolerance to preferred products

IV-administered drugs billed to medical benefit — site‑of‑service denials possible

Claims for IV‑administered drugs must be processed under the medical benefit (not pharmacy); failure to meet site‑of‑service medical necessity criteria for an IV administration site may result in claim denial.

• IV-administered drugs → bill via medical benefit
• Site-of-service criteria not met → service considered not medically necessary and may be denied

Formulary applicability check — removed exception may cause denial

If a provider relies on a previously-removed formulary exception (Open formulary ID: 6062; Rx Plan F1) coverage may be denied — verify which policy governs the member (policy 5.01.550 vs. 5.01.647) before submitting requests.

Denial risk if medical necessity or documentation requirements are not met

Failure to meet product-specific medical necessity criteria or to provide required documentation of prior trials, age/weight thresholds, or continued clinical response may result in denial or reduced authorization.

• Missing required prior trials or intolerance documentation
• Not meeting age or weight thresholds (e.g., Kevzara PJIA weight ≥63 kg)
• Insufficient chart notes showing ongoing clinical benefit for re-authorization

Re-authorization duration updated to 12 months — reflect in requests

Re-authorization duration for approvals was changed from 3 years to 12 months; ensure re-authorization requests reflect the 12‑month limit to avoid denial for exceeding allowable authorization length.

• Re-authorization duration: 12 months (updated from 3 years)

Infliximab/Remicade new‑start prior therapy requirement — document failures

New starts of infliximab (Janssen unbranded) and Remicade require documentation of inadequate response or intolerance to preferred products; failure to document this prior therapy requirement may trigger denial.

• Document inadequate response/intolerance to preferred infliximab alternatives before initiating infliximab (Janssen) or Remicade