Neighborhood Health Plan RI tocilizumab Prior Auth Policy

Indications and Medical Necessity Criteria

Rheumatoid arthritis (RA) — Initial approval

Authorization of 12 months may be granted for adults with moderately to severely active RA when ONE of the following is met

RA approval pathways: 1) Prior receipt of a biologic or targeted synthetic DMARD indicated for RA (e.g., Rinvoq, Xeljanz). OR 2) Biomarker testing: either positive rheumatoid factor (RF) or positive anti-cyclic citrullinated peptide (anti-CCP), OR tested for all of RF, anti-CCP, and C-reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR).

Authorization period: 12 months

Articular juvenile idiopathic arthritis — Initial approval

Authorization of 12 months may be granted for members ≥2 years when ANY of the following are met

aJIA approval criteria: i) Inadequate response to methotrexate or another conventional synthetic DMARD at adequate dose and duration. ii) Inadequate response to scheduled NSAIDs and/or intra-articular glucocorticoids AND one of: involvement of ankle, wrist, hip, sacroiliac joint, and/or TMJ; presence of erosive disease or enthesitis; delay in diagnosis; elevated inflammatory markers; or symmetric disease. iii) Member has risk factors for disease severity (see Appendix B) AND meets one of: high-risk joint involvement (e.g., cervical spine, wrist, hip), high disease activity, or judged at high risk for disabling joint disease.age >=2 years

Authorization period: 12 months

Systemic juvenile idiopathic arthritis (sJIA) — Initial approval

Authorization of 12 months may be granted for members ≥2 years when the following is met

sJIA approval: Member has active systemic features (e.g., fever, evanescent rash, lymphadenopathy, hepatomegaly, splenomegaly, serositis).age >=2 years

Authorization period: 12 months; prior receipt of a biologic is an alternative pathway.

Giant cell arteritis (GCA) — Initial approval

Authorization of 12 months may be granted when diagnosis is confirmed by either

GCA diagnostic confirmation: Temporal artery biopsy or cross-sectional imaging, OR elevated acute-phase reactants (high ESR and/or high CRP).

Authorization period: 12 months

Systemic sclerosis-associated interstitial lung disease (SSc-ILD) — Initial approval

Authorization of 12 months may be granted when the following is met

SSc-ILD diagnostic confirmation: Diagnosis confirmed by high-resolution computed tomography (HRCT) of the chest.

Authorization period: 12 months

Cytokine release syndrome (CRS) — Initial approval

Authorization may be granted for members ≥2 years for CAR T cell-induced CRS or for refractory CRS related to blinatumomab

CRS approval: 1) CAR T cell-induced CRS (severe or life-threatening) — authorization of 1 month. 2) Refractory CRS related to blinatumomab therapy — authorization of 1 month.age >=2 years

Authorization period: 1 month

Unicentric Castleman disease — Initial approval

Authorization of 12 months may be granted when ALL of the following are met

Unicentric Castleman criteria: Member is HIV-negative; member is HHV-8-negative; requested medication will be used as a single agent; disease has progressed following treatment of relapsed/refractory disease.

Authorization period: 12 months

Multicentric Castleman disease — Initial approval

Authorization of 12 months may be granted when BOTH of the following are met

Multicentric Castleman criteria: Requested medication will be used as a single agent; disease has progressed following treatment of relapsed/refractory or progressive disease.

Authorization period: 12 months

Immune checkpoint inhibitor-related toxicity — Initial approval

Authorization of 12 months may be granted when the member has severe immunotherapy-related inflammatory arthritis and ONE of the following is met

ICI-related toxicity criteria: i) Inadequate response to corticosteroids or a conventional synthetic DMARD (e.g., methotrexate, sulfasalazine, leflunomide, hydroxychloroquine). OR ii) Intolerance or contraindication to corticosteroids and a conventional synthetic DMARD.

Authorization period: 12 months

Acute graft versus host disease — Initial approval

Authorization of 12 months may be granted when ONE of the following is met

Acute GVHD criteria: i) Inadequate response to systemic corticosteroids. OR ii) Intolerance or contraindication to corticosteroids.

Authorization period: 12 months

Immune checkpoint inhibitor-related toxicity — Initial

Immune checkpoint inhibitor-related toxicity (initial authorization): Covered when ANY of the following are met

Immune checkpoint inhibitor-related inflammatory arthritis: Member has severe immunotherapy-related inflammatory arthritis and has had an inadequate response to corticosteroids or a conventional synthetic drug (e.g., methotrexate, sulfasalazine, leflunomide, hydroxychloroquine).

Authorization of 12 months may be granted.

Immune checkpoint inhibitor-related inflammatory arthritis - intolerance: Member has an intolerance or contraindication to corticosteroids and a conventional synthetic drug (e.g., methotrexate, sulfasalazine, leflunomide, hydroxychloroquine).

Authorization of 12 months may be granted.

Acute graft versus host disease — Initial

Acute graft versus host disease (initial authorization): Covered when ANY of the following are met

Inadequate steroid response: Member has experienced an inadequate response to systemic corticosteroids.

Authorization of 12 months may be granted.

Steroid intolerance/contraindication: Member has an intolerance or contraindication to corticosteroids.

Authorization of 12 months may be granted.

Polymyalgia rheumatica — Initial

Polymyalgia rheumatica (initial authorization): Covered when ANY of the following are met

Inadequate steroid response: Member has experienced an inadequate response to systemic corticosteroids.

Authorization of 12 months may be granted.

Flare during taper: Member has experienced a disease flare during a taper with systemic corticosteroids.

Authorization of 12 months may be granted.

Inadequate methotrexate response: Member has experienced an inadequate response to methotrexate.

Authorization of 12 months may be granted.

Intolerance/contraindication to steroids and methotrexate: Member has experienced an intolerance or contraindication to both systemic corticosteroids and methotrexate (see Appendix A).

Rheumatoid arthritis — Initial

Rheumatoid arthritis (initial authorization): Covered when ALL of the following are met

Population and response: Adult members using requested medication for moderately to severely active RA and achieve or maintain a positive clinical response as evidenced by disease activity improvement of at least 20% from baseline in tender joint count, swollen joint count, pain, or disability.>=20% improvement

Authorization of 12 months may be granted.

Articular juvenile idiopathic arthritis — Initial

Articular juvenile idiopathic arthritis (initial authorization): Covered when ALL of the following are met

Age and response: Members ≥2 years using requested medication for active articular JIA and achieve or maintain positive clinical response evidenced by low disease activity or improvement in number of active joints, limitation of movement, or functional ability from baseline.age >=2 years

Authorization of 12 months may be granted.

Systemic juvenile idiopathic arthritis — Initial

Systemic juvenile idiopathic arthritis (initial authorization): Covered when ALL of the following are met

Age and response: Members ≥2 years using requested medication for sJIA and achieve or maintain positive clinical response evidenced by low disease activity or improvement in joints, function, or systemic features (e.g., fever, rash, lymphadenopathy, hepatomegaly, splenomegaly, serositis).age >=2 years

Authorization of 12 months may be granted.

Giant cell arteritis — Initial

Giant cell arteritis (initial authorization): Covered when ALL of the following are met

Adult and response: Adult members using requested medication for GCA who achieve or maintain positive clinical response as evidenced by low disease activity or improvement in GCA signs and symptoms (e.g., headaches, scalp tenderness, temporal artery changes, constitutional symptoms, jaw/tongue claudication, visual symptoms, PMR symptoms, limb claudication).

Authorization of 12 months may be granted.

SSc-ILD — Initial

Systemic sclerosis-associated interstitial lung disease (initial authorization): Covered when ALL of the following are met

Current therapy requirement: Adult members using requested medication for SSc-ILD when the member is currently receiving treatment with Actemra or Tyenne.

Authorization of 12 months may be granted.

Immune checkpoint inhibitor-related toxicity — Continuation

Immune checkpoint inhibitor-related toxicity (continued therapy): Covered when ALL of the following are met

Continued response: Members using the requested medication for immunotherapy-related inflammatory arthritis who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms from baseline.

Authorization of 12 months may be granted.

CRS and acute GVHD — Continuation

Continuation requirements for CRS and acute GVHD

Meet initial criteria: All members requesting continuation of therapy for cytokine release syndrome and acute graft versus host disease must meet all initial authorization criteria.

Unicentric and Multicentric Castleman disease — Continuation

Castleman disease — Continuation

No progression/toxicity: Authorization of 12 months may be granted for continued treatment when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Polymyalgia rheumatica — Continuation

Continued response: Members using the requested medication for PMR who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in morning stiffness, hip/shoulder pain, range of motion, or CRP/ESR from baseline.

Authorization of 12 months may be granted.

All uses of tocilizumab that are not listed as FDA-approved indications or supported compendial uses in this policy are considered experimental/investigational and not medically necessary.

Before initiating tocilizumab, the member must have a documented negative tuberculosis (TB) test (TST or IGRA) within 6 months when biologic- or targeted-synthetic–naïve; positive screening requires further evaluation to exclude active disease and active TB must not be treated with tocilizumab. Additionally, the requested medication must not be used concomitantly with any other biologic drug or targeted synthetic drug.

Use of tocilizumab for indications outside those specifically listed as FDA-approved or compendial in this policy is considered not medically necessary and will not be authorized.

Prior Authorization and Documentation Requirements

Prior Authorization

Prior authorization required; typical duration

Prior authorization is required for Actemra and its biosimilars. Authorizations are typically granted for 12 months for most chronic indications (see specific indication criteria). Shorter authorizations (e.g., 1 month) may be granted for acute indications such as CAR T cell–induced cytokine release syndrome. Providers must submit a prior authorization request with supporting clinical documentation as outlined below.

Typical authorization duration: 12 months for chronic indications (RA, JIA, sJIA, GCA, SSc-ILD, Castleman disease, immune checkpoint inhibitor toxicity, acute GVHD, PMR).
Authorization of 1 month may be granted for CAR T cell–induced CRS and refractory CRS related to blinatumomab.
Providers should request the duration consistent with the member’s diagnosis and clinical course.

Documentation Required

TB screening and concomitant biologic/targeted-synthetic restrictions

Criteria Thresholds, Screening, and Definitions

RA clinical response threshold

Threshold>= 20% improvement from baseline in tender joint count, swollen joint count, pain, or disability

Applies toAdult members with moderately to severely active rheumatoid arthritis

Authorization period12 months when threshold met

TB screening window

Required testDocumented negative TB test (TST or IGRA)

Screening windowWithin 6 months prior to initiating therapy for biologic‑naïve persons

If positive

Clinical Background and Scope

Tocilizumab (Actemra and listed biosimilars) is covered in the outpatient setting for a range of inflammatory and immune-mediated conditions, including rheumatoid arthritis, juvenile idiopathic arthritis subtypes, giant cell arteritis, systemic sclerosis–associated interstitial lung disease, cytokine release syndrome, Castleman disease, immune checkpoint inhibitor–related inflammatory arthritis, acute graft-versus-host disease, and polymyalgia rheumatica when the policy’s specific diagnostic and prior-therapy criteria are met. For all outpatient indications, prior authorization is required and documentation must include relevant testing and prior-therapy history. Providers must ensure a documented negative TB screen within 6 months for biologic-naïve patients and must not prescribe tocilizumab concomitantly with other biologic or targeted synthetic agents.

OpenPayer

Tocilizumab (Actemra and listed biosimilars) — Coverage and Prior Authorization Criteria

Indications and Medical Necessity Criteria

Prior Authorization and Documentation Requirements

Criteria Thresholds, Screening, and Definitions

Clinical Background and Scope