mhn certolizumab (Cimzia) Coverage & Prior Auth | OpenPayer

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mhn certolizumab (Cimzia) Coverage & Prior Auth | OpenPayer

Axial Spondylitis (AS or nr-axSpA) — Initial Therapy

Covered when ALL of the following are met

Axial Spondylitis criteria: Member has diagnosis of AS or nr-axSpA; prescribed by or in consultation with a rheumatologist; age ≥ 18 years; failure of at least TWO NSAIDs at up to maximally indicated doses, each used for ≥ 4 weeks unless clinically significant adverse effects are experienced, all are contraindicated, or previously failed a biologic agent for AS or nr-axSpA; for AS specifically, member meets ALL of the following each used for > 3 consecutive months unless clinically significant adverse effects or contraindicated: (a) failure of one adalimumab product unless member has history of failure of two TNF blockers; (b) failure of Taltz; (c) if not responsive or intolerant to one or more TNF blockers, trial of Xeljanz/Xeljanz XR unless cardiovascular risk outweighs benefit; prior authorization may be required for listed comparators; member does not have combination use with biological DMARDs or JAK inhibitors; dose does not exceed 400 mg at weeks 0, 2, and 4 followed by maintenance 400 mg every 4 weeks.

Crohn's Disease — Initial Therapy

Covered when ALL of the following are met

Crohn's Disease criteria: Diagnosis of Crohn's disease; prescribed by or in consultation with a gastroenterologist; age ≥ 18 years; member meets one of: (a) failure of a ≥ 3 consecutive month trial of at least ONE immunomodulator (e.g., azathioprine, 6-MP, methotrexate) at up to maximally indicated doses unless adverse effects or contraindicated; or (b) medical justification supports inability to use immunomodulators; member also meets one of: (a) failure of a ≥ 3 consecutive month trial of one adalimumab product; or (b) history of failure of two TNF blockers; failure of a ≥ 3 consecutive month trial of one ustekinumab product unless adverse effects/contraindicated; member does not have combination use with biological DMARDs or JAK inhibitors; dose does not exceed 400 mg at weeks 0, 2, and 4 followed by maintenance 400 mg every 4 weeks.

Plaque Psoriasis — Initial Therapy

Covered when ALL of the following are met

Plaque Psoriasis criteria: Diagnosis of moderate-to-severe plaque psoriasis evidenced by either ≥ 3% BSA involvement or involvement of hands, feet, scalp, face, or genital area; prescribed by or in consultation with a dermatologist or rheumatologist; age ≥ 18 years; member meets one of: (a) failure of a ≥ 3 consecutive month trial of methotrexate at up to maximally indicated doses; (b) intolerance/contraindication to methotrexate and failure of a ≥ 3 month trial of cyclosporine or acitretin; or (c) intolerance/contraindication to methotrexate, cyclosporine, and acitretin and failure of phototherapy; member also meets one of: (a) failure of a ≥ 3 month trial of one adalimumab product; or (b) history of failure of two TNF blockers; failure of a ≥ 3 month trial of Taltz; failure of a ≥ 3 month trial of one ustekinumab product; member does not have combination use with biological DMARDs or JAK inhibitors; dose does not exceed 400 mg every 2 weeks.

Psoriatic Arthritis — Initial Therapy

Covered when ALL of the following are met

Psoriatic Arthritis criteria: Diagnosis of psoriatic arthritis; prescribed by or in consultation with a dermatologist or rheumatologist; age ≥ 18 years; failure of ALL of the following each used for ≥ 3 consecutive months unless adverse effects or contraindicated: (a) one adalimumab product (unless history of failure of two TNF blockers); (b) Otezla/Otezla XR; (c) Taltz; (d) one ustekinumab product; and (e) if not responsive or intolerant to one or more TNF blockers, trial of Xeljanz/Xeljanz XR unless cardiovascular risk outweighs benefit; prior authorization may be required for listed comparators; member does not have combination use with biological DMARDs or JAK inhibitors; dose does not exceed 400 mg at weeks 0, 2, and 4 followed by maintenance 400 mg every 4 weeks; approval duration: 12 months.

Rheumatoid Arthritis — Initial Therapy

Covered when ALL of the following are met

Rheumatoid Arthritis criteria: Diagnosis of rheumatoid arthritis per ACR criteria; prescribed by or in consultation with a rheumatologist; age ≥ 18 years; member meets one of: (a) failure of a ≥ 3 consecutive month trial of methotrexate at up to maximally indicated doses; or (b) intolerance/contraindication to methotrexate and failure of a ≥ 3 consecutive month trial of at least ONE conventional DMARD (e.g., sulfasalazine, leflunomide, hydroxychloroquine); failure of ALL of the following each used for ≥ 3 months unless adverse effects or contraindicated: (a) one adalimumab product (unless history of failure of two TNF blockers); (b) Actemra; and (c) if not responsive or intolerant to one or more TNF blockers, trial of Xeljanz/Xeljanz XR unless cardiovascular risk outweighs benefit; documentation of baseline disease activity score (CDAI or RAPID3) required; member does not have combination use with biological DMARDs or JAK inhibitors; dose does not exceed 400 mg at weeks 0, 2, and 4 followed by maintenance 400 mg every 4 weeks; approval duration: 12 months.

Polyarticular Juvenile Idiopathic Arthritis (pJIA) — Initial Therapy

Covered when ALL of the following are met

pJIA criteria: Diagnosis of polyarticular juvenile idiopathic arthritis evidenced by ≥ 5 joints with active arthritis; prescribed by or in consultation with a rheumatologist; age ≥ 2 years; member meets one of: (a) failure of a ≥ 3 consecutive month trial of methotrexate at up to maximally indicated doses; (b) intolerance/contraindication to methotrexate and failure of a ≥ 3 month trial of leflunomide or sulfasalazine; (c) for sacroiliitis/axial involvement, failure of a ≥ 4 week trial of an NSAID; or (d) documentation of high disease activity; failure of ALL of the following each used for ≥ 3 months unless adverse effects or contraindicated: (a) one adalimumab product (unless history of failure of two TNF blockers); (b) Actemra; and (c) if not responsive or intolerant to one or more TNF blockers, trial of Xeljanz unless cardiovascular risk outweighs benefit; prior authorization may be required for listed comparators; member does not have combination use with biological DMARDs or JAK inhibitors; dosing limited by weight-based loading and maintenance regimens: 10–<20 kg: loading 100 mg at weeks 0,2,4 then maintenance 50 mg at week 6 and q2w; 20–<40 kg: loading 200 mg at weeks 0,2,4 then maintenance 100 mg at week 6 and q2w; ≥40 kg: loading 400 mg at weeks 0,2,4 then maintenance 200 mg at week 6 and q2w; maximum pJIA maintenance dose = 200 mg every 2 weeks.

Other Diagnoses / Indications

Covered when ONE of the following is met

Other uses: If drug label has changed within the last 6 months not yet reflected in this policy, follow the applicable formulary/no-coverage/non-formulary policy (CP.PMN.255 or CP.PMN.16); if requested use is not listed and criterion 1 does not apply, refer to off-label use policy CP.PMN.53.

Continued Therapy

Continuation is covered when ALL of the following are met

Continued therapy criteria: Member currently receiving medication via Centene benefit or previously met initial approval criteria (or continuity of care applies); member is responding positively to therapy (for RA: decreased CDAI or RAPID3 from baseline or justified alternative assessment; for other indications: clinical response documented); member does not have combination use with biological DMARDs or JAK inhibitors; if request is for dose increase, new dose does not exceed indication-specific maximums (for CD, RA, PsA, AS, nr-axSpA: 400 mg every 4 weeks; for pJIA: 200 mg every 2 weeks; for PsO: 400 mg every 2 weeks). Approval duration: 12 months.

Initial therapy coverage criteria

Covered when ALL of the following are met (indication- and dosing-specific):

Indication: Requested use is for an FDA-approved indication listed in dosing (e.g., CD, RA, PsA, AS, nr-axSpA, PsO, pJIA)

Dosing conformity: Prescribed dosing matches the indication-appropriate regimen and weight-based pediatric dosing as specified (examples: CD loading 400 mg SC at 0,2,4 weeks then 400 mg q4w; RA/PsA/AS maintenance 200 mg SC q2w or 400 mg SC q4w; pJIA weight-based loading and maintenance per Appendix/dosing table)

Safety screening: Documentation of latent TB testing prior to initiation and monitoring plan during therapy; awareness of boxed warnings and plan to discontinue if serious infection develops (perform TB testing and treat latent TB prior to starting Cimzia)

No concurrent excluded agents: No combination use with other biological DMARDs or potent immunosuppressants (listed classes and examples) as such combination use is not authorized and may lead to denial

CD medical justification criteria

Clinical justification notes for inability to use immunomodulator (Crohn's disease):

CD-specific justification: One of: inability to induce short-term symptomatic remission with a 3-month trial of systemic glucocorticoids; high-risk factors for intestinal complications including initial extensive ileal/ileocolonic/proximal GI involvement, initial extensive perianal/severe rectal disease, fistulizing disease (perianal, enterocutaneous, rectovaginal), deep ulcerations; other high-risk features for postoperative recurrence (short time to surgery, ileum/colon location, perianal fistula, prior resection, pre-surgery corticosteroid use)

Used to support medical justification for biologic when immunomodulator cannot be used

General dosing and indication compliance

Policy governs use when indicated and subject to prior authorization, step therapy, and preferred product redirections; dosing varies by indication.

Dosing compliance: Prescribed dosing must match indication-specific loading and maintenance regimens (examples: adult CD 400 mg SC at 0,2,4 weeks then 400 mg q4w; RA/PsA/AS initial 400 mg at 0,2,4 weeks with maintenance 200 mg SC every other week or 400 mg every 4 weeks; pJIA weight-tiered loading and maintenance per dosing table)

Exact approval criteria (prior therapy trials and comparator requirements) are detailed in Sections I–III

Combination therapy with other biological disease‑modifying antirheumatic drugs (bDMARDs) or other potent immunosuppressants is not authorized. The policy specifically lists multiple classes and agents (including TNF antagonists, interleukin agents, JAK inhibitors, anti‑CD20 agents, co‑stimulation modulators, integrin receptor antagonists, TYK2 inhibitors, and S1P modulators) as examples where additive immunosuppression increases the risk of neutropenia and serious infections and therefore precludes concurrent use.

Uses that are non‑FDA approved and not otherwise addressed in this policy are excluded from coverage unless the request includes sufficient off‑label documentation meeting the requirements of off‑label use policy CP.PMN.53 (Medicaid) demonstrating efficacy and safety.

The policy explicitly excludes concurrent administration of certolizumab with other biologic DMARDs or potent immunosuppressants because of additive immunosuppression and elevated infection risk. Examples and classes are enumerated in the exclusions and requests for such combination therapy may be denied as not authorized.

The HCPCS descriptor for J0717 (Injection, certolizumab pegol, 1 mg) notes that the code may be used when the drug is administered under direct physician supervision but is not for use when the drug is self‑administered, implying that self‑administered dosing should not be billed using this administration code.

Use of certolizumab in combination with other specified immunosuppressive biologics or potent agents (the enumerated TNF antagonists, interleukin agents, JAK inhibitors, anti‑CD20 agents, co‑stimulation modulators, integrin antagonists, TYK2 inhibitors, S1P modulators, etc.) is considered not authorized and medically inappropriate because of the increased risks associated with additive immunosuppression.

Concurrent therapy with other bDMARDs or potent immunosuppressants (for example other TNF antagonists, interleukin inhibitors, JAK inhibitors, anti‑CD20 agents, or similar agents listed in the policy) is considered not authorized / not medically appropriate due to additive immunosuppression and heightened infection risk; such combinations are specifically listed as exclusions.

The policy cautions that inclusion or exclusion of codes in the document does not guarantee coverage. Providers must follow current professional coding guidance and ensure appropriate prior authorization and compliance with step‑therapy or preferred product requirements; absence of required authorization or failure to meet policy criteria may render a claim not covered.

What Providers Must Do

Prior Authorization

Indication- and dosing-based prior authorization

Prior authorization is required. Requests must document the FDA‑approved indication and the dosing regimen requested (including loading and maintenance doses and formulation: vial or prefilled syringe). Prior authorization may also be required for several comparator or alternative agents (for example, adalimumab products, Taltz, ustekinumab products, Xeljanz/Xeljanz XR, Otezla/Otezla XR).

Provider must document the specific indication being treated (e.g., AS, nr‑axSpA, CD, PsO, RA, pJIA) and the exact dosing schedule requested (loading and maintenance doses; single‑use vial vs prefilled syringe).
Prior authorization may be required for comparator agents cited in the criteria (adalimumab products, Taltz, ustekinumab products, Xeljanz/XR, Otezla/Otezla XR).

Prior Authorization

Prior authorization and therapeutic alternative requirements

Prior authorization decisions require documentation of adherence to step‑therapy, therapeutic alternatives, or allowed bypass criteria. Providers must show trials of required prior therapies or documented justification for an exception or bypass (e.g., history of failure of two TNF blockers, intolerance, contraindication, or prior biologic use allowing conventional therapy bypass).

Therapeutic alternatives listed in the policy (preferred conventional DMARDs, immunomodulators, small molecules, and preferred biologic/biosimilar products) should be used when clinically appropriate; if a non‑preferred biologic is requested, documentation must justify why preferred alternatives are not appropriate.
Policy includes redirection to preferred products (examples: required use of one preferred adalimumab product or preferred ustekinumab/Stelara biosimilars where specified).
Bypass of conventional therapies is allowed in certain circumstances, for example if the member has previously failed a biologic agent for that condition as specified in the criteria.

Documentation Required

Provider must submit documentation (office notes, labs, or other clinical information)

Providers must submit clinical documentation to support that the member has met ALL approval criteria. Lack of adequate documentation may result in denial or delay of the request.

Submit office chart notes, relevant labs, prior therapy trial dates and durations, documented adverse effects or contraindications, and specialty consult notes when required (e.g., rheumatology, gastroenterology, dermatology).
Documentation must include evidence of trials/failures or intolerance of required step‑therapy agents (NSAIDs, methotrexate, other conventional DMARDs, specified biologics or classes) with duration per policy (typically ≥ 3 months or ≥ 4 weeks for NSAIDs unless noted).
Requests for non‑FDA indications require sufficient off‑label justification per off‑label use policies; absence of adequate justification may lead to denial.

Documentation Required

TB testing and prior therapy documentation

Prior to initiating therapy, providers must document latent tuberculosis (TB) testing and include a monitoring plan. The policy includes boxed‑warning monitoring requirements related to serious infections and malignancy risks.

Perform and document a test for latent TB before starting therapy; if positive, document initiation of TB treatment prior to starting the biologic.
Monitor patients for active TB during treatment even if the initial latent TB test is negative; include monitoring plan and results in submission when available.

Step Therapy

Step therapy: members must have failed specified prior treatments

Step‑therapy requirements apply where specified: members must have failed the policy‑specified prior treatments before approval, unless a documented contraindication or intolerance or allowed bypass is present.

Examples include failure of TWO NSAIDs for axial spondylitis (each used ≥ 4 weeks), failure of ≥ 3 consecutive months of methotrexate or other conventional DMARDs where required, and failure of specified biologics (e.g., one adalimumab product or history of two TNF blocker failures) as listed per indication.
Step‑therapy exceptions (medical justification, intolerance, contraindication, or prior biologic failure) must be clearly documented.

Denial Risk

Use of non-preferred biologics or failure to follow therapeutic alternative/redirection

Use of non‑preferred biologics or failure to follow therapeutic alternative/redirection may affect coverage. Providers must document why preferred products are inappropriate when requesting non‑preferred agents.

Policy lists preferred adalimumab products (e.g., Yusimry, Hadlima, Simlandi, adalimumab‑aaty, adalimumab‑adaz, adalimumab‑adbm, adalimumab‑fkjp) and preferred ustekinumab/Stelara biosimilars where applicable; providers should follow redirection requirements unless clinical justification for a different agent is provided.
Failure to try or document failure of required preferred or step‑therapy agents may lead to denial.

Billing Rule

Inclusion or exclusion of codes does not guarantee coverage

Inclusion or exclusion of codes in this policy is informational only and does not guarantee coverage. Providers should follow current professional coding guidance when submitting claims.

Codes referenced in the clinical policy are for informational purposes only; check the most up‑to‑date coding sources prior to claim submission.
Coverage is determined by meeting documented clinical criteria, not solely by coding.