Obtain prior authorization — validity and site-of-care

Prior authorization is required for Cimzia. Initial approvals are provided for 6 months (180 days); renewals may be authorized every 12 months (365 days). Site-of-care specialty infusion program requirements apply when relevant (refer to Moda Site of Care Policy).

• Initial prior authorization validity: 180 days.
• Renewal prior authorization validity: 365 days.
• Site-of-care specialty infusion program requirements must be met when applicable.

Prior authorization required — document prior trials or continuation

Submit a prior authorization request demonstrating the member meets indication-specific criteria and that the member has had prior trial and inadequate response, contraindication, or intolerance to required alternative agents (requirements differ by indication and by Commercial vs Medicaid). Continuing treatment is an alternative pathway.

• Provide documentation of prior therapy trials (3-month trials for most alternatives unless otherwise noted).
• Indicate if the request is for continued treatment for a member already established on biologic/targeted synthetic therapy.

Include dosing and response documentation; bill correctly

For prior authorization, document indication-specific baseline and response measures and confirm adherence to required loading and maintenance dosing (e.g., receipt of three loading doses when applicable). If provider-administered, billing may use HCPCS J0717 per policy.

• Document objective baseline measures and evidence of response on renewal (see disease-specific tools).
• Document receipt of loading doses and maintenance dosing as specified (e.g., 400 mg at weeks 0,2,4 then maintenance 200 mg Q2W or 400 mg Q4W).
• If drug is administered by provider, bill using J0717 (injection, certolizumab pegol, 1 mg) where appropriate.

PA applied after NQTL review (indication, safety, cost)

Prior authorization is applied after consideration of NQTL factors; the NQTL checklist shows indication, safety/efficacy, and drug cost were reasons to consider prior authorization for this drug.

• NQTL factors considered: indication (Yes), safety and efficacy (Yes), cost (Yes), potential for misuse/abuse (No).

Submit Appendix 1 ICD-10 code; follow Medicare guidance where applicable

When requesting coverage or submitting claims, include an appropriate ICD-10 diagnosis code from Appendix 1. For Medicare members, applicable NCD/LCD/LCA or Medicare contractor requirements may supersede — reference CMS/Medicare guidance where relevant.

• Use an Appendix 1 ICD-10 code that matches the member's diagnosis on prior authorization and claim submissions.
• Check Medicare NCD/LCD/LCA guidance for Part B where applicable; Medicare Part B covered diagnosis codes are listed as N/A in this policy but contractor rules may apply.

Document required prior agent trials per indication

For each indication, provide documentation that required prior agent trials were completed and that the member had inadequate response, contraindication, or intolerance to those agents (specific lists differ by indication and by Commercial vs Medicaid).

• Commercial and Medicaid required alternative agent lists differ by indication — include which agent(s) were trialed and trial duration (commonly 3 months).
• If member is already established on biologic/targeted synthetic therapy, document that status as an alternative to step therapy.

Confirm step-therapy trials and duration (usually 3 months)

Ensure documentation shows the member tried and had inadequate response, contraindication, or intolerance to specified alternative agents for the required trial period (typically a 3-month trial) before approving Cimzia, unless the member is already established on therapy.

• Typical required trial duration for alternatives is 3 months unless otherwise specified.
• Document specific alternative agent(s) tried and clinical reason for failure/intolerance/contraindication.

Psoriasis dose escalation requires documented initial response and dosing milestones

For plaque psoriasis, dose escalation is permitted only after the patient has shown initial response, received the three specified loading doses and at least one maintenance dose, and demonstrated response by treatment week 6 with subsequent loss of response to justify escalation.

• Required: documentation of initial response, receipt of loading doses (400 mg at weeks 0, 2, 4) and at least one maintenance dose before escalation.
• Dose escalation limited to maximum dose/frequency specified in the dosing section and considered case-by-case.

Step therapy sequences: not fully specified here — see indication sections

This section does not list a step-by-step sequence for step therapy; the NQTL checklist explains factors considered for PA design but specific step therapy sequences are provided within indication-specific criteria elsewhere in the policy.

• Review indication-specific sections for the precise alternative agents required per member type (Commercial vs Medicaid).

Document baseline disease severity with objective measures

Document baseline disease severity using an objective tool and evidence of moderate-to-severe (or active) disease for the indicated condition when submitting a PA request.

• Use disease-specific objective measures (e.g., DAS28, JADAS, PASI, CRP, MRI findings) as described in the indication-specific criteria.
• Include documented assessment confirming moderate-to-severe or active disease.

Pre-treatment screening: HBV, TB, vaccinations, concurrent therapy

Provide pre-treatment screening documentation: hepatitis B virus (HBV) screening, latent tuberculosis (TB) screening with plan for ongoing monitoring, verification of up-to-date vaccinations, and confirmation the member is not receiving another biologic or targeted synthetic therapy.

• HBV screening must be completed prior to initiating treatment.
• Latent TB screening must be completed prior to initiating treatment with ongoing monitoring during therapy.
• Confirm member has not recently received live vaccines and is up to date with age-appropriate vaccinations.

Submit baseline and objective response data at renewal

For renewals, provide objective documentation of disease response compared to baseline using indication-specific tools (e.g., DAS28 or ACR20 for RA; Harvey‑Bradshaw Index or CRP for Crohn's; JADAS or ACR‑Pedi for pJIA; ASDAS/BASDAI or ASAS40 for nr-axSpA; PASI/PGA/BSA for PsO).

• Include the baseline objective measure and the measure at renewal to demonstrate improvement.
• Renewal requires meeting the renewal criteria and absence of unacceptable toxicity.

For PsO escalation, document loading doses, initial response, and maintenance dosing

When considering psoriasis dose escalation, document initial clinical response and confirm the member received the three loading doses and at least one maintenance dose at the specified intervals prior to escalation.

• Document timing and dosing of the three loading doses (400 mg at weeks 0, 2, 4) and at least one maintenance dose.
• Show initial response and subsequent loss of response by treatment week 6 to support escalation.

Document the required diagnosis using Appendix 1 ICD-10 codes

Include the member's ICD-10 diagnosis code from Appendix 1 on the prior authorization and claim submissions; Appendix 1 contains the covered diagnosis codes (e.g., K50.x, L40.x, M05.x series).

• Use an Appendix 1 code that matches the clinical diagnosis exactly when requesting coverage.
• Appendix 1 lists extensive RA, juvenile arthritis, axial spondyloarthritis, psoriasis, and Crohn's disease codes.

Require submission of Appendix 1 ICD-10 code on PA/claim

When requesting coverage, submit the member's ICD-10 diagnosis code from Appendix 1 with the PA request; the appendix contains the covered diagnosis codes for rheumatoid and juvenile arthritis and related spondyloarthritis and dermatologic conditions.

• Ensure the submitted diagnosis code is listed in Appendix 1 to avoid coverage denial.
• If the diagnosis is not listed in Appendix 1, coverage may be denied (see diagnosis-code based denial risk).

Clinical exclusions that may trigger denial (infection, vaccines, concurrent biologics)

Do not initiate or continue Cimzia in the presence of active infection, recent live vaccines, lack of required TB screening/monitoring, or if the member is receiving another biologic/targeted synthetic therapy — these clinical exclusions can trigger denial.

• Active infection or clinically important localized infections are exclusions to initiation.
• Members must not receive live vaccines immediately prior to or during therapy.
• Concurrent treatment with another biologic or targeted synthetic therapy is not allowed.

Renewal denials: expired authorization or unacceptable toxicity

Renewal may be denied if the authorization duration has been exceeded or if there is unacceptable toxicity from the drug — examples include severe hypersensitivity, serious infection, heart failure, lupus‑like syndrome, demyelinating disease, cytopenias, malignancy, or hepatitis B reactivation.

• Verify authorization duration and that renewal criteria are met before submitting a renewal.
• Document absence of unacceptable drug-related toxicity to support renewal.

Avoid billing misuse of J0717 for self-administered doses

Do not bill J0717 when the product is self-administered; J0717 is for physician‑supervised administration and inappropriate use of this code for self‑administered doses may trigger claim denial.

• J0717 = Injection, certolizumab pegol, 1 mg; 1 billable unit = 1 mg.
• Use J0717 only when the drug is administered under direct physician supervision per Medicare guidance; it is not for self-administered product.

NQTL findings that supported prior authorization

Prior authorization and utilization management were designed after reviewing NQTL factors; indication, safety/efficacy, and cost supported consideration of PA for Cimzia and may trigger PA requirements.

• NQTL checklist: indication (Yes), safety/efficacy (Yes), cost (Yes) — these drove PA design.
• Utilization management methods are applied comparably across MH/SUD and M/S drugs per the appendix.

Diagnosis-code based denial risk — use Appendix 1 codes

Use of Cimzia for a diagnosis not listed in Appendix 1 may lead to coverage denial if no applicable Appendix 1 ICD-10 code is submitted with the request or claim.

• Confirm the member's diagnosis code is included in Appendix 1; otherwise, coverage may be denied.
• Appendix 1 contains extensive lists of covered codes for RA, pJIA, nr-axSpA, PsO, and Crohn's disease.