Prior authorization validity and required submission data

Initial prior authorization is valid for 6 months (180 days); renewals may be requested every 12 months (365 days). Submission must document member age and baseline disease severity assessment plus required infection and vaccination screening prior to initiation.

• Initial PA: 6 months (180 days)
• Renewal interval: every 12 months (365 days)
• Include age and baseline objective severity assessment
• Document HBV screening, TB screening, and up-to-date vaccinations

Prior authorization required for initial therapy — document prior trials or continuation

Prior authorization is required for initiation unless the patient is already established on biologic/targeted therapy; PA requests must document required prior trials or meet indication-specific continuation rules (examples vary by payer and indication).

• Document prior trial(s) or state patient is continuing therapy per indication-specific rules
• Examples include payer-specific trial lists (e.g., adalimumab, etanercept, Cosentyx SC, Rinvoq)
• If already established on biologic/targeted therapy, prior-trial requirements may be waived

PA consideration and affected billing codes

PA may be applied to Cosentyx based on the utilization management NQTL assessment; billable HCPCS codes for IV and SQ formulations are listed and may be used to identify affected claims.

• NQTL checklist was used when designing PA (includes cost, indication, safety)
• Affected HCPCS codes include J3247 and general drug coding (see HCPCS table)

Prior authorization may be applied (NQTL basis)

The NQTL checklist indicates prior authorization may be applied to this drug group — factors considered include indication, safety/efficacy, misuse potential, medical necessity, and cost.

• Appendix A NQTL Factor Checklist informed PA design
• Cost was specifically noted as a reason to consider PA

Step therapy — document prior biologic/alternative agent trial and outcome

Many indications require a prior trial and inadequate response, intolerance, or contraindication to specified biologic or alternative agents; PA must include documentation of trial duration and outcome or reason for exemption.

• Commercial and Medicaid lists differ — include exact agent tried (e.g., adalimumab, etanercept, Cosentyx SC, Rinvoq)
• Document trial duration (commonly ≥3 months where specified) and inadequate response/intolerance/contraindication
• Pediatric-specific prior‑trial lists exist for age-based groups

Step therapy requirements — document agent, duration, and outcome

Step therapy requirements commonly mandate inadequate response, intolerance, or contraindication to specified first-line agents before Cosentyx is authorized; include payer- and indication-specific agent names and trial durations in the PA request.

• Examples: 3-month trial of listed alternatives for Commercial/Medicaid where specified
• For ERA and HS, specified alternative trials (NSAID/csDMARD or adalimumab/Cosentyx SC) are required unless already on biologic therapy

Step therapy sequence not specified in excerpt — use indication/payer lists

The provided excerpt does not specify a uniform step-sequence for all indications; the NQTL appendix notes PA methods were considered but specific step-therapy sequences are not detailed here.

• If sequence is required by payer, use the indication-specific lists in sections for Commercial vs Medicaid
• When sequence is unclear, document the exact prior agents tried and rationale for selection

Required baseline documentation before starting therapy

Prior to initiation, providers must document baseline disease severity using an objective measure/tool, screen for HBV, confirm up-to-date vaccinations, screen for latent TB with plan for ongoing TB monitoring, and confirm absence of active infection and no concurrent biologic/targeted synthetic therapy.

• Baseline objective disease severity assessment (e.g., BSA, PASI, joint counts, CRP, ASDAS/BASDAI as applicable)
• HBV screening prior to treatment
• Confirm member is up to date with age-appropriate vaccinations and will not receive live vaccines during therapy
• Latent TB screening prior to initiation and plan for ongoing TB monitoring
• Confirm no active infection and no concurrent biologic/targeted synthetic therapy

nr‑axSpA — document objective inflammation and imaging

For nr-axSpA PA requests, document objective signs of inflammation (elevated CRP above ULN and/or sacroiliitis on MRI), absence of definitive radiographic sacroiliac joint structural damage, documented active disease, and prior NSAID trial history or established biologic therapy status.

• CRP above upper limit of normal and/or MRI evidence of sacroiliitis
• No definitive radiographic sacroiliac structural damage documented
• Documented active disease
• Adequate trial and failure of at least two NSAIDs unless contraindicated, or documentation that member is established on biologic/targeted therapy

Renewal documentation — continued criteria, response, and safety

For renewal requests document that the member continues to meet universal and indication‑specific criteria, demonstrate disease response with appropriate measures, and confirm absence of unacceptable toxicity (examples: severe/new IBD, serious infections, HBV reactivation, hypersensitivity).

• Evidence of disease response (e.g., PASI/BSA for PsO; joint counts/CRP/imaging for PsA; ASDAS/BASDAI or ASAS40 for axial disease; HiSCR for HS; JADAS/ACR‑Pedi for pediatric arthritis)
• Statement that member continues to meet universal and indication‑specific criteria
• Document absence of unacceptable toxicity or adverse events listed

Document product, route, dose, and pediatric weight

Document the specific product formulation (NDC), route of administration (subcutaneous vs intravenous), exact dose, and for pediatric patients include current patient weight to support the dosing selected.

• Include NDC/product presentation (e.g., 00078-1070-xx, 00078-0639-xx, 00078-1056-xx, 00078-1168-xx)
• Specify route: SC vs IV and that IV vial is for adult IV use only
• Record exact dose and dosing schedule being requested
• For pediatric dosing, include patient weight category to match dosing guidance

Medicare Part B documentation note — consult NCD/LCD/LCA

Consult CMS NCD/LCD/LCA guidance for Medicare Part B applicability where relevant; documentation and coverage must comply with any applicable NCD/LCD/LCA requirements referenced by CMS.

• Medicare coverage and Part B rules may apply to outpatient drugs — check NCD/LCD/LCA guidance
• Policy notes N/A for Medicare Part B Covered Diagnosis Codes in this excerpt but CMS documents may still be relevant

Denial risk — age and baseline assessment missing or below minimum

PA requests may be denied if the member is below the minimum age specified for the indication or if baseline disease severity has not been assessed and documented with an objective measure.

• Confirm member meets indication‑specific minimum age (policy lists ages per indication)
• Provide baseline objective severity assessment (e.g., BSA, PASI, joint counts, CRP) to avoid denial

Denial risk — infection, screening, and concurrent therapy exclusions

PA may be denied for active infection, missing TB/HBV screening, use of live vaccines during therapy, or concurrent treatment with another biologic/targeted synthetic therapy; confirm these exclusions before submission.

• No active infection present
• Latent TB screening completed and plan for ongoing monitoring
• HBV screening completed prior to treatment
• Member will not receive live vaccines during therapy
• No concurrent biologic or targeted synthetic therapy

Denial risk — missing prior‑trial documentation

Requests can be denied if required prior trials (including duration and outcome) of specified agents are not documented; include documentation of inadequate response, intolerance, or contraindication to the named prior agents per payer and indication.

• Document agent(s) tried (e.g., adalimumab, etanercept, Cosentyx SC, Rinvoq)
• Document trial duration (commonly 3 months where specified) and outcome (inadequate response/intolerance/contraindication)
• If exempted, document reason (e.g., already established on biologic, contraindication)

PA consideration for cost — ensure full clinical justification

PA may be applied in part because of drug cost; include complete clinical justification and meet NQTL-based documentation expectations to support medical necessity.

• Appendix A notes cost as a factor to consider for PA
• Provide clear clinical rationale and required objective measures to address utilization management concerns

Prior authorization considerations (NQTL) — factors reviewed

When submitting PA, be prepared for NQTL-based review: the checklist considered indication, safety/efficacy, potential for misuse, medical necessity, and cost when designing PA requirements.

• NQTL factors reviewed: indication, safety/efficacy, misuse potential, medical necessity, and cost
• Expect PA review to reflect these considerations

Operational NQTL/PA note — follow indication‑specific lists

Operational note: NQTL/PA methods are referenced in the Appendix but additional operational details (e.g., step sequences) are not included in this excerpt; follow payer-specific prior‑therapy lists in the indication sections when completing PA submissions.

• Appendix A references NQTLs and PA methods
• Use the Commercial vs Medicaid prior‑trial lists in the indication sections for operational step requirements