CurrentBlue Cross Blue Shield - IowaPolicy 05.02.11

Otezla_Drug_Policy

Defines medical necessity criteria, required documentation, prescriber specialties, quantity limits, dosing guidance, and continuation criteria for Otezla (apremilast) for FDA-approved and select compendial indications (plaque psoriasis, psoriatic arthritis, Behçet's oral ulcers, and immune checkpoint inhibitor-related toxicity). Applies to initial and continuation prior authorization decisions for Wellmark members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyOtezla_Drug_Policy

Policy CodePolicy 05.02.11

Change TypeClarified (reviewed Oct 2025no clinical changes)

Effective DateNov 19, 2025

Next Review Date

Key ActionSubmit prior authorization with required documentation (initial: chart notes/medical record/claims history of prior meds or reasons to avoid; continuation: documentation of clinical response).

SourceLink

POLICY UPDATE CHANGES

Policy reviewed October 2025; current effective date November 19, 2025.

4FDA-approved indications listed

1Compendial indication listed

60Common monthly tablet limit

12Typical authorization duration (months)

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Coverage Summary

This policy (Policy #: 05.02.11) defines coverage for Otezla (apremilast) and ensures appropriate patient selection based on FDA labeling, clinical guidelines, and evidence. It covers FDA-approved indications including plaque psoriasis (adults and pediatric patients ≥ 6 years and weighing ≥ 20 kg when candidates for phototherapy or systemic therapy), psoriatic arthritis (adult and pediatric patients ≥ 6 years and ≥ 20 kg with active disease), and oral ulcers associated with Behçet's disease in adults, as well as the compendial indication for immune checkpoint inhibitor-related toxicity. Typical authorization duration is 12 months. Overall coverage stance: covered with criteria, per the policy effective November 19, 2025.

Key thresholds for Otezla (apremilast) therapy

Pediatric age & weight threshold>= 6 years AND >= 20 kg

Otezla 20 mg tablet quantity limit60 per 30 days

Otezla 30 mg tablet quantity limit60 per 30 days

Otezla starter pack quantity limit2 packs (110 tablets) per lifetime

Otezla XR starter pack quantity limit1 pack per lifetime

Otezla XR 75 mg tablet quantity limit30 per 30 days

Authorization duration12 months

Initial Therapy Criteria

Covered Indications and Initial Approval Criteria

Authorization of 12 months may be granted when ALL applicable age/weight and indication-specific criteria are met:

Required Documentation for Prior Authorization

Submission of the following is necessary to initiate prior authorization review:

Required documentation

Initial requests (PsO, PsA): Initial requests: chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable) including response; if therapy is not advisable, documentation of clinical reason to avoid therapy
Continuation requests: chart notes or medical record documentation supporting positive clinical response to therapy

Continuation (Renewal) Criteria

Authorization of 12 months may be granted when the member achieves or maintains positive clinical response as evidenced by ANY of the following:

Plaque psoriasis response: Plaque psoriasis: reduction in body surface area (BSA) affected from baseline OR improvement in signs and symptoms from baseline (e.g., itching, redness, flaking, scaling, burning, cracking, pain)
Psoriatic arthritis response: Psoriatic arthritis: improvement in any of: number of swollen joints, number of tender joints, dactylitis, enthesitis, axial disease, skin and/or nail involvement, functional status, or C-reactive protein (CRP)
Behçet's response: Behçet's disease: low disease activity or improvement in signs and symptoms

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Submit a prior authorization request with required documentation. For initial requests include chart notes, medical record documentation, or claims history supporting prior medications tried and responses, or documentation of clinical reasons to avoid those therapies. For continuation requests include chart notes or medical record documentation demonstrating positive clinical response. For Behçet's disease initial requests, include prior treatment history and response.

Initial: chart notes/medical record/claims history of prior medications tried and response, or clinical reason to avoid therapy
Continuation: chart notes/medical record documenting positive clinical response
Behçet's initial: prior treatment history and response

Documentation Required

Prescriber specialty requirement for initial approval

Initial prescriber must be the listed specialist or in consultation with one. Required specialties vary by indication as follows.

Applicable Codes and Product Identifiers

Procedures and Billing Codesmixed

N/A	No specific CPT/HCPCS/ICD-10/revenue codes specified; use appropriate codes to report provider services

Drug (NDC) and Product Codes referenced in policy textNDC

apremilast 20 mg tablet	Otezla (apremilast) 20 mg tablets - quantity limit 60 per 30 days
apremilast 30 mg tablet	Otezla (apremilast) 30 mg tablets - quantity limit 60 per 30 days
Otezla starter pack	Otezla starter pack - quantity limit 2 packs (110 tablets) per lifetime
Otezla XR starter pack	Otezla XR starter pack - quantity limit 1 pack per lifetime
Otezla XR 75 mg tablet	Otezla XR 75 mg tablets - quantity limit 30 per 30 days

Clinical Evidence and References

Evidence sources informing this policy include the primary product reference: Otezla [package insert] (Amgen Inc.; April 2024), and clinical practice guidelines referenced in the policy such as the AAD-NPF psoriasis guidance, GRAPPA recommendations, EULAR recommendations, and the ACR/NPF PsA guideline.

Background

Background/purpose: The intent of this Otezla drug policy is to ensure appropriate selection of patients for apremilast therapy consistent with product labeling, clinical guidelines, and clinical studies. The policy covers FDA-approved indications (plaque psoriasis, psoriatic arthritis, Behçet's oral ulcers) for adults and pediatric patients ≥ 6 years and ≥ 20 kg, and includes a compendial use for immune checkpoint inhibitor–related toxicity. The policy specifies required documentation for prior authorization (initial and continuation), prescriber specialty requirements, dosing/quantity limits, and continuation criteria to support appropriate and evidence-based use.

Policy metadata

Policy number05.02.11

PayerWellmark Blue Cross and Blue Shield

Effective dateNovember 19, 2025

Last review dateOctober 2025

StatusCURRENT

Revision History

2025-10-01review

Policy reviewed October 2025; no clinical policy statement changes indicated in document metadata (review noted in revision history).

2025-10-01revision

Policy revised October 2025; metadata indicates review and revision occurred but no clinical policy statement changes were indicated.

2025-11-19effective_dateLatest

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyOtezla_Drug_Policy

Policy CodePolicy 05.02.11

Change TypeClarified (reviewed Oct 2025no clinical changes)

Effective DateNov 19, 2025

Next Review Date

SourceLink

On This Page

Behçet's initial requests:

Behçet's disease (initial requests only): chart notes, medical record documentation, or claims history supporting previous medications tried including response (if applicable)

Applies to initial requests only

Prescriber Specialty Requirement (initial approvals only)

Medication must be prescribed by or in consultation with one of the following specialists depending on indication:

Prescriber specialty requirement (initial approvals only)

Plaque psoriasis prescriber: Plaque psoriasis: dermatologist
Psoriatic arthritis prescriber: Psoriatic arthritis: rheumatologist or dermatologist
Behçet's prescriber: Behçet's disease: rheumatologist
ICI-related toxicity prescriber: Immune checkpoint inhibitor-related toxicity: dermatologist, hematologist, or oncologist

ICI-related toxicity response: Immune checkpoint inhibitor-related toxicity: low disease activity or improvement in signs and symptoms

Concomitant Therapy Exclusion

Concomitant therapy exclusion: Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication

Applies to all indications

Plaque psoriasis: dermatologist
Psoriatic arthritis: rheumatologist or dermatologist
Behçet's disease: rheumatologist
Immune checkpoint inhibitor–related toxicity: dermatologist, hematologist, or oncologist

Billing Rule

Quantity limits enforced

Quantity limits are enforced per product formulation and strength.

Otezla starter pack: 2 packs (110 tablets) per lifetime
Otezla 20 mg tablets: 60 per 30 days
Otezla 30 mg tablets: 60 per 30 days
Otezla XR starter pack: 1 pack per lifetime
Otezla XR 75 mg tablets: 30 per 30 days

Denial Risk

Denial if criteria not met

Claims may be denied as not medically necessary if the member does not meet the indication‑specific criteria, age/weight requirements, or the concomitant therapy exclusion.

Documentation Required

Continuation monitoring

For renewal, provide objective and/or clinical evidence of improvement from baseline. Acceptable measures include, by indication, reduction in body surface area (BSA) or improvement in signs/symptoms for plaque psoriasis; improvement in swollen/tender joint counts, dactylitis, enthesitis, axial disease, skin or nail involvement, functional status, or C‑reactive protein (CRP) for psoriatic arthritis; and low disease activity or symptomatic improvement for Behçet's disease and immune checkpoint inhibitor‑related toxicity.

Plaque psoriasis: BSA reduction or improvement in signs/symptoms (itching, redness, scaling, etc.)
Psoriatic arthritis: improved swollen/tender joint counts, dactylitis, enthesitis, axial disease, skin/nail involvement, functional status, or CRP
Behçet's disease: low disease activity or symptom improvement
Immune checkpoint inhibitor‑related toxicity: low disease activity or symptom improvement

Scope summaryDefines medical necessity criteria, required documentation, prescriber specialties, quantity limits, dosing guidance, and continuation criteria for Otezla (apremilast) for FDA-approved and select compendial indications (plaque psoriasis, psoriatic arthritis, Behçet's oral ulcers, and immune checkpoint inhibitor-related toxicity). Applies to initial and continuation prior authorization decisions for Wellmark members.

Current effective date November 19, 2025 (policy reviewed October 2025; no material clinical policy statement changes indicated).