ModifiedCignaPolicy N/A

Inflammatory Conditions - Otezla / Otezla XR Prior Authorization Policy

Prior authorization requirements and medical necessity criteria for coverage of apremilast (Otezla and Otezla XR) for specified inflammatory indications under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Otezla / Otezla XR Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial — added Otezla XRexpanded pediatric criteriaweight thresholds added

Effective DateN/A

Next Review DateMay 21, 2025

Key ActionObtain prior authorization and document required prior systemic therapy and specialist consultation when submitting requests for Otezla or Otezla XR.

SourceLink

POLICY UPDATE CHANGES

Otezla XR was added with the same criteria as Otezla for Behcet's disease, plaque psoriasis, and psoriatic arthritis.

Expanded pediatric age requirement for psoriatic arthritis from ≥18 to ≥6 years of age.

Weight requirements were added: Otezla ≥ 20 kg and Otezla XR ≥ 50 kg for pediatric indications.

3FDA-approved indications listed

4 moInitial approval (Behcet's, PsO)

6 moInitial approval (PsA)

1 yr

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Concurrent biologic useNot covered

~40Agents listed (approx)

Coverage Criteria for Otezla / Otezla XR

Psoriatic Arthritis — Covered when ONE of the following is met

Psoriatic Arthritis. Approve for the duration noted if the patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Patient is ≥ 6 years of age.
- Patient meets ONE of the following: a) If Otezla is being requested, the patient weighs ≥ 20 kg; OR b) If Otezla XR is being requested, the patient weighs ≥ 50 kg.
  weight threshold depends on formulation
- The medication is prescribed by or in consultation with a rheumatologist or dermatologist.
B) Patient is Currently Receiving Otezla/Otezla XR
- Patient has been established on the requested drug for at least 6 months.
  A patient who has received < 6 months of therapy or who is restarting therapy is reviewed under criterion A (Initial Therapy).
- Patient meets at least ONE of the following: a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating Otezla); OR b) Compared with baseline, patient experienced an improvement in at least one symptom, such as less joint pain, morning stiffness, or fatigue; improved function or activities of daily living; decreased soft tissue swelling in joints or tendon sheaths.
  Examples of standardized measures include DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC, Leeds Dactylitis Instrument Score, Minimal Disease Activity (MDA), PsAID-12, and/or serum markers (e.g., CRP, ESR).

Coding and Weight/Patient Criteria

Coding guidance and denial riskmixed

affected codes

Providers must bill using the most appropriate codes as of the date of submission; claims for services without covered codes will be denied.

No CPT/HCPCS/ICD-10/NDC codes in appendixmixed

No codes listed

Pediatric weight thresholds — Otezla / Otezla XR

Otezla (apremilast)Pediatric weight threshold: ≥ 20 kg for pediatric indications (≥ 6 years of age)

Otezla XR (apremilast extended‑release)Pediatric weight threshold: ≥ 50 kg for pediatric indications (≥ 6 years of age)

Applies toWeight criteria referenced in initial therapy sections for plaque psoriasis and psoriatic arthritis

Prior Authorization, Prescribing, and Documentation

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended for prescription benefit coverage of Otezla and Otezla XR. Approvals are provided for the durations specified in the main policy criteria (months referenced as 30-day periods). The appendix does not specify prior authorization steps or operational documentation; providers must follow the main policy for authorization submission requirements and documentation.

Otezla ® (apremilast tablets - Amgen)
Otezla XR ™ (apremilast extended-release tablets - Amgen)

Note

Appendix Informational Only — Refer to Main Policy

The appendix is informational only and does not include authorization or denial criteria. Use the main policy body for coverage criteria, clinical requirements, and operational instructions for approvals and denials.

Definitions and Drug Names

Otezla / Otezla XR — overview

Drug classOral phosphodiesterase 4 (PDE4) inhibitors (apremilast)

ProductsOtezla (apremilast) and Otezla XR (apremilast extended‑release)

FDA‑approved indications (summary)Behcet's disease (adults, oral ulcers), plaque psoriasis (adults; pediatrics ≥6 years with weight thresholds), psoriatic arthritis (adults; pediatrics ≥6 years with weight thresholds)

SC — definition

AbbreviationSC = Subcutaneous

Context noteUsed in appendix to denote route of administration for biologic agents (e.g., SC injection)

Reference instruction

Background

Apremilast (Otezla, Otezla XR) is an oral phosphodiesterase 4 (PDE4) inhibitor. The agent has FDA‑approved indications that include treatment of Behcet's disease (oral ulcers), plaque psoriasis, and psoriatic arthritis, with age and weight considerations for certain pediatric uses. The Appendix and policy reference prescribing information and clinical guidelines for indication details.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Otezla / Otezla XR Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial — added Otezla XRexpanded pediatric criteriaweight thresholds added

Effective DateN/A

Next Review DateMay 21, 2025

Key ActionObtain prior authorization and document required prior systemic therapy and specialist consultation when submitting requests for Otezla or Otezla XR.

SourceLink

On This Page

Documentation Required

Specialist Prescribing / Consultation Required for Initial Approval

Initial prescribing requires that Otezla/Otezla XR be prescribed by, or in consultation with, a physician who specializes in the condition being treated (e.g., dermatologist or rheumatologist as specified per indication). This specialist consultation requirement applies to initial approvals.

Behcet's disease: prescribed by or in consultation with a rheumatologist or dermatologist.
Plaque psoriasis: prescribed by or in consultation with a dermatologist.
Psoriatic arthritis: prescribed by or in consultation with a rheumatologist or dermatologist.

Documentation Required

Required Prior Systemic Therapy for Initial Treatment

For certain FDA‑approved indications (for example, Behcet's disease and plaque psoriasis), initial therapy approval requires documentation of a trial of at least one other systemic agent or a documented contraindication/intolerance to such agents. Examples of acceptable prior systemic therapies are listed in the main policy.

Behcet's disease: trial of at least one other systemic therapy (e.g., colchicine, systemic corticosteroids, azathioprine, thalidomide, interferon alpha, or TNF inhibitors).
Plaque psoriasis: trial of at least one traditional systemic agent for ≥ 3 months (e.g., methotrexate, cyclosporine, acitretin) unless intolerant, or documented contraindication to methotrexate; exceptions noted if prior biologic trial completed.

Step Therapy

Step Therapy — None Specified in Appendix

No step therapy requirements are detailed in the appendix. Any step therapy rules (if applicable) will be specified in the main policy; providers should not assume additional step requirements based on the appendix alone.

Denial Risk

Coding and Denial Risk

Claims submitted without the appropriate covered diagnosis or procedure codes as outlined in the main policy will be denied as not covered. Ensure the most appropriate and current codes are used at time of submission.

Refer to prescribing information for specific formulation and administration details

IV — definition

AbbreviationIV = Intravenous

Context noteUsed in appendix to denote route of administration for some biologic agents (e.g., IV infusion)

Reference instructionRefer to prescribing information for infusion schedules and administration guidance

TNF — definition

AbbreviationTNF = Tumor necrosis factor

Context noteListed in appendix as a mechanism of action category for biologic agents (e.g., anti‑TNF therapies)

ExamplesSee appendix agent list for examples of TNF inhibitors (e.g., adalimumab) and related indications

JAK/TYK2 — definition

AbbreviationJAK/TYK2 = Janus kinase / Tyrosine kinase 2 pathways

Context noteListed in appendix as mechanism categories for targeted synthetic therapies (JAK inhibitors, TYK2 inhibitors)

Reference instructionRefer to individual agent prescribing information for specific pathway inhibition and clinical indications