mhn apremilast coverage & prior auth

Coverage Criteria

Initial Therapy - Behçet's Disease

Behçet's Disease (coverage when ALL of the following are met):

Behcet_Criteria: 1) Diagnosis of oral ulcers in members with BD;

Behcet_Criteria: 2) Prescribed by or in consultation with a dermatologist or rheumatologist;

Behcet_Criteria: 3) Age ≥ 18 years;

Behcet_Criteria: 4) Failure of a topical corticosteroid at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;

Examples: triamcinolone acetonide cream (see Appendix B for potency guidance)

Behcet_Criteria: 5) Failure of an oral corticosteroid at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;

Example: prednisone

Behcet_Criteria: 6) Failure of colchicine at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;

Behcet_Criteria: 7) Dose does not exceed formulation-specific maxima: either Otezla up to 60 mg/day (2 tablets/day) or Otezla XR up to 75 mg/day (1 tablet/day).

Initial Therapy - Plaque Psoriasis

Plaque Psoriasis (coverage when ALL of the following are met):

PsO_Criteria: 1) Diagnosis of plaque psoriasis (PsO);

PsO_Criteria: 2) Age/weight criteria: either (a) Age ≥ 18 years; OR (b) Age 6 to <18 years with moderate-to-severe disease and documentation of weight meeting formulation-specific thresholds (Otezla: weight ≥ 20 kg; Otezla XR: weight ≥ 50 kg);

For pediatric patients, moderate-to-severe defined by BSA ≥ 3% or involvement of hands/feet/scalp/face/genital area

PsO_Criteria: 3) Prescribed by or in consultation with a dermatologist or rheumatologist;

PsO_Criteria: 4) Prior therapy requirements unless member previously failed a biologic: either (a) moderate-to-severe disease with failure of a ≥ 3 consecutive month trial of methotrexate at up to maximally indicated doses OR intolerance/contraindication to MTX with failure of a ≥ 3 month trial of cyclosporine or acitretin OR intolerance/contraindication to MTX/cyclosporine/acitretin with failure of phototherapy; OR (b) mild disease with failure of a medium to ultra-high potency topical corticosteroid AND failure of one topical agent (calcipotriene, calcitriol, or tazarotene);

Initial Therapy - Psoriatic Arthritis

Psoriatic Arthritis (coverage when ALL of the following are met):

PsA_Criteria: 1) Diagnosis of psoriatic arthritis (PsA);

PsA_Criteria: 2) Prescribed by or in consultation with a dermatologist or rheumatologist;

PsA_Criteria: 3) Age ≥ 6 years;

PsA_Criteria: 4) Documentation of weight meeting formulation-specific thresholds: Otezla weight ≥ 20 kg OR Otezla XR weight ≥ 50 kg;

PsA_Criteria: 5) If used concomitantly with a biologic DMARD, member must have failed a ≥ 3 consecutive month trial of methotrexate used in combination with the biologic at up to maximally indicated doses OR, if MTX-intolerant/contraindicated, failure of a ≥ 3 month trial of cyclosporine or acitretin used in combination with the biologic;

Continuation Therapy

Continued Therapy (all indications):

Continued_Therapy: 1) Member is currently receiving medication via Centene benefit or previously met initial approval criteria (or continuity of care applies);

Continued_Therapy: 2) Member is responding positively to therapy;

Continued_Therapy: 3) For pediatric PsA and PsO, documentation of weight/formulation applies; any request for a dose increase must not exceed the stated maxima for the indication and age/weight cohort.

Approval duration: 12 months

Requests for use of apremilast for indications that are not FDA‑approved and are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety consistent with the plan's off‑label use policy (CP.PMN.53) or other applicable evidence of coverage documents. Prior authorization determinations for off‑label uses will require the clinical rationale and supporting records demonstrating that the requested indication meets those off‑label criteria.

Apremilast is contraindicated in persons with a known hypersensitivity to apremilast or to any of the excipients in the formulation. Presence of this documented hypersensitivity is a basis for denial of coverage and must be identified and reported by the prescriber when submitting prior authorization requests.

Uses of apremilast for indications that are neither FDA‑approved nor supported by off‑label documentation per CP.PMN.53 are explicitly not authorized. Providers seeking coverage for such non‑approved indications must supply the off‑label evidence required by CP.PMN.53; absent that documentation, the request will be denied.

Initial Therapy Criteria

Initial Therapy

Initial therapy coverage criteria per indication:

Initial_BD: Behçet's Disease: diagnosis of oral ulcers; specialist prescriber; age ≥ 18 years; failures of topical corticosteroid, oral corticosteroid, and colchicine at up to maximally indicated doses unless contraindicated; and dose limits per formulation (Otezla up to 60 mg/day or Otezla XR up to 75 mg/day).

Initial_PsO: Plaque Psoriasis: diagnosis; age/weight criteria (adult or pediatric with weight thresholds); specialist prescriber; prior therapy requirements by severity or prior biologic failure; biologic-concomitant rules when applicable; and dosing limits per age/weight/formulation (including pediatric 40 mg/day for 20 to <50 kg).

Initial_PsA: Psoriatic Arthritis: diagnosis; specialist prescriber; age ≥ 6 years; weight/formulation documentation; biologic-concomitant rules when applicable; and dosing limits per age/weight/formulation.

Continuation Therapy Criteria

Continuation Therapy

Continuation therapy requirements for all indications:

Drug_Continuation: 1) Member is currently receiving medication via Centene benefit or previously met initial approval criteria;

Drug_Continuation: 2) Member is responding positively to therapy;

Drug_Continuation: 3) For pediatric PsA and PsO: documentation of weight/formulation applies; dose increases are allowed only within the stated maxima for the indication and age/weight cohort.

Approval duration: 12 months

Continuation therapy guidance

Continuation therapy guidance and policy history notes:

Step Therapy Requirements

Clinical scenario	Step-therapy requirement
Plaque psoriasis — moderate-to-severe disease (adult or pediatric meeting severity/weight criteria)	Failure of a ≥3 consecutive month trial of methotrexate (MTX) at up to maximally indicated doses is required; if MTX is intolerant/contraindicated, failure of a ≥3 month trial of cyclosporine or acitretin is required (or failure of phototherapy if intolerant to MTX/cyclosporine/acitretin).
Plaque psoriasis — mild disease	Failure of a medium to ultra‑high potency topical corticosteroid AND failure of one topical agent (calcipotriene, calcitriol, or tazarotene) is required unless contraindicated or clinically significant adverse effects are documented.
Plaque psoriasis — concomitant use with a biologic DMARD	Failure of a ≥3 consecutive month trial of MTX used in combination with the biologic at up to maximally indicated doses is required; if MTX is intolerant/contraindicated, failure of a ≥3 month trial of cyclosporine or acitretin used in combination with the biologic is required.
Psoriatic arthritis (PsA) when policy step-therapy applies	Documented failure/intolerance of conventional systemic therapy (e.g., MTX for ≥3 months at maximally indicated doses) or alternative conventional DMARDs per policy may be required prior to approval.

Note	Guidance
Policy cross-reference and program history	Refer to the main policy criteria for full, indication‑specific step‑therapy details; program history notes allow phototherapy as an alternative to systemic conventional DMARDs in some PsO patients and clarify bypass of conventional therapies when a biologic has already failed. Reviewers should use the full criteria for case‑level decisions.
Pediatric and formulation considerations	Pediatric extensions and weight thresholds (Otezla ≥20 kg; Otezla XR ≥50 kg) affect step‑therapy applicability — consult the main criteria for pediatric dosing and step requirements.

Coding and Dosing Thresholds

Weight thresholds for pediatric dosing — formulation specific

Pediatric weight thresholdsTwo formulation-specific thresholds: for Otezla (immediate-release) weight ≥ 20 kg; for Otezla XR (extended‑release) weight ≥ 50 kg.

Applicability by indicationUsed for pediatric patients with PsO or PsA per the policy age/weight criteria; weight thresholds determine eligible formulation and dosing.

Weight band dosing notePatients 20 kg to <50 kg are eligible for Otezla (IR) with pediatric dosing limits; patients ≥50 kg may use either Otezla (IR) or Otezla XR per adult titration/maintenance.

Otezla XR — extended‑release apremilast (75 mg QD)

DefinitionOtezla XR is the extended‑release formulation of apremilast formulated as a 75 mg once‑daily tablet.

Maintenance dosing

Quantity Limits and Dosing Limits

Apremilast (Otezla IR/XR) — quantity and maintenance limits

Per‑regimen limitsQuantity limits follow the labeled titration and maintenance regimens; initial titration pack and maintenance dosing determine allowed daily totals.

Maximum maintenance doses (adults)Otezla (IR): maximum maintenance 60 mg/day (typically 30 mg PO BID); Otezla XR: maximum maintenance 75 mg/day (75 mg PO QD).

Pediatric maintenance limitsFor pediatric patients ≥50 kg: same adult maxima (Otezla 60 mg/day; Otezla XR 75 mg/day). For weight 20 to <50 kg: Otezla (IR) maintenance up to 40 mg/day per pediatric dosing guidance.

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include clinical documentation demonstrating the member meets the specific indication criteria and all policy requirements.

PA must specify the exact product requested (Otezla immediate‑release vs Otezla XR extended‑release) and the dosing regimen including titration schedule and maintenance dose.
Provider must document prior treatment trials and failures where required by the indication (e.g., topical and/or systemic therapies, phototherapy, methotrexate, cyclosporine, acitretin, colchicine, oral and topical corticosteroids) or document contraindication/intolerance to those agents.
For plaque psoriasis and when prescribing concomitantly with biologic DMARDs, step‑therapy requirements apply (specified trials of methotrexate and, if applicable, cyclosporine/acitretin or phototherapy) unless the member previously failed a biologic agent as noted in policy.
Requests for non‑FDA approved (off‑label) indications that are not addressed by this policy will not be authorized unless sufficient supporting documentation of efficacy and safety is submitted per off‑label use policies (e.g., CP.PMN.53) or applicable evidence‑of‑coverage documents.
Provider must submit supporting documentation (e.g., office/clinic chart notes, lab results, imaging, prior authorization forms) that demonstrate the member meets ALL approval criteria.
Prescribers should state the exact tablet strength/formulation and the dosing regimen chosen (including titration days 1–5 and maintenance dose, and maximum maintenance dose limits) in the PA submission.

Background

Apremilast is an oral phosphodiesterase‑4 (PDE4) inhibitor indicated for plaque psoriasis, psoriatic arthritis, and oral ulcers associated with Behçet's disease. Coverage under this policy is limited to those FDA‑approved indications and to off‑label uses only when supported by the plan's off‑label criteria. Note that patients with a documented hypersensitivity to apremilast or any excipient are contraindicated for therapy and should not be started on apremilast.

Definitions and Terms

Abbreviations

BDBehçet's disease

DMARDdisease‑modifying anti‑rheumatic drug

MTXmethotrexate

PDE4phosphodiesterase 4

PsOplaque psoriasis

PsApsoriatic arthritis

Otezla XR — extended‑release formulation (clarification)

Formulation summary

Site of Care

Note

Oral formulation can be taken in outpatient/home settings

Oral apremilast formulations (immediate‑release and extended‑release) are suitable for outpatient/home administration per the product labeling.

Immediate‑release tablets available in 10, 20, 30 mg strengths; XR available as 75 mg tablet; starter 28‑day pack available.

OpenPayer

Apremilast (Otezla, Otezla XR) Coverage Criteria