Clinical Policy: Apremilast (Otezla)
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Defines medical necessity, prior authorization, and renewal criteria for apremilast (Otezla) for Medicaid members, covering FDA-labeled indications and certain off-label pathways; applies to providers prescribing for Peach State Health Plan members.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-01: Initial Therapy — Behçet's Disease — Covered when ALL of the following are met
Covered when ALL of the following are met
Approval duration: 6 months
inv-02: Initial Therapy — Plaque Psoriasis — Covered when ALL of the following are met
Covered when ALL of the following are met
Approval duration: 6 months
inv-03: Initial Therapy — Psoriatic Arthritis — Covered when ALL of the following are met
Covered when ALL of the following are met
Approval duration: 6 months
inv-04: Initial Therapy — Other Indications — Covered when ONE of the following is met
Covered when ONE of the following is met
Approval duration: 6 months
inv-05: Continued Therapy — Continued coverage when ALL of the following are met
Continued coverage when ALL of the following are met
Approval duration: 12 months
Non–FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the plan's off‑label use requirements. Follow policy CP.PMN.53 (Off‑Label Use Policy) or provide applicable evidence of coverage documentation to support approval.
Coverage is contraindicated for members with a known hypersensitivity to apremilast or to any excipient in the formulation. Requests for apremilast for such members should be denied per this contraindication.
Initial Therapy Criteria
inv-19: Initial Therapy — Initial approval criteria vary by diagnosis; specialist involvement and prior therapy trials are required as specified.
Initial approval criteria vary by diagnosis; specialist involvement and prior therapy trials are required as specified.
Approval duration: 6 months
inv-20: Initiation / Titration — Titration schedule for initiation per product labeling
Titration schedule for initiation per product labeling
Follow label for age/weight-specific adjustments
Continuation / Renewal Criteria
inv-21: Continuation Therapy — Continuation criteria for all indications
Continuation criteria for all indications
Approval duration: 12 months
Step Therapy and Prior Treatment Requirements
| Indication | Required trials / prior therapies |
|---|---|
| Plaque Psoriasis (moderate-to-severe) | Failure of a ≥3 consecutive month trial of methotrexate at up to maximally indicated doses; if MTX is intolerant/contraindicated, failure of a ≥3 consecutive month trial of cyclosporine or acitretin at up to maximally indicated doses; if intolerant/contraindicated to MTX, cyclosporine, and acitretin, failure of phototherapy unless contraindicated or clinically significant adverse effects are experienced. |
| Plaque Psoriasis (mild) | Failure of a medium- to ultra‑high‑potency topical corticosteroid (unless contraindicated or clinically significant adverse effects) AND failure of one topical agent (calcipotriene, calcitriol, or tazarotene) unless contraindicated or clinically significant adverse effects are experienced. |
| Psoriatic Arthritis (PsA) | If used concomitantly with a biologic DMARD: failure of a ≥3 consecutive month trial of methotrexate used in combination with the biologic at up to maximally indicated doses; or if MTX is intolerant/contraindicated, failure of a ≥3 consecutive month trial of cyclosporine or acitretin used in combination with the biologic at up to maximally indicated doses. |
| General (when applicable) | Trials of conventional systemic therapies (e.g., methotrexate, cyclosporine, acitretin) or appropriate topical therapies per disease severity and age as specified in indication‑specific criteria (see plaque PsO and PsA pathways). |
| Policy history / past requirement | Notes from prior reviews |
|---|---|
| Prior policy language required failure of conventional DMARDs before approval. | Appendix D references 'Failure of a trial of conventional DMARDs' as part of general information and prior review notes document that phototherapy was allowed as an alternative to conventional systemic DMARDs for moderate‑to‑severe PsO in 2Q 2022 review. |
Provider Actions and Requirements
Prior authorization required
Prior authorization is required. Submit a prior authorization request with supporting clinical documentation that demonstrates the member meets all applicable medical necessity criteria in this policy.
Follow labeled titration and maintenance dosing
Prescriptions must follow the labeled titration schedule (Days 1–5) and maintenance dosing per product labeling: adults maintenance dose Day 6 and thereafter 30 mg PO twice daily; pediatric weight-based maintenance dosing applies as specified in the policy.
- Titration Days 1–5: Day 1 10 mg PO QAM; Day 2 10 mg QAM and 10 mg QPM; Day 3 10 mg QAM and 20 mg QPM; Day 4 20 mg QAM and 20 mg QPM; Day 5 20 mg QAM and 30 mg QPM.
- Adult maintenance (Day 6+): 30 mg PO BID.
- Pediatric maintenance: weight ≥50 kg → 30 mg PO BID; weight 20 to <50 kg → 20 mg PO BID.
Document therapeutic trials (failures/intolerance) of conventional agents
For plaque psoriasis and psoriatic arthritis, the request must document failure of (or intolerance/contraindication to) specified conventional systemic therapies per the indication-specific pathways before approval.
- Plaque Psoriasis (moderate-to-severe): failure of a ≥3 month trial of methotrexate at maximally indicated doses, or if MTX intolerant/contraindicated, failure of a ≥3 month trial of cyclosporine or acitretin, or failure of phototherapy when applicable.
- Psoriatic Arthritis (concomitant biologic use): failure of a ≥3 month trial of methotrexate used in combination with the biologic, or if MTX intolerant/contraindicated, failure of cyclosporine or acitretin used in combination for ≥3 months.
Policy references prior DMARD / phototherapy requirements
The policy references prior requirements for trial/failure of conventional DMARDs (and phototherapy as an alternative for PsO in prior reviews); include documentation demonstrating these prior therapy trials where applicable.
- Appendix D notes failure of a trial of conventional DMARDs is relevant to prior reviews and treatment considerations.
- Policy history indicates phototherapy was allowed as an alternative to systemic conventional DMARDs for moderate-to-severe PsO in 2Q 2022.
Required supporting documentation
Providers must submit documentation such as office chart notes, laboratory results, or other clinical information supporting that the member meets all approval criteria.
- Include documentation of diagnosis, prior therapy trials (dates/duration/doses), specialist consultation if required, and weight for pediatric PsO where applicable.
Evidence base and coverage limits
This policy was developed from a review of standards of practice, peer-reviewed literature, FDA approval and guidelines; coverage decisions remain subject to the member's benefit contract and state Medicaid rules.
- Coverage determinations are also subject to evidence of coverage, state and federal requirements, and Health Plan-level administrative policies.
Incomplete documentation may cause denial or pend
Requests that lack required documentation (office notes, labs, or other clinical information) demonstrating the member meets all approval criteria may be denied or pended.
- Ensure prior therapy documentation, specialist consultation notes, dosing information, and pediatric weight (if applicable) are included to avoid denials or pendings.
Known hypersensitivity is a contraindication
Coverage is contraindicated for members with a known hypersensitivity to apremilast or any of its excipients; such cases should not be approved.
- Appendix C lists 'known hypersensitivity to apremilast or to any of the excipients in the formulation' as a contraindication.
Definitions and Acronyms
Background
Apremilast (Otezla) is a phosphodiesterase‑4 (PDE4) inhibitor with FDA‑labeled indications that include adult psoriatic arthritis, adult plaque psoriasis, pediatric plaque psoriasis in patients age ≥6 years and ≥20 kg, and treatment of oral ulcers associated with Behçet's disease. The policy aligns coverage to these labeled indications and applies indication‑specific age, weight and dosing limits, specialist involvement, and prior therapy requirements as described elsewhere in the policy.
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