CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Otezla (apremilast) — coverage criteria for psoriasis, psoriatic arthritis, Behcet's disease, and immunotherapy-related toxicity

Criteria for prior authorization, documentation, prescriber specialty, and continuation requirements for apremilast (Otezla) for plaque psoriasis, psoriatic arthritis, oral ulcers of Behcet's disease, and immune checkpoint inhibitor-related psoriasis/psoriasiform toxicity for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOtezla (apremilast) — coverage criteria for psoriasis, psoriatic arthritis, Behcet's disease, and immunotherapy-related toxicity

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with chart notes or claims history documenting prior therapies and clinical response, or rationale for avoiding recommended therapies.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 motypical authorization duration

>=6 yrsmin age PsO

not allowedno concomitant biologic/ts

Topical potencyAppendix A

Reasons to avoid systemic

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Coverage Criteria

Initial Therapy — Plaque psoriasis

Authorization of 12 months may be granted for members 6 years and older when ONE of the following is met:

Plaque psoriasis initial criteria: i. Prior receipt of a biologic or targeted synthetic drug indicated for treatment of plaque psoriasis; OR ii. Inadequate response or intolerance to ONE of the following: a. Phototherapy (e.g., UVB, PUVA); b. Topical therapies (e.g., medium or higher potency topical corticosteroids, calcineurin inhibitors, vitamin D analogs); OR iii. Contraindication or clinical reason to avoid BOTH phototherapy and topical therapies (see Appendix B for clinical reasons to avoid systemic agents); OR iv. Inadequate response or intolerance to ONE of methotrexate, cyclosporine, or acitretin; OR v. Clinical reason to avoid ALL of methotrexate, cyclosporine, and acitretin (see Appendix B).

Includes pediatric eligibility (>= 6 years and >= 20 kg).

Initial Therapy — Psoriatic arthritis

Authorization of 12 months may be granted for adult members when either prior biologic/targeted synthetic use or one of the following is met:

Psoriatic arthritis initial criteria: 1. Prior receipt of a biologic or targeted synthetic drug indicated for active psoriatic arthritis; OR 2. Inadequate response to methotrexate, leflunomide, or another conventional synthetic DMARD (e.g., sulfasalazine) administered at an adequate dose and duration; OR 3. Intolerance or contraindication to methotrexate or leflunomide or another conventional synthetic DMARD; OR 4. Presence of enthesitis.

Applies to adult members.

Initial Therapy — Behcet's disease

Authorization of 12 months may be granted for adult members for oral ulcers associated with Behcet's disease when:

Behcet's initial criteria: 1. Prior receipt of a biologic indicated for treatment of Behcet's disease; OR 2. Inadequate response to at least one nonbiologic medication for Behcet's disease (e.g., colchicine, systemic glucocorticoids, azathioprine).

Applies to adult members.

Initial Therapy — Immune checkpoint inhibitor-related toxicity

Authorization of 12 months may be granted for treatment of moderate to severe immunotherapy-related psoriasis/psoriasiform diseases when specified criteria are met:

Immune checkpoint inhibitor-related toxicity initial criteria: 1. Inadequate response to medium or higher potency topical corticosteroids; OR 2. Intolerance or contraindication to medium or higher potency topical corticosteroids.

Refers to Appendix A for topical corticosteroid potency classifications.

Continuation Therapy — Plaque psoriasis

Authorization of 12 months may be granted for continuation when ALL members achieve or maintain a positive clinical response evidenced by either:

Plaque psoriasis continuation: 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).

Applies to members 6 years and older including new members.

Continuation Therapy — Psoriatic arthritis

Authorization of 12 months may be granted for continuation when members achieve or maintain improvement in any of the following from baseline:

Psoriatic arthritis continuation: Number of swollen joints; number of tender joints; dactylitis; enthesitis; axial disease; skin and/or nail involvement; functional status; C-reactive protein (CRP).

Applies to adult members including new members.

Continuation Therapy — Behcet's disease and Immune checkpoint inhibitor-related toxicity

Authorization of 12 months may be granted for continuation when members achieve or maintain a positive clinical response as evidenced by specified criteria:

Behcet's and Immune-related continuation: Positive clinical response or low disease activity documented in chart notes or medical records; improvement in signs and symptoms of the condition.

Applies to adult members (Behcet's) and all members (immune-related toxicity) including new members.

Requests for apremilast for indications other than the FDA-approved uses (plaque psoriasis, psoriatic arthritis, oral ulcers of Behcet's disease) and the specified compendial use (immune checkpoint inhibitor–related toxicity) are not covered. All other indications are considered experimental/investigational and not medically necessary.

Systemic agents such as methotrexate, cyclosporine, acitretin, or leflunomide should be avoided in patients with certain conditions or risk factors. Examples include: clinical diagnosis of alcohol use disorder, alcoholic liver disease, or other chronic liver disease; significant drug interactions or risk of treatment-related toxicity; pregnancy or planned pregnancy; breastfeeding; significant comorbidities that prohibit systemic therapy (for example, severe liver or kidney disease, blood dyscrasias, or uncontrolled hypertension); known hypersensitivity; or a documented history of intolerance or adverse event to these agents. Document the clinical rationale when avoiding these systemic agents.

Use of apremilast for indications other than the listed FDA-approved indications and the compendial use for immune checkpoint inhibitor–related toxicity is not covered. Such requests are considered not medically necessary.

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Requirement and Duration

Prior authorization may be granted for up to 12 months when indication-specific criteria are met and required documentation is provided. Requests for indications not listed (i.e., not FDA-approved or compendial uses) are considered experimental/investigational and are not medically necessary.

Authorization duration: up to 12 months when criteria met
Unsupported indications: considered experimental/investigational and not medically necessary

Step Therapy

Step Therapy and Required Trials

Step therapy requirements apply for plaque psoriasis and psoriatic arthritis where prior trials of specified therapies are required before approval of biologic or targeted synthetic agents. Documented inadequate response or intolerance to the listed therapies is required unless a documented clinical reason to avoid the therapy is provided.

Plaque psoriasis: prior biologic/targeted synthetic OR inadequate response/intolerance to phototherapy or topical therapies OR inadequate response/intolerance to methotrexate, cyclosporine, or acitretin; or documented reason to avoid those systemic agents

Background

Apremilast (Otezla) is covered for its FDA‑approved indications—plaque psoriasis, psoriatic arthritis, and oral ulcers associated with Behcet's disease—and for the compendial use of immune checkpoint inhibitor–related toxicity when the policy criteria are met. Coverage is limited to the specified indications and required documentation, prior‑therapy conditions, and continuation criteria detailed elsewhere in the policy.

Definitions and Related Terms

Pediatric plaque psoriasis eligibility

Age and weightPatients 6 years of age and older and weighing at least 20 kg

Disease severity and candidacyModerate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy

Authorization durationPrior authorization may be granted for 12 months when criteria are met

Compendial use

Compendial indicationUse for immune checkpoint inhibitor-related toxicity (immunotherapy-related psoriasis/psoriasiform diseases)

Coverage stance for other usesAll other indications are considered experimental/investigational and not medically necessary

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOtezla (apremilast) — coverage criteria for psoriasis, psoriatic arthritis, Behcet's disease, and immunotherapy-related toxicity

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with chart notes or claims history documenting prior therapies and clinical response, or rationale for avoiding recommended therapies.

SourceLink

On This Page

Psoriatic arthritis: inadequate response to methotrexate, leflunomide, or another conventional synthetic agent (e.g., sulfasalazine), or intolerance/contraindication, or presence of enthesitis

Behcet's disease and immune checkpoint inhibitor–related toxicity: prior nonbiologic therapy or topical high/medium potency corticosteroids trials as specified

Prior Authorization

Clinical Exceptions to Step Therapy

Clinical exceptions to step therapy may be allowed when there is a documented contraindication, intolerance, or other clinical reason to bypass required trials. The clinical rationale for avoiding specified systemic agents must be documented in the medical record.

Exceptions permitted when systemic agents are contraindicated or not advisable
Document clinical rationale when avoiding required therapies to support exception requests

Documentation Required

Documentation Required for Prior Authorization

Initial prior authorization requests must include chart notes, medical record documentation, or claims history supporting prior medications tried and response to therapy. If a required therapy was not tried because it is not advisable, documentation of the clinical reason to avoid that therapy must be provided. Continuation requests must include documentation of clinical improvement or positive response.

Initial requests: chart notes, medical records, or claims history showing prior therapies and responses; if therapy avoided, provide clinical justification
Continuation requests: documentation of improvement in signs and symptoms or positive clinical response

Note

Reference Material for Prior Authorization Reviews

Appendices provide reference material used during prior authorization review, including a table of topical corticosteroid relative potencies (Appendix A) and examples of clinical reasons to avoid systemic agents such as methotrexate, cyclosporine, acitretin, or leflunomide (Appendix B). Reviewers may reference these appendices when assessing step-therapy compliance or clinical exception rationale.

Appendix A: Relative potency of select topical corticosteroid products to support topical therapy trial assessments
Appendix B: Examples of clinical reasons to avoid methotrexate, cyclosporine, acitretin, or leflunomide (e.g., pregnancy, alcohol use disorder, significant liver or kidney disease, drug interactions, hypersensitivity, prior intolerance)

Authorization context

Authorization of 12 months may be granted when criteria for immune checkpoint inhibitor-related toxicity are met

Relative potency groups

DefinitionGrouping of topical corticosteroid products by clinical potency with assigned potency groups (e.g., medium potency = group 4; lower‑mid, low, least potent groups) as listed in Appendix A

ContentsAppendix A lists drugs, dosage forms, and strengths organized by potency groups

Reference for criteriaCriteria for immune checkpoint inhibitor‑related toxicity refer to Appendix A for potency classifications

Clinical reasons to avoid systemic agents

Alcohol and liver diseaseClinical diagnosis of alcohol use disorder, alcoholic liver disease, or other chronic liver disease

Drug interactions and toxicity riskDrug interaction or risk of treatment‑related toxicity that contraindicates systemic agents

Reproductive considerationsPregnancy or currently planning pregnancy, and breastfeeding

Significant comorbiditySignificant comorbidity prohibiting systemic agents (e.g., liver or kidney disease, blood dyscrasias, uncontrolled hypertension)

Hypersensitivity or prior intoleranceKnown hypersensitivity or history of intolerance/adverse event to the systemic agent