CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Otezla and Otezla XR

Defines Medicaid coverage criteria for Otezla and Otezla XR (apremilast) for FDA-approved indications (plaque psoriasis, psoriatic arthritis, oral ulcers in Behçet's), continuation criteria, quantity limits, and required documentation; excludes non‑FDA/compendial uses as investigational.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOtezla and Otezla XR

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFeb 1, 2020

Next Review Date

Key ActionProvider must submit the member's chart or medical record documenting medical necessity and the specific criteria met for the applicable indication (including BSA, weight, prior trials and intolerances).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this update.

3Covered indications

12Auth duration (months)

2Daily tablet limit (20/30 mg)

1Daily tablet limit (XR 75 mg)

Coverage summary

Policy covers apremilast (Otezla/Otezla XR) per FDA‑approved indications for plaque psoriasis, active psoriatic arthritis, and oral ulcers associated with Behçet's syndrome in pediatric and adult populations with specified weight and prior‑therapy requirements; other indications are considered investigational. Authorization may be granted for up to 12 months when all applicable criteria are met (including documentation of BSA, weight thresholds, prior trials/intolerances, specialist prescribing, and no concomitant use with biologic response modifiers or certain oral agents). Effective date: 2020-02-01; Last review: 2026-03-01.

Initial therapy — Authorization criteria

Plaque psoriasis - Authorization (12 months)

Otezla/Otezla XR are covered for the listed indications provided all approval criteria are met and there are no member exclusions:

General Requirements

Submission of the member's chart or medical record documenting medical necessity based on the criteria corresponding to the applicable indication
Otezla or Otezla XR will not be used concomitantly with an injectable biologic response modifier (e.g., TNF-inhibitors, IL-inhibitors) or other oral non-biologic agent (e.g., tofacitinib, baricitinib, upadacitinib)
Otezla or Otezla XR is prescribed by, or in consultation with, a specialist in dermatology or rheumatology

Severity-based requirements (pick applicable branch)

Pediatric specific
- Documentation of affected area(s) and percentage of affected body surface area (BSA); pediatric members must have at least 10% of BSA affected>=10% BSA
  Crucial body areas defined as hands, feet, face, neck, scalp, genitals/groin, intertriginous areas
- Pediatric members have crucial body areas affected (hands, feet, face, neck, scalp, genitals/groin, intertriginous areas)
Mild plaque psoriasis (adult)
- Documentation that the member experienced an inadequate treatment response or intolerance from two of the following therapies (as monotherapy or with a topical corticosteroid) within the last 12 months: topical calcineurin inhibitors, topical vitamin D analogs, topical retinoid, phototherapy
  Contraindications/adverse effects/intolerance must be documented
- Documentation that the member experienced an inadequate treatment response or intolerance from Zoryve (roflumilast) cream 0.3% within the last 12 months
  If switching from a biologic for psoriasis or has concomitant psoriatic arthritis, trial of Zoryve is not required
Moderate to severe plaque psoriasis
- Documentation that member has at least 10% of BSA affected OR crucial body areas are affected>=10% BSA or crucial areas
- Documentation of inadequate response to at least a 3-month trial of methotrexate, cyclosporine, or acitretin, or clinically significant adverse effects from these agents>=3 months
- Documentation of inadequate response to at least a 3-month trial of phototherapy (e.g., UVB, PUVA), unless intolerance experienced>=3 months
- Documentation that the member has had an inadequate response, intolerance, or contraindication to at least a 6-month trial of ustekinumab biosimilar at maximum tolerated doses>=6 months

Active psoriatic arthritis (PsA) - Authorization (12 months)

Authorization of 12 months may be granted when ALL criteria below are met:

Active psoriatic arthritis (PsA) requirements

Pediatric (<18) specific requirements
- Documentation that member weighs at least 20 kg if the request is for Otezla OR at least 50 kg if the request is for Otezla XR>=20 kg for Otezla; >=50 kg for Otezla XR
- Documentation that member has had at least a 6-month trial of ustekinumab biosimilar>=6 months
Adult (≥18) specific requirements
- Documentation that member has had an inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab

Behçet's syndrome - Oral ulcers (Authorization 12 months)

Authorization of 12 months may be granted when ALL of the following are met:

Behçet's syndrome - Oral ulcers

Member has oral ulcers associated with Behçet's syndrome
Documentation of inadequate response to at least one nonbiologic medication for Behçet's disease (e.g., colchicine, systemic glucocorticoids, azathioprine)

Continuation therapy criteria

Continuation of therapy

Authorization of 12 months may be granted for continuation when ALL of the following are met:

Documentation member achieves or maintains positive clinical response with Otezla/Otezla XR as evidenced by low disease activity or improvement in signs and symptoms

Excluded indications / investigational uses

Excluded indications

All other indications not listed above are:

Considered experimental/investigational and are not a covered benefit

Applicable codes and quantity limits

Quantity limit by strength/formulationmixedCovered

Otezla 20 mg tablet	Quantity limit: 2 tablets per day
Otezla 30 mg tablet	Quantity limit: 2 tablets per day
Otezla Starter Therapy Pack	Quantity limit: 55 tablets per 28 days
Otezla XR Starter Therapy Pack	Quantity limit: 41 tablets per 28 days
Otezla XR 75 mg tablet	Quantity limit: 1 tablet per day

NDC / Drug identifiersNDC

No codes listed

What providers must do

Prior Authorization

Submit medical record for medical necessity

Submit the member's chart or medical record documenting medical necessity and which approval criteria are met for the applicable indication. Include documentation of affected area(s) and percentage of body surface area (BSA), member weight when pediatric (per product-specific weight thresholds), and details of prior treatment trials and any intolerances or contraindications.

Affected area(s) and percent BSA
Member weight for pediatric requests (Otezla >=20 kg; Otezla XR >=50 kg)
Documentation of prior treatment trials and durations and any intolerances/contraindications

Documentation Required

Specialist prescriber requirement

Otezla or Otezla XR must be prescribed by, or in consultation with, a specialist in dermatology or rheumatology.

Denial Risk

Concomitant therapy exclusion

Claims may be denied or not approved if Otezla or Otezla XR is used concomitantly with injectable biologic response modifiers or certain oral non-biologic agents.

Injectable biologics: TNF-inhibitors and IL-inhibitors (examples listed in policy)
Oral agents: tofacitinib, baricitinib, upadacitinib

Billing Rule

Quantity limits enforcement

Pharmacy claims will be limited to the specified quantity limits per formulation; dispense and billing must adhere to these limits.

Otezla 20 mg tablet — 2 tablets per day
Otezla 30 mg tablet — 2 tablets per day
Otezla XR 75 mg tablet — 1 tablet per day
Otezla Starter Therapy Pack — 55 tablets per 28 days
Otezla XR Starter Therapy Pack — 41 tablets per 28 days

Documentation Required

Trials and intolerances must be documented

Providers must document inadequate response, intolerance, or contraindication to required prior therapies and include the duration of trials as specified by indication (e.g., 3-month or 6-month trials where required).

3-month trials: methotrexate, cyclosporine, acitretin, phototherapy, adalimumab (where specified)
6-month trials: ustekinumab biosimilar (where specified)
Document intolerances, adverse effects, or contraindications when applicable

Clinical evidence and references

Key evidence and guidance references include the Otezla package insert: Otezla [package insert], Amgen Inc.; April 2024, and guideline references cited in the policy such as the Joint AAD‑NPF psoriasis guidelines and GRAPPA psoriatic arthritis treatment recommendations.

Definitions

Crucial body areas: hands, feet, face, neck, scalp, genitals/groin, intertriginous areas.

Revision history

2020-02-01effective

Policy effective

2026-03-01last_reviewLatest

Last reviewed

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOtezla and Otezla XR

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFeb 1, 2020

Next Review Date

SourceLink

On This Page

Contraindications/adverse effects/intolerance must be documented

If member is ≥18 years: documentation of inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab>=3 months

Documentation that member has had an inadequate response, intolerance, or contraindication to at least a 6-month trial of ustekinumab biosimilar at maximum tolerated doses>=6 months

Documentation member has enthesitis