CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Oral Isotretinoin Prior Authorization

Defines prior authorization requirements for oral isotretinoin products (brand and generic) for members of Neighborhood Health Plan of Rhode Island; applies to indications including severe nodular acne, refractory acne, severe refractory rosacea, and listed compendial uses.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOral Isotretinoin Prior Authorization

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateAug 1, 2021

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis, prior topical and oral antibiotic trial, patient age, and planned treatment duration with required intervals between courses.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

40wmaximum total treatment duration

>=8wminimum interval between courses

12+minimum age (Absorica)

5 mmnodule diameter

Multiplenamed products listed

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Coverage Criteria

Coverage criteria

Covered when EITHER of the following sets of conditions are met:

Primary acne/rosacea indications: Patient has diagnosis of severe recalcitrant nodular acne vulgaris OR refractory acne vulgaris OR severe refractory rosacea AND patient has tried and had an inadequate treatment response to any topical acne product AND an oral antibiotic AND treatment will be limited to 40 weeks (2 courses) or less with at least 8 weeks between each coursetreatment duration <=40 weeks; interval between courses >=8 weeks

Applies to primary indication approvals

Compendial/other indications: Patient has one of the following diagnoses: neuroblastoma; cutaneous T-cell lymphoma (CTCL) (e.g., mycosis fungoides, Sézary syndrome); high risk for developing skin cancer (squamous cell cancers); transient acantholytic dermatosis (Grover's disease); keratosis follicularis (Darier disease); lamellar ichthyosis; pityriasis rubra pilarisnone

Listed compendial uses that may qualify for coverage

Female patients who are pregnant are excluded from isotretinoin therapy due to its teratogenicity; isotretinoin is indicated only for female patients who are not pregnant. Because of significant adverse effects associated with isotretinoin, it is reserved for patients unresponsive to conventional therapy, including systemic antibiotics.

Use of isotretinoin for diagnoses not listed in the allowable primary indications (severe recalcitrant nodular acne vulgaris, refractory acne vulgaris, severe refractory rosacea) or the listed compendial uses is not supported by this policy.

Named Products, Limits, and Key Values

Named isotretinoin productsmixed

Absorica	isotretinoin (brand)
Absorica LD	isotretinoin (brand)
Accutane	isotretinoin (brand)
Amnesteem	isotretinoin (brand)
Claravis	isotretinoin (brand)
Myorisan	isotretinoin (brand)
Zenatane	isotretinoin (brand)

inv-05: Minimum interval between courses — retreatment waiting period

Minimum retreatment waiting period>= 8 weeks between completion of one course and initiation of a subsequent course

RationaleImprovement may continue after stopping isotretinoin; second course should not be started until at least 8 weeks after completion of the first course

ApplicabilityApplies when a second course is considered for patients who previously completed a course of isotretinoin

inv-06: Maximum total treatment duration — up to 2 courses / 40 weeks

Maximum total treatment duration40 weeks (up to 2 courses)

Course limitTreatment limited to two courses total when seeking coverage under primary indications

Provider Actions and Authorization Requirements

Prior Authorization

Prior authorization required; approval conditions

Prior authorization is required for all oral isotretinoin products; approval is granted when the patient has an eligible diagnosis (severe recalcitrant nodular acne, refractory acne, or severe refractory rosacea) and the required prior therapy trials or an accepted compendial diagnosis are documented. Treatment must be limited to 40 weeks (up to 2 courses) with at least an 8‑week interval between courses.

Step Therapy

Required prior therapies: topical plus oral antibiotic

Before isotretinoin will be approved for primary acne/rosacea indications, the patient must have tried and had an inadequate response to any topical acne product AND an oral antibiotic.

Documentation Required

Background

Isotretinoin is an oral retinoid indicated for the treatment of severe recalcitrant nodular acne and selected other serious dermatologic conditions. It is typically reserved for patients who have failed conventional therapy, including systemic antibiotics, because of its significant adverse effects and teratogenic risk. A single course of therapy (approximately 15–20 weeks) often produces prolonged remission; if retreatment is required, a second course should be delayed at least 8 weeks after completion of the first course.

Definitions

inv-12: Definition of nodular acne — inflammatory lesions >= 5 mm and 'severe' implies many nodules

Nodule size defining nodular acneInflammatory lesions with diameter ≥ 5 mm

'Severe' nodular acne meaning'Severe' denotes many nodules (as opposed to few or several)

Lesion characteristicsNodules may become suppurative or hemorrhagic

Age/indication noteAbsorica indicated for non-pregnant patients 12 years and older with multiple inflammatory nodules ≥5 mm