Atopic Dermatitis

POLICY NUMBER

L.5.01.522

Adbry (tralokinumab-ldm) injection

Cibinqo (abrocitinib) tablet

Eucrisa (crisaborole) ointment 2%

Opzelura (ruxolitinib) cream 1.5%

Rinvoq (upadacitinib)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Atopic dermatitis is a chronic, pruritic, inflammatory skin disease. Symptoms include pruritus, skin dryness, erythema, oozing and crusting, and lichenification. There are three classifications of atopic dermatitis:

• Mild – Areas of dry skin, infrequent itching (with or without small areas of redness); little impact on everyday activities, sleep, and psychosocial well-being

• Moderate – Areas of dry skin, frequent itching, redness (with or without excoriation and localized skin thickening); moderate impact on everyday activities and psychosocial well-being, frequently disturbed sleep

• Severe – Widespread areas of dry skin, incessant itching, redness (with or without excoriation, extensive skin thickening, bleeding, oozing, cracking, and alteration of pigmentation); severe limitation of everyday activities and psychosocial functioning, nightly loss of sleep.

The goals of treatment are to reduce symptoms, specifically pruritus, and prevent exacerbations. Standard treatment approaches center on the use of topical anti-inflammatories, including topical corticosteroids and topical calcineurin inhibitors, and skin moisturizers primarily, although patients with severe disease may require phototherapy or systemic treatment.

Quantity Limits

 Related policies -

• Dupixent (dupilumab)

POLICY

Prior authorization is required.

The use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review.

Initial Criteria

The requested agent may be considered medically necessary when ALL of the following criteria are met:

1. ONE of the following

   1. The individual is 3 months of age or older and the request is for Eucrisa (crisaborole);

   2. The individual is 12 years of age or older and the request is for Rinvoq (upadacitinib); OR

   3. The individual is 18 years of age or older and the request is for Adbry (tralokinumab-ldrm);

2. ONE of the following:

   1. The individual has a documented diagnosis of mild to moderate atopic dermatitis and the request is for Eucrisa (crisaborole);

   2. The individual has a documented diagnosis of moderate to severe atopic dermatitis and the request is for Rinvoq (upadacitinib) or Adbry (tralokinumab-ldrm);

3. Request is for Eucrisa and ONE of the following:

   1. The individual has tried and failed (see definition of Failure in Policy Guidelines section) at least a mid-potency topical steroid AND a topical calcineurin inhibitor (e.g., pimecrolimus, tacrolimus) for maintenance therapy (At least one must be within the last 180 days; the other may be in the last 999 days); OR

   2. The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL mid-potency topical steroids and ALL topical calcineurin inhibitors;

4. The request is for Rinvoq (upadacitinib) or Adbry (tralokinumab-ldrm) and ALL of the following:

   1. ONE of the following:

      1. The individual has at least 10% body surface area involvement; OR

      2. The individual has involvement of the palms and/or soles of the feet;

   2. ONE of the following:

      1. The individual has tried and failed (see definition of Failure in Policy Guidelines section) a systemic immunosuppressant for atopic dermatitis within the last 180 days (e.g., methotrexate, azathioprine, CellCept, cyclosporine);

      2. The individual has tried and failed (see definition of Failure in Policy Guidelines section) at least a mid-potency topical steroid for a minimum of 4 weeks AND a topical calcineurin inhibitor (e.g., pimecrolimus, tacrolimus) for maintenance therapy for a minimum of 6 weeks (At least one must be within the last 180 days; the other may be in the last 999 days); 

      3. The member’s medication history documents prior use of another biologic immunomodulator agent for treatment of AD; OR

      4. The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to all systemic immunosuppressants and topical agents for treatment of AD;

   3. The prescriber is a specialist or has consulted with a specialist in an area of the individual's diagnosis (e.g., dermatologist); OR

   4. The individual is not currently being treated with another biologic immunomodulatory agent (i.e., TNF-inhibitor, IL-inhibitor, anti IgE antibody, etc.) or Otezla;

5. BOTH of the following:

   1. The prescriber has documented the individual's current pruritus and other symptom severity (e.g., erythema, edema, xerosis, erosions/excoriations, oozing and crusting, and/or lichenification; OR

   2. The individual will continue with topical emollients as a component of maintenance treatment to aid in the prevention of flares;

6. The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent; AND

7. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

Length of Approval: Eucrisa (crisaborole): 6 months                                Rinvoq (upadacitinib): 12 months                                Adbry (tralokinumab-ldrm): 12 months

Renewal Criteria

The requested agent may be approved for RENEWAL when ALL of the following criteria are met:

1. The individual has been previously approved for therapy with the requested agent through the BCBSMS PA process;

2. The individual has documented clinical improvement (i.e., reduction or stabilization from baseline in at least one of the following: affected body surface area, flares, pruritus, erythema, edema, xerosis, erosions/excoriations, oozing and crusting, and/or lichenification);

3. The request is for Rinvoq (upadacitinib) and BOTH of the following:

   1. The prescriber is a specialist or has consulted with a specialist in an area of the individual's diagnosis (e.g., dermatologist); OR

   2. The individual is not currently being treated with another biologic immunomodulatory agent (i.e., TNF-inhibitor, IL-inhibitor, anti IgE antibody, etc.) or Otezla;

4. The individual will continue with topical emollients as a component of maintenance treatment to aid in the prevention of flares;

5. The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent; AND

6. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

Length of Approval: 12 months

 Cibinqo (abrocitinib) and Opzelura (ruxolitinib) cream are considered not medically necessary as there are other options covered by the Plan for the treatment of atopic dermatitis.

POLICY EXCEPTIONS

State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

1. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

2. appropriate with regard to standards of good medical practice; and

3. not solely for the convenience of the Member, his or her Provider; and

4. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary. BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Medication Failure

Medication failure is defined as disease progression at generally accepted doses (for >3 months use) as appropriate for the disease state being treated. Dosages below the recommended dose for the specific condition being treated and/or experience of common side effects of medication will not be considered medication failure or lack of response for the purpose of this review.

BCBSMS determines patient medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If member is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the member and/or requesting provider to obtain said records and to submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.

POLICY HISTORY

02/05/2019: New policy added. Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Effective 01/01/2019.

11/01/2020: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added statement to perform a formulary drug search on the patient's member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member's benefit plan. Policy description updated regarding drug quantity limits. Medically necessary policy statement updated to change age requirement from "2 years" to "3 months." Added renewal evaluation criteria. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders." Added information regarding medication failure and BCBSMS request for medical records. Sources updated.

03/11/2022: Policy title changed from "Eucrisa (crisaborole)" to "Atopic Dermatitis." Policy updated to add Rinvoq (upadacitinib). Policy description updated regarding atopic dermatitis and goals of treatment. Added quantity limit for Rinvoq (upadacitinib). Policy section extensively revised to specify initial and renewal criteria for Eucrisa (crisaborole) and Rinvoq (upadacitinib). Policy Guidelines updated regarding BCBSMS request for medical records. Sources updated.

04/14/2022: Policy updated to include Opzelura (ruxolitinib) cream 1.5%. Revised medically necessary criteria for Rinvoq (upadacitinib). Added policy statement that Opzelura (ruxolitinib) cream is considered not medically necessary as there are other options covered by the Plan for the treatment of mild to moderate atopic dermatitis. Sources updated.

11/03/2022: Policy updated to include Adbry (tralokinumab-ldm) and Cibinqo (abrocitinib). Policy description updated to add quantity limit for Adbry (tralokinumab-ldrm) injection. Medically necessary policy statement updated to include indications for Adbry (tralokinumab-ldrm). Revised policy statement to include Cibinqo (abrocitinib) as not medically necessary as there are other options covered by the Plan for the treatment of atopic dermatitis. Sources updated.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

11/11/2024: Policy language updated to change "member" to "individual." Medically necessary policy statement updated to specify criteria for requesting Eucrisa, Rinvoq, and Adbry.

06/03/2025: Policy reviewed by Pharmacy & Therapeutics (P&T) Committee; no changes.

SOURCE(S)

1. Treatment of atopic dermatitis (eczema). UpToDate. Last updated February 2022. www.uptodate.com

2. Eucrisa prescribing information. Pfizer. January 2021. Last accessed September 2021.

3. Rinvoq prescribing information. AbbVie Inc. January 2022. Last accessed February 2022.

4. Opzelura prescribing information. Incyte Corporation. September 2021. Last accessed March 2022.

5. Adbry prescribing information. LEO Pharam Inc. July 2022. Last accessed November 2022.

6. Cibinqo prescribing information. Pfizer Laboratories Div Pfizer Inc. February 2022. Last accessed November 2022.

CODE REFERENCE

None