Isotretinoin Products

POLICY NUMBER

L.5.01.443

AbsoricaAbsorica LDAmnesteemClaravisZenatane

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

Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne in patients 12 years of age and older. Nodules are inflammatory lesions with a diameter of 5mm or more. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, means “many” as opposed to “few or several” nodules.

Isotretinoin dosage is adjusted and individualized according to side effects and disease response. Recommended course of therapy: initial dose 0.5 to 1 mg/kg/day (range is 0.5 to 2 mg/kg/day) divided into 2 doses with food, for 15 to 20 weeks. Failure to take isotretinoin with food will significantly decrease absorption. After a period of >2 months off therapy, and if warranted by persistent or recurring severe nodular acne, a second course of therapy may be initiated.

Isotretinoin must not be used by patients who are or may become pregnant. There is an extremely high risk that life threatening birth defects will result if pregnancy occurs while taking isotretinoin in any amount, even for short periods of time. Because of this, isotretinoin is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration called iPLEDGE. Prescribers and dispensing pharmacies must be enrolled and activated with iPLEDGE. Patients must also be enrolled and meet all requirements of iPLEDGE.

POLICY

Prior authorization is required.

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.

Absorica and Absorica LD are currently not covered on any BCBSMS formulary. 

Initial Evaluation

Isotretinoin may be considered medically necessary when ALL of the following criteria are met:

1. The individual is 12 years of age or older;

2. ONE of the following:

   1. The individual has a documented diagnosis of severe acne (nodular acne, scarring, etc.) with documented history of failure following at least 60 consecutive days within the past year of ALL of the following in combination:

      1. Oral antibiotics (e.g. azithromycin, doxycycline, erythromycin, minocycline, trimethoprim/sulfamethoxazole);

      2. One topical retinoid or retinoid-like medication; AND

      3. One topical non-retinoid medication (e.g. benzoyl peroxide, clindamycin, erythromycin, sulfacetamide); OR

   2. The individual has a documented diagnosis of a severe acne vulgaris variant (e.g., acne fulminans, acne conglobata);

3. The individual does not have any contraindication(s) to therapy with the requested agent; AND

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

Length of Approval: Not to exceed a total cumulative dose of 150mg/kg [Max: 6 months]

Second Course Evaluation

A SECOND COURSE of isotretinoin therapy may be approved when ALL of the following criteria are met:

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

2. The individual has documented persistent or recurring severe recalcitrant nodular acne after ≥2 months off isotretinoin therapy;

3. The individual does not have any contraindication(s) to therapy with the requested agent; AND

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

Length of Approval: Not to exceed a total cumulative dose of 150mg/kg [Max: 6 months] 

BCBSMS will approve a maximum of two courses (up to 12 total months) of isotretinoin therapy.

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:

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

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

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

D. 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.

Medication Failure

Medication failure is defined as disease progression at generally accepted doses (for >60 consecutive days) of combination therapy with an oral antibiotic, topical retinoid(s), and topical non-retinoid(s). 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

09/01/2013: New policy added.

11/18/2013: Policy statement updated to clarify the history of failure following adequate trial: "6 weeks" was changed to "60 days." Also, the statement "on two oral antibiotics" was changed to "on oral antibiotics."

06/25/2014: Policy statement on Initial Therapy revised with the following changes: 1) Removed "In cases when oral antibiotics are not indicated and patient has documented failure of an adequate trial (> 6 weeks) of benzoyl peroxide and topical antibiotic" from the criteria. 2) Added "Confirmed diagnosis of severe cystic acne."

08/31/2015: Medical policy revised to add ICD-10 codes.

05/27/2016: Policy number L.5.01.443 added. Investigative definition updated in Policy Guidelines section.

08/24/2016: Policy statement criteria for initial therapy updated for clarity purposes: "Confirmed diagnosis of severe cystic acne" changed to "Confirmed diagnosis of acne vulgaris variants, acne fulminans and acne conglobata."

11/01/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.

09/01/2017: Policy updated to add Zenatane and Myorisan to the list of products.

11/14/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

07/01/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy section updated to state that Absorica® is currently not covered on any BCBSMS formularies. Policy statement for initial therapy updated for clarity: 1) approval criteria updated to add "documented history" for history of failure following adequate trial and for the use of topical therapy. 2) for history of failure following adequate trial, "60 days" changed to "60 consecutive days within the past year." Sources updated.

11/01/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. For initial therapy, policy statement regarding documented use of topical therapy updated to add "for 60 consecutive days within the past year." Sources updated.

04/13/2020: Policy section updated to add that Absorica LD is currently not covered on any BCBSMS formularies. Policy statement criteria for initial therapy revised for clarity. Approval criteria for continuation of therapy revised to add the following statements: 1) The total daily dose is 10mg/kg/day or less AND 2) Member has continued to and will continue to utilize topical retinoid and/or non-retinoid therapy throughout isotretinoin therapy.

05/04/2020: Made the following correction for continuation of therapy: "10mg/kg/day" should be "1mg/kg/day."

05/18/2020: Medically necessary statement updated regarding examples of oral antibiotics and non-retinoid topical therapy. Added medically necessary criteria that the total daily dose is 1mg/kg/day or less. Policy statement criteria for continuation of therapy updated to remove the following statement: Member has continued to and will continue to utilize topical retinoid and/or non-retinoid therapy throughout isotretinoin therapy.

07/13/2021: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added statement to 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. Policy section updated to add that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Medically necessary criteria for initial evaluation revised regarding member age requirement, contraindications, dosage information, and length of approval. Added approval criteria for second course evaluation. Policy Exceptions updated. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Removed investigative definition. Added information regarding BCBSMS request for medical records and defined medication failure. Sources updated. Code Reference section updated to change "Covered Codes" to "Medically Necessary Codes."

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.

06/03/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy updated to remove Myorisan. Policy description updated regarding Isotretinoin and pregnancy. Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Medically necessary criteria updated regarding oral antibiotics and dose requirements. Removed criteria that the prescriber is an ABMS/AOA board certified dermatologist. Second course evaluation criteria updated regarding dose requirement. Length of approval updated for initial and second course evaluation. Sources updated.

SOURCE(S)

1. Absorica prescribing information. Sun Pharmaceutical Industries, Inc. June 2023. Last accessed March 2025.

2. Amnesteem prescribing information. Mylan Pharmaceuticals Inc. August 2022. Last accessed March 2025.

3. Claravis prescribing information. Teva Pharmaceuticals USA, Inc. August 2022. Last accessed March 2025.

4. Reynolds, Rachel V. et al. Guidelines of care for the management of acne vulgaris. Journal of the American Academy of Dermatology, Volume 90, Issue 5, 1006.e1 - 1006.e30.

5. Zenatane prescribing information. Dr. Reddy's Laboratories Limited. February 2025. Last accessed March 2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

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