Pharmacy Prior Authorization Criteria

Isotretinoin

Indications for Prior Authorization

Absorica, Absorica LD

• For diagnosis of Severe recalcitrant nodular acne
  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 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, means “many” as opposed to “few or several” nodules. Because of significant adverse reactions associated with its use, isotretinoin should be reserved for patients with multiple severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, isotretinoin is indicated only for those female patients who are not pregnant, because isotreinoin can cause severe birth defects.

  Limitations of Use:

  A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience with isotretinoin has shown that patients may continue to improve following treatment with isotretinoin. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth.

Criteria

Brand Absorica, Absorica LD

Prior Authorization (Initial Authorization)

Length of Approval: 5 Months [1-4, 10]

• Diagnosis of acne [1, 6-7, D]
AND
• One of the following:
• Prescribed by a dermatologist
OR
• Trial and failure, contraindication, or intolerance to an adequate trial (at least 6 weeks) on both of the following conventional therapy regimens:
• One topical retinoid or retinoid-like agent [e.g., Retin-A/Retin-A Micro (tretinoin)] [2,4]
AND
• Combination therapy with benzoyl peroxide and one of the following: [2-5]
• Oral antibiotic [e.g., Ery-Tab (erythromycin), Minocin (minocycline)] [1, 4, A]
OR
• If oral antibiotics are not indicated, a topical antibiotic [e.g., Cleocin-T (clindamycin), erythromycin, BenzaClin (benzoyl peroxide/clindamycin), Benzamycin (benzoyl peroxide/erythromycin)] [2-4]

Brand Absorica, Absorica LD

Authorization will be given only by clinical pharmacist review for up to 5 months.

Prior Authorization (Reauthorization)

Length of Approval: 5 Month(s)
For diagnosis of Persistent or Recurring Acne After 2 Months Off Therapy

• After more than 2 months off therapy, persistent or recurring acne is still present [1, 6-7, B, D]

Brand Absorica, Absorica LD

Authorization will be given only by clinical pharmacist review for 1 month to allow for titration up to target dose within a treatment cycle (20 weeks). *See background section for dosing regimens

Prior Authorization (Reauthorization)

Length of Approval: 1 Month(s)
For diagnosis of Dose Titration

• Confirmation that the cumulative dose is less than 150 mg/kg (there is little therapeutic benefit to be gained by increasing the cumulative dose beyond 150 mg/kg) [1, 6, C]*

P & T Revisions

2024-08-19, 2024-01-02, 2023-02-21, 2023-02-17, 2022-01-27, 2021-09-28, 2021-06-01, 2021-05-19, 2021-03-04, 2021-02-03, 2020-02-03

References

1. Absorica/Absorica LD Prescribing Information. Sun Pharmaceutical Industries, Inc. Cranbury, NJ. June 2023.
2. Haider A, Shaw JC. Treatment of acne vulgaris. JAMA. 2004;292(6):726-735.
3. Gollnick H, Cunliffe W, Berson D, et al. Management of Acne: A report from a global alliance to improve outcomes in acne. J Am Acad Dermatol. 2003;49(suppl 1):S1-38.
4. Goldsmith LA, Bolognia JL, Callen JP, et al. American Academy of Dermatology concensus conference on the safe and optimal use of isotretinoin: Summary and recommendations. J Am Acad Dermatol. 2004;50:900-6.
5. Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003;49(3):S200-S210.
6. American Academy of Dermatology. Clinical Guidelines of Care for Acne Vulgaris Management. Available at: http://www.aad.org/education/clinical-guidelines. Accessed January 2, 2024.
7. Micromedex Healthcare Series [database on the Internet]. Greenwood Village (CO): Thomson Reuters (Healthcare) Inc.; Updated periodically. Available by subscription at: http://www.thomsonhc.com/. Accessed January 2, 2024.

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End Notes

1. Isotretinoin use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines. Concomitant treatment with tetracyclines should therefore be avoided. [1]
2. Experience has shown that patients may continue to improve while off isotretinoin therapy. After a period of 2 months or more 'off therapy', and if warranted by persistent or recurring severe nodular acne, a second course of therapy of isotretinoin may be initiated. [1]
3. According to the AAD, acne experts feel strongly that initial flaring can be decreased with a beginning dose of 0.5 mg/kg/day or less. Lower doses can be used for longer periods of time with a total cumulative dose of 120 to 150 mg/kg. [9]
4. Isotretinoin has been effective in treating mild-to-moderate acne vulgaris in a double-blind, placebo-controlled study (n=127), for acne in a study of 156 patients, and for mild-to-moderate acne vulgaris in a double-blind study (n=268) [11]. Additionally, the American Academy of Dermatology recommends isotretinoin for the treatment of severe nodular acne, and states that it may be appropriate for the treatment of moderate acne that is treatment-resistant or for the management of acne that is producing physical scarring and/or psychosocial distress [9].

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Revision History

• 2024-08-19: Updated authorization note in dose titration reauth section as requested by PA team.
• 2024-01-02: Annual review. Updated references.
• 2023-02-21: Removed Accutane, Amnesteem, Claravis, Myorisan and Zenatane as targets from guideline. Updated references.
• 2023-02-17: Removed generic isotretinoin products as targets from guideline. Updated references.
• 2022-01-27: Annual review - updated references.
• 2021-09-28: Added generics for absorica to guideline. No changes to criteria.
• 2021-06-01: Added generics for absorica to guideline. No changes to criteria.
• 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
• 2021-03-04: Added new Accutane products. Updated background and references.
• 2021-02-03: Annual review - updated references.
• 2020-02-03: Added new formulation Absorica LD. Updated background and references.

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