SEYSARA (sarecycline)

SEYSARA (sarecycline)

SELF ADMINISTRATION - ORAL

Indication for Prior Authorization:

Treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older

Coverage Criteria:

• Patient is 9 years of age or older; AND
• Diagnosis of acne vulgaris is confirmed by chart note documentation; AND
• Patient has tried and failed generic oral minocycline (capsules or tablets); AND
• Patient has tried and failed generic oral doxycycline capsules; AND
• Dosing is appropriate for current weight; AND
• Will not be used in combination with oral retinoids (e.g. acitretin, isotretinoin, bexarotene) or penicillin.

Dosing:

Recommended dosage of Seysara® is weight based:

• 60 mg once daily for patients who weigh 33-54 kg.
• 100 mg once daily for patients who weigh 55-84 kg.
• 150 mg once daily for patients who weight 85-136 kg.

Coverage Duration:

12 weeks.  The efficacy of Seysara® beyond 12 weeks and safety beyond 12 months have not been established.

Authorization is Not Covered for the Following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Additional Information:

• Seysara® has not been evaluated in the treatment of infections.

Review History:

• 10/2018 – Approved by FDA.
• 09/03/2019 - Annual review.
• 12/30/2020 – Annual review; Format updated.

References:

• Seysara [package insert]. Exton, PA: Almirall, LLC; June 2020.
• Zaenglein AL, Pathy AL, Schlosser BJ, Alikhan A, Baldwin HE, Berson DS, Bowe WP, Graber EM, Harper JC, Kang S, Keri JE. Guidelines of care for the management of acne vulgaris. Journal of the American Academy of Dermatology. 2016 May 1;74(5):945-73.