Under some plans, including plans that use an open or closed formulary, Accutane, Amnesteem, Claravis, isotretinoin, Minocin Pac Kit, Solodyn and Sotret are subject to precertification.  If precertification requirements apply Aetna considers Accutane, Amnesteem, Claravis, isotretinoin, Minocin Pac Kit, Solodyn and Sotret to be medically necessary for those members who meet of the following precertification criteria:

A. Diagnosis of severe recalcitrant nodular or cystic acne

AND

B. One of the following:

1. Member already has evidence of scarring OR
2. Contraindication to either systemic antibiotic, minocycline or doxycycline OR
3. Intolerance to either systemic antibiotic, minocycline or doxycycline OR
4. Failure of an adequate trial of one month of either systemic antibiotic, minocycline or doxycycline.

AND

C.  If female, in accordance with FDA iPLEDGE program that requires completing an informed consent form, obtaining counseling about the risks and requirements for safe use of isotretinoin, and, for women of childbearing potential (non-hysterctomized), complying with required pregnancy testing and use of contraception, patient is not pregnant (report of negative pregnancy test obtained) and has been counseled about the use of reliable contraception 1 month before, during, and 1 month after isotretinoin therapy.

For Minocin Pac Kit and Solodyn

Under some plans, including plans that use an open or closed formulary, Minocin Pac Kit and Solodyn are subject to precertification for members less than or equal to 8 years of age.  Aetna considers Minocin Pac Kit and Solodyn to be medically necessary for those members who meet the following precertification criteria:

 A. Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for medical use of Solodyn in patients younger than 12 years old for acne or in pediatric patients younger than or equal to 8 years old OR the medical use of Minocin Pac Kit in pediatric patients younger than or equal to 8 years of old.

Accutane, Minocin Pac Kit, Solodyn and Sotret 30mg are currently Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan.* Therefore, they are excluded from coverage for members enrolled in prescription drug benefits plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Accutane, Minocin Pac Kit, Solodyn and Sotret 30mg to be medically necessary for those members who meet the following criteria:

For Accutane and Sotret 30mg

A. A documented:

• Contraindication to one preferred generic alternative agent indicated for the member's condition OR
• Intolerance to one preferred generic alternative agent indicated for the member's condition OR
• Allergy to one preferred generic alternative agent indicated for the member's condition OR
• Failure of an adequate trial of one month of one preferred generic alternative agent indicated for the member's condition
   

For Minocin Pac Kit and Solodyn

A.   A documented:

• Contraindication to one preferred generic minocycline product indicated for the member's condition OR
• Intolerance to one preferred generic minocycline product indicated for the member's condition OR
• Allergy to one preferred generic minocycline product indicated for the member's condition OR
• Failure of an adequate trial of one month of one preferred generic minocycline product indicated for the member's condition
   
   

Special Notes:

Solodyn is an extended release, once-daily minocycline tablet that is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years  of age or older.  The safety of Solodyn has not been established beyond 12 weeks of use.   Solodyn has not been evaluated in the treatment of infections.  The use of drugs in the  tetracycline class, the class Solodyn belongs too, may cause permanent teeth discoloration  (yellow-gray-brown) during tooth development (last half of pregnancy, infancy and childhood up to  the age of 8 years).