Subject: Tetracyclines

Status	Drug	PR	PR-QL	PR-AL	ST	M EX‡
P	demeclocycline tab			X
P	doxycycline tab, cap			X
P	minocycline er tab			X
P	minocycline tab, cap			X
P	tetracycline tab, cap			X
NP	Declomycin®  (demeclocycline tab)			X
NP	Doryx®  (doxycycline tab)			X
NP	Dynacin®  (minocycline tab, cap)	X		X
NP	Minocin®  (minocycline tab, cap)	X		X
NP	Monodox®  (doxycycline cap)	X		X
NP	Solodyn™  (minocycoline extended release tablets)			X
NP	Sumycin®  (tetracycline tab, syrup)			X
NP	Vibramycin®  (doxycycline cap/susp)			X
NP	Vibratab®  (doxycycline tab)			X
FE	Adoxa™ Pak  (doxycycline )	X		X		X
FE	Oraxyl®  (doxycyline hyclate cap)			X		X

Policy:

1. Precertification Criteria


Under some plans, including plans that use an open or closed formulary, Adoxa/Pak, Sumycin, Declomycin, Doryx, Vibratab, Monodox, Solodyn, Vibramycin, Minocin, Oraxyl, Dynacin, generic tetracycline, demeclocyline, doxycycline and minocycline are subject to precertification for members less than 8 years of age.   If precertification requirements apply Aetna considers these agents to be medically necessary for those members who meet the following precertification criteria:  

 

(A AND B) For ALL

    

A. Member is less than 8 years of age



          AND



            B. Documented rare infectious diagnosis that requires use of tetracyclines in young children (examples include juvenile periodontitis or Mediterranean spotted fever)


For Adoxa, Dynacin, Minocin and Monodox (C AND D AND E) OR (C AND F AND G)

C.  Member is 8 years of age or greater
AND
D. Documented diagnosis of acne or rosacea
AND
E. A documented:

• Contraindication to the preferred generic alternative doxycycline (for Adoxa, Dynacin or Monodox) OR minocycline (for Minocin only)
• Intolerance to the preferred generic alternative doxycycline (for Adoxa, Dynacin or Monodox) OR minocycline (for Minocin only)
• Allergy to the preferred generic alternative doxycycline (for Adoxa, Dynacin or Monodox) OR minocycline (for Minocin only)
• Failure of an adequate trial of one month of the preferred generic alternative doxycycline (for Adoxa, Dynacin or Monodox) OR minocycline (for Minocin only)
  OR

F. A Documented diagnosis of infection other than acne or rosacea
AND
G. A documented:

• Contraindication to the preferred generic alternative doxycycline (for Adoxa, Dynacin or Monodox) OR minocycline (for Minocin only)
• Intolerance to the preferred generic alternative doxycycline (for Adoxa, Dynacin or Monodox) OR minocycline (for Minocin only)
• Allergy to the preferred generic alternative doxycycline (for Adoxa, Dynacin or Monodox) OR minocycline (for Minocin only)
• Failure of an adequate trial of three days of the preferred generic alternative doxycycline (for Adoxa, Dynacin or Monodox) OR minocycline (for Minocin only)


 

2. Medical Exception Criteria


Adoxa/Pak and Oraxyl are currently included on the Aetna Formulary Exclusions List.* Therefore, Adoxa/Pak and Oraxyl are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted.  Adoxa/Pak and Oraxyl are considered to be medically necessary for those members who meet the criteria specified below:

 

For Members less than 8 years of age 

For All - (A AND B AND C)
           

For Members 8 years of age and older

Oraxyl - C Only
            Adoxa/Pak – (D and E) or (F and G) 

 

A.  Member is less than 8 years of age


          AND


B.  Documented rare infectious diagnosis that requires use of tetracyclines in young children (examples include juvenile periodontitis or Mediterranean spotted fever)


AND


C.   A documented:

• Contraindication to the preferred alternative generic doxycycline OR,
• Intolerance to the preferred alternative generic doxycycline OR,
• Allergy to the preferred alternative generic doxycycline OR,
• Failure of an adequate trial of three days of the preferred alternative generic doxycycline.

OR

D. Documented diagnosis of acne or rosacea
AND
E. A documented:

• Contraindication to the preferred generic alternative doxycycline (for Adoxa, Dynacin or Monodox) OR minocycline (for Minocin only)
• Intolerance to the preferred generic alternative doxycycline (for Adoxa, Dynacin or Monodox) OR minocycline (for Minocin only)
• Allergy to the preferred generic alternative doxycycline (for Adoxa, Dynacin or Monodox) OR minocycline (for Minocin only)
• Failure of an adequate trial of one month of the preferred generic alternative doxycycline (for Adoxa, Dynacin or Monodox) OR minocycline (for Minocin only)
  OR 

F. A Documented diagnosis of infection other than acne or rosacea
AND
G. A documented:

• Contraindication to the preferred generic alternative doxycycline (for Adoxa, Dynacin or Monodox) OR minocycline (for Minocin only)
• Intolerance to the preferred generic alternative doxycycline (for Adoxa, Dynacin or Monodox) OR minocycline (for Minocin only)
• Allergy to the preferred generic alternative doxycycline (for Adoxa, Dynacin or Monodox) OR minocycline (for Minocin only)
• Failure of an adequate trial of three days of the preferred generic alternative doxycycline (for Adoxa, Dynacin or Monodox) OR minocycline (for Minocin only)
   

Place of Service:

Outpatient

The above policy is based on the following references:

1. DrugPoints® System ( www.statref.com) Thomson Micromedex, Greenwood Village, CO. Updated periodically.
2. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
3. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
4. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
5. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.Sandford, Jay P., Gilbert, David N., Moellering, R.C. Sande, M.A.: Sandford Guide to Antimicrobial Therapy, 31st edition, Copyright 2004, Antimicrobial Therapy Inc. Hyde Park, Vt.
6. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically. 
7. Sandford, JP, Gilbert, DN, Moellering, RC, Sande, MA: Sanford Guide to Antimicrobial Therapy, 39th  edition, 2009
8. CDC Division of Vector Borne Infectious Disease: Lyme Disease found at http://www.cdc.gov/ncidod/dvbid/lyme/qa.htm#treated

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

August 06, 2010