Clinical Pharmacy Program Guidelines for Declomycin-ARIZONA

Program Prior Authorization Medication Declomycin (demeclocycline HCl) tablets Markets in Scope Arizona

1. Background:

Demeclocycline has been shown to be active against a variety of microorganisms.

2. Coverage Criteria:

A. Authorization

1. Declomycin will be approved based on one the following:

a. Diagnosis of one of the following: • Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae • Respiratory tract infections caused by Mycoplasma pneumoniae • due to trachomatis • (Ornithosis) due to due to • Inclusion conjunctivitis caused by Chlamydia trachomatis • Nongonococcal urethritis in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis • due to recurrentis • Chancroid caused by Haemophilus ducreyi • Plague due to Yersinia pestis • Tularemia due to Francisella tularensis • Cholera caused by Vibrio cholerae • Campylobacter fetus infections cause by Campylobacter fetus • Brucellosis due to Brucella species (in conjunction with streptomycin) • Bartonellosis due to Bartonella bacilliformis • Granuloma inguinale caused by Calymmatobacterium granulomatis • Infection due to Escherichia coli • Infection due to Enterobacter aerogenes • Infection due to Shigella species • Infection due to Acinetobacter species • Respiratory tract infections caused by Haemophilus influenza Confidential and Proprietary, © 2018 UnitedHealthcare Services Inc.

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• Respiratory tract and urinary tract infections caused by Klebsiella species • Upper respiratory infections caused by Streptococcus pneumoniae • Skin and skin structure infections caused by Staphylococcus aureus. • Uncomplicated urethritis in men due to Neisseria gonorrhoeae, and for the treatment of other uncomplicated gonococcal infections • Infections in women caused by Neisseria gonorrhoeae • caused by pallidum subspecies pallidum • caused by subspecies pertenue • Listeriosis due to Listeria monocytogenes • Anthrax due to Bacillus anthracis • Vincent’s infection caused by Fusobacterium fusiforme • Actinomycosis caused by Actinomyces israelii • Clostridial diseases caused by Clostridium species • Acute intestinal amebiasis, as adjunctive therapy • Severe acne, as adjunctive therapy

-OR-

b. The drug has been recognized for treatment of the indication by the Infectious Diseases Society of America (IDSA).

Authorization duration based on provider and/or IDSA recommended treatment durations, up to 6 months.

3. References:

1. Demeclocycline Prescribing Information. Amneal Pharmaceuticals LLC, March 2017.

Program Program type – Prior Authorization Change Control Date Change July 2018 New policy specific to Arizona

Confidential and Proprietary, © 2018 UnitedHealthcare Services Inc.

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