ORACEA (doxycycline delayed-release capsule)

ORACEA (doxycycline delayed-release capsule)

SELF ADMINISTRATION-ORAL

Indication for Prior Authorization:

• Treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients. No meaningful effect was demonstrated for generalized erythema (redness) of rosacea
• Limitations of Use:
  • This formulation of doxycycline has not been evaluated in the treatment or prevention of infections. Oracea should not be used for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease
  • To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, Oracea should be used only as indicated
  • Efficacy of Oracea beyond 16 weeks and safety beyond 9 months have not been established
  • Oracea has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea

Coverage Criteria:

• Patient is 18 years of age or older, AND
• Patient has a diagnosis of pustular/papular rosacea confirmed by medical record documentation, AND
• Patient has tried and failed a preferred topical agent (e.g., metronidazole gel)

Dosing:

• Recommended dose: 40 mg (1 capsule) once daily
• Efficacy of Oracea beyond 16 weeks and safety beyond 9 months have not been established

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

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:

• Teratogenic Effect: Oracea should not be used during pregnancy (Pregnancy Category D)
• Breastfeeding: Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in infants from doxycycline, Oracea should not be used in mothers who breastfeed
• Pseudomembranous Colitis: Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including doxycycline, and may range in severity from mild to fatal colitis
• Metabolic Effects: If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable
• Additional warnings for photosensitivity, autoimmune syndromes, tissue hyperpigmentation, pseudotumor cerebri, development of drug resistant bacteria, and superinfection

Review History:

• 1/4/21- Annual review, format updated
• 7/5/18- Annual review

References: 

• Oracea [package insert]. Fort Worth (TX): Galderma Laboratories, L.P.; 2017.