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L.5.01.460
Oracea (doxycyclinedelayed-release)
Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
Oracea (doxycycline) capsules are filled with both immediate-release and delayed-release beads that together provide a dose of 40mg anhydrous doxycycline. Oracea (doxycycline) is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. No meaningful effect was demonstrated for generalized erythema (redness) of rosacea. Oracea (doxycycline) has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea or in the treatment or prevention of infections.
Prior authorization is required.
The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.
Initial Evaluation
Oracea (doxycycline, biphasic release) may be considered medically necessary when ALL of the following criteria are met:
The individual is 18 years of age or older;
The individual has a documented diagnosis of rosacea;
The individual is not currently being treated with another oral antibiotic for the treatment of rosacea orthe individual is currently being treated with another oral antibiotic for the treatment of rosacea and the antibiotic will be discontinued before starting the requested agent;
ONE of the following:
The individual has failed (see definition of Failure in the Policy Guidelines section) a prescription topical rosacea treatment (e.g. azelaic acid, metronidazole, sodium sulfacetamide and sulfur); OR
The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL prescription topical rosacea treatments;
ONE of the following:
The individual has failed (see definition of Failure in the Policy Guidelines section) immediate-release doxycycline; OR
The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL immediate-release doxycycline formulations; AND
The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.
Length of Approval: 6 months
State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
Medication Failure
Medication failure is defined as disease progression at generally accepted doses (for >3 months use) as appropriate for the disease state being treated. Dosages below the recommended dose for the specific condition being treated and/or experience of common side effects of medication will not be considered medication failure or lack of response for the purpose of this review.
BCBSMS determines patient medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If member is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the member and/or requesting provider to obtain said records and to submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.
01/01/2014: New policy added.
08/03/2015: Code Reference section updated for ICD-10.
10/26/2015: Policy section updated to state: Previous use of samples or vouchers/coupons will not be considered for authorization.
05/31/2016: Policy number L.5.01.460 added. Investigative definition updated in Policy Guidelines section.
11/01/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.
11/14/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.
11/01/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy updated to add generic drug name. Policy section updated to add that prior authorization is required. The use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Sources updated.
10/01/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy section updated to change patient age requirement from "8 years" to "18 years." Added length of approval of up to 9 months. Sources updated.
05/01/2021: Medically necessary policy statement criteria revised. Added statement that Oracea (doxycycline DR) for longer than 4 months is not recommended and will not be approved for continuation. Policy Exceptions updated. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders," to add information regarding BCBSMS request for medical records, and to define medication failure. Sources updated.
02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
06/03/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy title changed from "Oracea (doxycycline DR)" to "Oracea (doxycycline, biphasic release)." Policy description updated regarding Oracea (doxycycline) capsules. Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Policy statement criteria updated to change "patient" to "individual" and "preferred oral doxycycline" to "immediate-release doxycycline." Length of approval updated. Removed renewal evaluation policy statement. Sources updated.
Oracea prescribing information. Galderma Laboratories, L.P. September 2022. Last accessed March 2025.
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