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L.5.01.502
Impavido (miltefosine)
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.
Leishmaniasis is a disease caused by Leishmania parasites and is transmitted to humans through the bites of infected sand flies. The disease occurs primarily in tropical and subtropical climates. Most cases diagnosed in the United States occur in people who were infected while traveling or living in other countries.
Impavido (miltefosine) is an antileishmanial drug indicated in adults and pediatric patients ≥12 years of age and weighing ≥30kg for the treatment of the following:
Visceral leishmaniasis due to Leishmania donovani;
Cutaneous leishmaniasisLeishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis;
Mucosal leishmaniasis due to Leishmania braziliensis.
Prior authorization is required.
The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.
Impavido (miltefosine) may be considered medically necessary when ALL of the following criteria are met:
BOTH of the following:
The individual is 12 years of age or older; AND
The individual weighs ≥30kg;
The individual has a documented diagnosis of leishmaniasis due to Leishmania donovani, Leishmania braziliensis, Leishmania guyanensis, or Leishmania panamensis;
The individual does not have any contraindication(s) to therapy with the requested agent;
If female of reproductive potential, BOTH of the following:
The provider has obtained a negative pregnancy test; AND
The provider has advised to use effective contraception during therapy and for 5 months after therapy; AND
The prescribed dosage is within the FDA approved labeled dosage.
Length of Approval: 28 days
Weight | Dosage and Administration |
30kg to 44kg | One 50mg capsule twice daily with food (breakfast and dinner) |
45kg or greater | One 50mg capsule three times daily with food (breakfast, lunch, and dinner) |
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.
09/21/2016: New policy added. Policy number L.5.01.502.
11/01/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.
08/15/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.
11/01/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description and policy statement updated to include advising men of reproductive potential to use effective contraception during therapy and for 5 months after Impavido therapy. Policy section updated to state that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Sources section updated.
07/31/2020: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added drug name to the top of the policy. Added statement to perform a formulary drug search on the 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. Policy description updated. Policy section updated to add weight, dosage, and administration criteria. Length of approval is 28 days. Sources updated.
07/13/2021: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding Impavido (miltefosine) indications. Policy section updated to revise medically necessary criteria. Policy Exceptions updated. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Added information regarding BCBSMS request for medical records. 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.
10/01/2024: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description revised to list indications for Impavido (miltefosine). Policy language updated to change "member" to "individual." Sources updated.
09/09/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding Leishmaniasis and indications for Impavido (miltefosine). 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. Medically necessary statement regarding females of reproductive potential revised to list criteria. Sources updated.
Aronson N, Herwaldt BL, Libman M, et al. Diagnosis and Treatment of Leishmaniasis: Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA) and the American Society of Tropical Medicine and Hygiene (ASTMH). Am J Trop Med Hyg. 2017 Jan 11;96(1):24-45. doi: 10.4269/ajtmh.16-84256. Epub 2016 Dec 7. PMID: 27927991; PMCID: PMC5239701.
CDC Clinical Overview of Leishmaniasis. March 13, 2024. Last accessed June 2025. https://www.cdc.gov/leishmaniasis/hcp/clinical-overview/index.html
Impavido prescribing information. Profounda Inc. April 2025. Last accessed June 2025.
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