Impavido (miltefosine) prior authorization
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Prior authorization guideline for Impavido (miltefosine) covering approval criteria and duration for treatment of leishmaniasis for CareOregon members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Impavido (miltefosine)
Initial therapy — Covered when ALL of the following are met
Covered when ALL of the following are met
Impavido approval criteria
- 2) The request is from or in consultation with an Infectious Disease specialist
- 3) The member has tried and failed IV amphotericin B or Ambisome
Requests that do not meet the approval criteria should be considered non-covered. Specifically, therapy with Impavido (miltefosine) is intended only for treatment of visceral, cutaneous, or mucosal leishmaniasis; requests for other diagnoses do not satisfy the coverage criteria and may be denied.
Impavido will not be approved for indications outside of visceral, cutaneous, or mucosal leishmaniasis. Additionally, requests that are not submitted by or in consultation with an Infectious Disease specialist, or that lack documentation of prior trial and failure of IV amphotericin B or Ambisome, do not meet medical necessity and are not covered.
Provider Requirements and Authorization Rules
Prior authorization required; approve up to 28 days
Prior authorization must be obtained for Impavido (miltefosine). When approved, authorization should be for a maximum duration of 28 days.
Prior therapy required: IV amphotericin B or Ambisome failure
Member must have trialed and failed intravenous amphotericin B or Ambisome prior to approval of Impavido.
Document diagnosis and specialist consultation
Include documentation that confirms the diagnosis is visceral, cutaneous, and/or mucosal leishmaniasis and that the request is from or in consultation with an Infectious Disease specialist.
Denial risk if approval criteria are not met
Requests that do not meet the approval criteria are subject to denial.
- Examples include requests for indications other than visceral, cutaneous, or mucosal leishmaniasis.
- Requests not from or in consultation with an Infectious Disease specialist.
- Requests without evidence of trial and failure of IV amphotericin B or Ambisome.
Background
Leishmaniasis can present as visceral, cutaneous, or mucosal disease and may require systemic therapy. Miltefosine (Impavido) is an oral agent used for treatment of leishmaniasis when indicated. Prior authorization is required, and when approved the authorization should be for a maximum of 28 days. Approval is limited to cases where the request is for one of the specified forms of leishmaniasis, is from or in consultation with an Infectious Disease specialist, and the member has tried and failed IV amphotericin B or Ambisome prior to initiation.
Definitions
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