CurrentMass General Brigham Health PlanPolicy N/A

Mytesi (crofelemer) prior authorization for non-infectious diarrhea in HIV/AIDS

This policy governs prior authorization requirements for Mytesi (crofelemer) under the commercial/exchange pharmacy benefit for adult patients with HIV/AIDS experiencing non-infectious diarrhea while on antiretroviral therapy.

Policy Summary

PayerMass General Brigham Health Plan

PolicyMytesi (crofelemer) prior authorization for non-infectious diarrhea in HIV/AIDS

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFeb 20, 2019

Next Review DateN/A

Key ActionObtain prior authorization and document age, HIV/AIDS diagnosis with active antiretroviral therapy, prior inadequate response or intolerance to loperamide and diphenoxylate/atropine; for continuation, document ongoing antiretroviral therapy and physician-assessed symptom improvement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Commercialapplicable plan

≥18minimum age

12 moapproval duration

trial of 2 agentstreatment prerequisites

Coverage Criteria for Mytesi (crofelemer)

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Initial Therapy

Covered when ALL of the following are met

Initial Authorization Criteria: Patient is ≥ 18 years of age; Patient has a diagnosis of human immunodeficiency virus (HIV) or acquired immunodeficiency disease (AIDS) and is actively receiving antiretroviral therapy which has resulted in a non-infectious form of diarrhea; Patient has experienced an inadequate response or intolerance to treatment with both loperamide and diphenoxylate w/atropine.

Continuation Therapy

Continuation allowed when ALL of the following are met

Continuation Criteria: Patient continues to actively receive antiretroviral therapy; Symptom improvement per physician assessment.

Coverage for Mytesi (crofelemer) is limited to the treatment of non-infectious diarrhea in adult patients with HIV/AIDS who are actively receiving antiretroviral therapy. Requests for use to treat diarrhea due to an identifiable infectious pathogen are outside this indication and are not covered under this policy. Approval requires documentation that the diarrhea is attributable to antiretroviral therapy rather than an infectious cause.

Prior authorization will be required and approval is contingent on meeting all initial or continuation criteria, including age and prior treatment trials. Specifically, for initial therapy the patient must be ≥ 18 years, have a diagnosis of HIV/AIDS while actively receiving antiretroviral therapy that has resulted in non-infectious diarrhea, and have had an inadequate response or intolerance to both loperamide and diphenoxylate with atropine. Continuation approvals require ongoing antiretroviral therapy and physician-assessed symptom improvement.

Provider Requirements and Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is required for Mytesi (crofelemer) when billed under the commercial/exchange pharmacy benefit.

Step Therapy

Step therapy not required

No step therapy program is specified for Mytesi in this policy (Step Therapy not selected).

Documentation Required

Required documentation to support authorization

Provider must document the patient meets the policy’s coverage criteria, including age, diagnosis, antiretroviral therapy status, prior trials, and for continuation requests, ongoing therapy and symptom improvement.

Patient is ≥ 18 years of age
Diagnosis of HIV or AIDS
Active receipt of antiretroviral (anti-retroviral) therapy with resulting non-infectious diarrhea
Prior inadequate response or intolerance to both loperamide and diphenoxylate with atropine
For continuation: documentation of ongoing antiretroviral therapy and physician-assessed symptom improvement

Denial Risk

Denial risk for unmet coverage criteria

Requests that do not meet all listed coverage criteria are at risk for denial.

Patient age < 18 years
No diagnosis of HIV/AIDS or diarrhea attributable to antiretroviral therapy (i.e., infectious causes)
No documentation of active antiretroviral therapy
No documented inadequate response or intolerance to both loperamide and diphenoxylate/atropine

Definitions

Non-infectious diarrhea in HIV/AIDS — definition

DefinitionDiarrhea occurring in adult patients with HIV/AIDS that is related to antiretroviral (anti-retroviral) therapy and not due to an infectious pathogen.

Intended populationAdults (≥18 years) with HIV/AIDS receiving antiretroviral therapy who develop non-infectious diarrhea.

Clinical attributionSymptoms attributed to antiretroviral therapy rather than an infectious cause; infectious causes are not the indicated use.

Indication contextSpecifically referenced as the indication for Mytesi (crofelemer) for symptomatic relief in this population.

Policy scopeApplies to non-infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy under the commercial/exchange pharmacy benefit prior authorization policy.