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ph-91153

Ivermectin Prior Authorization Program Summary

Policy Number: PH-91153

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.

POLICY REVIEW CYCLE

Effective Date	Date of Origin
01-01-2025

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Stromectol^® (ivermectin) Tablet	Treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. Treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus.	Generic equivalent available	1

Agent(s)

FDA Indication(s)

Notes

Ref#

Stromectol^®

(ivermectin)

Tablet

Treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis.
Treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus.

Generic equivalent available

See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Ivermectin

Most strongyloidiasis and onchocerciasis infections are treated with a single dose. If the infection is not cleared, a single dose retreatment at 3 months for onchocerciasis, and a single dose retreatment at 3 or 12 months for strongyloidiasis can be used.(2)

The Center for Disease Control and Prevention reports that the highest 95^th percentile weight by age is 127.6 kg for females and 139.9 kg for males.(3)

Safety

Ivermectin is contraindicated in patients who are hypersensitive to any component of this product.(1)

REFERENCES

Number	Reference
1	Stromectol prescribing information. Merck Sharp & Dohme Corp. May 2022.
2	IBM Micromedex. Ivermectin.
3	National Center for Health Statistics. Center for Disease Control and Prevention. Available at: https://www.cdc.gov/nchs/fastats/body-measurements.htm..

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)	Target Generic Agent(s)	Strength	Targeted MSC	Available MSC	Final Age Limit	Preferred Status

Stromectol	ivermectin tab	3 MG	M ; N ; O ; Y	O ; Y

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Stromectol	ivermectin tab	3 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
	Target Agent(s) will be approved when ALL of the following are met: ONE of the following: The patient has a diagnosis of strongyloidiasis due to Strongyloides stercoralis (medical records required) OR The patient has a diagnosis of onchocerciasis due to Onchocerca volvulus (medical records required) OR The patient has another FDA labeled indication for the requested agent and route of administration OR The patient has another indication that is supported in compendia for the requested agent and route of administration AND The patient does NOT have any FDA labeled contraindications to the requested agent AND ONE of the following: The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication OR The requested quantity (dose) is supported in compendia for the requested indication Compendia Allowed: AHFS or DrugDex with 1 or 2a level of evidence Length of Approval: 1 month

Module

Clinical Criteria for Approval

Target Agent(s) will be approved when ALL of the following are met:

ONE of the following:
1. The patient has a diagnosis of strongyloidiasis due to Strongyloides stercoralis (medical records required) OR
2. The patient has a diagnosis of onchocerciasis due to Onchocerca volvulus (medical records required) OR
3. The patient has another FDA labeled indication for the requested agent and route of administration OR
4. The patient has another indication that is supported in compendia for the requested agent and route of administration AND
The patient does NOT have any FDA labeled contraindications to the requested agent AND
ONE of the following:
1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication OR
2. The requested quantity (dose) is supported in compendia for the requested indication

Compendia Allowed: AHFS or DrugDex with 1 or 2a level of evidence

Length of Approval: 1 month

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment