Nifurtimox (Lampit) Form

Nifurtimox (Lampit®) is a nitrofuran antiprotozoal.
FDA Approved Indication(s) Lampit indicated in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American trypanosomiasis), caused by Trypanosoma cruzi (T. cruzi).
Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Lampit is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Chagas Disease (must meet all):

1. Diagnosis of Chagas disease confirmed by one of the following (a, b, or c, see Appendix D): a. Detection of circulating T. cruzi trypomastigotes on microscopy; b. Detection of T. cruzi DNA by polymerase chain reaction assay; c. Two positive diagnostic serologic tests showing IgG antibodies to T. cruzi and meeting both of the following (i and ii): i. The two tests use different techniques (e.g., enzyme-linked immunosorbent assay [ELISA], immunofluorescent antibody test [IFA]); ii. The two tests use different antigens (e.g., whole-parasite lysate, recombinant antigens);
2. Prescribed by or in consultation with an infectious disease specialist;
   3. Member has not yet received 60 days of Lampit therapy for the current infection;
   4. Dose (weight-based) does not exceed 300 mg per day (see Appendix D for off-label dosing requests). Approval duration: 60 days total B. Other diagnoses/indications (must meet 1 or 2):

3. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): Page 1 of 7

   CLINICAL POLICY Nifurtimox a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

4. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Chagas Disease (must meet all):
5. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
6. Member has not yet received 60 days of Lampit therapy for the current infection;
   3. If request is for a dose increase, new dose (weight-based) does not exceed 300 mg per day (see Appendix D for off-label dosing requests). Approval duration: 60 days total B. Other diagnoses/indications (must meet 1 or 2):
7. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

8. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
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   CLINICAL POLICY Nifurtimox III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key CDC: Centers for Disease Control and Prevention FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
   Not applicable IgG: immunoglobulin G T cruzi: Trypanosoma cruzi WHO: World Health Organization Appendix C: Contraindications/Boxed Warnings • Contraindication(s):
   o Known hypersensitivity to nifurtimox or to any of the excipients in Lampit o Alcohol consumption during treatment • Boxed warning(s): none reported Appendix D: General Information • Diagnostic tests:
   o Laboratories offering testing for Chagas disease include ARUP Laboratories, Mayo Clinic Laboratories, and Quest Diagnostics. IgG serology is performed in the majority of cases. After obtaining initial serologic IgG test results, providers should consult their state health department and the CDC for guidance on serologic confirmation. If two results are discordant, a third assay may be needed. Donor screening tests and Immunoglobulin M (IgM) serology tests are not considered diagnostic tests. • Off-label dosing requests for Chagas disease: o Dosing for populations outside FDA-approved age ranges or for longer than 60 days may be appropriate and should be reviewed on a case-by-case basis. See CDC consultation resources below for questions. • State reporting requirements: o According to the CDC (https://www.cdc.gov/mmwr/volumes/67/wr/mm6726a2.htm), in 2017 Chagas disease was reportable in six states: Arizona, Arkansas, Louisiana, Mississippi, Tennessee, and Texas.
   • Consultation resources: o Centers for Disease Control and Prevention (CDC)  Parasitic Diseases: https://www.cdc.gov/parasites/chagas/ - 404-718-4745, chagas@cdc.gov  CDC recommended guidance document: Bern C, Montgomery SP, Herwaldt BL, et al. Evaluation and treatment of Chagas disease in the United States: a systematic review. JAMA 2007; 298:2171.  CDC Drug Service: 404-639-3670  CDC Emergency Operations Center: 770-488-7100
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   CLINICAL POLICY Nifurtimox o World Health Organization (WHO)  Outside the US: https://www.who.int/health-topics/chagas-disease
   o American Society of Tropical Medicine and Hygiene  Directory of consultants: http://www.astmh.org/education-resources/clinical- Maximum Dose 300 mg/day Duration /
   Frequency PO TID for 60 days consultants-directory V. Dosage and Administration
   Indication Dosing Regimen Chagas disease Tablet # -

   • 30 mg Dose Body Weight (mg)
     Range (kg)
     15 mg ½ T
     2.5 to 4.5 kg
     1 T
     30 mg
     4.6 to < 9 kg
     1 ½ T
     9 to < 13 kg
     45 mg
     2 T
     13 to < 18 kg 60 mg
     2 ½ T
     18 to < 22 kg 75 mg
     22 to < 27 kg 90 mg
     3 T
     27 to < 35 kg 120 mg 4 T
     35 to < 41 kg 180 mg —
     41 to < 51 kg 120 mg —
     51 to < 71 kg 180 mg —
     71 to < 91 kg 240 mg —
     300 mg —
     ≥ 91 kg
     Tablet # - 120 mg
     —
     —
     —
     ½ T
     —
     —
     1 T
     1 ½ T
     1 T
     1 ½ T
     2 T
     2 ½ T
     VI. Product Availability
     Tablets: 30 mg, 120 mg VII.