Medications for Parasitic Infections Duration Limit for 30-Day Period

Cigna National Formulary Coverage Policy

Drug Quantity Management – Per Days Medications for Parasitic Infections Duration Limit for 30-Day Period

Table of Contents Product Identifer(s)

National Formulary Medical Necessity ...... 1 59534 Conditions Not Covered...... 4 Background ...... 4 References ...... 6 Revision History ...... 6

INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations.

National Formulary Medical Necessity

Drugs Affected • albendazole 200 mg tablets (Albenza®) • artemether/lumefantrine – 20 mg/120 mg tablets (Coartem®) • atovaquone/proguanil – 250 mg/100 mg, 62.5 mg/25 mg tablets (Malarone) • benznidazole 12.5 mg, 100 mg tablets (Benznidazole) • ivermectin 3 mg tablets (Stromectol®) • mebendazole 100 mg chewable tablets (Emverm™ ) • mefloquine 250 mg tablets (generics) • miltefosine 50 mg capsules (Impavido®) • moxidectin 2 mg tablets • nifurtimox 30 mg, 120 mg tablets (Lampit) • nitazoxanide 500 mg tablets, 100 mg/5 ml suspension (Alinia®) • primaquine phosphate 26.3 mg tablets • quinine sulfate 324 mg capsules (Qualaquin®)

Page 1 of 6 Cigna National Formulary Coverage Policy: DQM Per Days Medications for Parasitic Infections • tafenoquine 100 mg tablets (Arakoda™) • tafenoquine 150 mg tablets (Krintafel) • tinidazole 250 mg, 500 mg tablets (Tindamax®)

Quantity Limits Generic name Quantity Limit for 30 day period Albenza (albendazole) 200 mg tablets 120 tablets Malarone 62.5 mg/25 mg tablets 90 tablets A quantity of 180 tablets is allowed in the previous 180 days without prior authorization. Malarone 250 mg/100 mg tablets 30 tablets A quantity of 60 tablets is allowed in the previous 180 days without prior authorization. Coartem 20 mg/120 mg tablets 24 tablets Benznidazole 12.5 mg tablets. A quantity of 720 tablets is allowed in the previous 360 tablets 180 days without prior authorization. Benznidazole 100 mg tablets – for individuals up to 150 kg. A quantity of 720 tablets 360 tablets is allowed in the previous 180 days without prior authorization. Stromectol (ivermectin) 3 mg tablets – for individuals up to 150 kg 20 tablets Emverm 100 mg chewable tablets 6 tablets Mefloquine 250 mg tablets. 5 tablets A quantity of 13 tablets is allowed in the previous 180 days without prior authorization. Impavido 50 mg capsules 84 capsules Moxidectin 2 mg tablets 4 tablets Lampit 30 mg tablets. A quantity of 720 tablets is allowed in the previous 180 days 360 tablets without prior authorization. Lampit 120 mg tablets – A quantity of 540 tablets is allowed in the previous 180 days 270 tablets without prior authorization. Alinia 500 mg tablets 14 tablets Alinia 100 mg/5 ml suspension 360 ml Primaquine phosphate 26.3 mg tablets. A quantity of 120 tablets is allowed in the 60 tablets previous 180 days is allowed without prior authorization. Qualaquin 324 mg capsules 42 capsules Arakoda 100 mg tablets. A quantity of 20 tablets is allowed in the previous 180 days 10 tablets without prior authorization. Krintafel 150 mg tablets 2 tablets Tindamax (tinidazole) 500 mg tablets 20 tablets Tindamax (tinidazole) 250 mg tablets 40 tablets

The purpose of this quantity limit is to prevent the stockpiling, misuse and/or overuse of the above medications. The quantity level limits for a 30-day period in the table above will be placed on these medications. For coverage of additional quantities, prior authorization is required.

Criteria

Cigna covers quantities as medically necessary when the following criteria are met:

Albenza 200 mg tablets 1. Individuals with a diagnosis of Baylisascariasis caused by Baylisascaris procyonis, a quantity sufficient to treat an individual at a dose of up to 37 mg/kg/day for 20 days may be approved. 2. Individuals with a diagnosis of Clonorchiasis caused by Clonorchis sinensis, a quantity sufficient to treat an individual at a dose of up to 10 mg/kg/day for 7 days may be approved.

Page 2 of 6 Cigna National Formulary Coverage Policy: DQM Per Days Medications for Parasitic Infections Benznidazole 12.5 mg tablets 1. For individuals diagnosed with a new episode of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi since the last 60 day treatment, an additional supply of up to 720 tablets (360 tablets/30 days) may be approved.

Benznidazole 100 mg tablets 1. Individuals who weigh greater than 150 kg, a quantity sufficient to treat an individual at a dose of up to 8 mg/kg/day for 60 days may be approved. 2. For individuals diagnosed with a new episode of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi since the last 60 day treatment, an additional supply of up to 720 tablets (360 tablets/30 days) may be approved.

Stromectol (ivermectin) 3 mg tablets 1. Individuals with a diagnosis of Trichuriasis caused by Trichuris trichiura (whipworm), a quantity sufficient to treat an individual at a dose of 200 mcg/kg/day for 3 days may be approved.

2. Individuals with hyperinfection syndrome or disseminated strongyloidasis, a quantity sufficient to treat an individual at a dose of 200 mcg/kg/day until stool and/or sputum exams are negative for 2 weeks.

3. Individuals who weigh greater than 150 kg, a quantity sufficient to treat an individual at a dose of 200 mcg/kg/day for 2 days may be approved.

Malarone (atovaquone/proguanil) 62.5 mg/25 mg tablets 1. Individuals who weigh 40 kg or less and need prophylaxis therapy for greater than 60 days, a quantity sufficient to allow up to 3 (three) tablets daily for a period that includes 2 days before entering a malaria endemic area and continue daily during the stay in the endemic area and for 7 (seven) days after return may be approved.

Malarone (atovaquone/proguanil) 250 mg/100 mg tablets 1. Individuals who weigh more than 40 kg and need prophylaxis therapy for greater than 60 days, a quantity sufficient to allow up to 1 (one) tablet daily for a period that includes 2 days before entering a malaria endemic area and continue daily during the stay in the endemic area and for 7 (seven) days after return may be approved.

Coartem 20 mg/120 mg tablets 1. No overrides recommended.

Emverm 100 mg chewable tablets 1. Individuals with a diagnosis of Capillariasis caused by Capillaria philippinensis, a total quantity 80 tablets may be approved. This will allow for the recommended treatment of 400 mg/day for 20 days.

2. Individuals with a diagnosis of Trichinellosis caused by Trichinella spiralis and other Trichinella species, a total quantity 195 tablets may be approved. This will allow for the recommended treatment of 500 mg three times daily for 13 days.

3. Individuals with a diagnosis of Toxocariasis or Visceral Larva Migrans, a total quantity 40 tablets may be approved. This will allow for the recommended treatment of 400 mg two times daily for 5 days.

Mefloquine 250 mg tablets 1. Individuals who need prophylaxis therapy for greater than 60 days, a quantity sufficient to allow one tablet weekly for a period that includes 3 weeks before entering a malaria endemic area and continue weekly during the stay in the endemic area and for 4 weeks after return may be approved.

Impavido 50 mg capsules 1. No overrides recommended. Moxidectin 2 mg tablets

Page 3 of 6 Cigna National Formulary Coverage Policy: DQM Per Days Medications for Parasitic Infections 1. No overrides recommended.

Lampit 30 mg tablets 1. For individuals diagnosed with a new episode of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi since the last 60 day treatment, an additional supply of up to 720 tablets (360 tablets/30 days) may be approved.

Lampit 120 mg tablets 1. For individuals diagnosed with a new episode of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi since the last 60 day treatment, an additional supply of up to 540 tablets (270 tablets/30 days) may be approved.

Alinia 500 mg tablets or 100 mg/5 ml suspension 1. Immunocompromised individuals (e.g., transplant individuals, HIV individuals) with a diagnosis of Cryptosporidiosis caused by Cryptosporidium species, a total quantity of up to 42 tablets or 1,080 ml of suspension may be approved. This will allow for the recommended treatment of 500 mg two times daily for 21 days.

Primaquine phosphate 26.3 mg tablets 1. Individuals who need prophylaxis therapy for greater than 60 days, a quantity sufficient to allow up to 2 (two) tablets daily for a period that includes 2 days before entering a malaria endemic area and continue daily during the stay in the endemic area and for 7 (seven) days after return may be approved.

Qualaquin 324 mg capsules 1. No overrides recommended.

Arakoda 100 mg tablets 1. Individuals who need prophylaxis therapy for greater than 60 days or if initiating therapy, a quantity sufficient to allow up to 2 tablets daily for 3 days as a loading dose then 2 (two) tablets weekly during the stay in the endemic area and for 1 week after return from the endemic area may be approved.

Krintafel 150 mg tablets 1. No overrides recommended.

Tindamax (tinidazole) 250 mg, 500 mg tablets 1. No overrides recommended.

Conditions Not Covered

Any other exception is considered not medically necessary.

Background

Overview The antiparasitic medications listed in Table 1 above are used in the treatment of various parasitic infections. Drug selection, dose, and duration for treatment and/or prophylaxis are dependent upon the parasite. Table 2 below provides drug specific approved indications.

Page 4 of 6 Cigna National Formulary Coverage Policy: DQM Per Days Medications for Parasitic Infections Table 2. Drug Specific Indications Drug Indication Albenza tablets Hydatid Disease caused by Echinococcus granulosus Neurocysticercosis caused by Taenia solium

Benznidazole tablets Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi

Stromectol (ivermectin) tablets Strongyloidiasis caused by Strongyloides stercoralis Onchocerciasis caused by Onchocerca volvulus Malarone (atovaquone/proguanil) tablets Malaria infections caused by Plasmodium falciparum

Coartem tablets Malaria infections caused by Plasmodium falciparum

Emverm chewable tablets Enterobiasis caused by Enterobius vermicularis (pinworm) Trichuriasis caused by Trichuris trichiura (whipworm) Ascariasis caused by Ascaris lumbricoides (common roundworm) Ancylostomasis caused by Ancylostoma duodenale (common hookworm) Necatoriasis caused by Necator americanus (American hookworm) Mefloquine tablets Malaria infections caused by Plasmodium falciparum and Plasmodium vivax Impavido capsules Visceral leishmaniasis caused by Leishmania donovani Cutaneous leishmaniasis caused by Leishmania braziliensis, Leishmania guyanensis, Leishmania panamensis Mucosal leishmaniasis caused by Leishmania braziliensis Moxidectin tablets Onchocerciasis due to Onchocerca volvulus

Lampit tablets Chagas disease (American Trypanosomiasis), caused by Trypanosoma cruzi Alinia tablets, suspension Giardiasis caused by Giardia lamblia Cryptosporidiosis caused by Cryptosporidium parvum

Primaquine phosphate tablets Malaria infections caused by Plasmodium vivax

Qualaquin capsules Malaria infections caused by Plasmodium falciparum Arakoda tablets Malaria infections caused by Plasmodium falciparum or Plasmodium vivax Krintafel tablets Malaria infections caused by Plasmodium vivax Tindamax (tinidazole) tablets Trichomoniasis caused by Trichomonas vaginalis Giardiasis caused by Giardia lamblia or Giardia duodenalis Amebiasis caused by Entamoeba histolytica Bacterial Vaginosis

Page 5 of 6 Cigna National Formulary Coverage Policy: DQM Per Days Medications for Parasitic Infections References

1. Albenza tablets [prescribing information]. Hayward, CA: Impax Specialty Pharma; July 2019. 2. Benznidazole tablets [prescribing information]. Florham Park, NJ: Exeltis USA, Inc.; August 2017. 3. Stromectol tablets [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.; February 2018. 4. Emverm chewable tablets [prescribing information]. Horsham, PA: Amedra Pharmaceuticals, LLC.; June 2017. 5. Alinia tablets and suspension [prescribing information]. Tampa, FL: Romark Laboratories, L.C.; April 2017. 6. Tindamax tablets [prescribing information]. San Antonio, TX: Mission Pharmacal Company; January 2013.. 7. Treatment Guidelines from the Medical Letter – Drugs for Parasitic Infections. New Rochelle, NY: Medical Letter, Vol. 11 (Suppl), 2013. 8. Coartem tablets [prescribing information]. East Hanover, NJ; Novartis Pharmaceuticals Corporation; August 2019. 9. Impavido capsules [prescribing information]. Orlando, FL: Profounda Inc.; June 2019. 10. Malarone tablets [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; February 2019. 11. Mefloquine tablets [prescribing information]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; August 2016. 12. Primaquine phosphate tablets [prescribing information]. Short Hills, NJ: Bayshore Pharmaceuticals LLC; November 2017. 13. Qualaquin capsules [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; August 2019. 14. Moxidectin tablets [prescribing information]. Melbourne, Victoria, Australia: Medicines Development for Global Health; January 2019. 15. Arakoda tablets [prescribing information]. Washington, DC: Sixty Degrees Pharmaceuticals, LLC; August 2018. 16. Krintafel tablets [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; July 2018. 17. Arguin PM, Tan KR. Chapter 3. Infectious diseases related to travel. Malaria. In. Centers for Disease Control and Prevention. 2014 Yellow Book - Traveler's Health. Atlanta: U.S. Department of Health and Human Services, Public Health Service. 2014. Accessed April 2, 2020. 18. Parasites – Strongyloides, Resources for Health Professionals. Centers for Disease Control and Prevention. Last updated January 14, 2019. Accessed April 2, 2020. 19. Lampit tablets [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; August 2020.

Revision History

Type of Summary of Changes Approval Date Revision Selected Add Lampit to policy. Reviewed and approved at TAC. 09/23/2020 Revision

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