MYCOBUTIN, Rifabutin Form

Rifabutin (Mycobutin®) is a derivative of rifamycin, an antimycobacterial agent. FDA Approved Indication(s) Mycobutin is indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection. 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 Mycobutin is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Mycobacterium avium Complex Prophylaxis (must meet all):

1. Request is for MAC prophylaxis in member with HIV;
2. Prescribed by or in consultation with an HIV or infectious disease specialist;
3. Age ≥ 18 years;
4. Failure of azithromycin or clarithromycin, unless clinically significant adverse effects are experienced or both are contraindicated;
   5. If request is for brand Mycobutin, member must use generic rifabutin unless contraindicated or clinically significant adverse effects are experienced;
   6. Dose does not exceed 300 mg (2 capsules) per day. Approval duration: 12 months B. Helicobacter pylori Infection (off-label) (must meet all):
      For Talicia® requests, see CP.PMN.277 Ulcer Therapy Combinations
5. Diagnosis of H. pylori infection;
6. Prescribed by or in consultation with a gastroenterologist or infectious disease specialist;
7. Age ≥ 18 years;

8. Failure of a first-line treatment regimen (see Appendix B), unless contraindicated, clinically significant adverse effects are experienced, or culture and sensitivity report shows resistance or lack of susceptibility of H. pylori to all first-line treatment regimens;

   5. Prescribed in combination with amoxicillin and a proton pump inhibitor; Page 1 of 8

   CLINICAL POLICY Rifabutin

   6. If request is for brand Mycobutin, member must use generic rifabutin unless contraindicated or clinically significant adverse effects are experienced;
   7. Dose does not exceed 300 mg (2 capsules) per day for 10 days. Approval duration: 10 days C. Tuberculosis (off-label) (must meet all):
   8. Diagnosis of tuberculosis infection in member with HIV;
9. Prescribed by or in consultation with an HIV or infectious disease specialist;
10. Documentation of current or anticipated treatment with protease inhibitors, non- nucleoside reverse transcriptase inhibitors (NNRTIs), or integrase strand transfer inhibitors (INSTIs) other than elvitegravir for the treatment of HIV infection;
    4. Age ≥ 18 years;.
11. If request is for brand Mycobutin, member must use generic rifabutin unless contraindicated or clinically significant adverse effects are experienced;
    
    6. Dose does not exceed one of the following (a or b): a. 300 mg (2 capsules) per day; b. 600 mg (4 capsules) per day and member is being treated with efavirenz
       Approval duration: 12 months D. 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: 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: HIM.PA.103 for health insurance marketplace and CP.PMN.16 for Medicaid; or
12. 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: HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid.
    II. Continued Therapy A. Mycobacterium avium Complex Prophylaxis (must meet all):
    
    1. 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);
13. Member is responding positively to therapy;

14. If request is for brand Mycobutin, member must use generic rifabutin unless contraindicated or clinically significant adverse effects are experienced;
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    CLINICAL POLICY Rifabutin

    4. If request is for a dose increase, new dose does not exceed 300 mg (2 capsules) per day. Approval duration: 12 months B. Helicobacter pylori Infection
    5. Re-authorization is not permitted. Members must meet the initial approval criteria. Approval duration: Not applicable C. Tuberculosis (off-label) (must meet all):
    6. 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);
    7. Member has not received more than 12 months of therapy;
15. Documentation of current treatment with protease inhibitors, non-nucleoside reverse transcriptase inhibitors (NNRTIs), or integrase strand transfer inhibitors (INSTIs) other than elvitegravir for the treatment of HIV infection;
    4. If request is for brand Mycobutin, member must use generic rifabutin unless contraindicated or clinically significant adverse effects are experienced;
    5. If request is for a dose increase, new dose does not exceed one of the following (a or b): a. 300 mg (2 capsules) per day; b. 600 mg (4 capsules) per day and member is being treated with efavirenz. Approval duration: Up to a total duration of 12 months D. Other diagnoses/indications (must meet 1 or 2):
    6. 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: 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: HIM.PA.103 for health insurance marketplace and CP.PMN.16 for Medicaid; or

16. 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: HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid.
    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 – Page 3 of 8

    CLINICAL POLICY Rifabutin
    CP.PMN.53 for Medicaid and HIM.PA.154 for health insurance marketplace or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration INSTIs: integrase strand transfer inhibitors
    MAC: Mycobacterium avium complex NNRTI: non-nucleoside reverse transcriptase inhibitors Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Dosing Regimen Drug Name Dose Limit/ Maximum Dose 500 mg/day azithromycin MAC: 1,200 mg PO once weekly or 600 mg PO twice weekly clarithromycin MAC: 500 mg PO BID clarithromycin triple regimen H. pylori infection: 14 days: PPI (standard or double dose) BID; Clarithromycin 500 mg; Amoxicillin 1,000 mg or metronidazole 500 mg TID (if penicillin allergy) H. pylori infection: 10-14 days: PPI (standard dose) BID; bismuth subcitrate (120- 300 mg) or subsalicylate (300 mg) QID; tetracycline 500 mg QID; metronidazole 250 mg QID or 500 mg TID-QID H. pylori infection: 10-14 days: PPI (standard dose) BID; Clarithromycin 500 mg; Amoxicillin 1,000 mg;
    Metronidazole or tinidazole 500 mg H. pylori infection: 5-7 days of BID PPI (standard dose) + amoxicillin 1,000 mg; followed by 5-7 days of BID PPI, clarithromycin 500 mg + metronidazole/tinidazole bismuth quadruple regimen concomitant regimen sequential regimen hybrid regimen H. pylori infection: 7 days of BID PPI (standard dose) + amoxicillin 1,000 mg; followed by 7 days of BID PPI, amoxicillin + clarithromycin 500 mg + metronidazole/tinidazole H. pylori infection: 10-14 days: levofloxacin triple regimen Page 4 of 8 1.5 g/day See dosing regimen See dosing regimen See dosing regimen See dosing regimen See dosing regimen See dosing regimen

    CLINICAL POLICY Rifabutin
    Drug Name Dosing Regimen Dose Limit/ Maximum Dose levofloxacin sequential regimen PPI (standard dose) BID; levofloxacin 500 mg QD; amoxicillin 1,000 mg BID H. pylori infection: 5-7 days of BID PPI (standard dose) + amoxicillin 1,000 mg; followed by 5-7 days of BID PPI, amoxicillin + metronidazole/tinidazole + QD levofloxacin 500 mg rifabutin triple H. pylori infection: 10 days of BID PPI (standard dose) + amoxicillin 1,000 mg BID + rifabutin 300 mg QD See dosing regimen See dosing regimen Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): Clinically significant hypersensitivity to rifabutin or to any other rifamycins • Boxed warning(s): none reported Appendix D: General Information • There is no evidence that rifabutin is an effective prophylaxis against Mycobacterium tuberculosis. V. Dosage and Administration
    Indication MAC prophylaxis Tuberculosis infection in patients co-infected with HIV H. pylori infection (off-label) VI. Product Availability
    Capsule: 150 mg Dosing Regimen 300 mg PO QD or 150 mg PO BID 300 mg (approximately 5 mg/kg) PO QD in combination with other agents for up to 12 months
    300 mg PO QD with amoxicillin 1 g PO BID and proton pump inhibitor PO BID Maximum Dose 300 mg/day 300 mg/day (600 mg/day if treatment with efavirenz) 300 mg/day VII.