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CYCLOSERINE, PRETOMANID and SIRTURO®

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CYCLOSERINE, PRETOMANID and SIRTURO® PHARMACY COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 2/13/2020 SECTION: DRUGS LAST REVIEW DATE: 5/20/2021 LAST CRITERIA REVISION DATE: 5/20/2021 ARCHIVE DATE: CYCLOSERINE PRETOMANID SIRTURO® (bedaquiline) Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Pharmacy Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. This Pharmacy Coverage Guideline provides information related to coverage determinations only and does not imply that a service or treatment is clinically appropriate or inappropriate. The provider and the member are responsible for all decisions regarding the appropriateness of care. Providers should provide BCBSAZ complete medical rationale when requesting any exceptions to these guidelines. The section identified as “Description” defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as “Criteria” defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Pharmacy Coverage Guidelines are subject to change as new information becomes available. For purposes of this Pharmacy Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. BLUE CROSS®, BLUE SHIELD® and the Cross and Shield Symbols are registered service marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. All other trademarks and service marks contained in this guideline are the property of their respective owners, which are not affiliated with BCBSAZ. This Pharmacy Coverage Guideline does not apply to FEP or other states’ Blues Plans. Information about medications that require precertification is available at www.azblue.com/pharmacy. Some large (100+) benefit plan groups may customize certain benefits, including adding or deleting precertification requirements. All applicable benefit plan provisions apply, e.g., waiting periods, limitations, exclusions, waivers and benefit maximums. Precertification for medication(s) or product(s) indicated in this guideline requires completion of the request form in its entirety with the chart notes as documentation. All requested data must be provided. Once completed the form must be signed by the prescribing provider and faxed back to BCBSAZ Pharmacy Management at (602) 864-3126 or emailed to [email protected]. Incomplete forms or forms without the chart notes will be returned. Page 1 of 9 PHARMACY COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 2/13/2020 SECTION: DRUGS LAST REVIEW DATE: 5/20/2021 LAST CRITERIA REVISION DATE: 5/20/2021 ARCHIVE DATE: CYCLOSERINE PRETOMANID SIRTURO® (bedaquiline) Cycloserine Criteria: Criteria for therapy: Cycloserine is considered medically necessary and will be approved when ALL of the following criteria are met: 1. Prescriber is a physician specializing in the patient’s diagnosis or is in consultation with a Pulmonologist or Infectious Disease Specialist 2. Individual is 18 years of age or older 3. A confirmed diagnosis of active pulmonary or extra-pulmonary tuberculosis (including renal disease) where the causative organism is susceptible to cycloserine 4. Use is to be supervised by and undertaken by the appropriate state or local agency Tuberculosis Clinic responsible for a directly observed therapy (DOT) 5. Use is with a combination regimen of other drugs with known susceptibility for tuberculosis 6. ALL of the following baseline tests have been completed before initiation of treatment with continued monitoring as clinically appropriate: a. Culture and sensitivity report shows susceptibility to cycloserine b. Susceptibility to the other anti-tuberculosis agents in regimen 7. There are NO contraindications. Contraindications include: a. Epilepsy b. Severe renal insufficiency c. Excessive concurrent use of alcohol d. Depression e. Severe anxiety f. Psychosis Approval duration: 1-month supply, individual to be directed to appropriate state or local agency responsible for DOT Will not be renewed Criteria for a request for non-FDA use or indication, treatment with dosing, frequency, or duration outside the FDA-approved dosing, frequency, and duration, refer to one of the following Pharmacy Coverage Guideline: 1. Off-Label Use of a Non-Cancer Medications 2. Off-Label Use of a Cancer Medication for the Treatment of Cancer without a Specific Coverage Guideline Page 2 of 9 PHARMACY COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 2/13/2020 SECTION: DRUGS LAST REVIEW DATE: 5/20/2021 LAST CRITERIA REVISION DATE: 5/20/2021 ARCHIVE DATE: CYCLOSERINE PRETOMANID SIRTURO® (bedaquiline) Pretomanid Criteria: Criteria for therapy: Pretomanid is considered medically necessary and will be approved when ALL of the following criteria are met: 1. Prescriber is a physician specializing in the patient’s diagnosis or is in consultation with an Infectious Disease Specialist 2. Individual is 18 years of age or older 3. A confirmed diagnosis of pulmonary tuberculosis (TB) that is ONE of the following: a. Extensive drug resistant (XDR TB) b. Treatment-intolerant multi-drug resistant (TI-MDR TB) c. Nonresponsive multi-drug resistant (NR-MDR TB) 4. Use is to be supervised by and undertaken by the appropriate state or local agency Tuberculosis Clinic responsible for a directly observed therapy (DOT) 5. Use is with a combination regimen of Pretomanid, Sirturo (bedaquiline), and linezolid (brand Zyvox or generic) 6. Individual does not have ANY of the following conditions: a. Drug-sensitive (DS) tuberculosis b. Latent infection due to Mycobacterium tuberculosis c. Extra-pulmonary infection due to Mycobacterium tuberculosis d. MDR-TB that is not treatment-intolerant or nonresponsive to standard therapy e. Hepatic impairment f. Renal impairment 7. ALL of the following baseline tests have been completed before initiation of treatment with continued monitoring as clinically appropriate: a. Alanine aminotransferase b. Aspartate aminotransferase c. Alkaline phosphatase d. Bilirubin e. Serum potassium, calcium, and magnesium, correct if abnormal f. Electrocardiogram (ECG) 8. There are no contraindications to the use of linezolid (brand Zyvox or generic) or Sirturo (bedaquiline) Page 3 of 9 PHARMACY COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 2/13/2020 SECTION: DRUGS LAST REVIEW DATE: 5/20/2021 LAST CRITERIA REVISION DATE: 5/20/2021 ARCHIVE DATE: CYCLOSERINE PRETOMANID SIRTURO® (bedaquiline) Approval duration: 1-month supply, individual to be directed to appropriate state or local agency responsible for DOT Will not be renewed Criteria for a request for non-FDA use or indication, treatment with dosing, frequency, or duration outside the FDA-approved dosing, frequency, and duration, refer to one of the following Pharmacy Coverage Guideline: 1. Off-Label Use of a Non-Cancer Medications 2. Off-Label Use of a Cancer Medication for the Treatment of Cancer without a Specific Coverage Guideline Sirturo (bedaquiline) Criteria: Criteria for therapy: Sirturo (bedaquiline) is considered medically necessary and will be approved when ALL of the following criteria are met: 1. Prescriber is a physician specializing in the patient’s diagnosis or is in consultation with an Infectious Disease Specialist 2. Individual is 5 years of age or older and weighs at least 15 kg 3. A confirmed diagnosis pulmonary multi-drug resistant (MDR) tuberculosis (TB) 4. Use is to be supervised by and undertaken by the appropriate state or local agency Tuberculosis Clinic responsible for a directly observed therapy (DOT) 5. Use is with a combination regimen with at least 3 other drugs to which the individual’s MDR TB is shown to be susceptible or with at least 4 other drugs to which the individual’s MDR TB is likely to be susceptible 6. Individual does not have ANY of the following conditions: a. Drug-sensitive (DS) tuberculosis; b. Latent infection due to Mycobacterium tuberculosis; c. Extra-pulmonary tuberculosis infections caused by non-tuberculous mycobacteria d. HIV infected individual with MDR TB 7. ALL of the following baseline tests have been completed before initiation of treatment with continued monitoring as clinically appropriate: a. Electrocardiogram (ECG) b. Assessment for signs and symptoms of liver disease Page 4 of 9 PHARMACY COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 2/13/2020 SECTION: DRUGS LAST REVIEW DATE: 5/20/2021 LAST CRITERIA REVISION DATE: 5/20/2021 ARCHIVE DATE: CYCLOSERINE PRETOMANID SIRTURO® (bedaquiline) c. Serum potassium, calcium, and magnesium and correct if abnormal d. Alanine aminotransferase e. Aspartate aminotransferase f. Alkaline phosphatase g. Bilirubin Initial approval duration: 1-month supply, individual to be directed to appropriate state or local agency responsible for DOT Will not be renewed Criteria for a request for non-FDA use or indication, treatment with dosing, frequency, or duration outside the FDA-approved dosing, frequency, and duration, refer to one of the following Pharmacy Coverage Guideline: 1. Off-Label Use of a Non-Cancer
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