Clean the rubber tops of both the Epithalon vial and the BAC water vial with an alcohol swab Draw 1 mL of bacteriostatic water into a 3 mL syringe Slowly inject the BAC water into the Epithalon vial, directing the stream against the side wall of the vial rather than onto the powder directly Gently swirl the vial until the powder is fully dissolved, do not shake Draw 20 units from the reconstituted vial into an insulin syringe for each nightly injection Store the reconstituted vial in the refrigerator in the black protective case provided Injection Site, Technique, and Storage Inject subcutaneously into the abdomen each night
Statistical Analysis We calculated that a sample size of 3400 would provide an effective power of 99% for the coprimary and confirmatory secondary end points, which were tested in a prespecified hierarchical order
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Successful appeals require: A Letter of Medical Necessity from the prescribing provider that specifically addresses why tirzepatide is medically necessary for this patient, why alternative treatments are inadequate, and how the patient meets the payer clinical criteria