Sivextro tablets Prior Authorization Criteria – Medicare Part D

Prior Authorization Criteria for Approval

Sivextro tablets will be approved when ALL of the following are met:

1. The patient has ONE of the following:

   1. BOTH of the following:

      1. A documented acute bacterial skin and skin structure infection (ABSSSI) defined as a bacterial infection of the skin with a lesion size area of at least 75 cm2 (lesion size measured by the area of redness, edema, or induration)
         AND
      2. The infection is due to Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus, Streptococcus intermedius, Streptococcus constellatus, or Enterococcus faecalis
         OR

   2. Another indication that is supported in CMS approved compendia for the requested medication
      AND

2. The patient is within the FDA labeled age for the requested medication
   AND

3. ONE of the following:

   1. The requested medication is prescribed by an infectious disease specialist or the prescriber has consulted with an infectious disease specialist on treatment of this patient
      OR

   2. The requested medication is NOT prescribed by an infectious disease specialist or the prescriber has NOT consulted with an infectious disease specialist on treatment of this patient AND ONE of the following:

      1. There is documentation of resistance to TWO of the following: beta lactams, macrolides, clindamycin, tetracycline, or co-trimoxazole at the site of infection
         OR
      2. The patient has an intolerance or hypersensitivity to TWO of the following: beta-lactams, macrolides, clindamycin, tetracyclines, or co-trimoxazole
         OR
      3. The patient has an FDA labeled contraindication to TWO of the following: beta-lactams, macrolides, clindamycin, tetracyclines, or co-trimoxazole
         OR
      4. There is documentation of resistance to vancomycin at the site of infection
         OR
      5. The patient has an intolerance or hypersensitivity to vancomycin
         OR
      6. The patient has an FDA labeled contraindication to vancomycin
         AND

4. The patient will NOT be using the requested medication in combination with linezolid for the same infection
   AND

5. The requested dose is within FDA labeled dosing or supported in CMS approved compendia dosing for the requested indication

Length of Approval:

6 days for ABSSSI

30 days for all other indications