Sivextro – NC Standard

Restricted Product(s)

• Sivextro® (tedizolid)

FDA Approved Use

• For the treatment of adults and pediatric patients ≥ 12 years of age with acute bacterial skin and skin structure infections caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus areas (including methicillin-resistant and methicillinsusceptible isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), and Enterococcus faecalis. 

Quantity Limit Exception Criteria

1. The drug has been recognized for treatment of the indication by the Infectious Disease Society of America (IDSA) (medical record documentation required); AND
   1. The patient has tried and failed linezolid (generic Zyvox), if culture and susceptibility confirm susceptibility (medical record documentation required); OR 
   2. The patient has a clinical contraindication/intolerance to linezolid (generic Zyvox) (medical record documentation required); OR
2. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
3. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
4. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
5. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).
   
   Duration of approval: 90 days (3 months) 

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.

December 2023: Criteria update: Formatting updates only.
October 2021: Original utilization management policy issued.