Diagnosis: Infectious Disease - Bacterial Infection
Treatment: Pharmacy/Prescription Drugs

The patient is a female who developed a surgical site infection secondary to Mycobacterium abscessus after a breast augmentation and abdominoplasty. The patient underwent removal of breast implants, which resulted in resolution of infection at this site, but the soft tissue infection in the abdominal area has persisted despite extensive antibiotic therapy.

Antimicrobial therapy has been challenging secondary to the multi-drug resistance of the isolate and adverse effects of antibiotics, including linezolid, which resulted in peripheral neuropathy. Linezolid therapy was exchanged with Sivextro (tedizolid) therapy. Her physician requests extended treatment with tedizolid. The health plan denied the request as not medically necessary.

The health plan's determination is overturned.

The clinical information submitted for review documents that this patient has a refractory and persistent soft tissue infection secondary to M. abscessus. Infections secondary to nontuberculous mycobacteria, including M. abscessus, are challenging and require the utility of multiple drugs at the same time in order to prevent the development of resistance. Moreover, the length of therapy is often extended before it can be resolved.

There are currently no FDA-approved drugs, including tedizolid, for the treatment of M. abscessus because these infections are relatively rare, and no clinical trials have been performed to assess efficacy. That being said, there are peer-reviewed publications outlining the effectiveness of tedizolid (along with other agents) in treating M. abscessus soft tissue infections. Soft tissue infections secondary to nontuberculous infections must be treated for many months (reference #1).

This patient has a documented soft tissue infection secondary to multi-drug resistant M. abscessus. She has experienced a significant adverse effect (peripheral neuropathy) secondary to linezolid, which is one of the few active drugs against this pathogen. Tedizolid (Sivextro) has the same antibacterial activity as linezolid without the side effects, including peripheral neuropathy. Nontuberculous mycobacterial infections must be treated with multiple agents (typically 3) in order to prevent rapid development of antimicrobial resistance. Based on this patient's clinical scenario, tedizolid is medically necessary.