Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Advanced Lung Disease from Non-Tuberculous Mycobacterial Infection; Mycobacterium Abscessus
Treatment: Nuzyra 150MG (milligrams) OR (oral) TABS (tablets)
The health plan denied the requested medication, Nuzyra 150 MG OR TABS, as not medically necessary.
The health plan's determination is upheld.

The patient is a female with a history of coronary artery disease (CAD), status post COVID (coronavirus disease) pneumonia, with severe bronchiectatic disease and with a diagnosis of nontuberculous mycobacterium (NTM); she had 3 sputums in June that were culture positive for Mycobacteroides (M.) abscessus, and one culture was polymerase chain reaction (PCR) positive for mycobacterium avium complex (MAC), raising the possibility of dual infection with both M. abscessus and MAC.

She is reported to be cachectic, with recent weight loss, and significant pulmonary disease by chest computed tomography (CT) which was noted as worsened from the previous CT. An infectious disease (ID) physician ordered a treatment regimen of Azithromycin, Omadacycline, and inhaled Amikacin.

The request for Nuzyra was denied by the health plan based on available alternatives offered instead: Amikacin, Clarithromycin, Linezolid, Imipenem, Cefoxitin, and Tigecycline. There were no susceptibilities reported for the cultures done in June. An appeal made by provider stated that Nuzyra is likely to have activity against the M. abscessus. However, there is no evidence of susceptibility testing having been done on the isolate, and no documentation in the notes as to why this agent specifically would need to be used in lieu of other first line agents offered by the health plan.
At issue is the medical necessity for the requested treatment with Nuzyra.

The health plan's determination of medical necessity is upheld, in whole.

The request for treatment with Nuzyra is not medically necessary for this patient.
While Omadacycline (Nuzyra) is now considered a first line agent, there are other first line treatment options offered by the health plan that could be used in initial regimen. In addition, I find no indication that susceptibility testing was done on the isolate. In addition, the patient had not been initiated, and failed, other first line treatment options.

From Rizzo et al [8] reference:
From current literature, Omadacycline demonstrated potency against M. abscessus strains that displayed high-level resistance to a number of antibacterials used to treat M. abscessus infections, including Clarithromycin, Azithromycin, Amikacin, Cefoxitin, Imipenem, and also synergized the effects of Clarithromycin, Azithromycin, Cefdinir, and Linezolid against several isolates
Results showed that after 4 weeks of treatment, Omadacycline reduced M. abscessus lung burden by approximately 1-3 log units with no change in minimum inhibitory concentrations (MICs) over the course of treatment, suggesting high efficacy of Omadacycline for treatment of M. abscessus pulmonary infections. Omadacycline was also noted to demonstrate potent in vitro effects against 22 isolates of Mycobacterium chelonae and 20 isolates of M. fortuitum spp., with a MIC 90 of 0.250 milligrams/milliliter (mg/ml) and 0.5 mg/ml, respectively. These values were similar to that seen with Tigecycline, but 32- and 256-fold more potent than Amikacin and Doxycycline, respectively.
Per UpToDate, Omadacycline has gained interest because it is an oral agent and within vitro activity similar to Tigecycilne, with promising early clinical experience.