Diagnosis: Mycobacterium avium complex (MAC)
Treatment: Arikayce 590MG/8.4ML (milligrams/milliliters) IN (inhalation) SUSP (suspension)
The insurer denied the Arikayce 590MG/8.4ML IN SUSP
The denial is upheld.

The patient is a female with coronary artery disease (CAD) who was referred to infectious disease (ID) for Nontuberculous mycobacteria (NTM) infection. Computed tomography (CT) of the chest showed extensive bronchiectasis with pulmonary opacities, progressed from prior CT. Three sputum cultures in June grew out Mycobacterium (M.) abscessus, and a polymerase chain reaction (PCR) probe on one culture showed Mycobacterium avium complex (MAC), raising the possibility of mixed infection. The subject under review is the medical necessity for the requested Arikayce.

The health plan's determination is upheld.

Based on the provided records, the treatment with Arikayce is not medically necessary for this patient. First, there is no indication of any susceptibility testing performed on the isolates, or, if done, what were the results. Treatment decisions would typically be based on those results.

Second, current treatment guidelines for either isolate, M. Abscessus or MAC, do not include inhaled Amikacin (Arikayce) as initial therapy.

M. abscessus is resistant to many antibiotics and thus is very difficult to treat. Isolates are usually susceptible only in vitro to the parenteral agents amikacin, cefoxitin, and imipenem, and to oral macrolides (clarithromycin and azithromycin). (1, 2) Combination therapy of intravenous amikacin with cefoxitin or imipenem and an oral macrolide have been recommended by the American Thoracic Society (ATS)/Infectious Diseases Society of America (IDSA) and many other experts.(5) Based on current literature and this patient's infection and clinical status, the health plan's determination of medical necessity is upheld in whole.