Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Complex ileocolonic Crohn's disease
Treatment: Lab testing for serum measurement of serum antibodies to tumor
necrosis blockers due to adalimumab (80145)
The insurer denied the Lab testing for serum measurement of serum antibodies to
tumor necrosis blockers due to adalimumab (80145)
The denial is overturned.

The patient is a female with ileocolonic Cohn's disease. She has failed sixmercaptopurine (6MP). Approximately seven years ago, the patient was started on
Humira, every two weeks. She had clinic worsening. Therapeutic drug level
monitoring (TDM) confirmed low Humira (adalimumab level) and magnetic
resonance elastography (MRE) results were consistent with eight to ten centimeters
of markedly thickened terminal ileum, luminal narrowing and proximal dilatation.
The Humira was escalated to weekly dosing.

Approximately six years ago, the patient underwent ileal resection. The patient was
post operative and went back to Humira every two weeks. Approximately five years
ago, dose was escalated to weekly dosing secondary to a low Humira
(adalimumab) level of 3.8 and increased inflammatory markers. Approximately
three years ago, dose was de-escalated to every two weeks, after a trough level of
12. Approximately a year ago, the patient was escalated to every week following a
low trough level.

The attending physician (AP) is suspecting lose of response or antibody
development, despite escalated dose. The AP requested adalimumab trough level.
The denial letter states the denial for lab testing for serum measurement of serum
antibodies to tumor necrosis blockers due to adalimumab (procedure code 80145)
provided per insurance policy is considered investigational.

Yes, the health plan should cover the lab testing for serum measurement of serum
antibodies to tumor necrosis blockers due to adalimumab (80145).

Biologics level monitoring and antibodies evaluation is currently considered the
standard of care in management of inflammatory bowel disease. Based on the test
results, dose adjustment or switching to a different agent can be considered and
thus it provides valuable information to the clinician.

Per the American Gastroenterology Association (AGA) consensus statement and guidelines 2019 (Clinical Gastroenterology and Hepatology 2019;17:1655-1668), they recommended checking drug/antibody concentration testing for anti-tumor necrosis factors (TNFs )(including adalimumab) as following: 
1) It is appropriate to order drug/antibody concentration testing at least once during maintenance for patients on all anti-TNFs. 
2) It is appropriate to order drug/antibody concentration testing of anti-TNFs at the end of induction in primary non-responders. 
3) It is appropriate to order drug/antibody concentration testing for all anti-TNFs in patients with confirmed secondary loss of response. (1)

The AP (attending physician) is suspecting lose of response or antibody
development, despite escalated dose, and has requested adalimumab trough level;
thus it meets the criteria.

Yes, the requested health service or treatment is more beneficial than any standard
treatment for the insured's condition or disease.
Biologics level monitoring and antibodies evaluation is currently considered the
standard of care in management of inflammatory bowel disease. Based on the test
results dose adjustment or switching to different agent can be considered and thus
it provides valuable information to the clinician.