Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Acromegaly

Treatment Mycapssa 20 milligram (mg) capsules, five (5) capsules per day

The insurer denied coverage for Mycapssa 20 milligram (mg) capsules, five (5) capsules per day

The denial is overturned 

The treating provider has diagnosed the patient with acromegaly. The patient is status-post trans-sphenoidal surgery with residual pituitary tumor. The patient had been on somatostatin injections in the past, but they did not control his symptoms. The treating provider has noted the patient has an elevated insulin-like growth factor 1 (IGF-1); therefore, the treating provider is recommending a dose escalation to Mycapssa 20 milligram (mg) capsules, five (5) capsules per day.

Per the progress report, "The patient is seen for acromegaly management. The patient has been taking Mycapssa 60 mg in the morning and 40mg in the evening. The patient states he is doing well. IGF-1 is 246. A magnetic resonance imaging showed intrasellar tumor."

A dose increase of Mycapssa is a reasonable next approach. The dose is increased when the IGF-1 levels are not with normal limits. This patient's IGF-1 levels are above the age-related levels. Therefore, the dose increase is standard of care and as stated, a reasonable next step in this patient's clinical setting.      

Mycapssa 20 milligram (mg) capsules, five (5) capsules per day is considered medically necessary for this patient.

"Pituitary adenomas are benign tumors comprising approximately 16% [percent] of all primary cranial neoplasms. Functioning pituitary adenomas (prolactinomas, somatotroph, corticotroph, thyrotroph and rarely gonadotroph adenomas) cause complex clinical syndromes and require prompt treatment to reduce associated morbidity and mortality. Treatment approaches include transsphenoidal surgery, medical therapy and radiation. Medical therapy is the primary therapy for prolactinomas, and surgery by a skilled neurosurgeon is the first-line approach for other functioning pituitary adenomas. A multimodal treatment is frequently necessary to achieve biochemical and clinical control, especially, when surgery is not curative or when medical therapy fails. Several emerging, novel, medical treatments for acromegaly, Cushing's disease and prolactinomas are in phase II and III clinical trials and may become effective additions to the current drug armamentarium. The availability of various management options will allow an individualized treatment approach based on the unique tumor type, clinical situation and patient preference." (Varlamov, E. V. et al.).

The patient had good response with IM (intramuscular) somatostatin, however, due to side effects can no longer continue. The patient has had good response with no adverse events to oral octreotide (Mycapssa), however, the patient's IGF-1 levels are elevated. The dose is increased when the IGF-1 levels are not with normal limits. This patient's IGF-1 levels are above the age-related levels, therefore, the requested Mycapssa 20 milligram (mg) capsules, five (5) capsules per day is considered medically necessary for this patient.  
                                                       
The health plan did not act reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage for Mycapssa 20 milligram (mg) capsules, five (5) capsules per day is overturned. Medical Necessity is substantiated.