Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Constipation. 
Treatment: Motegrity 2MG tablets. 

The insurer denied coverage for Motegrity 2MG tablets. 
The denial is overturned. 

This female patient has been followed by a Gastroenterologist for constipation. The patient has tried several medications, but reportedly has only had a beneficial reaction from Motegrity.

The insurer requires the patient utilize formulary drugs prior to non-formulary options. However, while the formulary option is not likely to cause an adverse reaction, the patient has tried some of the formulary alternatives and the have been ineffective. The formulary drug is likely to be more effective than the formulary options. The patient did not respond to Amitiza, Linzess, Miralax, Ducolax, Trulance, or Magnesium. 

The Food and drug Administration (FDA) has approved Motegrity (prucalopride) for the treatment of adults with chronic idiopathic constipation, according to a company press release. Motegrity (prucalopride, Shire), a once-daily, oral selective serotonin-4 (5-HT4) receptor agonist, improves bowel motility by stimulating colonic peristalsis, according to the release. (FDA, 2018). 

"Prucalopride (proo kal' oh pride) is a highly selective serotonin type 4 (5-HT4) receptor agonist that increases the release of serotonin by the specialized enterochromaffin cells in the mucosa of the gut and stimulates intestinal peristalsis and tone. Serotonin (5-HT) is released in response to chemical and mechanical stimulation and acts through the type 4 receptors that are common in the intestinal mucosa to increase peristalsis and intestinal tone. 5-HT4 receptors are also found in the central nervous system, urinary bladder and atria of the heart, which may explain some of the adverse effects of 5-HT4 receptor agonists. Prucalopride was found to improve symptoms of bloating and gastric distension in patients with gastroparesis and to decrease symptoms of reflux in patients with GERD [gastroesophageal reflux disease]. Prucalopride was approved in the United States in 2018 for treatment of idiopathic chronic constipation. Prucalopride is available in tablets of 1 and 2 mg under the brand name Motegrity. The recommended dose in adults is 2 mg once daily with a lower dose recommended for patients with renal impairment (creatinine clearance less than 30 mL/min)." (LiverTox, 2019). 

"Chronic idiopathic constipation (CIC) can be defined as bowel movements that are difficult to pass, are not occurring frequently, or have incomplete evacuation during defecation. A high-fiber diet and laxatives are the commonly used treatments, but in many cases, they do not produce satisfactory results. The first line of treatment is osmotic laxatives. If there is no improvement, the second line is guanylate cyclase-C (GCC) agonists like linaclotide or prokinetic agents such as prucalopride. On December 14, 2018, the United States Food and Drug Administration (US FDA) approved prucalopride for treating chronic idiopathic constipation. Prucalopride is a prokinetic agent which works at the 5-hydroxytryptamine receptor 4 (5-HT4) as an agonist with greater receptor selectivity. Patients on prucalopride reported improved symptoms, quality of life and satisfaction." (Tameez Ud Din, A., Khan, A. H., Bajwa, H., Maqsood, M. H., & Malik, M. N., 2019). 

The requested for Motegrity 2MG tablets should be covered instead of the available products on the plan's formulary for continuity of care based on established clinical results as noted by the patient's provider. 

The health plan did not act reasonably with sound medical judgment and in the best interest of the patient. 

The health plan's denial of the request for Formulary Exception for Motegrity 2MG tablets is overturned.