Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Digestive System/Gastrointestinal. Treatment: Pharmacy/Prescription Drugs. The insurer denied Motegrity. The denial is upheld. 

This is a female patient, who has previously tried and failed Miralax, Colace, Senna, Metamucil and Linzess for treatment of chronic idiopathic constipation. Therefore, the attending provider would like to use Motegrity to treat her chronic constipation.
At issue is whether the formulary drugs, lubiprostone (generic Amitiza), Linzess will be or have been ineffective, would not be as effective as the non-formulary drug, Motegrity (prucalopride) or would have adverse effects.

The health plan's determination is upheld in whole.

The formulary drug, lubiprostone (generic Amitiza), will be as effective as the non-formulary drug, Motegrity (prucalopride) and would have the same spectrum of adverse effects. The patient has already tried and failed Linzess. It is reasonable to try lubiprostone.
Constipation is a common symptom that may be primary (idiopathic or functional) or associated with a number of disorders or medications. 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. High-fiber diet and laxatives are the commonly used treatments, however 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. Mu-opiate antagonists are effective for managing opioid-induced constipation. Constipation that is refractory to available laxatives should be evaluated for defecatory disorders and slow-transit constipation using studies of anorectal function and colonic transit.
Lubiprostone is approved for irritable bowel syndrome-Constipation predominant (IBS-C) in women and for Chronic Constipation (CC) in adults. A prostone derived from prostaglandin E1, lubiprostone is a locally acting, highly selective activator of type-2 chloride channels and cystic fibrosis transmembrane conductance regulator chloride channels, located on the apical aspect enterocytes resulting in the passive paracellular movement of sodium and water. The luminal distension by increased intestinal fluid promotes gastrointestinal (GI) tract motility which in turn increases the intestinal and colonic transit. Lubiprostone also enhances and stimulates contraction in colonic as well as gastric muscles through prostaglandin E receptors, suggesting direct effects on GI motility. This drug has been approved by the Food and Drug Administration (FDA) as a treatment for women and men with chronic constipation at a dose of 24 microgram (g), twice daily, and for women with IBS-C at a dose of 8 g, twice daily. Lubiprostone has been consistently demonstrated to be superior to placebo for increasing the number of spontaneous bowel movements, improving stool consistency, reducing straining, bloating and overall constipation symptoms in several large, multicenter randomized controlled trial (RCT)s involving CC and IBS-C.
Drossman et al evaluated over 1100 IBS-C patients in a placebo-controlled RCT, demonstrating that lubiprostone 8 g twice daily resulted in significantly higher overall response compared to placebo over 12 weeks of treatment. 
Therefore, formulary drugs, lubiprostone (generic Amitiza), will be as effective as the non-formulary drug, Motegrity (prucalopride) and would have the same spectrum of adverse effects.