Chronic Idiopathic Constipation denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for the medication Linzess capsules. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee’s chronic idiopathic constipation. A review of the records indicates that the enrollee has been diagnosed with chronic idiopathic constipation, gastroesophageal reflux disease with esophagitis, with a history of anorexia. The records indicated ongoing constipation issues despite referral to the registered dietician and eating disorder coach, as well as use of fiber, Colace, and administration of enemas several times per week. The enrollee is noted to have adequate hydration and activity level.The submitted documentation supports the medical necessity of the requested medication.

The patient is a 49-year-old female who has been diagnosed with chronic idiopathic constipation. On an earlier date, the records noted that the patient was being treated with dicyclomine. Per the provider appeal form dated earlier this year, the patient has failed treatment with MiraLAX, Colace, senna, Metamucil, and Bentyl. The patient has requested authorization and coverage for Trulance. The Health Plan denied the request and reported the requested medication is not medically necessary for the treatment of this patient. At issue in this case is whether Trulance is medically necessary for the treatment of the patient’s medical condition. Miner and colleagues performed a randomized, double-blinded, placebo-controlled phase III clinical trial assessing the efficacy and safety of plecanatide (Trulance).

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Linzess for treatment of the enrollee’s chronic idiopathic constipation. Findings: The physician reviewer found that according to the American Gastroenterological Association (AGA), the first-line of therapy for patients with constipation should be an osmotic agent, and then a stimulant laxative should be tried. The guidelines also state that a newer agent such as Linzess should be considered when symptoms do not respond to such laxatives. In multicenter, randomized, blinded, placebo-controlled Phase III clinical trials, Linzess significantly increased weekly spontaneous bowel movements in patients with chronic constipation, but was associated with adverse effects. The prescribing information approved by the U.S.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Linzess 290 mcg. The U.S. Food and Drug Administration (FDA) has approved the use of Linzess for the treatment of patients with chronic idiopathic constipation. The current American Gastroenterological Association (AGA) guidelines for the treatment of constipation recommend the use of osmotic and then stimulant laxatives before advanced agents such as Linzess. This patient’s records document a history of chronic constipation, diverticulitis, and abdominal pain, as well as small bowel obstruction. Although the patient has constipation, the documentation does not report failure of safe, effective initially recommended over the counter laxative alternatives to support an indication for treatment with Linzess. Moreover, the U.S.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving chronic idiopathic constipation, then check the rights and deadlines that apply to your plan.