Linzess 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.

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for Linzess. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the patient’s medical condition. The submitted documentation supports the medical necessity of the requested medication. In placebo-controlled Phase III clinical trials, Linzess is indicated to restore colonic function in chronic constipation, and is U.S. Food and Drug Administration-approved for chronic constipation. Researchers found Linzess has a mechanism of action that differs from osmotic laxatives and stimulant laxatives, and can be effective even if those patients who have failed traditional treatment with laxatives and stimulant laxatives.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for (1) Linzess and (2) surgery to treat irritable bowel syndrome (IBS) and gastroesophageal reflux disease (GERD). Findings: The physician reviewer found that The U.S. Food and Drug Administration (FDA) approves the use of Linzess for the treatment of irritable bowel syndrome with constipation, and chronic idiopathic constipation. The American Gastroenterological Association guidelines for the treatment of constipation recommend the use of osmotic and stimulant laxatives prior to advanced agents such as Linzess, stating, “A newer agent should be considered when symptoms do not respond to laxatives.” In this case, the records noted that the patient reported diarrhea. As Linzess would make diarrheal symptoms worse, it is not medically indicated.

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.

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 Linzess, then check the rights and deadlines that apply to your plan.