Zelnorm denials in California external review

What the reviewers wrote

Where the denial was overturned

The patient is a 36-year-old female with constipation predominant irritable bowel syndrome (IBS). Although the patient has responded to therapy with Zelnorm, she quickly relapses once therapy is discontinued. Relapse of her IBS has resulted in painful perianal disease that has required surgery in the past. The Health Plan has denied authorization for Zelnorm therapy on the basis that it is not medically necessary for treatment of the patient’s IBS.Though it has been suggested that the Food and Drug Administration (FDA) has approved the use of Zelnorm for 4-6 weeks with one repeat, the FDA actually suggests that therapy for 12 weeks should be considered in those patients who respond by 4-6 weeks. The FDA approval never discusses repeat dosing. Furthermore, labeled indications for any drug do not necessarily reflect standard of care or prudent use.

The patient is a 56-year-old woman with irritable bowel syndrome (IBS) who has not responded to traditional therapies for this disorder. The records provided indicate the patient did respond to treatment with an approved therapy, Zelnorm. Since Zelnorm was discontinued the patient’s symptoms have returned. She has requested authorization for further treatment with Zelnorm. The Health Plan has denied this request on the basis that Zelnorm is not medically necessary for treatment of the patient’s medical condition. Although the FDA approval for Zelnorm is limited to several weeks, IBS is a lifelong condition. It appears this patient has tried multiple other alternatives without relief. It also appears the patient has had a positive response to a low dose of Zelnorm.

Where the denial was upheld

This patient is a 28-year-old woman who has irritable bowel syndrome (IBS) with constipation dominance. The patient has been taking Zelnorm for several months. The submitted documentation indicates that since the patient has been taking Zelnorm she has had normal bowel habits and no abdominal pain. The Food and Drug Administration (FDA) approved dosage for Zelnorm is 6mg twice daily for four to six weeks, which could be extended another four to six weeks depending upon results. The patient wishes to continue treatment with Zelnorm. The Health Plan has denied authorization for Zelnorm on the basis that it is not medically indicated.Although the duration of the patient’s use of Zelnorm has exceeded FDA guidelines, IBS and constipation are lifelong conditions. The patient’s provider has indicated that the patient has not responded to any conventional medications.

The patient is a 46-year-old female with a longstanding history of irritable bowel syndrome (IBS). Zelnorm has relieved her constipation, bloating, and abdominal pain. The patient has requested authorization for a longer duration of Zelnorm therapy. The Health Plan has denied the request on the basis that continuation of Zelnorm is not medically indicated.Although the duration of the patient’s use of Zelnorm has exceeded FDA guidelines, IBS and constipation are lifelong conditions. The patient’s provider has indicated that the patient has not responded to any conventional medications. In addition, it has been noted that the patient’s symptoms returned once Zelnorm was discontinued. In this particular case, given the patient’s clinical condition and her past success with Zelnorm, continued use of Zelnorm may be medically indicated.

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