Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Irritable Bowel Syndrome with Constipation.
Treatment: Movantik.

The insurer denied Movantik.  The determination is upheld.

The patient is requesting Movantik (naloxegol) to treat irritable bowel syndrome with constipation (IBS-C). This patient has tried and failed fiber supplements (Metamucil) and other laxatives including Miralax, Amitiza and Linzess. Therefore, the attending provider would like to use Movantik to treat her IBS-C since she has responded to this medication in the past. At issue is the medical necessity of Movantik.

The requested health service/treatment of Movantik is not medically necessary for this patient.

Opioid-induced constipation (OIC) is one of the most the most common side effects of opioid use leading to deterioration in quality of life of the patient and also has potentially deleterious repercussions on adherence and compliance to opioid therapy. With the current liberal use of opioids by physicians even for non-cancer chronic pain, the situation is further complicated as these patients are not undergoing palliative care and hence there cannot be any justification to subject these patients to the severe constipation brought on by opioid therapy which is no less debilitating than the chronic pain. The goal in these patients is to prevent the opioid-induced constipation but at the same time allow the analgesic activity of opioids. Many drugs have been used with limited success, but the most specific among them were the peripherally acting mu opioid receptor antagonists. Methylnaltrexone and alvimopan were the early drugs in this group but were not approved for oral use in OIC. Naloxegol, the latest peripherally acting mu opioid receptor antagonist and has been Food and Drug Administration (FDA) approved since 2014 for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. 
[http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204760s000lbl.pdf]

The predominant studies on which naloxegol got its FDA approval are KODIAC-04 (National Clinical Trial (NCT) 01309841) and KODIAC-05 (NCT01323790): Two identical Phase III, multicenter, randomized, double-blind, placebo-controlled trials conducted in 652 and 700 patients, respectively. Selected patients were on stable regimen of 30-1000 mg/day of morphine for non-cancer pain with less than three spontaneous bowel movements (SBMs), and patients were randomly assigned to naloxegol 12.5, 25 milligrams (mg) or placebo once a day for 12 weeks. The primary endpoint considered was =3 SBMs per week or an increase of =1 SBMs from baseline for =9 of 12 weeks and an increase of =3 for final 4 weeks. KODIAC-04 showed significant improvement with naloxegol compared to placebo at both the doses, but in KODIAC-05 trial only 25 mg of naloxegol produced statistically significant results. An additional study for efficacy KODIAC-8 (NCT01336205): A 52 week, multicenter, open-label study included 804 patients out of these 84 patients were taken as roll over from previous KODIAC-4 trial. All were on 30-1000 mg/day morphine for more than 4 weeks for non-cancer pain with less than three SBMs. The subjects were randomly assigned into 25 milligrams (mg) /day of naloxegol or usual palliative care. The results demonstrated that 25 mg/day of naloxegol for up to 52 weeks was safe and usually well tolerated. There was no reversal of analgesic effect of opioids used in these studies as measured by the pain rating scale and need of opioid.

However, there are no data in the published medical literature to show that Movantik can be used for irritable bowel syndrome with constipation (IBS-C) nor is this an FDA approved indication for use of this medication. There is no evidence in the medical records provided that this patient is on narcotic pain medications and has opioid induced constipation. Therefore, Movantik is not medically necessary.