Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1:  The patient is a 30-year-old woman with idiopathic gastroparesis who has had considerable weight loss. She is only able to tolerate liquids and has failed several therapies such as erythromycin, domperidone and Reglan. Gastric emptying was delayed although the exam was only performed for 90 minutes. A request has been made for authorization for Enterra therapy (gastric stimulation). The Health Plan has denied this request citing a lack of peer-reviewed evidence supporting the therapy.It appears the patient has idiopathic gastroparesis. Review of the relevant literature reveals inadequate support for Enterra therapy. Although one trial (the WAVES trial) showed the therapy was beneficial, there is insufficient data demonstrating long-term efficacy. At this time Enterra therapy remains an unproven treatment for idiopathic gastroparesis and as such cannot be recommended. Therefore, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 2:  The patient is a 30-year-old female with a one-year history of idiopathic gastroparesis. She developed symptoms of nausea, vomiting and reports upper quadrant pain, and loss of appetite since August 2005. The patient was diagnosed with idiopathic gastroparesis based upon abnormal gastric empyting findings. A solid food gastric emptying scan showed only 35% emptying at 90 minutes. An endoscopy performed in February 2006 showed retained food in the stomach. The pylorus was noted to be patulous. The patient has been given a therapeutic trial of metoclopramide, erythromycin and domperidone without much relief. She is currently on domperidone 20 mg four times a day, but she continues to vomit. She has lost 40-50 pounds within 9-10 months time. Proton pump inhibitors and compazine suppositories are of no benefit. The patients provider has recommended the patient receive Enterra therapy. The Health Plan has denied authorization for the requested therapy on the basis that it is considered investigational.There is sufficient evidence in the peer-reviewed journals to support the long-term efficacy of Enterra therapy in the treatment of diabetic and idiopathic gastroparesis. The procedure is considered the standard of care for the management of medically refractory gastroparesis, both diabetic and idiopathic.Currently, there are only two FDA approved treatments for gastroparesis: the medication, Reglan, and gastric electrical stimulation (Enterra therapy). A randomized, double-blinded, cross-over study of 33 patients (WAVESS Study Group) concluded high frequency/low energy gastric electric stimulation significantly decreased vomiting frequency and gastrointestinal symptoms and improved quality of life in patients with severe gastroparesis.The gastric electrical stimulator used in the WAVESS trial was submitted for review by the Food and Drug Administration. Because of the lack of a controlled trial showing clear-cut efficacy, the FDA did not approve the device for unrestricted marketing for the treatment of gastroparesis. However, because of the promise shown in the uncontrolled trials, the device was approved as a humanitarian use device (HUD). The device received humanitarian device exemption approval in March 2000 to be used for the treatment of refractory diabetic and idiopathic gastroparesis under FDA conditions of approval. A second sham-controlled trial ultimately will need to be performed before the Enterra device is formally approved for open, unrestricted marketing. Though there is only a small body of literature attesting to its efficacy and it has not yet been accepted for general use by the medical community, the difficulties in obtaining unequivocal data proving efficacy in a rare condition were recognized by the FDA in granting a HUD exemption. This approval does show the judgment of the approving panel that the device is likely to be helpful. In the case of this patient, other alternative treatments have been exhausted without success. Based upon the available literature, the evaluation by the FDA, and the use of this treatment in selected cases by experts in gastrointestinal motility disorder, I have determined that Enterra therapy is likely to be more beneficial for this patient than any available standard therapy. Therefore, the Health Plans denial should be overturned.Physician 3:  The patient is a 30-year-old female with a history of gastroparesis. A 40-pound weight loss has been documented. An EGD study showed food in the stomach and the patient has tried erythromycin, Reglan and domperidone but has not responded. A solid food emptying study showed 35% emptying in 90 minutes. It is said that the patient requires IV hydration every two weeks. She vomits 3-4 times a day and has been symptomatic since 2005. Enterra therapy has been recommended by the patients provider, but was denied by the Health Plan.The Enterra therapy system received marketing approval by the FDA under the Humanitarian Device Exemption in March 2000. This system been studied in the multicenter Worldwide Anti-Vomiting Electrical Stimulation Study (WAVESS) trial. Though the trial involved a small number of patients, the 12-month improvement in symptoms and quality of life was greater than 50%. In addition, this form of therapy reduced the rate of hospitalization 30% in the first year after implantation. Benefits from this form of therapy were also reported in the GEMS study group in 1997 and 1999. Furthermore, in an article by McCallum, et. al., the authors concluded gastric pacing improves emptying and symptoms in patients with gastroparesis. The entry criteria as outlined by the manufacturer of the Enterra therapy system has been met by the patient. These include symptomatic gastroparesis for greater than one year, refractory or intolerant to at least 2 anti-emetic and prokinetic drug classes, frequency of vomiting greater than 7 times per week, and delayed gastric emptying defined by greater than 60% retention at 2 hours and greater than 10% at 4 hours.The studies cited above demonstrate the safety and efficacy of Enterra therapy in properly selected patients. This patient has failed all conservative medical therapy and clearly the morbidity that she is experiencing from her condition warrants a trial of Enterra therapy in this case.Based upon the information set forth above, I have determined that the requested therapy is likely to be more beneficial for this patient than any available standard therapy. Therefore, the Health Plans denial should be overturned.