Cymbalta denials in California external review

What the reviewers wrote

Where the denial was overturned

The patient is a 52-year-old male with a many year history of pain-related problems reported to include fibromyalgia, reflex dystrophy, degenerative disc disease, right hand complex pain, severe recurrent abdominal pain of unclear etiology, irritable bowel syndrome (IBS), chronic fatigue, depression and various surgical procedures. Cymbalta was prescribed by the patient’s gastroenterologist as treatment for IBS and incidentally for fibromyalgia after several failed trials of other medications over an extended period of time. The patient was evaluated by a rheumatologist in January 2006, and was found to have fibromyalgia with uncontrolled acute and chronic pain.

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested authorization and coverage for Cymbalta, gene testing for medication (Genesight test), and cognitive therapy twice a week for treatment of the enrollee’s medical condition. Regarding the requested gene testing for medication (Genesight test), the evidence base does not appear to support the use of pharmacogenomic testing under the present circumstances. Studies by researchers point out that there is still considerable controversy on whether the adjustment of dosage driven by genetic information may improve therapeutic efficacy, and/or whether adverse events are prevented, to an extent of any practical importance in clinical practice. These references also mention that routine application of pharmacogenetic dose adjustment in clinical practice requires prospective validation.

Where the denial was upheld

The submitted records indicate the patient has depression and diabetic peripheral neuropathy, which has been painful and disabling. Prior treatments were not sufficiently helpful in controlling depression and pain. It is reported that when the patient’s dose of Cymbalta was increased to 120 mg per day the patient was greatly improved and was able to discontinue multiple other medications. A letter from the patient’s spouse supports the clinical benefit and no note is made of adverse effects. A letter from the patient’s provider also reports benefit but does not relate the patient’s clinical status on a lower dosage. The patient has requested authorization and coverage for Cymbalta 120 mg per day. The Health Plan has denied this request.The patient has diabetes mellitus, neuropathy and depression. FDA indications for Cymbalta include depression and diabetic peripheral neuropathic pain.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Cymbalta for treatment of the enrollee’s depression and back pain. Findings: The physician reviewer found that the request for brand name Cymbalta is not medically necessary for treatment of the patient’s medical condition. A study compared patients initiating antidepressant therapy with a brand versus generic medication, found “no significant difference in the likelihood of discontinuation of the initially dispensed medication during the first 180 days of SSRI [selective serotonin reuptake inhibitors] or SNRI [selective norepinephrine reuptake inhibitors] therapy.” In addition, Cymbalta is well known to have significant side effects that include nausea. There is a lack of adequate studies to support the use of brand name versus generic in this clinical setting.

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