Pregabalin 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 Lyrica 100 mg. Findings: The physician reviewer found that Lyrica 100 mg is medically necessary for treatment for the patient’s chronic neuropathic pain. Gabapentin and pregabalin have similar safety and efficacy in the medical literature for chronic neuropathic pain. According to studies, pregabalin has a multidimensional effect across a range of disorders that have of a pathogenesis involving a central nervous system response of abnormal hyperexcitability. “The use of pregabalin in these complex and difficult-to-treat conditions is associated with rapid and durable clinically significant improvements in several outcome measures relating to core symptoms, including pain, anxiety and sleep, and improvements in overall health status and health-related quality-of-life”.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for pregabalin 75 mg, two tablets a day.The use of gabapentin, another related gamma aminobutyric acid (GABA) analog, is recommended by American College of Chest Physicians for the management of unexplained cough, not mediated by asthma, eosinophilic/allergic processes, upper airway cough syndrome, or gastroesophageal reflux. Additionally, according to Vertigan and colleagues, pregabalin was effective in treating chronic refractory cough in a randomized trial in which 40 adults were assigned to take pregabalin with speech pathology treatment (SPT) or placebo with SPT.

Where the denial was upheld

The patient has requested authorization and coverage for pregabalin capsules 25 mg. The U.S. Food and Drug Administration (FDA) approved indications for pregabalin include neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, adult patients with partial onset seizures, fibromyalgia, and neuropathic pain associated with spinal cord injury. Medical literature studies showed limited evidence of benefit in neuropathic back pain or sciatica, neuropathic cancer pain, or polyneuropathy.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for pregabalin. Pregabalin is an antiepileptic drug used in the management of chronic pain conditions. According to the current medical literature, the efficacy of antiepileptic drugs for complex regional pain syndrome (CRPS)-related pain has not been well-studied. In this case, the patient has a history of CRPS of the left foot, which has been refractory to interventional treatments, including lumbar sympathetic blocks, peripheral nerve blocks, medication management, physical therapy, home exercises, chiropractic, massages, non-steroidal anti-inflammatory drugs (NSAIDs), hot/cold compress, opioids, surgical interventions, and neuropathic medications. There is a paucity of medical literature supporting the safety and efficacy of pregabalin for the treatment of patients with CRPS.

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