Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Nucynta extended-release (ER) 12-hour 100 mg tablets. Baron and colleagues report in a review of five years of clinical data on the use of tapentadol (brand name Nucynta) prolonged release (PR) for chronic pain, The clinical study program demonstrated effective and generally well-tolerated treatment for up to two years in a broad range of chronic pain conditions, including those with neuropathic pain components. This was confirmed in routine clinical practice observations.  The authors further noted, Functionality, health status and quality of life also improved under tapentadol PR treatment. The gastrointestinal tolerability profile was more favorable compared to other tested World Health Organization (WHO) III opioids. Tapentadol PR has a good safety profile and no evidence of acquired tolerance from the long-term data so far collected. Gupta and colleagues state regarding the treatment of painful diabetic neuropathy, Currently, tapentadol is the only opioid specifically approved by the U.S. Food and Drug Administration (FDA) for use in treating painful diabetic neuropathy. Tapentadol is a strong analgesic that combines the mechanisms of a -opioid receptor agonist, like a typical opioid, and a norepinephrine reuptake inhibitor. The opioid effects inhibit ascending pain signals in the spine, while increased synaptic levels of norepinephrine potentiate descending inhibitory signaling. Freo and colleagues found, In randomized controlled trials, tapentadol has proved to be effective in relieving neuropathic pain in diabetic peripheral neuropathy and in chronic low back pain. In observational studies, tapentadol reduced neuropathic pain in chemotherapy-induced peripheral neuropathies, blood and solid cancers, and the neuropathic pain component in neck pain and Parkinson's disease. On determining when to initiate or continue opioids for chronic pain, Dowell and colleagues report, Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate.  The Federation of State Medical Boards (FSMB) strongly recommends prescribers use opioid therapy for chronic pain that is not cancer-related, or part of palliative care or end-of-life care, only when non-opioid and non-pharmacological options have not been effective. In this case, the patient has chronic neuropathic pain due to diabetic neuropathy which is not responding to standard opioid therapy with hydrocodone, Gralise, or Cymbalta. The patients CURES report and urine drug screens have been appropriate with no evidence of drug seeking behavior. The provider has recommended a trial of Nucynta to treat the patients neuropathic pain. Given that current medical literature supports the use of Nucynta in this clinical setting, and as the records show that that the provider and patient are following current evidence-based guidelines pertaining to the use of opioids for the management of non-cancer pain, the requested medication is medically indicated. Therefore, Nucynta extended-release (ER) 12-hour 100 mg tablets are medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in anesthesiology with sub-specialty certification in pain medicine and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.