Subsys denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested Subsys spray for treatment of his malignant neoplasm of larynx and chronic pain syndrome. The physician review found that according to the National Comprehensive Cancer Network (NCCN), rapidly acting transmucosal fentanyl may be considered in patients who are opioid-dependent and have brief episodes of pain that is not effectively controlled or attributed to inadequate dosing of around-the-clock opioids medications. The NCCN guidelines also indicate that transmucosal fentanyl is often the choice for patients who are unable to swallow. Additionally, the U.S. Food and Drug Administration (FDA) states that Subsys is indicated for the management of breakthrough pain in adults with cancer, who are already routinely taking other opioid pain medicines around-the-clock for cancer pain.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested Subsys for treatment of his medical condition. Findings: The physician reviewer found that based on the clinical documentation submitted for review, the medical necessity for Subsys has not been established. Subsys is not medically necessary in this clinical setting. The requested medication is indicated for malignant pain. The patient has chronic non-malignant pain. The current standard of care for chronic pain is treatment in a multidisciplinary practice to include physical therapy, massage therapy, behavioral therapy, and injections to help reduce pain. There are a variety of anticonvulsants and anti-depressants considered adjunctive to this therapy. If there is poor response to conservative therapy then interventional treatments should be considered.

Nature of Statutory Criteria/Case Summary: An enrollee has requested Subsys (fentanyl sublingual spray) for treatment of his medical condition. Findings: The physician reviewer found that based on the documentation submitted for review, the medical necessity for Subsys (fentanyl sublingual spray) has not been established. According to the documentation submitted for review the patient has non-malignant chronic pain, which will often worsen or recur as a result of opioid rebound. The current standard of care for chronic pain is treatment in a multidisciplinary pain management practice to include physical therapy, massage therapy, cognitive behavioral therapy, and injections to help reduce pain.

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