Subutex denials in California external review

What the reviewers wrote

Where the denial was overturned

A 21-year-old male enrollee has requested Subutex, 8 mg (30 tablets per month) for treatment of his opioid dependence in remission. Findings: The physician reviewer found that a review of the literature shows that buprenorphine-naloxone (Suboxone) and buprenorphine (Subutex) are effective in the treatment of patients with opioid substance addictions. “Based on the available literature, it appears that buprenorphine, buprenorphine-naloxone, and methadone are similarly efficacious for the treatment of opioid-dependent patients (Boothby and Doerin).

A 47-year-old male enrollee has requested the prescription medication Subutex (8 mg tablets / 90 per month) for the treatment of his back pain. Findings: The physician reviewer found that chronic pain management is often met with significant difficulties due to its complicated and multifactorial etiology. Although Subutex has recently been approved for the treatment of opiate addiction, buprenorphine has been used for the treatment of pain for many years. The drug is a partial agonist with a high affinity for the μ receptors, making it very useful in the treatment of opiate addiction. Additionally, there are several studies in which a transdermal system was used to deliver buprenorphine in the management of chronic pain.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Subutex. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee medical history.Findings: The documentation provided does not support the medical necessity for the requested medication in this clinical setting. The stepwise World Health Organization (WHO) ladder for pain relief is considered a reasonable approach to pain control in the palliative and the non-palliative settings (Raffa and Pergolizzi). However, in the documentation available for review, there were no objective treatment goals for pain and function noted for the requested medication. The Centers for Disease Control and Prevention (CDC) guideline states when opioids are started, providers should prescribe the lowest effective dosage.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage of Subutex 2 mg sublingual (SL) twice daily for treatment of the enrollee who has a history of low back pain. Findings: The physician reviewer found that the documentation provided does not support the medical necessity for the requested medication in this clinical setting. The stepwise World Health Organization (WHO) ladder for pain relief is considered the reasonable approach to pain control in the palliative and the non-palliative setting. However, in the documentation available for review, no objective treatment goals for pain and function were noted for the requested medication. Behavior therapy was not noted as performed despite much research to support its use. Additionally, not all non-opioid medications classes have been optimized or tried.

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