ASRA leadership has written letters to both Blue Cross Blue Shield of Tennessee and Highmark Blue Cross Blue Shield of Pennsylvania to raise critical concerns about the classification decision, citing evidence that not only does HF-10 demonstrate clinical effectiveness, but the therapy is a welcomed nonopioid option for patients.
“This modality is precisely the sort of treatment that the CDC Guideline would seem to recommend in light of the opioid crisis in America,” said Dr. David Provenzano, president of Pain Diagnostics and Interventional Care in Sewickley, PA.
The Centers for Disease Control (CDC) Guideline for Prescribing Opioids for Chronic Pain urges physicians to find nonopioid therapies for patients experiencing chronic pain. One such therapy is HF-10, Provenzano argues. The treatment has been found to provide significant improvement in 67% of patients, according to a key randomized clinical trial (RCT) published in 2015 by Leonardo Kapural, MD, and colleagues. By comparison, studies of patients receiving pharmacologic therapy have demonstrated less than 50% have significant improvement (Dworkin et al., 2003).
The Kapural study, in fact, was used to support the Food and Drug Administration's original approval of HF-10, and, as one of the largest-ever RCTs of SCS interventional pain therapy, the work recently received the highest quality score in a systematic review and methodological assessment of SCS therapies by Grider et al. (2015).
As more evidence pours in showing the toll that opioids are taking on our society, including a recent study in JAMA suggesting they may even increase the risk of heart attack (Ray et al., 2016), finding alternative therapies is critical to helping patients with chronic pain.
The American Society of Regional Anesthesia supports the CDC Guideline for Prescribing Opioids for Chronic Pain with some caveats. One concern that ASRA, along with the American Society of Anesthesiologists, raised with the CDC in advance of the guideline's final publication, was that nonopioid interventional options may not be covered by insurance. In the case of HF-10, that prediction has come to fruition.
Dr. Provenzano is a member of the ASRA Board of Directors. ASRA is the largest anesthesiology subspecialty association with 4,000 members in more than 60 countries.
References
Dworkin RH, Backonja M, Rowbotham MC, et al. Advances in neuropathic pain: Diagnosis, mechanisms, and treatment recommendations. Arch Neurol 2003; 60: 1524-34.Grider JS, Manchikanti L, Carayannopoulos A, et al. Effectiveness of spinal cord stimulation in chronic spinal pain: A systematic review. Pain Physician 2016; 19: E33-54.Kapural L, Yu C, Doust MW, et al. Novel 10-kHz high-frequency therapy (HF10 therapy) is superior to traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain: The SENZA-RCT randomized controlled trial. Anesthesiology 2015; 123: 851-60.Ray WA, Chung CP, Murray KT, Hall K, Stein M. Prescription of long-acting opioids and mortality in patients with chronic noncancer pain. JAMA 2016; 315:2415-23. doi: 10.1001/jama.2016.7789
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