Here is the substantive part of the appeal (skipping lead and end/wrap paragraphs as they contain history and private information).... Now for the necessary stuff....if you use this, do NOT plagiarize and reword to meet your situation/use only what may apply to you. In ALL circumstances, your use is voluntary and predicated upon your pledge to conduct your own research and is now and forever used at your own risk or benefit. Thus you assume responsibility for choosing to incorporate any of this medical research data into any appeal. Terms of use are binding upon your heirs and assigns:
Summarily, in patient/policy holder handbook insurer holds out either FDA approval based on treatment intended for a specified medical diagnosis (in this case, a pharmaceutical treatment OR recognition in clinical study or a review article in a “major” peer reviewed professional journal such that the efficacy of Buprenorphine/Suboxone is demonstrative, over time, in the health outcomes of the study participants and that benefits outweigh effects. Please accept the following scholarly data found in response to same:
1. Johnson RE, Fudula PJ, Payne R. Buprenorphine: Considerations for Pain Management. J Pain Symptom Manage. 2005; 29(3):297-326. Rolley E. Johnson, Ph. D., Behavioral Pharmacology Research Department, Johns Hopkins University, and in the forefront of matters of Buprenorphine studies in pain management says to his fellow practitioners in way of peer journaling: “Buprenorphine, is a partial mu-opioid agonist which has been in clinical use for over 25 years, and has been found to be amenable to new formulation technology based on its physiochemical and pharmacological profile”.
2. In Europe, Buprenorphine (in transdermal form) has been approved for the treatment of chronic pain (e.g., Griessinger, Sittl, & Likar, 2005; Sittl, 2005).
3. The off-label use of sublingual buprenorphine tablets to treat chronic pain has been described in two clinical reports, one describing its use in a series of chronic pain patients who were responding poorly to other opioid analgesics (Malinoff et al., 2005) See “Sublingual Buprenorphine is Effective in the Treatment of Chronic Pain Syndrome – Am J Ther. 2005 Sep-Oct.12(5):379-84”, abstract as follows:
“Many patients with chronic pain have less than optimal therapeutic outcomes after prolonged treatment with opiate analgesics. Worsening of pain perception, functional capacity, and mood often result. Medical detoxification is often undertaken in this situation. Ninety-five consecutive patients (49 men and 46 women; age range, 26-84) with chronic noncancer pain (maldynia) were referred by local pain clinics for detox-ification from long-term opiate analgesic (LTOA) therapy. All patients had failed treatment as manifest by increasing pain levels, worsening functional capacity, and, in 8%, the emergence of opiate addiction. Length of prior LTOA therapy ranged from 1.5 to 27 years (mean, 8.8 years). After a minimum of 12 hours of abstinence from all opiate analgesics, patients were given low doses of sublingual (SL) buprenorphine or buprenorphine/ naloxone (Reckitt Benckiser). Maintenance dosing was individualized to treat chronic pain. Daily SL dose of buprenorphine ranged from 4 to 16 mg (mean, 8 mg) in divided doses. Mean duration of treatment is 8.8 months (range, 2.4-16.6 months). At clinic appointments, patients were assessed for pain reports, functional capacity, and mood inventory. Eighty-six percent of patients experienced moderate to substantial relief of pain accompanied by both improved mood and functioning. Patient and family satisfaction was robust. Only 6 patients discontinued therapy secondary to side effects and/or exacerbation of pain. In this open-label study, SL buprenorphine and buprenorphine/naloxone were well tolerated and safe and appeared to be effective in the treatment of chronic pain patients refractory to LTOA.
and the other describing the response of patients with both pain and addiction (Heit & Gourlay, 2008 Clinical Journal of Pain wherein it is noted that Buprenorphine is known for its “off-label” use for “both acute and chronic pain”).
In both of these reports, the authors reported that their patients were successfully treated with Buprenorphine, with resultant pain relief and improved mood and functioning.
4. In a similar manner, two earlier publications describe the open-label use of the parenteral formulation of Buprenorphine administered sublingually to treat patients with chronic pain (Adriaensen, Mattelaer, & Vanmeenen, 1985; Nasar, McLeavy, & Knox, 1986). Both studies reported good analgesia and low incidence or time-limited unwanted side effects.
5. There is also evidence from several preclinical studies and one study with human subjects that, in contrast to pure mu-agonists, Buprenorphine exerts a lasting anti-hyperalgesic effect (Hans, 2007; Koppert, et al., 2005).
6. Published case report of improvement in PTSD symptoms when Buprenorphine was used. Danovitch, 2009.
7. 717 Iraq and Afghanistan veterans with PTSD and chronic pain, who switched from opioid to Buprenorphine therapy had significantly improved PTSD and pain symptom severity scores compared to controls who remained on moderately high-dose opioid therapy pursuant to the preliminary data of Dr. Karen Seal, et al. Additionally, Dr. Seal said that VA database searches revealed “signal of significant improvement in co-morbid PTSD patients” that were converted from traditional opioids to buprenorphine in comparison to a control group that remained on moderately high dose opioids at fifty morphine equivalents a day or more was referred to in continuing research.
Perhaps of poignant interest to insurer should be the study which supports total cost effectiveness despite the increased pharmacological costs of Buprenorphine (over that of traditional, opioids) via the marked lowering of related health services (to include inpatient, outpatient and Emergency room charges) pertaining to Buprenorphine-medication assisted therapy (B-MAT) adherent patients, resulting in an total average health care cost increase of per patient of over $20,000 when the insurance company (in this cited study, Aetna) denied B-MAT therapy based on the linear models therein compiled.
See, J Subst Abuse Treat., 2014 Apr; 46(4):456-62. doi: 10.1016/ j.jsat.2013.10.014. E-publication 2013 Nov 12 as found on NCBI –US National Library of Medicine National Institutes of Health at PUBMed.gov.
