Buprenorphine Access in California James J. Gasper, PharmD, BCPP Pharmacy Benefits Division Department of Health Care Services james.gasper@dhcs.ca.gov
Source: CDPH Vital Statisitics Death Statistical Master File Prepared by CDPH, Safe and Active Communities Branch Report generated from http://epicenter.cdph.ca.gov on Dec 19, 2014 Opioid Poisoning Deaths in California 5 year totals: 2008-2012 (All opioids, All intents) rate per 100,000 12 17.9 13.5 19 Statewide 4.9 22 23.9 17.6 13.2 16.3 11.2
No Methadone Maintenance in Rural/Northern Counties
Treatment Saves Lives Overdose Deaths Methadone Buprenorphine Schwartz et al. Am J Public Health 2013;103:917-922
History of Buprenorphine Discovered in 1966 Injectable form approved by FDA in 1985 for the treatment of pain (C-V) Sublingual form approved by FDA in 2002 for the treatment of opioid addiction (Rescheduled to C-III) Transdermal patch approved by FDA in 2010 and buccal film in 2015 for treatment of pain
How does it work Partial agonist on mu opioid receptor Binds with high affinity and dissociates slowly Pain relief, cravings, high Slowed breathing, nausea, vomiting, constipation Antagonist on kappa opioid receptor Interferes with the negative mood state of withdrawal Psychopharmacology 2002;161:1-16. J Substance Abuse Treatment 2000;18:277-281
Spectrum of Opioid Activity 100% Effect Opioid Agonist Opioid Effect Pharmacological Ceiling Opioid Partial Agonist Log Dose Opioid Antagonist Clinical Guidelines for the Use of Buprenorphine for the Treatment of Opiate Addiction 2004
Dose Response Effects at 2mg, 4mg, and 8 mg sublingual dose Physiological effects of increasing doses No difference between doses in heart rate, blood pressure, respiration rate, or oxygen saturation Subjective effect of increasing doses No difference in drug liking or intoxication Clin Pharmacokinet 2004;43:329-340
Wide Therapeutic Index Therapeutic Index = Median Lethal Dose Median Effective Dose 15000 10000 5000 0 464 Morphine 12,313 Buprenorphine Br J Pharmacol 1977;60:547
Buprenorphine for Addiction Percentage of Opioid Negative Urine Samples 25 20 * * n = 323 % 15 18 % 21 % 10 5 0 6 % BUP+NAL 16/4 BUP 16 PLB Bup 16 mg + * P<0.001 Naloxone Bup 16 mg Placebo NEJM 2003;349:949-58
Switching to Buprenorphine for Pain N = 35 Danielle Daitch et al. Pain Med 2014;15:2087-2094
Formulations Dosage Form Sublingual tabs/film Buccal film (high dose) Transdermal patch Buccal Film (low dose) Injectable Indication Addiction Addiction Pain Pain Pain
DATA 2000 Waiver: X number Allows qualified physicians to obtain a waiver from the requirement to obtain a separate DEA registration as a methadone clinic Can prescribe and administer schedule III - IV opioids FDA approved for the treatment of addiction Limited to 30 patients first year then may apply for a 100 patient limit (bill in Congress to increase to 250)
Prescribing Buprenorphine Pain Any DEA-licensed prescriber (including mid-levels) Any formulation Addiction DATA 2000 waivered physicians Sublingual tablets/film buccal film (high dose) Depends on the indication
Prescribing Buprenorphine Pain + Addiction What is the intended use?
Medi-Cal Coverage for Buprenorphine All formulations of buprenorphine are carved out from managed care regardless of the indication As of June of 2015 no TAR required for formulations FDA approved for addiction being used for addiction by a DATA 2000 waivered physician All other forms and indications require a TAR
Medi-Cal Coverage and Prescribing Requirements Form Indication TAR DATA 2000 waiver required Sublingual Film/Tabs, Buccal film (high dose) Transdermal patch Buccal film (low dose) Addiction No Yes Pain Yes No Pain Yes No Pain Yes No
Statewide Initiatives Removal of TAR requirement last June for addiction All plan letter to health plans (must cover physician services when prescribing buprenorphine as part of managed care) Drug Medi-Cal Organized Delivery System (to provide full spectrum of addiction treatment) CDC grant supporting academic detailing in high burden communities for providers and pharmacists HRSA funding for 36 clinics in CA to expand access to substance abuse services Opioid Safety Coalitions Network Plus everything CHCF is doing!