Effectiveness of a Retrospective Drug Utilization Review on Potentially Unsafe Opioid and Central Nervous System Combination Therapy.

BACKGROUND: Drug overdose deaths are the leading cause of unintentional death in the United States, and opioid-related mortality is the primary contributor (75.2%). Among opioid-related mortalities, opioids are most commonly taken with benzodiazepines (30.1%) and antidepressants (13.4%). The utility of a retrospective drug utilization review (DUR) program initiated by a commercial health plan for members taking potentially unsafe opioid and central nervous system (CNS) combination therapy is currently unknown. OBJECTIVE: To determine the effectiveness of a retrospective DUR program on potentially unsafe opioid and CNS combination therapy. METHODS: This research is a pre-post study utilizing pharmacy claims data from 2.6 million commercially insured members enrolled in a health plan in the Midwest. Members were required to be at least aged 18 years as of August 30, 2013, and continuously enrolled from May 2, 2013, through February 15, 2014. Members with 1 or more paid claims for an opioid at least 200 morphine equivalent dose (MED) daily and a concur- rent supply of another opioid, benzodiazepine, or antidepressant from May 2, 2013, through August 30, 2013 (120-day preintervention period) were targeted for the retrospective DUR program. These exclusion criteria were applied: members belonging to commercial groups requiring permission on claims data analyses, missing or invalid prescriber information, or presence of pharmacy claims indicating human immunodeficiency virus or acquired immunodeficiency syndrome during the 2 years prior to the pre-intervention period. Prescribers of high-dose opioids received a mailing (intervention) containing a member-specific letter, medication profile, and satisfaction survey to determine the prescriber-perceived clinical value of the program. To assess the effectiveness of the retrospective DUR program, criteria was reapplied to identify members still meeting criteria 120 days postintervention (February 15, 2014). Paired samples t-test was used to compare pre-post results. RESULTS: Of 2,236,243 eligible members aged 18 years and older, 980 met DUR criteria. Prescribers for these members subsequently received a mailing regarding potentially unsafe opioid and CNS combination therapy. A total of 671 prescribers were sent a mailing regarding these 980 members. Among the 980 members meeting DUR criteria, distribution of prescriber specialty was family medicine (25.9%), physical medicine and rehabilitation (14.4%), internal medicine (13.0%), pain (9.2%), anesthesiology (7.0%), other (8.8%), and unknown (21.7%). High-dose opioids most commonly identified by the DUR were oxycodone extended release (27.6%), morphine sulfate extended release (17.7%), and fentanyl patch (13.1%). After reapplying DUR criteria to identify members still meeting criteria 120 days after the DUR, 528 members remained, representing a 28.1% reduction in high-risk opioid use. Survey response rate was 23.6% (231 of 980 surveys returned). The majority (62.3%) of respondents reported that this retrospective DUR program was useful in their daily practice. CONCLUSIONS: A 28.1% reduction in potentially unsafe opioid and CNS combination therapy was observed after implementing a retrospective DUR program targeting high-risk opioid use. Among members remaining high risk after the DUR, the change in total unique opioids and total daily MED was nonsignificant. Members remaining at high risk after the DUR can be targeted for further interventions such as care management and member education regarding fraud, waste, and abuse. A majority of prescribers (90.5%) self-report using their states' prescription monitoring programs when prescribing controlled substances.

Formulary management of 2 new agents: lorcaserin and phentermine/topiramate for weight loss.

BACKGROUND: Obesity may lead to the development of multiple chronic disease states, including hypertension, dyslipidemia, and type 2 diabetes mellitus. Over a half billion adults worldwide are affected by obesity, and more than two-thirds of adults are either obese or overweight in the United States. Diet and exercise have been the mainstays of treatment in this population; however, once failed, noninvasive, long-term effective treatment modality is lacking, and medications may potentially fill the void. Lorcaserin and phentermine/topiramate were approved by the FDA in June 2012 and July 2012, respectively, as adjuncts to diet and exercise for chronic weight management of obese (body mass index [BMI] ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) individuals with comorbidities. OBJECTIVE: To review the phase 3 trials of lorcaserin and phentermine/topiramate and provide managed care considerations that may be taken into account as a result. METHODS: A MEDLINE review was performed for articles published and available through September 17, 2012, using keywords "lorcaserin" or "phentermine/topiramate" with an emphasis on phase 3 trials. The literature search was limited to randomized controlled trials in humans published in the English language. Additional information on lorcaserin from its FDA review was obtained from the FDA website. RESULTS: 5 pivotal phase 3 trials were identified: 3 for lorcaserin and 2 for phentermine/topiramate. Both agents demonstrated a statistically significant higher proportion of individuals who lost ≥ 5% of body weight, as well as higher mean weight loss when compared with placebo. Safety concerns for lorcaserin include cardiac valvulopathy and increased risk of psychiatric, cognitive, and serotonergic adverse effects. Teratogenicity and increased heart rate are major safety concerns regarding phentermine/topiramate. CONCLUSIONS: Health care decision makers have many factors to consider when developing strategies to fight obesity. Despite a great need for new therapies to treat obesity, medications used for weight loss have significant side-effect profiles and contraindications that may limit therapy. An appropriate utilization management strategy is needed.