US FDA Modernization Act, section 114: uses, opportunities and implications for comparative effectiveness research.

BACKGROUND: Section 114 of the 1997 US FDA Modernization Act (FDAMA) is an important vehicle for pharmaceutical companies to promote the economic value of their drugs to formulary decision makers, but little is known about how the Section has been interpreted and used. METHODS: We conducted a web-based survey of a convenience sample of 35 outcomes directors of major pharmaceutical and biotechnology companies. We asked them about their interpretation of, and experiences with, Section 114, as well as their views regarding the FDA's role in the matter, and whether the advent of comparative effectiveness research (CER) will affect the use of Section 114 promotions. RESULTS: Of the 35 experts, 16 (46%) completed the survey. 81% stated they always or frequently consider using Section 114 when making promotional claims for drugs. 75% stated that the FDA should issue guidance on how to make such promotions to payers, especially what qualifies as "healthcare economic information" and "competent and reliable scientific evidence." Most expected to use Section 114 to a greater extent in the future, and agreed that the increased focus on CER would increase Section 114 use. CONCLUSIONS: The survey suggests strong awareness about Section 114 among the outcomes directors and some use of the Section for promotional purposes. It also reflects a belief that CER will increase use of Section 114 promotions, and that guidance from the FDA is needed. More clarity - and, ideally, flexible interpretation - from the FDA is warranted, especially given the rise of CER.

Use of atypical antipsychotic drugs for schizophrenia in Maine Medicaid following a policy change.

More than one-third of Medicaid programs and Medicare Part D plans use prior authorization (PA) policies to control the use of atypical antipsychotics (AAs). We used Medicaid and Medicare claims data to investigate how Maine's PA policy affected AA use, treatment discontinuities, and spending among schizophrenia patients initiating AA therapy. Patients initiating AAs during Maine's policy experienced a 29 percent greater risk of treatment discontinuity than patients initiating AAs before the policy took effect; no change occurred in a comparison state. AA spending was slightly lower in both states. Observed increases in treatment discontinuities without cost savings suggest that AAs should be exempt from PA for patients with severe mental illnesses.

Physician perceptions of the use of medications for attention deficit hyperactivity disorder.

BACKGROUND: Attention deficit hyperactivity disorder (ADHD) is a prevalent mental health condition, occurring in 3% to 5% of school-aged children. Although stimulant medications are a recommended treatment for this disorder, physicians. views of these medications have not been systematically evaluated. OBJECTIVE: This study examined physician-prescriber perceptions of using medications to treat ADHD symptoms in children or adolescents. METHODS: A survey was developed with 4 physicians expert in treating ADHD in children. The survey was pilot-tested with a sample of 10 practicing physicians. A sample of 1,000 physicians, with a history of prescribing stimulant medications to children or adolescents, was randomly selected and mailed a 30-item survey. Items were rated on a 7-point response scale (strongly agree, agree, slightly agree, undecided, slightly disagree, disagree, strongly disagree). RESULTS: A total of 365 physicians responded to the survey, for a 37% response rate. More than 92% of respondents strongly agreed or agreed that ADHD symptoms cause problems in pediatric patients and stimulants are effective in treating ADHD. The stimulant drug side effects of decreased appetite or weight loss, sleep disruption, and exacerbation of anxiety were a concern (strongly agree or agree response) for 32%, 50%, and 22% of physicians, respectively. Diversion of ADHD medication was a concern for 19% of respondents. Physicians reported that controlled medications for children or adolescents with ADHD are a burden for themselves (32% strongly agreed or agreed), for their staff (37% strongly agreed or agreed), and for parents (40% strongly agreed or agreed). Approximately 38% of physicians responded that they would prefer prescribing a nonstimulant medication with a U.S. Food and Drug Administration indication for treating children or adolescents instead of a stimulant medication, and 58% would prefer prescribing a noncontrolled medication that does not have evidence of abuse potential versus one that is controlled and has evidence of abuse potential. CONCLUSION: Although physicians overwhelmingly perceive stimulant medications as being effective for treating ADHD symptoms in children or adolescents, many would prefer a nonstimulant medication. While many physicians consider the side effects of the stimulants easily managed, others are concerned about prescribing stimulants because of their side effects, risk of diversion, and administrative burden. The majority of physicians would prefer to prescribe a noncontrolled medication without abuse potential instead of a controlled medication to treat children or adolescents with ADHD.