Tufts Center for the Study of Drug Development

About: Tufts Center for the Study of Drug Development is a based out in . It is known for research contribution in the topics: Drug development & Clinical trial. The organization has 78 authors who have published 258 publications receiving 16047 citations.

Rising Drug Costs Drives the Growth of Pharmacy Benefit Managers Exclusion Lists: Are Exclusion Decisions Value-Based?

Abstract: Objective We examine whether drugs’ excluded versus recommended status on pharmacy benefit manager exclusion lists corresponds to evidence from cost-effectiveness analyses, lack of evidence, or rebates. Data Sources To find cost-effectiveness data for drugs on 2016 exclusion lists of CVS Caremark and Express Scripts, we searched the Tufts Cost-Effectiveness Analysis Registry and the peer-reviewed literature. Study Design For each excluded and recommended drug, we compared the mean cost-per-QALY, and we calculated the difference between the numbers of excluded and recommended drugs for which we could find no cost-effectiveness evidence. Data Collection As keywords in our searches, we used the brand and generic drug name and “cost-effectiveness” and “cost-per-quality-adjusted life-year.” Of 240 retrieved studies, 110 were selected for analysis. Principal Findings The mean cost-per-QALY for excluded drugs was higher ($51,611) than the cost-per-QALY for recommended drugs ($49,474), but not statistically significant. We could find no cost-effectiveness evidence in the Registry or peer-reviewed literature for 23 of the excluded drugs, and no evidence for 5 of the recommended drugs. Conclusions Cost-effectiveness does not correlate with a drug's excluded or recommended status. Lack of cost-effectiveness evidence favors a drug's excluded status.

Mobile Nurse Services in Clinical Trials Usage and Industry Perceptions

Abstract: With the pharmaceutical industry’s increased attention on enhancing patient experiences during their participation in clinical trials, the use of mobile nurse (MN) services to support the conduct of clinical trial assessments in the home (or in alternative locations other than in investigational sites) has been gaining momentum. Because no quantitative data capturing industry-wide practices are available, in July 2014, Tufts Center for the Study of Drug Development and Hoffman-La Roche conducted an online survey to gather data on the prevalence and utilization of MN services in clinical trials taking into account the following factors: industry perceptions of the business model, risks barriers to adoption, vendor landscape, cost, and prospects for future growth. A total of 113 respondents answered the survey, with 53 respondents answering all questions. The use of MN services in clinical trials is an established and growing business practice. Utilization of MN services has so far been most prevalent in North America, followed by Western Europe. Sponsor companies that have adopted this model have done so mainly to improve patient retention and protocol compliance, as well as improve access to rare patients. Most of the companies surveyed work directly with vendors specializing in home nurse services. Experience with vendors was considered favorable in most cases. Building effective partnerships with 1 to 2 vendors is considered a key factor for long-term success.

Are Regulation and Innovation Priorities Serving Public Health Needs

Abstract: A host of challenges confront healthcare authorities worldwide. Topping the list is the demand for innovative new medicines to treat a range of both infectious and non-communicable diseases, while containing spiraling healthcare costs. The challenge is particularly great in therapeutic areas where, despite significant medical need and economic impact, the technical challenges and commercial risk of development serve as disincentives to drug sponsors. These areas include cardiovascular diseases as well as diseases and disorders of the central nervous system. Currently, the development and approval of new active substances, with its disproportionate focus on oncology, is not in alignment with healthcare needs in most geographic regions. In this article, we discuss the origins of this misalignment and suggest various approaches to address healthcare needs going forward.