FDA Breakthrough Therapy Designation Reduced Late-Stage Drug Development Time.

The Food and Drug Administration's (FDA's) breakthrough therapy designation (BTD) program was created to increase patient access to safe and effective therapies by supporting the efficient clinical development of qualifying, clinically meaningful therapies. Using a new data set of key development milestones for drugs approved between 2006 and 2020, including both BTD drugs and a set of comparator drugs identified by FDA experts, we estimated the BTD program's impact on time spent in late-stage clinical development, measured as the elapsed time between a drug's end-of-Phase-II meeting with regulators and its approval for marketing. Our analysis suggests that the BTD program lowers late-stage clinical development time by 30 percent. Our findings provide insight into future regulatory and innovation policies aimed at driving efficiency in medical product development to ensure timely patient access to the most clinically meaningful therapies.

Benefit-Cost Analysis of the HHS COVID-19 Campaign: April 2021-March 2022.

INTRODUCTION: This study estimated the benefits and costs of the U.S. Department of Health and Human Services' We Can Do This COVID-19 public education campaign (the Campaign) and associated vaccination-related impacts. METHODS: Weekly media market and national Campaign expenditures were used to estimate weekly first-dose vaccinations that would not have occurred absent the Campaign, weekly Campaign-attributed complete vaccinations, and corresponding COVID-19 cases, hospitalizations, and deaths averted. Benefits were valued using estimated morbidity and mortality reductions and associated values of a statistical life and a statistical case. Costs were estimated using Campaign paid media expenditures and corresponding vaccination costs. The net Campaign and vaccination benefit and return on investment were calculated. Analyses were conducted from 2022 to 2024. RESULTS: Between April 2021 and March 2022, an estimated 55.9 million doses of COVID-19 vaccines would not have been administered absent the Campaign. Campaign-attributed vaccinations resulted in 2,576,133 fewer mild COVID-19 cases, 243,979 fewer nonfatal COVID-19 hospitalizations, and 51,675 lives saved from COVID-19. The total Campaign benefit was $740.2 billion, and Campaign and vaccination costs totaled $8.3 billion, with net benefits of approximately $732.0 billion. For every $1 spent, the Campaign and corresponding vaccination costs resulted in benefits of approximately $89.54. CONCLUSIONS: The We Can Do This COVID-19 public education campaign saved more than 50,000 lives and prevented hundreds of thousands of hospitalizations and millions of COVID-19 cases, representing hundreds of billions of dollars in benefits in less than one year. Findings suggest that public education campaigns are a cost-effective approach to reducing COVID-19 morbidity and mortality.

A survey on perceived medication guide reading and comprehension ease among US adults.

Medication guides (MGs) provide patients with important information about certain prescription drugs to help them take these drugs safely. We surveyed US residents about their perceptions of MG readability and understandability. We randomly sampled 5204 US residents (age 18+) from Ipsos's KnowledgePanel to complete a two-part survey. Only respondents who reported receiving an MG with their prescription drugs (n = 3852) completed part 2, which included two key items: How easy to [(1)read/(2)understand] are the MGs that you have received from a pharmacy along with your prescription medicines? (1 = Very easy, 5 = Very difficult; reverse-coded). Health literacy (HL) and demographic data were also collected. After weighting our data, we found that 85% of respondents who reported receiving an MG perceived this information as 'very easy' (27.3%), 'somewhat easy' (28.3%) or 'about average' (29.3%) to read. Eighty-seven percent of respondents who reported receiving an MG perceived it as 'very easy' (27.6%), 'somewhat easy' (30.2%) or 'about average' (29.5%) to understand. ANOVAs revealed higher average perceived MG reading and comprehension ease scores among respondents presumed to have adequate versus inadequate HL (ps ≤ 0.0006). Younger or less-educated respondents and non-Hispanic Blacks perceived MGs as easier to read and understand, on average, than their counterparts (ps ≤ 0.0001). Many of these relationships remained intact in models predicting perceived MG reading and comprehension ease (ps ≤ 0.001). Adjusted R2 values across models were small, however (≤0.06). Our findings suggest most US residents (18+) who received MGs perceived them to be 'about average' to 'very easy' to read and understand.

Physician Understanding and Willingness to Prescribe Biosimilars: Findings from a US National Survey.

BACKGROUND: Biosimilars have the potential to increase patient access and significantly reduce healthcare costs in the US. However, uptake in the US has been slower than anticipated, limiting the benefits of biosimilar competition. Understanding the factors that affect uptake is critically important to realize the benefits of biosimilars. METHODS: A US national survey study was conducted electronically from December 11, 2019 to January 8, 2020. The survey was administered to 507 US healthcare professionals practicing in dermatology, gastroenterology, hematology, oncology, nephrology, or rheumatology. The survey evaluated prescriber attitudes toward biosimilars in general, as well as prescriber decision making, using a series of hypothetical scenarios with fictional biological products. RESULTS: Fewer than half had a baseline understanding of key elements of biosimilarity, even among respondents who had previously prescribed a biosimilar. Regardless of previous experience, all respondents benefited from receiving additional information about biosimilarity, indicating the potential benefits of educational efforts for prescribers across all specialties and levels of experience. Prescriber choice was driven primarily by formulary status; however, respondents identified a variety of factors that would influence their willingness to prescribe a biosimilar, including financial savings to the patient, pharmacovigilance, patient experience, and education on the FDA approval process. Over one-third of participants indicated a preference for reference products and nearly half indicated a hesitancy to try biosimilars until they have been on the market longer. Naming conventions for biosimilars did not affect prescribers' willingness to prescribe biosimilars. CONCLUSIONS: Gaps in prescriber knowledge and hesitancy toward biosimilars remain significant challenges for biosimilar uptake. While formulary status of a biosimilar product strongly influences prescriber choice, additional prescriber education on biosimilarity is needed.