Case Western Reserve University

THURSDAY, March 6, 2025 -- Florida’s insurance regulator is demanding detailed prescription data on millions of patients, raising alarms over patient privacy. In January, the Florida Office of Insurance Regulation asked pharmacy benefit managers -- companies that manage prescription drug plans -- to hand over highly personal data about prescriptions filled in the state last year. The data request includes the patients' full names and dates of birth, names of medications filled and doctors they've seen. It’s unclear why the state wants these details. In a letter to one benefit manager reviewed by The New York Times , the regulator said Florida needed to check whether pharmacy benefit managers are following a 2023 state law that aimed to lower drug prices. But employers and others say the request could expose highly sensitive health data to misuse. “You don’t need such granular patient information for purposes of oversight,” Sharona Hoffman , a health law and privacy expert at Case Western Reserve University, told The Times . “You have to worry: Is the government actually trying to get information about reproductive care or transgender care or mental health care?” she added. The data demand comes at a time when Florida has passed strict laws restricting abortion access and transgender care. These laws require that doctors dispense abortion pills in person and limit access to gender-affirming care for minors. Florida’s data request could, in theory, be used to check whether doctors are following these laws -- although the state has not said whether that’s the reason, The Times reported. The American Benefits Council , which represents 430 large employers and service organizations, said the request "violates the health privacy and security of millions of Floridians,” and that the state had failed to clearly outline its authority or reasons for the action. “We have a duty to employees and their data,” Katy Johnson , the president of the council, said in an interview. Shiloh Elliott , a spokeswoman for the Florida Office of Insurance Regulation, said the objections “are clearly from those who do not want to be regulated or have any oversight in their industry." She added that the office “will continue to request data in the best interest to protect consumers.” Elliott added that concerns “should be addressed to the actual health care insurance companies that have had countless data breaches exposing millions of Americans’ sensitive information.” Experts say Florida already has access to prescription data for Medicaid patients, but that data is usually tightly restricted to staff who need it. Joseph Shields , president of Transparency-Rx, a trade group for smaller benefit managers, called Florida’s request “pretty expansive and unprecedented.” Rosa Novo , benefits director for Miami-Dade County Public Schools, which provides health insurance to about 45,000 people, told The Times she supports efforts to reduce drug prices -- but not at the expense of their privacy. “My doctor is the only one who should know that,” Novo said. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

BOSTON, Feb. 20, 2025 /PRNewswire/ -- Researchers from Analysis Group, a global leader in health economics and outcomes research (HEOR), have co-developed a new framework that leverages findings from clinical trials and real-world evidence (RWE) to assess the holistic value of innovative therapies that are used in multiple indications. The access-focused patient-centric (APAC) framework, described in an article published in Advances in Therapy, encourages formulary decision makers to take a broad and dynamic view of their utilization management responsibilities to ensure that patients have rapid, predictable, and sustained access to the treatments that they need. Advances in the development of highly targeted therapies have provided more effective treatment options for patients than ever before, including notably for those with immune-mediated inflammatory diseases (IMIDs) such as psoriasis, rheumatoid arthritis, and inflammatory bowel diseases. As a result of this and the evolving US health care system, there is an ever-growing need for a pragmatic approach for informing payers about the holistic value of innovative therapies used in multiple indications. However, commonly accepted economic modeling tools used by formulary decision makers for that purpose typically focus on clinical outcomes related to the effects of singular medications on individual diseases, as compared to established treatments. Although those tools may have historically been effective for their stated purpose, they may miss our contemporary understanding of the "whole disease" concept and may not reflect the full and evolving experiences of patients. For example, many patients living with IMIDs not only experience the symptoms of their respective conditions, but must also contend with the impacts of the disease on their quality of life, productivity, and interpersonal relationships, among other factors. Moreover, traditional tools are not designed to inform decision makers about the full value of medications that are indicated for multiple conditions, nor when a manufacturer offers a portfolio of such medications. To advance understanding in this area, an Analysis Group team led by Managing Principal Min Yang, Manager Qing Liu, and academic affiliate Lou Garrison collaborated with researchers from AbbVie and several prominent universities to jointly develop this novel APAC methodology. In the Advances in Therapy article, the authors describe the foundational elements of their approach and explain how it can be adapted to provide a common framework to help payers make informed and timely decisions about medication access. "The APAC framework emphasizes evidence-based patient-centricity," said Dr. Yang. "By accounting for both efficacy and impacts of advanced therapies on quality of life and productivity from a multi-indication formulary portfolio perspective, APAC can provide practical and quantifiable information that is relevant to formulary decision makers." The researchers conclude that the APAC framework "may serve as a bridge to communicate patient-centric benefits of innovative therapies" and that its use could allow formulary decision makers to better facilitate the timely delivery of innovative treatments. "Formulary decision making can be challenging, and effective utilization management is essential," commented Professor Garrison. "It was a pleasure to tackle this important issue with HEOR colleagues from Analysis Group, AbbVie, and academia to frame a new approach to this complex problem. This novel perspective emphasizes the role of utilization management as a complement to traditional cost-effectiveness analysis, aiming to support formulary decision makers in providing rapid and appropriate access in a patient-centered manner. This should help to efficiently deliver advanced therapies to health plan members, thereby improving their health outcomes while enhancing equity among patients." The article, "An Access-Focused Patient-Centric Value Assessment Framework for Medication Formulary Decision-Making in Immune-Mediated Inflammatory Diseases," was published in December by Advances in Therapy. In addition to Dr. Yang, Dr. Liu, and Professor Garrison, investigators included Drs. Manish Mittal, Pankaj Patel, and Jerry Clewell of AbbVie; Dr. A. Mark Fendrick of the University of Michigan; Dr. Diana Brixner of the University of Utah; Dr. Bruce W. Sherman of Case Western Reserve University; and Dr. Yifei Liu of the University of Missouri – Kansas City. Funding was provided by AbbVie. To learn more about Analysis Group's HEOR capabilities, visit . About Analysis Group's HEOR, Epidemiology & Market Access Practice Founded in 1981, Analysis Group is one of the largest international economics consulting firms, with more than 1,500 professionals across 15 offices. Analysis Group's health care experts apply analytical expertise to regulatory real-world evidence, health economics and outcomes research, clinical research, market access and commercial strategy, and health care policy engagements, as well as drug safety-related engagements in epidemiology. Analysis Group's internal experts, together with its network of affiliated experts from academia, industry, and government, provide our clients with exceptional breadth and depth of expertise and end-to-end consulting services globally. Contact: Analysis Group Jennifer Cathell, +1 617 425 8255 [email protected] SOURCE Analysis Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Scientists at the University of Pittsburgh Rehab Neural Engineering Labs (RNEL) say they helped advance new neuroprosthetic brain-computer interface (BCI) technology. The BCI technology could enable people to feel the shape and movement of objects over the “skin” of a bionic hand. Researchers published their study findings in Nature Biomedical Engineering and Science. The outcomes demonstrate the progress of a technology designed to recreate realistic tactile feedback to prosthetic hands by direct, carefully timed electrical stimulation of the brain. Researchers from the University of Chicago lead the group. It also includes scientists and engineers at Northwestern University, Case Western Reserve University and BCI maker Blackrock Neurotech. The University of Pittsburgh RNEL have teamed up before on BCI work, working on a BCI for remote trials back in 2022. Together, the scientists and engineers are designing, building, implementing and refining BCI devices and robotic prosthetic arms. These technologies could restore both movement control and sensation in those who lost significant limb function. “We hope to integrate the results of these two studies into our robotics systems, where we have already shown that even simple stimulation strategies can improve people’s abilities to control robotic arms with their brains,” said co-author Robert Gaunt, associate professor of physical medicine and rehabilitation and lead of the stimulation work at Pitt. The approach involves placing tiny electrode arrays in the parts of the brain responsible for moving and feeling the hand. On one side of the brain, the arrays allow a participant to move a robotic arm by thinking about movement. The other side uses feedback from sensors to trigger pulses of electrical activity. Known as intracortical microstimulation, this process produces a tactile sensation. Testing revealed that participants felt a stronger, clearer touch when the system stimulated two closely spaced electrodes. This improved their ability to locate and gauge pressure on the correct part of the hand. The complementary paper published in outlined how scientists identified pairs or clusters of electrodes whose “touch zones” overlapped. The scientists activated them in carefully orchestrated patterns, generating sensations that progressed across the sensory map. This created sensations that let users feel the boundaries of an object or the motion of something sliding along their skin. The researchers hope that the advancements could pave way for prosthetics that enable confident handling of everyday objects and responses to shifting stimuli.