Celgene’s Richard Bagger Elected NPC Board Chair
(11/28, Chain Drug Review) reports “...‘I look forward to serving as chair of NPC’s board of directors and working to further NPC’s examination of important health policy questions,’ Bagger said. ‘As we continue to move toward a more value-driven health care system that provides innovative treatments for patients and advances creative solutions to health care challenges, NPC’s work in exploring key issues of evidence, value, access and innovation is more important than ever. It is an honor, together with my fellow board members, to support NPC’s important work.’” Full
Amgen Cuts Repatha's Price By 60 Percent. Will Value-Based Pricing Support Value-based Patient Access?
(11/28, James C. Robinson, Health Affairs Blog) comments “...Sanofi now have reduced the net price of PCSK9 inhibitors towards ICER's value-based benchmarks. If value-based prices of this sort are to be sustained, they need to be accompanied by value-based patient access. Access begins with the removal of onerous prior authorization and cost sharing obstacles but extends to active support for appropriate prescription and adherence. Such active support is necessary in many clinical areas, but is particularly challenging for cardiovascular disease therapies.” Full
Real-World Data of Lacosamide for Focal Seizures Confirms Clinical Trial Outcomes
(11/29, Kenneth Bender, PharmD, MA, MD Magazine) reports “Outcomes and safety experiences with lacosamide (Vimpat) monotherapy for focal seizures in real-world practice were found to be similar to those in clinical trials, although with seizure-free status attained by more patients who received lacosamide as first-line monotherapy than those converted to lacosamide after unsatisfactory or adverse response with other antiepileptic drug treatments.” Full
Video: Turning Raw Data into Real-World Evidence
(11/29, PCORI) “Robert Califf, Chair of the Board of Directors for the People-Centered Research Foundation, shares how PCORnet, PCORI, and other organizations are harnessing raw data to uncover real-world evidence that will allow patients and their families to make better-informed healthcare decisions.” View Video
Big Data Firm Tackles "Regulatory Grade" Real-World Evidence (RWE)
(11/28, Pharmaceutical Commerce) reports “By calling itself the ‘world's first digital contract research organization,’ Verantos is putting out a marker that gathering the clinical data necessary for drug approvals is going to be different, going forward. The company has now launched a commercial service to gather data from electronic health records , process the data in its system that includes natural language processing and machine learning, and produce observational (or other types) of clinical data of sufficient quality to, for example, justify approval of new indications for drugs.” Full
Clinical Challenges: Do Asthma Biologic Benefits Justify High Cost?
(11/28, Salynn Boyles, MedPage Today) reports “...‘All five biologics modestly reduce asthma exacerbations and improve daily quality of life,’ ICER Chief Medical Officer David Rind, MD, noted in a statement released on Nov. 13. ‘However, the treatments' net prices appear to be far out of alignment with these incremental clinical benefits, and the entire therapy class would need to see price discounts of at least 50% to reach commonly cited thresholds for cost-effectiveness.’” Full
School of Public Health Awarded $4 Million for Training Program to Improve Patient Care Research
(11/29, Mohamed Ibrahim, Minnesota Daily) reports “...The program, called the Learning Health System Mentored Career Development Program (MN-LHS), is funded by a $4 million grant from the [AHRQ], as well as [PCORI]. The program is one of 11 chosen to receive the grant which will be disbursed over five years. ‘It's kind of flipping it around, where it's narrowing the gap between academia and practice,’ said Tim Beebe, a professor in the University's School of Public Health and program co-director. ‘It's just a different way of doing research, and the genesis of questions is more grassroots and inductive.’” Full
UK: NICE Approves Bayer's Liver Cancer Drug
(11/29, Joy Persaud, PharmaPhorum) reports “NICE has given Bayer's advanced liver cancer therapy Stivarga (regorafenib) the go-ahead after it undertook a rapid review following earlier guidance that rejected the drug. The medicine is for adults in England and Wales whose liver is well functioning but unable to be surgically removed and who have already taken Bayer's life extending medicine Nexavar (sorafenib).” Full
Lilly to Present Clinical Data for Verzenio® (abemaciclib) and Real-World Evidence across HR+, HER2- Metastatic Breast Cancer at 2018 SABCS
(11/29, Eli Lilly Press Release) “...‘The presentations at SABCS encompass a wide range of data on Verzenio – from new analyses evaluating Verzenio's single agent activity in advanced breast cancer to more information investigating its potential use in early stage disease – along with real-world evidence analyses on advanced breast cancer that can help inform oncologists as they individualize treatment decisions for their patients living with metastatic disease,’ said Maura Dickler, M.D., vice president, late phase development, Lilly Oncology.” Full
ICER Appoints Athelia "Tia" Tilson as Vice President of Development
(11/29, ICER Press Release) “...Most recently at Ariadne Labs, a joint center of health systems innovation at Brigham and Women's Hospital and the Harvard Chan School of Public Health, Ms. Tilson has more than 20 years of experience in fundraising in higher education, hospitals, and global health. As Director of Development at Ariadne Labs, she led a $25 million three-year fundraising campaign, surpassing its goal by raising $32 million in only two years. Ms. Tilson has played key strategic roles in introducing, developing and growing fundraising programs at MIT, Boston Children's Hospital and Pathfinder International.” Full
UNC Researchers Awarded $1.3 Million to Put Diabetes Discovery into Practice Across the U.S.
(11/29, UNC Health Care Press Release) “UNC School of Medicine researchers Katrina Donahue, MD, MPH, and Laura Young, MD, PhD, have been awarded $1.3 million for the PCORI Dissemination and Implementation project titled ‘Rethink the Strip: De-adoption of Glucose Monitoring for Non-Insulin Treated Type 2 Diabetes in Primary Care.’ [PCORI] funds studies that help patients and those who care for them make better-informed healthcare decisions.” Full
PCORI Offers up to $20M for Anxiety Treatment Research
(11/28, America's Essential Hospitals News Release) “A new funding opportunity through [PCORI] will provide up to $20 million for comparative effectiveness studies of evidence-based clinical strategies to treat anxiety disorders in children, adolescents, and young adults...PCORI will release a full funding announcement on Jan. 3, 2019, and hold an informational town hall session for interested applicants on Jan. 22 at noon ET.” Full
Meta-Analyses and RCTs in Oncology—What Is the Right Balance?
December 2018, The Lancet Oncology
The Lancet Oncology
NPC @ AcademyHealth 2019 National Health Policy Conference
February 4 - 5, 2019
National Pharmaceutical Council