In a recent post on the IVI-sponsored Health Affairs featured blog series, Tim Horn and Sean Dickson propose changes to the current system of drug pricing regulation focusing on four areas: Pricing formulas Price increase penalties Pool pricing guidelines Reporting transparency Read the full article here. About the Health Affairs/IVI Featured Blog Series: Drugs and Medical Innovation [...]
In a recent post on the IVI-sponsored Health Affairs featured blog series, Jerry Avorn sums up the status quo in medical regulation and evidence-based prescribing. Avorn uses his commentary to call out flaws in the 21st Century Cures Act, illustrate how the appointment of a new FDA Commissioner may influence "right-to-try" laws, and discuss the promise [...]
In a recent post on the IVI-sponsored Health Affairs featured blog series, Max Bronstein, Emil Kakkis, David Fajgenbaum, and Chip Chambers address the current landscape of drug development, making the case for the OPEN ACT (Orphan Product Extensions Now, Accelerating Cures and Treatments), new legislation that would extend the exclusivity period for any drug repurposed for [...]
In a recent post on the IVI-sponsored Health Affairs featured blog series, Robert Bohrer addresses the current system in place for the accelerated approval of novel drugs and notes the delicate issues that regulators are confronted with. Bohrer suggests that a new "conditional approval" approach may be the best compromise and provide a way forward. Read [...]
In a recent post on the IVI-sponsored Health Affairs featured blog series, Sarah Rosenberg-Wohl and coauthors discuss the potential of private insurer funding for CER through "Coverage with Evidence Development," using the Wisdom Study as a real-world case study. Read the full article here. About the Health Affairs/IVI Featured Blog Series: Drugs and Medical Innovation -- In partnership [...]
In a recent post on the IVI-sponsored Health Affairs featured blog series, Claire Laporte explains why the patent process dispute between biosimilar and branded drug manufacturers is headed all the way to the Supreme Court and why the outcome could influence intellectual property laws and protections for trade secrets. Read the full article here. About the Health [...]
In a recent post on the IVI-sponsored Health Affairs featured blog series, Peter Bach, Zachary Helms, and Nancy Yu leverage public data to estimate both the premiums that companies earn and the amount they spend on research, challenging pharmaceutical companies' claims regarding R&D spending. Read the full article here. About the Health Affairs/IVI Featured Blog Series: Drugs [...]
In a recent post on the IVI-sponsored Health Affairs featured blog series, the National Pharmaceutical Council's Robert Dubois (also member of IVI Strategic Advisory Panel) and Kimberly Westrich examine current value assessment models' readiness for use in healthcare decision-making. Applying NPC's 35 Guiding Practices, they conclude that all existing frameworks possess individual strengths and weaknesses, but [...]
In a recent post on the IVI-sponsored Health Affairs featured blog series, Jonathan Darrow, Aaron Kesselheim, and Jessica Lasky-Su outline the goals and promise of the Precision Medicine Initiative and Cancer Moonshot. Although they also outline some of the key challenges and limitations, the authors recognize that there is a significant opportunity to translate the advances [...]
In a recent post on the IVI-sponsored Health Affairs featured blog series, Robert Galvin and Troyen Brennan make the case for employers and pharmacy benefit managers to challenge drug manufacturers' pricing models as a means of keeping costs in check, particularly in regard to launch prices. They suggest a strategy in which employers and pharmacy benefit [...]
