Contact

PORTAL generates evidence to advance safe, effective, and affordable medications.

Our Work

PORTAL is one of the nation’s leading independent academic research groups addressing the development, regulation, evidence-based use, and cost of medical products.

PORTAL is an interdisciplinary team focused on generating evidence to make people healthier and live longer by improving how prescription drugs and other therapeutics are developed, regulated, used, and reimbursed. We deliver rigorous, timely research and engage with stakeholders to advance evidence-based policy solutions.

PORTAL is a research group in the Division of Pharmacoepidemiology and Pharmacoeconomics within the Department of Medicine at Brigham and Women’s Hospital and Harvard Medical School.

Innovation Incentives and Competition

Regulation and Clinical Evidence

Price, Value, and Access
Featured Article

List Price Reductions Among Brand-Name ICS-LABA Inhalers In 2024 Were Associated With Increased Generic Uptake

Han J, Wang SV, Kesselheim AS, Avorn J, Feldman WB | Health Affairs

Following the American Rescue Plan Act’s removal of the Medicaid rebate cap in January 2024, brand-name ICS-LABA manufacturers reduced list prices by 21-50%, and generic ICS-LABA use immediately increased by 23%, driven by gains in commercial plans and Medicare. The authors conclude that these list price reductions likely limited brand-name manufacturers’ ability to offer large rebates to pharmacy benefits managers (PBMs), disrupting financial incentives that had previously affected formulary design that suppressed generic uptake.

Read More

Subscribe to the PORTAL Post

Get the latest research and updates from PORTAL delivered straight to your inbox in our monthly newsletter.

Submit Form

New to Prescription Drug Policy?

Join the more than 100,000 people who have enrolled in our free, online HarvardX course, Prescription Drug Regulation, Cost, and Access: Current Controversies in Context. Led by PORTAL faculty, this course explores the major issues affecting the regulatory approval and evidence-based use of prescription drugs.

The Latest From PORTAL

Talk bubble graphics representing commentary and opinion.

Reforming Payment for Clinician-Administered Drugs—Most-Favored-Nation Pricing in Medicare Part B

Hwang TJ, Clemans-Cope L, Kesselheim AS - New England Journal of Medicine

  • Commentary & Opinion
| May 2026
  • Price, Value, and Access
The Trump administration’s proposed GLOBE model would align Medicare Part B payments for clinician-administered drugs with international pricing benchmarks, with CMS estimating $11.9 billion in Medicare savings and $6.2 billion in reduced beneficiary cost-sharing over seven years. The model would be strengthened by incorporating clinical benefit into rebate determinations, replacing the lowest-available-list-price benchmark with average international prices to reduce manufacturer gaming, and expanding the program nationwide if evidence of improved health outcomes emerges.
View Source
Simple graphic of magnifying glass examining papers to signify reviewing research publications.

Implications of Medicare Negotiation and Most-Favored-Nation Pricing for Cancer Medicine Costs

Hwang TJ, Tibau A, Kesselheim AS, Vokinger KN - JAMA Health Forum

  • Research Publications
| May 2026
  • Price, Value, and Access
In this cohort study of brand-name cancer drugs in Medicare Part B and Part D, applying most-favored-nation (MFN) pricing tied to international benchmarks in 2024 could have reduced Medicare drug spending by an incremental 28-41% compared to Medicare negotiation alone. However, the long-term sustainability of MFN savings is uncertain given the potential for manufacturer gaming, and policymakers should explore sharing savings with patients by eliminating out-of-pocket costs for highly effective therapies.
View Source
Talk bubble graphics representing commentary and opinion.

Op-Ed: Congress Must Repair USPTO’s Inter Partes Review Process

Tu SS, Rai AK, Kesselheim AS - Law360

  • Commentary & Opinion
| May 2026
  • Innovation Incentives and Competition
Recent administrative changes at the USPTO, including centralized institution authority, unexplained discretionary denials, and non-merits-based decision criteria, have sharply constrained access to inter partes review and are now spreading to ex parte reexamination, leaving fewer viable mechanisms to challenge potentially invalid patents. Congress should enact legislation requiring written explanations for all denials, subjecting those decisions to judicial review under the Administrative Procedure Act’s arbitrary and capricious standard, and reestablishing IPR’s core function of removing erroneously granted patents to protect competition and the public interest.
View Source
View More

Program On Regulation, Therapeutics, And Law (PORTAL)
Division of Pharmacoepidemiology and Pharmacoeconomics
Brigham and Women's Hospital • Harvard Medical School
41 Avenue Louis Pasteur, Suite 0B17, Boston, MA 02115

©2026 Program On Regulation, Therapeutics, And Law (PORTAL). All rights reserved.