April 23rd 2025
CMS’ draft guidance on real-world data study protocols marks a significant move toward transparency and rigor in Medicare coverage decisions.
February 12th 2025
A Complex Patent & Pricing Picture: Regulating Psychedelics More of a Journey Than a Trip
March 8th 2022Pharma and legal experts weigh in on the rush to secure intellectual property around psychedelic medicines, the value imperative that should govern pricing strategies, and the likely long-haul battle for more widespread decriminalization of these drugs.
Drug Costs Central Issue in Budget Battles
December 7th 2021As Congress struggles to reach agreement on funding for leading social and spending initiatives and to avoid default on government borrowing, the White House is emphasizing that reduced spending on prescription drugs can help offset some of the steep costs.
Generics Makers Also Fight Price Controls
November 12th 2021The Democratic proposal to authorize price negotiations on costly medicines covered by Medicare and to penalize firms that raise prices faster than inflation has drawn opposition pharma and biotech companies. More surprisingly, generic companies also are objecting to the changes on the table.
China 2021 National Reimbursement Drug List Outlook
November 11th 2021The 2021 National Reimbursement Drug List (NRDL) process has been unfolding in China since June this year, with several key themes emerging. Building on Simon-Kucher’s experience with the NRDL, the authors make three recommendations on negotiation strategies going into the process.
Improving Readiness for Volume-Based Procurement in China
October 13th 2021Volume-based procurement (VoBP) has been gathering momentum in China, both at national and regional levels. Major pharmaceutical players stand to see large impacts on their branded generics portfolio, and need to move fast to improve organizational and system readiness.
Will Price Controls Limit Drug Development? The Debate Heats Up
September 3rd 2021Legislative proposals for curbing outlays on prescription drugs have moved to center stage, as Congress looks hard for ways to pay for costly initiatives to repair the nation’s infrastructure, offset global warming and expand health care programs.
Project Orbis: Implications for Access and Pricing in the UK
February 17th 2021Post-Brexit, the UK’s MHRA is looking to join Project Orbis, a global program to speed up patient access to innovative cancer treatments. This article looks at the implications of Project Orbis for commercialization in the UK and the key considerations for industry in considering the project as a pathway.