Study Finds Costs of Brand Abuses Have Exploded in 4 Years, Harming Patient Access to Affordable Generic and Biosimilar Medicines
WASHINGTON DC (September 4, 2018) – Continued efforts to delay patient access to biosimilar and generic drugs have an increasing negative impact on patients, according to an updated report released today by Matrix Global Advisors (MGA). The report, commissioned by the Association for Accessible Medicines, examined the ongoing misuse of restricted access and Risk Evaluation and Mitigation Strategies (REMS) programs.
It found that such misuse results in $13.4 billion in annual lost savings, an increase of 250 percent in the last four years. In addition, abuse of restricted access programs can be expected to affect more biosimilars as their development increases.
According to the study, “Unrealized Savings from the Misuse of REMS and Non-REMS Barriers,” yearly lost savings include $5.2 billion to the federal government and more than $1.8 billion in additional out-of-pocket costs for patients. As the report’s author, MGA CEO Alex Brill, notes, the findings are conservative. Absent congressional action, these costs can be expected to increase.
“Unfortunately, withholding samples is an accepted business practice for some as a means to artificially protect and extend their monopolies beyond what Congress intended,” says AAM President and CEO Chip Davis. “That is why Congress must pass the bipartisan Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act.”
By preventing generic and biosimilar developers from obtaining samples needed to conduct studies for FDA approval, some brand manufacturers are able to delay or prevent competition from lower-cost medicines.
FDA Commissioner Scott Gottlieb has highlighted the importance of this issue, calling for brand companies to “stop the shenanigans” and publicly releasing a “name and shame” list of inquiries FDA has received from prospective generic applicants about brand drug products.
AAM Senior Vice President of Policy & Strategic Alliances and Executive Director of AAM’s Biosimilars Council Christine Simmon highlighted the impact of these abuses on biosimilars at FDA’s Facilitating Competition and Innovation in the Biological Products Marketplace public hearing:
“As biologic spending continues to grow, restricted access schemes will have an increasingly harmful effect on potential cost-saving biosimilar competition. Today, there are more than 60 biosimilar development programs underway – promising new savings and access for patients. But without access to samples of the brand reference products, it’s simply impossible for biosimilar manufacturers to develop more affordable alternatives to what’s currently available to America’s patients.”