The landscape around us looks much different today than it did just one year ago. As our industry changes within the evolving pharmaceutical ecosystem, we must speak with one voice to drive home the message that a robust generic drug and biosimilars marketplace is necessary to sustain affordable health care.
Patient health and well-being depends on the uninterrupted availability of lower-cost generic and biosimilar medicines. Moreover, as patients live longer the importance of a robust and sustainable generic and biosimilar medicines industry becomes only that much more important. Policymakers must act quickly to ensure continued saving and market-based competition, as well as prevent shortages, for future availability of affordable medicines. This requires:
Short-term CR adds biosimilars to Part D, but discourages biosimilar adoption in Part B
Association for Accessible Medicines is calling on Congress to take meaningful action to lower prescription drug costs with the Prescription for Savings. Patients win when market-based competition from FDA-approved generics and biosimilars deliver savings at the pharmacy counter.
To this end, we recommend these seven policy solutions:
Congress should amend the Part D coverage gap discount program to classify biosimilars as “applicable drugs” in the Coverage Gap Discount Program. This change would allow biosimilar manufacturers to pay the 50 percent discounts paid by their brand competitors, and participate on a level playing field to compete for placement on the Part D plan’s formulary. It would reduce both patient out-of-pocket costs and Part D program spending.
On October 17, 2017, the Senate Health, Education, Labor and Pensions Committee, under the leadership of Senators Lamar Alexander (R-TN) and Patty Murray (D-WA), convened a hearing to explore why drug prices are so high. The committee asked trade associations representing different parts of the prescription drug supply chain – manufacturers, wholesalers, pharmacy benefits managers and pharmacists – to help it understand what can be done to provide some relief for the millions of Americans burdened by skyrocketing prescription drug costs.
WASHINGTON, DC (September 19, 2017) — Today, the Association for Accessible Medicines (AAM) and its Biosimilars Council released an analysis finding that if the Centers for Medicare & Medicaid Services (CMS) were to revise its current reimbursement policy for biosimilar medicines, the federal government could save $11.4 billion on medicines over the next 10 years.
September is nearly upon us, and registration is open for the Association for Accessible Medicines (AAM) and its Biosimilars Council’s 2017 two-day conference – Leading on Biosimilars, taking place on September 12 & 13 in Washington, D.C. The conference will feature presentations from key industry leaders, U.S. Government agency officials, and academic experts regarding the dynamic landscape of the biosimilars industry.
Since it was created in 2007, the Food & Drug Administration’s (FDA’s) Risk Evaluation and Mitigation Strategies (REMS) has been an important tool for patient safety by ensuring that the benefits of a drug or biological product outweigh its safety risks. FDA-mandated REMS serve a clear public health purpose, yet some brand drug companies have been misusing this patient safety program and other restricted access drug programs to extend market monopolies, intentionally limiting patient access to biosimilars.
The ninth annual Generic Drug Access and Savings in the U.S. report demonstrates the vital role that generics and biosimilars play in the United States’ healthcare system. For the first time, the third-party researchers who conducted the study analyzed the differences between brand and generic abandonment behaviors and found some surprising results.