It has now been more than 100 days since the Trump administration released the American Patients First blueprint, an effort to lower ever-increasing drug prices in the United States.
It has now been more than 100 days since the Trump administration released the American Patients First blueprint, an effort to lower ever-increasing drug prices in the United States. To recap the achievements of the first 100 days of the plan, the government released a report entitled “Report on 100 Days of Action on the American Patient [sic] First Blueprint,” that outlined shifts in the industry since the plan’s release.
The blueprint contained 4 main strategies for decreasing drug prices, including increased competition, better negotiation, incentives for lower list prices, and reducing out-of-pocket costs.
According to the report, the FDA approved more generic drugs last month than in “any single month in its history.” Additionally, the FDA also recently approved the first generic version of EpiPen under a new regulatory pathway designed to speed up the development and review of generic drugs that lack competition in the marketplace.
Since the plan was announced in May 2018, the FDA also approved 3 biosimilars (Fulphila, Retacrit, and Nivestym), though the report incorrectly notes that 1 biosimilar was approved in this period, and that only 10 biosimilars have ever been approved. A long-awaited Biosimilar Action Plan was also announced by the FDA in an effort to encourage more biosimilar uptake.
More recently, HHS also launched a working group to analyze how the “safe importation of drugs could address price spikes by manufacturers in the United States of sole-source drugs that do not have blocking patents or exclusivities.”
In terms of better negotiation, CMS recently updated its policy to allow Medicare Advantage plans to negotiate drug prices for Part B drugs by allowing plans to employ step therapy to newly diagnosed patients. The move has been a point of contention for some advocacy organizations who believe that step therapy can be harmful to their patients’ health and quality of life.
In the past few months, major pharmaceutical companies have agreed to withhold or freeze price hikes on drugs for the remainder of the year. However, the question still remains whether patients will be able to feel any cost savings from these measures, as several analysts have shared doubts.
CMS also recently made changed to its Drug Pricing Dashboard that highlights the individual drugs with the highest price increases in Medicaid, Part B, and Part D, as well as listing the manufacturers of the products.
Going forward, the report notes that “HHS has plans in the works to deliver on every aspect of the blueprint, and market actors who have responded to actions so far can expect reforms that aim toward a new, patient-friendly system to continue.”