President Donald Trump campaigned on a promise to reduce health care costs and make prescription drugs more affordable. Ever since the election, biosimilar advocates have been anxiously awaiting the release of a detailed plan, to see what role biosimilars would play in that larger strategy.
The administration’s recent announcement did not disappoint. Trump’s health care blueprint, “American Patients First,” contains several key commitments and proposals that would help make biological drugs — particularly biosimilars — more accessible and affordable for millions of Americans.
Biosimilars offer the same quality of treatment as their reference biologics and have the potential to bring down costs to the entire health care system over time. Because they can be developed more quickly and efficiently than brand-name drugs, biosimilars can cost patients up to 40 percent less than their reference products — making them a logical component of any effort to make prescriptions more affordable.
In its blueprint, the administration is emphasizing the implementation of an important recent change to the way biosimilars are categorized under Medicare, which will incentivize the development of additional lower-cost biosimilars. In late 2017, the Centers for Medicare and Medicaid Services announced a policy change that provides each biosimilar for a given biologic with its own billing code. The new rule could reduce Medicare costs by $65 billion over the next 10 years and is expected to lead to savings of 30 percent more than under the old rule. Creating greater competition in the biologics market will encourage manufacturers to actively engage in biosimilar research and development.
Importantly, the White House blueprint also commits to finalizing changes that would allow Medicare beneficiaries receiving low-income subsidies to access biosimilars at a lower cost. Under the previous billing policy, all biosimilars with the same reference biologic drug would have been reimbursed based on the average sales price of the group. This meant that biosimilars with significant differences would be treated as though they were the same product, which would have decreased competition in the marketplace.
The new policy will ensure a robust, competitive biosimilars market by increasing the potential for innovation while lowering risks associated with developing and marketing these complex products.
In addition to these specific commitments, the president’s plan indicates that the Food and Drug Administration will build on its efforts to educate health care providers, patients and payers about biosimilars and interchangeable products. Raising awareness about these innovative treatment options will help increase demand, which in turn will encourage greater market competition and uptake overall.
Finally, the blueprint serves as a jumping-off point for a larger conversation by posing a series of questions for expert and stakeholder input. These questions seek to address the wide-ranging challenges that biosimilars face when they enter the marketplace and patients are denied access to these lower-cost medicines, as well as look for ways to improve the approval process for interchangeable biosimilars.
The administration also expressed interest in enhancing the Purple Book, the FDA’s official guide to biologics and biosimilars, to make it a better resource for prescribers, pharmacists and patients.
Increased competition lowers prices and benefits patients. The White House plan recognizes that biosimilars are good for competition, and the administration is clearly committed to making them more readily available. We applaud that commitment and urge the administration to continue working to bring these life-changing, affordable treatments to even more Americans.
Juliana M. Reed is the president of the Biosimilars Forum, a nonprofit organization whose mission is to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines and improving health care.
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