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Coming soon to a pharmacy near you: Biosimilars

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Christine Simmon

Working at the forefront of health care, pharmacists have seen myriad transformations of the prescription medicines landscape. And they are about to see another new development: biosimilars dispensed at the pharmacy. The expanded availability of biosimilars will also change the role of pharmacists, increasing their ability to help patients access more-affordable treatments.

Currently, biologic therapies play a growing role in effectively treating diseases that were, in the past, difficult or impossible to manage. However, their success has been accompanied by high costs for patients and the U.S. health care system. In fact, specialty and biologic medicines represent fewer than 3% of all prescriptions in the United States, but more than 53% of all spending. Fortunately, biosimilar medicines are becoming more available to patients. These are lower-cost alternatives approved by the Food and Drug Administration have no clinically meaningful differences from the expensive brand biologic.

Today, 20 biosimilars are available to patients. And despite barriers to competition and market entry, biosimilars are clearly demonstrating their ability to improve patient access to treatments while lowering costs.

For instance, biosimilar utilization has already saved patients and taxpayers $4.5 billion, and biosimilars have been used in more than 121 million days of patient therapy. In fact, the use of biosimilars has allowed almost 10 million additional days of therapy than otherwise would have been provided.

Biosimilars and the competition they create have a track record of lowering these high prices of reference biologics as a result of head-to-head price competition. In fact, biosimilars are, on average, 30% less costly than their reference biologic and have caused the average sales price of the reference biologic to decline as well.

To date, biosimilar competition has been only among physician-administered products. This will change beginning in 2023, when new biosimilars dispensed at the pharmacy will enter the market. This next chapter in biosimilar competition will place pharmacists in a critical role in lowering costs for their patients.

In 2023, six FDA-approved biosimilars to Humira are set to come to market. This is the result of pro-patient patent settlements, without which biosimilars might have been delayed for another 14 years. The advent of biosimilar competition sets the stage to lower costs of this important treatment, which in 2020 alone had U.S. revenue of over $16 billion, surpassing the revenue of the entire National Football League.

Pharmacists will play a critical role in the adoption of pharmacy-dispensed biosimilars such as Humira. As trusted advisors to patients, pharmacists will be critical in educating patients about biosimilars, dispensing biosimilars and navigating state substitution laws as well as health plan formularies to ensure patients receive the lowest-cost option appropriate for their care.

Education on the science of biosimilars is a key component. The FDA has been a leader in educating providers and patients alike, publishing the resources needed to combat misinformation campaigns and other efforts to sow confusion about the effectiveness of biosimilars. These resources and others from the FDA give pharmacists the information needed to maintain the patient relationships they have built and answer questions with certainty and credibility.

In addition, as with generics, biosimilar substitution is subject to state law. Every state has enacted laws governing biologic and biosimilar substitution. Pharmacists’ understanding of these state laws is a foundational element in ensuring that patients enjoy the savings that the biosimilars to Humira will provide.

Finally, pharmacists will have to navigate different plan formularies. This is an area where policy leadership by Congress and the Centers for Medicare and Medicaid Services (CMS) is critical. Although CMS has announced flexibility for plan sponsors to have a second, “preferred,” specialty tier with a lower cost-sharing amount, this is only a first step. It is important that Congress and CMS act to ensure that biosimilars are placed on a dedicated specialty tier with lower cost-sharing to ensure patients realize the savings available through biosimilars. Bipartisan legislation recently introduced in Congress, the Ensuring Access to Lower-Cost Medicines for Seniors Act (H.R. 2846), would accomplish this. Likewise, proposals to modernize the Medicare drug program can clearly signal to health plans the need to prioritize lower-cost biosimilars in their formulary design.

Recent forecasts suggest biosimilars could provide $133 billion in savings by 2025. Pharmacists must prepare today to be a resource for their patients and help them understand the safety, efficacy and savings potential of biosimilars.

Christine Simmon is senior vice president of policy at the Association for Accessible Medicines and executive director of the Biosimilars Council.



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