Barriers to Biosimilars in the US

Women in the United States can expect to spend almost
50 years of their lives taking prescription medications. And the cost of those medications can be painful. In fact, 4 out of 10 (43%) women have not been able to fill a prescription and almost 1 in 10 have not taken their medications as prescribed due to cost at some point in their lives.

It’s no surprise that people have trouble paying for medications. In 2021, out-of-pocket drug costs
rose more than 9% to $633.5 billion.

Drug costs can be especially high for patients taking drugs called biologics and biosimilars because the cost of these drugs can be especially high.

Biologics are made with living cells instead of chemicals. Currently, most biologics treat conditions such as cancer, diabetes, and autoimmune disorders. They offer valuable treatment options, but they are expensive and are often patented for a long time, meaning that the company that developed the drug is the only one that can market it and decide the price. while alone
2% of prescriptions in 2021 were for biological medications, they constituted almost half (46%) of all drug spending ($260 billion) in the US.

Biosimilars, which are close copies of biologics, work the same way but cost less than biologics. Like generic drugs, biosimilar treatments are available after a biological drug’s patent expires. They are generally cheaper than the original brand-name biologic, which is called the reference product, but they can still be expensive because they are complex to manufacture.

Read: Clinically speaking: What are biosimilars? >>

“I think it’s time for us all to realize that just as a generic drug saves money on drug costs, a biosimilar will save money on biologic costs,” said Lisa Kennedy Sheldon, Ph.D., ANP. -BC, AOCNP, CGNC, FAAN, Oncology Nurse Practitioner and Global Nurse Consultant at Dogcove Consulting Group.

According to the
Association for Accessible Medicine (AAM), a lobby group that advocates for biosimilars and generic medicines, the average price of biosimilars is half (or less) the price of the reference product. Another estimate suggests that biosimilars cost on average a third less than their reference products. Biosimilars also force the prices of biologics to drop due to competition. As a result, AAM says biosimilars saved patients 9.4 billion dollars in 2022.

Barriers to biosimilars

Despite the benefits of biosimilars, they can be difficult to obtain in the US.

The FDA has approved 45 biosimilars so far, but that number could be higher. In Europe, 76 The use of biosimilars has been approved. Patent arguments between biologic drug manufacturers and biosimilar producers have slowed the introduction of biosimilars here.

And when biosimilars come to the United States, insurance won’t always cover them. Although health plans generally don’t want to pay for more expensive treatments if a cheaper one is available, pharmacy benefit managers (PBMs) sometimes incentivize health plans to recoup money when they cover higher-cost drugs . Without that same kind of incentive to cover lower-cost biosimilars, insurers will be less likely to add them to lists of covered drugs.

Not all healthcare providers (HCPs) will prescribe biosimilars. Although a poll showed that 9 in 10 oncologists said they are comfortable prescribing FDA-approved biosimilars, not all do. Five percent said they would only prescribe them based on clinical trial data, which is not always available.

Another barrier may be that many people do not understand what biosimilars are. Sheldon remembers when the first biosimilars were offered in the U.S. in 2015. Patients wanted to know if the new products were safe and would work. Those remain patients’ biggest concerns, he said.

“I’ve been talking about biosimilars and biologics for nine or 10 years,” Sheldon said. “All [patients] I want to know: ‘Is it going to work for me? Will it help me treat my illness, my problem, my problems?’”

Together, all of these barriers can make it difficult to access these less expensive biosimilars, although both individuals and the healthcare system as a whole could save money with easier access.

Patients pay the price for lack of access to biosimilars

Even when biosimilar products are covered by insurance, patients may still have to pay 20% of the cost through copayments or coinsurance. And those fees could cost people several thousand dollars a month or more. For many Americans, that’s simply too much.

Sheldon said he is concerned about costs that block fair access to treatment, particularly for people with lower incomes or people with less generous health insurance plans.

“I think we have an obligation as a society and as health care providers to make sure that we are [offering] the most cost-effective and effective treatments for people,” he said. According to Sheldon, it’s not just the individual that is affected by the fact that people cannot obtain less expensive biosimilars. Society also pays the price because we are missing the opportunity to reduce overall healthcare costs.

Sheldon argued that health plans should cover biosimilars to help reduce the overall cost of care and reduce financial burdens on patients and the system.

Open access to biosimilars

The government is trying to make it easier for patients to obtain biosimilars.

In 2010, Congress approved the Law on innovation and price competition for biological products reduce spending on biologics and shorten the path to approval of biosimilars. Most recently, a 2021 Executive Order on Promoting Competition in the U.S. Economy ordered the federal government to expand access to generic and biosimilar medications.

He Inflation Reduction Act (IRA), which became law in 2022, temporarily increases financial incentives for prescribing certain biosimilars administered in healthcare clinics or offices. However, this law does not reduce patient co-pays. Its aim is to encourage healthcare professionals to prescribe biosimilars, where appropriate.

There is also a new bill, Increased access to biosimilarsintroduced in the US House of Representatives in 2023, advancing the law-making process.

These developments are encouraging for Sheldon.

“There is an opportunity here for biosimilars,” he said. “[People] “They should be able to access biosimilars to save overall cost of care and out-of-pocket expenses.”

To get access to biosimilars for yourself or a loved one, there are strategies that can improve your chances of getting them, according to Michele Mosier, PharmD, founder of Health Defense Hope.

“Learn about biosimilars and their safety and effectiveness. Being well-informed allows you to engage in meaningful conversations with healthcare providers,” Mosier said. “Open communication encourages collaborative decision making for the most effective treatment plan.”

More generally, encourage patients to talk. You could help more people than yourself if you do this.

“Join forums and patient advocacy groups to share experiences and knowledge about the use of biosimilars,” Mosier said. “A united patient voice can drive awareness and policies that support broader access to biosimilars.”

This educational resource was created with the support of Sandoz.

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