Obstáculos de los biosimilares en EE.UU.

Women in the United States are projected to spend almost
50 years of their lives taking prescription medications. And the cost of these medications can be painfully high. In fact, 4 out of 10 (43%) of women have not been able to purchase prescription medications and almost 1 in 10 have not been able to take their medications as prescribed due to costs at some point in their lives.

It’s no surprise that people have a hard time paying for medications. In 2021, unreimbursed drug costs
rose more than 9% to $633.5 billion.

Drug costs can be especially difficult for patients who must take medications called biopharmaceuticals and biosimilars because the cost of these drugs can be especially high.

Biopharmaceuticals are prepared from living cells rather than chemicals. Currently, most biopharmaceuticals treat conditions such as cancer, diabetes, and autoimmune disorders. They provide valuable treatment options, but they are expensive and often have long-running patents, meaning the company that developed the drug is the only one that can market it and decide its price. although only the
2% of prescriptions in 2021 were for biological medications, they represent almost half (46%) of all drug spending ($260 billion) in the US.

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

Read: Health Conversation: What are biosimilars? >>

“It’s time for all of us to understand that just as a generic drug saves money when it comes to drug costs, a biosimilar will save money when it comes to biologic drug costs,” said Lisa Kennedy Sheldon. , Ph.D., ANP-BC, AOCNP, CGNC, FAAN, a professional oncology nurse and international nursing consultant with Dogcove Consulting Group.

According to
Association for accessible medicine [Asociación para medicamentos asequibles] (AAM), a lobbying group that advocates for biosimilars and generic drugs, the average price of biosimilars is half the price (or less) of reference products. Another estimate suggests that the cost of biosimilars is a third less, on average, than their reference products. Biosimilars also drive down biopharmaceutical prices due to competition. Consequently, the AAM indicates that biosimilar products saved patients $9.4 billion in 2022.

Obstacles of biosimilars

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

The FDA has approved 45 biosimilars So far, but that number could be higher. In Europe, the use of 76 biosimilars. Patent-related discussions between biodrug manufacturers and biosimilar producers have delayed the introduction of biosimilars here.

And when biosimilars are available in the US, insurance companies don’t always cover them. Although medical airlines usually do not want more expensive treatments if a cheaper price is available, pharmaceutical benefit managers (PBMs) sometimes provide incentives for medical airlines to recover more money when they cover higher-priced drugs. cost. Without the same kind of incentive to cover lower-cost biosimilars, insurers may be less likely to add them to lists of covered drugs.

Not all healthcare providers (HCPs) consider prescribing biosimilars. although a poll indicated that 9 in 10 oncologists said they feel fine prescribing FDA-approved biosimilars, not all do. 5% said they were only prescribed based on clinical trial data, which is not always available.

Another obstacle could cause many people to not understand what biosimilars are. Sheldon remembers when biosimilars first became available in 2015. Patients wanted to know if the new products were safe and would work. Those are still patients’ primary concerns, she said.

“He’s been talking about biosimilars and biopharmaceuticals for nine or 10 years,” Sheldon said. “All [los pacientes] They want to know, ‘Will it work for me? Will it alleviate my illness, my problem, my difficulties?

Taken together, these obstacles can make it difficult to access these less expensive biosimilars, even though individuals and the medical system as a whole could save money with better access.

Patients pay a higher price for lack of access to biosimilars

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

Sheldon said he worries that costs will block fair access to treatments, particularly for people with lower incomes or who have less generous health insurance plans.

“Society and health care providers have the obligation to [ofrecer] the most economical and effective treatments for patients,” he said. According to Sheldon, it doesn’t just affect the patient when that person can’t get less expensive biosimilars. Society also pays the price because we lose the opportunity to reduce overall medical costs.

Sheldon says medical planes should cover biosimilars, which will be helpful in reducing overall costs of care and decreasing financial burdens on patients and the system.

Provide access to biosimilars

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

In 2010, Congress passed the biopharmaceutical price competition and innovation law to reduce biopharmaceutical expenses and make the process to access biosimilars shorter. More recently, a 2021 executive order to promote competition in the U.S. economy instructed the federal government to increase access to generic and biosimilar medications.

The Inflation Reduction Act (IRA), which took effect in 2022, temporarily increases financial incentives for prescribing certain biosimilars administered in clinics or healthcare providers’ offices. However, this law does not reduce patient co-pays. Their goal is to encourage healthcare providers to prescribe biosimilars, if appropriate.

There is also a new bill, increase access to biosimilarsintroduced in the US House of Representatives in 2023, and is currently in the legislative process.

These events are talented for Sheldon.

“There is an opportunity for the use of biosimilars,” he said. “[Las personas] “They should be able to access biosimilars to save their overall costs of care and their unreimbursed expenses.”

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

“Get information about biosimilars, their safety and effectiveness. Staying well informed will empower you to engage in meaningful conversations with healthcare providers,” Mosier said. “Open communication promotes collaborative decision-making, which will allow you to obtain the most effective treatment plan.”

More generally, she encourages her patients to speak their minds. You could help more people than yourself if you do this.

“Join patient awareness groups and forums to share experiences and views about the use of biosimilars,” Mosier said. “A unified patient voice can promote awareness and policies that incentivize broader access to biosimilars.”

This educational resource was prepared with the support ofSandoz.

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