For Santina Murine, the drugs Enbrel and Orencia turned out to be miracles.
Rheumatoid arthritis had affected the Utica resident's ankles and wrists to the point that she could barely walk or do much of anything, she said.
"I think three days after I started taking (Enbrel), I was pain free," Murine recalled. "I mean, absolutely pain free."
But the miracle is over.
Technical changes have changed the way Medicare pays for Orencia. As a result, Murine's portion of the bill went up – to $750 or $800 a month, more than she can afford, she said. Now off the drugs for at least six months, the pain and stiffness are back so badly that she can't hold a cup of coffee, she said.
Murine is not the only American driven away from biologic drugs by their price tag. These drugs, which are made from living organisms instead of chemical compounds, can cost as much as hundreds of thousands of dollars a year. But for some conditions, they offer breakthrough treatments.
Help might be on the horizon for those who can't afford these drugs. The federal Food and Drug Administration is working on an approval process for a group of drugs known as biosimilars, a process mandated by the Affordable Care Act. These are non-brand-name drugs that work like brand-name biologic drugs. The concept is similar to generic drugs, but biosimilars are not exact copies of the brand-name biologics.
"We know from the experience of other countries that there are successful biosimilar pathways – European Union, Canada, I believe Australia — where they have been able to lower the cost and maintain good care," said Mona Chitre, vice president, pharmacy management at Excellus BlueCross BlueShield.
Dr. James Wymer, an associate professor of neurology at Albany Medical Center, who treats multiple sclerosis patients on biologics, said they "have just been phenomenal."
"They've made a dramatic change in the treatment of the disease," he said. "Prior to using the biologics, we were limited to chemotherapy-type drugs. Now, we have biologics that have significantly reduced the disease. They're provided better control. Patients are just doing better."
Excellus supports the approval of biosimilars as a way to lower health care costs and provide better patient access.
By 2014, biologics, which are used by 2 percent of the population, are expected to account for 40 percent of all prescription drug spending, according to Excellus.
So, biosimilars could bring huge savings – possibly $250 billion over 10 years if just 11 biosimilars are approved, according to a study cited by Excellus.
"This is the trend. This is where we will see the explosion of new treatments in pharmacy," Chitre said. "This is where all manufacturers are focusing their efforts."
Page 2 of 2 - The Biotechnology Industry Organization does favor federal approval for biosimilars with a number of caveats:
- An approval process more rigorous than the one for generic drugs.
- Different names for biosimilars and biologics to avoid confusion.
- State rules that prevent automatic substitution of biosimilars in pharmacies.
Wymer agreed that the details of the FDA approval process will be key to protecting patients.
"If a biosimilar is slightly off, it may have a huge difference both in effectiveness and also in the risk that goes along with it," Wymer said.
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