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In health care, even how you name something can become a debate with billions of dollars on the line.
With a new wave of cheaper versions of biologic drugs expected to soon become available in the United States, the health-care industry is still fighting over key ground rules for these drugs — more than four years after the Affordable Care Act cleared a pathway for this new drug classification. That includes what names these copy-cat version of biologic drugs should actually go by.
Biologics, which treat serious diseases like cancer and multiple sclerosis, are usually more expensive than conventional drugs, and they're also harder to make. Unlike traditional drugs made from chemicals, biologics are made from the proteins of living organisms. So that also makes it impossible to exactly duplicate biologics, but copy cat "biosimilars" are near-replicas of these drugs and have been selling at about 20 percent to 30 percent lower than the biologic price in foreign markets.
Biosimilars are still waiting to break into the United States, though. By one estimate, the U.S. market for these drugs will grow from virtually nothing to $36 billion by the end of the decade. Faster adoption of these biosimilars in the United States could amount to hundreds of billions of dollars in savings for the health-care system, according to estimates from the pharmacy benefits manager Express Scripts. How quickly they're adopted, though, will depend on policies that are still being decided — like the naming issue.
The question comes down to this: Should biosimilars be allowed to share the same as the biologics they're substituting, similar to the way generic drugs share an identification with the brand-name product. The answer to this question will likely help determine how widely biosimilars will be used when they're approved in the United States.
Stakeholders over the past few weeks have been making their cases to the Food and Drug Administration over the naming policy. Generic drugmakers, Express Scripts and 30 other groups last month called on the FDA to allow biologics and the copy-cat biosimilars to share a name, pointing to practices in other countries where the drugs are already available.
"Patients, prescribers and dispensers of these drugs need to be able to easily identify which drugs bear a relation to one another in order to maximize the potential savings from the biosimilar approval pathway," the groups wrote last month.
Not everyone feels the same way, though. Just last week, 10 groups representing specialty physicians urged the FDA to require unique names for biosimilars, citing the difficulty of trying to copy the original biologics among other reasons. "Distinct nonproprietary names will help to alert physicians that each product, while safe and effective, may differ slightly," they wrote.
A few Senators earlier this month asked FDA to clarify the naming issue after the regulatory agency accepted its first-ever application for a biosimilar. So there may be more clarity on this issue — and the billions of dollars at stake — soon.
Correction: An earlier version of the story said biosimilars were selling at 20 percent to 30 percent of the biologic price in foreign markets. They're actually selling at a discount of 20 percent to 30 percent.
Top health policy reads from around the Web:
California wants stricter review of insurance rates. "A new poll shows 69% of California voters back Proposition 45, a November ballot measure giving the insurance commissioner the power to stop excessive health-insurance rate increases. Under current law, state regulators cannot deny rate increases they deem unreasonable or excessive. The ballot measure would grant that authority to the insurance commissioner and establish a process for outside groups to challenge rate filings." Chad Terhune in the Los Angeles Times.
How worried should people be about medical record theft? "As more doctors and hospitals go digital with medical records, the size and frequency of data breaches are alarming privacy advocates and public health officials. Although health care providers face serious penalties if they allow patients' electronic records to be breached, thieves also have tremendous incentives to get around protections because health records contain so much valuable information. Privacy experts argue the health industry has been slow to respond to such incidents by adopting the encryption techniques used for years by financial companies." Eric Whitney for Kaiser Health News.
Immigrants face trouble confirming ACA coverage. "In July, al Mamoori, a delivery driver who is designated as a permanent resident, was among the hundreds of thousands of individuals across the country who received letters from the U.S. Department of Health and Human Services asking for proof of their citizenship or immigration status. He has since uploaded documents to healthcare.gov to prove his residency. But with a fast-approaching Sept. 5 deadline, al Mamoori said he has not received any confirmation from federal officials that his citizenship has been verified and is uncertain whether he will retain his coverage next month." Alexa Ura in the Texas Tribune.