Allowing pharmacists to independently fill prescriptions with biosimilars can offer community oncology practices a way to cut costs and increase access to cancer care for patients, according to Lucy Langer, MD.
Implementing automatic substitution, or therapeutic interchange, has increased access to biosimilars for patients at Compass Oncology West in northern Oregon, according to Lucy Langer, MD, practice president and chair of the National Policy Executive Committee for The US Oncology Network.
“In my practice, we have taken a therapeutic interchange approach," she said in a webinar sponsored by the Pacific Business Group on Health and the Integrated Benefits Institute. "So, instead of leaving it in the physicians’ hands, we have stated that where the biosimilar exists with the specific value-based contracts that we're trying to achieve, we give our pharmacists the green light to perform that interchange behind the scenes. There are exceptions, of course."
At Compass, the use of therapeutic interchange is made to conform to National Comprehensive Cancer Network guidelines, “which takes into account not only the clinical evidence, but also the economics and the interchangeability of agents. So these are all important considerations, not just for providing the gold standard of care, but also for ensuring that we are good stewards of the resources in our market,” Langer said.
The concept of interchangeability for biosimilars as defined by the FDA is similar to therapeutic interchange, except that so far no biosimilars have been designated interchangeable by the FDA. To obtain the designation, biosimilar manufacturers must run additional trials, even though, Langer noted, there is no difference in efficacy between a biosimilar and an interchangeable biosimilar.
“The goal of the practices in using a therapeutic interchange policy would be to bring their P&T [pharmacy and therapeutics] committees together to present to the overall physician population of that practice and make the argument that the therapeutic interchange is safe and effective and would have no clinical impact on the patients,” said Langer.
Biosimilars’ Role in Practice Savings
Langer said that biosimilars can promote access to biologics for patients and market competition, which are both necessary to drive down costs for patients and practices.
In the US Oncology Network of more than 1400 physicians, 25% are enrolled in the Oncology Care Model (OCM), which is a value-based model from CMS designed to provide better, more affordable care.
Langer said that all of the key components to the running of an OCM practice, such as offering 24/7 access to clinicians and adhering to nationally recognized clinical guidelines, cost the practice money, meaning that cost management is a key driver of OCM practice behaviors.
“Frankly, the drugs of choice for the practice are the drugs that the practice is able to purchase at a lower cost. And nobody would argue that those drugs are not interchangeable. What we're doing now is we're starting to toe the line of what will happen when we start to look at biosimilars,” said Langer.
For an example, Langer cited data showing that European prices for epoetin alfa and granulocyte colony-stimulating factor (GCSF) products for Germany, France, Italy, and the United Kingdom dropped significantly following the market introduction of biosimilars for those agents.
Why Is Oncology Care so Expensive?
Langer said that past policies, such as the Medicare Modernization Act of 2003 and federal budget cuts, or sequestration, have impacted drug margins for oncology practices.
“I know it's tempting to say that oncologists are driven to order the more expensive drugs because they’d get more money for their pockets, but it's really the drug margin that allows us to pay our staff to keep our lights on, and to be able to provide the care that we do for our patients,” she said.
Additionally, she said, the rise of novel agents and targeted biologic therapies that are favored in the oncology space has increased patient survival rates, although drug prices have soared. Sometime in the early 2000s, the monthly median price of the newer cancer drugs rose above the median monthly household income in the United States, she said. By 2014, the median monthly cost for treatment with those advanced drugs was 2.5 times the median monthly household income.
Langer also noted that many oncology practices are independent from hospitals, which makes them ineligible for discounts offered through the 340B Drug Pricing Program.
“340B pricing was meant to provide drugs at lower cost for hospital-based oncology clinics that were serving a predominantly underserved population,” she said. "Without stepping too far into the political landscape, we could all agree that this [savings advantage] has been used healthily and perhaps, has been overused, which has resulted in a disparity in the cost to acquire the same drug between hospitals and independent providers."
Langer pointed to a practice impact report from the Community Oncology Alliance, which showed a significant uptick from 2010 to 2018 in community oncology practices that were financially struggling, acquired by hospitals, or closed as a result of increased financial pressures.
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