Healthcare costs have increased dramatically over the past decade in the United States, with the cost of cancer care and cancer drugs rising even faster than other therapies.
This is most evident in the price of new biologic therapies, several of which have revolutionized treatment for cancer patients, but at an extraordinarily high cost. The median price for newly approved biologic cancer therapies well exceeds $10,000 per month, which is several times greater than the median U.S. monthly household income.
At the same time, health insurance plans are passing on a greater share of the cost of healthcare to patients through deductibles and coverage restrictions. Overall, patients and their families are facing an increasing financial burden that may limit access to effective therapies or even prevent appropriate treatment of potentially curable cancers.
Reigning in costs
As a result, professional organizations and policy makers are looking at possible strategies for reigning in the continuous upward spiraling of healthcare costs. The recent expiration of patents on several biologic agents used for cancer treatment and supportive care creates an important opportunity for competition to help bring down care costs.
Biologic agents are large, complicated, and varied molecules produced in living organisms that cannot be fully characterized, may vary from lot to lot, and may induce antibodies that block their effects.
Multiple companies have been developing highly similar biologic agents (biosimilars) by replicating the complex production process of these molecules. In order to reduce the cost of developing biologic drugs and foster competition, the U.S. Food and Drug Administration (FDA) has developed a rigorous review and approval process with greater emphasis on molecular characterization, and preclinical pharmacology and immunogenicity studies to assure the final product is highly similar to the original biologic, but with less requirement for large, expensive clinical trials.
As we know from nearly a decade of experience with biosimilars in Europe, the evidence shows they are safe and effective alternatives to their original counterparts. Nevertheless, to further assure biosimilars remain safe and effective, the FDA is placing emphasis on careful monitoring for any delayed or unusual toxicities following approval.
The American Society of Clinical Oncology (ASCO) recently published a statement on the role of biosimilars as an important part of the multifaceted solution to curbing rising cancer care costs. ASCO recognizes the challenge that rising cancer care costs and the overall financial burden cancer care represent for patients and their families, resulting in increasing debt, and even bankruptcy or premature stopping of potentially curative treatment. Such financial toxicity may represent a major barrier to accessing the best care worsen patient outcomes including survival.
ASCO also emphasizes the importance of physician and patient education about biosimilars, and other efforts to reduce healthcare costs and improve the quality, and therefore overall value, of cancer care.
Finally, unlike small chemical drugs and generics, the molecular characteristics and behavior of complex biologic agents have the potential to drift over time with relatively minor changes in manufacturing and ingredients.
Importantly, such changes may be true of both the original innovator agent as well as biosimilars, and therefore require greater understanding and awareness of the complex processes involved, and the need for continuous vigilance concerning any indication of immunogenicity or loss of efficacy and safety. Such vigilance is particularly important for biosimilars as FDA approval may be extrapolated to other indications that the originator agent has received without providing additional clinical evidence.
The rise of biosimilars
There are currently 14 approved biosimilars in the United States, including five supportive care agents used in oncology and two cancer therapies that will become available in practice in the coming year. While early biosimilars for supporting patients receiving cancer chemotherapy have been integrated into clinical guidelines and routine clinical practice, access to confirmatory research evidence by clinicians and professional organizations beyond FDA approval appears to be important for such practice integration.
With transparent reporting, careful regulatory evaluation, and post-approval vigilance, using these biosimilars and the many soon to come is expected to gain more traction in the United States, leading to more competitive pricing and improved patient access to these important and potentially curative therapies.
Along with the safe and effective introduction of biosimilars, other measures to reduce the enormous financial burden of cancer on patients, families, and society must be pursued. This way, we may all benefit from the exciting progress in our understanding of cancer and improved approaches to effective cancer treatment and prevention.
Gary H. Lyman, M.D., M.P.H., F.A.S.C.O., F.R.C.P., Senior Lead, Health Care Quality and Policy, Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, [email protected]