For the past three years, Amgen has faithfully released an annual “Trends in Biosimilars Report.” This year’s report highlights various viewpoints from experts in the United States reimbursement community, as well as information on current physician and patient perceptions.
While much of the report will not provide surprising or new information for our readers who are well-versed in biosimilars, it does call attention to several trends that we should have our eyes on.
Transparency Isn’t Going Anywhere
Seth Ginsberg, the president of the Global Healthy Living Foundation writes in his report, “If you want us (and our physicians) to be confident in our choice of biologic or biosimilar, we want…full transparency at the manufacturer level. We want to know who’s making the product, how it’s made, and what their track record is.”
BioPharma-Reporter.com even launched its own survey asking whether American-made biosimilars would be more successful in the U.S. Out of 117 people, 70 percent believe manufacturing location will not make a biosimilar more successful. A second question asked if U.S. physicians and patients would care about where a biosimilar was made. Seventy-five percent of 118 respondents said, “No.”
Initiatives Against Non-Medical Switching Becoming Popular
Patients’ concerns about non-medical switching have been prominent over the past year or so. In his statement, Ginsberg also noted that “We aren’t willing to let financial and bureaucratic obstacles stand between us and the biologics we depend on. [Global Healthy Living Foundation] recently helped write a bill, adopted into law in New York State, which allows for an appeal process and accelerated approval pathway when an insurer requires a patient to obtain prior authorization or go through steps to get their meds. Prior to that legislation, patients and physicians had little recourse if insurance companies required a step-edit.” That law was signed by Governor Andrew Cuomo in December 2016.
Insurance plans often implement step therapy programs to put patients on more cost-effective treatments prior to paying for newer, more costly, medications. Therefore, patients who are prescribed a high-cost treatment may be required to try other treatments and demonstrate they are not effective before being able to receive the higher-cost treatment. These steps can be avoided if physicians obtain authorization from the insurer.
The New York state law is not the only law that has been implemented to improve the prior authorization process. Just a quick glance at the National Conference of State Legislatures webpage on prescription drug legislation will show that there are several other bills in various states on similar topics. For example, Arkansas, California, Georgia, Hawaii, Missouri, Ohio, Oklahoma, and West Virginia have legislation pending and/or approved that will impact step therapy and prior authorization protocols.
Legislation like this allows physicians to authorize the use of the reference product for biologic patients who are just starting out with a new insurance company. It’s likely that these laws will continue to be implemented in the coming months and years.
The Importance of the Supply Chain
When selecting treatments, there are several factors payors consider including the device, available dosages, and patient support programs. However, as we begin to enter the age of oncology biosimilars, supply-chain reliability is expected to become a large consideration. According to the Amgen report, shortages are particularly common in the oncology field. Such a shortage can lead to disruptions in therapy, or forcing doctors to determine which patients can be taken off therapy earlier than planned.
Just as patients will judge a brand based on its quality, this report suggests supply-chain reliability will be another competitive factor. The size of the U.S. market cannot be compared to the European markets. As such, a company’s success abroad will not necessarily translate to success in the U.S. without adequate supply-chain preparations.