By Kathleen P. Wolff, MBA
Specialty Pharma Journal
As the high cost of new biologic medicines sends U.S. healthcare costs soaring, payers are anxiously anticipating the introduction of biosimilar medicines – biological products, approved by FDA because they are highly similar to an already FDA-approved biological product. However, there is one stakeholder whose influence over biosimilar adoption may be underestimated. At the Biosimilars 20/20 conference in Philadelphia held earlier this summer, that stakeholder was identified as the physician.
Complexity of the regulatory approval process, a lack of real-world data, uncertainty about the regulatory process, control issues involving a physician’s authority to determine the appropriate medications and legal concerns were among the challenges cited by featured speaker Bimal Shah, MD, MBA, Service Line Vice President, Premier Research Services, Premier, Inc., at the conference hosted by the Specialty Pharma Education Center (SPEC).
Dr. Shah, a practicing cardiologist, said the introduction of biosimilars will be much more complex than the introduction of generic medicines. “I lived through the era of seeing Lipitor go generic, and also Plavix going generic, and what I will tell you is, there was an immense amount of confusion, not only on the providers’ part but also on the patients’ part. And if we want to look at a case study of how this transition to biosimilars is going to go, I’m going to say it’s going to be just as complex, if not more so for a whole host of reasons,” Dr. Shah said.
The challenges presented by Dr. Shah offered a reality check on developments in recent months, which seem to suggest a new era is underway in biosimilar development in the U.S. The approval of filgrastim-sndz, (Zarxio, Sandoz), approved by the U.S. Food and Drug Administration on March 6, 2015, has been hailed as a long-awaited, watershed event, following the Biologics Price Competition and Innovation Act (BPCIA) of 2009, which was passed as part of the Affordable Care Act, and signed into law in 2010.
At Premier, one of the nation’s largest group purchasing organizations (GPOs) by volume, Dr. Shah has seen how biosimilar products are viewed by physicians and has been struck by the lack of awareness. “We push about $41 billion of product through our channel per year and we touch about 3,600 U.S. hospitals,” said Dr. Shah. “At major medical centers when you talk to oncologists, they are sometimes unaware about this space or the upcoming biosimilar therapies. Over the last six months as I’ve had some conversations at the C-suite level, I’ve educated them about these biosimilar products coming to market.”
Dr. Shah said education is needed, even at the most basic level of writing prescriptions. “I don’t even know how to write for a biosimilar. That has not been well addressed by the FDA. So yes, sure I can write for the brand name for the originator or the brand name for the biologic, but a lot of us still write for the generics for some of these (small molecule) medications, so how do I go about understanding and doing that (for the biosimilar product)?”
Trust in the safety and efficacy was also cited as a barrier to adoption. The FDA defines biosimilars as “products that have been shown to have no clinically meaningful differences from the reference product.” However, physicians will want to see the clinical data for themselves, as well as any real world data.
“Right now today, if you look at a survey of physicians in 2014, only about a third of physicians who have heard about biosimilars actually feel comfortable prescribing them. And that’s even after you’ve shown them the data about safety and efficacy. So that’s a huge, huge hurdle and chasm that needs to be crossed,” said Dr. Shah. Additionally, physicians are likely to see the bureaucracy involved in prescribing biosimilars as a burden. “I’ll say as a provider, ‘I just want to practice medicine. I don’t need to think about this. I just want to be able to write the script and not have to deal with anything,’” Dr. Shah said.
Other speakers acknowledged Dr. Shah’s concerns. “When you think about it, why should the physicians support it?” said Steve Miller, MD, MBA, Senior Vice President and Chief Medical Officer of Express Scripts. In addition to the physicians’ need for supporting data, Dr. Miller cited the likely discussions physicians will need to have with pharmacists about substitutions and the explanations they will need to have with patients regarding the switch. “Physicians will see it as more work,” said Dr. Miller, who has taken a lead role in the promotion of legislation to create a regulatory pathway for biosimilars in the United States.
Another nagging concern cited by Dr. Shah was physician liability. “What happens for the first patient that I prescribe a biosimilar to, and they go out and … have an adverse event, right? And it may not be related to the biosimilar product at all. It may just be that patient has a lot of comorbidities or that’s just part of their biology that they’re going to have a reaction. But the next thing I know, I get an affidavit from a legal firm and I’ve got to go testify (as to ) why I started that patient on that medication as opposed to something else that might be considered the accepted standard of care,” he said.
As a solution, Dr. Shah made three recommendations to mitigate confusion in the marketplace and promote rapid adoption. “Number one is that you’ve got to provide data to the physicians,” he said. “Two, is you have to educate patients as well. Even if you’ve gotten the providers on board, I will tell you right now, the providers don’t have the time to educate the patients.”
Dr. Shah’s third suggestion to market access involves removing any barriers. In a survey conducted by Premier regarding biosimilars, the two critical questions that Chief Pharmacy Officer participants in provider organizations asked were: “Can I get it through my normal distribution channel?” and “Is the indication the same for the originator?”
Finally, the speed with which these provider issues are addressed may play an important role in achieving the cost savings envisioned by payers. Dr. Shah cited statistics showing that branded products take between 12 to 14 years to gain up to 70 percent adoption. “I would say that most of us are not going to wait that long for these therapies to have that sort of run rate to get to the market and have the impact that we think they can,” he said.