One in three medications dispensed in the US is a Biologic. Patent expiration brings attempts to protect this high-dollar market.
Testimony on Biologics, Biosimilars, and Interchangeables
Abigail Nobel, BSN, RN, MA
January 30, 2018
My name is Abigail Nobel. I’m a health policy nurse and I oppose Section 17755 (5) of HB 4472, which provides for a superfluous and protectionist notification process.
The bill came to first hearing in the other chamber when I was fully occupied with my father’s terminal cancer diagnosis. I appreciate you hearing me now.
All points in my Oct. 20, 2015 House and Feb. 16, 2016 Senate testimony against the notification provision remain true. The intervening two years have escalated the dismal facts surrounding the standard patient healthcare experience. Healthcare professionals are kept even busier with documentation requirements. Physician stress, depression and suicide continue to rise, and patients are being heard even less. Healthcare cost inflation continues to grow faster than the general Consumer Price Index. According to FRED blog, an economic data publication of the Federal Reserve Bank of St. Louis, “In the past 20 years … headline CPI has grown at an average annual rate of 2.2%, whereas the price level of medical care has grown at an average annual rate of 3.6%—about 70% faster.”
The economic recovery has not extended to healthcare, and provisions like this one are part of what stand in its way.
Why? In economic terms, HB 4472 Sec. 17755 (5) is a market barrier, pure and simple. It serves zero safety function.
- As industry advocates have testified, FDA is in charge of safety for these important drugs with immense potential for patient, Medicare, and Medicaid savings. Indeed it is, and it has clearly declared the approval process by which Biosimilar safety is assured and will be maintained: “The manufacturer must also demonstrate that, for a product administered to a patient more than once, there is no additional risk or reduced efficacy if a patient switches back and forth between an interchangeable product and a reference product, compared to using the reference product without switching.”
Section (5) leaps well beyond FDA approval and usage statements. Section (5) gallops into the protectionist, market barrier end zone that benefits only those who profit from less substitution of these cost-saving Biosimilars. This provision is not needed for safety under FDA guidelines.
“All biosimilar and interchangeable products meet FDA’s rigorous standards for approval for the indications (medical conditions) described in product labeling. Once a biosimilar has been approved by FDA, patients and health care providers can be assured of the safety and effectiveness of these products, just as they would for the reference product.” – FDA website.
“Prescribers and patients can expect that the interchangeable product will have the same clinical result as the reference product. Prescribers and their patients can be assured that an FDA-approved interchangeable product has been thoroughly tested and has met FDA’s high standards for approval. Meeting these standards means that health care professionals and patients can be assured of the safety and effectiveness of an interchangeable product, just as they would be for a reference product.” – FDA website.
- The claim is that this notification keeps physicians in the loop regarding medication substitution. This is false on multiple levels. No physician will read it, because doing so is not mandated by this bill, and no one has time these days for anything that isn’t absolutely imperative; and because it will be buried in the blizzard of other mandated record-keeping. Digging it up will become important to the physician only when a patient complains of an undesired medication effect, and even then it will be more efficient and informative to contact the pharmacist directly by phone. Except under this provision, that professional will be more occupied by another paperwork demand and less available for the really important conversations like this one. Finally, no physician needs this notification, because long before this medication hits the pharmacy shelves, his email, professional journals, office mail, and electronic advertising will have been inundated with the information that there is a new Biosimilar substitute on the market demanding his consideration. Given the huge price differential, it will also be placed onto insurance formularies fairly early. If somehow the physician misses these notices, his patients will have heard of the lower cost option and be asking him for it. Assuming they have time in the 7-minute office visit the average patient is now allowed in our frazzled healthcare system.
In the real world of healthcare today, the claim that this provision is necessary to keep physicians informed about their patients’ dispensed meds is not merely false and superfluous. It is actually likely to distract them from the conversations that are relevant to their patients’ care, including patients themselves.
- Finally, Industry advocates of this provision have testified that they as manufacturers are obligated to track Biosimilar products. With this bill, they transfer their obligation and time cost to pharmacies. Pharmacies are one of the faces of healthcare patients actually see. I ask this committee to let manufacturers use one of the existing paths to meet their tracking obligation without getting between providers and patients in the prescribing and FDA-approved substitution process.
Thank you. I am happy to answer any questions.
Abigail Nobel
Testimony submitted via email.
Note: The Senate Health Policy Committee voted to pass the bill without amendment and recommending immediate effect. As of this publication on February 13, 2018, the full senate has not yet voted on HB 4472.
Readers may find Michigan senator contact information here.
March 8. Follow up note: the senate unanimously passed HB 4472 on February 15. Governor Snyder signed it into law February 28, and it took immediate effect on March 1.