For those unfamiliar with biologic medications (the most widely known is probably Humira,) they are popular and effective medications made from biological, rather than chemical, processes. Related products, known as interchangeable biosimilars, are products the FDA has determined can be substituted by pharmacists for the original product, and which have met additional criteria to meet patient safety, much like generics.
Pharmacy substitution has been allowed by New Hampshire law for many years now with nothing but positive results. However, a bill making its way through the State House threatens to change the way these products are dispensed in a potentially unsafe way.
HB 1365, would take us in a radically different direction by allowing pharmacists to substitute interchangeable biosimilars for one another without a doctor’s consent. The problem with HB 1365 is not the use of biologic medication or the pharmacists. Biologics are safe, and important medications and pharmacists in our state do a great job. The issue with HB 1365 is that decisions which should be between a doctor and a patient are suddenly being shifted to a third party. This bill would allow pharmacists to essentially make a final decision about a patient’s medication without even notifying their doctor beforehand.
Proponents of HB 1365 argue that if product A is interchangeable with product B, and product A is interchangeable with product C, then product B must be interchangeable with product C. However, it is not that simple and the FDA agrees. There are layers and layers of testing that must be done in order to put interchangeable biosimilars onto the market to ensure that the original medication and the interchangeable biosimilar are in fact safe to substitute.
However, the FDA does not do this type of comparative testing with two interchangeable biosimilars. There is simply no research to prove or disprove that each individual interchangeable biosimilar can be safely substituted for one another. That is why they are currently not allowed to be substituted for one another.
While New Hampshire is not afraid to lead the nation when it comes to good ideas, no other state in the country allows this type of practice. And there is a good reason for that.
First, there are safety concerns for the patients. As much as we all try to learn about risk factors when it comes to our health, most of us do not have advanced medical degrees. At the end of the day, we need to take the advice from doctors.
Which brings up a second issue. This bill directly prevents doctors from making the final decision about what medications their patients are receiving. I think we all agree that the trust placed in a doctor-patient relationship is an important one and leads to better health results. This bill would place another party between doctor and patient.
Finally, this bill would put us out of compliance with the FDA on biologic medications. It is unclear what the consequences of going out of compliance would be, but it is unlikely that the FDA would turn a blind eye. This raises the possibility of litigation, loss of funding, or products simply becoming unavailable in the state due to safety concerns.
Some have argued that this interchangeable substitution is allowed in the European Union. This is a commonly made mistake. The EU has a different definition of interchangeable biosimilars that confuses the issue here in the states. Currently, they do not allow the process that HB 1365 would put into New Hampshire law. There is no indication that is going to change soon.
Prescription drug prices are too high and are a very real problem for Granite Staters. However, there are many pieces of important legislation this year that will safely make a real impact for New Hampshire patients. For example, this year I was the prime sponsor of SB 555, a bill that would ensure pharmaceutical rebates are passed through to the patient at the pharmacy counter. SB 555 and other bills like it would mean real savings for real people. HB 1365 is simply not the answer.
