Last week, I had the opportunity to make a difference in the lives of patients in Colorado by sharing my story in front of the Senate Health & Human Services Committee. The Committee was hearing testimony concerning SB71, a bill that will help the state of Colorado figure out how to regulate biosimilars when they eventually come to market.
Many of us living with RA (and other chronic illnesses) currently rely on biologic medications to function in our day-to-day lives. Biologic medications have very unique, complex molecular structures that are made from living cells. These structures are not easily replicated, which means that it's not possible to create "generic" versions of biologic medications (which is one of the reasons biologics are so expensive!)
Right now scientists and pharmaceutical companies are working to develop biosimilar versions of many biologic medications. Eventually, the Food and Drug Administration (FDA) may decide that some of these biosimilars will be considered interchangeable with the biologic medications they mimic. In fact, earlier this month an FDA advisory committee voted to recommend that the government approve its first biosimilar application. So it is only a matter of time until biosimilars come to the market. But while biosimilars have the potential to provide lower-cost access to treatment, even the slightest difference - whether in the manufacturing or even the handling process - could have a significant health impact on patients.
SB71 attempts to update Colorado law to cover biologics and biosimilars in a way that protects patients. Importantly, it requires pharmacies to notify patients and their doctors if a biosimilar is substituted for the biologic the doctor prescribed. This notification requirement is particularly important to help patients have the information they need to make the best possible decisions about their healthcare. (If you'd like to read the full text of the proposed bill you can find it here.)
Here's the testimony I gave last week in support of SB71:
Good afternoon Mr. Chairman and members of the Committee. My name is Mariah Leach. I am a patient advocate and member of the Global Healthy Living Foundation's 50 State Network. I want to thank you for allowing me to speak today. I live in Louisville and I was diagnosed with rheumatoid arthritis at the age of 25, right in the middle of law school at CU. Today I am here to support the passage of Senate Bill 71.
I have taken biologic medications for six years to treat my rheumatoid arthritis. Without these medications I never would have gotten my condition well enough under control to graduate from law school. Since then I have been off biologics only twice - after I became pregnant with each of my sons. My older son is 2.5 and my younger son was born six months ago today.
During my most recent pregnancy, my RA flared so badly that I couldn't get out of bed, let alone take care of my first child. My rheumatologist, OB, and pediatrician decided together that the best course of action was for me to re-start my biologic medication during my third trimester. The data showing that this would be relatively safe for my unborn son was extremely limited, which made it a very difficult decision. But with the help of my biologic medication I was able to manage the remainder of my pregnancy. Luckily I had no additional complications and my second son was born healthy.
After making such a difficult decision, what if the pharmacy had substituted a biosimilar for the biologic my doctor had prescribed without my knowledge? And without my doctor's knowledge? Such a substitution could have put me and my unborn son at risk. Senate Bill 71 updates Colorado law to protect patients like me, making sure that patients - and their doctors - have the information necessary to make these complicated decisions.
I may not be able to control my toddler, but I do want to be control of my own health as well as the treatments I receive. Recently the biologic medication I am on stopped working for me. This means that I will have to switch to a different biologic - my third since my diagnosis - in the hopes that it will be more effective.
But what if I experience an adverse reaction from my new medication? How am I supposed to adequately manage my disease - and consequently live my life - if I don't even know what drugs I am actually receiving? It's vital that an accurate and transparent medical record is established. This will allow my doctor and I to determine which medication is responsible for any adverse reactions so that we can take the necessary steps quickly. I want and need this information and so does my doctor.
As a patient living with rheumatoid arthritis, I know that biosimilars have amazing potential. The development of these medications gives me hope, because if I run out of options for traditional biologic medications I can potentially turn to a biosimilar. I have also struggled to afford my biologic medication, so when you couple more options for treatment with the projected affordability it's easy to see the promise biosimilars hold. But this promise will be jeopardized if we do not pass legislation that puts patient safety and transparency first.
The Global Healthy Living Foundation and I urge the members of this Committee to support Senate Bill 71. I truly appreciate your consideration of my remarks and I would be happy to answer any questions you may have. Thank you so much for your time and attention.
After my testimony - and the testimony of many others including pharmaceutical companies, pharmacy groups, and other patients - the Committee voted to pass the bill. At first they adopted an amendment to take out the important notification language in the bill, but this decision was later reversed. Now the bill has been passed through the Colorado Senate with the notification language intact. If it can get through the House Committee we are on our way to having a real law in Colorado that will help protect patients, and it's very exciting to have been a part of that!!