I often hear my patients ask the same questions: Why do I need to change to another infusible biosimilar again? Why do I need to get my infusion therapy sent by a specialty pharmacy? Will I be able to continue my therapy on time?
The answers are not straightforward. The story begins in 2016 when came to market in the U.S. Biosimilars are near identical copies of the original therapy with the same active ingredient, mechanism of action, and risks -- but they cost less. They are made to be interchangeable with the original therapy. While this sounds reasonable at face value, the issue stems from onerous requirements implemented by insurance companies and pharmacy benefit managers (PBMs) mandating use of very specific "preferred" therapies. I've seen the consequences firsthand at my community practice that provides infusion services.
My patient Savannah* is a classic example. She has ulcerative colitis, a chronic condition that causes inflammation in her colon. It took quite a bit of time until we found her the appropriate infusion therapy and dosing schedule to get her into remission and feeling well. Savannah's insurer subsequently required her to change to another biosimilar. However, the required prior authorization was repeatedly denied, which delayed her therapy and risked disease recurrence.
If that wasn't frustrating enough, the insurance company's "preferred biosimilar" reimbursement was less than the drug would cost the practice to purchase. This forced the practice to go through a specialty pharmacy rather than risk a financial loss if reimbursement didn't cover the cost of the medication. This prompted yet another prior authorization, and the clock restarted, ticking down the minutes to yet another delay in therapy.
My colleague reviewed our internal 2023 data on how long it took our staff to get prior authorizations for infusion therapy patients, and subsequently, how long it took for patients to start therapy. The findings showed that specialty pharmacies were associated with significant delays in drug start time at our practice. This is why the , along with many other medical organizations and individual physicians, has been on a crusade to fight prior authorization policies.
PBMs, often owned by or affiliated with insurance companies, negotiate drug costs with the manufacturer and then get a rebate for using that same drug. The insurance company then puts this drug on its preferred formulary. These prices and preferences can change multiple times throughout a given year.
Unfortunately, the negotiated drug purchase price can be lower than insurance companies will reimburse physician practices, thereby putting medical practices in a precarious financial position if they are to maintain the preferred treatment course for patients. As in the example I shared about Savannah, if the insurance company does not offer a financially viable biosimilar option, the practice has to arrange to obtain it through a specialty pharmacy (often owned by insurance companies), which has high administrative burden and . This entire process works against best practices and unnecessarily endangers patients.
For many healthcare specialties across the country, this is a dangerous trend that can negatively affect access at a time when . This trend makes it unsustainable for physician practices to keep delivering high-quality infusion services in the outpatient setting. If this continues, patients could be forced to go to hospitals for infusions, which of care and is not in the best interest of the healthcare system.
For my patient Savannah, all of this is incredibly stressful, which is a risk factor for her disease and often leads to painful flare-ups. Moreover, she works full-time, so any delay in her care can have major consequences. Navigating this system has become her second full-time job.
The Federal Trade Commission recently released a on PBMs' anticompetitive practices, including their troubling rebate policies and how they impact patients' access to the drugs they need. PBMs and the insurance giants who own them have to rethink their troubling policies. Let us doctors use our medical expertise to prescribe individual patients the drugs they need, and ensure they are delivered without delay. Do not make practices decide between large financial risk and care delivery. Offering greater transparency into these processes can help too.
I am hopeful that if we speak up as a collective, we can create effective change before it is too late.
*Patient's name has been changed for privacy.
is the chair of the American Gastroenterological Association IBD Community Care Initiative and the director of the Chronic Care Inflammatory Bowel Disease Program and Research at Capital Digestive Care in Washington.
Disclosures
Cohen is medical director of infusion services at Capital Digestive Care/MGG Division. She is also a consultant for Pfizer, Abbvie, and Takeda, and a member of the speaker bureau for Abbvie, Takeda, and Janssen.