In recent years, biosimilars have emerged as a promising treatment for psoriasis, offering a cost-effective alternative to expensive biologics. These medications are designed to be nearly identical to biologic drugs such as Enbrel, Humira, Remicade, and Stelara, with the potential to significantly reduce treatment costs. Despite their approval by the FDA, biosimilars remain difficult for many psoriasis patients to access, with numerous hurdles preventing them from becoming widely available.
Biosimilars, also known as "follow-on" drugs, are created after the patent for a biologic drug expires. They are highly similar to the original drug in terms of structure and function but are typically sold at a lower price. For example, a biosimilar for Humira, a popular biologic, can cost as little as $674 per pen, compared to the original drug's $3,650 per pen. This price difference has the potential to make treatment more affordable for patients, but despite these advantages, the path to market for biosimilars has been fraught with obstacles.
One major issue is the reluctance of health insurance companies to cover biosimilars. Many insurers continue to favor biologics over their cheaper counterparts, often because they have negotiated larger rebates with the manufacturers of these brand-name drugs. According to Dr. Kavita Y. Sarin, a professor of dermatology at Stanford Medicine, insurance companies are incentivized to list biologics on their formularies due to the financial arrangements between pharmacy benefit managers (PBMs) and biologic manufacturers. As a result, biosimilars struggle to make their way onto insurance formularies, making them harder for patients to access.
Additionally, insurance companies often require patients to go through “step therapy” before they can access biosimilars. This means patients must try and fail on other treatments, even if they’ve already tried them in the past, before they can gain approval for a biosimilar. This policy delays access to potentially more effective and affordable treatments, leaving many patients frustrated and in pain.
Legal battles have also played a significant role in preventing biosimilars from reaching the market. Patent disputes between biologic manufacturers and biosimilar developers have led to significant delays in the availability of these medications. For instance, the biosimilar Amjevita was approved by the FDA in 2016, but it only became available to patients in January 2023, seven years later. Patent disputes and legal settlements between companies can extend this waiting period, sometimes for years, ultimately leaving patients with fewer treatment options.
In addition to these hurdles, many patients are unfamiliar with biosimilars. A survey conducted by the American Academy of Dermatology found that over 70% of psoriasis patients have limited understanding of biosimilars. This lack of knowledge can create hesitation and distrust among patients, who may view these medications as inferior simply because they are cheaper. This perception, combined with limited communication between doctors and patients, further hinders the widespread adoption of biosimilars.
However, despite these challenges, research has consistently shown that biosimilars are as safe and effective as their originator biologics. Duc Binh Phan, MSc, a research associate at the University of Manchester, reviewed 16 studies of biosimilars such as adalimumab, etanercept, and infliximab and found that they were generally as effective as the original biologic drugs. While a few studies showed a higher risk of adverse events with certain biosimilars, the overall consensus is that these medications provide similar clinical outcomes at a lower cost.
One common issue is that patients who switch from a biologic to a biosimilar sometimes stop their treatment due to minor side effects or psychological factors. The "nocebo effect," where patients expect a treatment to fail, can exacerbate this problem. As a result, some patients may feel that the biosimilar is not as effective as the original biologic, even when it performs similarly in clinical trials.
Even if patients manage to receive a biosimilar prescription, there is still a risk that their medication could be switched without their knowledge. In some states, pharmacies may substitute a biosimilar for the reference biologic if it has been designated as "interchangeable" by the FDA. Additionally, insurance companies may require patients to switch from one biosimilar to another or even back to the original biologic, depending on formulary changes. In these cases, the cost savings from using a biosimilar may not always be passed on to the patient, but rather to the insurer or PBM.
Melissa C. Leeolou, a fourth-year medical student at Stanford University and a lifelong psoriasis patient, emphasized the importance of patients understanding the benefits and potential of biosimilars. She encouraged patients to talk to their doctors about biosimilars, as they could be an important option for reducing treatment costs. Leeolou also recommended that patients be aware of the possibility of their medication being switched, and if that happens, they should discuss the issue with their doctor to ensure they are receiving the most appropriate treatment.
In conclusion, while biosimilars offer significant promise in improving access to affordable psoriasis treatment, patients continue to face numerous obstacles in obtaining them. From insurance companies’ preference for biologics to legal delays and patient misconceptions, the road to widespread adoption of biosimilars is still challenging. However, as awareness of biosimilars grows and policies evolve, these medications have the potential to revolutionize psoriasis treatment, providing patients with more affordable options and improving their overall quality of life. The key for patients lies in understanding their treatment options, communicating with healthcare providers, and advocating for better access to these life-changing medications.