The NHS’s decision to switch multiple sclerosis (MS) patients from Tysabri, a well-established treatment, to Tyruko, a cheaper biosimilar drug, has led to significant complications for many individuals. These complications, including relapses of their MS symptoms, debilitating side effects, and hospitalizations, have raised concerns about the long-term consequences of this decision. The transition, which began in April 2024, was part of NHS England’s broader initiative to save money by switching to lower-cost, off-patent medications. Tyruko, a version of Tysabri that has been produced by the pharmaceutical company Sandoz, was marketed as a safe, effective alternative, with no significant differences from the original drug. However, the reality for many patients has been far more complicated.
The Initial Shift: NHS’s Push for Savings
The NHS’s strategy to reduce drug costs by promoting the use of biosimilars, such as Tyruko, is part of an effort to save £1 billion over the next five years. While biosimilars are designed to be as safe and effective as their branded counterparts, they are generally much cheaper, with some versions being 72% less expensive. For NHS England, this move seemed like a sensible financial decision, especially given that the health service spends a staggering £17 billion annually on medicines.
However, the switch to Tyruko has not been without its issues. Starting in April 2024, patients with active, relapsing MS who were receiving Tysabri began to be switched to Tyruko. This change affected a large number of patients at various hospitals, with the largest group at Charing Cross Hospital in London. Imperial College Healthcare NHS Trust, which oversees Charing Cross, had 345 MS patients on Tysabri before the switch. The initial expectation was that any side effects from the transition would be mild and short-lived. Previous instances of switching patients to biosimilars had resulted in only minor disruptions, so the healthcare professionals at Charing Cross Hospital were prepared for this.
The Unforeseen Consequences: Severe Side Effects
Despite these expectations, many patients at Charing Cross reported severe, ongoing side effects after switching to Tyruko. Around half of the patients who were transitioned to the biosimilar experienced significant health complications, which worsened over time. The side effects were far more severe than anticipated, including symptoms such as fatigue, pain, difficulty using their legs, sudden weight gain, and loss of mobility. Some patients even had to be hospitalized due to the worsening of their MS symptoms.
In response, the medical team at Charing Cross Hospital began reviewing each case individually, and all patients who had been switched to Tyruko were eventually switched back to Tysabri. By the end of 2024, Imperial had reverted all its MS patients on Tyruko back to Tysabri, after receiving numerous reports of escalating and persistent side effects. The hospital admitted that while they had expected some short-term side effects, the prolonged and worsening nature of the symptoms was not anticipated. The patients, who had previously been stable on Tysabri for years, suddenly found themselves grappling with debilitating symptoms that significantly impacted their daily lives.
The Broader Impact: Nationwide Concerns
While NHS England has maintained that these side effects are confined to the experience of patients at Charing Cross Hospital, there are growing concerns that the problem may be more widespread. Some patients who were switched to Tyruko have reported similar adverse effects at other hospitals, including those located in different regions of the UK. One patient from Charing Cross claimed to know of individuals from at least 15 other hospitals across the country who had experienced setbacks after switching to Tyruko. This suggests that the problems could be more common than NHS officials are willing to acknowledge.
The primary concern among MS patients and their families is the lack of transparency and communication surrounding the switch. Many patients, some of whom had been stable on Tysabri for several years, were not adequately informed of the potential risks associated with the transition to a biosimilar. This lack of communication has left many feeling helpless, frustrated, and uncertain about the effectiveness of their treatment. As one patient at Charing Cross Hospital described, “It was awful for me. I had been doing so well on Tysabri, and suddenly, I was hit with all these symptoms. It felt like I had been abandoned by the system.”
The Response from Healthcare Providers
NHS England has responded by initiating discussions with the Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA). The goal of these discussions is to determine whether the side effects seen in patients on Tyruko can be attributed to the drug itself or whether other factors, such as the progression of the disease or other underlying health conditions, may be at play. These discussions are critical for understanding the full extent of the problem and formulating an appropriate response.
A spokesperson for Sandoz, the manufacturer of Tyruko, has stated that patient safety is their top priority. They are working with NHS England and the regulatory authorities to understand the situation at Charing Cross Hospital and to investigate the reasons behind the severe side effects reported by patients. Sandoz maintains that Tyruko is considered to be interchangeable with Tysabri by the MHRA, which has determined that there are no meaningful differences between the two drugs. However, the experiences of patients at Charing Cross Hospital suggest otherwise, and further investigation is needed to determine the root cause of the adverse reactions.
Financial Implications: Saving Money at What Cost?
The switch to Tyruko was part of a larger strategy by NHS England to cut healthcare costs by using cheaper drugs. While the NHS’s financial challenges are well-documented, the question arises whether the cost savings achieved by using Tyruko will be offset by the costs of addressing the adverse effects that many patients are experiencing. Hospitalizations, extended treatment periods, and the long-term impact on patients’ quality of life could all contribute to additional costs for the health system.
The financial savings promised by NHS England could also be undermined if patients who experience complications from Tyruko require more intensive care or longer hospital stays as a result of the switch. For some patients, the side effects may have a lasting impact on their physical and mental health, potentially reducing their ability to work or engage in normal activities. This could lead to long-term economic consequences, both for the patients involved and for the broader health system.
The Role of MS Charities and Advocacy Groups
MS charities and advocacy groups have expressed concern about the experiences of patients who have switched to Tyruko. The Multiple Sclerosis Trust and the MS Society have both acknowledged that a small number of patients have experienced severe symptoms after the transition. However, both organizations have also noted that the majority of patients have not reported any issues with Tyruko, and that the situation may be more complicated for those with highly active MS. In these cases, new symptoms may be a natural part of the disease’s progression, making it difficult to attribute the worsening of symptoms solely to the switch to Tyruko.
The MS Society has urged NHS England to investigate the issue further and to ensure that patients are properly informed of the risks involved in switching to biosimilars like Tyruko. MS patients should not have to bear the burden of uncertainty or worsening symptoms because of a decision made by the health service to save money. The organization has also called for greater transparency from NHS England and pharmaceutical companies regarding the safety and effectiveness of biosimilars.
As the debate over Tyruko continues, it is crucial that NHS England, healthcare professionals, and patient advocacy groups work together to address the concerns of MS patients. An in-depth investigation into the side effects of Tyruko, including whether they are more prevalent in patients with highly active MS, is needed to ensure that patients receive the best possible care. In addition, better communication is essential to ensure that patients are fully informed of the risks and benefits of switching to a biosimilar drug.
Patients who have experienced complications after switching to Tyruko should be provided with the necessary support to manage their symptoms and receive appropriate treatment. In the long term, the NHS must prioritize patient safety and well-being over cost-saving measures that could have unintended consequences. Ultimately, the health and quality of life of MS patients must be the driving force behind any decisions made regarding the treatment options available to them.