On 14 July 2021, the National Institute for Health and Care Excellence (Nice) issued new guidelines that approved certain kinds of biological medicines, known as biosimilars, to be prescribed for people living with moderate rheumatoid arthritis (RA). These guidelines signal a significant development for the treatment of this disease as it gives patients earlier access to important medicines that could have drastic long-term implications for their quality of life.
RA is an autoimmune disease where the body’s immune system mistakenly attacks the cells that line the joints, causing inflammation to the joint lining. In moderate stages, RA presents with increased fatigue, joint pain, and swelling and stiffness that varies in intensity at different times. It can also be accompanied by a low-grade fever. As the disease progresses, the swelling, stiffness, and pain becomes more severe and can result in irreparable damage to the joints, including the cartilage, and surrounding bone, thus the importance of early biologic treatment. In addition, those living with the disease can experience greater levels of fatigue, reduced cognitive functions, osteoporosis, cardiovascular events, weight loss, anaemia, and an increased risk of cancer.
According to the National Rheumatoid Arthritis Society, roughly 1% of the UK’s population has RA, making it the most common form of inflammatory arthritis in the country. The disease is known to affect women more than men (around two to three times as many women, in fact) and, according to Nice, is responsible for “approximately one-third of people” stopping work because of pain and disability “within two years of its onset and this increases thereafter”. The longer an individual goes without a diagnosis or receiving appropriate treatment, the more likely they are to suffer irreparable damage to their joints. As Dr Maria Leandro, consultant rheumatologist and honorary senior lecturer at the Centre for Rheumatology at University College London, says: “Studies have shown that in patients with rheumatoid arthritis even some months’ delay in starting treatment is associated with lower chance of responding very well to treatment and achieving what we call remission, ie, no symptoms or signs of inflammation.”
Traditionally, moderate RA has been managed through a range of methods. These include supportive approaches such as physiotherapy and occupational therapy, which can help maintain joint mobility and manage potential problems with an individual’s lifestyle. In more severe cases, surgery can be used to address problems with the joints once they have developed. But by far the most important treatment is the long-term use of medication to ease symptoms and to slow the disease’s progress.
RA is typically treated using conventional disease-modifying antirheumatic drugs (cDMARDs), which can also be used to treat other diseases such as psoriatic arthritis, systemic lupus erythematosus and ankylosing spondylitis. They include hydroxychloroquine, methotrexate, sulfasalazine, leflunomide and azathioprine. These drugs, which usually appear in pill form, work to suppress the body’s inflammatory and overactive immune systems. In many cases, the symptoms of patients who get early access to these drugs can go into remission, but it is not always the case. “What happens is that some patients can achieve remission with the conventional standard DMARDs, such as methotrexate, but many do not,” says Leandro. “We see more good responses to conventional standard DMARDs in patients who were diagnosed early and started treatment early but even then, not all will respond.”
There are also biological versions available to patients, called bDMARDs. While conventional DMARDs target the entire immune system, bDMARDs are targeted drugs that work by, for example, blocking cytokines, small proteins that play an important role in controlling the growth and activity of other immune system cells. In the case of RA, one of the cytokines affected is called a tumour necrosis factor (TNF), which is principally responsible for the inflammation associated with this disease. bDMARDs, which are administered through injections or infusions, help prevent TNF from binding with receptors and so limit inflammation.
bDMARDs have been used to treat RA since the late 1990s, and include a range of different types of drugs, including well-known etanercept, but prior to Nice’s decision in July, only patients living with “severe” RA could access them, unlike the treatment guideline in the European Union. This is because, despite their effectiveness, bDMARDs, like other forms of biological medicines, are extremely expensive. When a new medicine is created, it usually undergoes a period of patent protection to allow its developers a chance to recover the cost of their research and development while also turning a profit. This pushes up the price of the product, which can be a significant barrier for patients and health services who wish to access it. This is why biosimilar medications are of such importance to healthcare systems.
Biosimilars are copies of existing biological medicines that are produced by other manufacturers at the end of the period of exclusivity of an original product, known as a “reference medicine”. These drugs are usually cheaper as there is less of a need to recover the development costs as the reference drugs. By being more affordable, the availability of new biosimilars introduces greater competition to the pharmaceutical market and helps bring down the price of other medications, such as the reference drugs, for patients and healthcare providers, which helps to maintain a sustainable healthcare system. The budget saved from the whole healthcare expenditure on biosimilars can be reinvested to patients in different ways, such as increased patient services, hospital beds, and a reimbursement extension (where the NHS agrees to refund the cost of the medicine) to new rare diseases.
Nice’s announcement is so important because it lets clinicians prescribe biosimilars of known bDMARDs for the treatment of moderate RA, which not only promises to save the NHS hundreds of thousands of pounds per year, but also provides earlier access to biological treatments to patients experiencing milder forms of RA. The news means more people living with RA will have a chance to be treated earlier to avoid a future of pain, discomfort, and possible disability, including irreversible joint damage.
To learn more about biosimilars and their potential to transform the way biologic therapies are brought to patients, visit Samsung Bioepis