Currently, UK eligibility criteria for starting biologics in patients with rheumatoid arthritis (RA) set a threshold of a disease activity score in a count of 28 joints of 5.1 or higher—the threshold for severe disease—on at least 2 occasions measured 1 month apart.
Ahead of the National Health Service (NHS) Health and Care Innovation Expo, held this week in Manchester, United Kingdom, Korean biosimilar developer Celltrion is calling on the NHS to lower the threshold for starting biologic therapy in patients with rheumatoid arthritis (RA).
Currently, UK eligibility criteria for starting biologics in patients with RA set a threshold of a disease activity score in a count of 28 joints (DAS28) of 5.1 or higher—the threshold for severe disease—on at least 2 occasions measured 1 month apart.
Rheumatologist Ben Parker, MBChB, PhD, of the Manchester University Hospitals, said in a statement supporting Celltrion’s position, “A UK patient’s burden of disease must be much more severe before they qualify for biologic therapy, compared to a French patient. As a treating physician, I strongly believe that this inequality needs to be addressed so that our patients can realize the same benefits of early treatment as their European neighbors.”
Ho Ung Kim, head of strategy and operations at Celltrion Healthcare said, “We have identified clear disparities in access to biologics across Europe. Patients diagnosed with less than severe disease activity should be able to get just as good and cost-effective benefit from biologics as patients with severely active disease, as this will help them achieve a better quality of life.”
Kim pointed to recent data on cost savings that the use of biosimilars has provided to the NHS, which showed that switching patients to biosimilars of infliximab (including Celltrion's product, sold as Inflectra and Remsima), etanercept, and rituximab delivered a cumulative savings equivalent to approximately $275 million in US currency in the last fiscal year. “With the proven savings, gained through the use of biosimilars, this could be a real opportunity for the NHS to address these concerning inequalities,” said Kim.
The National Institute for Health and Care Excellence (NICE), the UK cost watchdog, has issued guidance that RA therapy should consist of at least 2 conventional disease-modifying anti-rheumatic drugs (DMARDs), 1 of which must be methotrexate unless it is contraindicated, plus glucocorticoids as first-line treatment. A patient must try this conventional first-line treatment for at least 6 months without adequate response before becoming eligible for a biologic. After becoming eligible, a patient must start with the least expensive biologic, taking into consideration any administration costs, the necessary dose, and the product’s price per dose.
In order to stay on a biologic, says NICE, a UK patient must show a moderate drop in DAS28 every 6 months, a drop that the British Society of Rheumatology (BSR) has called into question. According to BSR, “If you start at a lower baseline score, you may get a smaller drop in DAS28. For many patients, a drop of 0.6 can constitute a significant improvement.”