Issues in accessing biologics for lupus patients in Ireland

Irish rheumatologists are struggling to access two recently-approved biological drugs to treat lupus, the ISR 2022 Spring Meeting heard. 

Dr Eoghan McCarthy, Consultant Rheumatologist at Beaumont Hospital, Dublin, gave an update on the use of biologic drugs in systemic lupus erythematosus (SLE), the most common type of lupus. 

The monoclonal antibody drug belimumab, which can be used to treat patients with SLE over the age of five years and adults with lupus nephritis, has been approved for use in the EU since 2011. Another monoclonal antibody, anifrolumab, which is given to SLE patients with autoantibodies who still have moderate-to-severe disease despite standard treatment, was approved in the EU in February 2022. Neither drug are currently available in Ireland, however, he said. 

“It is disease activity that you need to try and get under control as quickly as possible because those are the things that will cause damage,” Dr McCarthy told the meeting. “But over time… the treatments that you’re actually exposing these patients to is what causes the accumulation of damage.” 

“So, anything you can do to reduce damage, and therefore anything you can do to reduce the accumulative burden of steroid exposure to these patients, and reducing disease activity in a rapid manner will be associated with improved outcomes for our patients. And that’s the desperation that we all have as rheumatologists… how do you manage to do that without having to rely on such toxic medications.” 

Belimumab was approved as an add-on therapy for SLE. “I think it is important that, actually, it looks like it’s a reasonably safe drug in terms of standard of care,” said Dr McCarthy. The drug is approved for patients with active, antibody-positive SLE with a high degree of disease activity despite already receiving standard treatment. 

Anifrolumab, approved only months before the ISR Spring Meeting, “looks to be quite a promising drug”, he commented. “There’s a rationale that interferon inhibitors may… reduce SLE activity.” 

In SLE, a protein called type I interferon is involved in causing the immune system to attack normal cells and tissues. Anifrolumab works by blocking the action of this protein and then reduces inflammation and organ damage. 

As part of showing the efficacy of biologics in the real world, Dr McCarthy spoke about the British Isles Lupus Assessment Group Biologic Register (BILAG-BR), a study underway in UK hospitals to assess the safety and effectiveness of biologic and biosimilar treatment for SLE. “The fact that we are demonstrating efficacy in the type of patients that are walking into your clinic is important,” he said. 

“For patients, I think it’s really important to understand the application and the safety of these drugs in the real-world setting, particularly as more and more of them come through,” he added, “because all our patients are going to be receiving a kind of belimumab or anifrolumab on the background of having probably multiple courses of [other treatments].” 

Dr McCarthy told the Medical Independent (MI) that the main takeaway from his talk at the meeting was that: “We as treating clinicians in Ireland are unable to access either belimumab or anifrolumab at present.” 

In response to queries from MI as to why this was the case, the HSE said it had not received the necessary applications for the drugs from their manufacturers. 

“Pharmaceutical companies are required to submit formal applications to the HSE if they wish their medicines to be added to the list of reimbursable items/funded via hospitals,” a spokesperson for the Executive said. 

The corporate pharmaceutical unit (CPU) within the HSE is responsible for accepting and considering pricing and reimbursement applications from the pharmaceutical industry. “As of 30 May 2022, the HSE CPU can confirm that a pricing and reimbursement application has not been submitted by the pharmaceutical company (AstraZeneca) for anifrolumab.” 

Regarding belimumab, the HSE drugs group, responsible for recommendations on pricing and reimbursement of medicines, was “unable to support the pricing approval of this medicine in 2013 due to the absence of a health technology assessment (HTA)”. The HSE spokesperson said, to date, GlaxoSmithKline Pharmaceuticals has not submitted a HTA dossier for belimumab to the National Centre for Pharmacoeconomics for assessment. 

Irish Society for Rheumatology, Spring Meeting, Sligo Park Hotel, 19-20 May 2022