NEWCASTLE-UPON-TYNE, UK—British rheumatologists often have their hands tied when it comes to prescribing tumor necrosis factor (TNF)-alpha blockers to patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS), according to new survey results published online in the journal Rheumatology.1 The striking lack of access occurs despite guidance from the National Institute for Clinical Excellence (NICE) instructing health care trusts to provide these medications for RA patients who meet treatment guidelines.

"Anti-TNF drugs are not the right drugs for everybody, but where they are we should be saying so, and taking action where they are not provided." —Leslie J. Kay, MD.
Investigators connected with the British Society for Rheumatology Biologics Register (BSRBR) surveyed all 509 UK consultant rheumatologists concerning provision and use of TNF inhibitors. About half of the rheumatologists responded to the survey; among them, 46% reported some form of limitation in prescribing TNF blockers to their RA patients, mainly due to capped funding or numbers of patients, staffing, or lack of other facilities. The situation is even worse for patients with AS and PsA. While 67% of the rheumatologists said they could prescribe these drugs to patients with AS or PsA at least sometimes, 33% of rheumatologists had no access at all for these conditions.

"We had heard anecdotally that some rheumatologists seemed to be more limited in their access than others, so I suppose we were surprised at the widespread nature of the limitations," said lead author Lesley J. Kay, MD, a member of the BSRBR management committee and an honorary clinical senior lecturer at Newcastle University in Newcastle-upon-Tyne, UK. Dr. Kay told CIAOMed that she will  be repeating the survey in January to see if the situation has changed.

Currently in the UK, local primary care trusts make individual decisions about how to allocate their budgets and are supposed to fund any treatment mandated by NICE to all patients meeting criteria. Sometimes these trusts only allocate a fixed amount of money or limit the number of patients who can be treated. TNF-inhibitors are NICE-approved for RA and received NICE approval for PsA in June 2006 after the survey had been completed. NICE is expected to issue guidance for the use of these agents in AS in 2007. Some of the doctors who responded to the survey may practice in regions not covered by NICE, but the survey was anonymous so researchers could not tease out the findings by region.

Surprising findings

Responding physicians cited a large number of access problems including a fixed number of patients to be treated per month and fixed financial caps (70%) and bans on treating new patients until the next fiscal year. Slightly more than 20% said staffing was hindering access to these drugs, and 9% cited lack of other facilities. Thirty-six percent of respondents reported having a waiting list of patients needing TNF-inhibitor treatment, with a median waiting time of 4 weeks and a maximum of 156 weeks.
Increase access

Potential solutions may include auditing and monitoring the problem, Dr. Kay told CIAOMed. "Helping the primary care trusts to realize how much difference these drugs make and if that fails, notifying the strategic health authorities [who oversee the primary care trusts] about the primary care trusts' failure to adhere to NICE guidance," she said. "Anti-TNF drugs are not the right drugs for everybody, but where they are we should be saying so, and [we should be] taking action where they are not provided."

Problem not seen in other parts of Europe

In the Netherlands, the situation is brighter, said Désirée van der Heijde, MD, a professor of rheumatology at the University Hospital Maastricht in the Netherlands. "We have access to the TNF-blockers etanercept and adalimumab for all approved indications (RA, PsA, AS)," she said. "For infliximab, it is more dependent on the hospital where you work." She added that infliximab use is very limited in her hospital where it can only be implemented…"if the other two TNF-blockers failed, AND there is still room within the budget, which is sufficient for about 7 patients. The reason is that intravenous drugs and subcutaneous drugs are reimbursed differently: the first belongs to the lump sum budget of the hospital, the second is paid by health insurance."


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Reference

1. Kay LJ, Griffiths ID. UK Consultant rheumatologists; access to biological agents and views on the BSR Biologics Register. Rheumatology. 2006 Oct 11; [Epub ahead of print].