Diane Lacaille, MD, MHSc, FRCPC
bh IN BRIEF
Biologics are expensive, but are they worth it? Dr. Lacaille has been at the fore in researching the effects of rheumatoid arthritis (RA) on the workplace. These drugs typically have very positive, quick, and longlasting effects on most of those who take them. That noted, these drugs are not for everyone, and it is only a minority of RA patients who take them. The cost of time off work, productivity loss, and disability is also very significant, and employers need to consider calculating both cost and benefit in deciding coverage and reimbursement.
Making Sense of Biologic Agents
Over the last decade, the advent of biologic agents has revolutionalized the treatment of inflammatory forms of arthritis, such as rheumatoid arthritis (RA), psoriatic arthritis, and ankylosing spondylitis. These agents are dramatically effective in controlling inflammation. They act very rapidly, often within 1 to 2 weeks of administration, compared to traditional disease modifying anti-rheumatic drugs (DMARDs) that require 2 to 3 months to start working. Plus, biologics have proven superior in controlling fatigue. Among people with RA, our focus group research described fatigue as the most limiting aspect of their illness. This clearly affects workplaces.
Biologic agents are also remarkably effective at halting joint damage. While DMARDs can slow the progression of joint damage, they can't completely stop it. Radiographic studies running over five years indicate little to no progression when biologics effectively control inflammation. Long-term studies generally demonstrate the initial benefit is maintained over time, although one drug (infliximab) sometimes requires higher doses to control auto-antibodies that develop against the medication.
What people who respond to biologics universally describe is: "I got my life back!" For many of them this happened dramatically after one or two doses of the medication. Typically, they describe waking-up one morning and feeling "normal" again. This is amazing for anyone living with constant pain and with the veil of fatigue and malaise. Seeing patients in their first follow-up visit after starting a biologic is one of the most rewarding moments for me.
To prescribe or not? What influences the decision?
If these medications have such a wonderful benefit, should they not be used more widely? Unfortunately, the high cost of production restricts their use to patients who have failed traditional therapy. Further, the optimal timing to introduce biologic agents has not been clearly established.
Currently, less than 10% of Canadians with RA are on biologic agents; many others don't need them. Biologics have serious side effects, mainly increased risk of infections. As well, research has shown most RA patients respond well to traditional DMARD therapy when it is administered early and aggressively and with a targeted approach where the treatment is stepped up if active inflammation and swollen joints persist.
There seems to be a window of opportunity early in the disease, within the first year or two, when the process of inflammation and joint destruction can be more easily controlled or put into remission. Intense research is underway to identify prognostic markers for people more likely to experience aggressive RA and those with disease that is likely to be resistant to traditional DMARDs.
Biologic agents and the workplace
High quality studies are increasingly demonstrating that biologic agents, especially those used against RA, are effective at reducing time missed from work, and increasing productivity. While there is much peripheral evidence, research has not yet proved that biologics can prevent work disability, however this is in part due to methodological issues. Work disability takes five to ten years to occur in sufficient numbers to demonstrate the effectiveness of an intervention and randomized trials are not conducted for such long periods. Studies of employment and RA consistently identify pain and physical function as important predictors of work loss. Biologic agents have a clear impact on these factors, and are therefore likely to prevent disability.
In the pre-biologic era, 32% to 50% of employees reported stopping work due to their RA within ten years of disease onset. This has important implications for the labour force since people often get RA in their 30s and 40s, in their prime working years. One study in osteoarthritis and rheumatoid arthritis found that at-work productivity loss was the largest component of indirect cost.
Spending $25,000 per year for a biologic to control RA may seem prohibitive, but only until employers consider the cost of the illness itself, including decreased productivity at work, payment of disability benefits, and the loss of a skilled or valuable employee who needs to be replaced and retrained. Knowing this, the cost may actually be well worthwhile.
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