An interview with Kevin Bowen, MD, MBA, Principal Health Outcomes Researcher at Prime Therapeutics
Are guideline recommendations consistent with real-world treatment of patients with rheumatoid arthritis (RA)?
First, RA treatment guidelines, such as the 2015 American College of Rheumatology (ACR) and the 2016 European League Against Rheumatism (EULAR) updates, are extremely valuable as RA experts compiled and assessed available information and developed RA treatment recommendations. Both guidelines express agreement that:
1) All individuals with RA should be started on disease-modifying antirheumatic drugs (DMARDs) as soon as possible after diagnosis and DMARD therapy of some sort should usually continue indefinitely.
2) Use of one of the lowest cost conventional synthetic DMARDs, most commonly methotrexate, should be first-line therapy. A trial of a different or a series of different DMARD regimens should be used in patients for whom treatment fails, with switches after sufficient time on therapy to evaluate the patient’s response, typically at least 12 weeks.
3) RA patients should be regularly monitored using structured RA disease activity measures to guide adjustments of treatment aimed at a target of clinical remission or, if this is not achievable, low disease activity.
4) Many RA patients will require treatment with a series of different DMARD regimens.
To answer your question, our retrospective study of claims information from a large cohort of RA patients identified some deviations from these recommendations. These findings may represent opportunities for managed care’s concurrent responsibilities: (1) to promote what is best for individual members with health problems such as RA, and (2) to protect the interests of all members of a health plan by encouraging wise use of health care resources. We found:
1) Many members with RA did not receive any DMARD therapy during long periods of follow-up after their first claim which indicated the RA diagnosis. This appears to be a “gap in care.” Closing this gap would involve additional direct cost for drugs but might also decrease the subsequent direct and indirect costs associated with disability from RA.
2) Most health plans have implemented strategies such as step therapy to encourage trial of a conventional synthetic DMARD (csDMARD). However, among members not subject to step therapy, we found many members moved directly to a high cost biologic or targeted synthetic DMARD (b/tsDMARD) therapy. In addition, among those who were subject to step therapy, we found many members moved quickly to a b/tsDMARD, often much less than 12 weeks after their first claim for a csDMARD. In both instances, it is likely that high quality care could have been provided at much lower drug cost for some of these members.
3) Many members with RA do not have claims evidence of regular monitoring by a care provider as advocated by the guidelines. We looked for office visits with rheumatologists and/or the laboratory tests C-reactive protein or erythrocyte sedimentation rate. If this monitoring is not occurring regularly, it seems likely there are members who continue taking b/tsDMARDs that are not working, which wastes health care resources.
4) We found a large proportion of members starting on a b/tsDMARD discontinued their initial therapy within a matter of months and the majority of these members did not receive a trial of an alternative DMARD therapy. This is also a gap in care that may be related to inadequate follow-up and monitoring.
The EULAR and ACR guidelines differ in the recommendation they make for patients who fail first-line therapy with a csDMARD. EULAR recommends a trial of combination csDMARDs, such as “triple therapy” with methotrexate, hydroxychloroquine, and suslfasalazine (unless the patient has poor prognostic features defined in the guideline). ACR recommends either a trial of combination csDMARDs or use of a biological DMARD as the next step. On this important point, the ACR guidelines do not support optimizing csDMARDs before b/tsDMARDs, to ensure the most cost-effective therapies are tried first. In our study, most individuals switching from conventional monotherapy, such as methotrexate, went directly to a biologic agent. There was very little use of triple therapy.
How do costs of care typically compare between members with RA and member without RA?
In our study, we compared total medical and pharmacy claims costs for about 26,000 members with RA with that of a randomly selected group of members without RA who were matched, five to one, based on gender, age, and health plan. This study design was selected to bring out the costs that were associated with RA, by removing the influence of costs that are only associated with groups of members with the same gender and age distribution as those with RA.
We found the mean 2016 cost for all RA members, excluding the cost of DMARDs, was about two times that of non-RA members (about $16,000 compared with $8,000). The mean cost for all RA members with a b/tsDMARD claim, excluding cost of DMARDs, was also 2 times that of non-RA members, but their total mean cost was about 6.4 times higher (about $52,000 compared with $8000).
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What is the largest driver of cost among patients with RA, aside from treatment costs?
Leading categories of excess cost for RA members compared with matched members without RA include: inpatient stays for musculoskeletal procedures (eg, knee replacement); outpatient medical claims for diagnostic radiology, office visits, musculoskeletal procedures and laboratory tests; and pharmacy claims for pain medications such as NSAIDs and opioids. Most of this expense appears to be the direct cost of managing RA or the cost of treating joint damage that has accumulated over extended time periods.
How do comorbidities factor in to cost management among RA patient populations?
In our study results, expense for treatment of comorbidities associated with RA—that is, concurrent chronic conditions that are in excess among members with RA compared with matched members without RA— appeared to be a very minor fraction of the excess cost associated with RA.
Can biosimilars help mitigate the high costs of biologics?
Yes. Any factors that might lower the cost of biologic or targeted synthetic DMARDs could have a meaningful impact on health plan spending.
Is there anything else you would like to add about your RA research?
Individuals with RA had 3.5 times higher total cost of care than a matched comparison sample of members without RA. In 2016, two-thirds of the higher cost among all RA members was due to b/tsDMARDs that were used by 33.6% of all RA members. The findings identify limited opportunities for short-term, off-setting medical cost savings from optimized DMARD therapy. Since much of the excess expense is for RA medical care management, or articular or other damage that has likely accumulated over the course of years, it may not be reduced by subsequent anti-inflammatory drug therapy.
In this study, RA members using only conventional DMARDs (eg, methotrexate) had slightly lower medical costs than RA members using biologic DMARDs with or without a conventional DMARD. This finding is consistent with randomized controlled trials comparing the cost-effectiveness of optimized conventional DMARD therapy (eg, triple conventional DMARD therapy) to biologic therapy with methotrexate.
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