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The Role of Clinical Pathways in Patient Care

VBCR - April 2014, Volume 3, No 2 - VBCR Perspectives
Gary R. Feldman, MD, FACR
Medical Director
Pacific Arthritis Care Center
Los Angeles, CA

As healthcare reform continues to unfold, an increasing amount of pressure is being placed on payers, providers, and patients to address the rising cost of care. Greater attention is being paid to patients with inflammatory arthritis and other autoimmune conditions treated with chronic biologic therapies. Although the cost of many healthcare services is stabilizing, specialty pharmacy costs continue to rise at an unsustainable rate.1 Rheumatoid arthritis has become one of the most expensive chronic illnesses to treat based on average patient cost. This is due to an increasing percentage of patients on biologic therapies and these agents’ continuing rise in cost.2

Payers are becoming more aggressive in deploying strategies to control the cost of care. Such measures do not always consider efficacy or toxicity for each patient’s clinical situation, but instead, place emphasis on cost reduction as the overriding goal. They include:

  • Cost shifting: placing biologics in their own specialty pharmacy tiers with up to 20% to 30% higher copayments.3
  • Reduced reimbursements to providers: for in-office biologic therapies and administration.
  • Step therapies/medical necessity documentation: reducing access to therapies that are indicated, and for which multiple treatment choices exist.

Rheumatologists have options available to them that could change how coverage decisions are made. Clinical pathways are one of these options. They are tools used to guide care, and achieve clinical objectives that conform to clinicians’ priorities and also satisfy payers’ needs.4 In oncology practice—which has certain parallels to rheumatology—pathways have been developed and used in clinical practice that are physician-driven and use evidence-based medicine.

The process of developing pathways is rigorous and requires thorough review of all available data. It places the greatest emphasis on efficacy, followed by toxicity, and only then, compares the cost of varying treatment approaches. Pathways are designed to achieve desired outcomes for the majority of patients and treatment scenarios. Ideally, they will conform to the 80/20 rule, which is generally accepted by payers. Eighty percent of patients with a given diagnosis will be successfully treated by the recommended therapeutic course, and 20% may have to go outside the pathway to achieve clinical goals. Pathways are also designed to be broad enough to give clinicians adequate choices for them to manage patients and narrow enough to better predict the cost of episodes of care.

Using clinical pathways in the treatment of patients with multiple cancers has been shown to reduce the cost of care without compromising outcomes, and in some cases, has also been shown to reduce toxicity.5,6 Despite this apparent success in oncology, it is not a given that this approach will be successful in rheumatology. We may undoubtedly need to alter the model of pathways to adapt to the differences between the treatment of patients with chronic autoimmune diseases vis-à-vis more episodic cancer therapies.

The lack of consensus among rheumatologists on what metrics of activity and outcomes should be used in practice hampers the creation of pathways that can be widely accepted. Oncologists have had the opportunity to substitute a number of generic drugs into their regimens, which has generated significant cost-savings. Until biosimilars—agents considered “interchangeable” with US Food and Drug Administration–licensed biologics,7—come to market for rheumatologists to prescribe, the same potential for savings is not present in autoimmune diseases. There are currently limited data on head-to-head trials comparing biologic therapies, but as the approval process of biosimilars progresses, these data will increase significantly. These findings can be used to evaluate whether new agents will be cost-effective alternatives to branded biologics.

Whether rheumatologists are comfortable with it or not, a cost-benefit analysis will play an increasing role in coverage decisions; this will affect the management of their patients. Clinical pathways may be a viable option to balance appropriate care with cost concerns in this era of health reform. For autoimmune diseases, this will take some degree of adaptation on the part of rheumatologists, but there is already a track record for the successful use of pathways in clinical oncology care.8

References
  1. Miller SB, Hoffman TA, Houts JC, et al. The rise of specialty pharmacy costs. Dis Manag Health Out. 2007;15:83-89.
  2. The Express Scripts Research & New Solutions Lab. 2011 Drug Trend Report. Express Scripts. www.drugtrendreport.com/docs/DTR-2011.pdf. Published April 2012. Accessed March 17, 2014.
  3. The Kaiser Family Foundation and Health Research & Education Trust. 2013 Employer Health Benefit Survey; Kaiser Family Foundation. http://kff.org/private-insurance/report/2013-employer-health-benefits/. Published August 20, 2013. Accessed March 17, 2014.
  4. Kinsman L, Rotter T, James E, et al. What is a clinical pathway? Development of a definition to inform the debate. BMC Med. May 2010 [Epub ahead of print].
  5. Neubauer MA, Hoverman JR, Kolodziej M, et al. Cost-effectiveness of evidence-based treatment guidelines for the treatment of non-small-cell lung cancer in the community setting. J Oncol Pract. 2010;6:12-18.
  6. Hoverman JR, Cartwright TH, Patt DA, et al. Pathways, outcomes and cost of colon cancer: retrospective in two distinct databases. J Oncol Pract. 2011;7(3 Suppl):52S-59S.
  7. US Food and Drug Administration. Biosimilars. www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/default.htm. Accessed March 25, 2014.
  8. More evidence that clinically proven integrated cancer care enhances quality and controls cost. American Society of Clinical Oncology, Quality Care Symposium. November 30, 2012.
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Last modified: May 21, 2015
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