Current Thinking Behind Decision Making in Oncology Clinical Pathway Design
Published Online: December 13, 2013
Rhonda Greenapple, MSPH
The wide variety and high cost of available treatments for patients with cancer can present challenges to clinicians for deciding upon the most appropriate and cost-effective care.1 These challenges will only increase with time because recent data show that there are now nearly 1000 medicines and vaccines in the oncology pipeline.2 Moreover, the cost for currently available cancer medications increased 22.3% in 2012, with utilization increasing 3.4%.3 Genetically targeted therapies represent much of the increase in the cost of cancer medicines. In 2012, specialty conditions accounted for 24.5% of the drug spend in the United States, with many of the 22 new specialty drugs approved that year costing more than $10,000 per month of treatment.2 The increasing number, type, and cost of cancer therapies confront healthcare providers and payers alike with a pressing need for a method to identify the most effective treatments and reduce cancer care–related costs.
Clinical pathways are a means by which clinicians can arrive at appropriate treatment decisions in cancer care and, at the same time, help reduce costly treatment variation and improve quality of care.1 In addition, oncology care providers who adhere to clinical pathways can benefit from financial and administrative incentives offered by payers.4 When pathways were first introduced, however, oncologists were concerned that they would face payer-imposed limitations to exercising their clinical judgment when treating patients.5 Nevertheless, clinical pathways have gained traction in the healthcare marketplace as payers have sought to collaborate with providers in the design and implementation of clinical pathways. Accordingly, physician involvement in the development of clinical pathways is now recognized as critical to their adoption and success.1
Reimbursement Intelligence (RI), a market access consulting firm, completed an online survey in August 2013 of 50 oncology providers representing independent community practices, hospital-affiliated practices, physician network–affiliated practices, and hospitals/academic medical centers. In addition, 20 in-depth interviews were conducted with a subset of respondents responsible for pathway design. The objective was to learn more about the decision-making process in clinical pathway development.
The Model of Cancer Care Is Shifting to Clinical Pathways
The development of clinical pathways can be seen as a shift toward a new model for making cancer care treatment decisions, based on increasingly restrictive decision-making criteria. At the broad end of the decision criteria spectrum, for example, are earlier models such as that used by Medicare. This decision model determines coverage using the compendia of authoritative sources, which determines the level of clinical evidence to support on- and off-label uses of oncology drugs. Somewhat more focused recommendations for treatment, although still broad in nature, are those written by professional societies with National Comprehensive Cancer Network (NCCN) guidelines most prominent. These recommendations are utilized to determine coverage of a product by a private payer. Now, with the advent of clinical pathways, we are seeing highly specific recommendations for patient management being developed by providers for use in their particular organizations.
Pathways are becoming increasingly prevalent, as evidenced by the majority of RI survey respondents reporting that they currently utilize pathways in the treatment of breast, lung, and colorectal cancers.
Oncology Providers Lead the Way in Developing of Pathway Design
There has been an influx of pathway design companies available to assist payers and oncology practices. Pathway companies can track and report utilization and identify benchmarks of adherence to pathways. They can also identify where there may be inappropriate or excessive utilization of treatments and services such as colonystimulating factors and imaging. Survey questions about pathway design showed that 45% of the pathway users developed their own pathways, with the remainder of pathway users receiving pathway design assistance from pathway vendors such as US Oncology and Via Oncology (28% and 14% of users, respectively). This extensive use of pathway design assistance may reflect oncology providers’ ability to customize their pathways even within a system that uses a pathway vendor.
Oncology providers want to make sure the pathways reflect the needs of the patient population within their practice, and many pathway design companies allow some flexibility regarding drugs that are not on pathway. Figure 1 reinforces that oncologists, not payers, are the key players in pathway design. Those who participated in the design of clinical pathways were most often oncologists within the practice (77%), followed by pathway vendors (27%), pharmacists (27%), and payer representatives (15%). Oncologists’ leadership ensures the pathways reflect the latest clinical treatment.
Safety and Efficacy Are Top Considerations for Inclusion of Treatments, Followed by Cost
So how do pathway users decide upon a given treatment regimen versus another in designing a clinical pathway?
In mid-2009, a statewide collaboration between Blue Cross Blue Shield of Michigan (a single-state, not-for-profit BCBS plan), Physician Resource Management (a state physician organization), and Cardinal Health Specialty Solutions (an oncology benefit management company) created a clinical pathway program in which physicians developed the content, structure, and implementation of the program.1 In this program, pathway regimen selections were considered in order of descending priority starting with treatment efficacy, then toxicity, then cost.
Decision making was similar in the 2010 program, a collaboration between Aetna and The US Oncology Care Network, wherein efficacy was given first priority, toxicity was second, and if both efficacy and toxicity were similar, then the lower-cost regimen was preferred for incorporation into the pathway.5
Given that many pathway designers placed safety immediately after efficacy as a consideration in selecting treatment, a natural question arises as to which factors carry the most weight in evaluating the relative safety and tolerability of different drugs being considered for placement on pathways. The RI survey results shown in Figure 2 indicated that clinical trial design was the top safety/tolerability consideration for pathway placement, followed by the amount of time a drug was on the market, and real-world performance of the drug.
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