As clinical pathways are being actively implemented and tested by health plans, opinions differ on their usefulness and credibility, depending on whom you ask. Pathways evolved as a tool to address the lack of standardization across healthcare. They could even be visualized as a quality tool that would ensure providers strictly follow a predetermined path of care, a move that could potentially avoid waste and restrain costs. Providers disagree, however. We are the best judges of our patient’s treatment, they are saying.
Clinical pathways could prove to be an extremely useful tool for oncologists trying to keep up with the barrage of new molecular research on cancer. The complexities associated with cancer have made it quite cumbersome for physicians and other healthcare providers to stay abreast of the constant data flow on disease progression for each cancer type and connect all the dots—from genetic information, to treatments the patient may respond to, to follow-up care. However, standardization, although preventing confusion and unnecessary care, might also prevent physicians from providing a more personalized approach.
Impetus for Developing Clinical Pathways
The National Pharmaceutical Council (NPC) conducted a survey and telephone interviews among medical and pharmacy directors from payer organizations, providers from a group practice or hospital, and pathway vendors. The interviews and survey responses supported the review of published literature on electronic databases, gray literature, and websites of care pathway vendors, payers, and major oncology provider networks conducted by NPC.1
The authors found that care pathway development may be triggered by:
Disease states associated with a high cost of treatment (most common)
High prevalence rates (most common)
Availability of multiple branded therapies
Heterogeneity in treatment patterns.
More than 50% of survey respondents shared that disease areas were selected based on cost of care (62%) and variation in treatment patterns (57%); only 33% reported selection based on clinical outcomes. With respect to evidence used for developing pathways, more than 80% of those surveyed said they turned to treatment guidelines and randomized clinical trials as their primary data sources. Those who participated in interviews identified the quality of efficacy-reporting studies as the most important consideration for inclusion in care pathway development, followed by data on safety or tolerability and, finally, costs. However, in survey responses, 81%, 71%, and 57% identified medical (nonpharmaceutical) costs, pharmaceutical costs, and healthcare resource use, respectively, as measures that are considered in care pathway development.
There is evidence to document that standardization of care delivered to treat a specific condition can be cost-effective. A study evaluating the use of clinical pathways in the treatment of lung cancer patients in an outpatient community setting was published in the Journal of Oncology Practice
The study included patients with non–small cell lung cancer who were initiated on chemotherapy in practices that were a part of the US Oncology network. The study compared the cost of care and overall survival at 1 year for patients who were on- versus off-pathway, and discovered 35% lower outpatient costs for the on-pathway patients ($18,042 vs $27,737 off-pathway). The trend was mirrored among patients treated in the adjuvant and first-line settings, but not in the second-line setting, the authors reported.
Could Generics and Biosimilars Bend the Cost Curve?
If cost control is an important consideration for payers in ensuring adherence to pathways, raising provider—and patient—awareness on the availability of therapeutically equivalent generic versions of the more expensive brand-name drugs should be given priority. The American College of Physicians recently published the results of a survey that found physician and patient perceptions about the safety and efficacy of lower-cost options significantly influence the use of these medications.3
A survey among patients across the United States found that although a majority of surveyed patients understand that generic medications are less expensive and believe they can bring more value to healthcare, only 36% said they’d prefer to use the generic version themselves. Their main concerns? Safety and efficacy of the generic products. Physicians, too, were not 100% on board, with 25% of those surveyed expressing similar concerns with the safety and efficacy of generic products.
According to Lee N. Newcomer, MD, MHA, senior vice president, Oncology, Genetics, and Women’s Health, UnitedHealthcare, savings from pathways will continue only if they are supported by a reimbursement plan that pays a higher margin for generic drugs or effective, low-cost branded drugs—which will stop physicians from choosing high-cost drugs on their treatment regimen.4
This parallels the healthcare system’s increasing focus on high-value care—ensuring that patient and healthcare dollars are spent on treatment regimens that significantly improve outcomes at reasonable costs. Value frameworks developed by both the American Society of Clinical Oncology and the National Comprehensive Cancer Network hope to serve this purpose: both frameworks consider clinical efficacy, toxicity, and cost to identify the most valuable care for patients.5
Are Pathways Restricting Access?
An important argument being presented, especially by oncologists, is against the one-size-fits-all design of clinical pathways. Increasing evidence suggests that an individual tumor is a heterogeneous mix of cells that makes the disease very difficult to treat and creates a case for a more personalized approach. Via Oncology, a pathway vendor, respects this need and has a more personalized approach to the process, as discussed
by the company’s CEO, Kathy Lokay.
In an interview with OncLive, Ray Page, DO, PhD, president of The Center for Cancer and Blood Disorders in Fort Worth, Texas, said, “Today, we have hundreds of drugs out there, and very targeted drugs that only work in certain subsets of tumors. Drugs are very sophisticated, very targeted, have very limited indications, and are very expensive. I can’t just go pull a drug off the shelf and say, ‘Well, it’s got an indication for lung cancer, so let’s just give it.’ It’s not going to work unless you use it in the right population. Given the amount of knowledge you need to maintain an understanding of when to use the drug, we need a pathway system that’s evidence-based, that helps guide you in today’s society.”6
Oncologists are pushing back. Page recently co-authored a paper in JAMA Oncology
that calls on oncologists to take the lead in the development of clinical pathways, rather than health plans. Additionally, the commentary demands that physicians should be allowed to develop one set of pathways that can be applied across health plans, which could reduce the administrative burden associated with using unique pathways for each plan.7
Whereas these are fledgling years for clinical pathways, with additional data and wider adoption will come a knowledgebase to adopt and improve on their development and clinical application. EBO