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Balancing Innovation With Cost in Diagnostic Testing

Gnanamba Varuni Kondagunta, MD
As clinical targets in more common malignancies emerge, testing and treatment options will increase. Balancing these choices with the high costs of new technology will be the challenge to ensure value in oncology care.
Advances in the understanding of cancer biology have presented molecular targets that can prove valuable for prognosis. The use of molecular diagnostic testing has blossomed simultaneously over the past 15 years, and a major area of research has been the development of targeted therapies that can be used to individualize treatment based on molecular profiles. The research has yielded major clinical successes, including the first targeted therapy, imatinib, for patients with chronic myeloid leukemia, and similar efforts are ongoing for other cancers. At the recent 2015 American Society of Clinical Oncology (ASCO) Annual Meeting, a search of abstracts and presentations yielded 842 results for the word target. These ranged from papers that studied molecular targets by disease type; by classification (ie, angiogenesis targets, growth factors); and newer immunologic therapeutics, including immune checkpoint-blocking antibodies that boost the patient’s immune system to attack the malignant cells (ie, anti-CTLA-4 and anti-PD-1 antibodies).

As clinical targets in more common malignancies including breast, lung, and colon cancers emerge, testing and treatment options will increase. Balancing these choices with the high costs associated with the new technology will be the challenge in order to determine value in oncology care.

The Rising Cost of Healthcare

As cancer research has made impressive progress toward treating and improving patient outcomes, costs have risen exponentially over the past 3 decades.1 The cost of healthcare has become an important topic in the United States. During his keynote address at ASCO’s annual meeting, Michael Porter, PhD, MBA, a world-renowned expert in economics and competitiveness who has written extensively about healthcare, emphasized the importance of considering cost of care in cancer treatment. During his presentation, “Value-Based Health Care Delivery,” Porter implored the cancer community to begin seriously thinking about how to maximize the value of care.

These ideas are being considered in the community at large, as 361 presentations at the meeting included the word cost in the title. Porter’s presentation looked for ways to maximize value of care. As a first step, testing and treatment regimens (“pathways”) need to be evaluated to minimize cost while maintaining or improving quality of care for patients, he said. This is especially important when considering newer molecular testing and targeted therapies, which may be more expensive compared with older tests and treatments. In my practice, we have implemented significant measures to deal with some of these cost issues while maintaining quality care in line with clinical, evidence-based guidelines.2

In June 2015, ASCO released a framework for assessing the value of newer cancer therapies and treatments. The hope is to establish a tool that physicians and patients can use, to determine the benefits and costs of various treatments. It is hoped that this will be useful in establishing the value of newer, costlier treatments as compared with standard treatments.3

The Center for Medicare and Medicaid Innovation (CMMI) has also established a process by which oncology specialty physician practices can apply to participate in a new payment model, which allows the practice to be reimbursed in an innovative way—arrangements that include accountability for episodes of care surrounding chemotherapy administration for cancer patients. This new Oncology Care Model (OCM) aims to provide higher quality coordinated oncology care. A pioneer program established by CMMI for a medical subspecialty, OCM ascertains that the cost of oncology services is being reevaluated.4

These examples clearly indicate that “value” has developed into an important aspect of clinical decision making for physicians and patients alike.

A Provider’s Perspective on Diagnostic Testing

I am one of 5 practicing medical oncologists at Crystal Run Healthcare, a physician-owned, multispecialty practice of over 300 physicians at multiple sites in New York. Crystal Run Healthcare has been a leader in value-based care for the past 10 years, being one of the first 27 accountable care organizations (ACOs) in Medicare Shared Savings Program and one of the first 6 ACOs to be accredited as part of the National Committee for Quality Assurance. We have also recently established our own healthcare plan, which also mirrors our philosophy of being a value-based organization. The oncology division was among the first 16 community cancer care practices nationwide to be certified by ASCO through their Quality Oncology Practice Initiative. In the oncology division, we have worked on variation reduction programs and established that pathways in oncology patient management result in high-quality, cost-effective care.

We have implemented a similar value-based approach to molecular diagnostic testing and treatments in my community setting.

Molecular diagnostic testing provides new information that can broaden treatment options, but in some cases these tests are not needed. Historically, pathology reports included information that described histologic findings and immunohistochemical stain profile. As targets such as Her2/neu (breast), epidermal growth factor (EGFR) (lung), KRAS (colon), and BRAF (melanoma) emerged, these became part of the routine testing done for each type of cancer. Newer methods to identify these targets include next generation sequencing (NGS), which allows for sequencing of tumor tissue or patient serum for somatic and germline mutations in a very short period of time. The advances in the chemistry behind these techniques have allowed for rapid sequencing but also a significant decrease in cost per base tested. Some of these tests may not be very expensive (eg, fluorescence in situ hybridization or FISH testing) but may be performed on a large number of patients (eg, all breast cancer patients), which can lead to multiplicative increase in cost for a population. More expensive molecular diagnostic tests (eg, NGS) are typically prescribed for select patients. Historically, physicians have not considered cost in determining treatment.

Multiplicative Cost of Less Expensive Tests

To illustrate an example of the multiplicative cost of a relatively inexpensive test in a large population, we will look at 2 patients with invasive breast cancer. The expression of Her2/neu can be evaluated with immunohistochemistry (IHC) assays as well as with more expensive, but more precise, FISH techniques. Her2/neu testing in invasive breast cancer is an important prognostic and predictive factor. Trastuzumab in the adjuvant and metastatic setting, and several other drugs, including lapatinib and pertuzumab in the metastatic setting, are important therapeutic options available to patients based on positive Her2/neu testing. The National Comprehensive Cancer Network (NCCN) Guidelines indicate that FISH testing should be pursued specifically when IHC testing is equivocal at 2+. When IHC is negative, 1+ (negative), or 3+ (positive), then FISH can be deferred—IHC being more definitive. Since discordance between IHC and FISH testing is observed in less than 2% of patients, appropriate use of FISH can avoid the excess cost.5



 
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