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Evidence-Based Oncology August 2015
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Precision Oncology: Are Payers on the Right Pathway?
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Precision Oncology: Are Payers on the Right Pathway?

Jerry Conway and Mark Oldroyd, JD
In oncology, the shift from a "companion diagnostic" to a "companion therapeutic" paradigm is in high gear. While the noise and confusion is leading many payers to avoid coverage, they can benefit by proactively taking steps to integrate precision oncology to better manage quality, access, and cost of cancer care.
A New Vision

In 2009, a 58-year-old man diagnosed with poorly differentiated adenocarcinoma of the lung received then standard of care diagnostics and treatment, including neoadjuvant therapy, surgical resection, and postoperative radiotherapy, which stabilized the disease. In 2012, the patient experienced abdominal pain, and a diagnostic workup confirmed relapse of his lung adenocarcinoma. Polymerase chain reaction (PCR) and fluorescent in situ hybridization (FISH)–based molecular testing of the EGFR, KRAS, BRAF, HER2, ALK, ROS1, and MET genes were each negative. After 2 cycles of standard chemotherapy, the tumor was refractory, and the patient’s condition worsened. Additional molecular testing was completed, and a novel RET/KIF5B gene fusion, discovered by Foundation Medicine in 2012,1 was reported. The patient was then started on the RET inhibitor vandetanib, leading to clinical remission.2

Following the discovery of the RET/KIF5B gene fusion by Foundation Medicine, additional data demonstrating clinical responses to another RET inhibitor, cabozantinib,3,4 led the National Comprehensive Cancer Network (NCCN) to include RET fusions and cabozantinib treatment in the 2014 guideline update recommending broad molecular profiling for lung adenocarcinoma patients.5 Thus, within 2 years, a previously unknown genomic alteration (RET fusion) and a matched targeted therapy option were identified and demonstrated clinical utility. This progression from discovery to guidelines to standard of care is one of many examples that underscore the rapid evolution from empirically selected cytotoxic treatment to genomically driven, precision oncology care for an increasingly broad population of patients.

The Unmet Need

Payers challenged with the task of managing quality, access, and cost of cancer care struggle to keep pace with the innovations and rapid evolution of precision oncology. The total costs of cancer are rising exponentially; annual costs for cancer care in the United States increased from $104 billion in 2006 to a projected $173 billion in 2020.6 At the same time, many patients are living longer. Largely due to earlier stage detection, two-thirds of Americans live at least 5 years after a cancer diagnosis, an improvement in survival since the collection of such data began in the Surveillance, Epidemiology, and End Results (SEER) Program in the 1970s.7 It is estimated that the number of new cancer cases will increase by 45% in the United States by 2030, making cancer the nation’s leading cause of death, driven largely by the growing number and aging of patients from the baby boomer generation.6

The current standard of care in oncology often results in wasted dollars. Adverse events associated with invasive procedures, non-targeted treatment toxicity and unnecessary testing, as well as emergency department (ED) visits and hospitalizations, all drive substantial human and financial costs associated with comorbidity, reduced quality of life, and even mortality. The idea of 1 empiric treatment approach for every patient with a particular cancer (eg, breast cancer) is not yielding the results required to make meaningful improvements in care. Because of failures with the empiric approach, and the new understanding that cancer is a disease of the genome, treatment is rapidly moving toward precision-based oncology care.

Understanding a patient’s cancer at the level of the genomic drivers requires new approaches to diagnostics. Current molecular diagnostic testing platforms are primarily “hotspot” tests (ie, a small segment or segments of the coding region within cancer genes where common alterations—usually only base substitutions and some insertions or deletions—are found). “Hotspot” tests have significant limitations, including the potential for missing clinically relevant genomic alterations, being too costly and inefficient, and using too much tissue. For example, insufficient tissue to complete all of the recommended diagnostic cancer tests is a growing problem. Using conventional methods (eg, FISH, immunohistochemistry, PCR), precious tissue is consumed by multiple types of “hotspot” tests. This challenge may affect patient safety, potential treatment efficacy, and cost-effectiveness of care. A recent study reported that the primary reason for not successfully testing all targetable alterations was insufficient tissue for the basic molecular testing itself, in addition to the fact that 2 or more biopsies were often required to complete requisite molecular testing.8 Insufficient tissue places the patient at risk for additional comorbid and costly procedure(s),9 which can be avoided with a tissue-sparing approach to testing.

Precision oncology cancer care is becoming routine, with more than 300 identified driver and tumor suppressor genes, hundreds of test options, and more than 40 FDA-approved targeted therapies available.10 Targeted therapy is primarily used in advanced stages of disease (ie, stage IV) since patient treatment and outcomes in earlier stages are often highly amenable to standard chemotherapy, radiation, and surgical resection. While molecular testing is standard for many advanced tumor types (eg, stage IV breast cancer), payers are reporting enormous costs from overutilization, often in excess of $10,000 per member diagnosed with cancer. And the influx continues—targeted therapy pipelines for commercial development include more than 470 drugs for more than 150 molecular targets in over 950 clinical trials.10

Professional organizations like the NCCN and the American Society of Clinical Oncology (ASCO) consider clinical trials to be standard of care for patients with cancer,11 and many new clinical trial designs are expanding access for patients.12 When approved by the FDA, targeted therapies are projected to cost in excess of $100,000 per year with the potential for “combination” targeted therapy to multiply this cost impact further.

Unfortunately, in sharp contrast to improved survival in early stage disease, the relative survival rates of patients with advanced cancer remain largely unchanged (Figure 1). Despite decades of research, promising advances in treatment, and billions of dollars of investment, improved outcomes and quality of life have yet to be realized for most patients with advanced cancer. Additionally, the explosive growth of molecular tests and related treatment options are overwhelming the payers’ ability to review and assess value for coverage and payment. Payers are clearly in need of simple solutions, and a new approach is required to improve outcomes and quality of life through improved safety, efficacy, and cost-effectiveness of diagnosis and treatment in later stages of disease.

The Payer Response Payers are responding with a variety of alternative payment solutions to managing the quality, accessibility, and accelerating costs of cancer care. Examples include but are not limited to payer-provider collaborative programs, such as:
  • Oncology medical homes
  • Pay for performance
  • Bundled payment
  • Limited provider networks
  • Nurse navigators
  • End-of-life support
  • Survivorship support
  • Treatment pathways
For example, United Healthcare, in a pilot initiated in 2009, reimbursed 5 oncology practices a flat fee for physician care and drug infusions in breast, colon, and lung cancer. While total costs were reduced by 34% compared with a control group, surprisingly, drug spending actually increased by 179% versus the same control group.13 In a recent article, Molly Gamble summarizes this trend by stating: “But more recently, in the move from fee-for-service to pay-for-performance, payers and providers seem genuinely interested in meeting each other halfway when it comes to cancer care and costs. Whether through clinical protocols, provider-patient counseling sessions, genetic testing, or oncology-specific accountable care organizations and bundled payments, oncology presents several collaborative opportunities for providers and payers to better align incentives.”14

Perhaps more controversial than other approaches, pathway-based programs have been developed and implemented to help streamline oncology decision making in an increasingly complex environment. These programs rely on evidence and provider incentives that reduce options and the trial-and-error approach common in many aspects of cancer care. Pathways align utilization and payment with evidence supporting a reasonable likelihood of improved safety, efficacy, and cost-effectiveness of treatment. Unfortunately, because these programs rely on empirical evidence and consensus opinion that is largely outdated and out of sync with new standard genomic practices, they are likely to yield a poor return on investment in terms of relative survival (Figure 1) and quality of life. Pathways may save some money in the short term, but in the long term may be less successful without the inclusion of precision oncology.



 
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