5-year costs, US model (Keegan et al.)
5-year costs, Canada model (Dragomir et al.)
Est. lifetime costs, Canada model (Sanyal et al.)
Novel Imaging and Biomarker Integration into AS
Novel biomarkers and advanced imaging with multiparametric magnetic resonance imaging (mp-MRI) are rapidly being developed and integrated into clinical practice for men with low-risk prostate cancer. No economic analyses incorporate mp-MRI or novel biomarkers for AS, both associated with increased up-front costs during the initial phase of cancer care. These tests may add considerable expense and should be the focus of future cost-effectiveness studies. Two scenarios where these technologies may prove cost-effective are by improving patient selection, thus decreasing additional treatment over time, and by reducing the need for repeat prostate biopsies; however, these remain to be shown.
A 31-gene expression assay (Prolaris®) and a 17-gene expression panel (Oncotype DX®) are both marketed toward selecting patients for AS, but cost ~$3000–$4000 USD. These assays may still prove cost-effective if they prove to increase the number of men who choose AS (thus deferring more expensive initial treatments) while reliably selecting men up front who are less likely to progress over time. Albala et al. demonstrated increased utilization of AS after Oncotype DX testing with decreased utilization of both prostatectomy and radiation therapy by 10 and 14%, respectively . Despite additional up-front costs associated with the assay, this resulted in a net per-patient savings of $2286 USD.
Mp-MRI has emerged as the modality of choice for prostate cancer imaging and particularly for selecting men for AS and possibly following them for disease progression. This imaging modality integrated with technology for targeted prostate biopsy may improve patient selection, by detecting clinically significant tumors earlier in the disease process when curative therapy may be recommended. The costs associated with MRI are much more variable between hospitals and health systems than the abovementioned biomarkers. MRI costs also have more potential to decrease over time as equipment become more efficient and less expensive. Although not studied in the setting of AS, mp-MRI is predicted to be cost-effective to select men with elevated PSA for prostate biopsy . Diaz et al. utilized serial mp-MRI for men on AS and demonstrated a relatively high negative predictive value of 80% for changes in Gleason grade , suggesting that this may also substitute for costly surveillance prostate biopsies .
Evolving Physician Payment Reform: The Impact on Active Surveillance
Both public and private healthcare payment systems are evolving with improved emphases on cost containment, quality of care, and efficiency. These reforms are rapidly moving away from the traditional fee-for-service model toward a global or episodic payment structure. The Affordable Care Act (ACA) represents the largest change to the US healthcare market in a generation. The ACA represents such a tremendous change to health policy when the Journal of the American Medical Association published a report by Barack Obama on the act’s impact, the only one ever written by a sitting president . Though many of the changes of the ACA are still to be defined through the regulatory process, without question the ACA presents an overhaul of the reimbursement structure that may eventually impact the economics of the AS .
First, and most significantly, the ACA will shift from a fee-based reimbursement to a value-based reimbursement . In this new paradigm, both reimbursements will also be tied to “quality” metrics. As one might expect, the quality metrics possible in AS versus active treatment that are distinctly different may be difficult to define. For example, one would expect a quality metric assessing blood transfusion and readmission after prostatectomy to impose a higher penalty than urinary retention after a surveillance biopsy. Moreover, in this paradigm, it has yet to be determined how AS payment would be determined. In the current model, a patient visit is paid as a patient visit. But in a value-based model , the physician could theoretically be paid a capitated annual fee per AS patient instead of a fee-per-visit, ultimately allowing providers to choose how they wish to arrange their surveillance algorithm. In most AS cost models, the greatest overall expense value is in patient contact-included prostate biopsies and PSA testing, with pathology and ultrasound being a much smaller portion of the expense [33, 34]. In the coming years, the regulatory framework will need to define how physicians are reimbursed for performing AS as well as which metrics these payments are associated with.
Second, the ACA has increased reimbursement rates to primary care physicians and further encourages the deployment of more primary care physicians . This shift in economic value may encourage more aspects of the surveillance to be performed by primary care physicians or even allied healthcare professionals such as nurse practitioners or physician assistants, with the specialist only involved for more invasive testing or treatment.
As stated before, the ACA also represents a cultural shift away from fee-for-service and toward payment for value. This shift is further reflected in the Medicare Reform and CHIP Reauthorization Act (MACRA) of 2015. Though limited only to Medicare beneficiaries in the United States, MACRA aims to change how the US government pays for healthcare services with a focus on quality over quantity, in other words, a focus on rewarding “value.” MACRA moves physicians into the Merit-Based Incentive Payment System , where physicians are rewarded for meeting certain “value” targets. Physicians can also opt to be paid under a standard bundled payment system. One model of dealing with these new payment methods would be the Oncology Care Model . This bundles all the costs associated with a single cancer type and redistributes them among the multiple players in a patient’s care.
Ultimately, as AS evolves into more refined risk stratification, the question of what constitutes a quality metric in the surveillance paradigm will grow. For example, some quality metrics are straightforward such as prophylactic antibiotic use before prostate biopsy or adequate sampling with 10–12 cores. But if a patient based on privately purchased proprietary genomics tests wants to go to a biannual instead of annual biopsy schedule , would his physician be penalized? This chapter does not seek to answer these regulatory quandaries based on social values. Instead, we pose these questions to evolve the conversation to further recognize that as social values shift, the individual decisions on AS will change.
Important limitations exist when interpreting these data from simulation. Long-term implications of treatment with any modality including AS are not considered including later recurrences, complications from treatment, or future medical costs. Infectious complications and hospitalizations from prostate biopsy, however rare, will add to the financial burden of AS; however, it is unclear if infectious complications are higher for men undergoing repeat biopsies . Most studies rely on Medicare reimbursement or payer fee schedules to help build their models. Out-of-pocket costs, estimated to range from $5576 for radical prostatectomy to $2010 for radiation therapy, are primarily the burden of the patient yet contribute to the overall costs of treating prostate cancer . Higher physical functional status after prostate cancer treatment associates with lower out-of-pocket costs and therefore may be lower with AS than the other therapies . More specifically, improved urinary and sexual functional domains are associated with better overall functional status and thus translate into lower indirect costs.
Moreover, indirect costs including lost productivity or early mortality were not considered. Patient travel costs, for example, are not insubstantial, and many countries have moved toward consolidating specialty care visits to help reduce travel time. These changes would carry over to a high patient contact protocol such as AS for prostate cancer .
In addition to the indirect costs, few studies have incorporated “benefit” into the cost analysis. Hayes et al. performed a similar analysis as Keegan et al., but included quality-adjusted life expectancy into their formula for outcomes . Despite including indirect costs, they still found that AS and WW were cheaper than active treatment over a lifetime. They also noted that WW yielded longer quality-adjusted life expectancy than AS for less cost, but that this benefit was lost when the chance of progression on AS went down to 15% . Overall, AS at that level was $15,000 more expensive than WW for two additional quality-adjusted life expectancy months.
Lastly, many of the economic analyses were based on North American (United States and Canada) healthcare models and may not be applicable globally.
Prostate cancer care can incur substantial costs at all stages of disease and will continue to rise in the new millennium. AS offers patients the opportunity to defer aggressive treatment until felt necessary. Longer-term risks with this approach appear low, and deferred treatment does not appear to compromise the chance for cure . AS appears to reduce prostate cancer healthcare expenditures by limiting costly therapies to those likely to benefit the most from aggressive treatment. As long-term data from AS clinical trials becomes available, the true cost-effectiveness of this approach can be measured along with the impact of novel technologies including MRI and gene-based biomarkers.