Screening for cancer: the economic, medical, and psychosocial issues.

Despite significant improvements in mortality over the past 20 years, cancer remains the second leading cause of death in the United States. One reason for the improvement in mortality is screening for several common cancers in people at average risk for breast, cervical, colorectal, and prostate cancers, and screening for lung cancer in those with a 20-plus pack-year history. Such screening may result in earlier diagnosis when the cancer is most likely to respond to treatment. However, there are no population-based screening recommendations for the majority of cancers in average-risk patients, most of which are not diagnosed until the later stages. One question is whether earlier diagnosis could not only reduce mortality rates but also reduce medical costs. Screening comes with several potential risks, including false positives and overdiagnosis, both of which can affect patients' mental health, increase morbidity and mortality, and lead to excess spending. Additionally, certain cancers can evade traditional screening tests and lead to false-negative results, which delays cancer detection, treatment, and may affect treatment efficacy. The advent of liquid biopsy tests that could screen for dozens of cancers holds promise for identifying more cancers early. However, the cost, the potential for overdiagnosis and false positives, and a lack of evidence demonstrating clinical utility or an improvement in health outcomes call into question their potential use for widespread screening. Government and managed care organizations will need to consider the risks and benefits of these assays in determining coverage.

Contrasting Effectiveness and Cost-Effectiveness of Colorectal Cancer Screening Under Commercial Insurance vs. Medicare.

OBJECTIVES: Most cost-effectiveness analyses of colorectal cancer (CRC) screening assume Medicare payment rates and a lifetime horizon. Our aims were to examine the implications of differential payment levels and time horizons for commercial insurers vs. Medicare on the cost-effectiveness of CRC screening. METHODS: We used our validated Markov cohort simulation of CRC screening in the average risk US population to examine CRC screening at ages 50-64 under commercial insurance, and at ages 65-80 under Medicare, using a health-care sector perspective. Model outcomes included discounted quality-adjusted life-years (QALYs) and costs per person, and incremental cost/QALY gained. RESULTS: Lifetime costs/person were 20-44% higher when assuming commercial payment rates rather than Medicare rates for people under 65. Most of the substantial clinical benefit of screening at ages 50-64 was realized at ages ≥65. For commercial payers with a time horizon of ages 50-64, fecal occult blood testing (FOBT) and fecal immunochemical testing (FIT) were cost-effective (<$61,000/QALY gained), but colonoscopy was costly (>$185,000/QALY gained). Medicare experienced substantial clinical benefits and cost-savings from screening done at ages <65, even if screening was not continued. Among those previously screened, continuing FOBT and FIT under Medicare was cost-saving and continuing colonoscopy was highly cost-effective (<$30,000/QALY gained), and initiating any screening in those previously unscreened was highly effective and cost-saving. CONCLUSIONS: Modeling suggests that CRC screening is highly cost-effective over a lifetime even when considering higher payment rates by commercial payers vs. Medicare. Screening may appear relatively costly for commercial payers if only a time horizon of ages 50-64 is considered, but it is predicted to yield substantial clinical and economic benefits that accrue primarily at ages ≥65 under Medicare.

Optimizing Anti-VEGF Treatment Outcomes for Patients with Neovascular Age-Related Macular Degeneration.

BACKGROUND: The introduction of anti-vascular endothelial growth factor (anti-VEGF) drugs to ophthalmology has revolutionized the treatment of neovascular age-related macular degeneration (nAMD). Despite this significant progress, gaps and challenges persist in the diagnosis of nAMD, initiation of treatment, and management of frequent intravitreal injections. Thus, nAMD remains a leading cause of blindness in the United States. OBJECTIVE: To present current knowledge, evidence, and expert perspectives on anti-VEGF therapies in nAMD to support managed care professionals and providers in decision making and collaborative strategies to overcome barriers to optimize anti-VEGF treatment outcomes among nAMD patients. SUMMARY: Three anti-VEGF therapies currently form the mainstay of treatment for nAMD, including 2 therapies approved by the FDA for treatment of nAMD (aflibercept and ranibizumab) and 1 therapy approved by the FDA for oncology indications and used off-label for treatment of nAMD (bevacizumab). In clinical trials, each of the 3 agents maintained visual acuity (VA) in approximately 90% or more of nAMD patients over 2 years. However, in long-term and real-world settings, significant gaps and challenges in diagnosis, treatment, and management pose barriers to achieving optimal outcomes for patients with nAMD. Many considerations, including individual patient characteristics, on-label versus off-label treatment, repackaging, and financial considerations, add to the complexity of nAMD decision making and management. Many factors may contribute to additional challenges leading to suboptimal long-term outcomes among nAMD patients, such as delays in diagnosis and/or treatment approval and initiation, individual patient response to different anti-VEGF therapies, lapses in physician regimentation of anti-VEGF injection and monitoring, and inadequate patient adherence to treatment and monitoring. These latter factors highlight the considerable logistical, emotional, and financial burdens of long-term, frequent intravitreal injections and the vital importance of personalized approaches to anti-VEGF treatment decision making and management for patients with nAMD. To address these challenges and reduce the number of yearly injections, studies have examined alternative dosing regimens, including extended fixed intervals, as needed, and treat-and-extend strategies in specific nAMD patient populations. New clinical evidence and insights into expert clinical practice discussed in this article can support managed care professionals in the key role they play in addressing challenges in nAMD treatment and management and optimizing patient outcomes through appropriate management of anti-VEGF treatment. DISCLOSURES: PRIME Education is an independent medical education company and has been an accredited provider of continuing education for 23 years. There is no fee for this activity as it is sponsored by PRIME through an educational grant from Regeneron. All authors contributed to the writing and reviewing of the article. Wykoff reports consultancies/research grants from Alcon Laboratories, Genentech/Roche, Clearside, and Iconic Therapeutics; consultancies/honoraria, research grants, and speaker fees from Allergan and Regeneron; research grants from Allegro, Apellis, Aura, NEI, NIH, Novartis, OHR Pharmaceuticals, Ophthotech, pSivida, Roche, Santen, SciFluor, Tyrogenex; and consultancies for Alimera Sciences, Alnylam Pharmaceuticals, Bayer, DORC, ONL Therapeutics, Thrombogenics, and Valeant. Clark reports advisory board work, consultancies, research grants, and speaker fees from Genentech/Roche and Regeneron and consultancy for Bayer. Brill reports consultancies for Aries Pharma, Avella, BaroNova, Braeburn Pharmaceuticals, Cardinal Health, Endogastric Solutions, GeneNews, Halt Medical, Lumendi, Medtronic, Monteris Medical, Natera, Phosphorus, Rebiotix, Seno Medical, UCB, Vermillion, Echosens, and HAP Innovations. Brill is a shareholder in EndoChoice, GeneNews, SonarMD, and SynerZ and reports advisory board work with Nestle Health Sciences, Indivior Pharmaceuticals, Eli Lilly, Blue Earth Diagnostics, Bayer, and AstraZeneca. Nielson reports advisory board work/consultancy and research grants for Genentech/Roche; advisory board work and research grants from Regeneron; and research grants from Alcon and Ophthotech.

AGA White Paper: Training and Implementation of Endoscopic Image Enhancement Technologies.

Endoscopic image-enhancement technologies provide opportunities to visualize normal and abnormal tissues within the gastrointestinal (GI) tract in a manner that complements conventional white light endoscopic imaging. The additional information that is obtained enables the endoscopist to better identify, delineate, and characterize lesions and can facilitate targeted biopsies or, in some cases, eliminate the need to send samples for histologic analysis. Some of these technologies have been available for more than a decade, but despite this fact, there is limited use of these technologies by endoscopists. Lack of formalized training in their use and a scarcity of guidelines on implementation of these technologies into clinical practice are contributing factors. In November 2014, the American Gastroenterological Association's Center for GI Innovation and Technology conducted a 2-day workshop to discuss endoscopic image-enhancement technologies. This article represents the third of 3 separate documents generated from the workshop and discusses the published literature pertaining to training and outlines a proposed framework for the implementation of endoscopic image-enhancement technologies in clinical practice. There was general agreement among participants in the workshop on several key considerations. Training and competency assessment for endoscopic image-enhancement technologies should incorporate competency-based education paradigms. To facilitate successful training, multiple different educational models that can cater to variations in learning styles need to be developed, including classroom-style and self-directed programs, in-person and web-based options, image and video atlases, and endoscopic simulator programs. To ensure safe and appropriate use of these technologies over time, refresher courses, skill maintenance programs, and options for competency reassessment should be established. Participants also generally agreed that although early adopters of novel endoscopic image-enhancement modalities can successfully implement these technologies by pursuing training and ensuring self-competency, widespread implementation is likely to require support from GI societies and buy-in from other key stakeholders including payors/purchasers and patients. Continued work by manufacturers and the GI societies in providing training programs and patient education, working with payors and purchasers, and creating environments and policies that motivate endoscopists to adopt new practices is essential in creating widespread implementation.

Making a Medical Home for IBD Patients.

PURPOSE OF REVIEW: The transformation from fee for service to fee for value requires structural changes to the way gastroenterologists manage patients with inflammatory bowel disease (IBD). A team-based approach using technology to engage patients is necessary for success. The Patient-Centered Medical Home (PCMH) represents a unique model that brings together these essential features. This paper describes how the PCMH model has been successfully applied to the management of patients with IBD. RECENT FINDINGS: A review of the literature and three examples of IBD PCMH initiatives are presented in this document: they demonstrate how outcomes can be improved under the PCMH model. Population health and value-based payments will mold and shape how we can position our GI practices. The specialty medical home is an ideal way to begin this transition.

Reimbursement for Endoscopic Bariatric Therapies.

Intragastric devices may be of benefit to patients who are unable to achieve weight loss through lifestyle modification and pharmaceuticals. With the help of every member of a multidisciplinary team and ongoing commitment from patients, small, practical steps and goals can lead to long-lasting, healthy weight loss.

White Paper AGA: An Episode-of-Care Framework for the Management of Obesity-Moving Toward High Value, High Quality Care: A Report From the American Gastroenterological Association Institute Obesity Episode of Care and Bundle Initiative Work Group.

The American Gastroenterological Association acknowledges the need for gastroenterologists to participate in and provide value-based care for both cognitive and procedural conditions. Episodes of care are designed to engage specialists in the movement toward fee for value, while facilitating improved outcomes and patient experience and a reduction in unnecessary services and overall costs. The episode of care model puts the patient at the center of all activity related to their particular diagnosis, procedure, or health care event, rather than on a physician's specific services. It encourages and incents communication, collaboration, and coordination across the full continuum of care and creates accountability for the patient's entire experience and outcome. This paper outlines a collaborative approach involving multiple stakeholders for gastrointestinal practices to assess their ability to participate in and implement an episode of care for obesity and understand the essentials of coding and billing for these services.

Does Hepatitis C Treatment Adherence Affect Risk of Liver Transplantation? A Historical Cohort Study.

BACKGROUND: Chronic hepatitis C virus (HCV) is the primary cause of liver failure leading to transplantation, and medication adherence is essential to the therapeutic efficacy of HCV treatments. While there is evidence linking poor adherence with increased utilization and cost, published literature lacks examination of the association between medication adherence and risk of liver transplant. In addition, the impact of HCV treatment on total costs of liver transplantation is not well documented. OBJECTIVES: To compare (a) the relative risk of liver transplant by adherence in patients treated for HCV and (b) the total health care costs in treated and untreated patients who require liver transplant. METHODS: This observational, historical cohort study was conducted using administrative data from the Humana Research Database. To be included, patients were required to have a documented HCV diagnosis or treatment between January 1, 2008, and June 30, 2013. Patients were excluded if they had a hepatitis B diagnosis, were not fully insured by a commercial or Medicare Advantage Prescription Drug plan, or were outside the age range of 19-89 years. No minimum pre- or post-index enrollment period was required, and patients were followed for their entire post-index enrollment through December 31, 2013. The study population was divided into treated and untreated groups and then subdivided by presence or absence of a liver transplant. Date of liver transplant was defined as the index date for untreated liver transplant patients; otherwise, the index date was defined as either the date of first observed HCV treatment or diagnosis date (if no treatment or liver transplant). Cox proportional hazards models were used to estimate the relative risk of liver transplant by level of treatment adherence (> 80%, 50%-79%, and < 50%) based on proportion of days covered. General linearized models with log link and gamma distribution were used to compare median total health care costs from index date until end of study period (or death/disenrollment, whichever came first) between treated and untreated liver transplant patients. All costs were converted to 2013 U.S. dollars and reported as total costs per patient and per patient per month (PPPM) to account for varying follow-up periods. RESULTS: Of the 53,423 patients identified with HCV, 10,377 met exclusion criteria, leaving 43,046 patients (primarily Caucasian, males, mean age of 58 years) in the initial cohort. Only 6.29% (n = 2,708) of the total HCV cohort received HCV treatment, and less than 1% (n = 366, 0.8%) received a liver transplant. Although there were no significant differences in the risk of liver transplant by adherence level, there was an upwards trend in the rate of liver transplant as adherence worsened (> 80%: 1.25%; 50%-79%: 1.30%; and < 50%: 1.99%), and the average days to liver transplant was longer with higher adherence (> 80%: 683; 50%-79%: 623; < 50%: 454). Only 48 (13.11%) patients who received a liver transplant were treated for HCV. Adjusted median total and PPPM health care costs measured from index date until end of the study period were significantly higher for patients who received HCV treatment compared with those who did not (total=$231,139 vs. $86,167, adjusted P < 0.001; PPPM=$20,583 vs. $5,778, adjusted P = 0.008), driven by HCV-related medical costs and total pharmacy costs. CONCLUSIONS: Adherence with HCV regimens did not affect risk of liver transplant, underscoring the need for further evidence linking treatment adherence to future liver transplant risk. HCV-treated patients who required liver transplant incurred significantly higher health care costs than those without HCV treatment before liver transplant. Introduction of newer all-oral direct-acting antiviral regimens, with higher acquisition costs, will require further research to more accurately assess medication adherence and its relationship with transplantation, as well as with total health care costs. DISCLOSURES: No outside funding supported this research. Ems, Worley, Racsa, Gregory, Anderson, and Holt are employees of Humana. Brill has participated in a physician advisory board at Humana. The authors have no other financial disclosures to report. Study concept and design were contributed by Ems, Racsa, Worley, and Anderson, along with Gregory, Brill, and Holt. Racsa took the lead in data collection, along with Ems and Worley. All authors participated in data interpretation. Anderson, along with the other authors, wrote the manuscript, which was revised by Brill and Holt, with assistance from the other authors.