Are We Ready for a New Approach to Comparing Coverage and Reimbursement Policies for Medical Nutrition in Key Markets: An ISPOR Special Interest Group Report.

OBJECTIVES: Healthcare policy makers should ensure optimal patient access to medical nutrition (MN) as part of the management of nutrition-related disorders and conditions. Questions remain whether current healthcare policies reflect the clinical and economic benefits of MN. The objective of this article is to characterize coverage and reimbursement of MN, defined as food for special medical purposes/medical food for a diverse set of countries, including Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Italy, Japan, The Netherlands, Singapore, Spain, United Kingdom, and United States. METHODS: Data sources included published literature and online sources. ISPOR's Nutrition Economics Special Interest Group developed a data collection form to guide data extraction that included reimbursement coverage, years that reimbursement policies were established, and presence of a formal health technology assessment (HTA) for MN technologies. RESULTS: Reimbursement coverage of MN technologies varied across the countries that were reviewed. All but 3 countries limited coverage to specific formulations of products, regardless of demonstrated clinical benefit. The year that reimbursement policies were established varied across countries (ranging from 1984 to 2017), and only 4 countries regularly update policies. France and Brazil are the only countries with a formal HTA process for MN technologies. CONCLUSIONS: Most countries have limited MN reimbursement, have not updated reimbursement policies, and lack HTA for MN technologies. These limitations may lead to suboptimal access to MN technologies where they are indicated to manage nutrition-related disorders and conditions, with the potential of negatively affecting patient and healthcare system outcomes.

A Meal Replacement Program for the Treatment of Obesity: A Cost-Effectiveness Analysis from the Swiss Payer's Perspective.

BACKGROUND: Obesity is a disease associated with high direct medical costs and high indirect costs resulting from productivity loss. The high prevalence of obesity generates the need for payers to identify cost-effective weight loss approaches. Among various weight management techniques, the OPTI (Optifast®) program is a clinically recognised total meal replacement diet that can lead to significant weight loss and reduction in complications. This study's objective is to assess OPTI program's cost-effectiveness in Switzerland in comparison to "no intervention" and pharmacotherapy. METHODS: An event-driven decision-analytic model was used to estimate the payer's cost savings through the reimbursement of OPTI program over a 1-year period as well as a lifetime in Switzerland. The analysis was performed on a broad population of people with obesity with a body mass index (BMI) higher than 30 kg/m2 following the OPTI program vs two comparators (liraglutide and "no intervention"). The model incorporated a higher risk of complications due to an increased BMI and their related healthcare costs. Data sources included published literature, clinical trials, official Swiss price/tariff lists and national population statistics. The primary perspective was that of a Swiss payer. Scenario analyses - for example, for patients with existing complications (such as myocardial infarction, stroke, type 2 diabetes mellitus) or severe obesity - were conducted to test the robustness of the results. RESULTS: The OPTI program results in cost savings of CHF 20,886 (€ 18,724) and CHF 15,382 (€ 13,790) per person compared with "no intervention" and liraglutide 3 mg, respectively. In addition, OPTI program led to 1.133 and 0.734 quality-adjusted life years (QALYs) gained respectively against its comparators. Scenario analyses showed similar outcomes with cost savings and QALYs gained. CONCLUSION: OPTI program is a dominant strategy compared to "no intervention" and liraglutide 3 mg as it leads to both cost savings and QALY gain. Therefore, reimbursing the OPTI program for patients with obesity would be cost-effective for Swiss payers.

Real-World Evidence of Treatment, Tolerance, Healthcare Utilization, and Costs Among Postacute Care Adult Patients Receiving Enteral Peptide-Based Diets in the United States.

OBJECTIVE: Peptide -based (PB) enteral tube feeding (ETF) formulas have been shown to reduce gastrointestinal (GI) intolerance in patients receiving enteral nutrition. However, limited data exist in relation to their use in the postacute/home care setting. We sought to assess the real-world GI tolerance, healthcare utilization, and resource use costs of 100% whey-protein PB ETF in adults in a postacute care setting and describe their demographic, clinical, and treatment characteristics. METHOD: Using medical claims data from the United States, we analyzed GI intolerance events occurring in adults receiving 100% whey-protein PB ETF (Peptamen® adult formulas) for one year before and after initiation of ETF. Resource use costs were subsequently estimated using a multivariate general linearized model and adjusted for age, gender, and Charlson Comorbidity Index score. RESULTS: The proportion of adults experiencing no GI intolerance events increased from 41% (418/1022) to 59% (601/1022) in the one-year period after initiation of 100% whey PB ETF (P < .001). The proportion of patients with at least one hospital inpatient visit also decreased from 100% (1022/1022) to 72% (737/1022) over the same period, and the mean number of inpatient visits per patient decreased from 15.6 to 13.0. Cost modeling revealed that outpatient visits accounted for 42% ($1174/$2820) of total estimated healthcare resource costs in the first 30 days after 100% whey PB ETF initiation, with only 9% ($255/$2820) due to emergency room visits. CONCLUSION: These 100% whey-protein PB ETF formulas are a valuable nutrition treatment option for patients with or at risk of malnutrition who show intolerance to standard ETF formulas and may reduce hospital inpatient visits and associated costs.

Value of Nutrition Support Therapy: Impact on Clinical and Economic Outcomes in the United States.

OBJECTIVE: Healthcare leaders seek guidance on prudent investment in programs that improve patient outcomes and reduce costs, which includes the value of nutrition therapy. The purpose of this project was to conduct an evidence review and evaluate claims analyses to understand the financial and quality impact of nutrition support therapy on high-priority therapeutic conditions. METHODS: Task 1 included a review of existing literature from 2013 to 2018 to identify evidence that demonstrated the clinical and economic impact of nutrition intervention on patient outcomes across 13 therapeutic areas (TAs). In Task 2, analytic claims modeling was performed using the Medicare Parts A and B claims 5% sample dataset. Beneficiaries diagnosed in 5 selected TAs (sepsis, gastrointestinal [GI] cancer, hospital-acquired infections, surgical complications, and pancreatitis) were identified in the studies from Task 1, and their care costs were modeled based on nutrition intervention. RESULTS: Beginning with 1099 identified articles, 43 articles met the criteria, with a final 8 articles used for the Medicare claims modeling. As examples of the modeling demonstrated, the use of advanced enteral nutrition formula could save at least $52 million annually in a sepsis population. The total projected annual cost savings from the 5 TAs was $580 million. CONCLUSION: Overall, optimization of nutrition support therapy for specific patient populations is estimated to reduce Medicare spending by millions of dollars per year across key TAs. These findings demonstrate the evidence-based value proposition of timely nutrition support to improve clinical outcomes and yield substantial cost savings.

A health economic model to assess the cost-effectiveness of OPTIFAST for the treatment of obesity in the United States.

OBJECTIVES: Obesity is associated with high direct medical costs and indirect costs resulting from productivity loss. The high prevalence of obesity generates a justified need to identify cost-effective weight loss approaches from a payer's perspective. Within the variety of weight management techniques, OPTIFAST is a clinically recognized and scientifically proven total meal replacement Low Calorie Diet that provides meaningful results in terms of weight loss and reduction in comorbidities. The objective of this study is assess potential cost-savings of the OPTIFAST program in the US, as compared to "no intervention" and pharmacotherapy. METHODS: An event-driven decision analytic model was used to estimate payer's cost-savings from reimbursement of the 1-year OPTIFAST program over 3 years in the US. The analysis was performed for the broad population of obese persons (BMI >30 kg/m2) undergoing the OPTIFAST program vs liraglutide 3 mg, naltrexone/bupropion and vs "no intervention". The model included the risk of complications related to increased BMI. Data sources included published literature, clinical trials, official US price/tariff lists, and national population statistics. The primary perspective was that of a US payer; costs were provided in 2016 US dollars. RESULTS: OPTIFAST leads over a period of 3 years to cost-savings of USD 9,285 per class I and II obese patient (BMI 30-39.9 kg/m2) as compared to liraglutide and USD 685 as compared to naltrexone/bupropion. In the same time perspective, the OPTIFAST program leads to a reduction of cost of obesity complications of USD 1,951 as compared to "no intervention", with the incremental cost-effectiveness ratio of USD 6,475 per QALY. Scenario analyses also show substantial cost-savings in patients with class III obesity (BMI ≥ 40.0 kg/m2) and patients with obesity (BMI = 30-39.9 kg/m2) and type 2 diabetes vs all three previous comparators and bariatric surgery. CONCLUSIONS: Reimbursing OPTIFAST leads to meaningful cost-savings for US payers as compared with "no intervention" and liraglutide and naltrexone/bupropion in obese patients. Similar results can be expected in matching healthcare settings of other countries. Moreover, OPTIFAST has additional clinical and economic advantages through very low complication and adverse events rates.