Medical Cost Offsets Research Articles

Cost Offset of Dapagliflozin in the US Medicare Population with Cardio-Kidney Metabolic Syndrome.

Cardiovascular-kidney-metabolic (CKM) syndrome is highly prevalent in the US Medicare population and is projected to increase further. Sodium-glucose co-transporter2 inhibitors have indications in chronic kidney disease (CKD), heart failure (HF), and type2 diabetes (T2D), providing protective efficacy across conditions within CKM syndrome. The objective of this study was to develop a model to extrapolate key outcomes observed in pivotal clinical trials to the US Medicare population, and to assess the potential direct cost offsets associated with dapagliflozin therapy. All US 2022 Medicare beneficiaries (≥ 65years of age) eligible to receive dapagliflozin were estimated according to drug label indication and Medicare enrollment and claims data. Incidence of key outcomes from the dapagliflozin clinical program were modelled over a 4-year time horizon based on patient-level data with CKD, HF, and T2D. Published cost data of relevant clinical outcomes were used to calculate direct medical care cost-offset associated with treatment with dapagliflozin. In a population of 13.1million patients with CKM syndrome, treatment with dapagliflozin in addition to historical standard of care (hSoC) versus hSoC alone led to fewer incidents of HF-related events (hospitalization for HF, 613,545; urgent HF visit, 98,896), renal events (kidney failure, 285,041; ≥ 50% sustained decline in kidney function, 375,137), and 450,355fewer deaths (of which 225,346 and 13,206 incidences of cardiovascular and renal death were avoided). In total this led to medical care cost offsets of $99.3billion versus treatment with hSoC only (dapagliflozin plus hSoC, $310.3billion; hSoC, $211.0billion). By extrapolating data from trials across multiple indications within CKM syndrome, this broader perspective shows that considerable medical care cost offsets may result through attenuated incidence of clinical events in CKD, T2D, and HF populations if treated with dapagliflozin in addition to hSoC over a 4-year time horizon. Graphical abstract available for this article.

Translating the efficacy of dapagliflozin in chronic kidney disease to lower healthcare resource utilization and costs: a medical care cost offset analysis

AimsDapagliflozin was approved for use in patients with chronic kidney disease (CKD) based on results of the DAPA-CKD trial, demonstrating attenuation of CKD progression and reduced risk of cardio-renal outcomes and all-cause mortality (ACM) versus placebo, in addition to standard therapy. The study objective was to assess the potential medical care cost offsets associated with reduced rates of cardio-renal outcomes across 31 countries and regions.Materials and methodsA comparative cost-determination framework estimated outcome-related costs of dapagliflozin plus standard therapy versus standard therapy alone over a 3-year horizon based on the DAPA-CKD trial. Incidence rates of end-stage kidney disease (ESKD), hospitalizations for heart failure (HHF), acute kidney injury (AKI), and ACM were estimated for a treated population of 100,000 patients. Associated medical care costs for non-fatal events were calculated using sources from a review of publicly available data specific to each considered setting.ResultsPatients treated with dapagliflozin plus standard therapy experienced fewer incidents of ESKD (7,221 vs 10,767; number needed to treat, NNT: 28), HHF (2,370 vs 4,684; NNT: 43), AKI (4,110 vs. 5,819; NNT: 58), and ACM (6,383 vs 8,874; NNT: 40) per 100,000 treated patients versus those treated with standard therapy alone. Across 31 countries/regions, reductions in clinical events were associated with a 33% reduction in total costs, or a cumulative mean medical care cost offset of $264 million per 100,000 patients over 3 years.Limitations and conclusionsThis analysis is limited by the quality of country/region-specific data available for medical care event costs. Based on the DAPA-CKD trial, we show that treatment with dapagliflozin may prevent cardio-renal event incidence at the population level, which could have positive effects upon healthcare service delivery worldwide. The analysis was restricted to outcome-associated costs and did not consider the cost of drug treatments and disease management.

Budget Impact Analysis of Expanding Gliflozin Coverage in the CKD Population: A French Perspective.

Gliflozins have historically been indicated for type 2 diabetes in France. However, their efficacy has recently been demonstrated in heart failure and chronic kidney disease (CKD), with positive recommendations by Haute Autorité de Santé for gliflozin therapies in these indications. The study objective was to investigate the 5-year budget impact associated with the introduction of gliflozins in addition to standard therapy in people with CKD and elevated albuminuria, regardless of diabetes status, from the perspective of the French healthcare system. A budget impact model was developed to estimate the 5-year implications of incorporating gliflozins in the treatment of patients withCKD in France, using efficacy data from the Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) trial. Direct medical costs associated with drug acquisition and management, treatment-related adverse events, dialysis and kidney transplantation, and adverse clinical outcomes were considered. Market share forecasts were estimated from historical data and expert opinions. Event rates were derived from trial data, while cost data were sourced from published estimates. The introduction of gliflozins was estimated to be cost saving compared to the no gliflozins scenario, with an expected cumulative 5-year budget impact of -€650 million, driven by slowed disease progression in patients treated with gliflozins, with fewer patients cumulatively progressing to end-stage kidney disease (84,526 vs. 92,062). This, in addition to fewer hospitalisations for heart failure and deaths from any cause, led to substantial medical care cost offsets (kidney-related: -€894 million; hospitalisation for heart failure: -€14.3 million; end-of-life care: -€17.3 million) to the additional drug acquisition (€273 million) and treatment-related adverse events costs (€2.98 million). In concert with early diagnosis and proactive management of CKD, the expansion of the gliflozin indications into the French CKD population presents the opportunity to reduce the substantial burden associated with cardio-renal complications which outweighs the additional cost of the new treatment. INFOGRAPHIC.

Estimating the Lifetime Medical Cost Burden of an Allogeneic Hematopoietic Cell Transplantation Patient and the Value of Addressing the Unmet Need

Background: Allogeneic hematopoietic cell transplantation (allo-HCT) management has evolved, with the emergence of molecular detection assays and therapies to treat post-HCT complications such as graft-versus-host disease (GVHD). However, this approach could increase the economic burden on healthcare systems by only managing complications that occur after the initial transplant. Instead, alternative therapies involving novel engineered donor allografts to replace standard allo-HCT to prevent late complications may potentially improve outcomes and address a greater unmet need. Objective: To estimate (1) the average total lifetime medical costs of an allo-HCT and (2) to estimate the net monetary savings and value associated with reducing late complications. Methods: A short-term decision tree (100-day) and a long-term semi-Markov partitioned survival model were developed that estimated the average per-patient lifetime cost and expected quality-adjusted life years (QALYs) for an allo-HCT patient from a United States healthcare system perspective. The allo-HCT patient population represented an average 53-year-old patient who was undergoing an allo-HCT to treat the three most common indications for allo-HCT: acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndromes (MDS), distributed as 51%, 21%, and 28%, respectively. Key model clinical inputs included: overall survival, GVHD-free relapse-free survival (GRFS), incidence of both acute and chronic GVHD, relapse of the primary disease, and infections. Following the first 100 days, the patient cohort was assigned to 3 mutually exclusive health states in a semi-Markov partitioned survival model for the remainder of their lifetime: (1) GRFS, (2) progressed and/or GVHD, and (3) death. The projected time spent in each health state was derived from data provided by CIBMTR. Costs pertaining to allo-HCT and associated complications were obtained from the published literature based on medical claims analyses of payments (paid amounts) and were converted into costs using the American Hospital Association (AHA) commercial payment-to-cost ratio. Maintenance therapy costs for FLT3-ITD positive AML and Ph+ ALL cases were also included and were based on published literature, expert opinion, and prescribing information. The key outcomes were direct medical costs and expected QALYs. Cost results were reported as a range based on varying the percent of chronic GVHD patients that remained on treatment after two years (15% or 39%) as derived from the published literature. Scenario analyses were conducted to estimate the potential clinical and economic value that may be realized by improving GRFS outcomes. The scenario analyses to address some of the unmet need were modeled as a doubled improvement in GRFS (69% GRFS in year 1 as opposed to 34%) to estimate changes in allo-HCT-associated costs and survival. A willingness-to-pay threshold of $150,000 was used to monetize the QALYs gained as a result of improving GRFS outcomes. Results: Over a lifetime, the average per-patient medical cost of allo-HCT was estimated to range from $942,373 to $1,247,917. Of those total costs, 23% to 30% were incurred within the 1st 100 days and 42% to 56% within the 1st year. Of the medical costs estimated, the majority of the costs were for chronic GVHD treatment (37% to 53%) followed by the allo-HCT procedure (15% to 19%). Expected lifetime QALYs of an allo-HCT patient were estimated to be 4.7. In the scenario analyses, the unmet need that could be addressed by improving GRFS outcomes (via the medical cost offsets and QALYs gained) was associated with a net monetary value that ranged from $695,709 to $911,062. Of the estimated net monetary value, 85% to 88% was driven by direct medical cost savings while the remaining 12% to 15% was due to value of the gain in expected QALYs. Conclusions: The current per-patient cost of allo-HCT carries a substantial medical cost burden often exceeding $1M over the lifetime of the patient. Innovative research efforts focused on disease control and reduction or elimination of late complications altogether, particularly cGVHD, may provide the greatest value in improved patient outcomes and reduced healthcare spending. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

PUK16 A Cost-Offset Analysis of the Roxadustat Incident Dialysis-Dependent Global Phase 3 Program: A US Healthcare Perspective

Chronic kidney disease (CKD) is a costly public health issue, which affects 13.4% of the population globally. Anemia is a common complication in CKD patients, resulting in reduced health-related quality of life and high healthcare costs. The objective of this analysis is to estimate the direct medical care cost offsets of the investigational agent roxadustat for the treatment of anemia in patients with incident dialysis-dependent (ID) CKD from a US healthcare perspective. Data from the roxadustat global phase 3 program were used to estimate the incidence of iron supplementation/rescue therapy use (i.e. intravenous iron, erythropoiesis-stimulating agents [ESAs] or red blood cell transfusions) and major adverse cardiovascular events (MACE+) for roxadustat compared with ESAs in ID patients with anemia of CKD. MACE+ included myocardial infarction, stroke, hospitalized unstable angina, hospitalized congestive heart failure, cardiovascular death, and other death. Published US cost data were used to estimate event costs. Drug acquisition costs for roxadustat and ESAs were not considered. A hypothetical cohort of 10,000 US adult ID patients (90% undergoing hemodialysis, 10% undergoing peritoneal dialysis) with treatable anemia was modeled to determine net medical care cost offsets annually and cumulatively compared with ESAs over a 4-year time horizon. Preliminary results for patients with ID CKD show that, compared with ESAs, roxadustat could produce sizeable net medical care cost offsets from decreases in iron supplementation/rescue therapy usage and MACE+. Cumulative medical care cost offsets for iron supplementation/rescue therapy use and MACE+ were an estimated US$156,498 and US$12,882,500, respectively, for roxadustat compared with ESAs for the entire cohort of patients with ID CKD. This analysis provides evidence that treatment with roxadustat in ID patients with anemia of CKD could result in considerable medical care cost offsets for roxadustat compared with ESAs for iron supplementation/rescue therapy usage and MACE+.

PND14 Expanding the Components of Economic Analyses of Pharmacotherapy for Parkinson's Disease

Medications that treat the motor symptoms of Parkinson’s disease (PD) do not necessarily yield short-term, clinically significant direct medical cost offsets. However, these medications may minimize other negative effects of motor dysfunction on the daily lives of patients living with PD and of their caregivers. Many of these effects are historically not well-captured in economic models of PD pharmacotherapy, although they are consistent with “Augmented CEA” and with the newest constructs included in ICER’s value assessment framework (“Other Benefits or Disadvantages” and “Contextual Considerations”). Due to the breadth of motor symptoms’ direct impact on activities of daily living, the early age of onset of PD (relative to other neurodegenerative diseases), the unrelenting progressive nature of PD, the length of time patients live with PD, and the severity of late-stage PD, we believe the capture of these effects is critical. We conducted a targeted literature review, exploring eight often-overlooked elements that should be consistently included in PD models of pharmacotherapy cost-utility: Patients’ early retirement; absenteeism and presenteeism among patients remaining in the labor force; caregivers’ unplanned retirement; absenteeism and presenteeism among caregivers remaining in the labor force; paid nonmedical care and home modification expenditures; proportional QALY shortfalls; and the value of hope (in treatment effectiveness), noting that the value of hope is especially relevant in a disease where high heterogeneity of treatment effects is positively correlated with disease progression. A typology matching motor symptom effects with the design requirements of PD clinical trials, open-label trial extensions, and prospective observational studies followed from the literature review. In this presentation, we describe the typology, its expected utility for the design of industry-sponsored studies, and its limitations.

MO551A COST-OFFSET ANALYSIS OF THE ROXADUSTAT DIALYSIS-DEPENDENT GLOBAL PHASE 3 PROGRAM: A CANADIAN HEALTHCARE PERSPECTIVE

Abstract Background and Aims Chronic kidney disease (CKD) is a costly public health issue, which affects 13.4% of the population globally. Anaemia is a common complication in patients with CKD resulting in reduced health-related quality of life and high healthcare costs. The objective of this analysis was to estimate the direct medical care cost offsets of the investigational agent roxadustat for the treatment of anaemia in patients with dialysis-dependent (DD) CKD from a Canadian healthcare perspective. Method Data from the roxadustat global phase 3 program were used to estimate the incidence of rescue therapy or iron supplementation use (i.e. intravenous iron, erythropoiesis-stimulating agents [ESAs] or red blood cell transfusions) and major adverse cardiovascular events (MACE+) for roxadustat compared with ESAs in DD patients with anaemia of CKD. MACE+ included myocardial infarction, stroke, unstable angina requiring hospitalization, congestive heart failure (CHF) requiring hospitalization, cardiovascular death and other death. Published Canadian cost data were used to estimate event costs. Drug acquisition costs for roxadustat and ESAs were not considered. A hypothetical cohort of 10,000 Canadian adult DD patients (90% undergoing haemodialysis, 10% undergoing peritoneal dialysis) with treatable anaemia was modelled to determine net medical care cost offsets annually and cumulatively compared with ESAs over a 4-year time horizon. Results Preliminary results for patients with DD CKD show that, compared with ESAs, roxadustat could produce sizeable net medical care cost offsets resulting from reductions in rescue therapy or iron supplementation use, specifically red blood cell transfusions, and from reductions in MACE+, specifically CHF hospitalizations. For the entire cohort of patients with DD CKD, cumulative medical care cost offsets for roxadustat were an estimated $162,609 for rescue therapy or iron supplementation use and $1,027,070 for MACE+ compared with ESAs. Conclusion This analysis provides evidence that treatment with roxadustat in DD patients with anaemia of CKD could result in considerable medical care cost offsets for roxadustat compared with ESAs.

POS-321 TRANSLATING THE FINDINGS OF THE ROXADUSTAT NDD GLOBAL PHASE 3 PROGRAM INTO COST OFFSETS FROM A CANADIAN HEALTHCARE PERSPECTIVE

Chronic kidney disease (CKD) is a costly public health issue, with an estimated prevalence of 13.4% globally. Anemia is a common complication associated with CKD resulting in reduced health-related quality of life and high healthcare costs. The objective of this analysis was to estimate the direct medical care cost offsets of investigational agent roxadustat for the treatment of anemia in patients with non-dialysis dependent (NDD) CKD from a Canadian healthcare perspective. Data from the roxadustat global Phase 3 program were used to estimate the projected incidence of rescue therapy use (intravenous iron, erythropoiesis stimulating agents or red blood cell transfusions) and major adverse cardiovascular events-plus (MACE+) for roxadustat compared to standard of care (placebo) in NDD patients with anemia of CKD. MACE+ events included myocardial infarction, stroke, hospitalized unstable angina, hospitalized congestive heart failure, cardiovascular death, and other death. Published Canadian cost data were used to estimate the cost of each medical event. A hypothetical cohort of 10,000 NDD Canadian patients with anemia of CKD aged 18 years and older was modeled with net medical care cost offsets calculated in Canadian dollars for each of the five years and cumulatively. Patients who transitioned to dialysis during the time horizon of the analysis were also evaluated in this cost offsets analysis. Compared to standard of care, preliminary results of the model for patients with NDD CKD and patients who transitioned to dialysis during the five year horizon of the analysis showed that roxadustat could produce net medical care cost offsets resulting from the reductions in rescue therapy usage and reduction in MACE+ events (specifically hospitalizations due to HF). Cumulative medical care cost offsets for patients with NDD CKD and patients who transitioned to dialysis during the five year horizon of the analysis compared with standard of care were estimated for rescue therapy use ($1,428,501) and MACE+ ($1,496,865). This cost offsets analysis provides evidence that treatment with roxadustat, in NDD patients with anemia of CKD and patients who transition to dialysis, could result in lower total medical care net costs compared to the costs of standard of care.

Effect of compliance with GOLD treatment recommendations on COPD health care resource utilization, cost, and exacerbations among patients with COPD on maintenance therapy.

BACKGROUND: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) report for the management of chronic obstructive pulmonary disease (COPD) focuses on reducing existing symptoms, decreasing the risk of future exacerbations, and improving health status by recommending specific drug therapy based on exacerbation risk and symptoms. However, disparities exist between evidence-based recommendations and clinical practice. Research that quantifies the real-world effect of COPD regimen alignment with the GOLD recommendations on clinical and economic outcomes is needed. OBJECTIVE: To compare COPD-related health care resource utilization (HRU) and costs, as well as exacerbation rates, among patients with COPD on maintenance therapy based on 2017 GOLD treatment recommendation compliance status per GOLD ABCD risk group classification in a U.S. commercially insured/Medicare Advantage population. METHODS: This retrospective cohort study utilized administrative claims data in the HealthCore Integrated Research Database. The COPD population was identified using a previously validated claims-based predictive model. Among this population, patients with ≥ 1 claim for a COPD maintenance medication (earliest maintenance fill-date = index date) between January 1, 2014, and March 31, 2017, were identified. Patients were required to be aged ≥ 40 years, have ≥ 12 months of pre-index and ≥ 30 days of post-index health plan enrollment, with no diagnosis for asthma, cystic fibrosis, and/or lung cancer at any time from January 1, 2013, to March 31, 2018. Patients were categorized into exacerbation risk/symptomatology groups according to the 2017 GOLD ABCD assessment recommendations and were then classified into treatment-compliance status based on their maintenance therapy. Multivariable analyses were conducted to examine post-index COPD-related HRU, costs, and exacerbations by compliance status. RESULTS: The primary analytical study sample included 38,382 patients in the GOLD A/B group and 6,525 in the GOLD C/D group. Patients were further categorized into GOLD A (n = 19,345), B (n = 19,037), C (n = 1,865), and D (n = 4,670). GOLD-compliant regimens were observed in 32.9% of patients in the GOLD A/B group and in 58.9% of patients in the GOLD C/D group. Inhaled corticosteroid-containing regimens were the most commonly observed noncompliant regimen. Patients on compliant regimens had significantly fewer COPD-related inpatient and emergency department visits and therefore had significantly lower COPD-related medical costs in both the GOLD A/B and C/D cohorts. Similar results were observed for individual GOLD cohorts B, C, and D. These savings were offset by increased pharmacy expenditures. Being on GOLD guideline-compliant regimens significantly reduced the risk of exacerbation by 8% (hazard ratio [HR] = 0.92; P < 0.0001) in the GOLD A/B cohort and by 12% (HR = 0.88; P = 0.0005) in the GOLD C/D cohort, and was also associated with a significantly reduced exacerbation rate in the GOLD A/B (rate ratio [RR] = 0.93; P < 0.0001) and GOLD C/D (RR = 0.93; P = 0.0129) groups. CONCLUSIONS: This study suggests a continuing trend of high prevalence of suboptimal prescriber compliance to GOLD treatment recommendations. Treatment regimens compliant with GOLD recommendations were associated with improvement in exacerbations, reduced COPD-related HRU, and COPD-related medical cost offsets. DISCLOSURES: This study was funded by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI). BIPI was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations. Palli and Shaikh are employees of BIPI. Willey is an employee of HealthCore, which was contracted by BIPI to conduct this study. Zhou was an employee of HealthCore at the time of study execution. Data were presented in part during an AMCP webinar (recording not made public) held in lieu of the Spring 2020 AMCP conference, which was canceled due to the COVID-19 pandemic.

Alternative Reimbursement Models for High Cost Health Technologies

High cost health technologies, mostly targeting rare diseases and genetic disorders, are becoming a growing source of concern to public and private payers due to their potentially disruptive front-loaded budget impact. Current funding mechanisms, structured to cover incremental costs usually required to treat patients with chronic conditions, will have to be re-designed as highly effective curative therapies are disrupting the distribution of treatment cost with the long-term realisation of clinical benefits to patients. Pressure to make these treatments available and accessible to patients on the basis of effectiveness (i.e. cure) and future medical cost offsets was observed already with Hepatitis C drugs. Rapid advances in gene therapies and promising clinical trial results are likely to further increase the number of patients eligible for these high cost treatments. Sponsored by the Society of Actuaries (SOA) - Health Section, this work presents a framework for evaluating alternative reimbursement approaches, with considerations specific to public and private payer perspectives in the US and UK. Various financing and insurance-like models are explored, ultimately highlighting the strengths and weaknesses of each of these approaches to the type of health technologies at hand, and identifying areas where traditional insurance risk principles may break down. Illustrative scenarios using real-world data explore the applicability of these alternative reimbursement models to selected disease areas and therapies, and demonstrate the magnitude of the financial risks to payers. While traditional actuarial approaches are normally used to quantify the potential financial risk to payers of introducing novel technologies, health economic evaluations tend to focus on predicting long-term costs and outcomes of new treatments. Therefore, managing the financial uncertainty of high cost technologies while maximising patient clinical benefits is an area where both disciplines can leverage each other to develop effective and durable alternative reimbursement models.

Payer and Pharmaceutical Manufacturer Considerations for Outcomes-Based Agreements in the United States

BackgroundConsiderable interest exists among health care payers and pharmaceutical manufacturers in designing outcomes-based agreements (OBAs) for medications for which evidence on real-world effectiveness is limited at product launch. ObjectivesTo build hypothetical OBA models in which both payer and manufacturer can benefit. MethodsModels were developed for a hypothetical hypercholesterolemia OBA, in which the OBA was assumed to increase market access for a newly marketed medication. Fixed inputs were drug and outcome event costs from the literature over a 1-year OBA period. Model estimates were developed using a range of inputs for medication effectiveness, medical cost offsets, and the treated population size. Positive or negative feedback to the manufacturer was incorporated on the basis of expectations of drug performance through changes in the reimbursement level. Model simulations demonstrated that parameters had the greatest impact on payer cost and manufacturer reimbursement. ResultsModels suggested that changes in the size of the population treated and drug effectiveness had the largest influence on reimbursement and costs. Despite sharing risk for potential product underperformance, manufacturer reimbursement increased relative to having no OBA, if the OBA improved market access for the new product. Although reduction in medical costs did not fully offset the cost of the medication, the payer could still save on net costs per patient relative to having no OBA by tying reimbursement to drug effectiveness. ConclusionsPharmaceutical manufacturers and health care payers have demonstrated interest in OBAs, and under a certain set of assumptions both may benefit.

Financial Impact of Direct-Acting Oral Anticoagulants in Medicaid: Budgetary Assessment Based on Number Needed to Treat.

Faced with rising healthcare costs, state Medicaid programs need short-term, easily calculated budgetary estimates for new drugs, accounting for medical cost offsets due to clinical advantages. To estimate the budgetary impact of direct-acting oral anticoagulants (DOACs) compared with warfarin, an older, lower-cost vitamin K antagonist, on 12-month Medicaid expenditures for nonvalvular atrial fibrillation (NVAF) using number needed to treat (NNT). Medicaid utilization files, 2009 through second quarter 2015, were used to estimate OAC cost accounting for generic/brand statutory minimum (13/23%) and assumed maximum (13/50%) manufacturer rebates. NNTs were calculated from clinical trial reports to estimate avoided medical events for a hypothetical population of 500,000 enrollees (approximate NVAF prevalence×Medicaid enrollment) under two DOAC market share scenarios: 2015 actual and 50% increase. Medical service costs were based on published sources. Costs were inflation-adjusted (2015 US$). From 2009-2015, OAC reimbursement per claim increased by 173 and 279% under maximum and minimum rebate scenarios, respectively, while DOAC market share increased from 0 to 21%. Compared with a warfarin-only counterfactual, counts of ischemic strokes, intracranial hemorrhages, and systemic embolisms declined by 36, 280, and 111, respectively; counts of gastrointestinal hemorrhages increased by 794. Avoided events and reduced monitoring, respectively, offset 3-5% and 15-24% of increased drug cost. Net of offsets, DOAC-related cost increases were US$258-US$464 per patient per year (PPPY) in 2015 and US$309-US$579 PPPY after market share increase. Avoided medical events offset a small portion of DOAC-related drug cost increase. NNT-based calculations provide a transparent source of budgetary-impact information for new medications.

Event and Cost Offsets of Switching 20% of the Type 1 Diabetes Population in Germany From Multiple Daily Injections to Continuous Subcutaneous Insulin Infusion: A 4-Year Simulation Model.

Most patients with type 1 diabetes (T1D) administer insulin by multiple daily injections (MDI). However, continuous subcutaneous insulin infusion (CSII) therapy has been shown to improve glycemic control compared with MDI. The objective was to determine the key medical event and cost offsets generated over a 4-year period by introducing CSII to T1D patients who have inadequately controlled glucose metabolism on MDI in Germany. A decision-analytic budget impact model, simulating a treatment switch scenario, was developed. In the base case, all T1D patients received MDI, while in the switch scenario, 20% of the eligible T1D population, randomly selected, moved to CSII. The model focused on 2 medical endpoints and their corresponding cost offsets: severe hypoglycemic events requiring hospitalization (SHEH) and complication-borne diabetic events (CDEs) avoided. Event rates and costs were taken from the literature and official sources, adopting a health insurance perspective. Compared with the base case, treating 20% of patients with CSII in the switch scenario resulted in 47 864 fewer SHEH and 5543 fewer CDEs. This led to total cost offsets of €183 085 281 within the 4-year time horizon. Of these, 92% were driven by avoided SHEH. Compared to an expected budget impact (cost increase) of 83%, only treatment costs considered, the total impact of the switch scenario amounted merely to a 24.5% increase in costs (reduction by 58.5% points; a factor of 3.4). The use of CSII resulted in fewer SHEH and CDEs compared to MDI. The incurred CSII implementation costs are hence offset to a substantial degree by cost savings in complication treatment.

PHP72 - DOWNSTREAM MEDICAL COST OFFSETS IN MEDICARE FROM PRESCRIPTION DRUG USE IN EMPLOYER-SPONSORED INSURANCE

To estimate the impact of prescription drug utilization during pre-Medicare coverage years under employer-sponsored insurance on later medical spending in Medicare. Individuals found in both the Commercial and Medicare Supplemental Marketscan® files were selected. Study subjects were required to be 64 years old or younger at baseline and continuously eligible throughout the entire 5-year study period 2008-2012. The resulting panel dataset was comprised of 133,412 individuals who aged into Medicare, each with 5 annual observations. Conducted was an econometric analysis of the impact of aggregate prescription drug utilization on total, inpatient, and outpatient medical costs. Individual fixed effects Poisson models of these cost measures were estimated as a function of 1-, 2-, and 3-year lagged values of prescription drug utilization—measured as the number of days’ supply-adjusted fills. All models also included a robust set of controls. Among individuals covered by Medicare (ages 65-68), a 1 percent increase in prescription drug utilization 1 year prior was associated with a 0.363 percent decrease in total medical costs. Notably, medication use 2 years prior prompted a 0.123 percent decrease in total medical costs, and these offsets still persisted after 3 years (0.059 percent decrease). Effects were more pronounced for inpatient relative to outpatient costs. The pattern of declining, yet persistent, medical cost offsets for at least 3 years emerged for all three measures of medical costs. Pharmaceutical use is expected to lower spending on other medical services. The duration of these offsets may span multiple payers. Retirees entering Medicare who are healthier due to prior medication use are less costly. Indeed, the Medicare program is exposed to the consequences of prescription drug use 3 years prior to coverage. The evaluation of policies that could alter medication use among the near retired (such as the “Cadillac Tax”) should consider this important finding.

Budget impact model of a 5-grass sublingual immunotherapy tablet for the treatment of grass pollen-induced allergic rhinitis

Objective:Allergic rhinitis (AR) is a chronic disease with a substantial clinical and economic burden. This study estimated the potential budget impact (BI) associated with market entry of Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract Tablet for Sublingual Use (‘5-grass SLIT tablet’) for patients aged 10–65 with grass pollen-induced AR.Methods:A budget impact model was constructed to estimate the potential BI from a US payer perspective. The model calculated pharmacy, medical, and total (pharmacy + medical) costs per-member-per-month (PMPM) with and without market entry of the 5-grass SLIT tablet, considering a 3-year time horizon. The target population was determined using an epidemiological approach and existing literature. The treatment market shares without 5-grass SLIT tablet entry were derived from an analysis of de-identified insurance claims data. Pharmacy costs and medical utilization rates and costs were obtained from the claims data analysis and existing literature. One-way sensitivities were conducted for key model inputs.Results:Using an illustrative example of a hypothetical health plan with one million members, the estimated target population of AR patients aged 10–65 was 26,320. On a PMPM basis, pharmacy costs increased by $0.36, $0.44, and $0.51, while total costs (after medical cost offsets) increased by $0.15, $0.18, and $0.22 in the first, second, and third years following entry of the 5-grass SLIT tablet, respectively. Results were most sensitive to changes in the compliance rate, treatment duration, and price. The BI will vary from the base case example when alternative, payer-specific inputs are used.Conclusions:Using base case inputs, use of the 5-grass SLIT tablet to treat grass pollen-induced AR increased the pharmacy budget for a hypothetical third-party payer. Higher pharmacy costs were partially offset by lower medical budget due to reduced resource use compared with existing treatments.

Does Good Medication Adherence Really Save Payers Money?

Despite a growing consensus that better adherence with evidence-based medications can save payers money, assertions of cost offsets may be incomplete if they fail to consider additional drug costs and/or are biased by healthy adherer behaviors unobserved in typical medical claims-based analyses. The objective of this study was to determine whether controlling for healthy adherer bias (HAB) materially affected estimated medical cost offsets and additional drug spending associated with higher adherence. A total of 1273 Medicare beneficiaries with diabetes enrolled in Part D plans between 2006 and 2009. Using survey and claims data from the Medicare Current Beneficiary Survey, we measured medical and drug costs associated with good and poor adherence (proportion of days covered ≥ 80% and <80%, respectively) to oral antidiabetic drugs, ACE inhibitors/ARBs, and statins over 2 years. To test for HAB, we estimated pairs of regression models, one set containing variables typically controlled for in conventional claims analysis and a second set with survey-based variables selected to capture HAB effects. We found consistent evidence that controlling for HAB reduces estimated savings in medical costs from better adherence, and likewise, reduces estimates of additional adherence-related drug spending. For ACE inhibitors/ARBs we estimate that controlling for HAB reduced adherence-related medical cost offsets from $6389 to $4920 per person (P<0.05). Estimates of additional adherence-related drug costs were 26% and 14% lower in HAB-controlled models (P < 0.05). These results buttress the economic case for action by health care payers to improve medication adherence among insured persons with chronic disease. However, given the limitations of our research design, further research on larger samples with other disease states is clearly warranted.

PMH37 - Medical cost-offset of once-monthly Paliperidone palmitate Monotherapy and adjunctive Therapy in 15-month trial

PMH37 - Medical cost-offset of once-monthly Paliperidone palmitate Monotherapy and adjunctive Therapy in 15-month trial

Medical cost offsets from prescription drug utilization among Medicare beneficiaries.

This brief commentary extends earlier work on the value of adherence to derive medical cost offset estimates from prescription drug utilization. Among seniors with chronic vascular disease, 1% increases in condition-specific medication use were associated with significant (P less than 0.001) reductions in gross nonpharmacy medical costs in the amounts of 0.63% for dyslipidemia, 0.77% for congestive heart failure, 0.83% for diabetes, and 1.17% for hypertension.

Can CER be an effective tool for change in the development and assessment of new drugs and technologies?

Comparative effectiveness research (CER) has been proposed in the United States as a way to compare new drugs and technologies with established alternatives and determine not just whether a therapy works, but how well it works compared to other options. To define the current use of CER in the development of new drugs and technologies and explore what is needed for this research approach to reduce or stabilize health care costs in the United States. In 2010, the Patient-Centered Outcomes Research Institute (PCORI) was established by the Patient Protection and Affordable Care Act (PPACA) to coordinate federally funded CER and recommend research priorities. Hochman and McCormick's (2010) evaluation of 328 randomized trials, observational studies, and meta-analyses involving medications published between June 2008 and September 2009 in 6 key journals showed that most published research did not fulfill the criteria of CER (defined as comparison to active treatment) and that most study design is driven by FDA requirements rather than the need to develop evidence to facilitates election of the most effective therapy. Since PPACA provides alternative funding for CER, it could encourage funding more studies to help determine which treatment delivers the best value per unit of investment from clinical, humanistic, and economic perspectives. Manufacturers may avoid CER because it increases product development costs, but a drug proven more effective is more likely to be accepted by formulary committees, increasing the drug's market share, whereas payers may reject or limit use of a new drug that performs less effectively in comparative studies. CER may not directly reduce expenditures for drugs and medical technologies. The results may vary widely from case to case; however, despite often significantly higher prices for new drugs, it is important to look beyond product costs to the overall impact on health care costs, including medical cost offsets that may occur through improved health or decreased morbidity. To truly decrease cost and improve quality, cost-effectiveness will have to be integrated into CER with the objective of prioritizing efficient therapies in the real-world health care system. If the methods and output of CER improve, the resulting cost-effectiveness ratios will also be more useful to the payer. CER should ultimately, therefore, be a useful tool to help patients, providers, and decision makers provide the most effective and most cost-effective interventions.

“This Drug May Work, But Is It Worth the Cost?” Can Comparative Effectiveness Research Help Tame Rising Health Care Costs?

“This Drug May Work, But Is It Worth the Cost?” Can Comparative Effectiveness Research Help Tame Rising Health Care Costs?