AMCP Partnership Forum: What's Next for Specialty Medication Benefit Design and Reimbursement.

Rising specialty drug costs present a challenge for patients and payers. High-cost products, such as gene therapies or immunotherapies, can significantly affect the budget of a payer that does not have the ability to spread risk across a large population. Stakeholders are considering new reimbursement and benefit designs for specialty medications to improve efficiencies and better manage costs. The potential effect of changes to specialty medication benefit designs and reimbursement systems on patient care, access to medications, and the overall health care system are important considerations when assessing the benefits and challenges associated with reform proposals. Options to better manage the affordability of specialty medications are needed to ensure that patients can continue to access medications, while allowing payers to remain good stewards of health care dollars and supporting marketplace competition and incentives to stimulate innovation. New benefit designs that address these needs, while also supporting marketplace competition and providing incentives that stimulate innovation, have been considered. To explore options, AMCP convened a multidisciplinary stakeholder forum on December 10-11, 2019, in Alexandria, VA. Health care leaders representing academia, health plans, integrated delivery systems, industry leaders, pharmaceutical manufacturers, pharmacy benefit managers, employers, federal government agencies, national health care provider organizations, and patient advocacy organizations participated in the forum. The forum was designed for stakeholders to discuss strategies for the following: (a) reduce costs for beneficiaries while maintaining or improving access to prescription drugs; (b) support marketplace competition and incentives for biopharmaceutical innovation; (c) minimize physicians' financial risk associated with managing drug inventories; (d) remove adverse reimbursement incentives for prescribing higher priced drugs; (e) consider the cost-effectiveness of treatments and services across the health care continuum; and (f) support quality measurement and program evaluation metrics. Recommendations emerging from the forum included creation of novel payment models for the most expensive therapies that allow for larger risk pools, while maintaining the sustainability of the reinsurance market remains. Simplification and standardization were cited as goals for system reform and technological innovations that allow health care providers to view cost-effectiveness information at the point of prescribing, combined with value-based contracting were also recommended. Finally, ensuring that plans remain patient-centric and are designed to address patient needs holistically was stressed as an important goal. DISCLOSURES: This partnership forum was sponsored by Amgen, AstraZeneca, Bayer, GSK, Merck, Pfizer, PhRMA, Takeda, and Xcenda. These proceedings were prepared as a summary of the forum to represent common themes; they are not necessarily endorsed by all attendees nor should they be construed as reflecting group consensus.

Mud-Bath Therapy in Addition to Usual Care in Bilateral Knee Osteoarthritis: An Economic Evaluation Alongside a Randomized Controlled Trial.

OBJECTIVE: To perform a cost-effectiveness analysis of mud-bath therapy (MBT) in addition to usual treatment compared to usual treatment alone in patients with bilateral knee osteoarthritis (OA). METHODS: An economic evaluation alongside a randomized controlled trial was conducted. Patients were randomly assigned to receive either a 2-week cycle of MBT in addition to their usual treatment or to continue routine care alone. The EuroQol 5-domain questionnaire was administered at baseline, 2 weeks, and at 3, 6, 9, and 12 months. Direct health care resource consumption data up until 12 months were derived from a daily diary given to patients and returned at prescheduled followup visits. RESULTS: A total of 103 patients were included (n = 53 for MBT patients; n = 50 for controls). Overall, patients in the MBT group accrued mean ± SD 0.835 ± 0.10 quality-adjusted life years (QALYs) compared to 0.753 ± 0.11 in the control group (P < 0.001). Average direct costs per patient (€303 versus €975; P < 0.001) were higher in the control group, primarily because of hospitalization for total knee replacement and use of intraarticular hyaluronic acid. Bootstrapping replications of costs and QALY sample distributions consistently indicated that the MBT therapy combined with standard therapy represents a dominant strategy as compared with standard therapy alone. The probability of MBT being cost-effective at standard cost-effectiveness thresholds (e.g., €20,000/QALY) is 100%. CONCLUSION: The results of this cost-effectiveness analysis support the use of MBT as midterm complementary therapy in the management of knee OA.

Sub-national health care financing reforms in Indonesia.

Indonesia has seen an emergence of local health care financing schemes over the last decade, implemented and operated by district governments. Often motivated by the local political context and characterized by a large degree of heterogeneity in scope and design, the common objective of the district schemes is to address the coverage gaps for the informal sector left by national social health insurance programs. This paper investigates the effect of these local health care financing schemes on access to health care and financial protection. Using data from a unique survey among District Health Offices, combined with data from the annual National Socioeconomic Surveys, the study is based on a fixed effects analysis for a panel of 262 districts over the period 2004-10, exploiting variation in local health financing reforms across districts in terms of type of reform and timing of implementation. Although the schemes had a modest impact on average, they do seem to have provided some contribution to closing the coverage gap, by increasing outpatient utilization for households in the middle quintiles that tend to fall just outside the target population of the national subsidized programs. However, there seems to be little effect on hospitalization or financial protection, indicating the limitations of local health care financing policies. In addition, we see effect heterogeneity across districts due to differences in design features.

A Prospective Pilot Study of the Use of Telemedicine During Pediatric Transport: A High-Quality, Low-Cost Alternative to Conventional Telemedicine Systems.

OBJECTIVE: Few trials address the use of telemedicine during pediatric transport. We believe that video conferencing has equivalent quality, connectivity, and ease of operation, can be done economically, and will improve evaluation. METHODS: Prospective randomized pilot study was used to examine video versus cellular communication between the medical command officer (MCO) and pediatric transport team (TT) for children with moderate to severe illness undergoing interhospital transport. Twenty-five patients were randomized to cellular communication, and 25 patients were randomized to video. The MCO completed a Likert scale to evaluate connection, quality, and ease of operation. Call durations were recorded. A Likert scale to evaluate the communication mode on patient care was completed. RESULTS: Connection and audio quality were equivalent and there were no dropped calls. Average call duration in the phone group was 186 versus 139 seconds in the video group (P = 0.055). The MCO survey results were the following: 100% found video intuitive, 92% felt that disposition based on phone report was difficult, 80% felt that video provided better understanding of patient condition, 70% felt that video assisted disposition, and 80% believe that video should be used for transport. The iPad system offers a significant savings when compared with conventional telemedicine. CONCLUSIONS: Video conferencing seems as easy to complete as phone with equivalent quality and connectivity. Duration of video was equivalent to phone conferencing. Surveyed MCOs believed that video conferencing improved assessment and disposition. The iPad-based conferencing provided significant savings when compared with conventional cart-based or robotic units. Further evaluation of video conferencing during interhospital transport is warranted.

Cumplimiento de indicadores de proceso en personas con diabetes tipo 2 y la vinculación a incentivos en Atención Primaria / Compliance with process indicators in people with type 2 diabetes and linking incentives in Primary Care

OBJETIVO: Los programas de pago por desempeño para mejorar la calidad de la atención sanitaria se están extendiendo de forma progresiva, en particular para en Atención Primaria. Nuestro objetivo fue explorar la relación entre el grado de cumplimiento de los indicadores de proceso (IPr) de la diabetes mellitus tipo 2 (DM2) en Atención Primaria y la vinculación a incentivos económicos. DISEÑO: Estudio descriptivo observacional, descriptivo y transversal. Emplazamiento: Seis centros de salud del Distrito Aljarafe, Sevilla, seleccionados de forma aleatoria y estratificada por tamaño poblacional. PARTICIPANTES: De un total de 3.647 sujetos incluidos en el Proceso Asistencial Integrado de DM2 durante el 2008, se incluyó a 366 pacientes, según cálculo de tamaño muestral, mediante muestreo aleatorio estratificado. Mediciones: IPr: exploración de fondo de ojo y pies, hemoglobina glucosilada (HbA1c), perfil lipídico, microalbuminuria y electrocardiograma. Variables potencialmente confusoras: edad, género, característica de zona de residencia en pacientes y variables de los médicos. RESULTADOS: La edad media fue de 66,36 (desviación estándar -DE- 11,56 años); el 48,9% eran mujeres. Los IPr con mejor cumplimiento fueron la exploración de pies, HbA1c y perfil lipídico (59,6, 44,3 y 44, respectivamente). El 2,7% de los pacientes presentaban cumplimiento simultáneo de los 6 IPr y el 11,74% de los 3 IPr vinculados a incentivos. El cumplimiento de IPr vinculado y no a incentivos mostró asociación significativa (p = 0,001). CONCLUSIONES: El cumplimiento de los IPr para el cribado de complicaciones crónicas de la DM2 es en su mayoría bajo, aunque este fue superior en los indicadores vinculados a incentivos

OBJECTIVE: Pay-for-performance programs to improve the quality of health care are extending gradually, particularly en Primary Health Care. Our aim was to explore the relationship between the degree of compliance with the process indicators (PrI) of type 2 diabetes (T2DM) in Primary Care and linkage to incentives. DESIGN: Cross-sectional, descriptive, observational study. SETTING: Six Primary Health Care centers in Seville Aljarafe District randomly selected and stratified by population size. PARTICIPANTS: From 3.647 adults included in Integrated Healthcare Process of T2DM during 2008, 366 patients were included according sample size calculation by stratified random sampling. Measurements: PrI: eye and feet examination, glycated hemoglobin, lipid profile, microalbuminuria and electrocardiogram. Confounding: Age, gender, characteristics town for patients and professional variables. RESULTS: The mean age was 66.36 years (standard deviation [DE]: 11,56); 48.9% were women. PrI with better compliance were feet examination, glycated hemoglobin and lipid profile (59.6%, 44.3% and 44%, respectively). 2.7% of patients had simultaneous compliance of the six PrI and 11.74% of patients three PrI linkage to incentives. Statistical association was observed in the compliance of the PrI incentives linked or not (P = .001). CONCLUSIONS: The degree of compliance with the PrI for screening chronic complications of T2DM is mostly low but this was higher on indicators linked to incentives

Evaluation of dedicated infectious diseases pharmacists on antimicrobial stewardship teams.

PURPOSE: Patient care improvements and cost savings achieved by a large integrated health system through the implementation of antimicrobial stewardship programs (ASPs) at two hospitals are reported. METHODS: A pre-post analysis was conducted to evaluate cost and quality outcomes at the two ASP sites and three similar sites within the same health system not included in the ASP initiative. The utilization of 15 targeted antimicrobials and associated costs at the five sites during designated preimplementation and postimplementation periods were compared; changes in Hospital Standardized Mortality Ratio (HSMR) values for specific infections among Medicare patients were also assessed. RESULTS: In the year after ASP implementation, aggregate direct antimicrobial acquisition costs at the two study sites decreased 17.3% from prior-year levels and increased by 9.1% at the three comparator sites. Significant decreases in the consumption of targeted antimicrobial classes (antipseudomonals, quinolones, and agents active against methicillin-resistant Staphylococcus aureus) were observed at the ASP sites. Among the 2446 ASP interventions recorded, 72% involved discontinuing or narrowing the use of broad-spectrum antimicrobials. Although rates of health care-associated Clostridium difficile infection were little changed at both study sites after ASP implementation, HSMR data indicated substantial gains in combating sepsis and C. difficile and respiratory infections. CONCLUSION: After implementation of ASPs at two study sites, the utilization of all classes of antibiotics decreased and antimicrobial costs per 1000 patient-days decreased. While HSMR values for sepsis (including C. difficile-associated cases) and respiratory infections improved, the rate of C. difficile infections stayed the same.

[Embrace, a model for integrated elderly care]. / SamenOud, een model voor geïntegreerde ouderenzorg: studieprotocol van een gerandomiseerde studie naar de effectiviteit betreffende patiëntuitkomsten, kwaliteit van zorg, zorggebruik en kosten.

UNLABELLED: Ongoing growth in health care expenditures and changing patterns in the demand for health care challenge societies worldwide. The Chronic Care Model (CCM), combined with classification for care needs based on Kaiser Permanente (KP) Triangle, may offer a suitable framework for change. The aim of the present study is to investigate the effectiveness of Embrace, a population-based model for integrated elderly care, regarding patient outcomes, service use, costs, and quality of care. METHODS: The CCM and the KP Triangle were translated to the Dutch setting and adapted to the full elderly population living in the community. A randomized controlled trial with balanced allocation was designed to test the effectiveness of Embrace. Eligible elderly persons are 75 years and older and enrolled with one of the participating general practitioner practices. Based on scores on the INTERMED-Elderly Self-Assessment and Groningen Frailty Indicator, participants will be stratified into one of three strata: (A) robust; (B) frail; and (C) complex care needs. Next, participants will be randomized per stratum to Embrace or care as usual. Embrace encompasses an Elderly Care Team per general practitioner practice, an Electronic Elderly Record System, decision support instruments, and a self-management support and prevention program - combined with care and support intensity levels increasing from stratum A to stratum C. Primary outcome variables are patient outcomes, service use, costs, and quality of care. Data will be collected at baseline, twelve months after starting date, and during the intervention period. DISCUSSION: This study could provide evidence for the effectiveness of Embrace.

Use of cognitive enhancers and associated medical care costs among patients with dementia: a nationwide study in Taiwan.

BACKGROUND: Pharmaceutical therapy for patients with dementia including cholinesterase inhibitors (ChEI) and memantine is covered by Taiwan's National Health Insurance (NHI) but with strict reimbursement criteria. This study compared utilization of selected cognitive enhancers among elderly patients with dementia and estimated associated differences in medical care costs. METHODS: This study used medical claims and pharmacy claims from the NHI Research Database of Taiwan from 2009 to 2011, which included all patients 65 years or older diagnosed with dementia in their outpatient or inpatient claims. Both individual-level and market-level analysis were performed to calculate the average medical costs per person and the share of drug expenditures. Generalized linear models with propensity score adjustment estimated differences in medical care costs by use of selected cognitive enhancers. RESULTS: Users of ChEI had the highest medication and outpatient costs but the lowest inpatient costs among all users of cognitive enhancers. However, annual adjusted total medical care costs per ChEI user were not significantly different from those who used cerebral vasodilators (CBV). In 2011, 52.4% of the elderly with dementia in Taiwan used cognitive enhancers, but among them 88.3% used CBV while 9.2% used ChEI. Among patients with dementia who used at least one cognitive enhancer, the aggregated expenditure as a share of their total drug expenditures was 9.7% in 2011. CONCLUSION: Given that CBV had a much higher utilization rate than ChEI or memantine among elderly people with dementia, the strict reimbursement policy for ChEI and memantine may need to be revisited to increase access to those drugs by patients with dementia in Taiwan.

[Health economic evaluation of clinical pathway of traditional Chinese medicine in the treatment of mild acute pancreatitis].

OBJECTIVE: To evaluate the health economic value clinical pathway (CP) of traditional Chinese medicine in the treatment of mild acute pancreatitis (MAP). METHODS: Ninty one patients with MAP were enrolled prospectively in TCM clinical pathway group from June 2012 to February 2013, while the data of 80 MAP patients who were treated without TCM clinical pathway from June 2011 to May 2012, were analyzed retrospectively as control group. The health economic evaluation data used for the two groups comparison included: average length of stay, hospitalization expenses (total hospitalization expenses, total treatment cost, TCM treatment cost, herbal fees, medicine fees, and nursing care cost), as well as the usage of antibiotics/somatostatin, the release time of abdominal pain, the time of re-feeding, and patient satisfaction. RESULTS: There were no significant statistical differences in demographics, etiology, Ranson and Balthazar CT scores between the two groups (P > 0.05). Compared with non-CP group, the usage of antibiotics and somatostatin, the release time of abdominal pain, the time of re-feeding and patient satisfaction were all improved significantly in CP group (P < 0.05). The average length of stay in CP group was shorter than that of non-CP group (P < 0.05). Total hospitalization expenses [yen (11,089.89 +/- 4,318.29) vs. yen (8,960.34 +/- 4,328.91)], medicine fees [yen (6,563.80 +/- 2,743.87) vs. yen (3,988.28 +/- 2,128.10)] and nursing care cost [yen (110.51 +/- 37.24) vs. yen (93.32 +/- 35.20)] were all reduced in CP group, while TCM treatment cost [yen (609.59 +/- 624.42) vs. (968.29 +/- 769.68)] and herbal fees [yen (162.72 +/- 135.13) vs. yen (303.49 +/- 149.90)] were increased (P < 0.05). There was no significant statistical difference in total treatment cost between the two groups (P > 0.05). CONCLUSION: TCM clinical pathway of MAP can not only ensure the therapeutic effects, but also shorten the average length of stay, reduce medical cost and increase patient satisfaction.

An evaluation of cost and appropriateness of care as recommended by candidates on a national clinical skills examination.

BACKGROUND: The National Board of Osteopathic Medical Examiners administers the COMLEX-USA Level 2-PE, an assessment of clinical skills of osteopathic medical students. This evaluation includes developing a patient care plan. PURPOSE: Based on one simulated case, we investigated the appropriateness and cost of care and quantified their relationship to performance. METHODS: Four hundred sixty-seven postencounter notes were coded for appropriateness using expert physician judgments and for cost of care using Centers for Medicare and Medicaid Services data. Various outcome measures were correlated with physician scores. RESULTS: In this case, candidates recommended an average of 5.6 interventions with an average cost of $227 and appropriateness rating of 2.4 on a 1 (indicated) to 4 (potentially dangerous) scale. Total cost and inappropriateness of actions were negatively correlated with candidate scores (r = -.208, p < .0001 and r = -.318, p < .0001, respectively). CONCLUSIONS: Results from this investigation provide some evidence to support the validity of physician note ratings of patient care plans and demonstrate the need to include these principles in medical education.

Longitudinal assessment of a diabetes care management system in an integrated health network.

OBJECTIVE: To describe the results of longitudinal assessment of the results of a disease management process developed in a large integrated health care system that successfully improved care for patients with diabetes. Outcome measures included rates of testing of hemoglobin A1c (HbA1c) and low-density lipoprotein (LDL), rate of annual eye exams, and LDL and HbA1c values. METHODS: Intermountain Health Care (IHC) initiated the development of a Diabetes Care Management System (DCMS) in early 1998. The DCMS was developed as a comprehensive population-based disease management system. It includes provider education programs; performance feedback to physicians; clinical quality performance incentives for physicians; patient education programs; patient incentive, reminder systems to encourage compliance with best care process models; and tracking of physician behavior change and patient compliance with diabetes therapy. A multifaceted intervention and education approach was chosen because of the complexity of the diabetes treatment process. RESULTS: The percentage of patients with at least one annual HbA1c test increased from 78.5% in 1998 to 90.5% in 2002. During the same time period, the percentage of patients whose most recent HbA1c was less than 7.0 increased from 33.5% to 52.8%, average HbA1c decreased from 8.1 to 7.3, and the percentage of patients whose most recent HbA1c was greater than 9.5 decreased from 34.6% to 21.4%. The percentage of patients who had an LDL cholesterol screening test within the prior 2 years increased from 65.9% in 1998 to 91.7% in 2002. During the same time period, the percentage of patients whose most recent LDL cholesterol was less than 130 mg/dL increased from 39.9% to 69.8%. The percentage of diabetes patients who had an annual eye exam increased from 52% in 1998 to 62% in 2002. CONCLUSION: A multifaceted approach to improving diabetes management has led to improved performance in clinical measures related to diabetes care that have been shown to reduce the risk of patients with diabetes developing diabetes- related complications. All components of the diabetes management continuum of care, including primary care physicians, specialists, office staff, patients, diabetes educators, and others, were involved in the care improvement activities.

Examination of resource use and clinical interventions associated with chronic kidney disease in a managed care population.

BACKGROUND: The management of chronic kidney disease (CKD) is multifaceted, including monitoring, early diagnosis, and treatment of comorbidities such as diabetes, hypoalbuminemia, and anemia, and initiating timely procedures in preparation for dialysis such as vascular access placement. Presumably, optimal care provided to patients during the predialysis phase will produce a significant impact on morbidity and mortality outcomes. OBJECTIVE: A retrospective analysis was conducted to assess specific factors that may be associated with optimal quality of care for CKD patients during the predialysis phase. METHODS: Health care resource utilization and the occurrence of interventions associated with optimal predialysis care were evaluated with claims data. Predialysis erythropoietin (EPO) therapy, nephrology referrals, and nutritional supplement administration were all examined during the 12 months prior to dialysis. RESULTS: Medical and pharmacy claims from a managed care database were analyzed for 1,936 incident dialysis patients. Of these, 48.7% did not have any interventions associated with optimal care. Only a minority of patients received prescription iron preparations (6.8%), vitamin D (4.0%), and phosphate binders (7.7%). A total of 20.8% patients had a vascular access placement, and 29.8% were in the care of a nephrologist during this same time period. Only 10.5% received predialysis EPO, yet more than 40% were diagnosed with anemia. Of the EPO users, however, 72.4% were also receiving other interventions to appropriately manage CKD. CONCLUSION: These claims-documented results suggest that the lack of EPO use in predialysis patients in a managed care plan may predict overall suboptimal treatment of these patients. There is an apparent need for the proactive management of CKD in a managed care plan to potentially redistribute or reduce health care resource utilization while improving patient outcomes.

[Psychosocial medicine--a vision needed in medical education and patient care]. / Psychosoziale Medizin--eine notwendige Vision in der medizinischen Ausbildung und Versorgung.

Psychosocial medicine represents the psychosocial aspects in a holistic patient-orientated medicine. It is of great importance in medical education as well as in clinical in- and out-patient treatment. For the near future, further strengthening is necessary in order to prevent the psychosocial aspects from disappearing in medicine. The efficacy and effectiveness of psychosocial therapies need to be further improved.