Addressing cancer care inequities in sub-Saharan Africa: current challenges and proposed solutions.

INTRODUCTION: Cancer is a significant public health challenge globally, with nearly 2000 lives lost daily in Africa alone. Without adequate measures, mortality rates are likely to increase. The major challenge for cancer care in Africa is equity and prioritization, as cancer is not receiving adequate attention from policy-makers and strategic stakeholders in the healthcare space. This neglect is affecting the three primary tiers of cancer care: prevention, diagnosis, and treatment/management. To promote cancer care equity, addressing issues of equity and prioritization is crucial to ensure that everyone has an equal chance at cancer prevention, early detection, and appropriate care and follow-up treatment. METHODOLOGY: Using available literature, we provide an overview of the current state of cancer care in Africa and recommendations to close the gap. RESULTS: We highlight several factors that contribute to cancer care inequity in Africa, including inadequate funding for cancer research, poor cancer education or awareness, inadequate screening or diagnostic facilities, lack of a well-organized and effective cancer registry system and access to care, shortage of specialized medical staff, high costs for screening, vaccination, and treatment, lack of technical capacity, poor vaccination response, and/or late presentation of patients for cancer screening. We also provide recommendations to address some of these obstacles to achieving cancer care equity. Our recommendations are divided into national-level initiatives and capacity-based initiatives, including cancer health promotion and awareness by healthcare professionals during every hospital visit, encouraging screening and vaccine uptake, ensuring operational regional and national cancer registries, improving healthcare budgeting for staff, equipment, and facilities, building expertise through specialty training, funding for cancer research, providing insurance coverage for cancer care, and implementing mobile health technology for telemedicine diagnosis. CONCLUSION: Addressing challenges to cancer equity holistically would improve the likelihood of longer survival for cancer patients, lower the risk factors for groups that are already at risk, and ensure equitable access to cancer care on the continent. This study identifies the existing stance that African nations have on equity in cancer care, outlines the current constraints, and provides suggestions that could make the biggest difference in attaining equity in cancer care.

Primary care services in the English NHS: are they a thorn in the side of integrated care systems? A qualitative analysis.

BACKGROUND: As integrated care systems are embedded across England there are regions where the integration process has been evaluated and continues to evolve. Evaluation of these integrated systems contributes to our understanding of the challenges and facilitators to this ongoing process. This can support integrated care systems nationwide as they continue to develop. We describe how two integrated care partnerships in different localities, at differing stages of integration with contrasting approaches experienced challenges specifically when integrating with primary care services. The aim of this analysis was to focus on primary care services and how their existing structures impacted on the development of integrated care systems. METHODS: We carried out an exploratory approach to re-analysing our previously conducted 51 interviews as part of our prior evaluations of integrated health and care services which included primary care services. The interview data were thematically analysed, focussing on the role and engagement of primary care services with the integrated care systems in these two localities. RESULTS: Four key themes from the data are discussed: (i) Workforce engagement (engagement with integration), (ii) Organisational communication (information sharing), (iii) Financial issues, (iv) Managerial information systems (data sharing, IT systems and quality improvement data). We report on the challenges of ensuring the workforce feel engaged and informed. Communication is a factor in workforce relationships and trust which impacts on the success of integrated working. Financial issues highlight the conflict between budget decisions made by the integrated care systems when primary care services are set up as individual businesses. The incompatibility of information technology systems hinders integration of care systems with primary care. CONCLUSIONS: Integrated care systems are national policy. Their alignment with primary care services, long considered to be the cornerstone of the NHS, is more crucial than ever. The two localities we evaluated as integration developed both described different challenges and facilitators between primary care and integrated care systems. Differences between the two localities allow us to explore where progress has been made and why.

Assessing the cost-effectiveness of integrated case management of Neglected Tropical Diseases in Liberia.

BACKGROUND: In 2017, Liberia became one of the first countries in the African region to develop and implement a national strategy for integrated case management of Neglected Tropical Diseases (CM-NTDs), specifically Buruli ulcer, leprosy, lymphatic filariasis morbidities, and yaws. Implementing this plan moves the NTD program from many countries' fragmented (vertical) disease management. This study explores to what extent an integrated approach offers a cost-effective investment for national health systems. METHODS: This study is a mixed-method economic evaluation that explores the cost-effectiveness of the integrated CM-NTDs approach compared to the fragmented (vertical) disease management. Primary data were collected from two integrated intervention counties and two non-intervention counties to determine the relative cost-effectiveness of the integrated program model vs. fragmented (vertical) care. Data was sourced from the NTDs program annual budgets and financial reports for integrated CM-NTDs and Mass Drug Administration (MDA) to determine cost drivers and effectiveness. RESULTS: The total cost incurred by the integrated CM-NTD approach from 2017 to 2019 was US$ 789,856.30, with the highest percentage of costs for program staffing and motivation (41.8%), followed by operating costs (24.8%). In the two counties implementing fragmented (vertical) disease management, approximately US$ 325,000 was spent on the diagnosis of 84 persons and the treatment of twenty-four persons suffering from NTDs. While 2.5 times as much was spent in integrated counties, 9-10 times more patients were diagnosed and treated. CONCLUSIONS: The cost of a patient being diagnosed under the fragmented (vertical) implementation is five times higher than integrated CM-NTDs, and providing treatment is ten times as costly. Findings indicate that the integrated CM-NTDs strategy has achieved its primary objective of improved access to NTD services. The success of implementing an integrated CM-NTDs approach in Liberia, presented in this paper, demonstrates that NTD integration is a cost-minimizing solution.

Budget impact of prophylactic treatment of rVIII-SingleChain in moderate and severe hemophilia A in Italy.

INTRODUCTION: rVIII-SingleChain, a recombinant factor VIII (rFVIII), has demonstrated safety and efficacy in patients with hemophilia A in clinical trials and real-world evidence. This analysis aimed to estimate the potential budget impact of increasing the usage of rVIII-SingleChain for the prophylactic treatment of hemophilia A over 3 years in Italy. METHODS: Patients with moderate and severe hemophilia A receiving prophylaxis were included in the analysis. Epidemiological data were obtained from published literature. Mean product consumption and mean annual bleeding rate for rVIII-SingleChain, rFVIIIFc, octocog alfa and BAY 81-8973 were based on pooled real-world data from Italy, Germany and US. A budget impact model has been developed in order to compare two scenarios: a base-case scenario where current rVIII-SingleChain shares are kept constant over 3 years and an alternative scenario where rVIII-SingleChain shares increase by taking from other rFVIII products. Analysis 1 was based on the current Italian list prices and Analysis 2 considered current regional acquisition prices for both scenarios. RESULTS: Annually, adult patients treated with rVIII-SingleChain prophylaxis are expected to consume 324,589 units per patient, resulting in annual costs of €240,196 per patient. In Analysis 1, comparing the base case (constant market share of 9% rVIII-SingleChain over time) with the alternative scenario (higher rVIII-SingleChain market share and increasing from 15% in the first year to 25% in the third year), the total expenditure for prophylaxis using rFVIII products is expected to decrease by €1.4 million in Year 1, by €3.1 million in Year 2 and by €5.4 million in Year 3. In Analysis 2 based on regional prices, the results remained consistent. DISCUSSION/CONCLUSION: This analysis suggests that increasing utilization of rVIII-SingleChain in hemophilia A patients may lead to cost savings as a result of reduced consumption with uncompromised efficacy in bleed protection.

Why was the study done? Hemophilia A is a rare inherited bleeding disorder. People with severe hemophilia are more likely to bleed compared to people without hemophilia and bleeds can occur spontaneously or in response to trauma. Patients are treated with medication to reduce the chance of bleeding. However, the cost of treating patients with hemophilia can be high and place demands on the healthcare system.What did we do and find?This study looked at the cost of treating people with hemophilia in Italy and used a type of economic analysis (called budget impact modelling) to estimate the effect of increasing the use of a particular medication (rVIII-SingleChain), compared to other medications that are available. Different variations of the model were tested to compare a range of scenarios.The results of this analysis suggested that increasing the use of rVIII-SingleChain may lead to cost-savings for the Italian healthcare system, compared to using the other currently available treatments. This analysis suggests that the use of rVIII-SingleChain enables people with hemophilia A to remain protected from bleeds, whilst using less product compared to other available medications.What is the influence of this study on the wider field?This type of analysis can be useful to healthcare systems, to guide the decision-making process regarding which medications to use or when making decisions related to healthcare policy.

[Implementing a Global Treatment Budget for Psychiatric Hospital Services - What are Incentives, Requirements, and Challenges?] / Implementierung eines globalen Behandlungsbudgets in der Psychiatrie ­ Welche Anreize, Voraussetzungen und Herausforderungen gibt es?

OBJECTIVE: Since 2013, flexible and integrative psychiatric treatment models (FIT64b) have been set up in 22 German hospitals. FIT64b is based on a global treatment budget (GTB) covering costs for all psychiatric hospital services and is related to the number of patients treated. As part of the "PsychCare"-study we are examining incentives, requirements and challenges which relate to the introduction of FIT64b. METHODS: Expert interviews and focus groups (n = 29) were led with management and controlling staff from 7 FIT64b adopting hospitals and 3 statutory health insurance funds (SHI). A thematic analysis was conducted. RESULTS: A central component for the introduction of a GTB is a cooperative relation based on mutual trust between hospitals and SHI. Challenging are, above all, performance documentation and performance control of cross-sectoral treatment as well as the parallel structure of FIT64b and standard care. CONCLUSION: Apart from several surmountable obstacles to implementation, the GTB seems to be a strong driver for the future-oriented transformation of psychiatric hospital services in Germany. In the further development of GTB, the obligation to contract with all SHI should be considered.

The Impact of Global Budgeting on the Efficiency of Healthcare under a Single-Payer System in Taiwan.

Since 1995, a national health insurance (NHI) program has been in operation in Taiwan, which provides uniform comprehensive coverage. Forced by severe financial deficit, global budgeting reimbursement was adopted in the healthcare sector to control healthcare expenditures in 2002. A two-stage data envelopment analysis (DEA) approach was used to measure the efficiency of hospital resource allocation among stakeholders in Taiwan's NHI system, and to further explore the changes in resource allocation after the introduction of a global budgeting payment scheme. The dataset was collected from the annual statistical reports of Taiwan's Ministry of Health and Welfare (MOHW) and was used to estimate the efficiency of resource allocation in hospital-based healthcare services under global budgeting. In terms of efficiency during the period from 2003 to 2009, one-third of decision-making units (DMUs) improved their productivity in stage I, and seven out of the total of eighteen DMUs saw falls in financial efficiency in stage II. After global budgeting was implemented, there were significant positive impacts on the efficiency of hospital resource allocation in Taiwan. The two-stage DEA model for analyzing the effects of the global budgeting reimbursement system on productivity and financial efficiency represents a key decision-making tool for hospital administrators and policymakers.

A device category economic model of electrosurgery technologies across procedure types: a U.S. hospital budget impact analysis.

AIMS: The electrosurgical technology category is used widely, with a diverse spectrum of devices designed for different surgical needs. Historically, hospitals are supplied with electrosurgical devices from several manufacturers, and those devices are often evaluated separately; it may be more efficient to evaluate the category holistically. This study assessed the health economic impact of adopting an electrosurgical device-category from a single manufacturer. METHODS: A budget impact model was developed from a U.S. hospital perspective. The uptake of electrosurgical devices from EES (Ethicon Electrosurgery), including ultrasonic, advanced bipolar, smoke evacuators, and reusable dispersive electrodes were compared with similar MED (Medical Energy Devices) from multiple manufacturers. It was assumed that an average hospital performed 10,000 annual procedures 80% of which involved electrosurgery. Current utilization assumed 100% MED use, including advanced energy, conventional smoke mitigation options (e.g. ventilation, masks), and single-use disposable dispersive electrode devices. Future utilization assumed 100% EES use, including advanced energy devices, smoke evacuators (i.e. 80% uptake), and reusable dispersive electrodes. Surgical specialties included colorectal, bariatric, gynecology, thoracic and general surgery. Systematic reviews, network meta-analyses, and meta-regressions informed operating room (OR) time, hospital stay, and transfusion model inputs. Costs were assigned to model parameters, and price parity was assumed for advanced energy devices. The costs of disposables for dispersive electrodes and smoke-evacuators were included. RESULTS: The base-case analysis, which assessed the adoption of EES instead of MED for an average U.S. hospital predicted an annual savings of $824,760 ($101 per procedure). Savings were attributable to associated reductions with EES in OR time, days of hospital stay, and volume of disposable electrodes. Sensitivity analyses were consistent with these base-case findings. CONCLUSIONS: Category-wide adoption of electrosurgical devices from a single manufacturer demonstrated economic advantages compared with disaggregated product uptake. Future research should focus on informing comparisons of innovative electrosurgical devices.

Eligibility for Low-Dose Rivaroxaban Based on the COMPASS Trial: Insights from the Veterans Affairs Healthcare System.

INTRODUCTION: Low-dose rivaroxaban reduced major adverse cardiac and limb events among patients with stable atherosclerotic vascular disease (ASCVD) in the COMPASS trial. The objective of our study was to evaluate the eligibility and budgetary impact of the COMPASS trial in a real-world population. METHODS: The VA administrative and clinical databases were utilized to conduct a cross-sectional study to identify patients eligible for low-dose rivaroxaban receiving care at all 141 facilities between October 1, 2014 and September 30, 2015. Proportion of patients with stable ASCVD eligible for low-dose rivaroxaban and prevalence of multiple risk enrichment criteria among eligible patients. Pharmaceutical budgetary impact using VA pharmacy pricing. Chi-squared and Student's t tests were used to compare patients eligible versus ineligible patients. RESULTS: From an initial cohort of 1,248,214 patients with ASCVD, 488,495 patients (39.1%) met trial eligibility criteria. Eligible patients were older (74.2 vs 64.5 years) with higher proportion of hypertension (84.1% vs 82.1%) and diabetes (46.2% vs 32.9) compared with ineligible patients (p < 0.001 for all comparisons). A median of 38.7% (IQR 4.6%) of total ASCVD patients per facility were rivaroxaban eligible. Estimated annual VA pharmacy budgetary impact would range from $0.47 billion to $1.88 billion for 25% to 100% treatment penetration. Annual facility level pharmaceutical budgetary impact would be a median of $12.3 million (IQR $8.0-$16.3 million) for treatment of all eligible patients. Among eligible patients, age greater than 65 years was the most common risk enrichment factor (86.9%). Prevalence of eligible patients with multiple enrichment factors varied from 34.2% (one factor) to 6.2% (four or more). CONCLUSION: Over one third of patients with stable ASCVD may qualify for low-dose rivaroxaban within the VA. Additional studies are needed to understand eligibility in other populations and a formal cost-effectiveness analysis is warranted.

The Budget Impact of Including Rucaparib on a US Payer Formulary for the Treatment of Patients with Metastatic Ovarian Cancer.

OBJECTIVE: A budget impact model was constructed to assess the incremental budget impact that rucaparib availability would have on a US health plan. METHODS: An incremental budget impact was estimated over a 3-year horizon as the difference in total annual cost of treatment, with and without rucaparib available, for second-line maintenance, third-line treatment, and the combined maintenance and treatment settings. The hypothetical health plan includes one million covered lives, and commercial and Medicare lines of business. Alternative products included in the model were based on the National Comprehensive Cancer Network guidelines. The eligible patient population was estimated using an incidence-based approach. Modeled costs include drug acquisition, intravenous drug administration, required laboratory testing, and medical management of adverse events. RESULTS: In the maintenance setting, average total expenditures over 3 years were estimated to be US$1,465,043 with rucaparib versus US$1,461,350 without it as a treatment option; the average incremental budget impact was US$3693 (US$0.0003 per member per month [PMPM]). In the treatment setting, average total expenditures were estimated to be US$1,320,718 with rucaparib versus US$1,313,736 without it; the average incremental budget impact was US$6982 (US$0.0006 PMPM). Budget impact is smaller in commercial plans than Medicare because of the higher incidence of ovarian cancer in the over-65 population. CONCLUSION: The budget impact of adding rucaparib to the formulary for a health plan adds negligible PMPM costs of < US$0.001 in all tested settings and scenarios due to the small population eligible for therapy.

Budget impact analysis of darolutamide for treatment of nonmetastatic castration-resistant prostate cancer.

BACKGROUND: Darolutamide, a structurally distinct androgen receptor inhibitor approved for the treatment of men with nonmetastatic castration-resistant prostate cancer (nmCRPC), has been shown to increase metastasis-free survival among men with nmCRPC compared with placebo. This treatment has a novel chemical structure that may also have safety, tolerability, and efficacy advantages for men with nmCRPC. OBJECTIVE: To estimate the projected budget impact of including darolutamide on a U.S. payer formulary as a treatment option for men with nmCRPC. METHODS: A budget impact model was developed to evaluate darolutamide for nmCRPC for a hypothetical 1-million-member plan over a 5-year period. Costs (drug acquisition, drug administration, and treatment-related adverse events [AEs]) were estimated for 2 scenarios: with and without darolutamide treatment for nmCRPC. The budget impact of darolutamide was calculated as the difference in costs for these 2 scenarios. An analysis for high-risk nmCRPC also was conducted. The model included treatments recommended by the National Comprehensive Cancer Network (e.g., apalutamide and enzalutamide) and potential comparators that are used but are not specifically indicated for nmCRPC. All treatments were assumed to be administered in combination with a weighted average androgen deprivation therapy comparator (consisting of luteinizing hormone-releasing hormone [LHRH] agonists, LHRH antagonists, and first-generation antiandrogens). Market share estimates were derived from interviews with physicians treating men with nmCRPC. The model includes grade 3-4 AEs, and the rates were obtained from clinical trial data. Costs were taken from publicly available sources and varied in a one-way sensitivity analysis. RESULTS: For a plan with 1 million lives, there were approximately 90 incident cases of nmCRPC (46 high risk) each year, with 332 (109 high risk) treatment-eligible cases by year 5. Darolutamide's market share increased from 3.6% in year 1 to 18% in year 5. Given the utilization of other agents, introducing darolutamide along with other targeted therapies was predicted to increase the total budget by $158,640 ($0.0132 per member per month [PMPM]) in year 1, which decreased over time to a cost savings of $149,240 ($0.0124 PMPM) by year 5. The scenario with darolutamide showed reduced AE costs each year. Similar results were observed for the high-risk nmCRPC population. CONCLUSIONS: Adding darolutamide to a U.S. payer formulary for the treatment of nmCRPC can result in a manageable increase in the budget that is partly offset by AE costs in the first 4 years, followed by a cost savings by year 5. DISCLOSURES: This study was conducted by RTI Health Solutions under the direction of Bayer U.S. and was funded by Bayer U.S., which was involved in the design of the study; collection, analysis, and interpretation of the data; writing of the report; and the decision to submit the report for publication. Miles and Purser (and/or their institutions) are employees of RTI Health Solutions and received research funding from Bayer U.S. to develop the budget impact model. Appukkuttan and Farej are employees of Bayer U.S. Wen was an employee of Bayer U.S. at the time of the study. This study was presented as a poster at the AMCP Virtual Learning Event, April 20-24, 2020.

Financial Implications of Avapritinib for Treatment of Unresectable Gastrointestinal Stromal Tumors in Patients With a PDGFRA Exon 18 Variant or After 3 Previous Therapies in a Hypothetical US Health Plan.

Importance: With the approval of avapritinib for adults with unresectable or metastatic gastrointestinal stromal tumors (GISTs) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 variant, including PDGFRA D842V variants, and National Comprehensive Cancer Network guideline recommendations as an option for patients with GIST after third-line treatment, it is important to estimate the potential financial implications of avapritinib on a payer's budget. Objective: To estimate the budget impact associated with the introduction of avapritinib to a formulary for metastatic or unresectable GISTs in patients with a PDGFRA exon 18 variant or after 3 or more previous treatments from the perspective of a US health plan. Design, Setting, and Participants: For this economic evaluation, a 3-year budget impact model was developed in March 2020, incorporating costs for drug acquisition, testing, monitoring, adverse events, and postprogression treatment. The model assumed that avapritinib introduction would be associated with increased PDGFRA testing rates from the current 49% to 69%. The health plan population was assumed to be mixed 69% commercial, 22% Medicare, and 9% Medicaid. Base case assumptions included a GIST incidence rate of 9.6 diagnoses per million people, a metastatic PDGFRA exon 18 mutation rate of 1.9%, and progression rate from first-line to fourth-line treatment of 17%. Exposures: The model compared scenarios with and without avapritinib in a formulary. Main Outcomes and Measures: Annual, total, and per member per month (PMPM) budget impact. Results: In a hypothetical 1-million member plan, fewer than 0.1 new patients with a PDGFRA exon 18 variant per year and 1.2 patients receiving fourth-line therapy per year were eligible for treatment. With avapritinib available, the total increase in costs in year 3 for all eligible adult patients with a PDGFRA exon 18 variant was $46 875, or $0.004 PMPM. For patients undergoing fourth-line treatment, the total increase in costs in year 3 was $69 182, or $0.006 PMPM. The combined total budget impact in year 3 was $115 604, or $0.010 PMPM, including an offset of $3607 in postprogression costs avoided or delayed. The higher rates of molecular testing resulted in a minimal incremental testing cost of $453 in year 3. Conclusions and Relevance: These results suggest that adoption of avapritinib as a treatment option would have a minimal budget impact to a hypothetical US health plan. This would be primarily attributable to the small eligible patient population and cost offsets from reduced or delayed postprogression costs.

Hospital care pathway of women treated for Bartholin's gland abscess and budget impact analysis of outpatient management: A national hospital database analysis.

INTRODUCTION: Bartholin's gland abscesses cause severe pain and are a source of frequent emergency room visits. The most widespread treatment in France is incision-drainage during hospitalisation. A Word catheter, whose efficiency and safety would be identical, could be used without the need for hospitalisation, thus reducing the costs of Bartholin's gland abscess management. DESIGN: Retrospective cohort study. SETTING: French hospital (PMSI) database 2016-2017. POPULATION: 3539 women with Bartholin's gland abscess. METHOD: From the PMSI database, we identified the population that was treated for incision-drainage of a Bartholin's gland abscess in 2016. We also looked for secondary hospitalisations occurring within 12 months of initial treatment of Bartholin's gland abscess using 2016 and 2017 PMSI database data. MAIN OUTCOME(S): The identified population was described in terms of age, hospitalisation, length of stay and readmissions within 12 months and provided a 5-year budget impact analysis of the use of the Word catheter in France from a National Health Insurance perspective. RESULTS: In 2016, 3539 women (36 +/- 11.8 years) were hospitalised for 3646 incisions of the major vestibular gland linked to a Bartholin's gland abscess. 11.38 % (403/3,539) underwent at least one new Bartholin's gland procedure during the following year. The use of the Word catheter would allow potential savings over 5 years of €7.4 million. CONCLUSION: The use of the Word catheter could be cost-saving. These results must be validated by a clinical research step evaluating efficiency in the French context, comparing the Word catheter and incision-drainage side-by-side.

A welfare-theoretic model consistent with the practice of cost-effectiveness analysis and its implications.

I look at three debates in the health economics literature in the context of cost-effectiveness analysis (CEA): 1) inclusion of future costs, 2) discounting, and 3) consistency with a welfare-economic perspective. These debates thus far have been studied in isolation leading to confusion and lingering questions. I look at these three debates holistically and present a welfare theoretic model that is consistent with the practice of CEA and can help inform all of these three debates. It shows rationales for the recommendations of the Second Panel and clarifies some nuanced implications for the practice of CEA when taking a societal perspective in the context of distributional CEA and multi-sectorial budgets.

Budget Impact of Dabrafenib and Trametinib in Combination as Adjuvant Treatment of BRAF V600E/K Mutation-Positive Melanoma from a U.S. Commercial Payer Perspective.

BACKGROUND: Before the approval of dabrafenib and trametinib in combination, there were no approved therapies in the adjuvant setting that target the RAS/RAF/MEK/ERK pathway. OBJECTIVE: To evaluate the budget impact of dabrafenib and trametinib in combination for adjuvant treatment of patients with BRAF V600 mutation-positive resected Stage IIIA, IIIB, or IIIC melanoma from a U.S. commercial payer perspective using data from the COMBI-AD trial, as well as other sources. METHODS: The budget impact of dabrafenib and trametinib in combination for patients with BRAF V600E/K mutation-positive, resected Stage IIIA, IIIB, or IIIC melanoma was evaluated from the perspective of a hypothetical population of 1 million members with demographic characteristics consistent with those of a commercially insured U.S. insurance plan (i.e., adults aged less than 65 years) using an economic model developed in Microsoft Excel. The model compared melanoma-related health care costs over a 3-year projection period under 2 scenarios: (1) a reference scenario in which dabrafenib and trametinib are assumed to be unavailable for adjuvant therapy and (2) a new scenario in which the combination is assumed to be available. Treatments potentially displaced by dabrafenib and trametinib were assumed to include observation, high-dose interferon alpha-2b, ipilimumab, and nivolumab. Costs considered in the model include those of adjuvant therapies and treatment of locoregional and distant recurrences. The numbers of patients eligible for treatment with dabrafenib and trametinib were based on data from cancer registries, published sources, and assumptions. Treatment mixes under the reference and new scenarios were based on market research data, clinical expert opinion, and assumptions. Probabilities of recurrence and death were based on data from the COMBI-AD trial and an indirect treatment comparison. Medication costs were based on wholesale acquisition cost prices. Costs of distant recurrence were from a health insurance claims study. RESULTS: In a hypothetical population of 1 million commercially insured members, 48 patients were estimated to become eligible for treatment with dabrafenib and trametinib in combination over the 3-year projection period; in the new scenario, 10 patients were projected to receive such treatment. Cumulative costs of melanoma-related care were estimated to be $6.3 million in the reference scenario and $6.9 million in the new scenario. The budget impact of dabrafenib and trametinib in combination was an increase of $549 thousand overall and 1.5 cents per member per month. CONCLUSIONS: For a hypothetical U.S. commercial health plan of 1 million members, the budget impact of dabrafenib and trametinib in combination as adjuvant treatment for melanoma is likely to be relatively modest and within the range of published estimates for oncology therapies. These results may assist payers in making coverage decisions regarding the use of adjuvant dabrafenib and trametinib in melanoma. DISCLOSURES: Funding for this research was provided to Policy Analysis Inc. (PAI) by Novartis Pharmaceuticals. Stellato, Moynahan, and Delea are employed by PAI. Ndife, Koruth, Mishra, and Gunda are employed by Novartis. Ghate was employed by Novartis at the time of this study and is shareholder in Novartis, Provectus Biopharmaceuticals, and Mannkind Corporation. Gerbasi was employed by PAI at the time of this study and is currently an employee, and stockholder, of Sage Therapeutics. Delea reports grant funding from Merck and research funding from Amgen, Novartis, Sanofi, Seattle Genetics, Takeda, Jazz, EMD Serono, and 21st Century Oncology, unrelated to this work.

[Budget impact analysis of viscosupplementation for non-surgical treatment of knee osteoarthritis]. / Análise do impacto orçamentário da viscossuplementação no tratamento não cirúrgico da osteoartrite de joelho.

Knee osteoarthritis affects 3.8% of the world population and manifests as pain, edema, stiffness, and reduced joint function, impacting the patient's quality of life. Treatment consists of the pharmacological, non-pharmacological, and surgical modalities. Viscosupplementation (intraarticular hyaluronate) has been proposed to relieve symptoms and potentially postpone surgery. This study estimated the budget impact of the association of this drug and non-surgical treatment (standard treatment) from the perspective of the Brazilian Unified National Health System. Based on the assumption that 5% of patients proceed to treatment and on the direct costs of the pharmacological and non-pharmacological modalities, the authors calculated the reference and alternative scenarios that compared the different treatment options in a three-year timeline. The principal analysis estimated an incremental budget impact of approximately BRL 126 million (U$ 32 million) for one vial of hyaluronate a year and BRL 252 million (USD 64 million) for two vials a year. Diacerein, an oral chondroprotector, assessed as an alternative, showed a budget impact of BRL 334 million (USD 86 million) in relation to standard treatment, representing a 24% cost increase compared to two vials a year of hyaluronate, making it less economically advantageous. Viscosupplementation can provide better quality of life for patients, reduce costs for the health system, and optimize the flow of care in health services. The estimates presented in this study can assist administrators in the best use of resources and thus in decision-making on the technology's incorporation.

A osteoartrite de joelho afeta cerca de 3,8% da população mundial e se manifesta por dor, edema, rigidez e redução da função articular, impactando na qualidade de vida do paciente. O tratamento consiste na modalidade farmacológica, não farmacológica e cirúrgica. A viscossuplementação (ácido hialurônico intra-articular) se propõe a oferecer alívio dos sintomas e a possibilidade de adiamento da cirurgia. Este estudo estimou o impacto orçamentário entre a associação desse medicamento e o tratamento não cirúrgico (tratamento padrão), sob a perspectiva do Sistema Único de Saúde. Com base no pressuposto de que 5% dos portadores da doença seguem para tratamento e nos custos diretos das modalidades: farmacológica e não farmacológica foram calculados os cenários de referência e alternativos que compararam as diferentes opções de tratamento para um horizonte temporal de três anos. A análise principal estimou um impacto orçamentário incremental de aproximadamente R$ 126 milhões (1 ampola anual) e R$ 252 milhões (2 ampolas anuais). Já a diacereína, um condroprotetor oral, avaliada como uma opção alternativa, mostrou um impacto de R$ 334 milhões no orçamento em relação ao tratamento padrão, o que proporciona um aumento de 24% no custo em relação ao uso de 2 ampolas anuais de ácido hialurônico, tornando-a economicamente menos vantajosa. A viscossuplementação pode proporcionar maior qualidade de vida ao paciente, redução de custos para o sistema e otimização do fluxo de atendimento nas unidades de saúde. As estimativas apresentadas neste estudo podem auxiliar o gestor quanto à melhor utilização dos recursos financeiros e consequente tomada de decisão quanto à incorporação da tecnologia.

La osteoartritis de rodilla afecta a cerca de un 3,8% de la población mundial y se manifiesta por dolor, edema, rigidez y reducción de la función articular, impactando en la calidad de vida del paciente. El tratamiento consiste en la modalidad farmacológica, no farmacológica y quirúrgica. La viscosuplementación (ácido hialurónico intraarticular) se propone ofrecer un alivio de los síntomas y la posibilidad de un aplazamiento de la cirugía. Este estudio estimó el impacto presupuestario entre la asociación de este medicamento y el tratamiento no quirúrgico (tratamiento estándar), desde la perspectiva del Sistema Único de Salud. Basándonos en el supuesto de que un 5% de los portadores de la enfermedad siguen el tratamiento y en los costos directos de las modalidades tanto farmacológica, como no farmacológica, se calcularon los escenarios de referencia y alternativos que compararon las diferentes opciones de tratamiento para un horizonte temporal de tres años. El análisis principal estimó un impacto presupuestario incremental de aproximadamente BRL 126 millones (1 ampolla anual) y BRL 252 millones (2 ampollas anuales). En el caso de la diacereína, un condroprotector oral, evaluado como una opción alternativa, mostró un impacto de BRL 334 millones en el presupuesto, respecto al tratamiento estándar, lo que proporciona un aumento de un 24% en el costo, en relación con el uso de 2 ampollas anuales de ácido hialurónico, haciéndola económicamente menos ventajosa. La viscosuplementación puede proporcionar mayor calidad de vida al paciente, reducción de costes para el sistema y la optimización del flujo de atención en las unidades de salud. Las estimaciones presentadas en este estudio pueden ayudar al gestor en lo referente a una mejor utilización de los recursos financieros y, consecuentemente, en la toma de decisiones respecto a la incorporación de tecnología.

Modeling the Health and Budgetary Impacts of a Team-based Hypertension Care Intervention That Includes Pharmacists.

OBJECTIVE: The objective of this study was to assess the potential health and budgetary impacts of implementing a pharmacist-involved team-based hypertension management model in the United States. RESEARCH DESIGN: In 2017, we evaluated a pharmacist-involved team-based care intervention among 3 targeted groups using a microsimulation model designed to estimate cardiovascular event incidence and associated health care spending in a cross-section of individuals representative of the US population: implementing it among patients with: (1) newly diagnosed hypertension; (2) persistently (≥1 year) uncontrolled blood pressure (BP); or (3) treated, yet persistently uncontrolled BP-and report outcomes over 5 and 20 years. We describe the spending thresholds for each intervention strategy to achieve budget neutrality in 5 years from a payer's perspective. RESULTS: Offering this intervention could prevent 22.9-36.8 million person-years of uncontrolled BP and 77,200-230,900 heart attacks and strokes in 5 years (83.8-174.8 million and 393,200-922,900 in 20 years, respectively). Health and economic benefits strongly favored groups 2 and 3. Assuming an intervention cost of $525 per enrollee, the intervention generates 5-year budgetary cost-savings only for Medicare among groups 2 and 3. To achieve budget neutrality in 5 years across all groups, intervention costs per person need to be around $35 for Medicaid, $180 for private insurance, and $335 for Medicare enrollees. CONCLUSIONS: Adopting a pharmacist-involved team-based hypertension model could substantially improve BP control and cardiovascular outcomes in the United States. Net cost-savings among groups 2 and 3 make a compelling case for Medicare, but favorable economics may also be possible for private insurers, particularly if innovations could moderately lower the cost of delivering an effective intervention.

As Value Assessment Frameworks Evolve, Are They Finally Ready for Prime Time?

BACKGROUND: Value assessment frameworks have emerged as tools to assist healthcare decision makers in the United States in assessing the relative value of healthcare services and treatments. As more healthcare decision makers in the United States-including state government agencies, pharmacy benefit managers, employers, and health plans-publicly consider the adoption of value frameworks, it is increasingly important to critically evaluate their ability to accurately measure value and reliably inform decision making. OBJECTIVE: To examine the evolution of the value assessment landscape in the past two years, including new entrants and updated frameworks, and assess if these changes successfully advance the field of value assessment. METHODS: We analyzed the progress of the three currently active value assessment frameworks developed by the Institute for Clinical and Economic Review, the Innovation and Value Initiative, and the National Comprehensive Cancer Network, against six key areas of concern. RESULTS: Value assessment frameworks are moving closer to meeting the challenge of accurately measuring value and reliably informing healthcare decisions. Each of the six concerns has been addressed in some way by at least one framework. CONCLUSIONS: Although value assessments are potential inputs that can be considered for healthcare decision making, none of them should be the sole input for these decisions. Considering the limitations, they should, at most, be only one of many tools in the toolbox.

Target therapy versus dacarbazine in first-line treatment of advanced non-surgical and metastatic melanoma: budget impact analysis from the perspective of the Brazilian National Health System, 2018-2020. / Terapia-alvo versus dacarbazina no tratamento de primeira linha do melanoma avançado não cirúrgico e metastático: análise de impacto orçamentário na perspectiva do Sistema Único de Saúde, 2018-2020.

OBJECTIVE: to estimate the incremental budget impact of target therapy for first-line treatment of advanced non-surgical and metastatic melanoma compared to dacarbazine treatment. METHODS: budget impact analysis, from the Brazilian National Health System (SUS) perspective; based on demographic data and incidence estimates, the population over a three-year time horizon (2018-2020) was delimited and the direct medical costs were estimated; the reference scenario was treatment with dacarbazine, and the alternative scenarios were target therapy with vemurafenib, dabrafenib, vemurafenib + cobimetinib and dabrafenib + trametinib; uncertainty assessment was conducted through scenario analysis. RESULTS: the incremental budget impact ranged from R$ 451,867,881.00 to R$ 768,860,968.00, representing 0.70 to 1.53% of total SUS annual outpatient drugs expenditure; in best and worst scenario, results ranged from R$ 289,160,835.00 to R$ 1,107,081,926.00. CONCLUSION: the use of target therapy compared to dacarbazine implies an excessive impact on the budget, this bring unfovorable to its possible incorporation.

Effect of an Integrated Payment System on the Direct Economic Burden and Readmission of Rural Cerebral Infarction Inpatients: Evidence from Anhui, China.

Rural China is piloting an integrated payment system, which prepays a budget to a medical alliance rather than a single hospital. This study aims to evaluate the effect of this reform on the direct economic burden and readmission rates of cerebral infarction inpatients. The settlement records of 78,494 cerebral infarction inpatients were obtained from the New Rural Cooperative Medical Scheme (NRCMS) database in Dingyuan and Funan Counties in the Anhui Province. The direct economic burden was estimated by total costs, out-of-pocket expenditures, the out-of-pocket ratio, and the compensation ratio of the NRCMS. Generalized additive models and multivariable linear/logistic regression were applied to measure the changes of the dependent variables along with the year. Within the county, the total costs positively correlated to the year (ß = 313.10 in 2015; 163.06 in 2016). The out-of-pocket expenditures, out-of-pocket ratios, and the length-of-stay positively correlated to the year in 2015 (ß = 105.10, 0.01, and 0.18 respectively), and negatively correlated to the year in 2016 (ß = -58.40, -0.03, and -0.30, respectively). The odds ratios of the readmission rates were less than one within the county (0.70 in 2015; 0.53 in 2016). The integrated payment system in the Anhui Province has considerably reduced the direct economic burden for the rural cerebral infarction inpatients, and the readmission rate has decreased within the county. Inpatients' health outcomes should be given further attention, and the long-term effect of this reform model awaits further evaluation.