Reimbursement System Research Articles

Cost-utility analysis of Dexcom G6 real-time continuous glucose monitoring versus FreeStyle Libre 1 intermittently scanned continuous glucose monitoring in adults with type 1 diabetes in Belgium.

The aim of this study was to assess the long-term cost-effectiveness of Dexcom G6 real-time continuous glucose monitoring (rtCGM) with alert functionality compared with FreeStyle Libre1 intermittently scanned continuous glucose monitoring (isCGM) without alerts in adults with type 1 diabetes in Belgium. The IQVIA CORE Diabetes Model was used to estimate cost-effectiveness. Input data for the simulated baseline cohort were sourced from the randomised ALERTT1 trial (ClinicalTrials.gov. NCT03772600). The age of the participants was 42.9 ± 14.1 years (mean ± SD), and the baseline HbA1c was 57.8 ± 9.5 mmol/mol (7.4 ± 0.9%). Participants using rtCGM showed a reduction in HbA1c of 3.6 mmol/mol (0.36 percentage points) based on the 6-month mean between-group difference. In the base case, both rtCGM and isCGM were priced at €3.92/day (excluding value-added tax [VAT]) according to the Belgian reimbursement system. The analysis was performed from a Belgian healthcare payer perspective over a lifetime time horizon. Health outcomes were expressed as quality-adjusted life years. Probabilistic and one-way sensitivity analyses were used to account for parameter uncertainty. In the base case, rtCGM dominated isCGM, resulting in lower diabetes-related complication costs and better health outcomes. The associated main drivers favouring rtCGM were lower HbA1c, fewer severe hypoglycaemic events and reduced fear of hypoglycaemia. The results were robust under a wide range of one-way sensitivity analyses. In models where the price of rtCGM is €5.11/day (a price increase of 30.4%) or €12.34/day (a price increase of 214.8%), rtCGM was cost-neutral or reached an incremental cost-effectiveness ratio of €40,000 per quality-adjusted life year, respectively. When priced similarly, Dexcom G6 rtCGM with alert functionality has both economic and clinical benefits compared with FreeStyle Libre1 isCGM without alerts in adults with type 1 diabetes in Belgium, and appears to be a cost-effective glucose monitoring modality. Trial registration ClinicalTrials.gov NCT03772600.

Assessment of Patient Referrals with Large Numbers of Non-pedunculated Colorectal Lesions

Background: Large (≥20mm) non-pedunculated colorectal lesions are frequently referred to specialty centers for endoscopic resection. These lesions are technically challenging to resectand associated with substantially greater risk than smaller lesions. Patients with such polypsoften have synchronous lesions. We sought to identify evidence for whether synchronouslesions were sometimes the true basis for referral of large non-pedunculated colorectal polypsfrom community endoscopists to a tertiary center.
 Methods: We utilized a prospectively collected database of 1356 consecutive referred patients to an expert colonoscopist at our tertiary center between August 2019 and May 2023. We identified patients with ≥30 precancerous lesions resected from the colorectum during their first two colonoscopies at our center. Patients in the database with the same gender, within 3 yearsof age, and with the same location (proximal vs. distal colon) of the index large lesion referred for resection were identified as controls. Groups were compared for the size of index lesion, number of polyps resected by both centers, and size of polyps resected.
 Results: Among 1356 patients, 49 (3.6%) had ≥30 precancerous lesions resected at our center. Compared to controls, the index lesion was smaller in patients with ≥30 lesions (mean 28.9mmvs 23.3mm). Among patients with ≥30 synchronous polyps, the referring physician resected 10.6% of all synchronous lesions, compared to 47.8% in the control group (p<0.0001). Inpatients with ≥30 lesions, 84% of all synchronous lesions were <10mm, 15% were 10-19mm, and only 1% were >20mm.
 Conclusion: Our results suggest a subset of patients with large non-pedunculated colorectal precancerous lesions referred to tertiary centers are referred because of the number of lesions present, rather than technical challenges associated with resection of individual lesions. The rationale for these referrals is uncertain. It may lie in the reimbursement system, which only compensates physicians for the first polypectomy.

Leveraging Digital Workflows to Transition the Orthotics and Prosthetics Profession Toward a Client-Centric and Values-Based Care Model.

The orthotics and prosthetics (O&P) profession has a history of responding to market demands in a reactive rather than proactive manner. This has created significant impacts including shrinkage in scope of practice and constraint in remuneration for professional services due to a fee-for-device third party payer system. Rapid changes in technology and healthcare combined with an outdated device-centric reimbursement system are creating unprecedented challenges that threaten sustainability of the O&P profession. Hence, a reassessment of the value of O&P care, and the O&P workflow process is necessary to inform an update to the value proposition and practice model for sustainability. This article reviews key factors contributing to the current state of O&P, and potential solutions involving an update in practitioner competencies, and the care delivery model (from device-centric to client-centric and values-based). Updates could be achieved by leveraging the use of digital workflows that increase efficiencies and enhance the value of clinical outcomes. Eventually, these updates could enable the O&P profession to elevate the value proposition that aligns with its most important stakeholders: client-patients and third-party reimbursement agencies in a rapidly changing technology and healthcare landscape.

Epidemiology and patterns of empiric antimicrobial therapy practice in patients with community-onset sepsis using data from a Japanese nationwide medical claims database—the Japan Sepsis Alliance (JaSA) study group

ObjectivesWe aimed to describe empiric antimicrobial options for patients with community-onset sepsis using nationwide real-world data from Japan. MethodsThis retrospective cohort study used nationwide Japanese data from a medical reimbursement system database. Patients aged ≥20 years with both presumed infections and acute organ dysfunction who were admitted to hospitals from the outpatient department or emergency department between 2010 and 2017 were enrolled. We described the initial choices of antimicrobials for patients with sepsis stratified by intensive care unit (ICU) or ward. ResultsThere were 1,195,741 patients with community-onset sepsis; of these, 1,068,719 and 127,022 patients were admitted to the wards and ICU, respectively. Third-generation cephalosporins and carbapenem were most commonly used for patients with community-onset sepsis. We found that 1.7% and 6.0% of patients initially used antimicrobials for methicillin-resistant Staphylococcus aureus coverage in the wards and ICU, respectively. Although half of the patients initially used antipseudomonal agents, only a few patients used a combination of antipseudomonal agents. Moreover, few patients initially used a combination of antimicrobials to treat methicillin-resistant Staphylococcus aureus and Pseudomonas sp. ConclusionThird-generation cephalosporins and carbapenem were most frequently used for patients with sepsis. A combination therapy of antimicrobials for drug-resistant bacteria coverage was rarely provided to these patients.

Matters We Metric Vs. Metrics that Matter.

Geriatric fracture is a pressing global health issue, marked by elevated mortality and morbidity rates and escalating health care costs. The evolving health care system from fee-for-service to quality-based reimbursement has led to externally driven reward and reimbursement systems that may not account for the complexity of caring for older adults with fracture. The aim of this review is to highlight the need for a shift towards meaningful metrics that impact geriatric fracture care and to issue a call to action for all medical societies to advocate for national reimbursement and ranking systems that focus on metrics that truly matter. Traditional metrics, while easier to capture, may not necessarily represent high quality care and may even have unintentional adverse consequences. For example, the focus on reducing length of stay may lead to older patients being discharged too early, without adequately addressing pain, constipation, or delirium. In addition, a focus on mortality may miss the opportunity to deliver compassionate end-of-life care. Existing geriatric fracture care metrics have expanded beyond traditional metrics to include assessment by geriatricians, fracture prevention, and delirium assessments. However, there is a need to further consider and develop patient-focused metrics. The Age-Friendly Health Initiative (4Ms), which includes Mobility, Medication, Mentation, and what Matters is an evidence-based framework for assessing and acting on critical issues in the care of older adults. Additional metrics that should be considered include an assessment of nutrition and secondary fracture prevention. In the realm of geriatric fracture care, the metrics currently employed often revolve around adherence to established guidelines and are heavily influenced by financial considerations. It is crucial to shift the paradigm towards metrics that truly matter for geriatric fracture patients, recognizing the multifaceted nature of their care and the profound impact these fractures have on their lives.

The public health insurance funds as drivers for integrated care

The public health insurance funds are a unique player in the healthcare landscape. Belgium has seven public health insurance funds that operate the reimbursement system of health care services covered by the compulsory health insurance for their members and the payment of a replacement income in case of long-term illness. Public health insurance funds are present throughout the lifespan of their members, from birth to death, they are companion and point of contact for crucial moments in life at all ages.They play a key role in the rollout and implementation of key aspects of integrated care. 
 Not only are they responsible for the health care reimbursement, they are the guardians of the health insurance finance as well as the administrator. They are in control of the recognition and follow up of patients in incapacity for work and guide those patient in return to work and rehabilitation and reintegration. They have lots of experience in finance mechanisms and regulation within health care. 
 Next to their responsibilities in reimbursement, there’s also an important social service. The social workers are there to familiarize people with care, the organization of home care and to facilitate all preconditions to make this possible, but also to determine the severity of care and to open up as many social benefits as possible for those who are entitled to it. The public health insurance funds also generate data which they can use to evaluate the health system, provide for scientific research but also use to enhance population management and to weigh on decision- or policy makers. 
 After a short, interactive part, we will explore these different roles and demonstrate how they contribute to integrated care. Not only from the perspective of the public health care insurance institutions, but also from the perspective of collaboration amongst formal care givers surrounding one patient and from the perspective of several informal care givers. By using various testimonials, we let informal care givers share their experience and needs about integrated care.
 Despite the long history, many actors in Belgium are insufficiently aware of what exactly these different roles are. It is the task of the public health insurance funds to continue to fully focus on this and to participate in initiatives that can realize integrated care. Therefore, at least one good practice will be discussed from one of the 12 integrated care pilot projects in which the funds, together with the other care actors and the government, are looking for innovative actions to make integrated care possible.

CPAP resumption after a first termination and impact on all-cause mortality in France.

Continuation of continuous positive airway pressure (CPAP) therapy after initial prescription has been shown to reduce all-cause mortality versus therapy termination. However, there is a lack of data on the rates and impact of resuming CPAP in patients with obstructive sleep apnoea (OSA). This analysis determined the prevalence of CPAP resumption in the year after termination, characterised determinants of CPAP resumption, and examined the impact of CPAP resumption on all-cause mortality. French national health insurance reimbursement system data for adults aged ≥18 years were used. CPAP prescription was identified by specific treatment codes. Patients who resumed CPAP after first therapy termination and continued to use CPAP for 1 year were matched with those who resumed CPAP then terminated therapy for a second time. Out of 103 091 individuals with a first CPAP termination, 26% resumed CPAP over the next 12 months, and 65% of these were still using CPAP 1 year later. Significant predictors of CPAP continuation after resumption included male sex, hypertension and CPAP prescription by a pulmonologist. In the matched population, the risk of all-cause death was 38% lower in individuals who continued using CPAP after therapy resumption versus those who had a second therapy discontinuation (hazard ratio 0.62, 95% CI 0.48-0.79; p=0.0001). These data suggest that individuals with OSA who fail initial therapy with CPAP should be offered a second trial with the device to ensure that effective therapy is not withheld from those who might benefit.

An Optional Delinked Reward System: Making Pharmaceutical Innovation Work for Everyone.

Conflicts over pharmaceutical pricing are driven by the patients' need for affordable medicines and the producer's reward for the investments in developing innovative medicines. A single price cannot achieve both goals, as it will either obstruct access by patients or provide too low a return to investors. This has led to calls to "delink" the payment for innovation from the price paid for drugs, so that both goals can be met efficiently and without conflict. However, the details of how best to do that are unclear. This paper proposes a specific implementation for delinking the Optional Delinked Reward System (ODRS), which integrates ideas from numerous pharmaceutical reimbursement systems. The ODRS would allow firms to choose either to negotiate a sales price for a drug (as is the current practice in most countries) or to sell their drug at a low "generic" price with a supplementary "delinked" reward based on assessed health benefit. This model builds on recent innovations in drug reimbursement including the UK's Antibiotic Subscription Pilot and the Pneumococcal Vaccine Advanced Market Commitment. The ODRS would ensure affordable and immediate access for patients and a fair reward for innovators.

Review of Teledermatology: Lessons Learned from the COVID-19 Pandemic.

Utilization of telemedicine for dermatology has greatly expanded since the start of the COVID-19 pandemic, with over 500 new teledermatology studies published since 2020. An updated review on teledermatology is necessary to incorporate new findings and perspectives, and educate dermatologists on effective utilization. We discuss teledermatology in terms of diagnostic accuracy and clinical outcomes, patient and physician satisfaction, considerations for special patient populations, published practice guidelines, cost effectiveness and efficiency, as well as administrative regulations and policies. Our findings emphasize the need for dermatologist education, prioritization of reliable reimbursement systems, and technological innovations to support the continued development of teledermatology in the post-pandemic era.

OP148 Influence Of The Hospital-Based Health Technology Assessment Unit On New Technologies Transfer At The National Level In Kazakhstan

IntroductionThe hospital-based Health Technology Assessment (HB-HTA) Unit in the Hospital of the President’s Affairs Administration has been operating since 2015 and is the first example of the implementation of the HB-HTA system in Kazakhstani hospitals. In addition to assessing the feasibility of implementing new health technologies (HTs) into the hospital’s practice, the Unit also interacts with the National Regulatory Authority (NRA) to transfer new technologies into the National Reimbursement System (NRS). We report on the transformation of the HB-HTA Unit from a stand-alone entity to an integrated, specialized agency.MethodsData were drawn from reports of the HB-HTA Unit and internal NRA documents. Inclusion of new HTs into the NRS consists of the following sequential stages: (i) implementing the technology in at least one hospital; (ii) filing an application with the Ministry of Health Care (MoH) in the field of HTA to resolve the issue of reimbursement at the national level; (iii) in case of a positive decision, approval at the national level of the clinical protocol for using the medical intervention; (iv) agreement on the reimbursement price of the technology.ResultsBased on positive recommendations from the HB-HTA report in 2015, the hospital implemented 19 new nuclear medicine technologies. In 2016, the hospital initiated an application to the MoH to include these technologies in the NRS (previously, these technologies were carried out only for a fee or with private insurance). From 2016 to 2020, a positive decision from the MoH was received, protocols for medical interventions were published at the national level, and cost estimates were formulated. In 2021, 19 new medical services in nuclear imaging and scintigraphy were included in the NRS.ConclusionsDespite the long and bureaucratic process of including new HTs in the NRS, the HB-HTA Unit managed to speed up this process. One of the main priorities of the integrated HB-HTA Unit is to promote the transfer of HTs into the health system at the national level.

OP82 Positron Emission Tomography Combined With Computed Tomography Using 18F-Sodium Fluoride

IntroductionPositron emission tomography combined with computed tomography (PET/CT) using 18F-sodium fluoride (18F-NaF) is used for functional imaging in diseases to detect abnormally altered osteogenic activity, such as benign and malignant bone diseases and inflammatory or traumatic changes in skeletal bones.MethodsA systematic search of literature using keywords in the MEDLINE database was conducted to identify literature on the clinical and cost effectiveness of using PET/CT with 18F-NaF-based radiopharmaceuticals in the diagnosis of bone and cartilage cancer. The search retrieved 323 publications. The analysis included 11 publications that met the selection criteria, including one meta-analysis and ten literature reviews.ResultsThe pooled sensitivity, specificity, diagnostic odds ratio (DOR) and area under the receiver operating characteristic curve of 18F-NaF-based PET/CT for the detection of bone metastases were 0.98 (95% confidence interval [CI]: 0.95, 0.99), 0.90 (95% CI: 0.86, 0.93), 123.2, and 0.97, respectively. 18F-NaF-based PET/CT was highly effective in detecting bone metastases during staging and restaging of patients with high-risk prostate cancer. The effectiveness of 18F-NaF-based PET/CT was superior to bone scintigraphy with technetium-99m and single-photon emission computed tomography (SPECT) and was comparable to diffusion-weighted imaging.ConclusionsPET/CT with 18F-NaF is a more accurate method of localizing and characterizing malignant bone lesions than SPECT. This method has improved clinical accuracy and provides greater convenience for patients and referring physicians. PET/CT with 18F-NaF in malignant neoplasms is a more specific, sensitive study than 18F-fluorodeoxyglucose PET/CT. These results were submitted to the Ministry of Health for a decision on the inclusion of 18F-NaF-based PET/CT in the state reimbursement system.

An organization-wide analysis of laboratory test cost variables and costs as displayed in the electronic health record: first steps

Abstract Displaying the cost of laboratory tests and medications in the electronic health record (EHR) at the time of order may influence ordering practices. Our organization’s EHR was configured to display a semi-quantitative value adjacent to laboratory orders: “$” tests imply relatively little cost and “$$$$” tests imply resource intensive tests. Cost display is associated with charges from hospital or clinic fee schedules by default but can also be configured to reflect direct laboratory costs. To understand our system’s configuration and potentially improve the information being provided to our clinicians upon ordering, all the test ordering data was compiled and analyzed for all individual “orderable” tests within the year of 2021 (Jan 1st 2021 – Dec 31st 2021). Variables analyzed included frequency of test ordering, average test turnaround time, and each of the various possible measures of “cost”: direct costs based on labor and reagents/supplies (when available), reimbursement from the Clinical Laboratory Fee Schedule, and pricing from the fee schedule of the largest hospital in our organization (chargemaster). Results showed an extensive rightward skew in each of the “cost” variables, with most routine tests, like the complete blood count (CBC) or complete metabolic panel (CMP), falling in the lower price range and a number of outlier tests with much higher costs (newer forms of molecular testing). There was minimal linearity in correlations between the various price variables. Correlation between chargemaster price by quintile and actual dollar signs displayed in the EHR showed that the two often disagree. No definitive discernable logic was thus identified for the number of dollar signs shown in the EHR based on the possible “cost” variables analyzed here. Between the lab’s best estimate for direct costs and chargemaster pricing, a rough correlation with slope greater than 1 was identified, suggesting that chargemaster pricing is systematically higher than the cost of running each test. Between the cost of running each test and reimbursement via the Clinical Laboratory Fee Schedule, a rough correlation with slope less than 1 was identified, suggesting that lab costs are systematically higher than reimbursement. The current lack of strong correlations between these various “cost” variables is helpful as a first step in examining how to improve our organization’s EHR system, assessing our laboratory’s cost effectiveness, and discussing potential future considerations for hospital chargemaster pricing as well as the US system of reimbursement. Further work is needed to clarify the relationship between cost displays in EHR and physician ordering practices.

The barriers to interprofessional care for cancer cachexia among Japanese healthcare providers: A nationwide survey.

Cancer cachexia is a severe complication of advanced malignancy, with few therapeutic options. To promote interprofessional care for cancer cachexia, healthcare providers' needs should be addressed in detail. This pre-planned subgroup analysis of the Global Educational Needs Evaluation: a systemic interprofessional study in cancer cachexia (GENESIS-CC) survey aimed to identify barriers to interprofessional care of cancer cachexia in Japan. A nationwide survey was electronically conducted for healthcare providers in oncological or general healthcare facilities from January to March 2021 in Japan. The Japanese Regional Advisory Board developed a barrier scoring system with 33 from the 58 original survey items to quantify six domains of barriers: (1) lack of confidence, (2) lack of knowledge, (3) barriers in personal practice, (4) barriers in perception, (5) barriers in team practice and (6) barriers in education. The largest possible barrier score was set at 100 points. We compared the scores by profession. A total of 1227 valid responses were obtained from 302 (24.6%) physicians, 252 (20.5%) pharmacists, 236 (19.2%) nurses, 218 (17.8%) dietitians, 193 (15.7%) rehabilitation therapists and 26 (2.0%) other professionals. Overall, 460 (37.5%) were not very or at all confident about cancer cachexia care, 791 (84.1%) agreed or strongly agreed that care was influenced by reimbursement availability and 774 (81.9%) did not have cancer cachexia as a mandatory curriculum. The largest mean barrier score (±standard deviation) was 63.7±31.3 for education, followed by 55.6±21.8 for team practice, 43.7±32.5 for knowledge, 42.8±17.7 for perception and 36.5±16.7 for personal practice. There were statistically significant interprofessional differences in all domains (P<0.05), especially for pharmacists and nurses with the highest or second highest scores in most domains. There is a need to improve the educational system and team practices of cancer cachexia for most Japanese healthcare providers, especially pharmacists and nurses. Our study suggests the need to reform the mandatory educational curriculum and reimbursement system on cancer cachexia to promote interprofessional care for cancer cachexia in Japan.

Rotational Atherectomy, Orbital Atherectomy, and Intravascular Lithotripsy Comparison for Calcified Coronary Lesions.

In order to improve the percutaneous treatment of coronary artery calcifications (CAC) before stent implantation, methods such as rotational atherectomy (RA), orbital atherectomy (OA), and coronary intravascular lithotripsy (IVL) were invented. These techniques use different mechanisms of action and therefore have various short- and long-term outcomes. IVL employs sonic waves to modify CAC, whereas RA and OA use a rapidly rotating burr or crown. These methods have specific advantages and limitations, regarding their cost-efficiency, the movement of the device, their usefulness given the individual anatomy of both the lesion and the vessel, and the risk of specified complications. This study reviews the key findings of peer-reviewed articles available on Google Scholar with the keywords RA, OA, and IVL. Based on the collected data, successful stent delivery was assessed as 97.7% for OA, 92.4% for IVL, and 92.5% for RA, and 30-day prevalence of MACE (Major Adverse Cardiac Events) in OA-10.4%, IVL-7.2%, and RA-5%. There were no significant differences in the 1-year MACE. Compared to RA, OA and IVL are cost-effective approaches, but this is substantially dependent on the reimbursement system of the particular country. There is no standard method of CAC modification; therefore, a tailor-made approach is required.

A digital health solution for long-term cardiac monitoring supporting a value-based stroke care path

Abstract Introduction Long-term continuous cardiac monitoring in high-risk populations increases the chances of detecting atrial fibrillation and related arrhythmias[1]. In-hospital ECG monitoring is usually too brief to detect cardiac risk factors, while the availability and usability of ambulatory ECG is often lacking. Digital health tools are an attractive option for user-friendly, accurate, scalable mid-to-long-term cardiac risk monitoring[2]. These tools can also act as a driver to organize personalized care around the patient but that requires innovation in the reimbursement system. Recently Belgium established the mHealthBelgium validation pyramid[3], a 3-stage framework for reimbursement of digital health tools. Methods We used our remote monitoring platform to build a digital health solution for cardiac monitoring that provides direct diagnostic value and supports the care path for patients with cryptogenic stroke or transient ischemic attack. Our CE-certified solution has a cardiac chest patch to record ECG and motion data and a docking station at the patient’s home to securely send data to the cloud where data analytics is done. Our annotation flow detects atrial fibrillation and other stroke-relevant risk factors, reducing data burden for healthcare providers (HCP). HCPs interact with the raw and annotated data through a dashboard that generates reports and integrates with medical record systems. On-demand logistics allows hospitals to monitor as many patients as needed without delay and a pay-per-use model allows flexible monitoring periods and obviates the need for up-front device purchase. Results Since January 2022, more than 529 patients have been monitored with a median recording duration of 14 days±12 days. Approximately 205,500 hours of continuous ECG data was collected and 13421 potential risk factors were annotated, including 7227 potential atrial events (fibrillation or flutter) in 374 patients (&amp;gt;70%). In 45% of cases (n = 242), one or more events were confirmed by HCPs as clinically relevant. Our solution has progressed through the first two stages of the mHealth system by demonstrating CE-certification and interoperability with the government eHealth platform. For the final stage (M3), we have submitted one of the first dossiers in Belgium for improving the stroke care path with a more fit-for-purpose technology and coupling reimbursement to this specific use case instead of fee-for-service coding. Our proposal includes a real-world outcome data study. Conclusion We validate the importance and utility of remote monitoring of cardiac risk factors within the stroke care path. Retrospective results show that in 45% of cases, clinically relevant events were detected indicating that meaningful remote patient data is compatible with HCP workflows. The solution is progressing through a new care path-based reimbursement system that serves as a model for organizing value-based care around the patient's needs.Care path with remote patient monitoringReduced time to diagnosis with RPM

A concept for multi-winner tenders for medicinal products with balancing between efficient prices, long-term competition and sustainability of supply.

Achieving price efficiency via tenders, the sustainability of competition, and the prevention of shortages are hot topics in the debates about shaping the pharmaceutical markets. Single-winner tenders receive growing criticism for concentrating on achieving low prices at the expense of the long-term maintenance of a competitive pharmaceutical industry, the security of continuous supply, and disregarding the therapeutic needs of patient populations with specific conditions. This paper aims at drafting a concept to assist the design of multi-winner tenders for medicinal products with a focus on supply and sales guarantees, price efficiency, and equity in access. The concept shall be generally applicable to all kinds of medicinal products including generics, biosimilars, and on-patent products in the out- and in-patient sector. Principles for multi-winner tenders for medicinal products are set and a number of delimitations are made in order to get rid of factors that prevent clairvoyance amid the various pricing and reimbursement systems when designing a concept. The steps to plan and implement a multi-winner tendering procedure are drafted on the basis of the defined principles. The tender should consist of planning, bidding, preparation, sales, and evaluation phases. Pharmaceutical companies shall make bids with price and quantity pairs, which shall be ranked by prices and if applicable then taking into account other factors. The tenderer shall predefine market shares to the various places of the ranking. A double ceiling shall be applicable for the sales of the winners: their sales must not exceed their quantity offer and the predefined market share applicable to their place in the ranking. The implementation of the concept will require the careful adjustment of the tender conditions to the specificities of the pharmaceutical market concerned on the one hand and to the local pricing and reimbursement system on the other hand.

Oral health care intervention protocol for older adults at home in dental hygienists: a narrative literature review

Objectives: This study aims to propose a standard protocol for oral health care intervention activities by dental hygienists. Methods: A narrative literature review of home visit oral health care intervention activities reported in Cheonan, South Korea was conducted to enable the proposal of a standard home visit protocol for dental hygienists in the context of community care. Results: Oral health management intervention activities contributed to improving the quality of life, as well as the oral health, of older adults living at home. This was a result of applying a protocol consisting of oral observation, oral massage, expert oral hygiene management, oral muscle function training, and final stages. Conclusions: The visiting oral health intervention protocol was effective in resolving oral health problems of older adults. In the future, customized programs and reimbursement systems should be developed to promote oral health care for older adults that can be provided at home.

Vosoritide Therapy in Children with Achondroplasia: Early Experience and Practical Considerations for Clinical Practice.

Vosoritide is the first precision medical therapy approved to increase growth velocity in children with achondroplasia. Sharing early prescribing experiences across different regions could provide a framework for developing practical guidance for the real-world use of vosoritide. Two meetings were held to gather insight and early experience from experts in Europe, the Middle East, and the USA. The group comprised geneticists, pediatric endocrinologists, pediatricians, and orthopedic surgeons. Current practices and considerations for vosoritide were discussed, including administration practicalities, assessments, and how to manage expectations. A crucial step in the management of achondroplasia is to determine if adequate multidisciplinary support is in place. Training for families is essential, including practical information on administration of vosoritide, and how to recognize and manage injection-site reactions. Advocated techniques include establishing a routine, empowering patients by allowing them to choose injection sites, and managing pain. Patients may discontinue vosoritide if they cannot tolerate daily injections or are invited to participate in a clinical trial. Clinicians in Europe and the Middle East emphasized the importance of assessing adherence to daily injections, as non-adherence may impact response and reimbursement. Protocols for monitoring patients receiving vosoritide may be influenced by regional differences in reimbursement and healthcare systems. Core assessments may include pubertal staging, anthropometry, radiography to confirm open physes, the review of adverse events, and discussion of concomitant or new medications-but timing of these assessments may also differ regionally and vary across institutions. Patients and families should be informed that response to vosoritide can vary in both magnitude and timing. Keeping families informed regarding vosoritide clinical trial data is encouraged. The early real-world experience with vosoritide is generally positive. Sharing these insights is important to increase understanding of the practicalities of treatment with vosoritide in the clinical setting.

Shoulder replacement surgery’s rising demand, inequality of provision, and variation in outcomes: cohort study using Hospital Episode Statistics for England

BackgroundThe aim of this study was to forecast future patient demand for shoulder replacement surgery in England and investigate any geographic and socioeconomic inequalities in service provision and patient outcomes.MethodsFor this cohort study, all elective shoulder replacements carried out by NHS hospitals and NHS-funded care in England from 1999 to 2020 were identified using Hospital Episode Statistics data. Eligible patients were aged 18 years and older. Shoulder replacements for malignancy or acute trauma were excluded. Population estimates and projections were obtained from the Office for National Statistics. Standardised incidence rates and the risks of serious adverse events (SAEs) and revision surgery were calculated and stratified by geographical region, socioeconomic deprivation, sex, and age band. Hospital costs for each admission were calculated using Healthcare Resource Group codes and NHS Reference Costs based on the National Reimbursement System. Projected rates and hospital costs were predicted until the year 2050 for two scenarios of future growth.ResultsA total of 77,613 elective primary and 5847 revision shoulder replacements were available for analysis. Between 1999 and 2020, the standardised incidence of primary shoulder replacements in England quadrupled from 2.6 to 10.4 per 100,000 population, increasing predominantly in patients aged over 65 years. As many as 1 in 6 patients needed to travel to a different region for their surgery indicating inequality of service provision. A temporal increase in SAEs was observed: the 30-day risk increased from 1.3 to 4.8% and the 90-day risk increased from 2.4 to 6.0%. Patients from the more deprived socioeconomic groups appeared to have a higher risk of SAEs and revision surgery. Shoulder replacements are forecast to increase by up to 234% by 2050 in England, reaching 20,912 procedures per year with an associated annual cost to hospitals of £235 million.ConclusionsThis study reports a rising incidence of shoulder replacements, regional disparities in service provision, and an overall increasing risk of SAEs, especially in more deprived socioeconomic groups. These findings highlight the need for better healthcare planning to match local population demand, while more research is needed to understand and prevent the increase observed in SAEs.

Necessity for a System Implementing Therapeutic Drug Monitoring in Outpatient Settings Based on the Actual Use of Voriconazole Using the National Database of Health Insurance Claims and Specific Health Checkups of Japan: A Descriptive Epidemiological Study.

Voriconazole (VRCZ) is an antifungal drug that necessitates therapeutic monitoring (TDM). Typically, TDM is recommended for patients undergoing long-term outpatient treatment. However, in Japan, insurance reimbursement for TDM is only permitted for inpatients. There is a concern that VRCZ use is growing among outpatients, although information regarding this issue remains unavailable. Therefore, we aimed to clarify the use of VRCZ by utilizing data from the National Database of Health Insurance Claims and Specific Health Checkups in Japan. The use of branded and generic oral VRCZ from 2013 to 2019 was calculated using the defined daily doses/1000 inhabitants/d (DID) for each receipt type. Oral VRCZ was used more frequently in the outpatient setting than that in the inpatient setting, with use increasing over time. The use of generic drugs began in 2016 and accounted for 52.5% of the use in 2019 among outpatients. Considering outpatient prescriptions, 76.4-81.0% were dispensed at insurance pharmacies, indicating the need for community pharmacist involvement. Accordingly, the appropriate use of VRCZ in ambulatory care should be promoted in collaboration with community pharmacists, and a reimbursement system should be established to implement TDM in ambulatory care.