Cost-savings and potential cost-savings through the distribution of generic antiretroviral drugs within the statutory health insurance market of Germany between January 2017 and June 2019

Background Recent patent losses for antiretroviral drugs (ARV) have led to the debate of cost-saving through the replacement of patented drugs with generic drugs. The split of recommended single-tablet regimens (STR) into their single substance partners is one of the considerations mentioned in said debate. Particularly, generic tenofovir disoproxil/emtricitabine (TDF/FTC) is expected to hold untapped cost-saving potential, which may curb increasing overall expenditures for combined antiretroviral therapy (cART) within the statutory health insurance (SHI) of Germany. Methods Data of ARV reimbursed by the SHI were used to describe the trends of defined daily doses (DDD) as well as the revenue within the German ARV market. They were also used to determine the cost-savings of moving to generic drugs. The time period observed was between January 2017 and June 2019. The potential cost-savings were determined with following assumption in mind: the maximum possible use of generic ARV, including 1) the split of STR and replacing all substance partners with generic ones, and 2) replacing patented tenofovir alafenamide/emtricitabine (TAF/FTC) with generic TDF/FTC. Results Throughout the observation period, the DDD of generic ARV increased nearly five-fold while their revenue increased more than four-fold. Total cost-saving showed a sharp increase over the same period, with generic TDF/FTC accounting for a share of around 70%. The largest potential cost-saving could have been achieved through replacing patented TAF/FTC with generic TDF/FTC, peaking at nearly 10% of total revenue, but showing decreasing trends in general. Conclusion The progressive distribution of generic ARV ensured increasing cost-savings, but consequently curbed the potential cost-savings. Unique price reductions of generic TDF/FTC have played a pivotal role for these effects. In any case, substituting with generic ARV should not fail to adhere to the treatment guidelines and continue to consider the medical requirements for the treatment.

Nursing home-sensitive conditions: analysis of routine health insurance data and modified Delphi analysis of potentially avoidable hospitalizations

Background: Hospitalizations of nursing home residents are associated with various health risks. Previous research indicates that, to some extent, hospitalizations of this vulnerable population may be inappropriate and even avoidable. This study aimed to develop a consensus list of hospital discharge diagnoses considered to be nursing home-sensitive, i.e., avoidable. Methods: The study combined analyses of routine data from six statutory health insurance companies in Germany and a two-stage Delphi panel, enhanced by expert workshop discussions, to identify and corroborate relevant diagnoses. Experts from four different disciplines estimated the proportion of hospitalizations that could potentially have been prevented under optimal conditions. Results: We analyzed frequencies and costs of data for hospital admissions from 242,236 nursing home residents provided by statutory health insurance companies. We identified 117 hospital discharge diagnoses, which had a frequency of at least 0.1%. We recruited experts (primary care physicians, hospital specialists, nursing home professionals and researchers) to estimate the proportion of potentially avoidable hospitalizations for the 117 diagnoses deemed avoidable in two Delphi rounds (n=107 in Delphi Round 1 and n=96 in Delphi Round 2, effective response rate=91%). A total of 35 diagnoses with high and consistent estimates of the proportion of potentially avoidable hospitalizations were identified as nursing home-sensitive. In an expert workshop (n=16), a further 25 diagnoses were discussed that had not reached the criteria, of which another 23 were consented to be nursing home-sensitive conditions. Extrapolating the frequency and mean costs of these 58 diagnoses to the national German context yielded total potentially avoidable care costs of €768,304,547, associated with 219,955 nursing home-sensitive hospital admissions. Conclusion: A total of 58 nursing home-relevant diagnoses (ICD-10-GM three-digit level) were classified as nursing home-sensitive using an adapted Delphi procedure. Interventions should be developed to avoid hospital admission from nursing homes for these diagnoses.

How is and how should healthcare for people with multiple sclerosis in Germany be designed?–The rationale and protocol for the mixed-methods study Multiple Sclerosis–Patient-Oriented Care in Lower Saxony (MS-PoV)

Background Multiple sclerosis (MS) is the most common autoimmune inflammatory disease of the central nervous system in Europe, often causing severe physical, cognitive and emotional impairments. Currently, it is unclear whether the healthcare provisions of people with MS (PwMS) are in line with the recommendations for treatment based on guidelines or patients’ needs. The main objectives of the study are as follows: (a) to investigate how well PwMS are treated; and (b) to develop a needs-oriented, patient-centred care model. Methods This mixed-methods study focuses on adult PwMS living in Lower Saxony, a federal state in Germany. The qualitative study comprises focus groups with PwMS, physicians and people involved in the healthcare process as well as a future workshop. The quantitative study comprises a cross-sectional online survey and addresses the patient-relevant outcomes and needs, as previously determined by literature searches and focus groups. It will be administered to all PwMS who are insured by the statutory health insurance company involved in the project (n~7,000). The survey data will be linked to the longitudinal secondary data from the statutory health insurance company and data from the German MS registry where available. The linked and single data sources will be statistically analysed. Discussion By comprehensively comparing the current healthcare provisions with the needs and requirements of PwMS, the strengths and weaknesses of the overall healthcare process and provision of assistive devices can be identified. The barriers and facilitators of the health service providers and their impact on daily life will be explored (qualitative analyses). Reliable recommendations for improvements will be given based on a study population drawn from the largest statutory health insurance company in Lower Saxony (quantitative analyses). However, the inherent advantages and limitations of the qualitative and quantitative research approaches need to be considered. Trial registration The study is registered at German Clinical Trials Register DRKS00021741.

Comparison of Survival Between Patients Receiving General Ambulatory Palliative Care and Patients Receiving Other Palliative Care - Analysis of Data of a Statutory Health Insurance Data

Background The care of palliative patients takes place as non-specialized and specialized care, in both ambulatory and stationary settings. However, palliative care is largely provided as non-specialized care in the ambulatory sector (AAPV). This study aimed to investigate whether the survival curves of AAPV patients differed from those of the more intensive palliative care modalities and whether AAPV palliative care was appropriate in terms of timing.Methods The study is based on claims data from a large statutory health insurance. The analysis included 4,177 patients who received palliative care starting in 2015 and who were fully insured one year before and one year after palliative care or until death. The probability of survival was observed for 12 months. Patients were classified into group A, which consisted of patients who received palliative care only with AAPV, and group B including patients who received stationary or specialized ambulatory palliative care. Group A was further divided into two subgroups. Patients who received AAPV on only 1 day were assigned to Subgroup A1, and patients who received AAPV on two or more days were assigned to Subgroup A2. The survival analysis was carried out using Kaplan-Meier curves. The median survival times were compared with the log-rank test.Results The survival curves differed between groups A and B, except in the first quartile of the survival distribution. The median survival was significantly longer in group A (137 days, n=2,763) than in group B (47 days, n=1,424, p<0.0001) and shorter in group A1 (35 days, n=986) than in group A2 (217 days, n=1,767, p<0.0001). The survival rate during the 12-month follow-up was higher in group A (42%) than in group B (11%) and lower in group A1 (38%) than in group A2 (44%).Conclusions The results of the analysis revealed that patients who received the first palliative care shortly before death suspected insufficient care, especially patients who received AAPV for only 1 day and no further palliative care until death or 12-month follow-up. Palliative care should start as early as necessary and be continuous until the end of life.

Regional utilisation of preventive services in old age – Study protocol of a mixed methods study (Preprint)

BACKGROUND In Germany the proportion of people with chronic diseases and multimorbidity is increasing. To counteract the emergence and worsening of age-related conditions there is a need for preventive care structures and measures. The preventive services that are financed by the statutory health insurance (SHI) (e.g. vaccinations, cancer screening) are only used by part of the German population. There are no current findings about the utilisation of these services by the elderly and older population in the eastern German federal state of Saxony-Anhalt, which is particularly strongly affected by demographic change. OBJECTIVE The aim of the present study is to investigate the determinants of, reasons for, and barriers to utilisation of preventive services financed by the SHI in Saxony-Anhalt in the 55 plus age group. METHODS In the study a mixed methods approach is used. The actual use of preventive services will be shown by means of a claims data analysis looking at data on statutory outpatient medical care from both the Central Research Institute of Ambulatory Health Care in Germany (Zi) and the Association of Statutory Health Insurance Dentists in Saxony-Anhalt (KZV LSA). The determinants, attitudes and behaviours associated with use will be analysed through a cross-sectional survey as well as qualitative data from semi-structured interviews with residents of Saxony-Anhalt and from focus group discussions with physicians. A stocktake and systematic evaluation of digitally available information material on colorectal cancer screening by way of example, provides an insight into the information available as well as its quality. To assess the quality of relevant information material a catalogue of criteria was developed. The conceptual framework of the study is Andersen’s behavioural model of health services use (last modified in 2014). RESULTS The Zi and KZV LSA are currently preparing the requested claims data. The survey was carried out from April to June 2021 in two urban and two rural municipalities (encompassing a small town and surrounding area) in Saxony-Anhalt. In total 3,665 people were contacted, with a response rate of 25.84% (n=954). For the semi-structured interviews 18 participants from the four different study regions were recruited in the same time period. The recruitment of physicians for the focus group discussions is currently ongoing. For the systematic evaluation of existing information material on colorectal cancer screening 37 different information materials were identified on the websites of a total of 16 healthcare actors. CONCLUSIONS The study will provide current and reliable data on the use of preventive services in the 55 plus age group in Saxony-Anhalt. It will yield insights into the determinants, reasons and barriers associated with their utilisation. The results will reveal the potential for preventive measures and enable concrete recommendations for action for the target population of the study. CLINICALTRIAL German Clinical Trials Register, DRKS00024059. Registration date 15/01/2021

COVID-19 Associated Contact Restrictions in Germany: Marked Decline in Children’s Outpatient Visits for Infectious Diseases without Increasing Visits for Mental Health Disorders

Children have a low risk for severe COVID-19 infections, but indirect consequences of the pandemic may affect their health. We evaluated nationwide data on children’s outpatient visits before and during the first wave of the COVID-19 pandemic in Germany. Data from the National Association of Statutory Health Insurance Physicians for all children with statutory health insurance and at least one physician’s office visit between January 2019 and June 2020 were evaluated for total visits and selected diagnoses for the 2nd quarter of 2019 (8.29 million children, controls) and the 2nd quarter of 2020 (8.5 million, pandemic). Outpatient visits per child fell by 18% during the first wave of the pandemic. Outpatient visits associated with diagnosed infections fell markedly by 51%, particularly for children up to age 5 years for gastroenteritis (73%), otitis media (71%), and streptococcal angina (78%). Outpatient visits for diagnosed chronic physical disorders (diabetes, celiac disease, and hay fever) and mental and behavioral disorders showed little change. Reduced contact between children appears to markedly reduce infection transmission. Infection risks in educational settings should be attenuated after the pandemic through targeted education and counseling and appropriate relationship prevention measures to improve quality of life and opportunities for children and to reduce stress and lost work time for parents.

Choosing a Specialist: An Explanatory Study of Factors Influencing Patients in Choosing a Urologist

<b><i>Objectives:</i></b> While research on doctor-patient interaction has often focused on the decision-making abilities of physicians, it rarely centers around the question of how patients choose their respective practitioners. Research on fundamental decision processes is of high importance and understanding the factors that influence people’s choices in real-life decision-making would potentially provide patients, and physicians alike, with the means to provide better resources to achieve greater satisfaction from visits to a medical practitioner. <b><i>Methods:</i></b> At our tertiary referral center, patients were given the opportunity to voluntarily participate in our survey. We collected questionnaires from 1,002 patients during their visit from November 2018 to February 2020. Statistical analysis was performed using SPSS V26.0 software (SPSS Statistics, Version 26.0.; IBM, Armonk, NY, USA). Results are reported as percentages for categorial variables. <b><i>Results:</i></b> Our patient cohort consisted of a higher percentage of men than of women (82 vs. 18%) with significantly more men having a university-based education (44 vs. 31%; <i>p</i> = 0.001). Women were more likely to have statutory health insurance than men (85 vs. 74%; <i>p</i> = 0.013). Men significantly preferred to be treated by a doctor of the same sex (24 vs. 8%; <i>p</i> &#x3c; 0.001), which significantly increased with age. Overall, more women than men trusted a referral by their primary care physician (75 vs. 66%, <i>p</i> = 0.017), while preference of a higher academic degree in the attending urologist was significantly correlated with the patients’ education. <b><i>Conclusions:</i></b> Information on a specialist, such as professional qualifications and academic accomplishments, is easily accessible to patients with or without access to the Internet. However, recommendations and referrals, in addition to consistent care by the same treating physician, seem to be of high importance to all patients, regardless of gender or age.

Continuity in palliative care – analysis of intersectoral palliative care based on routine data of a statutory health insurance

Background The goal of palliative care is to prevent and alleviate a suffering of incurable ill patients. A continuous intersectoral palliative care is important. The aim of this study is to analyse the continuity of palliative care, particularly the time gaps between hospital discharge and subsequent palliative care as well as the timing of the last palliative care before the patient’s death. Methods The analysis was based on claims data from a large statutory health insurance. Patients who received their first palliative care in 2015 were included. The course of palliative care was followed for 12 months. Time intervals between discharge from hospital and first subsequent palliative care as well as between last palliative care and death were analysed. The continuity in palliative care was defined as an interval of less than 14 days between palliative care. Data were analysed using descriptive statistics and Chi-Square. Results In 2015, 4177 patients with first palliative care were identified in the catchment area of the statutory health insurance. After general inpatient palliative care, 415 patients were transferred to subsequent palliative care, of these 67.7% (n = 281) received subsequent care within 14 days. After a stay in a palliative care ward, 124 patients received subsequent palliative care, of these 75.0% (n = 93) within 14 days. Altogether, 147 discharges did not receive subsequent palliative care. During the 12-months follow-up period, 2866 (68.7%) patients died, of these 78.7% (n = 2256) received palliative care within the last 2 weeks of life. Of these, 1223 patients received general ambulatory palliative care, 631 patients received specialised ambulatory palliative care, 313 patients received their last palliative care at a hospital and 89 patients received it in a hospice. Conclusions The majority of the palliative care patients received continuous palliative care. However, there are some patients who did not receive continuous palliative care. After inpatient palliative care, each patient should receive a discharge management for a continuation of palliative care. Readmissions of patients after discharge from inpatients palliative care can be an indication for a lack of support in the ambulatory health care setting and for an insufficient discharge management. Palliative care training and possibilities for palliative care consultations by specialists should strengthen the GPs in palliative care.

Successful Regression in Patients with Progressive Keratoconus by Corneal Crosslinking

Background Since 2019, corneal collagen crosslinking (CXL) is included in the catalog of procedures covered by statutory health insurance in Germany. CXL is an established ophthalmological procedure for the last 20 years. The aim of this investigation was the measurement of progression before and after CXL. Material und Methods 65 consecutive eyes with progressive keratoconus from 53 patients were included in the retrospective study, which were observed at the University Eye Hospital Tübingen at least two years before and at least two years after CXL. The time of observation took place from October 2009 until March 2018. Parameters of interest had been the best corrected visual acuity (BCVA) and the keratometric values from the elevation maps measured by a Scheimpflug camera. Results 65 eyes of 53 patients had been documented. The study population included 46 (86.8%) male and 7 (13.2%) female subjects. The mean age was 24 ± 8 years. The averaged observation time between the primary consultation and CXL showed 25 ± 15 months. Preoperatively the mean BCVA pointed out in a significant increase (0.13 ± 0.17 [first visit] vs. 0.23 ± 0.22 [preOP], p < 0.0001) while the mean Kmax resulted in a statistically significant increase (46.34 ± 3.33 dpt [first visit] vs. 48.78 ± 4.17 dpt [preOP], p < 0.0001). The mean thinnest point of the cornea showed a significant decrease (490.48 ± 34.23 µm [first visit] vs. 468.62 ± 29.84 µm [preop], p < 0.0001). Postoperatively the mean BCVA resulted in a significant improvement at the 12th postoperative month in comparison to the preoperative measurement (0.23 ± 0.22 [preOP] vs. 0.16 ± 0.14 [12 months], p = 0.04 respectively 0.17 ± 0.17 [24 months], p = 0.0006). The mean Kmax demonstrated in the 12th postoperative month a significant reduction (48.78 ± 4.17 dpt [preOP] vs. 47.91 ± 3.41 dpt [12 months], p = 0.0009 respectively 48 ± 4.56 dpt [24 months], p = 0.0051). The mean thinnest point of the cornea indicated a decrease at the 12th postoperative month (468.62 ± 29.84 µm [preOP] vs. 459.82 ± 35.88 µm [12 months], p = 0.0078 respectively 453.47 ± 43.39 µm [24 months], p = 0.0227). Conclusion CXL is a successful procedure for the therapy of progressive keratoconus.