The rising prevalence of erectile dysfunction is increasingly becoming a significant public health problem in Germany, too, and the active ingredient sildenafil is an established treatment option for affected patients. The aim of the expert opinion was to work out the public health impact associated with a switch from Rx to OTC status for sildenafil 50 mg within the framework of a literature-based study.

The discussion about an OTC switch of sildenafil is characterized by two central leitmotifs. On the one hand, the illegal trade in counterfeit drugs should be reduced as far as possible. Second, low-threshold counseling services in pharmacies about the conditions underlying erectile dysfunction are intended to transfer more patients to structured medical treatment.

Methodology

First, the scientific evidence of successful OTC switches for selected active ingredients was analyzed in the form of case studies. Furthermore, the literature on OTC switches of sildenafil in neighboring European countries (especially the United Kingdom) was evaluated. In addition, expert interviews were conducted with representatives of pharmacy and patient associations to map current assessments. The assessment of the public health impact of a possible OTC switch of sildenafil was based on three domains: patient-relevant, health system-related and socio-economic impact.

Patient-relevant aspects: Since only about one-third of patients with erectile dysfunction consult a physician, and sildenafil is often taken without prior medical consultation, OTC dispensing through pharmacies could lead to low-threshold access to the care system. Pharmacies could seek contact with customers at the point-of-sale and refer patients to medical care if there are signs of the presence of underlying conditions. One estimate found that with an OTC switch, approximately 700,000 men with erectile dysfunction would benefit from an expansion of therapy.

Health system-related aspects: A clearly identifiable advantage of the OTC release of sildenafil for the health care system is the strengthening of the profession as well as the health care competence of pharmacists through sildenafil counseling services, since erectile dysfunction represents a new field of counseling for pharmacists. That pharmacists could also make a public health-relevant contribution in the case of an OTC release of sildenafil is shown by the results of a European observational study that investigated whether pharmacists can make an appropriate recommendation of sildenafil 50 mg for the treatment of erectile dysfunction.

Socio-economic aspects: Initially, an OTC switch from sildenafil does not result in any significant savings in drug costs, as these are to be borne by the patients themselves on the basis of a guideline issued by the Federal Joint Committee. However, since affected patients often do not visit their doctors, there is a risk that the underlying diseases or secondary diseases that promote erectile dysfunction are not diagnosed or are diagnosed only after a time delay, which can lead to more severe courses of the disease with high treatment costs. The goal of an OTC switch should therefore be to enable the diagnosis of the underlying diseases in a larger proportion of patients with erectile dysfunction and thus make a public health-relevant contribution.

Conclusion

In summary, a potential OTC switch of sildenafil 50 mg thus involves a balancing of the resulting patient benefit and patient safety. The current prescription requirement for sildenafil is intended to promote both patient safety and therapy for patients under medical care. However, because in the vast majority of cases the drug is obtained outside of medical treatment, a large proportion of affected patients remain inadequately treated. An OTC switch could help destigmatize sildenafil as well as erectile dysfunction and transition previously untreated patients into medical treatment through pharmacy information and low-threshold consultation.

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CDK 4/6 inhibitors represent a relatively new group of agents for the treatment of metastatic breast cancer. The first representative of this group entered the market in November 2016. Subsequently, two additional CDK 4/6 inhibitors, ribociclib and abemaciclib, were approved. In the meantime, all representatives of the new class of active ingredients have been subjected to a benefit assessment. As a result, no additional benefit was recognized for any of the preparations. At the same time, it can be seen that very different standards were applied in the assessment.

Based on the most recent benefit assessment, a comparative presentation of the procedures was carried out.

Results

It became apparent that IQWiG proceeded in a strikingly different manner when evaluating the individual active substances. The G-BA also shows inconsistencies in its assessments. For example, biases that may complicate the interpretation of a study result are assessed in strikingly different ways. While a clear effect in overall survival is negated due to conceivable biases, increased adverse events are taken into account in the assessment despite considerable concerns regarding the significance.

Critical evaluation of surrogate parameters also seems to focus on endpoints that might demonstrate the benefit of an agent. In the case of adverse events, no discussion of this topic is discernible. A significant line of argumentation by the G-BA in the balancing of benefits of CDK 4/6 inhibitors with increased adverse events relies heavily on asymptomatic neutropenia – an endpoint of at least questionable patient relevance.

Diabetes mellitus affects around nine percent of the population in Germany, and forecasts predict that this percentage will increase in the future. Many patients receive intensified insulin therapy, which is time-consuming, organizationally complex and requires intensive doctor-patient contact. This study was initiated on the assumption that consistent monitoring combined with individual medical care supported by telemedicine can significantly contribute to improving or stabilizing the metabolism of people with diabetes mellitus. The telemedical approach was based on consistent glucose measuring, which was transmitted electronically to the physician.

The evaluation was to investigate whether the care of patients with diabetes mellitus and intensified insulin therapy using telemedicine leads to an improvement in the glycemic metabolic status. The primary endpoint was the HbA1c level. The secondary endpoints were the additional costs of the intervention, further indicators of the glycemic metabolic status, the feasibility of the approach in the daily practice and in the daily life of the patients, and the patients’ satisfaction with the therapy. Data collection and project implementation were conducted from 01.10.2018 through 31.07.2019. The target groups of the project were patients with diabetes mellitus type-1 and type-2 as well as the treating physicians.

To provide answers to the research questions, a quasi-experimental study with a pre-post design was conducted. Within the study period of six months, there were two (patients) and three (physicians) survey time points. For the interviews, both self-developed and standardized questionnaires were used. Depending on the research question and endpoint, descriptive and/or inferential statistical analyses were used. Statistical data analysis was performed using SPSS Subscription Version 2019.

Lifestyle changes can reduce the risk of developing type 2 diabetes mellitus. The evaluated aha!2.0 program (“Different from today!”) focuses on the recognition of the diabetes mellitus type 2 risk and on the modification of lifestyle to reduce known risk factors. The aim of aha!2.0 was to estimate the point prevalence of participating individuals with a very high risk of type 2 diabetes mellitus in Schleswig-Holstein at the start of the study using FINDRISK. Furthermore, the development of the relevant endpoints body weight, waist circumference and body mass index was investigated.

Methods

The study was conducted between July 2014 and December 2016 in a single-arm longitudinal study design and 15-month follow-up (including 12 weeks of intervention) with a total of five control time points (t-1 to t3). Study participants were recruited in family practices in Schleswig-Holstein. Legally insured individuals aged 18 years and older who had identifiable abdominal obesity and/or a relevant family history and/or a sedentary lifestyle were included. The intervention consisted of the FINDRISK test (Module 1), which estimates the ten-year risk of developing type 2 diabetes mellitus by means of a score, and the lifestyle intervention itself (Module 2). Building on a doctor-insured discussion, participants received the aha! starter set, consisting of a Chip List©, a diet and exercise diary, an exercise band with exercise poster and a measuring tape to measure waist circumference.

Results

The point prevalence for individuals with a very high risk (50% according to FINDRISK) of developing type 2 diabetes mellitus in the next ten years was 12.2% [95% CI: 10.3, 14.5] in the population of individuals recruited in GP practices in Schleswig-Holstein with a GP-suspected type 2 diabetes mellitus risk. The 205 participants who completed the program over the 15-month follow-up period reduced their body weight by 4.5 kg [CI-95%: -5.6, -3.4], their waist circumference by -5.7 cm [95%-CI: -6.5, -4.7], and their body mass index by 1.6 kg/m² [95%-CI: -2.0, -1.2].

Conclusion

aha!2.0 proved to be implementable in Schleswig-Holstein. Participants were able to reduce modifiable risk factors for type 2 diabetes mellitus during the 15-month follow-up. Data from 205 of the original 935 participants (21.9%) could be evaluated at the last follow-up. Future studies of lifestyle interventions related to reduction of behavioral risk factors of DMT2 in the primary care setting should evaluate the effect of adherence-enhancing interventions.

Building on the results of aha!2.0, the project Dimini – Diabetes mellitus? Not for me! followed, which was funded by the Innovation Fund at the Federal Joint Committee from 2017 to 2020.

Publication

Binder, S., Püschner, F., Bertram, N., Weber, V., Amelung, V. E., Göhl, M. & Petersen, C. (2019). Lebensstilintervention Aha!2.0 zur Reduktion von modifizierbaren Risikofaktoren des Diabetes mellitus Typ 2 bei Risikopersonen: eine Longitudinalstudie im Hausarztsetting in Schleswig-Holstein. Diabetologie Und Stoffwechsel. https://doi.org/10.1055/a-0903-2468

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The white paper ” Care of Early Alzheimer’s Disease” examines the current state of research and highlights the causes, diagnosis, and treatment approaches of early Alzheimer’s disease.

The number of people affected by dementia in Germany is steadily increasing, with Alzheimer’s disease being the main cause in two-thirds of cases. Nevertheless, early Alzheimer’s disease is being diagnosed too rarely. Thus, the stigma associated with the disease keeps many people from seeing a doctor. The white paper “Care of Early Alzheimer’s Disease” deals with the current state of research and sheds light on causes, diagnostics and therapeutic approaches of early Alzheimer’s disease. In addition, the white paper provides proposed solutions to address existing and future care challenges. Experts consider prevention and early diagnosis to be crucial in this context.

At the beginning of the 2000s, Alzheimer’s disease could only be reliably diagnosed post-mortem by performing a brain autopsy. Today, the disease can be diagnosed prior to the onset of dementia. This became possible by detecting Alzheimer’s biomarkers, such as beta-amyloid or tau, in the cerebrospinal fluid or in positron emission tomography (PET), and likely in the near future also in the blood. These advances in Alzheimer’s research have far-reaching implications for the care of those affected and the reorganization of health care structures.

Among the most important learnings: Alzheimer’s care must start at an early stage. “We need interventions as early as possible to halt or slow the course of this progressive disease,” said Dr. Uwe Meier, chairman of the board of the Professional Association of German Neurologists (BDN) and a patron of the project. “In the case of advanced neurodegenerative degeneration, we can only accompany the course of the disease.”

In addition to the hope for pharmacological therapies, lifestyle aspects will also become more relevant in the future. “Whereas a decade ago dementia in Alzheimer’s disease was seen as a fateful event, today we assume that up to 40 percent of the risk of developing dementia depends on modifiable factors. It therefore seems possible to influence one’s own dementia risk by adopting an active and healthy lifestyle,” explains Prof. Dr. Frank Jessen, Director of the Department of Psychiatry and Psychotherapy at the University Hospital Cologne, who is a co-author and also a patron of the publication.

The National Dementia Strategy (NDS) signed by the German government in 2020 was an essential step. The task now is to set a new course in Germany to identify and treat early cognitive impairment and Alzheimer’s disease in a timely manner. The care of patients in the early stages of Alzheimer’s disease also requires significant effort. In the future, the care provision will also be concerned with ensuring that the expense of (differential) diagnostic procedures is appropriately remunerated and that appropriate structures are created. In addition, due to the expected growing needs, Alzheimer’s care will require a higher degree of networking between the treatment providers involved. In the view of the experts involved, pilot models, digital solutions and the expansion of outpatient memory clinics will therefore be key components of future care.

Publication

Free download of the white paper “Care of Early Alzheimer’s Disease” is available under: https://alzheimer-dialog.de/ (German language version only)

Transparency Note

The White Paper was prepared with the financial support of Biogen GmbH.

To increase the effectiveness and efficiency of care – that is the purpose of an electronic patient record (ePA). However, the introduction of ePA into the German healthcare system is proving to be extremely complex. Why is Germany having such a hard time with this change, and to what extent do ePA showcase countries like Denmark or Israel differ from Germany? The study conducted by inav consisted of a literature review, case studies and the development of a scorecard.

The focus of the literature review centered on the international evidence base on ePA, specifically the effects of ePA on health care delivery and existing evidence on implementation. The literature review was conducted using database queries on PubMed and Google Scholar. Systematic reviews published between January 1, 2010 and July 14, 2016 were considered.

In addition, the study included case studies to examine the situation and progress of ePA implementation and use in selected countries. The case studies were conducted for Denmark, Israel, the United States, and Austria. The selection was complemented by case studies on the corporate solutions of Apple and Google. The case studies were based on in-depth interviews with experts on a national and international level.

The third part of the study, the “European Scorecard”, was designed to classify the implementation status of the German ePA on a European scale and to compare it with selected countries. For the development of the scorecard, relevant indicators were identified that reflect the complexity of ePA implementation and are available and comparable for a wider range of countries. Once the scorecard was developed, a selection of 20 countries were rated in terms of ePA implementation and use using a traffic light system. In 2018, an update of the scorecard was conducted, also by the inav.

Based on the synopsis of the results of the three elements, recommended courses of action were determined in various subject areas.

Further Information (German language)

https://www.medhochzwei-verlag.de/Shop/ProduktDetail/die-elektronische-patientenakte-978-3-86216-331-1

https://www.stiftung-muench.org/wp-content/uploads/2018/09/Scorecard-final.pdf

The aim of the project was to identify recommendations for evidence generation and evaluation by means of in-use data in the benefit assessment of orphan drugs and medicinal products.

With the GSAV, the G-BA was authorized to require application-accompanying data collection and evaluation for the purpose of benefit assessment for orphan drugs and drugs with conditional approval or approval granted under special conditions. According to the intention of the legislator, non-randomized studies and thus lower certainty of results are also to be accepted.

Based on an overview of the current handling of non-randomized studies on the part of relevant organizations as well as an overview of methodological evaluation procedures, recommendations were formulated regarding evidence generation and evaluation, which serve the objective of being able to generate usable data for a quantifiable additional benefit and thus improve the evidence situation.

Publication

Bleß, H.: „Anwendungsbegleitende Daten in der Nutzenbewertung – Empfehlungen zur Evidenzgenerierung und -auswertung“, in: „Monitor Versorgungsforschung“ (01/20), S. 47-54, doi: 10.24945/MVF.01.20.1866-0533.2202

In January 2020, the German Bundestag (Parliament) passed a number of reforms to the legislation on organ donation. The so-called decision solution that has existed to date remains unchanged. However, in the future, the discussion and education about organ and tissue donation will be promoted and the personal decision will be better documented. As part of the Act to Encourage the Willingness to Donate Organs, an online registry is to be set up and general practitioners will be given the opportunity to provide their patients with open and unbiased advice on organ and tissue donation every two years.

In light of these changes, the Federal Centre for Health Education (BZgA) aimed to update the existing information material for general practitioners and to include the needs of general practitioners in the revision process in order to ensure maximum acceptance within the target group.

The aim of the evaluation was to have the contents of the brochure “Information on Organ and Tissue Donation. A Guideline for General Practitioners” reviewed by the target group. The intention was to analyze the support needs of general practitioners on the subject of organ and tissue donation and to determine which form of presentation the target group would prefer. The evaluation was commissioned by the Federal Center for Health Education (BZgA).

Both qualitative and quantitative survey methods were used in a mixed methods approach. This included assessing the target group’s views on the potential for optimizing the presentation of the brochure and its content. In addition, potential needs for support and the practicability of various forms of presentation were surveyed.

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