[Biosimilars and the efficiency principle]. / Biosimilars und das Wirtschaftlichkeitsgebot.

Biosimilars are subject to the efficiency evaluation according to section 106 Social Code Book Five (SGB V). The specific evaluation method influences the physician's prescription behaviour. In the case of an individual prescription limit evaluation (Richtgrößenprüfung), the prescription of biosimilars would usually not result in recourse but, as a start, in the initiation of the evaluation proceedings. Starting from 2017, the individual prescription limit evaluation will be cancelled. The active ingredient evaluation (Wirkstoffprüfung) expected instead at a regional level may provide for biosimilar to original drug ratios and result in recourses if these ratios are missed. First agreements on specific evaluation proceedings at a regional level are expected for this year.

[Termination of Reimbursement of Arthroscopy in Osteoarthritis of the Knee: Is This Decision Based on Scientific Grounds?] / Ausschluss der Arthroskopie bei Gonarthrose aus dem GKV-Leistungskatolog: Beruht diese Entscheidung auf wissenschaftlichen Kriterien?

Background In Germany, arthroscopy of the knee used to be an accepted procedure in the treatment of osteoarthritis of the knee. However, as of April 1, 2016 reimbursement for this procedure has been discontinued. This was a decision of the Joint Federal Committee (Gemeinsamer Bundesausschuss, G-BA). That decision was based on a report of the German Institute for Quality and Efficiency in Health Care (IQWiG). This report is essentially based on a few studies, three of which have been published in the renowned New England Journal of Medicine. According to the IQWiG, there is "no hint, indication or proof of a benefit of therapeutic arthroscopy" in osteoarthritis of the knee. Since this statement does not coincide with clinical observations commonly made by orthopaedic surgeons, the aim of this analysis was to evaluate the aforementioned studies according to criteria of evidence-based medicine. Material and Methods The three studies on which the IQWiG report is essentially based (Moseley et al. 2002, Kirkley et al. 2008 and Katz et al. 2013), all published in the New England Journal of Medicine, were analyzed according to the standards of evidence-based medicine. Results Although all of the evaluated studies were randomized controlled studies, there were considerable and serious deficiencies. These deficiencies include, among others, sampling bias that affects external validity and selection bias that affects internal validity. While a sham operation was performed in one study, resulting in an ideal blinding of study participants, that study used a non-validated primary outcome measure. That outcome score has not been used in subsequent publications and the algorithm presented for the calculation of the outcome score was incorrect. Although the other studies used validated main outcome measures, patients in those studies were not blinded. A number of further deficiencies were identified as well. Conclusion The studies on which the decision of the Joint Federal Committee is based do have several significant and at times severe methodological deficiencies. For instance, the results of these studies cannot be generalized to all patients suffering from osteoarthritis of the knee, solely on the basis of patient selection. Many of these deficiencies have not been mentioned till now, neither in the literature nor in the final report authored by the IQWiG. Therefore, it seems unlikely that the Joint Federal Committee was aware of these deficiencies when it decided to discontinue reimbursement for arthroscopy in patients with osteoarthritis of the knee. Unfortunately, not all patients suffering from osteoarthritis of the knee respond to conservative therapy. By discontinuing reimbursement for arthroscopy in this patient group, a commonly used treatment option has been withdrawn. The proportion of such patients was 30% after 6 months and 35% after 12 months in one of the studies considered by the IQWiG. It is hence conceivable that the indication for joint replacement surgery could become more generous after the withdrawal of arthroscopy as an alternative treatment option. In summary, it became clear that, given the variety and severity of the deficiencies of the underlying studies, the decision of the Joint Federal Committee could not have been based on scientific criteria. To this extent, it seems appropriate to revive the discussion about the exclusion of arthroscopy from the performance catalogue of the German Health Insurance System.

The Use of Economic Evaluation to Inform Newborn Screening Policy Decisions: The Washington State Experience.

POLICY POINTS: Newborn screening not only saves lives but can also yield net societal economic benefit, in addition to benefits such as improved quality of life to affected individuals and families. Calculations of net economic benefit from newborn screening include the monetary equivalent of avoided deaths and reductions in costs of care for complications associated with late-diagnosed individuals minus the additional costs of screening, diagnosis, and treatment associated with prompt diagnosis. Since 2001 the Washington State Department of Health has successfully implemented an approach to conducting evidence-based economic evaluations of disorders proposed for addition to the state-mandated newborn screening panel. CONTEXT: Economic evaluations can inform policy decisions on the expansion of newborn screening panels. This article documents the use of cost-benefit models in Washington State as part of the rule-making process that resulted in the implementation of screening for medium-chain acyl-CoA dehydrogenase (MCAD) deficiency and 4 other metabolic disorders in 2004, cystic fibrosis (CF) in 2006, 15 other metabolic disorders in 2008, and severe combined immune deficiency (SCID) in 2014. METHODS: We reviewed Washington State Department of Health internal reports and spreadsheet models of expected net societal benefit of adding disorders to the state newborn screening panel. We summarize the assumptions and findings for 2 models (MCAD and CF) and discuss them in relation to findings in the peer-reviewed literature. FINDINGS: The MCAD model projected a benefit-cost ratio of 3.4 to 1 based on assumptions of a 20.0 percentage point reduction in infant mortality and a 13.9 percentage point reduction in serious developmental disability. The CF model projected a benefit-cost ratio of 4.0-5.4 to 1 for a discount rate of 3%-4% and a plausible range of 1-2 percentage point reductions in deaths up to age 10 years. CONCLUSIONS: The Washington State cost-benefit models of newborn screening were broadly consistent with peer-reviewed literature, and their findings of net benefit appear to be robust to uncertainty in parameters. Public health newborn screening programs can develop their own capacity to project expected costs and benefits of expansion of newborn screening panels, although it would be most efficient if this capacity were shared among programs.

Internal Controlling of a Radiology Department.

Caused by legal reform initiatives there is a continuous need to increase effectiveness and efficiency in hospitals and surgeries, and thus to improve processes.Consequently the successful management of radiological departments and surgeries requires suitable structures and optimization processes to make optimization in the fields of medical quality, service quality and efficiency possible.In future in the DRG System it is necessary that the organisation of processes must focus on the whole clinical treatment of the patients (Clinical Pathways). Therefore the functions of controlling must be more established and adjusted. On the basis of select Controlling instruments like budgeting, performance indicators, process optimization, staff controlling and benchmarking the target-based and efficient control of radiological surgeries and departments is shown.

Decision making in Germany: is health economic evaluation as a supporting tool a sleeping beauty?

For many years, the legal situation within the statutory health insurance (SHI) system in Germany has allowed for health economic evaluations. There are various reasons why health economic evaluations have played virtually no role in decision making until now: to begin with, a method for the evaluation of the relation between benefits and costs which needed to be in accordance with the legal requirements had to be developed, the outcome of which was the efficiency frontier approach. Subsequent health care reforms have led to changing objectives and strategies. Currently, price negotiations of newly launched drugs are based on an early benefit assessment of dossiers submitted by pharmaceutical manufacturers. Other reasons might be the presently very comfortable financial situation of the statutory health insurance system as well as a historically grown societal fear and discomfort towards what is perceived to be a rationing of medicinal products. For the time being, it remains open how long the German health care system can afford to continue neglecting the benefits of health economic evaluations for drug and non-drug interventions, and when it will be time to wake this sleeping beauty.

[The costs of new drugs compared to current standard treatment]. / Die Preise neuer Arzneimittel im Vergleich zu ihren therapeutischen Alternativen.

BACKGROUND: Until AMNOG came into effect Germany had free pricing of new drugs. Our exemplary work investigates the costs of new drugs that were licensed in the two years prior to AMNOG, and compares them to the costs of standard treatment that has been used in pivotal trials. Also, the important components of pharmaceutical prices will be illustrated. METHOD: We retrospectively analysed the European Public Assessment Reports of proprietary medicinal products that the European Medicinal Agency initially approved in 2009 and 2010 and that were tested against an active control in at least one pivotal trial. RESULTS: If the standard treatment was a generic, the average pharmacy retail price of new drugs was 7.4 times (median 7.1) higher than that of standard treatment. If the standard treatment was an originator drug the average price was 1.4 times (median 1.2) higher than that of the new drug. There was no clear correlation of an increase in costs for new drugs and their "grade of innovation" as rated according to the criteria of Fricke. Our study shows that prices of new drugs must be linked to the evidence of comparative benefit; since German drug pricing is complex, cost saving effects obtained thereby will depend on a range of other rules and decisions.

[HTA-Perspective: Challenges in the early assessment of new oncological drugs]. / HTA-Perspektive: Herausforderungen bei der Frühbewertung neuer Onkologika.

Oncologic drug therapies have gained wide attention in the context of health policy priority setting for serious and socially significant diseases with high human and monetary costs. Due to uncertainties and scepticism about the actual therapeutic importance of newly approved oncology products, an early assessment programme was already established in Austria in 2007. The assessment of new oncology products is thereby faced with special challenges, since study populations are frequently not representative or the study design is laid out in such a manner that a definitive assessment of patient-relevant endpoints is not possible (cross-overs after interim assessments, surrogate parameters as primary endpoints, uncontrolled studies or those with unrealistic comparators, invalidated post-hoc identified biomarkers). On account of these major uncertainties, even the European Medicines Agency (EMA) is already contemplating multi-stage, "adaptive" approvals, and national reimbursement institutions are increasingly working with outcome-oriented, conditional reimbursement. (As supplied by publisher).

Hospital reimbursement incentives: is there a more effective option?--Part II.

As discussed in Part I of this article, hospital executives in Canada, Germany, and the United States manage their facilities' resources to maximize the incentives inherent in their respective reimbursement system and thereby increase their bottom line. It was also discussed that an additional supply of available hospitals, physicians, and other services will generate increased utilization. Part II discusses how the Patient Protection and Affordable Care Act of 2010 will eventually fail since it neither controls prices nor utilization (e.g., imaging, procedures, ambulatory surgery, discretionary spending). This article concludes with the discussion of the German multipayer approach with universal access and global budgets that might well be a model for U.S. healthcare in the future. Although the German healthcare system has a number of shortfalls, its paradigm could offer the most appropriate compromise when selecting the economic incentives to reduce the percentage of the U.S. gross domestic product expenditure for healthcare from 17.4% to roughly 12.0%.

[Integrated care in pain therapy: innovations and coordinated treatment offers from the "Techniker Krankenkasse"]. / Integrierte Versorgung in der Schmerztherapie : Innovationen und koordinierte Versorgungsangebote der Techniker Krankenkasse.

Sectorally segregated healthcare structures are seen as a major reason for deficits in quality and efficiency. With the introduction of §§ 140 a ff. SGB V, the sectoral splitting into outpatient, inpatient and rehabilitative services will be eliminated. This is especially true for the requirements of state-of-the-art multidisciplinary and comprehensive pain therapy. Through this form of contract competition and competition for the best idea, incentives shall be created for economic behaviour of market participants, above all the efficient use of limited resources and allocation of healthcare resources based on need. Selective contracts are essential competition parameters for continued innovative development of the healthcare system. They enable statutory healthcare providers to offer their insurants innovative treatments which are not available in standard care. Agreements can be made concerning higher levels of quality and healthcare services, incentives for economical behaviour and success-based payment models. The key idea is the orientation on the needs of the insurant. The successful realisation of innovation in pain therapy is described using a practical example. Professional contractual partners, high quality information and communication, the taking over of responsibility for treatment and cost effectiveness are factors essential the success of innovative treatment concepts.