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Selected Publications

2014-2010

2014

M. Schlander, S. Garattini, S. Holm, P. Kolominsky-Rabas, E. Nord, U. Persson, M. Postma, J. Richardson, S. Simoens, O. de Solà Morales, M. Toumi:

How (Not) To Assess the Social Value of Medical Interventions for Ultra-Rare Disorders (URDs): Recommendations from the URD Evaluation Project.

ISPOR Connections 20 (6), 2014: 15-17.

Many drugs for ultra-rare disorders (URDs) fail to meet conventional cost effectiveness thresholds. An international panel of experts (in the fields of HTA, health economics, and orphan drug regulation) argue that this failure is primarily due to deficiencies of the underlying logic of cost effectiveness. Hence a need is postulated for the adoption of alternative evaluation principles, which better capture social value (i.e., the public’s “social preferences”, such as cost value and social utility analysis).

M. Schlander, S. Garattini, S. Holm, P. Kolominsky-Rabas, E. Nord, U. Persson, M. Postma, J. Richardson, S. Simoens, O. de Solà Morales, M. Toumi:

Incremental cost per quality-adjusted life year gained? The need for alternative methods to evaluate medical interventions for ultra-rare disorders.

Journal of Comparative Effectiveness Research, 3 (4), 2014: 399-422.

Drugs for ultra-rare disorders (URDs) rank prominently among the most expensive medicines on a cost-per-patient basis. In light of the high fixed cost of R&D, this challenge is inversely related to the prevalence of URDs. The present paper sets out to explain the rationale underlying a recent expert consensus on these issues, recommending a more rigorous assessment of the clinical effectiveness of URDs, applying established standards of evidence-based medicine. In contrast, current health economic evaluation paradigms fail to adequately reflect normative and empirical concerns (i.e., morally defensible ‘social preferences’) regarding healthcare resource allocation. Hence there is a strong need for alternative economic evaluation models for URDs.

A. Gandjour, A. Gafni, M. Schlander:

Determining the price for pharmaceuticals in Germany: comparing a shortcut for IQWiG’s efficiency frontier method with the price set by the manufacturer for ticagrelor.

Expert Review of Pharmacoeconomics & Outcomes Research, 14 (1), 2014: 123-129.

Under current AMNOG price and reimbursement regulation in Germany, manufacturers and payers negotiate an appropriate reimbursement price for new products. If one of the parties involved wishes so, a formal evaluation of costs and benefits will be conducted by the Institute for Quality and Efficiency in Health Care (IQWiG). IQWiG will then make recommendations for a reimbursement price based on the ‘efficiency frontier’ in a given therapeutic area. The purpose of this study is to use the drug ticagrelor as an example to demonstrate a shortcut for the efficiency frontier method.

2013

Commentary on the Swiss Medical Board (SMB)

in: Neue Zürcher Zeitung, November 14, 2013.

M. Schlander, A. Jaecker, M. Voelkl:

Arzneimittelpreisregulierung nach den Prinzipien der Sozialen Marktwirtschaft.

Part 1: Die Pharmazeutische Industrie [PharmInd] 75 (3), 2013: 384-389.
Part 2: Die Pharmazeutische Industrie [PharmInd] 75 (4), 2013: 589-584.

Arzneimittelpreise: Preisbildung in einem besonderen Markt.

Deutsches Aerzteblatt 109 (11), 2012: A524-528 and A4.

Three closely related papers on pharmaceutical pricing - principles and policies in a social market economy.

M. Schlander, H. Sandmeier, C. Affolter, C. Bosshard, T. Cueni, P. Gyger, A. Hebborn, K. Huber, E. Kraft, P. Strupler, P. Suter:

Schweizer HTA-Konsensus, Umsetzungspapier 4/2012: Konkretisierung der WZW-Kriterien.

Basel, Bern, Solothurn and Wiesbaden, February 04, 2013.

M. Schlander, H. Sandmeier, C. Affolter, C. Bosshard, T. Cueni, P. Gyger, A. Hebborn, K. Huber, E. Kraft, P. Strupler, P. Suter:

Schweizer HTA-Konsensus, Umsetzungspapier 5/2012: Nutzenbewertung.

Basel, Bern, Solothurn and Wiesbaden, February 04, 2013.

M. Schlander, H. Sandmeier, C. Affolter, C. Bosshard, T. Cueni, P. Gyger, A. Hebborn, K. Huber, E. Kraft, P. Strupler, P. Suter:

Schweizer HTA-Konsensus, Umsetzungspapier 6/2012: Wirtschaftlichkeitsbewertung.

Basel, Bern, Solothurn and Wiesbaden, February 04, 2013.

2012

C. Affolter, H. Sandmeier, M. Schlander, C. Bosshard, T. Cueni, A. Faller, P. Gyger, A. Hebborn, K. Huber, E. Kraft, P. Suter:

Schweizer HTA-Konsensus, Umsetzungspapier 1/2012: Institutionelles.

Basel, Bern, Solothurn and Wiesbaden, November 13, 2012.

M. Schlander, H. Sandmeier, C. Affolter, C. Bosshard, T. Cueni, A. Faller, P. Gyger, A. Hebborn, K. Huber, E. Kraft, P. Suter:

Schweizer HTA-Konsensus, Umsetzungspapier 2/2012: Rapid (r-)HTAs.

Basel, Bern, Solothurn and Wiesbaden, November 13, 2012.

M. Schlander, H. Sandmeier, C. Affolter, C. Bosshard, T. Cueni, A. Faller, P. Gyger, A. Hebborn, K. Huber, E. Kraft, P. Suter:

Schweizer HTA-Konsensus, Umsetzungspapier 3/2012: Complete (c-) HTAs.

Basel, Bern, Solothurn and Wiesbaden, November 13, 2012.

M. Schlander, C. Affolter, H. Sandmeier, U. Brügger, C. Cao, T. Cueni, E. Kraft, G. de Pouvourville, A. Faller, P. Gyger, A. Hebborn, D. Herren, S. Kaufmann, R. Leu, P. Suter:

Swiss HTA Consensus Project: Guiding Principles.

Basel, Bern, Solothurn and Wiesbaden, March 13, 2012.

Michael Schlander:

Why Do Health Economists Complain that Health Politicians Don't Listen to Them? A Perspective from Germany.

ISPOR Connections 18 (6), 2012: 14.

A long-standing complaint among health economists is that politicians do not listen to them – or at least, many scholars believe so . After all, aren’t health systems across the globe plagued by budget constraints? Isn’t there an increasing recognition of the need to strive for more efficiency in service delivery? If members of the discipline are seen as experts in the allocation of scarce resources, these should be golden times for health economists.

2011

M. Schlander, C. Affolter, H. Sandmeier, U. Brügger, C. Cao, T. Cueni, G. de Pouvourville, A. Faller, P. Gyger, A. Hebborn, D. Herren, S. Kaufmann, R. Leu, P. Suter:

Swiss HTA Consensus Project:  Cornerstones for Further Development in Switzerland.

Basel, Bern, Solothurn and Wiesbaden, October 19, 2011.

M. Schlander, C. Affolter, H. Sandmeier, U. Brügger, C. Cao, T. Cueni, G. de Pouvourville, A. Faller, P. Gyger, A. Hebborn, D. Herren, S. Kaufmann, R. Leu, P. Suter:

Schweizer HTA-Konsensus-Projekt:  Eckpunkte für die Weiterentwicklung in der Schweiz.

Basel, Bern, Solothurn and Wiesbaden, October 19, 2011.

M. Schlander, C. Affolter, H. Sandmeier, U. Brügger, C. Cao, T. Cueni, G. de Pouvourville, A. Faller, P. Gyger, A. Hebborn, D. Herren, S. Kaufmann, R. Leu, P. Suter:

Schweizer HTA-Konsensus-Projekt:  Eckpunkte für die Weiterentwicklung in der Schweiz. Anhang/Appendix.

Basel, Bern, Solothurn and Wiesbaden, October 19, 2011.

M. Schlander, O. Schwarz, A. Rothenberger, V. Roessner:

Tic Disorders: Prevalence and Co-occurrence with Attention Deficit Hyperactivity Disorder in a German Community Sample.

European Psychiatry 26, 2011: 370-374.

Coexistence of tics and ADHD has important clinical and scientific implications. Tic disorders were observed in 2.3% of patients with ADHD. Conversely, the highest rate of ADHD cooccurring with tic disorders was found in adolescents (age 13-18 years, 15.1%).

2010

M. Schlander:

The Pharmaceutical Economics of Child Psychiatric Drug Treatment.

Current Pharmaceutical Design 16, 2010: 2443-2461 (19).

Comprehensive review of economic evaluations of child psychiatric drug treatment. Most studies of pharmacotreatment were cost effectiveness analyses (CEAs) concerned with attention-deficit/hyperactivity disorder (ADHD). Three evaluations were done by or on behalf of agencies as part of ADHD-related health technology assessments. A number of economic studies used patient-level data from specific randomized clinical trials, especially the NIMH-initiated MTA (in childhood ADHD) and TADS (in adolescent major depression) studies. Almost all studies relied on narrow scale symptom scales to assess effects of treatment, even when quality-adjusted life years (QALYs) were reported. In many cases, effectiveness data came from short-term studies, and extrapolation to a one-year time horizon was usually based on assumptions. Even those evaluations attempting to address longer time horizons by way of modeling did not include the impact of treatment on long-term sequelae of the conditions studied, mainly due to a paucity of robust clinical data. Nevertheless, currently available health economic evaluations broadly suggest an acceptable to attractive cost effectiveness of medication management of ADHD, whereas there is no such evidence for child psychiatric disorders other than ADHD.

M. Schlander:

Measures of Efficiency in Health Care: QALMs about QALYs?

German Journal for Evidence and Quality in Health Care [Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheitswesen (ZEFQ)] 104, 2010: 209-226. List of Abbrevations and References are available as Appendices.

Cost benefit analysis has been greeted with skepticism in the health policy field, primarily owing to resistance to a monetary measure of benefit and owing to concerns that willingness to pay may be unduly influenced by ability to pay. The move to cost utility analysis (CUA) however has not been without problems. The framework deviates from economic theory in important aspects and rests on a set of highly restrictive assumptions, some of which must be considered as empirically falsified. Results of CUAs do not seem to be aligned with well-documented social preferences and the needs of health care policy makers acting on behalf of society. By implication, there is reason to assume that a context-independent value of a quality-adjusted life year (QALY) does not exist, with potentially fatal consequences for any attempt to interpret CUAs in a normative way.

M. Schlander, G.-E. Trott, O. Schwarz:

The Health Economics fo Attention Deficit Hyperactivity Disorder in Germany - Part 1: Health Care Utilization and Cost of Illness.
[in German: Gesundheitsökonomie der Aufmerksamkeitsdefizit-/Hyperaktivitätsstörung (ADHS) in Deutschland - Teil 1: Versorgungsepidemiologie und Krankheitskosten.]

Nervenarzt 81 (3), 2010: 289-300.

In the German region of Nordbaden, 5% of children (aged 7–12 years) and 1.3% of adolescents(aged 13–19 years) were diagnosed with attention deficit hyperactivity disorder (ADHD) in 2003. About two thirds of these patients were not seen by a physician specialized in psychiatry. Now the National Association of Statutory Health Insurance Physicians in Germany (Kassenaerztliche Bundesvereinigung, KBV) has developed a proposal for the integrated provision of care for these patients, combining a guidelines-oriented multidisciplinary approach with a system of quality assurance. Against this background, currently available ADHD-related data are presented, covering epidemiology, comorbidity and differential diagnosis, health care utilization, and cost of illness. According to administrative data analyses from Nordbaden, direct medical costs for patients with ADHD, from the perspective of statutory health insurance (SHI), exceed those of matched controls by a factor of >2.5. On this basis, ADHD related expenditures of the German SHI may be estimated at around EUR 260 million in 2003, and almost certainly will have continued to grow further since. In addition to this, a diagnosis of ADHD is associated with substantial indirect cost. Although the literature on the burden of ADHD is incomplete, it seems plausible that the cost of illness might be comparable to that reported for alcohol and addiction disorders. Thus we anticipate an increasing relevance of formal health economic evaluations of health care programs offered to patients with ADHD.

T. Reinhold, B. Brüggenjürgen, M. Schlander, et al.:

Economic analysis based on multinational studies: methods for adapting findings to national contexts.

Journal of Public Health 18 (4), 2010: 327-335.

The main factors for limited transferability of health economic findings were found in country-specific differences in resource consumption and the resulting costs. These differences are affected by a number of cofactors (demography, epidemiology and individual patient’s factors) and overall health care system structures (e.g. payment systems, health provider incentives). Inherent limitations notwithstanding, country-specific health economic assessments can be realized using the pooled/split analyses approach and statistical and modelling approaches.

M. Schlander, G.-E. Trott, O. Schwarz:

The Health Economics fo Attention Deficit Hyperactivity Disorder in Germany - Part 2: Therapeutic Options and Their Cost Effectiveness.
[in German: Gesundheitsökonomie der Aufmerksamkeitsdefizit-/Hyperaktivitätsstörung (ADHS) in Deutschland - Teil 2: Therapeutische Optionen und ihre Kosteneffektivität.]

Nervenarzt 81 (3), 2010: 301-314.

Attention deficit hyperactivity disorder (ADHD) has been associated with a continuous increase of health care utilization and thus expenditures. This raises the issue of cost-effectiveness of health care provided for patients with ADHD. Comparative health economic evaluations generate relevant insights and typically report incremental cost-effectiveness ratios (ICERs) of alternatives versus an established standard. Typically, results of cost-effectiveness analyses (CEAs) are reported in terms of incremental cost-effectiveness ratios (ICERs). International evaluations, as well specific adaptations to Germany, indicate an acceptable to attractive cost-effectiveness – according to currently used international benchmarks – of an intense medication management strategy based on stimulants, primarily methylphenidate, with ICERs ranging from 20,000 EUR to 37,000 EUR per quality-adjusted life year (QALY) gained. Economic modeling studies also suggest cost-effectiveness of long-acting modified-release preparations of methylphenidate, owing to improved treatment compliance associated with simplified once daily administration schemes. Atomoxetine, in contrast, appears economically inferior compared to long-acting stimulants, given its higher acquisition costs and at best equal clinical effectiveness. There are currently no data supporting the cost-effectiveness of psychotherapeutic or behavioral interventions. Economic evaluations, which have been published to date, are generally limited by time horizons of up to 1 year and by their prevailing focus on ADHD core symptom improvement only. Therefore, further research into the cost-effectiveness of ADHD treatment strategies seems warranted.