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Response to Letter to the Editor on “Early benefit assessment of new drugs in Germany – Results from 2011 to 2012” [Health Policy 116(2–3) (2014) 147–153]
Health Policy 118 (2014) 272
Contents lists available at ScienceDirect
Health Policy journal homepage: www.elsevier.com/locate/healthpol
Letter to the Editor
Response to Letter to the Editor on “Early benefit assessment of new drugs in Germany – Results from 2011 to 2012” [Health Policy 116(2–3) (2014) 147–153] Orben et al. address three main issues in their letter to the editor: (1) that they calculated a different proportion of “successful” benefit assessments, (2) that IQWiG does not assess clinical evidence for subgroups due to “supposed formal reasons”, and (3) that price negotiations are only partly based on the outcome of the benefit assessment. (1) Depending on the research question, different approaches are possible to calculate the proportion of “successful” benefit assessments according to the Act on the Reform of the Market for Medicinal Products (AMNOG). From our point of view, the proportion of new drugs providing added benefit (to any subgroup of patients) is certainly of interest. Obviously, other analyses are also possible, for example, on the basis of patient subgroups. Further analyses could investigate added benefit by disease area or drug class. (2) From our point of view, the exclusion of data from studies with an inadequate design (e.g. due to an unfair comparison of interventions) or of patient populations not relevant to the research question (e.g. patients with disease stages requiring different comparator therapies) are not exclusions due to formal reasons, but reasons of content. This type of data evaluation is an essential part of IQWiG’s assessment of content and aims to ensure valid answers to the research question posed. The investigation of subgroups is important, as it cannot be expected that all patients benefit to the same extent from a given drug. One of the specific aims of AMNOG is to determine the added benefit in subgroups [1,2]: “In the benefit assessment it is examined whether an added benefit versus the appropriate comparator therapy is proven for the drug, what added benefit is proven for which patient groups and to what extent, how the available evidence is to be assessed, and
with what probability the proof [of added benefit] is provided in each case” [2]; (authors’ translation). However, the prerequisite for the investigation of subgroups is the provision of adequate data by the drug manufacturer – there is considerable room for improvement here. (3) The impact of the outcome of the benefit assessment on price negotiations is neither part of IQWiG’s benefit assessment nor of our article. References [1] SGB V Sozialgesetzbuch: Gesetzliche Krankenversicherung; § 35a SGB V Bewertung des Nutzens von Arzneimitteln mit neuen Wirkstoffen [SGB V Social Code Book: Statutory Health Insurance; § 35a SGB V assessment of the benefit of pharmaceuticals with new active ingredients]; 2014. Available from: http://www.sozialgesetzbuchsgb.de/sgbv/35a.html [cited 11.10.14]. [2] Bundesminister für Gesundheit. Verordnung über die Nutzenbewertung von Arzneimitteln nach § 35a Absatz 1 SGB V für Erstattungsvereinbarungen nach § 130b SGB V (ArzneimittelNutzenbewertungsverordnung – AM-NutzenV) [Regulation for Early Benefit Assessment of New Pharmaceuticals acc. to § 35a (1) Social Code Book V for reimbursement agreements acc. to § 130b Social Code Book V]. Bundesgesetzblatt Teil 2010;1(68):2324–8.
DOIs of the original articles:http://dx.doi.org/10.1016/j.healthpol.2014.10.009, http://dx.doi.org/10.1016/j.healthpol.2013.12.008. http://dx.doi.org/10.1016/j.healthpol.2014.10.011 0168-8510/© 2014 Published by Elsevier Ireland Ltd.
Helmut Hörn Katrin Nink ∗ Natalie McGauran Beate Wieseler Institute for Quality and Efficiency in Health Care, Im Mediapark 8, 50670 Cologne, Germany ∗ Corresponding author. Tel.: +49 0221 35685 250; fax: +49 0221 35685 1. E-mail address: [email protected] (K. Nink)
13 October 2014
Contents lists available at ScienceDirect
Health Policy journal homepage: www.elsevier.com/locate/healthpol
Letter to the Editor
Response to Letter to the Editor on “Early benefit assessment of new drugs in Germany – Results from 2011 to 2012” [Health Policy 116(2–3) (2014) 147–153] Orben et al. address three main issues in their letter to the editor: (1) that they calculated a different proportion of “successful” benefit assessments, (2) that IQWiG does not assess clinical evidence for subgroups due to “supposed formal reasons”, and (3) that price negotiations are only partly based on the outcome of the benefit assessment. (1) Depending on the research question, different approaches are possible to calculate the proportion of “successful” benefit assessments according to the Act on the Reform of the Market for Medicinal Products (AMNOG). From our point of view, the proportion of new drugs providing added benefit (to any subgroup of patients) is certainly of interest. Obviously, other analyses are also possible, for example, on the basis of patient subgroups. Further analyses could investigate added benefit by disease area or drug class. (2) From our point of view, the exclusion of data from studies with an inadequate design (e.g. due to an unfair comparison of interventions) or of patient populations not relevant to the research question (e.g. patients with disease stages requiring different comparator therapies) are not exclusions due to formal reasons, but reasons of content. This type of data evaluation is an essential part of IQWiG’s assessment of content and aims to ensure valid answers to the research question posed. The investigation of subgroups is important, as it cannot be expected that all patients benefit to the same extent from a given drug. One of the specific aims of AMNOG is to determine the added benefit in subgroups [1,2]: “In the benefit assessment it is examined whether an added benefit versus the appropriate comparator therapy is proven for the drug, what added benefit is proven for which patient groups and to what extent, how the available evidence is to be assessed, and
with what probability the proof [of added benefit] is provided in each case” [2]; (authors’ translation). However, the prerequisite for the investigation of subgroups is the provision of adequate data by the drug manufacturer – there is considerable room for improvement here. (3) The impact of the outcome of the benefit assessment on price negotiations is neither part of IQWiG’s benefit assessment nor of our article. References [1] SGB V Sozialgesetzbuch: Gesetzliche Krankenversicherung; § 35a SGB V Bewertung des Nutzens von Arzneimitteln mit neuen Wirkstoffen [SGB V Social Code Book: Statutory Health Insurance; § 35a SGB V assessment of the benefit of pharmaceuticals with new active ingredients]; 2014. Available from: http://www.sozialgesetzbuchsgb.de/sgbv/35a.html [cited 11.10.14]. [2] Bundesminister für Gesundheit. Verordnung über die Nutzenbewertung von Arzneimitteln nach § 35a Absatz 1 SGB V für Erstattungsvereinbarungen nach § 130b SGB V (ArzneimittelNutzenbewertungsverordnung – AM-NutzenV) [Regulation for Early Benefit Assessment of New Pharmaceuticals acc. to § 35a (1) Social Code Book V for reimbursement agreements acc. to § 130b Social Code Book V]. Bundesgesetzblatt Teil 2010;1(68):2324–8.
DOIs of the original articles:http://dx.doi.org/10.1016/j.healthpol.2014.10.009, http://dx.doi.org/10.1016/j.healthpol.2013.12.008. http://dx.doi.org/10.1016/j.healthpol.2014.10.011 0168-8510/© 2014 Published by Elsevier Ireland Ltd.
Helmut Hörn Katrin Nink ∗ Natalie McGauran Beate Wieseler Institute for Quality and Efficiency in Health Care, Im Mediapark 8, 50670 Cologne, Germany ∗ Corresponding author. Tel.: +49 0221 35685 250; fax: +49 0221 35685 1. E-mail address: [email protected] (K. Nink)
13 October 2014