Table 1.

Overview of information provided on Quality of Life in guidelines of Health Technology Assessment agencies.

Sources England: National Institute for health and Care Excellence (NICE). Guide to the methods of technology appraisal 2013. Process and methods guide. 4 April 2013. Available from: http://publications.nice.org.uk/pmg9; France: Rima de Sahb-Berkovitch et al. Assessing Cancer Drugs for Reimbursement: Methodology, Relationship between Effect Size and Medical Need. Thérapie 2010 Juillet-Août; 65 (4): 373–377 & Kleijnen S, Goettsch W, d’Andon A, et al. EUnetHTA JA WP5: Relative Effectiveness Assessments (REA) of Pharmaceuticals. Background review. July 2011 (version 5B); Germany: Institute for Quality and Efficiency in Health Care (IQWIG). General Methods. Version 4.1 of 28 November 2013. Available from: https://www.iqwig.de/download/IQWiG_General_Methods_Version_%204-1.pdf; The Netherlands: Zorginstituut Nederland. Dutch Assessment Procedures for the Reimbursement of Outpatient Medicines. Joint publication of the Ministry of Health, Welfare, and Sport and CVZ. March 1, 2010. Available from: http://www.zorginstituutnederland.nl/Dutch_assessment_Procedures_for_the_Reimbursement_of_Outpatient_Medicines.pdf; Poland: Agency for Health Technology Assessment. Guidelines for conducting Health Technology Assessment (HTA). Version 2.1. Warsaw, April 2009. Accessed from: http://www.aotm.gov.pl/www/assets/files/wytyczne_hta/2009/Guidelines_HTA_eng_MS_29062009.pdf; Scotland: Scottish Medicines Consortium. Guidance to Manufacturers for Completion of New Product Assessment Form (NPAF) (October 2014). Accessed from: https://www.scottishmedicines.org.uk/Submission_Process/Submission_guidance_and_forms/Templates-Guidance-for-Submission/Templates-Guidance-fkor-Submission

Jurisdiction	England/Wales	Francea	Germany	The Netherlands	Poland	Scotland
HTA organization	NICE	HAS	IQWIG	ZIN	AOTMiT	SMC
Separate REA analysis	No, part of cost-effectiveness analysis	Yes	Yes	Yes	No, part of cost-effectiveness analysis	No, part of cost-effectiveness analysis
Patient relevant endpoints	Survival or health-related quality of life	Mortality, morbidity, health-related quality of life	Mortality, morbidity or health-related quality of life	Morbidity, mortality and/or quality of life	Deaths, cases or recoveries, quality of life and adverse effects	Mortality, survival, incidence of disease, morbidity, functional performance, quality of life
Specific guidance on quality of life	For the cost-effectiveness analyses health effects should be expressed in QALYs EQ-5D is the preferred measure of health-related quality of life in adults. QOL data should be reported directly by patients and/or carers Valuation of QoL data should be representative sample of the UK population. The committee finds it helpful to have the perspective of patients or carers about how relevant the clinical outcomes and the standardized generic instruments for measuring health-related quality of life are to the disease or condition.	The Commission often bemoans the lack of quality-of-life data: tools are available in oncology but are difficult to use repeatedly in clinical trials and vary inter-individually, which reduces their relevance for deciding between treatments and therapeutic strategies. As cancers become chronic, other tools such as examining patient preference or utility could be taken into account by the Transparency Commission in oncology.	Use instruments that are suitable for use in clinical trials. RCTs are best suited to demonstrate an effect. If not possible, other efforts are required to minimize and assess bias (e.g. blinded documentation and assessment of outcomes). For particularly serious or even life-threatening diseases, it is usually not sufficient only to demonstrate an improvement in quality of life if at the same time it cannot be excluded with sufficient certainty that serious morbidity or even mortality are adversely affected to an extent no longer acceptable.	Very little research is undertaken that explicitly focuses on quality of life. However, the added value of a medicine may actually be expressed in the form of an improved quality of life…Firm conclusions cannot always be determined based on the Dutch results of research in which quality of life is a secondary parameter.	A cost-utility analysis should be used when: the health-related quality of life is one of the significant outcomes or if the compared technologies give very different clinical effects and it is necessary to find a common denominator. It is admissible to perform the quality-of-life measurement in the patient population or the preference measurement in the general population. The preference measurement for utility assessment is possible by using direct or indirect preference measuring methods. It is recommended to use indirect methods for preferences measurement—validated questionnaires in Polish. While measuring preferences with the EuroQol (EQ-5D) questionnaire, it is advised to use the Polish utility standard set obtained by means of the—time trade-off method.	Valuing medicines should include gains in length of life and quality of life, as well as adverse effects such as toxicity, which should be included as negative impacts on quality-of-life. SMC prefers generic and validated classification systems which are reliable and appropriate population preference values (choice-based method such as the time trade-off or standard gamble). Ideally, these data will be generated through randomized controlled studies. A higher cost/QALY may be accepted if: more than 3 months survival gain with sufficient quality of life to make the extra survival desirable […] or evidence of a substantial improvement in quality of life (with or without survival benefit). Evidence of a substantial improvement in quality of life (with or without survival benefit); Evidence of a substantial improvement in quality of life (with or without survival benefit).

^a No guideline was publicly available. Other sources were used