DECEMBER - JANUARYLIFE SCIENCES REVIEW8By Lothar Tremmel, Vice President, QCSR at CSL BehringTHE ROLE OF PATIENT REPORTED OUTCOMES TO SUPPORT REIMBURSEMENT AND MARKET ACCESS IN MAJOR EUROPEAN COUNTRIES AND THE UShe effect of new therapies on health-related quality of life (HRQoL) has become an important consideration in establishing reimbursement and market access in many countries. A patient reported outcome is any report of the status of a patient's health condition that comes directly from the patient without interpretation of the patient's response by a clinician or anyone else.1 The objective of this brief report is to describe the ways in which PROs are used to support reimbursement and market access in major European markets as well as the US.Countries that rely on cost-effectiveness modeling to evaluate reimbursement, such as the UK, use generic PROs that do not apply to a specific disease. The EQ-5D-5L is the tool preferred by NICE, the UK reimbursement agency, to determine the decrement TIN MY OPINIONLothar Tremmelin HRQoL associated with different health states included in cost-effectiveness models.2 The time that patients stay in different health states differ for different therapies. The different therapies used in the treatment of a condition are then compared in terms of their mean costs as well as the mean decrements in HRQoL associated with each therapy through the cost per quality of life year gained. Therapies with higher costs may still be cost-effective relative to other therapies if they lead to better outcomes and less time in health states associated with greater decrements in HRQoL.In Germany, reimbursement is evaluated based on the therapy's impact on mortality, morbidity, HRQoL and the adverse effects associated with the new treatment.3For the assessment of HRQoL, Germany prefers the SF-36 which is a different generic PRO but PROs developed for a specific disease are accepted provided they are well validated. GBA, the Germany reimbursement agency, has also established its own criteria to assess a clinically meaningful difference between the effect of the new therapy on HRQoL relative to standard of care.
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