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It is important to evaluate how the value of medicine is assessed, as it may have important implications for health technology and reimbursement assessments. The value equation could comprise 'incremental benefit/ outcome' (relative results of care in terms of patient health, comparing the innovation to best available alternative(s)) in the numerator and 'cost' (relative costs involved in the full cycle of care (or a defined period) for the patient's medical condition, incorporating the relevant cost-offsets due to displacement of best available alternative(s)) in the denominator. This 'relative value' combined with the overall net budget impact (of including the drug in the formulary or reimbursed drug list) at the concerned population level in the given institution/region/country may better inform the usefulness of the new therapeutic option to the healthcare system. As product value messages are created, anticipating external stakeholder questions and information needs, including addressing three main categories of 'uncertainties', namely the scientific uncertainties, usage uncertainties, and financial uncertainties, could facilitate demonstration of optimal product value and help informed decision-making to benefit all stakeholders involved in the process.
Keywords: value; access; innovation; uncertainties
Desire to improve efficiency in care delivery and achieve optimal outcomes with increasingly limited resources is in the minds of market access stakeholders globally (1-8). As regulatory agencies put forth stringent requirements for clinical evidence to approve products, these agencies have lately offered to open their doors for an early dialog with drug manufacturers related to design of clinical trials (including choice of subpopulation, endpoints, comparators, etc.) to help shape evidence generation for optimal patient outcomes and demonstration of relative (superior) value of the new intervention in relation to the alternatives (9). One of the ultimate goals is to eventually foster the development and expedite bringing new innovations into the market, to alleviate patient/societal burden in the concerned disease(s).
Marketing authorization of a product (the first step to market access) does not guarantee relevant approvals by payers or health governance organizations (HGOs) that are advised by health technology assessment bodies (HTABs); usefulness of the new therapeutic option to the healthcare system as assessed by payers/HGOs/HTABs (the second step to market access), thus, play a vital role in influencing use, adoption, and reimbursement of the new product in the market (10). Some countries...