Optimization of pharmaceutical research and development by early-phase assessment of investigational medicinal...

Small and mid-sized pharmaceutical innovators often have limited in-house health economics and market access expertise, and may struggle to align development strategies of investigational medicinal products with health system needs and payer expectations. Limited attention to building the health economic story during early development phases may ultimately result in suboptimal return on investment. Early-phase health technology assessment (eHTA) provides a structured approach to value maximization. Selection of the payment model helps to understand what value propositions are taken into account, in general, by the target payers of the new medicine. Fair judgement on the degree of innovation at the expected launch date is essential to choose the relevant propositions from the general list of value drivers. Development of the conceptual value framework translates target product profile into policy-relevant value propositions, such as health gain, expected cost savings through avoided medical events and delayed disease progression, value in use or health system benefits. Implementation of the health economics and outcomes research strategy helps to justify premium price based on added value and facilitate the appropriate order of target indications with the most return on investment. Effective integration of eHTA into the research and development process enables innovators to shorten time to reimbursement and increases the probability of clinical and commercial success for investigational medicinal products.