By Alastair Macdonald and Noolie Gregory, members of the Real World Evidence/Late Phase team at Syneos Health
Current metrics show that only one third of drug product launches meet expectations, despite the view from most manufacturers that they felt ready for launch.1 Therefore anticipating possible obstacles at the earliest opportunity and generating the appropriate evidence to mitigate these obstacles is essential. To achieve this it is important that, at the earliest planning stage, there is an Integrated Evidence Plan in place that has clearly identified the evidence gaps for not only the regulator but also payers, patients and physicians, to ensure that at product launch there are no impediments to reimbursement and return on investment (ROI) can therefore be maximized.
Importance of Evidence for Oncology Therapies
This is particularly relevant in the area of oncology where the dynamics of therapy have changed significantly with the development of immunotherapy options for patients both in monotherapy and in combination. The competitive landscape will continue to alter significantly over the next 3 to 5 years as this continues to evolve. Given the pace of drug approval, the rapidly changing landscape, new innovative therapies changing the standard of care and the challenge of administrating drugs, stakeholders are increasingly looking at cost versus benefit to the patient. Therefore, creating the necessary value story, as well as building patient and physician advocacy, will be imperative in ensuring good and early product adoption.