DIA 2019 Global Annual Meeting

Research costs are increasing exponentially and patient populations are becoming more targeted. Healthcare systems throughout the world are struggling to cope with the costs of ever more specialized medicines. While these drug candidates hold the promise of slowing, or even curing disease progression, these innovations also often have limited evidence on long-term impacts. Regulators might wrestle with decisions on early access, but payers may also be reluctant to grant coverage for eligible patient populations. Early access may mean continued evidence generation once the drug is on the market, but traditional payment methods may not be well suited to address these issues, and their use may result in reduced coverage and patient access. This forum will identify challenges associated with early access, as well as coverage and reimbursement decisions associated with novel drug types, where there may be incomplete evidence or uncertainty of long-term value. Participants will focus on whether the current system is equipped to handle upcoming, novel therapies, and if not, what approaches would be best to pursue.