OBJECTIVES

Optimising patient access to new medicines is a key priority for healthcare systems, who continually seek value-based approaches for reimbursement of innovative therapies. One such approach is dual-branding for a drug with the same active ingredient. Regulators permit dual-branding if the product meets a specific set of qualifying criteria. Although historically there have been challenges associated with this process, there are potential benefits for payers and healthcare systems. This research aims to assess the value and impact of dual branding on patient access in European markets.

METHODS

Eight dual-brand case studies were analysed through secondary research. Insights were validated in thirty-minute interviews with three European payer advisors.

RESULTS

Analysis of the key drivers for achieving successful regulatory approval of a dual-brand indicates it is a nuanced process determined by pre-defined qualifiers, which have varying levels of importance depending on the agent and therapy area. If regulatory approval is successful, the launch of a second brand has wide-ranging implications on market access. For example, the launch of cabozantinib’s second brand resulted in multiple benefits for patients, notably improved access in Italy and Spain, and faster time to market in France. However, trade-offs also exist with reimbursement of a dual brand, particularly the cost impact for payers, with manufacturers avoiding the price reduction typically associated with the indication expansion of a single-brand - although interestingly this was not always the case.

CONCLUSIONS

Dual-branding of drugs can provide value to payers and healthcare systems by improving patient access to novel treatments. However, the three traditional interdependent drivers of reimbursement: broad access, time to market and therapy cost, are seldom - if ever - achieved together. Payers will therefore need to carefully evaluate and balance the trade-offs when assessing dual-brands as a feasible and practical option to bolster patient access and achieve patient-centricity.