OBJECTIVES: This research examines access and reimbursement challenges for emerging neuropathic pain (NP) agents in the EU5 (France, Germany, Italy, Spain, UK) given rising disease prevalence, long-available and low-priced analgesics, and growing generic presence in key drug classes.

METHODS: Across the EU5, 259 GPs and pain specialists were surveyed regarding their prescribing for NP, while 15 payers who influence reimbursement were interviewed.

RESULTS: Interviewed payers demand staunch demonstration of clear clinical benefits from emerging NP therapies, specifying robust efficacy and/or safety improvements over existing standards of care (SOC). Similarly, the largest percentage of surveyed physicians across countries (25-46%) identify efficacy benefit versus SOC as their main driver for prescribing new drugs, followed by safety/tolerability advantages. Notably, payers interviewed consider the profile of emerging antiepileptic mirogabalin not sufficiently differentiated from that of pregabalin (Lyrica), warning that if superior efficacy is not proven, premium pricing and advantageous positioning cannot be justified. This is especially pertinent as our research also reveals that despite ongoing patent protection of pregabalin in NP, availability of generic pregabalin for non-NP indications represents a pricing and uptake barrier for new NP brands given off-label generic use in several EU5 markets. Yet, surveyed physicians’ estimated uptake of mirogabalin is 29-42%, with expected use relatively early in the treatment algorithm. This likely reflects the imprecise nature of prescribing owing to the complex pathology of NP. In addition, physicians cite NP-subtype-specific labeling as an uptake lever, reflecting interviewed payer consensus, which pinpoints NP-subtype-specific labelling as financially advantageous given the smaller patient population versus drugs with a broad pain label.

CONCLUSIONS: Optimal access and reimbursement are achievable for emerging NP agents that showcase superiority over SOC. Targeting NP/NP subtypes specifically would curry favor among payers due to reduced budgetary impact, and could encourage uptake over more-broadly labelled alternatives which may not target key mechanisms underlying neuropathy.