BACKGROUND: Relapse is a substantial risk factor for chronic diseases and is strongly associated with treatment discontinuation, where a major challenge in the management is maintaining treatment adherence. Evidence already in existence indicates that non-compliance increases the clinical and economic burden. Therefore, pharmaceutical companies are entering the market with long-acting modalities to address these compliance issues. The traditional HTA therapeutic benefit assessment, however, is independent of the mode of treatment.

OBJECTIVES: To outline the impact of Long-acting modality on inherent HTA and formulary access in the EU4 (Germany, France, Italy, and Spain) and USA.

METHODS: Primary research was conducted with twenty Payers across the EU4 and USA to understand the impact of long-acting mechanism of therapies on HTA ratings/ formulary decisions and price.

RESULTS: Payers believed that the long-acting modality has little-to-no impact on HTA ratings and formulary decision-making. Innovativeness, clinical outcomes, safety, and cost-effectiveness compared to the existing treatments were found to be key determining factors for higher price, and access. Payers cite Prolia (Densosumab), which is administered once every six months for postmenopausal osteoporosis in women who are at an increased risk of fractures, as an example. Due to its improved efficacy and adherence, Prolia received an ASMR IV and SMR Important rating by the Haute Autorité de Santé (HAS) in France during its initial assessment performed in 2011. However, following a reevaluation in 2018, the HAS rating was demoted to ASMR V and SMR Moderate attributed to safety concerns, and uncertain clinical benefits correlated to lower real-world compliance.

CONCLUSIONS: While the long-acting modality is an important benefit at the patient and prescriber level to achieve a relatively higher uptake/adherence, Payers and HTA bodies look beyond the long-acting mechanism to assess the therapeutic benefit, HTA rating, and pricing/reimbursement status of a novel therapy