OBJECTIVES:

To highlight instances where manufacturer HEOR data and/or pharmacoeconomic models positively influenced “changes” to US payer formulary coverage, or alternatively, instances where manufacturers invested in HEOR analyses with limited tangible impact on payer coverage decisions, and elucidate underlying payer rationale shaping value perceptions of manufacturer HEOR data.

METHODS:

The study employed a pragmatic literature, industry, and US payer policy review to determine instances of HEOR datasets tangibly impacting US payer formulary coverage, or having limited impact, supplemented by prior CBPartners HEOR-focused US payer primary research. Additionally, an online survey was conducted with a curated list of n=15 US payers across MCO, IDN, and PBM organizations to provide further context surrounding recent examples of manufacturer HEOR data materially influencing decisions at P&T, different ways HEOR data can subsequently change formulary coverage, and the extent to which “HEOR class effects” may negatively impact late-to-market competitors within crowded therapeutic classes.

RESULTS:

In one instance of HEOR data positively impacting formulary coverage, tiotropium bromide’s pharmaco-economic model linked its exacerbations data to downstream savings, which ultimately influenced some payers to prefer it in the COPD setting. However, other examples exist of HEOR data failing to move the needle for payers to substantially improve access or policy, such as PCSK-9 outcomes data subsequent HEOR impact. Additionally, as other therapy areas (i.e. moderate-severe asthma; diabetes; etc.) become more crowded and manufacturers seek further differentiation for their products, “HEOR class effects” may become more prevalent, whereby one product’s HEOR analyses negatively impacts future competitors by resetting the standards for payer data requirements.

CONCLUSIONS:

US payer organizations employ different philosophies towards incorporating HEOR analysis into changes (positive or negative) in formulary and access decisions, highlighting the benefit in studying evolving payer interpretations of manufacturer HEOR analyses to help reconcile underlying rationale shaping value perceptions.