The 340B Drug Pricing Program and Management of Advanced Prostate Cancer

Introduction: Oral targeted therapies are a standard of care for men with advanced prostate cancer. However, these therapies are expensive, which may be a barrier to some, particularly the most economically disadvantaged. Through investment in programs to assist this population, savings generated from the 340B program have the potential to mitigate barriers to initiating treatment with targeted therapies in these men.

Methods: We performed a retrospective study using a 20% national sample of fee-for-service Medicare beneficiaries diagnosed with advanced prostate cancer between 2012 and 2019. The outcome was the patient-level use of a targeted therapy for the first time. This study had two exposures. The first was 340B penetration, representing the percentage of all outpatient hospital revenue in a hospital referral region generated by a 340B hospital. The second was the degree of socioeconomic disadvantage, as measured by the social vulnerability index (SVI). Two separate Cox models were fit to measure relationships between each exposure and use of a targeted therapy. A third model was fitted to assess whether differences in utilization by SVI were mitigated by increasing 340B penetration.

Results: The use of a targeted therapy did not vary with 340B penetration (adjusted HR 1.1, 95% CI 0.96-1.2) for high versus low penetration. Conversely, socioeconomically disadvantaged men were less likely to initiate treatment. Those residing in the third SVI tertile (i.e., most vulnerable) were less likely to start on a targeted therapy compared to men in the first tertile (adjusted HR 0.85, 95% CI 0.78-0.92). However, increasing 340B penetration did not attenuate these differences (Wald test for the interaction term p = 0.10).

Conclusions: There was no association between a region's 340B penetration and use of a targeted therapy. Furthermore, although the use of a targeted therapy decreased with increased SVI, the 340B penetration of a region did not reduce this gap.