Novel antibiotic development has been relatively stagnant for decades, despite critical unmet need and the development of antimicrobial resistance (AMR) around the world. One of the main challenges novel antibiotics face is low utilization which creates obstacles for manufacturers in this space.

To understand this issue in more granularity, Avalere Health conducted a claims analysis of fee-for-service (FFS) Medicare beneficiaries who received drug therapy associated with a diagnosis for community acquired bacterial pneumonia (CABP) over a one-year period. We assessed where Medicare beneficiaries were being treated for CABP and how they progressed through various lines of antibiotic therapy. For the purposes of the analysis, Avalere Health assigned six drugs to first, second, and third-line treatment categories based on clinical practice guidelines and further informed through market research with providers treating CABP patients. Medicare beneficiary claims were then segmented into broad care channels: inpatient, outpatient, and pharmacy.

Avalere Health found that most patients with CABP were treated in the outpatient setting. Across inpatient, outpatient, and pharmacy channels, 81% of patients received a first line antibiotic, 38% received a second line antibiotic, and less than 1% received a third line antibiotic. Because one patient may receive a first, second, and/or third line antibiotic, these percents sum to more than 100%.

Medicare beneficiaries diagnosed with CABP and treated with an antibiotic in the inpatient setting were considered the most complex patients and constituted 21% of sample studied. Among this group, the majority (79%) received a first-line antibiotic and fewer received second- or third-line products (18% and 3%, respectively).

The analysis highlights that the need for novel antibiotics to address AMR remains high, but currently available first-line antibiotics are used to treat most CABP patients in the inpatient and outpatient settings. Additionally, new-to-market antibiotic products can face unique access dynamics including downward pricing pressure and payer restrictions that potentially limit access. It is paramount to understand market access factors like unique patient dynamics, prescriber treatment patterns, and payer considerations to guide the strategic development, commercialization, and improve patient access to novel antibiotics.

Methods

This analysis utilized the 100% Medicare FFS claims, accessed by Avalere Health via a research collaboration with Inovalon, Inc. and governed by a research-focused CMS Data Use Agreement. Patients included in this study were diagnosed with CABP in 2022 and received at least one of six selected antibiotics as treatment. Channel definitions were based on the setting for which an antibiotic claim was identified.