Physician Survey on Community-Acquired Bacterial Pneumonia

We conducted a survey on prescribing habits for community-acquired bacterial pneumonia (CABP) in order to better understand the existing unmet needs in the space, current treatment paradigms, and response to updated FDA guidance on the use of fluoroquinolones. We surveyed 120 healthcare professionals, including 34 emergency medicine specialists (EMR), 28 infectious disease specialists (INF), 26 hospitalists (HOS), 16 primary care providers (PCP), and 16 nurse practitioners (NP). We plan to explore the market opportunity for Paratek’s (NasdaqGM: PRTK) omadacycline in the context of our survey results in a follow-up note.

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Key Results from the Survey. Below are the most important findings from our analysis of the survey data:

  • Need for Oral Drugs Targeting Drug-Resistant Pathogens – This was most frequently cited—by 43% of physicians—as the biggest unmet need in CABP.
  • Most Important Features in Selecting an Antibiotic – The physicians cited the importance of an antibiotic being well-tolerated, having an IV-to-oral step-down, and having a low propensity to cause C. difficile infections.
  • Fluoroquinolone Use is Expected to Decrease in CABP – 56% of surveyed physicians expected to prescribe fluoroquinolones for CABP less often following the updated FDA guidance earlier this year.
  • Focus on Lowering Treatment Costs – Lower cost of therapy and reducing hospital stays, a major driver of treatment cost, were commonly cited as pressing unmet needs in CABP.
  • Empiric Treatment is Standard Practice in CABP – The surveyed physicians performed cultures only roughly 40% of the time in CABP patients, highlighting the importance of empiric treatment options.

Oral Antibiotics as a Route to Lower Overall Treatment Costs. Many of biggest unmet needs cited by the survey respondents reflect a desire in the healthcare community to reduce the amount of treatment for CABP that must be administered in the hospital setting. Oral antibiotics capable of treating drug-resistant pathogens, cited most frequently as the biggest unmet need in CABP, may allow for a greater percentage of patients to avoid hospital admission when bacterial resistance is suspected. In addition, a bioequivalent IV-to-oral option can permit earlier discharges from the hospital with a seamless transition to oral therapy. Since hospital stays are a major driver of treatment cost, reducing hospital admissions and enabling earlier discharges can have a substantial impact on healthcare expenditure. Each year in the US, CABP leads to over 1 million hospitalizations, resulting in over $17 billion in annual healthcare expenditure. There appears to be a strong need in the market for oral antibiotics that can reduce inpatient treatment for CABP.

Opportunity in CABP for Novel Antibiotics with Broad-Spectrum Activity. Fluoroquinolones have been a mainstay in the treatment of many community-acquired infections due to their broad-spectrum coverage of relevant pathogens as a monotherapy. This profile has made fluoroquinolones an attractive option for empiric therapy in CABP, particularly when bacterial resistance is a concern. The expected decrease in fluoroquinolone use in CABP, indicated by our survey results, will likely create an opportunity for novel antibiotics that match the broad-spectrum activity of fluoroquinolones with a cleaner safety profile. Of the drugs in development for CABP, Paratek’s (NasdaqGM: PRTK) omadacycline and Nabriva’s (NasdaqGS: NBRV) lefamulin are the two antibiotics that could likely fill this niche in the market if approved. Cempra’s (NasdaqGS: CEMP) Solithera (solithromycin), which has been plagued by concerns over potential liver injury, and Melinta’s (private) Baxdela (delafloxacin), a next-generation fluoroquinolone, are unlikely to satisfy physicians seeking safer alternatives to the fluoroquinolone drug class.

Figure 1. Most Frequently Cited as Biggest Unmet Needs in CABP

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Biggest Unmet Needs in CABP. We asked the physicians what they considered to be the biggest unmet needs in CABP, and permitted up to 5 answers. The top responses are shown in Figure 1. The most frequently cited response, by 43% (52/120) of physicians, was a desire for increased availability of oral drugs targeting drug-resistant pathogens. Reducing the duration of hospital stays (31%) and increasing the availability of bioequivalent IV-to-oral options (30%) were also reported as major needs in the space. Among the infectious disease specialists, who likely see many of the most severe cases of CABP, the two most pressing needs were increased availability of oral drugs targeting drug-resistant pathogens (54%) and bioequivalent IV-oral therapies (50%). Hospitalists and emergency medicine specialists also responded that once-daily dosing was a pressing need in the CABP space.

Tolerability and IV-to-Oral Stepdown Are the Most Important Characteristics When Selecting an Antibiotic. We asked the physicians what they considered to be the most important features in choosing to prescribe a certain antibiotic. The feature rated highest by the physicians was that an antibiotic be well-tolerated. Overall, 88% of surveyed physicians rated this feature either as important or very important. The survey results, shown in Figure 2, also indicate that having an IV-to-oral stepdown and a low propensity for C. difficile infections were particularly important features for the surveyed physicians. Coverage of resistant strains of Streptococcus pneumoniae was also a top response.

Current Empiric Treatment of CABP. Combination therapy consisting of a beta-lactam and a macrolide was reported as the most commonly used empiric treatment regimen for CABP patients, with 29% (35/120) of respondents describing this as their preferred empiric regimen and 87% (104/120) reporting at least some use. The surveyed healthcare providers used fluoroquinolones at similar rates. Fluoroquinolones were the preferred empiric therapy for 21% (25/120) of respondents and 83% (100/120) cited at least some use. In the hospital setting, including emergency medicine, ID specialists, and hospitalists, there are nearly twice as many respondents describing a beta-lactam/macrolide combination as their preferred regimen compared to those preferring fluoroquinolone monotherapy.

Figure 2. Most Important Characteristics in Selecting an Appropriate Antibiotic

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The survey also revealed that healthcare providers do not perform bacterial cultures or susceptibility testing for the majority of their CABP patients. The survey showed that they perform cultures for 43% of their CABP cases and susceptibility testing for 36% of their patients. This highlights the importance of broad spectrum coverage for empiric therapies, since the underlying pathogen and its specific susceptibility profile are not usually known. The surveyed physicians reported that 17% of their empirically treated CABP patients had to be switched to a new therapy for efficacy or safety/tolerability reasons.

Fluoroquinolone Use in CABP Expected to Decrease Following FDA Update. Overall, 56% (67/120) of physicians expected to prescribe fluoroquinolones less often for CABP patients following an update from the FDA recommending against the use of these antibiotics in acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections (uUTI). Fluoroquinolones are associated with a range of serious side effects, including tendon ruptures and neurological sequalae. Although the warning issued by the FDA did not touch on CABP, the survey responses suggest that concerns over the safety of fluoroquinolones may have spilled over into the CABP indication. Of the physicians expecting to prescribe less fluoroquinolones, 90% expected to shift to a beta-lactam and macrolide combination. The physicians also appeared willing to switch to clindamycin, a third-generation cephalosporin, or doxycycline, instead of a fluoroquinolone.

We also asked the respondents who did not expect to prescribe less fluoroquinolones for their reasoning. The most cited reason, by 32% of this group, was that the risk-reward profile was acceptable for their patients. Those who expected to continue prescribing at the same rate also reported a preference for monotherapy and broad spectrum coverage of relevant pathogens. 17% of this group expected their fluoroquinolone use to remain unchanged by the FDA warning since their use of this antibiotic was already quite limited. These results suggest that physicians continuing to use fluoroquinolones place a premium on monotherapies with broad spectrum coverage and that there may be an opportunity for novel antibiotics meeting these criteria with a better safety profile to cut into the market for fluoroquinolones.

Source: LifeSci Capital, LLC research report

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