Real-World Study Support for PROPEL® Sinus Implant

Patients receiving PROPEL® following endoscopic sinus surgery exhibited statistically significant lower healthcare resource utilization over a postoperative period of 18 months. This included all-cause otolaryngologist, ER/urgent care and outpatient visits, as well as sinus-related endoscopies

Sinus Surgery

We’ve covered the developing story of Intersect ENT’s PROPEL implant before, including in early 2021 when it gained a CMS code.

Chronic rhinosinusitis (CRS) causes severe symptoms, leading to patient discomfort, poor quality of life and added healthcare resource utilization (HCRU). Endoscopic sinus surgery (ESS) can improve CRS symptoms. However, post-surgical scarring, adhesion formation and early polyp recurrence can compromise surgical outcomes. Intersect ENT’s PROPEL sinus implants uniquely provide mechanical stenting of a patient’s sinuses. Beneficially the implant enables localized delivery of the corticosteroid mometasone furoate directly to healing sinus tissue. This has demonstrably improved outcomes after sinus surgery in previous studies.

Study details

The newly reported observational, cohort study used real-world evidence (RWE) data from adult patients with CRS with or without nasal polyps who underwent ESS. Results demonstrate that patients receiving PROPEL® sinus implants following sinus surgery had lower HCRU over a postoperative period of 18 months compared with patients who did not receive an implant. Find results from the first-of-its-kind study using RWE online in Current Medical Research and Opinion.

The study examined claims, electronic medical records and other data from patients with CRS with or without nasal polyps who underwent ESS between 2014 and 2019 and had at least 18 months of data before and after surgery. Patients receiving PROPEL sinus implants (N = 1,983) were matched to patients who did not receive implants (N = 1,983). The matched cohorts were similar with respect to age, sex, race, year of surgery, and insurance type. However, more patients in the implant cohort underwent surgery involving multiple sinuses than the non-implant cohort (94.8% vs. 85.1%), suggesting that patients in the implant cohort may have had greater disease severity than those in the non-implant cohort. Key study findings during the 18 months of post-surgical follow-up revealed that patients in the implant cohort compared to the non-implant cohort had a statistically significant reduction in:

  • All-cause otolaryngologist visits (47.3% vs. 59.6%, p < 0.001)
  • All-cause ER/urgent care visits (9.2% vs. 11.8%, p = 0.007)
  • All-cause outpatient visits (94.3% vs. 96.6%, p < 0.001)
  • Sinus-related endoscopies (39.1% vs. 43.8%, p = 0.003)

Although not statistically significant, fewer patients in the implant cohort underwent repeat surgery compared to the non-PROPEL cohort (4.6% vs. 5.3%, p = 0.273).

RWE sinus study limitations

In its press release, Intersect ENT points out the limitations of the RWE studies. For instance it says they cannot definitively establish causality and are designed to evaluate associations. Limitations in this study included: no identification of the specific sinuses in which implants were placed, imaging studies were limited to sinus related procedures (it is possible that imaging was completed on non-CRS related sinus issues), a lack of medication data available to allow for a complete assessment of medications used to treat CRS patients, and potential for incomplete data capture.

Investigator comments

“These real-world evidence results are compelling, especially given the potentially higher disease severity among patients who received PROPEL,” said James Kallman, MD, FACS lead author on the paper. “Due to this potential difference, the results may underestimate the full impact of PROPEL on healthcare resource utilization and revision surgery. The results indicate that PROPEL can reduce multiple aspects of healthcare resource utilization in chronic rhinosinusitis patients, which may translate into a reduction in these patients’ overall healthcare costs. Combined with the previously demonstrated clinical benefit that PROPEL can provide to patients, these real-world evidence results provide compelling evidence to support the use of PROPEL in patients undergoing endoscopic sinus surgery.”

Company comments

“As one of the first observational studies to use real-world evidence to assess healthcare resource utilization in patients with chronic sinusitis who underwent endoscopic sinus surgery, the results provide important longitudinal data that can support the use and reimbursement of the PROPEL sinus implants,” said Thomas A. West, President and Chief Executive Officer of Intersect ENT.

“The data show that patients receiving PROPEL had statistically significant lower healthcare resource utilization with respect to all-cause otolaryngologist, urgent care and outpatient visits, as well as sinus-related endoscopies, with a trend toward a reduction in revision sinus surgeries for the 18-month period following sinus surgery. These results clearly demonstrate a positive impact of the PROPEL sinus implants that translates into improved economic outcomes across the episodes of care for patients with chronic sinusitis undergoing sinus surgery. We intend to incorporate these findings into our ongoing discussions with payers as we strive to increase patient and physician access to PROPEL in appropriate populations.”

Source: Business Wire

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