Updating Treatments for Fecal Incontinence VI

1. What is the decision or change you are facing or struggling with where a summary of the evidence would be helpful?

We recommend that AHRQ update its March 21, 2016 systematic review entitled "Treatments for Fecal Incontinence" (FI) to reflect the latest evidence about treatment modalities, specifically including the latest evidence about perianal bulking with non-animal stabilized hyaluronic acid/dextranomer [NASHA/Dx FI]), a biocompatible injectable bulking agent, which is the only bulking agent approved by the U.S. Food and Drug Administration (FDA) for the treatment of FI.

2. Why are you struggling with this issue?

AHRQ's 2016 review was issued prior to availability of more recent studies demonstrating the long-term efficacy, safety, and durability of NASHA/Dx FI. This new evidence warrants an update, as the 2016 document ends with the words: "future studies with higher quality could change the conclusions of this review." Moreover, other bulking agents have not been studied to this degree or achieved approval by FDA for this indication, so we struggle with AHRQ's prior guidance generalized to all bulking agents, as they are not comparable. In addition,  as the prior review notes, sacral nerve stimulation (SNS) is a high-cost treatment, and we believe that the body of evidence now clearly demonstrates that its high cost and limited efficacy means it should be used only after failure of minimally-invasive options such as NASHA/Dx FI.  As a former appointee of CMS’ Medicare Evidence Development and Coverage Advisory Committee (MEDCAC), I recognize the importance of having current, contemporary clinical evidence to inform coverage decisions. I also note that important long-term data documenting treatment impact on patients' reported health-related quality of life was not considered in the prior review, but is now available following data which has been accepted for presentation at the 2020 PFDWeek Conference : Quiroz LH, Galliano Jr. DE, Da Silva G, et al. Efficacy and Safety of a Non-Animal Stabilized Hyaluronic Acid/Dextranomer (NASHA/Dx FI [Solesta®]) in Improving Fecal Incontinence: A Prospective, Single-arm, Multicenter, Clinical study with 36 Month Follow-up. (Abstract accepted for Presentation). In: PFDWeek 2020.

3. What do you want to see changed? How will you know that your issue is improving or has been addressed?

We would like to see all evidence of NASHA/Dx FI’s safety and effectiveness considered, including:

• Mellgren et al., 2014 Publication: Reports long-term efficacy of Solesta^® at 12 and 36 months, yet was not included among the sources cited for AHRQ's 2016 guideline.
• Franklin et al., 2016 Publication: Analyzed & highlighted the benefit of NASHA/Dx FI vs Sham in specific key patient sub-groups.
• NASHA/Dx FIPost Approval Study (PAS), 2020: 283-patient, 36-month, multi-center PAS with robust long-term outcomes data accepted by FDA for fulfillment of Solesta post-approval study requirements for fulfillment of an agreed post-marketing commitment and presentation at 2020 PFD WEEK with publication pending. The PAS  demonstrates:
  • Real-world safety, efficacy, and medical appropriateness of NASHA/Dx FI
  • Significant improvements in objective clinical measures, re-intervention rate (>80% of patients treated do not require re-intervention through 36-months post treatment), and durability
  • Sustained statistically & clinically significant improvement in the CCFIS and FIQL scales

Also, we believe this evidence warrants a recommendation for NASHA/Dx FI that is separate and distinct from that for other bulking agents, as none of the other bulking agents are approved by FDA for this indication and none have produced evidence of sustained safety and effectiveness in real-world use.

4. When do you need the evidence report?

Monday, March 15, 2021

5. What will you do with the evidence report?

We will use the updated guideline primarily to educate physicians, patients, and third-party payers with respect to the current state of evidence in the treatment of fecal incontinence, which affects up to 8.3% of non-institutionalized adults, drives over $11B in annual healthcare spending, and increases the likelihood of referral to a nursing home by 10–15%.

Supporting Document

Title or short description: Efficacy and Safety of a Non-Animal Stabilized Hyaluronic Acid/Dextranomer (NASHA/Dx FI [Solesta^®]) in Improving Fecal Incontinence (PDF, 179 KB)

Comments or notes about this file: Quiroz LH, Galliano Jr. DE, Da Silva G, et al. Efficacy and Safety of a Non-Animal Stabilized Hyaluronic Acid/Dextranomer (NASHA/Dx FI [Solesta^®]) in Improving Fecal Incontinence: A Prospective, Single-arm, Multicenter, Clinical study with 36 Month Follow-up (Abstract accepted for Presentation). In: PFDWeek 2020.

(Optional) About You

What is your role or perspective? Researcher who has evaluated QOL data from large post-approval study of FI Treatment

If you are you making a suggestion on behalf of an organization, please state the name of the organization: Boston Healthcare Associates

May we contact you if we have questions about your nomination? Yes