Coverage of Solesta for Fecal Incontinence

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

We are trying to get Solesta, the only FDA approved rectal bulking agent to treat Fecal Incontinence, paid for by Medicare, Medicaid and other insurance companies. Solesta, made by Palette Life Sciences, is indicated for the treatment of FI in patients 18 years and older who have failed conservative therapy (i.e., diet, fiber therapy and anti-motility medications). We are an aging population and more and more women are coming forward with FI and will be needing Solesta, however, it is much too expensive to be paid for out of pocket.

2. Why are you struggling with this issue?

I am a 68 year old active woman with Fecal Incontinence. Solesta has been a Godsend to me and had been covered at the time by my two previous insurance companies. When I went on Medicare, I was informed that Medicare would not cover Solesta. The out of pocket for me would have been $4,000.00–$5,000,00 every six to nine months. I could not afford that and neither could my doctors practice. I've had to go without for the past 2 years.

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 FI treated by the insurances as any other disability or illness. Since more and more women in particular (although men, too, can suffer from FI) are now admitting to having loss of bowel control or anal leakage, Medicare and other insurances need to be made aware of the need for Solesta to help us lead active lives with knowing we don't have to worry so much about the embarrassment of soiling ourselves.

4. When do you need the evidence report?

Friday, January 1, 2021

5. What will you do with the evidence report?

For some, Solesta may only be needed once or twice in their lives. For others, they may need an injection at the six or nine month mark or annually. Everyone reacts to the bulking agent differently. Being confident that a one has coverage for Solesta can ease the worry of "out of pocket" surprises for so many of us.

Supporting Document

Title or short description: My FI Journey

Comments or notes about this file: I was unable to download my story but I will send it with a hard copy of this questionnaire.

(Optional) About You

What is your role or perspective? Patient

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