In early July 2022, I learned from the American Association for the Study of Liver Disease (AASLD) that they’ll be updating their PSC Guidance to limit the use of oral vancomycin to clinical trials. Their Guidance will also state that treating IBD associated with PSC is outside their scope.
If this AASLD Guidance passes, insurance companies may start denying coverage of oral vancomycin.
Why Is the AASLD Limiting Vancomycin Access to Clinical Trials?
My fellow PSC advocates and I have asked AASLD multiple times to explain why they are recommending this restriction given that there are more than 21 papers published on OV’s effectiveness for PSC, no reported side effects within the PSC community, and hundreds of patients are taking vancomycin and doing well with both their gut and liver symptoms stable or normalized.
AASLD has not answered any of our questions.
How Will this New Guidance Affect You and Your Ability to Access Vancomycin?
Insurance companies will likely start denying coverage of oral vancomycin for PSC.
I and many other PSC patients may lose our medication. It’s the only medication on the market that has shown effectiveness to keep this terrifying, progressive liver disease in remission.
Oral vancomycin is an antibiotic shown to stop, slow, and even reverse the progression of PSC—an autoimmune liver disease. I’ve been taking vancomycin for my PSC for the past 4.5 years through my physician’s prescription, and it’s the healthiest I’ve ever been since being diagnosed with my chronic illnesses.
If you ARE taking vancomycin, this is how you may be impacted
If you’re currently taking vancomycin, you may start to see denials and lose your coverage. You’ll have to appeal this denial; we have appeal templates that we can share with you but success is not guaranteed.
During the appeal process, you may experience months of delay in coverage of vancomycin during which time you will have to pay out of pocket for vancomycin.
If you’re NOT taking vancomycin, this is how you may be impacted
If you’re currently not taking vancomycin, you may not be able to find a doctor willing to prescribe vancomycin outside of a clinical trial; if you do, insurance may not cover it.
I believe that every PSC patient should have the right to receive an vancomycin prescription from their doctor, and the new Guidelines will essentially take away this option to start vancomycin in the future.
What Does it Mean That Treating IBD Associated with PSC is Outside the AASLD’s Scope?
Because “treating IBD associated with PSC is outside the AASLD’s scope,” gastroenterologists will likely refuse to prescribe vancomycin to manage your IBD symptoms associated with your PSC.
The AASLD is essentially separating PSC-related IBD from PSC and calling them two unrelated diseases—which they are not, as 80% of PSC patients also have IBD. Ultimately, this will further prevent PSC patients from accessing OV.
Why Can’t PSC Patients Just Join a Clinical Trial?
There is only one vancomycin clinical trial in the US. This 18-month trial takes place at the Mayo Clinic sites and puts 50% of patients on placebo. The vancomycin dosing is 4 times a day with a liquid drug.
Unfortunately, this trial is not patient-friendly. Below is just some of the exclusion criteria:
- If you’re a child,
- If you’ve taken an antibiotic within the past 3 months of joining (AKA everyone currently taking oral vancomycin),
- If your liver numbers are not high enough (again, many patients taking oral vancomycin have normal liver numbers),
- If you have small-duct PSC,
- If your ulcerative colitis or Crohn’s is currently flaring,
- If you don’t have the time, ability, or economic means to regularly travel to a Mayo Clinic site. (Traveling for certain visits is at the patient’s own expense).
Many patients who lose vancomycin coverage won’t qualify or have the means to join this trial. You can read more of the inclusion and exclusion criteria here.
Can PSC Patients Pay for Oral Vancomycin Out-of-Pocket?
Though oral vancomycin is a generic drug, it’s not cheap. Depending on the patient’s brand, dose, and what pharmacy discounts they can find, the cost of a one-month supply of oral vancomycin can be hundreds to thousands of dollars per month.
This is a steep price that many of us cannot afford, especially since we’ll be on this medication long-term.
What You Can Do To Help Prevent This AASLD Guidance From Passing
My fellow advocates and I think it’s critically important to do two things:
- Sign the petition, and
- Share your patient stories by describing your (or your child’s) positive experience with oral vancomycin.
Maybe the AASLD doesn’t realize how many patients are taking vancomycin and have not considered the devastating effect this Guidance will have on the PSC community—it’s up to us to inform them.
1. Sign the Petition
Please SIGN THIS PETITION to request that the AASLD remove the language from the PSC Guidance that limits the use of vancomycin to patients in clinical trials.
2. Email Me Your Patient Letter
If you or a loved one has had a positive experience taking vancomycin for PSC, please write a short one-page letter detailing your symptoms, lab work, and quality of life before and after vancomycin. Be sure to include data (liver numbers, improved MRCP results, etc) wherever possible to back up your story. See a sample letter here.
When this blog post was originally published in July 2022, we asked the PSC community to send these letters directly to the AASLD. We are no longer asking you do this. On July 11, 2022, I emailed 50+ patient letters to the AASLD with the email subject line, “Do we matter to you?” and they never responded.
Since the AASLD is currently not acknowledging the PSC patient community, please just email your patient letters to me at jenna@thecomicalcolon.com. It’s still critical that we collect these powerful, inspiring patient stories as they can be used in other ways in this fight against the AASLD.
Thank You for Supporting the PSC Community
THANK YOU for taking the time to fight against these proposed Guidance. With your help, we can prevent the AASLD’s restrictive Guidance from being published.