On September 9, 2022, the American Association for the Study of Liver Diseases (AASLD) officially published their PSC Guidance as well as an Support Statement. In this post, I’m going to share why the Guidance for the oral vancomycin section is negative, why the Support Statement is positive, and what this means for PSC patients taking and who want to take oral vancomycin.
What is the AASLD Guidance?
Regarding oral vancomycin, the AASLD Guidance states: “Given the potential for antibiotic resistance and lack of adequate randomized clinical trials, at this point, there is insufficient evidence to recommend the use of oral vancomycin for the treatment of PSC.” (Read the rest of the Guidance here.)
In short, this Guidance is disappointing, biased, and NOT what the PSC community has been fighting for these past few months.
This Guidance relies heavily on Deneau’s retrospective matched analysis—a flawed and biased paper that was severely criticized by many prominent physicians in the hepatology and gastroenterology community.
Additionally, the phrase “potential for antibiotic resistance” is unfounded and not supported by any evidence that we’re aware of. This is simply theory. Yes, antibiotic resistance can occur when taking long-term IV antibiotics, but oral vancomycin has not shown to cause antibiotic resistant infections or any adverse side effects in the PSC community.
Hundreds of patients have taken oral vancomycin in clinical trials—none of which have documented antibiotic resistance in their subjects.
How May the AASLD Guidance Impact the PSC Patient’s Access to Oral Vancomycin
The phrasing of this Guidance will likely make it difficult for PSC patients to access oral vancomycin from both physicians and insurance companies.
Physicians May Not Prescribe Oral Vancomycin
Physicians may refuse to prescribe it in fear of if being sued if the patient gets an antibiotic resistant infection. (Remember, this fear is just theory).
Newly diagnosed PSC patients will probably have a difficult time finding a physician who will prescribe oral vancomycin. Additionally, physicians who currently prescribe may stop doing so.
Insurance Companies May Deny Coverage of Oral Vancomycin
The AASLD claims the phrasing of this Guidance is neutral, but it is not. Insurance companies are always looking for reasons to deny coverage of expensive medications and insurance companies will likely start denying coverage of oral vancomycin.
If you’re currently taking oral vancomycin, you may not see denials immediately; they may trickle in over the next six months as insurance companies become aware of this Guidance update.
What is the AASLD Support Statement?
The AASLD also published a supplemental material called the Support Statement. Unlike the Guidance, the Support Statement is positive.
Please read the Support Statement here. Here are four important positive statements the AASLD makes in the Support Statement:
- The Guidance does not make a recommendation for or against oral vancomycin for the treatment of PSC
- The decision to use an off-label medication should remain between the doctor and the patient
- The Guidance should not be used as justification to restrict insurance coverage of this treatment if a physician feels it is the right course of action
- We look forward to continuing to work with our patient community as dedicated allies in the quest for effective treatments and cures for all liver diseases, and we remain committed to engaging with and supporting the patient community to ensure they receive the care and treatment they need and deserve
The AASLD wrote this Support Statement because of YOU—the incredible PSC patients, caregivers, and advocates who wrote to the AASLD, signed the petition, and spread the news of this pending Guidance. The Children’s PSC Foundation also played an integral role; they were the only PSC-focused organization to actively advocate alongside the PSC community.
The Support Statement itself is a win and you should feel very proud for influencing the writing of this letter. Great work!
How May the AASLD Support Statement Impact the PSC Patient’s Access to Oral Vancomycin?
This Support Statement is not the Guidance and it is kept separate from the Guidance. Though it likely will not help patients access oral vancomycin, the Support Statement may be a helpful document in appeals.
You should bookmark the Support Statement on your browser so if your insurance ever denies coverage of oral vancomycin, you can easily locate and print the Support Statement to include in your case when you appeal!
Why is the Support Statement Separated from the Guidance?
We are disappointed that the Support Statement is not linked in the Guidance. I, personally, see this as an attempt to placate the PSC community.
The Support Statement claims that the Guidance “should not be used as justification to restrict coverage of this treatment if a physician feels it is the right course of action.” But how will insurance companies know that they cannot restrict coverage of this treatment if the Support Statement is not linked directly within the published Guidance??
How the AASLD Can Support the Patient Community to Ensure We Receive the Care and Treatment We Need and Deserve
The AASLD needs to hyperlink to the full Support Statement PDF directly within the Antibiotics section of the online Hepatology journal AND include the full Support Statement in the “Guidance Statement” area beneath the Antibiotics section in both the online and printed journal before the journal’s final version is officially published.
If the Support Statement is not linked directly in the Guidance, this will be detrimental to patients because physicians and insurance companies will not know to look for the Support Statement; they read the Guidance directly from the published paper, not the website.
I look forward to seeing the AASLD link to and include the Support Statement in their online and printed journal as they remain committed to supporting the patient community to ensure we receive the care and treatment we need.
What Happens if Your Oral Vancomycin is Denied By Insurance?
If your insurance company denies coverage of your oral vancomycin, PLEASE FILL OUT THIS FORM. It is VITAL that we stick together if we lose coverage of our medication. Cynthia Buness and I have an appeal template and supporting documentation and we can help you file your appeal.
The Google Form is important to fill out so that we can track which insurance companies are denying coverage.
Conclusion
Though the Guidance is not what we were hoping for, the Support Statement itself is a win as it may help PSC patients win insurance appeals. You should feel very proud for helping influence the writing of this letter.
The fight to making oral vancomycin accessible to the PSC community is far from over, but we are in a much better spot than we were months ago. This is all thanks to the Children’s PSC Foundation and each patient, caregiver, and family member who wrote a letter, signed the petition, and helped spread the word.
Always remember: our voices are powerful.