If you’re taking oral vancomycin for your PSC, there are three documents you NEED to be aware of.
Understanding these three documents may help you access oral vancomycin from a physician and from your insurance.
All three documents are associated with the American Association for the Study of Liver Diseases (AASLD). Let’s take a deep dive into each document.
Document 1: AASLD Guidance
The AASLD updated its PSC Guidance in August 2022. Disappointingly, the Guidance document is phrased in a negative/neutral way that states the AASLD cannot recommend the use of oral vancomycin for the treatment of PSC.
If you’re taking or considering taking oral vancomycin for your PSC, you NEED to be aware of this.
The AASLD 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.”
Let’s break this phrase down into its two parts.
Part 1: “Given the potential for antibiotic resistance…“
A big reason why physicians won’t prescribe oral vancomycin is because they fear the patient might develop antibiotic resistance. However, we cannot find any data about antibiotic resistance in the PSC community that justifies the AASLD putting that hedge in the Guidance.
Yes, antibiotic resistance can and does occur with IV vancomycin. But PSC patients take oral vancomycin. Approximately 300 PSC patients have taken oral vancomycin in the 21+ published papers showing oral vancomycin ‘s effectiveness, and not one case of antibiotic resistance has been reported.
Additionally, small studies have looked specifically for antibiotic resistance and any negative side effects. None have been found.
The AASLD claims to be “evidence-backed”—which is ironic because they refused to provide us any scientific backing to this statement when we’ve asked.
Part 2: “…lack of adequate randomized clinical trials, there is insufficient evidence to recommend the use of oral vancomycin for the treatment of PSC.“
Yes, more clinical trials are needed. But why would the AASLD ignore the findings of 21+ published papers including pilot studies, case series, case reports and all the patient anecdotes, to rely on the flawed and biased study mentioned in the Guidance? Because that biased study was written by one of the members on the AASLD decision-making committee.
How May the Guidance Impact the PSC Community?
This Guidance phrasing may be considered neutral by some, but, honestly, its phrasing is open to interpretation. And, sadly, patients will lose access to oral vancomycin because of this Guidance—both because physicians may not prescribe it (or will stop prescribing it) and because insurance will deny coverage.
I know this sounds bleak, but keep reading! The other two documents may benefit the PSC community access oral vancomycin.
Document 2: AASLD Support Statement
When the AASLD updated its PSC Guidance in August 2022, they also published a Support Statement.
This Support Statement is phrased in true neutral language—which is really good news for the PSC community! It states that the AASLD Guidance does not make a recommendation “for or against” the use of oral vancomycin for the treatment of PSC. The Support Statement might help you win appeals if your insurance denies coverage of oral vancomycin.
Unlike the Guidance (which is written in negative/neutral language and includes concerns that are unsupported by data and relies solely on a flawed and biased paper), the Support Statement is actually helpful.
Here are three key points the AASLD states in the Support Statement:
The Guidance notes the insufficiency of the evidence and accordingly does not make a recommendation for or against the use of oral vancomycin for the treatment of PSC.
In the absence of a definitive clinical trial, the decision to use an off-label medication should remain between the doctor and the patient.
Although there is not sufficient evidence to make a formal recommendation regarding the use of vancomycin for PSC, it should not be used as justification to restrict coverage of this treatment if a physician feels it is the right course of action.
If you have PSC and are taking or considering taking oral vancomycin, SAVE THIS LINK to the Support Statement. Better yet, download it. Print it. Hang it in on your wall in a picture frame.
How May the Support Statement Impact the PSC Community?
This document may help PSC patients win insurance appeals when fighting for oral vancomycin access!
If your insurance ever denies coverage of oral vancomycin, you must include this Support Statement in your appeal. Its pure neutral language cannot be misinterpreted: insurance companies CANNOT rely on the AASLD’s Guidance to deny coverage of oral vancomycin.
Document 3: AASLD Letter to the Editor
Some incredible advocates including PSC researcher Cynthia Buness and prominent physicians in the PSC space wrote a Letter to the Editor (LTE) for Hepatology, the journal run by the AASLD.
(What’s a Letter to the Editor? It’s a short communication that gets published in a journal that allows for readers to interact with the authors by sharing thoughts, criticisms, and opinions.)
This particular LTE was accepted and published in AASLD’s Hepatology, and the LTE explains why insurance should cover oral vancomycin for PSC. Since it was published in the AASLD’s very own journal, patients should benefit from he AASLD’s public support when dealing with insurance appeals.
Since the AASLD did not link their helpful PSC Support Statement in their biased Guidance LIKE THEY WERE SUPPOSED TO, this LTE is a big win! This LTE was published in the January 2023 edition of Hepatology.
How May the LTE Impact the PSC Community?
Having the AASLD’s public support that oral vancomycin should be covered by insurance should help patients win appeals if their oral vancomycin is denied coverage!
How so?
Well, the LTE does what the AASLD failed to do: it links the Support Statement to the published Guidance in their journal Hepatology.
The LTE authors copied and pasted the beneficial language from the AASLD’s Support Statement directly into the LTE. This is EXCELLENT because physicians and insurance companies can easily access and read published LTEs in online searches—which means they’ll see the helpful language quoted directly from the Support Statement AND the reasons oral vancomycin should be covered by insurance whenever they access the AASLD Guidelines.
Additionally, this LTE states that insurance companies should cover oral vancomycin for PSC, gives supporting economic reasons, and highlights published papers that support oral vancomycin therapy along with its positive effects on liver and gut disease symptoms.
Here are some beneficial statements you’ll find in the LTE:
Treating PSC with oral vancomycin might translate to fewer liver transplants, fewer hospitalizations for acute cholangitis, and other expensive consequences of not treating this devastating disease.
For responsive PSC/inflammatory bowel disease (IBD) patients, insurers stand to benefit financially by allowing OV to be substituted for biologic drugs. Biologics typically cost 5 times more than OV.
While OV does not work for all PSC patients, no other treatment (besides liver transplantation) has proven effective in even a subgroup of PSC patients. Medical and financial reasons for insurers to cover OV for PSC are compelling as long as the physician and patient can demonstrate that OV benefits the patient.
Now, when physicians and insurance companies read the AASLD’s published Guidance, they will also see the Support Statement because it’s linked and woven into the LTE.
In Conclusion
It’s difficult for PSC patients to access oral vancomycin. As you can see, there are political and self-serving reasons why the AASLD speaks negatively about it and why some physicians won’t prescribe it.
Thankfully, we have passionate advocates, physicians, and the Children’s PSC Foundation who are dedicated to supporting the PSC community by helping us access this potentially life-saving medication. Without the action from these advocates and physicians, we wouldn’t have the Support Statement or the LTE.
BE SURE to save the links and/or download the AASLD Guidance and the AASLD Support Statement and the Letter to the Editor.