Yes, insurance coverage for Bepirovirsen will be interesting for sure. I think they will for sure require a prior authorization for it. I will give you my opinion on things they might look at when deciding whether or not to approve the PA:
- What stage of liver disease do you currently have? Perhaps they think the benefit would be higher for people with more fibrosis (F2-F3), to avoid progression to cirrhosis or liver transplant.
- What’s your baseline surface antigen? Since the phase 3 trial only included people with HBsAg < 3000, it seems unlikely that they would approve it for anyone who is higher than this.
- Do you have a family history of liver cancer? People who do have a family history may also benefit more if they can be cured.
- How have you responded to the current treatments? They may require people to try current first-line treatments for some amount of time before approving Bepi, even though NUCs are not really meant to help people clear surface antigen.
We also need to keep in mind that the value proposition of Bepi is different than Vemlidy. Insurance is cracking down on Vemlidy because there are other much cheaper options that achieve the same therapeutic benefits. The only other medication that has been shown to achieve statistically significant functional cure rates for hepatitis B is peginterferon, and that drug is also expensive (brand name only), so if Bepirovirsen delivers better cure rates than peg-IFN, then the value of it, in terms of cost-effectiveness is actually quite compelling.