Wells Fargo Believes Some Patient Selection Criteria May Be...

Wells Fargo Believes Some Patient Selection Criteria May Be Relaxed

Wells Fargo says, On August 22, the Center for Medicare and Medicaid Services (CMS) is expected to issue a draft decision memo on THOR's request to expand reimbursement for LVAD therapy to include the entire patient population that was included in THOR's pivotal destination therapy (DT) trial. This includes the large population of Class IIIb patients who are also ineligible for heart transplant (CMS currently reimburses for sicker NYHA Class IV patients).
After analyzing the public comments posted on the CMS website, we think there is a less than 50% chance of reimbursement being expanded to include Class IIIb patients due to lack of clear risk/benefit data. There is no existing data set that compares the outcomes of LVAD therapy and medical management in Class IIIb patients, an issue that is highlighted in some of the comments. Moreover, given the risks associated with LVAD implantation (stroke, infection, bleeding etc.), it is possible that CMS will seek more clarity on the risks vs. benefits of LVAD therapy in Class IIIb patients before extending coverage. However, we believe that CMS will relax some of the other existing criteria such as body size, peak oxygen consumption and duration of failed medical management, resulting in an incremental increase in the addressable patient population for THOR and HTWR., the analysts add.
Wells Fargo mentions, Our current market model assumes minimal implants for Class IIIb patients, and as such we see no downside risk to our estimates arising from the CMS decision. On the other hand if reimbursement is extended to the Class IIIb population, we think the benefits will accrue over the long term since physicians will not change their implant practices right away.