• The Centers for Medicare and Medicaid Services (CMS) has introduced a draft national coverage determination (NCD) for amyloid-targeting Alzheimer's disease (AD) therapies which brings new uncertainties into investment decisions / ROI calculations.
• This analysis measures the potential impact of this NCD - using assumptions based on the current draft language and historical data about AD R&D trials and investment, we assume that the NCD will add 3 or more years to the time it takes for an AD asset to see any return on investment.
• Of the programs currently in development – IF the proposed NCD was in place at the time of program initiation, 93% of investments would have had negative ROI and therefore would not have likely been made.
• Furthermore, the results of our research find that many existing clinical development programs would likely be halted - this is not only true for amyloid-targeting therapies, but all AD treatments, as neurological disorders often use the same endpoint threshold when applying for CMS program participation.
• The NCD, if implemented, reduces our estimated 39 treatments with a net positive ROI to 3, with an assumed three-year delay; with a four-year delay, we find only one therapy with a positive ROI in our model.
• Finally, the NCD introduces new and material risks to the ROI calculations for potentially all products approved under the accelerated approval pathway, which is vital to supporting the development of treatments targeting high unmet medical needs and significant scientific challenges.

22 December 2021



Early in the Covid-19 pandemic, the case fatality rate was frightening. This metric represents the proportion of all known people infected with a disease who die from it. The World Health Organization initially put it as high as nearly 16% in Algeria.

Several colleagues and I at Vital Transformation began closely following the data on Covid-19 early in the pandemic. We wondered if case fatality rates might be skewed by lack of testing. We collected data on various indictors that early on were thought to be influencing the spread of Covid-19.

• Unprecedented cost increases – in an industry that already experienced serious patient access challenges in 2019, pre-US border policy and pre-COVID-19 – have put manufacturers under considerable strain worldwide.
• As a majority global plasma donations come from the United States, poorly considered, one-size-fits all reimbursement decisions will substantially increase the risk of patient access concerns and negatively impact the sector globally.
• The plasma industry is subject to many of the same pressures of other industries. As ingredient costs rise and reimbursement falls there must be a point where the viability of that industry is in jeopardy.