CER Daily Newsfeed

Beyond the Hype: RWD Is Not Just Another Acronym

(8/26, Sujay Jadhav, Health Data Management) comments “...Today’s healthcare system generates approximately a zettabyte (a trillion gigabytes) of data annually, and this amount is doubling every two years...The richness and scale of RWD enables researchers to perform deep analysis that can identify patterns that would otherwise remain obscure. This can best be accomplished by training algorithms to perform such calculations.” Full

The Role of RWD in Revolutionizing Clinical Trial Design

(8/27, Stephanie Baum, MedCity News) reports “...Leveraging RWD allows for the robust validation of real-world effectiveness. It facilitates the assessment of real-world endpoints such as overall survival, time to next treatment, time to treatment discontinuation, and progression-free survival. Research has shown a connection between real-world endpoints and outcomes observed in randomized clinical trials, validating the use of RWD for informing regulatory and payer decision-making.” Full

Perspectives from the Healthcare Economist: CMS Doesn’t Consider QALYs – What’s a Health Economist to Do?

(8/27, Jason Shafrin, The Evidence Base) comments “...Unlike other health technology assessment (HTA) bodies worldwide, however, CMS will not consider quality-adjusted life years (QALYs) when setting drug prices. The reason is rooted in US law: the Inflation Reduction Act prohibits the use of any metric that discriminates against the elderly or disabled...The question then becomes: if not QALYs, then what? The National Council on Disability has highlighted several potential alternatives, including equal value of life years (evLY), health years in total (HYT), and generalized risk-adjusted cost-effectiveness (GRACE). Each of these metrics attempts to preserve the benefits of quantifying health gains while sidestepping the perceived discrimination inherent in QALYs.” Full

MSD Works To Reverse English Funding Refusal For Winrevair; Reimbursement Plans Progress Elsewhere

(8/27, Neena Brizmohun, Pink Sheet) reports “...MSD is gearing up to demonstrate the value of its pulmonary arterial hypertension drug, after England’s health technology assessment institute provisionally said the product was not cost-effective. Meanwhile, the company told the Pink Sheet about Winrevair’s reimbursement status across Europe.” Subscription Required