The Economic Pandemic: Aggressive Testing Is Vital to Controlling the Spread of COVID19 and Saving Europe’s Economy

For the last month, a debate has raged over which approach to managing the spread of COVID-19 is correct. One aspect of this debate is about the efficacy of widespread testing. South Korea and Germany have pursued aggressive testing. The Netherlands, Sweden, and the UK – at least initially – limited testing and instead sought to create herd immunity by letting the virus run its course. Which approach is better? Given the implications of getting the choice wrong, opinions towards both approaches have been strong and vociferous. Adding to the confusion, experts disagree about which of many variables are more important for explaining higher rates of morbidity from COVID19. These include the percent of a population over 65 years of age, the case fatality rate, the population density of a region, the availability of hospital beds and ventilators per 1000 population, rates of tourism, usage of public transport, and number of university students in a given area to name a few.

Insulin prices and pharmacy benefit manager rebates: pin the tail on the patient

19 March 2020



What's the impact of Pharmaceutical Benefit Managers on US Insulin prices? In researching HR3, Vital Transformation found $2 bil in 'lost' revenue reported in Medicare Part D, but missing in audited actual sales on company balance sheets. Time to bring back the Rebate Rule?

Tying Medicare Part B Drug Prices to International Reference Pricing Will Devastate R&D

26th November 2019



According to Secretary Azar of Health and Human Services, implementing international reference pricing (IPI) in Medicare Part B will have minimal impacts. He has stated, “These savings, while substantial for American patients and taxpayers, cannot possibly pull out more than 1 percent of R&D.” As companies traditionally spend 20% of free cash flow on R&D, we have measured the IPI impact according to industry standard metrics.

International Reference Pricing Under H.R.3 Would Devastate the Emerging Biotechnology Sector, Leading to 56 Fewer New Medicines Coming to Market Over 10 Years

Vital Transformation projected the impact that utilizing international reference pricing for retail medicines (as proposed as part of the Lower Drug Costs Now Act of 2019, H.R.3) would have on the innovative biotechnology sector in the U.S. While the industry revenue reductions resulting from H.R.3 would harm industry innovation across the board, the analysis found that it would have an especially large impact on small, emerging biotech firms that rely on venture capital and revenue streams from the rest of the industry to finance their R&D investments. The result will be fewer medicines coming to market and available to patients.

International pricing index ‘accomplishes nothing it sets out to do’

By Sue Peschin and Duane Schulthess, 21 October 2019

Even with all of the political chatter in Washington, D.C., talk about controlling prescription drug prices is still rising above the din. Of all the proposals being batted around, one that bases prices on an international average of prices in mostly European countries has bipartisan support. This strategy, known as the international pricing index, is particularly worrisome.

First proposed by U.S. Health and Human Services Secretary Alex Azar in the fall of 2018 for Medicare Part B drugs, House Speaker Nancy Pelosi’s drug pricing plan expands it to allow the federal government to negotiate the cost of 250 prescription medicines that aren’t facing market competition. It also extends the negotiated price to insurers and the commercial market at large.

Making Real World Data Real – New RWE Methodologies for HTAs

With the increasing use of accelerated regulatory tools like the Food and Drug Administration’s breakthrough designation, there are mounting challenges for European health technology assessors (HTAs) to make an accurate assessment of the long- term value and performance of many new therapies. Data presented in evidence is often extrapolated from outcomes six months or less, and what’s good enough for regulatory approval often doesn’t meet the needs for comparative effectiveness, value, and outcomes measures for HTAs. Vital Transformation’s recent BMJ publication demonstrates a novel, practical approach to harnessing electronic health records and RWE to help solve this problem. However, access to robust deidentified patient records in Europe is key.

Are CAR-T therapies living up to their hype? A study using real-world data in two cohorts to determine how well they are actually working in practice compared with bone marrow transplants

18th July 2019

With the increasing demands being placed on HTAs in Europe, a methodology allowing for a valid assessment of the clinical effectiveness and costs for indications targeting small patient populations and orphan conditions, such as ALL, at the time of a reimbursement decision is vital. This is particularly true when the costs of these interventions are significantly high, such as in the case of CAR-T, where costs exceed US$375 000. By extracting RWD from live hospital EHRs, we were able to demonstrate a novel methodology that allows us to move beyond the use of proxies for clinical effectiveness measures extrapolated from clinical trials to obtain an assessment of the long-term outcomes and total costs of new therapies, such as CAR-T, compared with the next-best legacy treatment option.

Azar’s Plan To Tie U.S. Drug Prices To Foreign Ones Will Impact Investments In R&D

Photographer: Al Drago/Bloomberg © 2019 BLOOMBERG FINANCE LP Publish date: June 21, 2019 By John LaMattina, Contributor for Forbes Azar claims that HHS can reduce spending on Medicare Part B drugs with little impact on biopharmaceutical R&D investment. Duane Schulthess, Managing Director at VitalTransformation, questioned Azar’s claim on this. As he delved into specific compounds on Azar’s list of 27, he found some startling data. One striking case is with Biogen’s Multiple Sclerosis drug, Tysabri.

The International Pricing Index: What will be the Impact on Patients, Outcomes, and Innovation?

According to research from the US Health and Human Services, US tax payers pay 1.8 times the international price for medicines and are ‘subsidizing’ global healthcare. In order to combat this imbalance, the Trump administration is proposing the “International Pricing Index” (IPI) payment model to reduce reimbursement levels for the Centers for Medicare & Medicaid Services (CMS). Following Vital Transformation's research on investment success factors for biotech companies released at the European Health Forum Gastein, Vital Transformation presented original research modelling the potential impact both short and long term for patients, payers, and industry for such proposals, and show how the IPI can impact access and innovation broadly. As well, the panellists placed the IPI into the context of other models currently being investigated internationally such as value based payments, managed entry agreements, and adaptive pathways.