A paper by Birg (2022) aims to examine how mandatory increases in rebates for pharmaceutical products impacts the use of parallel imports. She uses a policy change from 2010 in Germany which mandated increased pharmaceutical rebates to identify the impact of this change. What are parallel imports? Parallel imports are drugs that are imported from another country without the authorization of the manufacturer…Wholesalers or parallel traders may resell goods that were placed on the market in one country in another country This issue is espeically relevant in Europe. In the European Union, paral ..read more

That is according to an article today from the BBC. NHS leaders in Scotland have discussed abandoning the founding principles of the service by having the wealthy pay for treatment. The discussion of a “two-tier” health service is mentioned in draft minutes of a meeting of Scotland’s NHS leaders in September. They also raise the possibility of curtailing some free prescriptions. Part of the rationale for considering this move are a large budget hole and many staff positions going unfilled. Last month the BMA in Scotland said the country’s health service was in a “perilous situation” and urg ..read more

Many studies (e.g., Okui 2020, Le Bon 2014, Blanchflower and Oswald 2009) have claimed that mental health exhibits a U shape where mental health decrease with a nadir at middle age and then increases as people grow into their elderly years. However, a recent study by Dijk and Mierau (2022) finds that mental health may be largely improving throughout a person’s life up until perhaps the end of life. This finding is based on data from the US Panel Study of Income Dynamics (PSID), German Socio-Economic Panel (SOEP) and the Dutch Longitudinal Internet Studies for the Social sciences (LISS) panel d ..read more

At first glance, one may think the answer is no. Randomization should insure that baseline characteristics are balanced across trial arms. In practice, however, sometimes baseline characteristics due differ somewhat by trial arm simply by chance, especially in smaller randomized controlled trials (RCTs). A JAMA Guide to Statistics and Methods by Holmberg et al. 2022 provides justification for why you would want to adjust for baseline characteristics in many cases. …adjusting for baseline characteristics in the analysis of RCTs is advised by both the European Medicines Agency and the US Food a ..read more

Impact of elections on health care.  “This is our COVID” Are patient satisfaction scores harming patients and physicians? The cost of satisfaction. Proposal for a healthcare minimum wage. Crypto news: Don’t regulate crypto. SBF interview ..read more

Clinical trials have detailed study protocols and are registered on ClinicalTrials.gov. What level of details are needed for real-world data (RWD) analyses that aim to estimate treatment effects? In Europe, the European Medicines Agency (EMA) requires registration of many study protocols using a template for observational post-authorization safety studies (PASS) conducted by marketing authorization holders. Other efforts include ISPE’s guidelines for good pharmacoepidemiology practice (GPP) section on protocol development, National Evaluation System for health Technology (NEST) protocol guidan ..read more

Real-world data is becoming increasingly important as the amount of data generation increases as does the speed of data processing. In the US, the 21st Century Cures Act was enacted in December 2016 and mandated that the Food and Drug Administration (FDA) create a framework for evaluating the use of real-world data help support the approval of new indications for already approved drugs as well as conduct or to satisfy drug post-approval study requirements. FDA published it’s Real-world Evidence Program in 2018. In the European Union, the European Medicines Agency (EMA) established a Coordinati ..read more

The generic share of total prescriptions dispensed in the US increased from 14% when the Hatch-Waxman legislation was passed [1984] to 42% by 2000 and 92% today. James C. Robinson in JAMA 2022 ..read more

Costs and benefits of advance preparations for future pandemics. ISPOR Europe Round-ups: Day 1, 2 and 3 Impending intergenerational crisis. Limited COVID-19 vaccine externalities? Free insulin (not real) Puerto Rico’s health success in the mid-20th century ..read more

That was the title of the second plenary at ISPOR Europe this year. One interesting slide from Nancy Devlin who outlined how different countries used different patient-reported outcome measures (PROMs). English NHS PROMs programme. Variation in provider performance linked to reimbursement UK Private Healthcare Information Network (PHIN). Part of an initiative to improve patient choice on quality and fees between private sector providers. Alberta Health Services & Alberta Health Quality Council. Evaluating service effectiveness and value for money. Sweden’s National Patient Quality Registe ..read more