Strong year for drug discovery

2023 was a strong year for drug discovery. Mullard et al. (2024) report: The FDA’s Center for Drug Evaluation and Research (CDER) approved 55 new drugs in 2023, as the small molecule and biologic pharmacopoeia continues to grow. This cohort is nearly 50% bigger than the new approval class of 2022, which fell below the…

How are drugs developed and financed? An overview

I just came across a nice overview article titled The financial ecosystem of pharmaceutical R&D. The white paper was developed for the Netherlands government and provides an overview of the drug development process and how (and by whom) it is financed. The white paper answers the following questions: What do different players do within the…

Do first-in-class cancer drugs receive a pricing premium?

According to a paper by Miljković et al. (2023), the answer is ‘no‘. The authors examine oncology treatments with FDA approvals between 2015 and 2020 and identify average wholesale prices from Redbook. Drugs were classified into three categories: (i) first approval of a new mechanism of action compound, (ii) next-in-class approval regardless the tumor type,…

Barriers to Fair Access

Last month, ICER released their 2023 “Assessment of Barriers to Fair Access” . The report concludes the following regarding 18 drugs evaluated. ICER defines “fair access” based on the following criteria: Cost sharing Cost sharing based on net price. Patient cost sharing should be based on the net price to the plan sponsor, not the…

Who are 340B third-party administrators?

That is the question asked by a recent paper by Nikpay et al. (2023). The authors begin by describing the magnitude of the 340B program: The 340B drug discount program is designed to lower drug costs and increase drug profits for safety-net providers, called “covered entities,” by entitling them to discounts on drugs for all…

Why Biden’s proposed patent seizures will hurt patients

The Hill reports today that: The Biden administration is rolling out a framework to enforce the government’s march-in authorities on drugs developed with taxpayer dollars, saying if drugmakers refuse to make their products “reasonably” available, then the government is prepared to give other companies license to produce those drugs at a lower cost…. If the company refuses…

How do different countries negotiate drug prices?

This question is particularly relevant with the passage of the Inflation Reduction Act (IRA) and the requirement that CMS negotiate a ‘maximum fair price’ for drugs with the biggest impact on Medicare’s bottom line. A Health Affairs Forefront paper by Lin et al. (2023) compares how drug price negotiation differs between Canada, France, Germany and…

Why does the UK pay less for medicines?

According to the OECD, In 2021 the U.S. spent $1,432/capita on pharmaceuticals compared to only $517/per capita in the UK. The UK’s figure was slightly higher that Poland and Norway, but less than Latvia, the Slovak Republic, Portugal and Romania. How does the UK spend so little on drugs? Many people focus on the efforts…

Drug approval times around the world

How long does it take different countries/regions to approve new medications? The US is the fastest and Europe is the slowest among selected major pharmaceutical markets according to a report by EFPIA. Moreover, while a majority (7 out of 10) of therapies in the US rely on expedited approval, in Europe less than 1 in…