Unbiased Analysis of Today's Healthcare Issues
Last month, FDA released guidance on the use of real-world evidence to support regulatory decision-making for new drugs. Below are some of the key points from this guidance document: Legislative mandate. The 21st Century Cures Act (Cures Act), signed December 2016, mandated that the FDA consider how to incorporate real world data (RWD) into regulator…
James Chambers has put together a series of papers looking at health gains (and cost effectiveness) using the Tufts Cost Effectiveness Analysis Registry. In these studies , he finds that treatments for rare diseases, specialty drugs, and those that receive expedited review are more likely to provide the largest health benefit (≥0.9 QALYs gained versus…
Perhaps according to a report from Stat News: A groundbreaking clause in a new deal between the Department of Health and Human Services and the pharmaceutical company Regeneron marks the first time the Biden administration has directly used its leverage to challenge drugmakers’ list prices, experts told STAT.The contract between Regeneron and the government requires…
All of us want new, improved medicines. Drugs that provide incremental benefits (often called “me too” drugs) are good, but truly revolutionary therapies are even better. However, how does one separate how “novel” a treatment is? Is there a way to quantify this? In fact there is. One way to do this is based on…
Here is the CMS Factsheet and news coverage from NY Times. The companies that make each of these drugs is listed below. Eliquis – Bristol Myers Squibb and Pfizer Jardiance- Boehringer Ingelheim and Eli Lilly Xarelto – Johnson & Johnson Januvia – Merck Farxiga – AstraZeneca Entresto – Novartis Enbrel – Amgen Imbruvica,- AbbVie and…
Copay cards are somewhat controversial. These cards or coupons are used to help patients afford copayments and deductible payments patients owe when using pharmaceuticals. On the one hand, these programs are highly beneficial for patients. Patient out-of-pocket costs have risen dramatically in recent years, even among the insured. For instance, whereas only 7% of workers…
While the Inflation Reduction Act (IRA) aims to lower the prices of pharmaceuticals, at the same time it exempts drugs treating rare diseases (i.e., orphan drugs) from drug price negotiation. However, this exemption is only valid if the orphan drugs has a single approved indication. Thus, a key question is how frequently orphan drugs are…
That is the subtitle of an NBER working paper by Charles Gray, Abby E. Alpert & Neeraj Sood. The author examine recent mergers between pharmacy benefit managers (PBMs) and health insurers. On the one hand, integration may beneficial to consumers. It could: (i) improve operational efficiencies, and (ii) better align PBM incentives with those of…
One piece of good news for consumers is that generic prices are falling. However, generic prices may be falling so much that drug shortages are occurring (which is not a good thing). Data from a working paper by Sardella (2023) finds a dramatic drop in generic prices in recent years. The authors claim that shortages…
CMS released a guidance on June 30, 2023 providing additional detail on on how the maximum fair price (MFP) will be calculated. The document also has nearly 100 pages of public input comments. A summary of some key points are below. Of most interest is that CMS is taking a ‘reference price’ based approach to…