Unbiased Analysis of Today's Healthcare Issues
The U.S. is one of the the few developed nations without a government-run health technology assessment (HTA) body. Or are they? A recent perspective in the New England Journal of Medicine by Peter Neumann and Sean Tunis argues that the Centers for Medicare and Medicaid Services (CMS) already is serving as a de facto HTA…
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…
How much money will IRA save Medicare? A paper by Hernandez et al. (2023) aims to answer this question. The methods they use are as follows: For the 10 drugs likely subject to negotiation by Medicare in 2026 based on 2020 gross spending and loss of exclusivity, we extracted 2020 data from 5 sources: (1)…
From Einav and Finkelstein (2023): …while 12.5% of individuals under 65 are uninsured at a point in time, twice as many—one in four—are uninsured at some point over a 2-y period. Moreover, the risk of losing insurance remained virtually unchanged with the introduction of the landmark ACA. Risk of insurance loss is particularly high for…
ASPE has a report out on the potential impact of the Inflation Reduction Act on Medicare Part D beneficiary out-of-pocket spending. This is a particularly relevant topic as the share of patients who have fallen into the catastrophic coverage has increased over time. Some of the medical conditions with the top out-of-pocket payments for Medicare…
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…
According to a paper by Garrison and Towse (2023) in Health Affairs Forefront the answer is ‘no’. I agree with them. Here is the rationale: …this request for R&D cost information reflects a fundamental misunderstanding of the economics of the regulated US and global pharmaceutical marketplace. Writing in this journal in 2004 on the pros…
That is the topic of a Health Affairs Forefront article (Sullivan et al. 2021) out today which is addresses the topic. The issue is particularly relevant as the Inflation Reduction Act (IRA)’s has a de facto ban on QALYs for use in setting a drug’s maximum fair price (MFP). The authors discuss some alternatives: The…
That is the summary takeaway I had form reviewing the 91 page CMS guidance on the Inflation Reduction Act (IRA) maximum fair price (MFP) negotiation released about 10 days ago. Below, I summarize some of the key findings. SELECTING DRUG FOR PRICE NEGOTIATION Unsurprisingly, CMS is looking for the highest cost drugs among the 10…
Medicare Part D has had a very odd benefit structure. First, you have a deductible with no coverage; then you get some coverage, then there is a coverage gap or “donut hole” with no coverage and finally there is very generous coverage in the ‘catastrophic phase’. This structure was espeically problematic for patients with high…