Unbiased Analysis of Today's Healthcare Issues
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…
Authorized generics (AGs) are generic drugs that–unlike independent generics–are sold by the brand-name drug manufacturer under a generic label. How big a role do these AGs play among Medicaid beneficiaries. A paper by Rome et al. (2023) aims to answer that using public Medicaid prescription use data between 2014 and 2020. Using these data, they…
Through what mechanisms are patients and physicians made aware of new pharmaceuticals and decide to prescribe them. It is well known that physician peer networks often help share information about new pharmaceuticals including clinical information as well as the providers own experience using the new treatment. Other studies have shown that direct to consumer advertising…
A Health Affiairs Forefront article by DiGiorgio (2023) argues the 340B has outlived its purposes. He writes: By mandating that drug companies give a large discount to covered entities, the majority of which are hospitals with disproportionate share or critical access designations, the 340B program was intended to provide a financial buffer for institutions such as the…
FDA’s Office of Generic Drugs issued their 2022 Annual Report. Generic drugs play a vital role in saving patients and payers money. To give an example, pregabalin capsules cost $450 for a 30-day supply during the end of its market exclusivity period, but priced dropped to $23 (a 95% decrease) during the first 12 months…
When you buy a car, there is the sticker price and what you actually paid after haggling with the dealer over discounts. For pharmaceuticals, the media typically reports on list prices which are analogous to the “sticker price” for cars. However, what really matters is the net price, which is the price after discounts and…
There is even less competition then we may have thought according to a paper out this month by Socal et al. (2023): We identified a total of 565 facilities producing 1,379 unique generic APIs across forty-two countries. India, China, and Italy were the top producers; 14 percent of APIs were manufactured in the US. About a…
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…
That is what various government bodies are considering. First lets turn to Medicaid via a report by Tyrus Jackson in JD Supra, The Medicaid and CHIP Payment and Access Commission (MACPAC) voted on January 27 to recommend that Congress grant states the ability to limit Medicaid coverage for drugs and biologicals approved under the FDA’s…
The year 2022 was a good, but perhaps not great year for innovation. According to the FDA’s Center for Drug Evaluation and Research’s (CDER) New Drug Therapy Approvals 2022 report, there were 37 novel drugs approved in 2022. This number is down from the historical rate of approvals between 2013-2021 (43.4 approvals per year) and…