Advertisement
Advertisement
Advertisement
Study: shows Medicare spending for ‘accelerated approval’ drugs on the rise

Study: shows Medicare spending for ‘accelerated approval’ drugs on the rise

Synopsis

According to research published by JAMA Health Forum, annual spending on pharmaceuticals granted fast clearance by the Food and Drug Administration has increased significantly over the last half-decade.

Study: shows Medicare spending for ‘accelerated approval’ drugs on the rise

Google

Advertisement

According to research published by JAMA Health Forum, annual spending on pharmaceuticals granted fast clearance by the Food and Drug Administration has increased significantly over the last half-decade.

The data shows, spending on the 66 drugs with an accelerated approved indication in Medicare Part D increased to $3.2 billion per year in 2019 from $2.1 billion in 2018.

Expenses for medications covered by Medicare Part B increased to $5.9 billion from $2.7 billion during the same time period.

This means that Medicare paid $9.1 billion on pharmaceuticals approved by the FDA under this program to treat critical or life-threatening illnesses, despite the fact that their safety and effectiveness had not yet been fully reviewed.

Spending on drugs with only accelerated approval indications, however, declined to $400 million from $700 million annually during the same five years.

Advertisement

The research is based on the most current five-year period for which data is available.

Read more: Study: Air pollution, other factors may impact the gender of babies in the region

Co-author Dr. Benjamin N. Rome told UPI in an email “Medicare is spending more and more each year on drugs approved through the accelerated approval pathway, but most of that spending was on drugs that have other non-accelerated approval indications,”

“This is important to keep in mind since any policies aimed at lowering prices for accelerated approval drugs will need to consider how to handle these drugs,” said Rome, a general internist and health policy researcher at Harvard Medical School in Boston.

The FDA approves medications for use under the accelerated approval program based on their potential to cure critical or life-threatening illnesses in early clinical trials.

Following this first approval, the clinical trial process continues, but the FDA has historically had difficulty modifying the drugs’ indications or approved uses or removing them from the market entirely, even if fresh data shows they have no established benefit, according to previous studies.

Advertisement

Despite the fact that pharmaceuticals approved through fast approval have yet to complete the three-phase clinical trial process, research shows that manufacturers continue to demand high prices for them.

Also Read

Study: sounds help pedestrians to detect the electric cars
Study: sounds help pedestrians to detect the electric cars

According to a study presented at the Acoustical Society of America me...

Advertisement
Advertisement
Read More News On

Catch all the Health News, Breaking News Event and Latest News Updates on The BOL News


Download The BOL News App to get the Daily News Update & Follow us on Google News.


End of Article

Next Story