The National  Memo Logo

Smart. Sharp. Funny. Fearless.

Monday, December 09, 2019 {{ new Date().getDay() }}

By Bill Berkrot

(Reuters) – An independent non-profit organization that evaluates clinical and cost effectiveness of new medicines said announced prices for a just-approved class of potent cholesterol lowering drugs were far too high, according to a draft report released on Tuesday.

The Boston-based Institute for Clinical and Economic Review (ICER) said its analyses indicated “that the price that best represents the overall benefits” the drugs may provide patients would be between $3,615 and $4,811 a year, a 67 percent discount off the list prices.

“Even if these drugs were used in just over 25 percent of eligible patients, then employers, insurers, and patients would need to spend on average more than $20 billion a year for these drugs,” ICER president Steven Pearson said in a statement.

It would take a further price reduction to an annual cost of $2,177 in order to not have to try to limit patient use to keep overall health care cost growth within bounds, ICER concluded.

The new injectable cholesterol fighters belong to a class known as PCSK9 inhibitors that in clinical trials lowered levels of “bad” LDL cholesterol by about 55-60 percent in patients who could not reduce their levels enough with inexpensive, widely-used statins, such as Lipitor, or those who could not tolerate statins. Ongoing studies will determine if they actually cut heart attacks as statins have been shown to do.

Praluent from Regeneron Pharmaceuticals and Sanofi has a U.S. price of $14,600 for a year of treatment. Amgen Inc set an annual price of $14,100 for its Repatha.

Depending on how they are used in practice, it has been estimated that between 3.5 million and 15 million Americans could be eligible for treatment, ICER said.

“There are serious questions regarding the price at which these drugs would represent a sensible value to patients and to the health care system,” the report said. ICER found that the two drugs appear to have equivalent overall effectiveness for most patient groups.

The drugs were initially approved for use in patients with a hereditary form of extreme high cholesterol and those with heart disease.

Amgen said it disagrees with ICER’s methodology, assumptions and preliminary conclusions. “We are concerned that … its short term budgetary focus will be used to create access barriers to innovative medicines like Repatha for appropriate patients,” Amgen spokeswoman Kristen Neese said in an emailed statement.

Regeneron said it needs to better understand the methodology used in the ICER analysis and called for a robust peer review process. “We are committed to providing affordable medicines and ensuring access to Praluent for patients who are prescribed the therapy,” Regeneron spokeswoman Hala Mizra said.

The PCSK9 drugs have been in the crosshairs of U.S. pharmacy benefit managers, such as Express Scripts and CVS Health. They hope to gain significant discounts for customers by offering the drugmakers preferential usage status in exchange for lower prices, as they have done with expensive new hepatitis C treatments.

Further entry of PCSK9 drugs from Pfizer and others could also lead to lower prices as competition intensifies.

(Reporting by Bill Berkrot; Editing by Grant McCool)

Photo: Cholesterol emboli in an interlobular artery. (Boonyarit Cheunsuchon, MD)

Advertising

Start your day with National Memo Newsletter

Know first.

The opinions that matter. Delivered to your inbox every morning

Sen. Bernie Sanders, left, and President Joe Biden during 2020 presidential debate

I look at September 2019 as a month where I missed something. We began with a trip to New York to do Seth Meyers’s and Dr. Oz’s shows. Why would we go on The Dr. Oz Show? For the same reason we had gone on Joe Rogan’s podcast in August: We could reach a vast audience that wasn’t paying attention to the standard political media. On Dr. Oz, Bernie could talk about Medicare for All and his own physical fitness. While at the time we believed Bernie was uncommonly healthy for his age, he was still 78. Questions would be raised related to his age, and we needed to begin building up the case that he was completely healthy and fit. It turned out to be a spectacular interview, ending with the two of them playing basketball on a makeshift court in the studio. Bernie appeared to be on top of the world.

Yet in retrospect, I should have seen Bernie growing more fatigued. After New York, with the school year starting, we did a series of rallies at colleges and universities in Iowa; this was the kickoff of our campus organizing program in the state. We would then fly to Colorado for a large rally in Denver before heading to Boulder to prep for the third debate, to take place in Houston on September 12. In Iowa, Bernie’s voice was a little hoarse. After the rally in Denver, he had completely blown it out. He sounded terrible.

Keep reading... Show less

Rep. James Clyburn

When I interviewed House Majority Whip James Clyburn in 2014 about his memoir Blessed Experiences: Genuinely Southern, Proudly Black, the South Carolina Democrat was confident in America’s ability to find its way, no matter how extreme the political swings might appear at any given time.

“The country from its inception is like the pendulum on a clock,” the congressman told me. “It goes back and forward. It tops out to the right and starts back to the left — it tops out to the left and starts back to the right.” And remember, he said, it “spends twice as much time in the center.”

Keep reading... Show less
{{ post.roar_specific_data.api_data.analytics }}