ICER Weekly View: March 8, 2019

From the desk of David Whitrap

Hello everyone. For all of you who attended or viewed yesterday’s public ICER meeting on the treatments for spinal muscular atrophy, I hope you’ll agree that the dialogue throughout the day demonstrated the critical role patients play during each of ICER’s assessments. We warmly thank each of the patient advocates who participated. For anyone who missed the meeting, a recording of the webcast will be online next week.

This morning, let’s take a look at the key pharmaceutical news:

  • Why the US doesn’t need to offshore cost-effectiveness to other countries;
  • The coming wave of potential cures;
  • A new treatment for depression;
  • An FDA Commissioner says goodbye;
  • An insulin-maker releases a half-price generic;
  • The potential conflicts of interest that hover over certain patient advocacy organizations;
  • Atul Gawande’s disruptive venture gets a name;
  • Pharma companies hire middlemen, too; and
  • Martin Shkreli is still in jail.

Alright, here we go…

Pharmaceutical News

For STAT News, longtime pharma reporter Ed Silverman makes the case that, instead of pegging US drug prices to what’s paid overseas (as the Administration has proposed), federal policymakers could rely on independent cost-effectiveness analyses already being conducted in this country. He writes:

“While a disease may look the same as we cross borders, the willingness to pay for a medicine can differ greatly… So why would we want to effectively outsource this process to other countries with different values — economic or otherwise? Actually, cost-effectiveness is used in the U.S. Just not by the federal government. Insurers and drug makers already calculate value, although their negotiations are increasingly influenced by cost-effectiveness reports issued by a nonprofit called the Institute for Clinical and Economic Review.”

Forget a drug-pricing index. Cost-effectiveness is a better bargain – STAT

The international pricing index is not wrongheaded. But the sad reality in the U.S. is that a bigger change is needed to fix a big problem.

And in his “Heard on the Street” column, the Wall Street Journal’s Charley Grant discusses the tension between the scientific promise of a gene therapy and the budgetary concerns that come with it. Consistent with why ICER recently decided to launch a new initiative on valuing potential cures, Mr. Grant’s column concludes like this:

“The perfect opportunity to rethink how medicine is paid for is here. But, should that be squandered, patients, insurers, investors, drug makers and the government could end up in a bitter battle over who will pay for these medical breakthroughs.” 

The Side Effects of Million-Dollar Drugs

The age of gene therapy promises a wave of life-changing and life-saving medicines. The high costs of such drugs, however, raise a number of thorny questions surrounding payment in the U.S.’s dysfunctional health-care system.

The FDA approved Spravato (esketamine), a version of ketamine, for people with depression who have not had success with other treatments. The manufacturer set of a list price between $4,720-$6,785 for the first month of treatment, and $2,360-$2,540 for subsequent months. ICER is currently assessing esketamine, and our Draft Evidence Report is scheduled to be published on March 21.

FDA Approves Esketamine Nasal Spray For Hard-To-Treat Depression

Editor’s note, March 6, 9:30 a.m.: This story was updated to include information about the price of Spravato. The Food and Drug Administration approved the first drug that can relieve depression in hours instead of weeks. Esketamine, a chemical cousin of the anesthetic and party drug ketamine, represents the first truly new kind of depression drug since Prozac hit the market in 1988.

This week, FDA Commissioner Scott Gottlieb announced his resignation. The Associated Press covers the announcement, while Evaluate comments on Dr. Gottlieb’s legacy of accelerating products to market based on surrogate endpoints.

FDA chief Scott Gottlieb steps down after nearly 2 years

WASHINGTON (AP) – Food and Drug Administration Commissioner Scott Gottlieb is stepping down after nearly two years leading the agency’s response to a host of public health challenges, including the opioid epidemic, rising drug prices and underage vaping. Gottlieb cited “the challenge of being apart from my family” in Connecticut when announcing his departure Tuesday in a note to FDA staff.

The Gottlieb legacy: a surge in unproven treatments?

Many in the biopharma sector will rue the departure of Scott Gottlieb, an FDA commissioner who pursed a permissive path for novel drugs at the US regulator. Will his successor be similarly inclined?

In the face of public outrage over the rising price of insulins, Eli Lilly announced it will sell a half-price generic version of its own Humalog.

Eli Lilly Will Sell Half-Price Version of Humalog, Its Popular Insulin

The drugmaker Eli Lilly will begin selling a cheaper version of its most popular insulin, Humalog, in an effort to head off criticism about the rising costs of prescription drugs, the company said Monday. Lilly will begin selling an “authorized generic” of Humalog 100 for $137.35 per vial, a 50 percent discount off the list price.

Kaiser Health News looked into how certain patient advocacy groups may be financially conflicted by the funding they receive from pharmaceutical companies. While most patient advocacy groups are well-intentioned, and every organization needs to find funding from somewhere, the article underscores why it’s important for policymakers to ensure they are responding to the needs of actual patients, and not just the desires of the companies that fund these organizations.

Big Pharma Gave Money To Patient Advocacy Groups Opposing Medicare Changes

Dozens of patient advocacy groups, like the Bonnie J. Addario Lung Cancer Foundation and the National Coalition for Cancer Survivorship, recently appeared in national advertisements objecting to a Trump administration proposal that could limit drugs covered by Medicare providers. But a Kaiser Health News analysis found that about half of the groups representing patients have received funding from the pharmaceutical industry.

In January 2018, Berkshire Hathaway, Amazon, and JP Morgan announced they would be forming a secretive new venture to disrupt the healthcare system. More than a year later, that partnership has a name: Haven.

The Imposing Venture of 3 Corporate Giants Gets a Not-So-Imposing New Name

We can finally put a name to the thing striking fear within the health care establishment: Haven. The secretive new venture, created by corporate titans Amazon, Berkshire Hathaway and JPMorgan Chase to transform health care for their employees, has gone without an official name for more than a year.

Do you remember last week when executives from seven pharmaceutical companies testified in front of the Senate Finance Committee? And do you remember when those executives blamed Pharmacy Benefit Managers (PBMs) for being partially responsible for high drug prices? Well, it turns out that, to lower the cost of their own employees’ prescription drugs, these same pharmaceutical companies hire PBMs.

Pharmaceutical companies hire drug pricing middlemen, too

The relationship with PBMs that drug companies don’t want to talk about.

And I know ICER’s Weekly View tries to stay above this sort of thing, but it’s hard to conclude this week’s edition without an update on how things are working out for “Pharma Bro” Martin Shkreli. So…

Martin Shkreli Steers His Company From Prison-With Contraband Cellphone

The disgraced pharmaceutical executive dubbed “Pharma Bro” remains the shadow power at the drug company that became a national lightning rod for jacking up the prices of rare drugs. Having made friends including ‘Krispy’ and ‘D-Block,’ he’s plotting a comeback.


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