ICER Weekly View 06-16-17


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From the desk of Mitchell Stein

Good morning. Lots of ICER activity this week, so much in fact that there’s no “In-depth” feature this week, so you have time to read about everything going on.  Specifically, this week we’ll look at:

ICER in the news – Wired magazine in-depth feature, Evidence Update on PCSK9 inhibitors along with 8(!) stories covering the release, topic announcement covering first gene therapy submitted to FDA, FDA reviewing ADOs, Virginia’s proton beam bill, and don’t forget to vote

Inside the Beltway – Administration meeting on drug pricing, Senate committee talks (a little) about drug pricing, and new head of the National Cancer Institute named

Industry Trends – SCOTUS on biosimilars, cost impacting adherence, prostate drug manufacturers working with charities. Nevada Gov signs insulin transparency bill, pharma productivity, BioPharma spotlight on gene therapy and the end of the Blink Health/Express Scripts deal

Company/Drug Specific – Invokana and Keytruda

Now, on to the news.


ICER In The News

Wired Magazine takes a detailed look at who ICER is and what they do.  Worth a read both for the content and because it’s exceptionally well written.

The New War on (Overpriced) Pharmaceuticals

Unless you have multiple myeloma, a rare and vicious cancer of the blood, chances are you haven’t heard of Revlimid. The immunomodulatory drug slows the growth of new blood vessels, and it’s a product of the kind of ingenuity and daring that once made the pharmaceutical industry among the most respected in America.

ICER has developed a New Evidence Update to its 2015 review of the comparative clinical effectiveness and value of PCSK9 inhibitors for management of high cholesterol.  The comparative clinical effectiveness portion of the update is now available; cost-effectiveness analyses will be posted at a later date.  The release was covered in BioPharmaDive, STAT, FiercePharmaThePharmaletter, MedpageToday, AJMC.comSeeking Alpha and the Pink Sheet (subscription required for Pink Sheet).

ICER will develop a report assessing the comparative clinical effectiveness and value of voretigene neparvovec (Spark Therapeutics), a potentially one-time gene therapy for vision loss associated with biallelic RPE65-mediated retinal disease. Voretigene neparvovec is the first gene therapy to be submitted for approval by the US Food and Drug Administration (FDA).

Coverage of the FDA’s decision to review all abuse-deterrent opioids includes discussion of ICER’s report on the topic.

Discussion of Virginia’s bill mandating equal treatment for proton beam therapy includes discussion of ICER’s work on the topic.

Reminder, voting ends June 23:  ICER’s founder and President, Steve Pearson, is on the ballot for Modern Healthcare’s 100 Most Influential People. You can read more about the award below. To vote for Steve (and others) directly, you may use this link: https://www.surveymonkey.com/r/KRZCJQ3 (note that to vote for Steve, you need to go to the bottom of the page and click next to reach the ballot page with his name on it.)

100 Most Influential People in Healthcare | Healthcare awards and recognition programs from Modern Healthcare

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Pharmaceutical News

Inside the Beltway

The Administration will hold a meeting today (Friday) to discuss drug prices.  An initial executive order is expected to follow shortly that might focus on value-based pricing.  However, expectations are that the order will be more industry friendly than might have been expected given the President’s comments during the campaign.

Trump administration preparing executive order on drug pricing

The Trump administration is preparing an executive order aimed at lowering drug prices, according to sources familiar with the process. President Trump is set to meet on Friday with key officials including Health and Human Services Secretary Tom Price and White House budget director Mick Mulvaney to discuss the order, which is expected to be issued in the coming weeks, possibly before the July 4 congressional recess, the sources said.

The Senate Health, Education, Labor and Pensions Committee met Tuesday for the first of three hearings on drug prices.  However, the Democrats on the committee ended up focusing more on other issues (specifically the lack of transparency in the ACA replacement bill process).

The National Cancer Institute gets a new leader.

UNC oncologist and researcher named head of the National Cancer Institute

President Trump has named Norman “Ned” Sharpless, the director of the University of North Carolina Lineberger Comprehensive Cancer Center, to lead the National Cancer Institute. The oncologist and geneticist will succeed Doug Lowy, who has been acting director of NCI since early 2015. Lowy is expected to remain at the institute as deputy director and a researcher.

Industry Trends

SCOTUS rules on case with huge implications for biosimilar industry – the six-month post-approval hold period is not needed – the clock can start before FDA approval.

US Supreme Court: No Six-Month Wait for Biosimilars After FDA Approval

Posted 12 June 2017 ByZachary Brennan The US Supreme Court on Monday ruled unanimously that biosimilar companies will not have to wait an additional six months after US Food and Drug Administration (FDA) approval before launching their new biosimilars.

“At least 28 million Americans have experienced a spike in the cost of their prescription medications in the past 12 months. And for 4 million of them, the price was so high they walked away without their prescription altogether, according to a new Consumer Reports survey.”

More than 4M leave the pharmacy without their meds due to cost

At least 28 million Americans have experienced a spike in the cost of their prescription medications in the past 12 months. And for 4 million of them, the price was so high they walked away without their prescription altogether, according to a new Consumer Reports survey.

The Wall Street Journal takes a look at the changing relationship between prostate drug manufacturers and charities that help patients pay for the drugs in the wake of a federal investigation (subscription required).

U.S. Probe Sheds Light on Charities’ Role in Boosting Drug Sales

U.S. sales of blockbuster prostate-cancer drugs have dropped sharply since the start of a federal investigation into charities that help patients pay for these drugs, a sign of how much the pharmaceutical industry relies on these foundations to support revenue.

Remember that Nevada bill about insulin pricing transparency?  Well, yesterday the Republican governor signed it – no one will be surprised if there are legal challenges.

Nevada forces drug makers to reveal insulin pricing, profits

Nevada now has the nation’s strictest rules requiring pharmaceutical companies to reveal how they set certain prescription drug prices. The bill Gov. Brian Sandoval signed on Thursday is sharply focused in insulin – one of many life-sustaining prescription treatments sold in America at…

Endpoints takes a look at productivity in the pharma industry.

The myth of “leaner and meaner” pharma

Pascal Soriot, chief executive officer of AstraZeneca, poses for a photograph outside the Houses of Commons on May 13, 2014 Bloomberg/Getty Is pharma shedding employees to protect and grow the bottom line? Judging from the headlines, you might think so. But actually, instead of getting “leaner and meaner,” most big

BioPharma shines a spotlight on Gene therapy with four feature articles.

That didn’t last long.

Blink Health ends Express Scripts contract over insulin program

Blink Health and Express Scripts partnered with Eli Lilly to provide up to a 40% discount on the drugmaker’s insulin. An Express Scripts spokesman said Blink ended the contract because it did not want an exclusive relationship with the PBM, a violation of their agreement.

Company/Drug Specific

Prevent a heart attack, lose a toe…  Matthew Herper takes a look at Invokana.

J&J Drug Prevents Heart Attacks At Cost Of Amputated Toes

Invokana, a diabetes drug made by Johnson & Johnson, decreases the risk of heart attacks and strokes, but also increases the risk of amputation, particularly of toes. The result is a blow to J&J, and a boost to rivals Eli Lilly and Boehringer Ingelheim, who make a similar drug called Jardiance, which has been shown to reduce the risk of cardiovascular death but does not appear to carry the amputation risk.

The string of good news on Keytruda couldn’t go on forever.  A slight bump as two clinical trials will stop enrolling new members to investigate an imbalance in death rates.  Note that this is NOT a clinical hold and patients currently being treated will continue to receive the drug.

Merck halts enrollment on two PhIII Keytruda combo studies as outside monitors flag a worrying rate of deaths

Merck $MRK has had to hit the brakes on enrolling new patients for two of its late-stage combo studies involving its blockbuster checkpoint Keytruda after the monitoring committee raised a red flag on an imbalance of deaths in the studies involving multiple myeloma. Treatment in the two trials will continue,

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