From the desk of Mitchell Stein
Good morning. Today is both “Fly A Kite Day” and “Global Wind Day.” Seems appropriate they fall on the same day, doesn’t it? I hope everyone gets to enjoy a little outside time this weekend, remember it’s important to step away from the computer now and then (do as I say, not as I do). However, don’t get up yet, first, let’s take a look at this week’s pharma news where we’ll cover:
ICER in the news – updated assessment of plaque psoriasis, an economist explains QALYs, and coverage of ICER’s CF report
Inside the Beltway – Still no significant price reductions, CREATES Act moves a tiny step forward, Gottlieb has a new reimbursement idea for antibiotics, and FDA permits more communications between manufacturers and payers
Industry Trends – The NY Times Editorial Board asks if the FDA is going too fast, drug prices going up, trust in drug firms going down, PWC says generics helping costs a little, CRISPR hits a speed bump, AT&T/Time Warner merger has implications for vertical mergers of interest (to us), right-to-try issues arise (already), more Alzheimer’s bad news, and Sprout asks the question does lowering the price of an ineffective drug matter
Now, on to the news.
ICER In The News
ICER released a condition update report assessing the comparative clinical effectiveness and value of targeted immunomodulators for the treatment of moderate-to-severe plaque psoriasis. ICER previously reviewed treatments for plaque psoriasis in 2016. In addition to incorporating new clinical data and updated costs for previously reviewed therapies, this condition update includes analyses of the recently approved medications guselkumab (Tremfya, Johnson & Johnson), tildrakizumab (Ilumya, Sun Pharma/Merck), and certolizumab pegol (Cimzia, UCB), as well as risankizumab (AbbVie), which was recently filed for review by the FDA.
“Our 2016 review found that all targeted therapies for plaque psoriasis are more effective than non-targeted agents, and that many are priced in alignment with the added benefit they provide patients. As a result, we urged insurers to consider limiting or altogether abandoning step therapy requirements for these agents,” noted Dan Ollendorf, Ph.D., Chief Scientific Officer at ICER. “In this update, which also looks at several additional new therapies, we find again that the evidence demonstrates relatively minor differences in overall effectiveness across all targeted agents. However, following two years of price increases since our original report, all older therapies have become significantly less cost-effective. Unfortunately, the newest approved therapies have been launched at prices that have tracked this upward trend and are therefore similarly overpriced in relation to their clinical value to patients.”
Institute for Clinical and Economic Review’s Updated Assessment of New Targeted Therapies for Plaque Psoriasis Notes Minor Distinctions in Effectiveness, While Recent Price Hikes Have Made Entire Drug Class Less Cost-Effective
Economist Timothy Taylor writing in BBN Times defines a QALY and discusses its use, including work done by ICER.
What’s the Value of a QALY? QALY is an abbreviation for “quality-adjusted life-year.” It refers to gains in health, which combine a time dimension and an adjustment for quality of life. Peter J. Neumann and Joshua T. Cohen offer a quick overview in “QALYs in 2018-Advantages and Concerns,” a “Viewpoint” article written for the Journal of the American Medical Association (May 24, 2018).
ThePharmaLetter reports on the release of ICER’s CF report (subscription required).
Inside the Beltway/State Regulatory Developments
It looks like we won’t be seeing any massive price cuts within the initially stated period and it remains unclear if and when we will see them (as reported byDonna Young in S&P Global).
The CREATES Act moves forward, but not by much. The Act, designed to be bipartisan and speed up some generic drug approvals, passed the Senate Judiciary Committee by a 16-5 margin. It now may get a vote on the Senate floor. However, in the House, no committee hearings on the bill have been scheduled this session, so the bill’s prospects remain unclear.
Posted 14 June 2018 | By Michael Mezher In a 16-5 vote, the Senate Judiciary Committee on Thursday voted to advance a bill aimed at increasing generic drug competition, known as the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act.
Heading into unchartered waters, Gottlieb proposes a new payment strategy for antibiotics. Endpoints News reports he suggests a subscription model for hospitals instead of paying by the pill. The idea would address some of the issues inherent in developing new drugs that we only want to use sparingly. However, it’s unclear if the current payment system could adapt to the new strategy.
Stepping into the pricing debate, FDA chief Scott Gottlieb proposes new reimbursement idea for antibiotics
In an attempt to make good on its promise to tackle the superbug problem, the FDA trotted out a new idea today that it hopes will address the reimbursement catch-22 inherent in the industry. Their idea? Treat drugs like software, having hospitals buy licenses to antibiotics instead of reimbursing on
In an attempt to spur innovation in pricing, the FDA permits more direct communication between manufacturers and payers, reports HealthcareDive.
First Published on Hoping to pave the way for greater adoption of value-based contracts, the Food and Drug Administration on Tuesday published final guidance that clarifies how drugmakers can share product information with payers while remaining compliant with FDA rules on communication.
The “paper of record” (NY Times) goes on record questioning the FDA’s faster approval of drugs (achieved, according to them, by lowering standards).
“It’s at least possible that if I know we’ve got to show actual, substantial benefits, or that it’s got to be novel in some way, that I might push harder,” says Dr. Steven Joffe, a pediatric oncologist at the University of Pennsylvania.
The Washington Post reports that exposure in the public square does not seem to be reining in drug prices.
Two weeks after Trump unveiled plan to lower drug prices, two cancer drugs got a $1,000-per-month price hike
Two weeks after President Trump in May unveiled a plan to lower drug prices for Americans, promising “it will start to take effect very soon,” the drug company Bayer hiked the list prices of two cancer drugs by more than $1,000 per month. Bayer wasn’t alone.
Trust in pharmaceutical firms falls even further (as reported by FiercePharma).
Trust has hit a new low for pharma in Edelman’s annual Trust Barometer survey. The 13-point drop from 51% to 38% in the U.S. was the category’s biggest nosedive in the five years the public relations and marketing firm has been tracking sentiment.
PWC out with a new report on generics and drug costs. While the FDA’s focus on speeding approval and increasing competition is expected to have an impact, the report reminds us that there are many drug costs issues where generics can’t help.
The Trump administration has largely held a steady course on the pharmaceutical industry, continuing trends in enforcement, approvals and policy even as it has sharply cutting back on the issuance of new regulations.
STAT reports (below) on a couple of speed bumps on the CRISPR super-highway. These issues are not expected to halt the use of the technology, but they serve as a good reminder that the technology is not magic and we must all beware the hype-machine. Or, as STAT’s Sharon Begley writes: Why reports about CRISPR’d cells and cancer aren’t calamitous — but shouldn’t be ignored.
diting cells’ genomes with CRISPR-Cas9 might increase the risk that the altered cells, intended to treat disease, will trigger cancer, two studies published on Monday warn – a potential game-changer for the companies developing CRISPR-based therapies. In the studies, published in Nature Medicine, scientists found that cells whose genomes are successfully edited by CRISPR-Cas9 have the potential to seed tumors inside a patient.
Why am I writing about a cable merger? Because if vertical integration mergers are not going to face anti-trust roadblocks, the Cigna-Express Scripts and Aetna-CVS deals are a go (as reported by businessinsider).
A judge just approved AT&T and Time Warner’s merger – and it could be good news for a series of healthcare mega-mergers
CVS Health and Aetna are planning to merge in a deal that would create a new, vertically integrated company containing a health insurer, a retail pharmacy, and a pharmacy benefits manager, which negotiates prescription-drug prices with drugmakers. While CVS and Aetna shareholders have approved the deal, it remains to be seen whether federal or state regulators will step in to block it.
The expected problems with implementing “right-to-try” have begun; Forbes reports on patients misunderstanding the law and questions of payment.
At last week’s annual convention of the Biotechnology Innovation Organization (BIO) in Boston, FDA Commissioner Scott Gottlieb said during an on-stage interview that his agency has recently initiated a formal process for handling “Right to Try,” the law passed May 30 that allows terminally ill patients to use experimental drugs that have not yet been approved.
Sadly, it’s time to talk about Alzheimer’s failures again. Below, Endpoints reports on Lilly’s termination of a Phase III study due to ineffectiveness. These results are the second major study to recently show no benefit from the BASE class of drugs. Another firm (vTv Therapeutics) also announced negative clinical trial results, but they are not ready to give up yet. Meanwhile, BioPharmaDive reports on Japanese firm Eisai looking for new ideas to fight the disease: Eisai looking past amyloid, tau with new drug discovery center.
PhIII Alzheimer’s drug goes bust – and a major setback at Eli Lilly and AstraZeneca may doom the class
Another big Phase III Alzheimer’s program is being scrapped at Eli Lilly $LLY and AstraZeneca $AZN, offering fresh evidence that the entire BACE class may be completely useless in slowing or preventing the disease in symptomatic patients. The drug this time is lanabecestat, which Lilly grabbed close to 4 years
Bloomberg reports that in an attempt to revive Addyi the price will be cut in half. Not sure if that will increase sales since the more significant problem seems to be lack of efficacy.
Sprout Pharmaceuticals Inc. is relaunching Addyi, the first-ever approved drug for low libido in women — and it’s slashing the drug’s price in half. The new price will be $400, down from $800 for a monthly prescription. The uninsured and those not covered for the treatment will pay no more than $99.