From the desk of Mitchell Stein
Good morning. I can’t help but lead with last night’s news that Walmart and Humana are talking about working more closely together, up to and including a purchase by Walmart of Humana. While reports indicate talks are in preliminary stages, the news caused a flurry of speculation on Twitter (because Twitter). It is worth noting that Walmart is the nation’s largest employer and while running the largest private benefits plan has already been trying to innovate. Also of note, Humana is particularly active in the senior insurance market with Medicare Advantage and Part D plans; they also own their own PBM. I won’t make any predictions on where this leads, but it is clear from this news and the other corporate changes in the works that the landscape for health care delivery and purchasing is changing and there will undoubtedly be impacts on how drugs are prescribed and accessed.
Of course, that wasn’t the only news this week. Here’s our full rundown for today:
ICER in the News – Final report on CAR-T therapies, new topic announcement of hereditary angioedema, profile of the Arnolds (one of ICER’s funders), Dan Ollendorf on value-pricing, two new ICER profiles, coverage of Hemophilia report, and ICER’s work on Vertex drugs
Inside the Beltway – HHS gets advisor on drug pricing, STAT asks where is the pharma CEO testimony, CA’s transparency law, VT’s transparency law, and a review of state-based gag clause bans
Industry Trends – Aetna to pass along rebates, are PBMs’ days numbered? EMA with some different decisions than FDA, Is P<0.05 too generous? CRISPR does work, Ohio drug prices, PhRMA, and coupons
Company/Drug Specific – Roche’s Tecentriq, Novartis & data, Biohaven & migraines, GSK & OTC, and Takeda & Shire
Weekly View In-depth – Biosimilars
Now, on to the news.
ICER In The News
ICER released a Final Evidence Report and Report-at-a-Glance on tisagenlecleucel (KymriahTM, Novartis) and axicabtagene ciloleucel (YescartaTM, Kite Pharma/Gilead), two CAR-T therapies for treatment of B-cell cancers. Policy recommendations highlight that, even though the pricing of current CAR-T therapies aligns with patient benefit, changes will be needed in future pricing, payment, and delivery mechanisms to ensure patient access without threatening health system affordability. ICER’s report was reviewed at a public meeting of the California Technology Assessment Forum (CTAF).
Institute for Clinical and Economic Review Final Report on CAR-T Therapies Highlights Need for Systemwide Changes to Ensure Affordability and Access to Innovative, One-Time Therapies
ICER announced plans to assess the comparative clinical effectiveness and value of therapies for hereditary angioedema, a rare condition characterized by attacks of deep tissue swelling within the skin and/or mucosa. The report is set to be reviewed during an October 2018 public meeting of the California Technology Assessment Forum and is tentatively expected to focus on four therapies for the prevention of hereditary angioedema attacks: lanadelumab (Shire), which is currently under review by the FDA with an approval decision expected in August of 2018, and three C1 esterase inhibitors (Haegarda®, CSL Behring; Cinryze®, Shire; and Ruconest®, Pharming).
Institute for Clinical and Economic Review to Assess Therapies for Hereditary Angioedema in Upcoming Assessment
STAT did a profile of the John and Laura Arnold and their funding of work related to drug pricing. They are one of ICER’s funders, and ICER is referenced in the article.
ohn Arnold is legendary for turning contrarian bets into heaps of money. The soft-spoken Texan was a whiz kid trader at Enron before its fall. He then ran his own hedge fund, specializing in energy trading. Before he turned 34, he was a billionaire. He can afford his prescription drugs.
ICER’s Chief Scientific Officer, Daniel Ollendorf, presented at Boston University on value assessment, including the use of cost-effectiveness and budgetary impact analyses in decision-making. The lecture can be viewed in its entirety through the link below.
PHForum2018 Daniel Ollendorf, Chief Scientific Officer, Institute for Clinical and Economic Review Read More Daniel Ollendorf has been the chief scientific officer of the Institute for Clinical and Economic Review (ICER) since 2007.
Both MM&M and BioCentury (subscription required to read full article) took a look at ICER’s role and expanding influence.
Pharma’s relationship with the Institute for Clinical and Economic Review is frequently uneasy. Occasionally, it’s downright hostile. Such reactions aren’t all that surprising. The nonprofit aims to assess the value of treatments based on real-world evidence and the baked-in costs of innovation.
The Institute for Clinical and Economic Review is rapidly becoming the closest thing the U.S. has to an HTA agency.As an independent, non-governmental body, ICER does not have the authority over reimbursement decisions accorded to European health technology assessment (HTA) agencies. U.S. payers are not required to reimburse drugs ICER determines to be cost-effective.
Hemophilia News Today (Hemlibra is an Effective and Cost-saving Hemophilia A Therapy, Report Finds) and AJMC (ICER Review Finds Hemlibra Lowers Costs and Improves Outcomes in Hemophilia A) reported on the results of ICER’s Evidence Report on Hemophilia A. Hemlibra was also in the news this week: Faced with fresh concerns about Hemlibra’s safety, Roche spells out what it knows about 5 deaths. Although the market reacted negatively to the news, Roche maintains the deaths were not related to the drug.
EP Vantage takes a look at ICER’s work on Vertex’s three CF drugs.
Inside the Beltway/State Regulatory Developments
HHS will have a senior advisor for drug pricing reform. Daniel Best, a former CVS/Caremark executive, was appointed by Azar to take the lead on the agency’s efforts to lower prices.
Department of Health and Human Services Secretary Alex Azar has tapped a former CVS Caremark executive to lead the agency’s efforts to lower drug prices. According to HHS, Daniel Best will be Azar’s senior advisor for drug pricing reform. Best was most recently a vice president of industry relations for CVS’s Medicare Part D business.
While Congress is out of town, STAT’s Erin Mershon takes the opportunity to look back and ask why pharma CEOs haven’t been called before committees.
ASHINGTON – It’s a rite of passage for executives in the hot seat: get hauled before Congress, sit for bipartisan tirades, squirm in the face of difficult questioning. Over the past six months, lawmakers have dragged in former Equifax CEO Richard Smith, Wells Fargo’s Tim Sloan, and Amtrak’s Richard Anderson.
The first reports are in regarding implementation of CA’s drug transparency law. So far, firms are complying; however, it will be a while before any impact on pricing can be determined.
California’s first-in-the-nation drug pricing transparency law is beginning to kick in – and to spur copycats, with Oregon’s governor last week signing a law that requires drug companies to disclose cost components they have long considered proprietary. Whether they’ll actually reduce prices is a crapshoot.
Vermont’s law has been in effect longer than California’s. STAT Plus (subscription required) took a look at the reaction as their annual report was issued: ““The results have been very disappointing,” William Lippert, who chairs the House Committee on Health Care, told us. “We took a first step toward transparency, but it wasn’t substantial enough to give us anything of true value. The thing that’s useful is that it identified some drugs and increases in their prices, but it’s only 10 drugs out of hundreds and hundreds.””
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NASHP takes a look at state-based gag clause bans.
A growing number of state legislatures across the country are introducing bills to outlaw a “gag clause” that prevents pharmacists from telling consumers when there are cheaper prescription drug alternatives available. Some of the bills also require fuller disclosure about the business relationships between pharmacy benefit managers, health plans, and pharmacies in order to address …
Aetna joins United on plans to pass along rebates to customers at point-of-sale instead of using in aggregate to lower premiums. (As with United, worth noting that Aetna’s self-funded clients already have this option yet few opt to do so.) Is this an attempt to counter manufacturers claims that insurers and PBMs are responsible for the drug cost issue? Is it a harbinger of changes in store as the ownership structure of PBMs shifts? Grab some popcorn; the changes are just starting.
Aetna Inc. will pass on the discounts it negotiates on prescription drugs to about 3 million of its members, the latest move by a health insurer to address Americans’ complaints about the cost of medicine.
Are PBMs’ days numbered? I asked my Magic Eight Ball and received the response: “Reply hazy try again.” What we do know is that between corporate realignments and possible “disruptors” entering health care, things are going to change.
What’s a great way for Amazon to prove it can make America’s healthcare system better for consumers? Cut the cost of a high priced generic drug by getting it out of the reimbursement structure dominated by middlemen called pharmacy benefit managers (PBMs), according to Julie Grant, a partner at VC firm Canaan Partners and board member of the Biden Cancer Initiative.
The European Medicines Agency (EMA) refused to approve two drugs that were approved last year by the FDA. EMA raised questions regarding the clinical trial data.
Posted 23 March 2018 | By Zachary Brennan The European Medicines Agency (EMA) on Friday raised questions about two treatments approved by the US Food and Drug Administration (FDA) in 2017.
Is P<0.05 too generous?
Lies, damn lies and statistics: A Stanford wiz says P<0.05 offers deceptive evidence of biopharmas' drug claims
The biopharma R&D world revolves around one simple formula: A P value of less than 0.05 in a pivotal study. But a top professor of medicine and statistics at Stanford says it’s a poor measure of value, and he wants to scrap it for something far more demanding – and
Remember all that fuss last year about CRISPR not working? Authors of the original study say never mind.
Share to email Share to facebook Share to twitter Share to linkedin Share to google Opinions expressed by Forbes Contributors are their own. Last July I wrote an articlethat was highly critical of a much-hypedNature Methods article that in turn claimed to have found a serious problem with the gene editing technology called CRISPR.
Questions arise regarding the behavior of Ohio’s Medicaid PBM: “Pharmacy benefit managers are receiving $1.54 per pill from Ohio’s Medicaid program for a drug commonly used to treat depression. The state pharmacy association and operators of nearly two dozen pharmacies across the state say those same pharmacy benefit managers, or PBMs, are paying them only about 18 cents for each of those pills.”
PhRMA goes after changes in how coupons are handled.
First Published on PhRMA, the powerful trade lobby for the drug industry, is out with a new ad push criticizing insurers and pharmacy benefit managers for changing how they process the copay coupons issued by drugmakers. The subject of PhRMA’s ire is a practice rolled out by UnitedHealthcare Group Inc.
Roche’s Tecentriq continues to rack up successes.
Roche AG’s checkpoint inhibitor Tecentriq helped previously untreated patients with advanced lung cancer live longer when combined with its own Avastin and chemotherapy, according to updated results from a key study. Adding Tecentriq to a treatment regimen of Avastin plus carboplatin and paclitaxel significantly lengthened overall survival when compared to Avastin and chemotherapy alone, Roche reported Monday.
Will Novartis be the first to master the technology of understanding their data in real time?
What does the youngest chief executive in Big Pharma want? A control room straight off the starship Enterprise. When Vas Narasimhan, 41, took the helm of drug giant Novartis in February, he’d already put the project in motion.
Biohaven’s new migraine drug is not the improvement the market had hoped. (ICER is in the midst of a review of migraine treatments; however, the Biohaven drug is not among those being considered).
(Reuters) – Biohaven Pharmaceutical Holding said its treatment for acute migraine cleared two late-stage studies, but investors worried about its commercial viability as the efficacy data failed to distinguish from Allergan’s rival treatment. Shares plunged as much as 33 percent to touch a record low of $16.51 in early trading on Monday.
GSK buys out Novartis for $13B, taking over their OTC joint venture.
Turns out GlaxoSmithKline didn’t walk away from Pfizer’s consumer health unit last week just because of its asking price. The British pharma giant had another buyout in mind-namely, a deal to take full control of its OTC venture with Novartis.
Will Takeda go after Shire? Should they?
Could Takeda pull off a $50B-plus Shire takeover? Maybe, but analysts and investors have their doubts if they should
The news bright and early Wednesday morning that Takeda $TKPYY was planning to make a run at Shire $SHPG caused more than a little head scratching among some of the analysts covering these companies. And it also caused some fretting among the Japanese company’s investors, who took Takeda’s share price
Weekly View In-depth
A topic always of interest, here’s your periodic reminder that while nine biosimilars have been approved, only three have reached the public due to ongoing patent litigation and deals between companies.
We’ll start off with this incredibly informative, detailed primer on biosimilars from Zachary Brennan (although I think he should have used the title “everything you wanted to know about biosimilars but were afraid to ask”).
For more than a decade now, biotech and pharmaceutical companies have brought a new class of treatments – biosimilars – to markets around the world (from the EU to India to South Korea to the US), offering cost savings for some of the most expensive medicines, though even in 2016, decades after companies began their quest to develop biosimilars, they are still only just beginning to see widespread adoption.
The FDA’s Gottlieb isn’t happy with the speed of biosimilar introductions.
Biosimilars and oncology.
FDA worries about USP (United States Pharmacopeia) process.
USP’s efforts to develop biological product monographs could impede or delay licensure of biosimilars and other biologics, Janet Woodcock, director of FDA’s Center for Drugs Evaluation and Research, and Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, wrote to USP CEO Ronald Piervincenzi in a letter on Wednesday.