ICER Weekly View 05-11-18

From the desk of Mitchell Stein


Good morning. The President will talk about prescription drug prices today (Friday). Last night, there was an off-the-record briefing of reporters on what will be included in the speech. We’ll take a look at what we might expect in the Inside the Beltway section below.

Before we get to that and the rest of the week’s news, an editorial note. Based on feedback from readers, I’m making a concerted effort to streamline Weekly View (WV). There’s no denying that over time, the newsletter has gotten longer than intended; so moving forward I’ll work to be more judicious regarding what to include. I’m also eliminating the Company/Drug Specific section – instead, you’ll find WV-worthy stories in the Industry Trend section. And finally, the In-depth section will become an occasional feature instead of a weekly staple. How does all that sound to you? Please let me know what you think of the changes (and any other feedback you want to share) by emailing with your thoughts.

This week we’ll look at:

ICER in the news – Draft evidence report on elagolix, ICER paper on drugs for rare conditions published, ICER’s CF work in the news, The Economist looks at drug prices, value-based formularies, and indication-specific pricing

Inside the Beltway – The President’s drug price speech (several articles), Gottlieb on breakthrough designations, Vermont wants to import, and the West Virginia pharma Senate race

Industry Trends – 60 minutes does drugs, a NASA for drug development, some say $1 million for this drug would be cheap, reigning in stem cell clinics, Takeda takeover, and Valeant name change

Now, on to the news.

ICER In The News

ICER released a Draft Evidence Report assessing the comparative clinical effectiveness and value of elagolix (AbbVie/Neurocrine Biosciences) for the management of endometriosis and associated pain. The release was covered by BioPharmaDive: AbbVie’s elagolix could put pressure on budgets, ICER estimates.

Institute for Clinical and Economic Review Releases Draft Evidence Report on Elagolix for Endometriosis

ICER President, Steve Pearson, MD, MSc; Chief Scientific Officer, Dan Ollendorf, PhD;  and Director of Health Economics, Rick Chapman, PhD, MS, published a paper providing an overview of the societal, ethical, and coverage/reimbursement landscape for consideration of novel treatments for rare diseases.

Evaluating and Valuing Drugs for Rare Conditions: No Easy Answers

ICER’s work on Vertex’s CF drug, along with the company’s response, continues to garner attention. In the STAT Plus article below (subscription required), ICER’s President Steve Pearson responded:

“We call them as we see them. We did our usual process working with patients, families, experts, and had lots of interaction with the manufacturer,” Pearson told us. “And nobody is talking about payers walking away from covering these drugs. This is about trying to get a fair price that is more affordable to families and the health system. This (review) doesn’t threaten patient access. That’s a bogeyman meant to stir up the patient community unfairly.”

Watchdog says Vertex CF drugs not cost effective; company calls analysis ‘sham’

Vertex would have to lower its prices from 71 percent to 77 percent in order to align costs with the benefits, according to a review by the Institute for Clinical and Economic Review.

The Economist takes a look at recent actions pushing back on high drug prices, including discussion of ICER’s work.

Americans, tired of high-priced drugs, are fighting back

IF ONE concern unites Americans, it is the high prices of prescription drugs. One incident in particular tarnished much of the pharma industry: in 2015 the price of an antiparasitic drug, Daraprim, jumped from $13.50 to $750 per pill. But large price increases remain stubbornly commonplace (see chart).

In a two-part post, Boston University’s Gilbert Benavidez discusses value-based formularies and how ICER’s work is being used to create them. Part 1 is below; Part 2 can be found here.

The Value-Based Drug Formulary

Gilbert Benavidez is a Policy Analyst with Boston University’s School of Public Health. He tweets at @GBinsolidarity. CVS, the second largest pharmacy benefit manager (PBM) in the US, takes drugs off its formulary if there’s a cheaper drug that’s just as clinically effective. This strategy is dubbed “value-based

A look at the approval of Novartis’s Kymriah for a second indication and the indication-specific pricing that is being tried. Includes mention of ICER’s work.

A cutting-edge new cancer treatment has two different price tags – and it could be the future of how we pay for drugs

Pharmaceutical News

Inside the Beltway/State Regulatory Developments

Later today (Friday) the President will give his address on prescription drug prices. As mentioned above, there was a briefing last night regarding what the speech will contain. For the most part, it seems to include what Azar and Gottlieb have been hinting. So, while the President has in the past gone off-book, here is what we’re told the speech will contain: A focus on other countries getting a “free ride” from our high prices, an easing of rules so generics can get to market without some of today’s legal obstacles, some sort of increase in negotiating (although not outright Medicare negotiation), and lowering of out-of-pocket costs. Below are two pieces summarizing last night’s briefing.

Trump plan for drug prices seen largely sparing industry

As U.S. President Donald Trump prepares to deliver a long-anticipated speech on Friday on curbing prescription drug costs, health industry insiders expect little in the way of policies that would hurt the drugmakers he once accused of “getting away with murder.”

Trump will not call for negotiation on Medicare drug prices despite Democratic hopes

President Trump Donald John Trump Trump greets 3 American detainees freed by North Korea Trump called Blankenship after Senate primary loss: report Education Dept to relax rules restricting faith-based institutions from getting federal aid MORE ‘s drug pricing plan will not include a call for Medicare to negotiate drug prices, a leading Democratic idea that Trump previously supported, a senior administration official said Thursday.

We may not have heard the speech yet, but Democrats have already offered their counterpoint.

Democrats offer counterpoint to Trump’s drug pricing policy before speech

ASHINGTON – A coterie of the country’s most powerful and recognizable Democrats gathered Thursday to offer their early rebuttal to President Trump’s anticipated Friday address on drug prices. As one lawmaker put it, the group was “hopeful, but … not optimistic” that Trump would deliver on his early promises to lower prescription drug prices.

While this piece was written before the speech details emerge, it remains relevant given we expect “American patients first” to be part of the remarks. Will the speech have a global impact on drug pricing?

Trump’s ‘America First’ agenda on drug pricing could backfire around the world

President Donald Trump wants Americans to get lower prices for medicines – and the rest of the world may pay for it. His “America First” message on drugs at home, coupled with pro-pharmaceutical industry policies abroad, could lead to higher costs for patients around the world – without making drugs more affordable for those in the U.S.

When is a breakthrough really a breakthrough? Scott Gottlieb thinks he knows.

Gottlieb pushes back against criticism of ‘breakthrough’ designation – STAT

ASHINGTON – Food and Drug Administration Commissioner Scott Gottlieb defended his agency’s “breakthrough therapy” program, which speeds review of drugs that show signs of benefit early on, amid criticism from academics that the therapies aren’t actually breakthroughs at all.

Vermont advances a bill to allow drug importation. While the idea has some support, there remain questions regarding implementation. Remember, for every action; there is a reaction – what will the reaction to this be on the other side of the boarder? For this to work, manufacturers will have to cooperate by providing adequate supplies to Canadian distributors. Stay tuned.

Vermont Legislature First in the Nation to Approve Rx Drug Importation from Canada – NASHP

For the first time in the United States, obtaining low-cost prescription drugs from Canada is one step closer to reality today following the Vermont state legislature’s landmark enactment of S.175. The bill now heads to Governor Philip Scott.

The West Virginia Senate race will have a unique pharma flavor.

West Virginia Senate race pits two candidates with close ties to pharma

ASHINGTON – The protester dressed as a gigantic, orange EpiPen injector was sent to Sen. Joe Manchin’s photo op last month as a reminder from Republicans: The vulnerable Democrat from West Virginia should expect his daughter’s company to be a campaign issue at every stop along his road to re-election.

Industry Trends

Come to see Peter Bach on camera, stay for the investigative journalism as Sixty Minutes looks at the pricing of Acthar, the impact of the price on one city’s budget, and what role the PBM played.

The problem with prescription drug prices

The Rockford File is the story of how one very expensive prescription drug threatened to financially cripple an entire city. That city is Rockford, Illinois, an old industrial town outside of Chicago. Rather than using a health insurance company, Rockford has, for years, paid its own health care costs for its 1,000 employees and their dependents.

Is it time to consider a NASA for drug development?

Building a NASA for Prescription Drugs

As longtime affordable medicines advocate James Love of Knowledge Ecology International points out, such ideas for drug development aren’t proposing anything the government doesn’t already do. The NIH, the Biomedical Advanced Research and Development Authority, and the National Cancer Institute already fund the full research process for some medicines developed in the United States today.

Forget the million dollar drug, how about $1.5 million. On the face of it, it sounds like a good deal – conservative estimates are that the price would be less than the cost of five years of standard treatment. However, upon further reflection, it’s not so obvious – due to churn (individuals changing insurance plans) many payers would not see the benefit of laying out the money up front.

First US drug priced at more than $1 million may be on the horizon

In the paradoxical world of drug pricing, the first U.S. price tag exceeding $1 million for a medicine is being contemplated as the nation’s agita over the cost of prescription drugs climbs ever higher.

Finally, movement to reign in unscrupulous stem cell clinic operators.

F.D.A. Moves to Stop Rogue Clinics From Using Unapproved Stem Cell Therapies

The Food and Drug Administration said on Wednesday that it was seeking court orders to stop two clinics from using unapproved stem cell treatments that in some cases have seriously harmed patients.

And it’s official. Takeda secures financing for its takeover of Shire.

Takeda Moves to Join Pharma Giants With $62 Billion Shire Deal

Takeda Pharmaceutical Co. is joining the drug industry’s giants with Japan’s biggest overseas takeover — a $62 billion deal for much larger rival Shire Plc. Chief Executive Officer Christophe Weber capped a drawn-out pursuit of the U.K.-listed company with an acquisition he described as transformational that will give Takeda wider reach into the world’s biggest drug market and strengthen its global pipeline for lucrative drugs that treat rare diseases.

Shakespeare said: “What’s in a name? That which we call a rose. By any other word would smell as sweet;” Valeant turning the quote upside down, seems to think they will smell sweeter if they are called by another name.

Valeant, Distancing Itself From Its Past, Will Change Its Name to Bausch Health

Valeant Pharmaceuticals International, the company whose enormous price increases on old drugs helped fuel public outrage over high drug costs, is changing its name, the company announced Tuesday. The new name will be Bausch Health Companies, to reflect the company’s better-known and more respected subsidiary, the eye care company Bausch + Lomb, which it acquired in 2013. 
@mhstein  |

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