ICER Weekly View 03-09-18

From the desk of Mitchell Stein


Good morning. Do I focus on Gottlieb talking tough on prices, the Express Scripts sale, or the gut-wrenching look at the impact of high drug prices? Or should I make a joke about Maine blaming me for the 18 inches of snow yesterday because in last week’s intro I commented that the previous storm didn’t bring us any? Never mind, there’s so much to cover let’s dive right in; here’s the full line-up for this week:

ICER in the news – Report on CAR-T CTAF meeting, review of ICER’s chronic low back and neck pain report, and AHIP drug panel includes discussion of ICER

Inside the Beltway – Gottlieb on “kabuki drug pricing,” prospects for the CREATES Act, review of 340B program, and Oregon drug transparency bill advances

Industry Trends – Cigna to purchase Express Scripts, United Health to pass pharmacy rebates to consumers, gut-wrenching piece on the impact of high drug prices, clotting factor prices, generic drug pricing probe widens, RTFs go unreported, money keeps flowing, flu hearing, innovation index results, the safety of biosimilars, and a history of the right-to-try movement

Company/Drug Specific – Sanofi, Merck, Dermira, Raxone, and Opdivo

Weekly View In-depth – Accelerated approvals

Now, on to the news.

ICER In The News

Biocentury reported on last Friday’s (3/2/18) CTAF meeting where CAR-T therapies were discussed. You can find all of ICER’s material on the topic here.

ICER panel split on value of CAR Ts

The Institute for Clinical and Economic Review’s California Technology Assessment Forum voted that the value of Kymriah tisagenlecleucel was intermediate, while the panel was mixed on whether the value of Yescarta axicabtagene ciloleucel was intermediate or low.Seven members voted that the value of Kymriah from Novartis AG (NYSE:NVS; SIX:NOVN) has an intermediate value compared with clofarabine, while 3 voted it had high value.

An Evidence to Practice article was published in JAMA; authored by Kaiser Permanente researchers it summarizes a recent ICER report on certain cognitive and mind-body therapies for chronic low back and neck pain. The full article is behind a paywall and can be found here.

Integrative non-drug therapies treat back pain at reasonable cost

ICER is mentioned in this report from of a drug pricing panel at the AHIP conference.

Drug Pricing Debate: Panel Talks About Transparency, Legislation

Pharmaceutical News

Inside the Beltway/State Regulatory Developments

FDA Commissioner Scott Gottlieb delivered a speech at an AHIP conference this week. He blamed industry for “Kabuki drug pricing” and expressed concern that the market was disincentivizing the production of biosimilars. You can read the text of his remarks here (Capturing the Benefits of Competition for Patients), and below are two accounts of the speech.

FDA commissioner to health insurers: You’re doing it wrong

Insurance is designed, theoretically, to protect against the catastrophic: tornadoes, floods, hurricanes – or, where our health is concerned, cancer or another devastating disease. To make that financial protection affordable, many pay into the system: the healthy are supposed to subsidize the sick.

Gottlieb to Health Insurers: Help Increase Biosimilar Competition

Insurers need to do their part to help encourage biosimilar competition to bring down the rising prices of biologics, FDA Commissioner Scott Gottlieb told the America’s Health Insurance Plans’ (AHIP) National Health Policy Conference in Washington, DC, on Wednesday.

Will the CREATES Act end up in the omnibus spending bill? Prospects remain unclear, two pieces of conflicting data below.

BioCentury – CREATES Act out, lobbyists say

The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act will not be included in the pending omnibus budget bill, anonymous lobbyists for the pharmaceutical industry told BioCentury Wednesday. Although the bill has bipartisan support and is aligned with Trump administration policies, a combination of lobbying muscle and political calculation have scuttled efforts to have it included in the omnibus bill.

GOP lawmaker meets with Ryan to push for drug pricing bill

Rep. Tom Marino Paul Ryan Paul Davis Ryan Republicans are avoiding gun talks as election looms The Hill’s 12:30 Report Flake to try to force vote on DACA stopgap plan MORE (R-Wis.) on Wednesday to push for the inclusion of a measure to fight high drug prices in a coming government funding bill.

A review of the 340B drug program and the proposed legislation to change it.

Proposed Reforms To The 340B Drug Discount Program

Drug price transparency bill moves to the Oregon Governor’s desk.

Drug price transparency bill passes Oregon Senate, heads to Gov. Kate Brown’s desk – Portland Business Journal

Legislation to shed light on prescription drug prices passed the Oregon Senate Friday and is headed to the desk of Gov. Kate Brown. House Bill 4005, which passed on a vote of 25-4, requires drug manufacturers to justify price hikes for more expensive prescription drugs.

Industry Trends

Just in case you hadn’t heard, Cigna is buying Express Scripts. I’m old enough to remember when large insurers were their own PBMs, looks like what’s old is new again. I know it’s hard to keep track, so as a reminder, three of the largest PBMs (that control 72% of the market) will now be part of insurance companies: OptumRx is already part of United, previously Aetna announced its purchase of CVS, and now Cigna buys Express Scripts. Below are two articles covering the deal and trying to peer into the future to see what it means. But truthfully, shruggie has the most appropriate prediction for how this all plays out  ¯\_(ツ)_/¯.

Cigna’s $54 Billion Purchase Of Express Scripts Could Upend The Prescription Drug Market

This morning, the health insurer Cigna announced that it plans to buy pharmacy benefit manager Express Scripts for $54 billion. And with that move – long-telegraphed but seismic – the market for prescription drugs could change dramatically. The big question: will patients benefit, or will this just protect insurance company bottom lines?

Cigna to Buy Express Scripts in $52 Billion Health Care Deal

Last year, Express acknowledged that it had parted ways with its largest customer, Anthem, after the insurance giant sued in 2016, claiming that Express was overcharging for drugs. The news led to speculation about how Express would replace the lost business, given that Anthem accounted for nearly a fifth of its revenue.

UnitedHealthcare announced that beginning in 2019, it will pass pharmacy rebates directly to consumers for the 7 million individuals covered by the firm’s insured large group plans. United (and other large insurers) note that their self-funded clients already have this option, but few take advantage, preferring to use the rebates to lower overall premiums instead. In their release, United said the impact of this change on policy would be “minimal.” Note that for that to be the case, the number of individuals who will see significant reductions in their drug costs will be much less than the 7 million impacted by the policy. (That is to be expected as not all of the 7 million will have significant drug costs, and of those who do, not all of them will take drugs covered by rebates.)

UnitedHealthcare Says It Will Pass On Rebates From Drug Companies to Consumers

Aiming to deflect criticism, the pharmaceutical industry has increasingly pointed the finger at both insurers and pharmacy managers for not sharing the rebates with customers filling prescriptions. The Pharmaceutical Research and Manufacturers of America, the industry trade group, rolled out an advertising campaign, “Share the Savings,” last year to make the case that by passing on the discounts, plans could significantly lower patients’ out-of-pocket bills.

There are probably as many prescriptions for addressing high drug prices as there are people reading this newsletter. This item doesn’t address any of them; what it does is remind us of the burden those high prices place on our family, friends, and neighbors by examining several individuals and their situations. Stunning work by Katie Thomas and Charles Ornstein reminding us why we keep searching for solutions to the problem.

The Price They Pay

The burden of high drug costs weighs most heavily on the sickest Americans. Drug makers have raised prices on treatments for life-threatening or chronic conditions like multiple sclerosis, diabetes and cancer. In turn, insurers have shifted more of those costs onto consumers.

This story uses clotting factor drugs as a case study in how the market has failed to lower price, despite there being several roughly similar options.

Miracle Of Hemophilia Drugs Comes At A Steep Price

When Landon Morris was diagnosed with hemophilia shortly after birth, his mother, Jessica Morris, was devastated. “It was like having your dreams – all the dreams you imagined for your child – just kind of disappear,” she recalled. Hemophilia, a rare bleeding disorder caused by a gene mutation that prevents blood from clotting properly, is typically passed from mother to son.

That probe into generic drug price fixing keeps getting bigger.

Probe Into Generic Drug Price Fixing Set To Widen

Forty-five states and the Department of Justice are claiming that generic-drug prices are fixed and the alleged collusion may have cost U.S. business and consumers more than $1 billion. In their complaint, prosecutors say that when pharmacies asked drugmakers for their lowest price, the manufacturers would rig the bidding process.

It’s not only Complete Response Letters (CRLs) that often go unreported upon receipt. Analysis shows Refusal to File (RTF) letters are often not disclosed.

Numbers show drugmakers are keeping RTFs under wraps

When Celgene Corp. revealed receipt of a Refusal-to-File (RTF) letter for its blockbuster hopeful multiple sclerosis drug ozanimod, shares in the big biotech dropped as much as 10% to linger near a 52-week low.

The money keeps flowing.

In Two Months, Biotech Startups Raised More Money Than In All Of 2013

Last week, biotechnology firms raised $758 million from VCs and angel investors, according to an analysis by Pitchbook, a data provider that tracks venture and private equity investments. In the year-to-date, venture capitalists have poured $2.8 billion into biotechnology startups.

The House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing yesterday on Examining U.S. Public Health Preparedness for and Response Efforts to Seasonal Influenza.

Officials urge pharma to drop egg-based flu vaccine, invest in new technologies

IDEA Pharma’s (a consulting firm) freshness index indicates that the 30 large and small firms examined for the study got just 11% of their 2017 revenue from drugs developed within the past five years.

How Stale Is Innovation in Drug Discovery? Think: 5-Year-Old Yogurt.

IDEA Pharma’s “Freshness Index” shows that pharma and biotech companies rely on old, stale drugs for revenue and are in an innovation rut.

A review of 90 studies did not show differences in efficacy or safety for biosimilar substitutions.

Review Finds Switching From Reference Product to Biosimilar ‘Not In…

Posted 05 March 2018 | By Zachary Brennan In what may be part of a growing body of evidence that helps green light the development of new interchangeable biosimilars, a review published Saturday in Drugs found that data collected to date suggest that switching from a reference medicine to a biosimilar “is not inherently dangerous, and that patients, healthcare professionals, and the public should not assume that it is problematic.”

A history of the right-to-try movement.

How the ‘right-to-try’ movement muscled its way into Washington

ASHINGTON – Five years ago, the phrase “right to try” wasn’t yet an inkling in the minds of its staunchest advocates. Today, the pithy shorthand for the campaign to get dying patients access to experimental treatments has been slapped on bumper stickers, emblazoned on T-shirts, and uttered by some of the most powerful figures in Washington.

Company/Drug Specific

Sanofi is spinning out its infectious disease unit.

Sanofi is jettisoning its infectious disease unit to Evotec – handing over cash, staff and a pipeline

Sanofi is spinning out its infectious disease research unit to Evotec, the German contract development organization known for its deal savviness.

Merck enters into partnership with Japan’s Eisai.

Merck partners with Eisai in sweeping bet on Keytruda combo

Merck & Co. will partner with Eisai Co. Ltd. to develop and market the Japanese pharma’s cancer drug Lenvima, inking a sweeping collaboration deal aimed at expanding its edge in oncology.

Dermira cancels development of their acne drug after failure in two Phase 3 studies.

Watch out below: Dermira axes acne drug after a catastrophic PhIII failure

Dermira set itself up for one of the big stock $DERM catalysts of Q1 with its Phase III acne studies for DRM01. And it got knocked down – hard – Monday morning as it reported the late-stage program had suffered a catastrophic failure. The primary endpoints for the two studies

NIH MS study showed no benefit from Raxone.

Santhera’s Raxone shows no efficacy benefit in MS study

ZURICH (Reuters) – Santhera Pharmaceuticals said on Monday a study of its medicine Raxone in primary progressive multiple sclerosis showed no difference between the treatment and placebo groups in disease progression, another setback for the Swiss drug company.

Bristol-Myers’ Opdivo gets another competitive edge with newly approved dosing schedule.

Opdivo gets more flexible dosing, gaining edge over competition

Bristol-Myers Squibb Co. announced Tuesday morning the Food and Drug Administration gave its blockbuster PD-1 inhibitor Opdivo an OK for a new dosing schedule. Opdivo is now the first PD-1/L1 approved for an every four-week dosing schedule, according to the company. The FDA also green lighted a shorter infusion time of just 30 minutes for the drug.

Weekly View In-depth

Accelerated Approvals

The FDA was pleased with a report on the history of accelerated approvals.

Accelerated Approval in Oncology: FDA Touts Successes, Responds to …

Posted 05 March 2018 | By Michael Mezher A majority of oncology treatments granted accelerated approval over the last 25 years have gone on to demonstrate a clinical benefit, US Food and Drug Administration (FDA) officials write in a review published in JAMA Oncology last week.

But not everyone was impressed. This Twitter stream from Dr. Prasad takes issue with the way the approvals were judged in the report.

Vinay Prasad on Twitter

Looks like we need a TWEETORIAL about the FDA using surrogate endpoints to approve cancer drugs: Are you ready? 
@mhstein  |

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