ICER Weekly View: July 26, 2019

From the desk of David Whitrap

Yesterday, ICER hosted a public meeting to review the clinical evidence, non-clinical benefits, and cost-effectiveness of treatments for Duchenne muscular dystrophy. This is a truly horrible disease for boys, and the parent testimony shared throughout the day anchored the conversation and brought tears to several members of our independent panel of experts. All of the tensions inherent to the US health system — unaffordable pricing, fears about insurers limiting patient access, clinical trials that don’t measure the outcomes that matter most to patients, the need to incentivize R&D for truly transformative therapies — were palpable.

Regardless of the opinions you may hold about ICER, if you have never been to one of these public meetings, I strongly encourage you to find one to attend in person. While often uncomfortable and never easy, this public process sure beats the alternative of having manufacturers and insurers making consequential decisions about drug pricing and access behind closed doors — without an independent view of the evidence, and without patients in the room.

Here’s what else happened this week:

  • ICER in the News: A favorable draft assessment of Vascepa and Xarelto, new confirmation of ICER’s earlier conclusions about abuse-deterrent opioids, and The Lancet’s call for drugs to be priced in alignment with how well each drug improves patients’ lives.
  • Pharmaceutical News: Why the best-selling drug of all time may be hurting future pharmaceutical innovation, how much the U.S. spends on treatments that other governments have chosen not to cover, the drug pricing proposals that are moving forward in D.C. just as PhRMA lobbying reaches a new high, and the latest compromise in Massachusetts’ attempt to lower Medicaid drug spending.

ICER in the News

On Wednesday, ICER released our Draft Evidence Report assessing the comparative clinical effectiveness and value of icosapent ethyl (Vascepa®, Amarin Pharma) and rivaroxaban (Xarelto®, Janssen Pharmaceuticals), additive cardiovascular disease (CVD) therapies. The draft report will be open to public comment through August 20th.

ICER Releases Draft Evidence Report
on Additive Cardiovascular Disease Therapies

While still just a draft analysis until after we receive public comment, media outlets noted the preliminary cost-effectiveness findings for both additive CVD therapies.

A Promising Fish-Oil Heart Capsule
Also Looks Cheap


Another win for Vascepa: Pricing watchdog ICER
calls Amarin’s fish-oil pill cost-effective


If abuse-deterrent formulations of opioids were expected to reduce overdose deaths, federal statistics don’t show it. Further, several researchers are suggesting that reformulated OxyContin, combined with tighter prescribing and other measures, accelerated the nationwide shift toward heroin and fentanyl. Matt Perrone at the Associated Press notes ICER’s similar conclusion last year, and asks important questions about why new data about the overall effect of abuse-deterrent opioids remain secret.

Revamped OxyContin was supposed
to reduce abuse, but has it?

(The Associated Press)

In its August issue, The Lancet Heamatology is running an editorial urging governments and regulatory bodies to go beyond approving drugs based on safety and efficacy endpoints, and also consider cost-effectiveness. The Journal states:

“The not-for-profit Institute for Clinical and Economic Review already provides independent, value-based pricing reports that have served to lower the cost of some drugs.”

The Value of Affordable Care
(The Lancet)

Pharmaceutical News

Humira has turned AbbVie into a global pharma giant — and the company has aggressively blocked competition to protect its sales. Fortune Magazine’s Sy Mukherjee details how a blockbuster medication became a case study in what’s killing drug innovation.

Protect at All Costs: How the Maker of the
World’s Bestselling Drug Keeps Prices Sky-High


As the U.S. grapples with rising prices for medicines, a new analysis finds Medicare spent more than $26 billion in recent years on dozens of medicines that were not recommended for coverage in three other wealthy nations because government advisory groups there found the drugs did not have sufficient value to justify the costs.

Medicare paid for medicines that three
other wealthy nations decided had little value

(STAT News)

As Congress considers legislation to lower drug prices, the pharmaceutical industry spent a record amount on lobbying in the first half of the year. Apart from individual company lobbying, PhRMA spent a record $16.1 million in the first six months of the year — after spending $27.5 million over the full year in 2018 (also a record).

Drugmakers shell out record amount lobbying Congress
(Financial Times)

Wendell Primus, top health care advisor to House Speaker Nancy Pelosi, said on Monday that the House leadership is almost ready to release its long-awaited bill to lower drug prices, but is opting to wait until September and not leave drug companies the opportunity to attack the bill during Congressional recess next month.

Pelosi aide: Major bill to lower
drug prices coming in September

(The Hill)

Meanwhile, a key Senate committee on Tuesday unveiled a long-awaited package of drug pricing reforms that would cap how much drug makers can hike their prices in Medicare.

GOP, Dems offer compromise
to reduce drug costs for seniors

(The Associated Press)

And over at the White House, President Trump is considering a sweeping executive order that would cut prices on virtually all branded prescription drugs sold to Medicare and other government programs. The order under discussion would be much broader than the Administration’s previously disclosed proposal to lower prices on just the physician-administered treatments that fall under Medicare Part B.

Exclusive: White House preparing order
that would cut drug prices for Medicare


And here in Massachusetts, lawmakers on Monday approved a compromise measure that is designed to lower prescription drug spending for the state Medicaid program. The new language was softened under pressure from the pharmaceutical industry, although consumer advocates maintain the diluted effort may still achieve some of its goals.

Massachusetts lawmakers approve
compromise bill to lower Medicaid drug spending

(STAT News)

Grover Norquist’s Americans for Tax Reform has attacked efforts to lower drug prices as “socialist price controls.” Kaiser Health News and PolitiFact partnered to investigate the specific policies being attacked to determine how much merit the “socialist” label has. Turns out, not very much.

A Conservative Group Paints Trump’s
Drug-Pricing Experiment As ‘Socialist.’ Is It?

(Kaiser Health News)


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