ICER Weekly View: March 15, 2019

From the desk of David Whitrap

What a week. We experienced a massive bribery scandal that helped students gain admission to elite universities, the international grounding of an entire fleet of aircraft, and the near inevitability of President Trump’s first veto. At least we had Pi Day mixed in to help lighten the mood.

But this morning, let’s take a look at:

  • ICER in the News: Our white paper on alternatives to pharmaceutical rebates, and our draft evidence report on a new treatment for MS.
  • Pharmaceutical News: A new interim FDA Commissioner, a hint that drug-price legislation might not be as bipartisan as hoped, a modest proposal to improve the International Price Index, PBMs’ upcoming date with Congress, UnitedHealthcare’s preemptive move on rebate sharing, contractual uncertainty for hospitals administering CAR-T therapies, and a look ahead to this weekend’s big cardiology meeting.

ICER in the News

This week, ICER published a white paper outlining the potential advantages and disadvantages of three alternatives to the rebate model that currently drives pharmaceutical price negotiation in the US. The paper, created as part of ICER’s membership program, aims to guide policymakers as they consider multiple reform options, including those recently proposed by the Trump Administration.

ICER Publishes White Paper on Alternative Models for Pharmaceutical Rebates

The white paper caught the attention of several media outlets, including the Pink Sheet, American Journal of Managed Care, BioCentury, and Xconomy (below).

Xconomy: Drug-Price Watchdog ICER Dives into Trump-Fueled Pharma Rebate Debate

Xconomy National – [ Updated 3/13/19, 12:20pm. See below.] With public and political winds blowing in the same direction, significant reform of the complicated U.S. drug-pricing system seems ever more likely. One part of the system that the Trump administration wants to overhaul are the secret rebates that drug makers, insurers, and middlemen negotiate behind closed doors.

Yesterday, ICER released our draft evidence report on siponimod (Mayzent) for treating secondary progressive multiple sclerosis. The public comment period is open now until April 10th.

ICER Releases Draft Evidence Report on Siponimod for Treating Secondary Progressive Multiple Sclerosis

Pharmaceutical News

Following last week’s announcement that Scott Gottlieb would resign from his role as FDA Commissioner, the Trump Administration on Tuesday named Ned Sharpless to be the interim (at least for now) replacement.

National Cancer Institute Director Ned Sharpless to Be Acting FDA Commissioner

National Cancer Institute Director Dr. Ned Sharpless will be named acting commissioner of the Food and Drug Administration, the Trump administration said.

Drug pricing is one of those rare policy areas in this current political climate where bipartisan deal-making may be possible. But this week showed that that deal-making process still requires quite a bit of work.

Divisions emerge over House drug price bills

Divisions are emerging in the House over what lawmakers hoped would be a bipartisan push to lower drug prices. Drug pricing is a rare area where members of both parties think there is a chance for a deal this year.

And speaking of new drug pricing policy, Jacob Morey and Daniel Charytonowicz wrote in Health Affairs about ways policymakers can improve upon the Trump Administration’s proposal to peg Medicare Part B drug prices to an International Pricing Index (IPI). In particular, the authors called for the US to adopt its own cost-effectiveness analyses that would incorporate values specific to our Medicare population:

“The gold standard in comparable countries is to incorporate cost-effectiveness analyses in determining a drug’s value, which is reflected in the price they are willing to pay for a given clinical outcome; the infamous value equals outcome/cost equation. The IPI Drug Pricing Model does not include a US-based cost-effectiveness analysis and would, therefore, deny an approach to pay for drugs based on values specific to the Medicare population. Medicare has the capacity to perform cost-effectiveness analyses, with proven resources such as the Congressional Budget Office and the independent, nonpartisan Institute for Clinical and Economic Review (ICER). As a matter of fact, the Department of Veteran Affairs has been collaborating with ICER since 2017. Medicare can further assist the US market by publishing cost-effectiveness analysis results for patients and commercial insurers to review and become informed consumers.”

International Pricing Index: Outsourcing Negotiations Will Continue The US Drug Cost Crisis | Health Affairs

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The Senate Finance Committee has invited more health care executives to testify about the rising costs of prescription drugs. This time, the focus will be on the pharmacy benefit management units of UnitedHealthcare, Cigna, Humana, CVS Health, and Prime Therapeutics. Mark your calendars for April 3rd.

U.S. Congress invites pharmacy benefit managers to third drug…

The U.S. Senate Finance Committee has invited executives from five pharmacy benefit managers to testify on April 3 on the rising costs of prescription medicines, in Congress’s latest effort to question industry officials directly over an issue voters consistently cite as a top concern.

One of these companies, UnitedHealthcare will have a fresh response to provide at this hearing. This week, the company announced it will require new employer clients to pass pharmaceutical rebates directly to consumers at the point of sale. (For those of you keeping track, this approach is “Option 2” within our new rebate white paper.)

UnitedHealthcare broadens direct drug rebate program

The nation’s largest health insurer is expanding a program that passes rebates from drugmakers directly to the people that use their medications. Beginning next year, all new employer-sponsored health plan customers that use UnitedHealthcare must give the discounts they get to consumers at the point of sale, the insurer said Tuesday.

A year ago, ICER determined that the new CAR-T therapies, despite being quite expensive, are priced in alignment with their life-saving clinical value. However, as reported this week in STAT News, an ad-hoc payment landscape persists where hospitals aren’t always sure how much, or when, they will be reimbursed for CAR-T.

Hospitals are saving lives with CAR-T. Getting paid is another story – STAT

W ASHINGTON – Penny Trentham’s hospital is missing more than a million bucks. For about seven months, doctors at Virginia Commonwealth University Massey Cancer Center in Richmond have been treating patients with CAR-T therapy, a cutting-edge medical procedure that uses a person’s own cells to fight against their cancer.

And finally, STAT’s Matt Herper raises the curtain on the annual American College of Cardiology meeting, which begins tomorrow. One of the more anticipated moments will be the results presentation of a 400,000-patient study that tested the Apple Watch’s ability to accurately detect heart rhythm problems.

At a big cardiology meeting, glitzy tech will collide with sober science

W e carry Star-Trek-style pocket computers, and worry that “screen time” is rotting our children’s brains. We know we’re living in the future. But it’s rare that we get actual hard data on whether a new technology we are inviting into our lives is a good idea.


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