ICER Weekly View: January 18, 2019

From the desk of David Whitrap

Good morning everyone. Here in Boston, we’ve seen exactly 0.2 inches of snowfall this winter. For those keeping score at home, that’s 22.7 inches less than what we’d seen by this time last year, and it’s half of what’s already fallen this season in famously frigid cities like El Paso and Tucson. It’s like the weather around here just decided to shut down, right alongside the federal government.

Well, things might be changing this weekend, as local meteorologists are predicting that clouds are ready to open and dump up to two feet of snow on parts of Massachusetts. Could this be a sign that the government is finally ready to open back up, too? Probably not. But on behalf of those 800,000 affected federal employees, I sure hope so.

This week we’ll look at:

  • ICER in the News: Our new initiative to study “Unsupported Price Increases,” the draft scope for our planned assessment of treatments for Duchenne muscular dystrophy, California dreamin’ about finding some negotiating leverage, and NBC Nightly News’ look at the clinical and economic value of the first gene therapy.
  • Pharmaceutical News: Lessons Medicare can learn from the V.A., a split-decision at an FDA Advisory Committee meeting, the shutdown’s potential slowdown of other FDA reviews, and how the US health system can achieve more cost savings from approved biosimilars.

ICER in the News

Yesterday afternoon, ICER announced that we will begin to assess whether the most significant drug price increases are supported by emerging evidence that could be used as clinical justification for the higher price. We are accepting public comment on our draft protocol through February 13th. Look for our first annual “Unsupported Price Increase” report by the end of October.

ICER also posted a Draft Scoping Document for our assessment of treatments for Duchenne muscular dystrophy. Our review will focus on eteplirsen (Exondys 51™, Sarepta Therapeutics), golodirsen (Sarepta Therapeutics), and deflazacort (Emflaza®, PTC Therapeutics). Public comment on the scope of this assessment must be received by February 1.

Last week, new California Governor Gavin Newsom signed an executive order aimed at lowering drug costs by having the state’s various public — and potentially private — payers band together to increase negotiating leverage with pharmaceutical companies. The New York Times spoke with several industry experts, including ICER’s Steve Pearson, about the potential implications.

California Adds Its Clout to States Battling High Drug Prices

Gavin Newsom dived into the highly charged debate over prescription drug prices in his first week as California’s governor, vowing action on a topic that has enraged the public but has proved resistant to easy fixes. His idea: Find strength in numbers.

On Wednesday evening, NBC Nightly News aired a segment about Luxturna, the gene therapy that treats an inherited form of blindness. Incorporating ICER’s value assessment and a brief interview with Steve Pearson, the segment reflects the tension between the treatment’s innovative science, its potential benefits for patients, and its unprecedentedly high price.

This gene therapy treatment for blindness is the most expensive drug in America

Luxturna is a groundbreaking new drug that’s a one-time treatment to restore sight. The CEO says the $850,000 price tag is based on what juries have awarded someone who’s been blinded, but an independent watchdog group calls the drug overpriced.

Pharmaceutical Industry News

A new analysis suggests that Medicare Part D would have saved $14.4 billion on its top 50 pills in 2016 — a 44% discount — if the program had obtained the same prices as the Department of Veterans Affairs. (In 2017, the V.A. began using ICER’s assessments to help inform its coverage policies and price negotiations.)

Medicare Part D could have saved $14.4b in 2016 by negotiating as the VA did – STAT

A s Congressional lawmakers push to negotiate prices for Medicare Part D, a new analysis finds the federal government could have saved $14.4 billion on the top 50 pills that were covered two years ago if the program obtained the same prices as the Department of Veterans Affairs, which already haggles for discounts.

The FDA Advisory Committee provided an 8-8 split-decision on whether to recommend approval of what would be the first oral medication for Type 1 diabetes. The agency is likely to decide by the end of March if the drug will reach the US market. (The New York Times)

F.D.A. Panel Splits on Whether to Approve New Diabetes Drug

The advisory committee voted 8-8 on approving the drug, to be called Zynquista, which would be the first oral medication for people with Type 1 diabetes. An advisory panel for the Food and Drug Administration split evenly on Thursday over whether the agency should approve the first oral medication to treat Type 1 diabetes.

Last week, we mentioned how the government shutdown may slow the FDA’s review of Aimmune’s treatment for peanut allergy. This week brings news that several other treatments may also be affected. (STAT)

A longer shutdown at FDA could put anticipated new drugs in jeopardy

W ASHINGTON – The government shutdown could soon jeopardize highly anticipated new drugs from Janssen, Sanofi, and Novartis for depression, diabetes and multiple sclerosis, as well as a host of other potential new therapies, according to a STAT analysis of upcoming regulatory decision dates.

And while negotiations around the shutdown seem to be stalled indefinitely, the two political parties are continuing to discuss various approaches to manage drug prices. (The Hill)

Dem chairman Cummings meets with Trump health chief to discuss drug prices

House Oversight Committee Chairman Elijah Cummings Elijah Eugene Cummings Overnight Health Care: Dem chair plans hearing on Medicare for all | Senate GOP talks drug prices with Trump health chief | PhRMA CEO hopeful Trump reverses course on controversial pricing proposal Key House Dem: I don’t want to ‘punish’ drug companies House Dems fire first salvo in drug pricing fight MORE (D-Md.)

At an industry conference earlier this week, HHS Secretary Alex Azar acknowledged the need for pharmacy-level interchangeability of biosimilars, so “PBMs can break through the rebate wall, confident they can move share to the biosimilar.” (Pink Sheet)

Medicare IPI Model Could Import Benefit Of Biosimilar Competition, Azar Suggests

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