The Week That Was: Come on, show 'em what you're worth

Our favorite bad boy is back in action…from jail. We at The Week That Was found it interesting that Martin Shkreli has returned to social media. The former CEO of Turing Pharmaceuticals, and the poster boy for price increases (brought up in spirit, but not by name in this week’s Senate Finance Committee hearing on drug pricing), turned to LinkedIn this week to get in a spat with STAT biopharma reporter Adam Feuerstein.
 
It seems Shkreli got back online last week and inaccurately described the length of his sentence to a commenter – leading Feuerstein to correct the record. Shkreli’s response? Predictions about the demise of Feuerstein’s employer, STAT (yes, a publication we link to a lot), and the path forward for digital media writ large. While the media industry is struggling (Buzzfeedand Huffington Post just had major layoffs), STAT is growing. So, we’re taking Feuerstein’s side on this one. Our prediction: we’ll be continuing to pitch STAT for many years to come.
 
You can read the full exchange here…and possibly more to come depending on Shkreli’s good behavior.  
 
Beyond Shkreli’s reemergence, lots of focus on drug pricing this week. We’ve got perspective on the big Senate hearing and thoughts on the latest in the Sen. Bernie Sanders v. Catalyst saga. But first: some other news.

Pulse on Pricing

Fireworks or fizzle?

C-SPAN was “must watch” tv this week with several high interest hearings – including the one we’d been awaiting on drug pricing. The opening statements from Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR) were fiery. But, our friends in pharma kept their cool with no major flubs. Some even shared personal stories, bringing an empathetic tone to the conversation and an acknowledgement that medicines can’t make a difference if patients can’t access them.

Key themes were as expected:  

• High list prices
• Price increases
• Investment in R&D vs. investment in marketing
• The difference between prices in the US and around the world
• Price gouging
• Patent thickets preventing competition 

Solutions discussed: 

• Many different legislative efforts, including the CREATES Act, price increase transparency legislation and enhancement of generic competition. Most received support from CEOs, though sometimes with stipulations.
• The concept of Medicaid negotiating prices in the states was more controversial, with some CEOs flagging a number of caveats before agreeing that it could bring down costs.
• Value-based or innovative contracting was brought up and supported by a number of CEOs.
• The proposed rule removing safe harbors for Medicare rebates received resounding support from all CEOS, though they noted they would have to see the final proposal. At the close of the hearing, Sen. Wyden asked “if rebates go away, will you support a black-letter law that your prices will go down by the same amount as the rebates?” All companies are supposed to share their responses to the question within 10 days.

What's next on the docket:

Insulin, payers, providers and patents.

Insulin pricing took second fiddle to a laser-focus on the price of anti-inflammatory drugs such as Humira. Sen. Grassley has sent letters to the top insulin makers about their insulin pricing and R&D, signaling there could be a hearing on insulin on the horizon.

In Sen. Grassley’s remarksat this week’s hearing, he instructed the pharma executives to refrain from pointing fingers at other stakeholders in the healthcare ecosystem such as middlemen. He specifically said, PBMs will “have their day” before the committee. While there is nothing scheduled just yet, PBMs, Group Purchasing Organizations and insurers should start prepping now for what’s to come.

Kaiser Health News and Voxhave been running “bill of the month” stories to highlight surprise medical bills. And, the bipartisan Senate health care price transparency working group is asking stakeholders for detailed information on surprise medical bills. Politicois reporting that lawmakers are looking into “how out-of-network bills should be paid for - while holding the patient harmless” – and new surprise medical bill legislation is imminent. All signs point to hospitals getting invited to the Congressional party soon.

Elsewhere in Congress:

Music to generic and biosimilar manufacturers’ ears. Sen. John Cornyn (R-TX) sayshe has spoken to the Chairman of the Senate Judiciary Committee about investigating how drug companies may be taking advantage of the patent system to stifle competition.

Designation Dilemmas

In this week’s feature, we’re looking at special designations – breakthrough therapy (BTD) and orphan drug (ODD). We still get jazzed about them and they certainly provide benefits for manufacturers in terms of expedited reviews and extended exclusivity. But, do they mean as much as they used to? And are they at risk for changes in the current environment?

Breakthrough Therapy

A recent study in Naturelooked at market reaction to 218 BTDs and found that commercial stage companies did not see bumps in their stock prices upon announcement of their designations. While, pre-commercial biotechs saw a transient benefit in stock price. There may be a bit of fatigue with so many BTDs going around.

Orphan Drug

ODD could become another element of the healthcare system scrutinized as part of the government’s focus on drug pricing. Catalyst Pharmaceuticals is under firefrom Senator Bernie Sanders (D-VT) for the price of its drug for Lambert-Eaton Myasthenic Syndrome (LEMS), a rare neuromuscular disorder. The issue: whether the drug is an appropriate use of the ODD, given it was already available to patients through expanded access and compounding pharmacies.

Background: Prior to the FDA approval, the active ingredient in Catalyst’s therapy was being provided off-label to LEMS patients via compounding pharmacies. Patients could also get it from Jacobus Pharmaceuticals through an expanded access program. Large parts of the LEMS community, including 100 treaters, argued that the new drug application filed by Catalyst was a misapplication of ODD.

Fast forward to today: Sen. Sanders has asked the FDA to not enforce Catalyst’s exclusivity protections against companies that had been making the product previously. Granting Sanders’ request would undercut the incentives created by the Orphan Drug Act (ODA), so it is unlikely the FDA will go that route. However, Sen. Sanders could escalate the issue by putting forward a proposal to modify ODA. Catalyst’s response: before their product, patients did not have access to an FDA approved product that had gone through rigorous clinical testing.

We’re keeping an eye on these issues so stay tuned!

Who wrote this? The managing editors of TWTW are are Randi Kahn, who is escaping the cold as you read this, and Dana Davis, who caught the bug going around NYC. 

Syneos Health Communications' Reputation & Risk Management Practice is a team of healthcare communications consultants, policy-shapers and crisis response specialists. We provide unique solutions to the evolving communications challenges in today’s healthcare industry, using evidence-based approaches to help our clients successfully navigate the most sensitive of situations.
Got thoughts? Contact Randi

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