Dispensed: Change at the FDA, insurance startup financials for 2018, and the first new depression drug in 35 years

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Dispensed: Change at the FDA, insurance startup financials for 2018, and the first new depression drug in 35 years

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Hollis Johnson/Business Insider

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Hello,

Hoo boy, it was a week. As I started to pull together the stories that kept us busy this week, it seemed like every day had another breaking development: from the authorized generic insulin, to FDA Commissioner Scott Gottlieb's imminent departure, to the approval of a new depression drug, and a name for the JPMorgan-Amazon Berkshire Hathaway-Amazon joint health venture (Haven!). Meanwhile, the Wall Street Journal had this fascinating update from Martin Shkreli's life in jail. I'm feeling very glad it's Friday.

I'm also curious to get your thoughts on The Journal's Livongo's plans for an initial public offering. Will we see other digital health companies (some unicorns, even) follow suit and get into the public market? Could get pretty interesting.

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To kick a busy week off, I actually wanted to go back to last Friday evening, when insurance filings for 2018 went online.

We spared you the trouble and expense of combing through health insurance startups Oscar Health and Clover Health's filings (more companies ahead! Still missing some filings...) to get to the good stuff.

On Monday, diabetes drugmaker Eli Lilly announced its plans to make an "authorized generic" version of Humalog that carries a list price of roughly half the branded version at $137 a vial. It's a big move from the drugmaker in the hopes to make insulin more affordable at a time when many are struggling with high out of pocket costs for the lifesaving drug.

I spoke to Laura Marston, who has been living with type 1 diabetes for decades. She remembers what it was like to pay that exact price back in 2012. I also got some insight into why Lilly chose to go the authorized generic route, and why the company picked that particular price tag.

Insulin

Jorge Ribas, The Washington Post via Getty Images

Laura Marston holds up a vial of Humalog, a type of insulin she takes for type 1 diabetes at her home in Washington, DC September 27, 2016. When she was first diagnosed at 14, the list price for the drug was $21 per vial

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A drugmaker just slashed the price of its life-saving medication by 50%, but people are worried the $137 price tag is still unaffordable

  • On Monday, diabetes drugmaker Eli Lilly said it plans to make an "authorized generic" version of its life-saving diabetes medication Humalog and sell it for half the price of the branded version at $137.35 a vial.
  • Humalog is a type of short-acting insulin, which helps people with diabetes process the sugar in their blood. Its list price has risen more than 1200% since it was first approved in 1996 to $274.70 a vial.
  • The lower price might still be unaffordable for many diabetics who pay the full amount for the drug.

And in diabetes-related news, Emma Court spoke to folks who use Dexcom's continuous glucose monitors about how the company's plans to lay off 13% of its work force might affect Dexcom's customer service.

Then Tuesday afternoon, we got the word that Gottlieb is leaving his post as FDA commissioner. Emma wrote up what it could mean for the e-cigarette and tobacco companies Gottlieb and the agency had taken on over the past two years.

FDA Commissioner Scott Gottlieb's abrupt departure could prove a major win for e-cigarette and tobacco companies

  • FDA Commissioner Scott Gottlieb is abruptly resigning from the position after about two years in the office, saying he wants to spend more time with his family.
  • Gottlieb has been a harsh critic of e-cigarette use among young people and has advanced tobacco proposals that would hit the industry hard.
  • His departure could be a boon for e-cigarette and tobacco companies, and public-health advocates worry that progress made under his leadership could be undone.

Erin Brodwin's got some killer reporting this week about how Juul plans to market to smokers and the implications of that as well as a fact-check on the risks associated with vaping.

Later on Tuesday, the FDA (which was presumably having quite a busy day!) approved Johnson & Johnson's depression drug esketamine, which will go by the brand name of Spravato.

Regulators just approved the first new depression drug since the 1980s, and some see blockbuster potential

  • On Tuesday, a drug inspired by ketamine and made by Johnson & Johnson became the first new depression drug in 35 years.
  • Regulators approved the drug, a nasal spray called Spravato, which is a brand name for esketamine.
    The approval comes on the heels of a favorable vote from experts last month who evaluated the drug's safety and effectiveness.
  • The list price of Spravato ranges from $590 to $885 per treatment session, depending on the dose a patient needs.
  • Several biotechs have novel antidepressants in the pipeline, including Allergan and Sage Therapeutics. Sage's drug is up for approval later this month.

Speaking of which, Allergan said Wednesday that its antidepressant rapastinel failed in three key trials. Interestingly, the company's stock was up on the news.

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Elsewhere, Emma took a look at the impact new gene therapies could have on the health system from a price perspective.

Drugs that cost as much as a house are on the way to treat rare and devastating diseases. The US is scrambling to figure out how to pay for them.

  • New medications that treat disease at the genetic level, called gene therapies, are incredibly promising. They could also come with million-dollar price tags.
  • Many more gene therapies are expected to become available in the coming years, but experts say the US health system isn't prepared.
  • New gene therapies could present a tremendous financial strain on private health insurers and government programs and inhibit access for patients, especially as products for more common conditions, like hemophilia, start getting approval.
  • "We as a society better be prepared" as we approach 2021, Dr. Steve Miller, the chief clinical officer of the $66 billion health insurer Cigna, told Business Insider.

Emma also combed through Roche and Spark Therapeutics' filings to bring you this breakdown of how Spark over the course of a dramatic 10 weeks got Roche all the way up to a $4.8 billion bid for the gene therapy maker.

Tangential to gene therapies, Erin has the scoop on how lab-grown meat might also benefit from the gene-editing tool Crispr. Right now, it's still in experimental stage.

On that note, and with likely way too much already to chew on, I'll leave you to head into your weekends. But as you recover and digest all that happened this week, feel free to send any thoughts, tips, and dream picks to serve as Gottlieb's replacement to me at lramsey@businessinsider.com or the whole health team at healthcare@businessinsider.com.

- Lydia

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