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The FDA on Friday approved Zolgensma, a gene replacement therapy from Novartis that treats spinal muscular atrophy, for use in children younger than 2.

Why it matters: The treatment attacks a debilitating genetic disease that often kills infants, and it will come with a price tag of more than $2.1 million, making Zolgensma the most expensive drug on the planet.

Details: Novartis said it will allow health insurance companies to pay the $2.1 million, which does not factor in potential rebates or discounts, over 5 years.

  • That puts Zolgensma's annual list price at $425,000, which Novartis said is less expensive than Spinraza, a competing therapy for spinal muscular atrophy made by Biogen.

Between the lines: The Institute for Clinical and Economic Review, a group that evaluates drug pricing and effectiveness, said in a statement that an appropriate all-in price range for Zolgensma would be between $1.1 million and $1.9 million — below what Novartis set.

  • Other ICER estimates say the price should be even lower, between $310,000 and $900,000.
  • Novartis acquired AveXis, the biotech firm that developed this gene therapy, for $8.7 billion last year, so investors want a return for that investment.

The bottom line: Zolgensma is emblematic of the new scientific advances that treat people with crippling diseases and of the debate society will have over how it should pay for these types of therapies.

Go deeper: The drug pricing debate is stuck in the past

Go deeper

Updated 1 hour ago - Politics & Policy

Coronavirus dashboard

Illustration: Sarah Grillo/Axios

  1. Health: Hospital crisis deepens as holiday season nears.
  2. Vaccine: Moderna to file for FDA emergency use authorizationVaccinating rural America won't be easy — Being last in the vaccine queue is young people's next big COVID test.
  3. Politics: Bipartisan group of senators seeks stimulus dealChuck Grassley returns to Senate after recovering from COVID-19.
  4. States: Cuomo orders emergency hospital protocols as COVID capacity dwindles.
  5. Economy: Wall Street wonders how bad economy has to get for Congress to act.
  6. 🎧 Podcast: The state of play of the top vaccines.
2 hours ago - Health

First blood test to help diagnose Alzheimer's goes public

Photo: Jerry Naunheim Jr./C2N Diagnostics via AP

A non-COVID medical breakthrough: People over 60 now have access to a blood test for Alzheimer's disease.

Why it matters: The existing PET brain scan test costs some people about $5,000 and often isn't covered by insurance, AP reports.

Updated 2 hours ago - Politics & Policy

Wisconsin, Arizona certify Biden's victories

Photo: Demetrius Freeman/The Washington Post via Getty Images

Arizona and Wisconsin officials confirmed the presidential election results in their states, formalizing President-elect Joe Biden's victories in the key battlegrounds.

Why it matters: The moves deal yet another blow to President Trump's efforts to block or delay certification in key swing states that he lost. 

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