Ex-FDA chief Gottlieb, Novartis’ CEO share concerns about new drug cures

By PharmaCompass

2019-05-24

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In a commentary published on CNBC’s website, ex-FDA Commissioner Scott Gottlieb said science offers the chance to cure debilitating and once-intractable disorders like hemophilia and sickle cell disease. “But we need to make sure the ability to access these therapies, or the risk that someone can be locked out of them, doesn’t widen gaps between the rich and poor,” he said.

“Gene therapies and other treatments that can cure — not just treat — disease are going to be expensive. All of the cost of innovating and reaping an economic return may need to be recouped in a single payment,” he said.

Gottlieb said instead of pricing it per dose for traditional medications, companies “should negotiate with states to offer Medicaid recipients a multi-year solution to their total population’s health.” Louisiana is experimenting with a payment model — known as the ‘Netflix model’ — to treat Hepatitis C in its Medicaid recipients and prison population.

In a similar commentary published on the same website, Novartis CEO Vas Narasimhan shared how advances in cell and gene therapies are beginning to yield powerful new treatments for some of the most devastating illnesses.

“By leveraging a patient’s own biology, cell and gene therapies are already reversing congenital blindness, curing aggressive forms of pediatric leukemia and may soon grant infants with neurological genetic conditions a second chance at life. Researchers are currently developing 300 of these therapies targeting more than 100 serious and often deadly diseases.”

By 2025, the FDA expects to approve 10 to 20 new cell and gene therapies each year.“This is a major breakthrough, but it will introduce new upfront cost challenges to our already stretched health-care system. Policymakers and companies must work together to solve these challenges so that patients can gain access to the tremendous benefit these therapies deliver,” Narasimhan added.

Health-care systems, however, are accustomed to treating chronic diseases with a pay-as-you-go model, spreading costs over months and years. They are currently unprepared to pay for a surge of new, single-treatment therapies with the potential to provide a lifetime of benefit.

This presents two urgent issues for our health-care system. “First, we need to develop new models to properly evaluate the tremendous benefit these therapies bring and second, we must develop new approaches for payment when value accumulates over a lifetime,” he said.

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“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

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