In this week’s Innovation Partners BioBlog, all eyes are on the pharmaceutical industry. The new Medicare coverage rules for CAR-T therapy may pave the way for adoption of more slow-growing meds. The FDA weighs criminal and civil charges against a subsidiary of Novartis for falsely reporting data. Meanwhile, Anthem’s PBM IngenioRx appears to be on track to court investors and please patients. This and more in this week’s Innovation Partners BioBlog.
Medicare’s new CAR-T coverage rules could boost adoption of slow-growing meds
The national Medicare coverage rule for CAR-T has been unveiled, and it could mean good news to drug makers. The rule lifts some restrictions and burdens on healthcare providers which may pave the way for the adoption of other therapies. Medicare announced this week that it would pay for the expensive CAR-T treatment. Gilead’s Yescarta comes with a price tag of $375,000 while Novartis’ Kymriah has a list price of $475,000.
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Anthem’s PBM IngenioRx is attracting outside insurers
Anthem’s new PBM IngenioRx is attracting outside insurers, the company said. After Cigna announced its acquisition of ExpressScripts, Anthem’s build-out of IngenioRx accelerated. Now, the company has added new features including enhanced support for patients and new digital engagement tools. IngenioRx is expected to save Anthem $4 billion.
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Trump administration announces departure of drug pricing adviser John O’Brien
John O’Brien, one of the key architects of the president’s plan to reduce prescription drug prices, plans to leave his role soon. Alex Azar, Department of Health and Human Services Secretary, announced that John Brooks, currently the principal deputy director of the Center for Medicare, will expand his role to fill the gap left by O’Brien’s departure. O’Brien has held the position since December 2018.
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FDA shatters generic drug approval record
The FDA set a new record this year in generic drug approval. To date, the agency has approved 1,028 generic drugs. This total already surpasses 971 approvals for the 2018 fiscal year, which runs from September 30 to October 1. The FDA pledges to continue working on the quality, timeliness, and efficiency of the generic drug approval process.
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CMS: Unsubsidized enrollment drops 40% on ACA exchanges from 2016 to 2018
A new Trump administration report found that 2.5 million unsubsidized customers left the Affordable Care Act’s (ACA’s) exchanges from 2016 to 2018, a 40% decrease. The Centers for Medicare & Medicaid Services (CMS) said that the decline in 2018 follows a decrease of 1.3 million unsubsidized people in 2017. But, enrollment in the subsidized population has remained steady, according to a report issued in mid-August. Affordability remains the single greatest challenge for those who do not qualify for subsidies.
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Democratic senators urge FDA to take action against drug company that hid faulty data
Democratic senators are urging the Food and Drug Administration) to take action against a AveXis, a subsidiary of Novartis, for falsifying data from the government while seeking approval for a $2.1 million gene therapy. The drug, Zolgensma, which treats spinal atrophy in infants, was approved in May. It is one of the most expensive drugs in history, and one that according to the Democrats, was pushed through FDA approval with false data. The FDA is considering criminal and civil penalties against the company.
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