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Janssen Seeking Medicare Add-On Payments For CAR-T Carvykti, But CMS May Be Skeptical

 
• By Cathy Kelly

J&J will need to convince the Centers for Medicare and Medicaid Services that its treatment is not substantially similar to existing CAR-T’s in order to qualify for supplemental Medicare reimbursement.

Add-On Payments To Hospitals Intended To Remove Barriers To Access • Source: Alamy

Janssen Biotech Inc. has reapplied for Medicare new technology add-on payments in 2023 for its recently-approved CAR-T therapy for multiple myeloma, Carvykti (ciltacabtagene autoleucel), despite indications that the Centers for Medicare and Medicaid Services may not believe the treatment meets the NTAP criteria for "newness."

CMS discussed the application for Carvykti and for 10 other drug therapies in its recently-released Medicare hospital inpatient payment update

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Will International Prices Influence Medicare Price Negotiation?

 
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A former CMS official suggested the most likely way it could happen is through a Center for Medicare and Medicaid Innovation demonstration.

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
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New Guidance Suggests SubQ Keytruda, Opdivo Formulations May Not Avoid Medicare Negotiations

 
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More from Government Payers

New Guidance Suggests SubQ Keytruda, Opdivo Formulations May Not Avoid Medicare Negotiations

 
• By Sarah Karlin-Smith

New draft guidance on the third cycle of Medicare drug price negotiations goes against Merck and BMS expectations for their cancer drugs. The guidance also tackles Part B and renegotiated prices for the first time.

House Budget Bill Includes Delayed Orphan Fix, Also Risks Downstream Cell and Gene Coverage

 
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The first two classes of negotiated drugs under the Inflation Reduction Act would not benefit from a rare disease adjustment House Republicans included in their reconciliation package.

Trump’s Rx Pricing Order: The Best-Case And Worst-Case Scenarios

 
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US trade and tariff leverage might successfully push European and other countries to pay more for medicines, but if not, President Trump’s executive order includes potential US drug withdrawal and other options to entice industry to lower US prices.