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CAR-T Coverage: CMS Takes Gradual Approach With Eye Toward New Entrants, Indications

 
• By Ramsey Baghdadi

As final decision looms, initial move to hold off on DRG but increase payment for CAR-T therapies shows CMS taking a slow and steady approach to paying for the products.

Virus Cell T-Cell cancer cell with receptors dendritic cells antigen-presenting cells mammalian immune system virus and virology concept 3d rendering - Illustration

The first public signs of challenges came in early 2018. The setting was advisory committee review for the Institute for Clinical and Economic Review of the groundbreaking CAR-T therapies KymriahandYescarta.

Instead of physician specialists lauding the clinical benefits of the new therapies from Novartis AG and Gilead Sciences Inc., doctors were lamenting the reimbursement hurdles inherent in a...

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US FDA’s Familiar Drug Pricing To-Do List

 
• By Michael McCaughan

President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.

Why Hympavzi Secured English Funding For Hemophilia B But Not Hemophilia A

 
• By Neena Brizmohun

Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.

US Most Favored Nations Policy: Higher Drug Spending In Germany Is ‘Difficult To Imagine’

 
• By Francesca Bruce

Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.

Japan Reimburses 11 New Drugs But Slashes Price Of Others By Up To 20%

 
• By Lisa Takagi

Japan's NHI program continues to give and take as 11 new drugs are granted reimbursement, while the prices of others - including three ophthalmic therapies - are cut by up to 20% under a Market Expansion Repricing scheme.

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EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
• By Eliza Slawther

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Why Hympavzi Secured English Funding For Hemophilia B But Not Hemophilia A

 
• By Neena Brizmohun

Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.