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Will Physician Demand For Repatha Put Pressure On Payer Restrictions?

 
• By Mary Jo Laffler

FOURIER outcomes data presented at the American College of Cardiology annual meeting fell short of expectations, but could increase physician demand for the PCSK9 inhibitor, making it harder for payers to say no.

Cholesterol plaque in artery

Physician demand could wind up being a determining factor in whether the reimbursement outlook for Amgen Inc.'s Repatha (evolocumab) improves following the long-awaited release of cardiovascular outcomes data for the PCSK9 inhibitor.

While the overall positive results of Amgen's FOURIER trial were announced last month, the level of benefit was unveiled March 17 at the American College of Cardiology annual meeting, in Washington, D.C

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EU HTA Regulation: ‘Stepping Beyond’ JCAs May Be Needed For Very Rare Disease Drugs

 
• By Francesca Bruce

Cooperation between health technology assessment bodies across the EU will lead to a better joint clinical assessment process over time, but patients cannot afford a lengthy wait for improvements, speakers at a cell & gene therapy conference said.

EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
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US FDA Not Industry’s ‘Sock Puppet,’ Ultragenyx’s Emil Kakkis Says

 
• By Sue Sutter

The biotech CEO said the Trump Administration’s treatment of FDA employees, including the HHS secretary’s comments about industry capture, are insulting to agency staff, but he is encouraged by FDA Commissioner Martin Makary’s talk of a new conditional approval pathway.

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• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.

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What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.