Experts Debate Vaccine Prioritization For Pandemic Threats, Neglected Diseases

Industry experts are grappling with the challenge of how to prioritize investment in vaccine development for future pandemic risks while also incentivizing development of vaccines for existing health problems like neglected tropical diseases. “One of the big issues is how do you balance the needs of pandemic threats . . . . and chronic and debilitating neglected diseases that are clearly a problem,” Peter Hotez, director of the Center for Global Health and Diseases at Baylor College of Medicine, said...
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FDA Issue: 
FDA Week - 04/19/2024
FDA Volume: 
Vol. 30, No. 16
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ASPR Has A ‘Head Start’ On Avian Flu Vaccines, O’Connell Says

HHS says it is prepared to combat a potential outbreak of avian influenza, along with other types of flu, due to its prior flu-focused investments, but industry experts say vaccine reserves should keep pace with innovation by including newly approved medical countermeasures. HHS Assistant Secretary for Administration for Strategic Preparedness and Response (ASPR) Dawn O’Connell said at an event Wednesday (April 10) at Johns Hopkins Center for Health Security that the agency is well-equipped to get a “head start” on...
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FDA Issue: 
FDA Week - 04/19/2024
FDA Volume: 
Vol. 30, No. 16
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Colorado Pharmacies Concerned Over PDAB UPL Reimbursements

Colorado pharmacies are concerned they may not receive adequate reimbursement after the state’s prescription drug affordability board (PDAB) determines an upper payment limit (UPL) for drugs it deems unaffordable, and a pharmacy group says it has unanswered questions about the process. Eyes are on Colorado’s PDAB as it is the first state in the nation to consider setting a UPL on a drug. The board is currently considering whether to set an upper payment limit on Amgen’s drug Enbrel, used...
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CMS Issue: 
Inside CMS - 04/18/2024
CMS Volume: 
Vol. 27, No. 16
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FDA Stakeholders: President’s 2025 Funding Request Falls Short

FDA stakeholder organization the Alliance for a Stronger FDA plans to ask Congress to fund the agency at a higher level than what is requested in the president’s fiscal 2025 budget proposal, saying the request isn’t enough to cover FDA’s needs after a disappointing 2024 budget cycle. “When setting our annual ask, we strive to be aspirational without being unrealistic,” the Alliance’s executive director, Steven Grossman, wrote in an email to supporters Friday (April 12). “One reality is that federal...
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FDA Issue: 
FDA Week - 04/19/2024
FDA Volume: 
Vol. 30, No. 16
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Thune To AHA: Lame Duck Package Could Reform PBMs, 340B & Doc Pay; Extend Telehealth

Senate Republican Whip John Thune (SD) told hospitals to expect that Congress will include several health care policies in a legislative package during the post-election lame duck session, likely containing provisions that address physician payments, reform pharmacy benefit managers and extend telehealth flexibilities. Thune (R-SD), who serves on the Senate Finance Committee, added during the American Hospital Association’s membership meeting on Tuesday (April 16) the next legislative package might also touch on the 340B program and extend health programs set...
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CMS Issue: 
Inside CMS - 04/18/2024
CMS Volume: 
Vol. 27, No. 16

E&C: Increased Consolidation Puts Health System At Cybersecurity Risk

Lawmakers on the House Energy & Commerce Committee are concerned that an uptick in consolidation in the health care sector, including insurance companies and clearinghouses, may compound damage from future cyberattacks with the most sensitive data for a large number of patients held by just a handful of companies. Lawmakers are also questioning whether the Federal Trade Commission (FTC) should step in to stop future large-scale mergers between health groups to protect consumers. The Change Healthcare cyberattack in late February...
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Cyber Work Group Urges Health Care Orgs To Harmonize Privacy, Security Teams

The Health Sector Coordinating Council’s (HSCC) cybersecurity arm is urging companies to improve the coordination between their privacy and security teams to ensure cybersecurity and data privacy risks are mitigated -- warning a disconnect between the teams exposes companies to potential fines, corrective action, litigation or reputational harm. Coordination between the two teams can help organizations comply with regulatory requirements like having to report a data breach within a certain number of days and other relevant deadlines, the coalition of...
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Burgess Floats ‘Warranty’ Value-Based Pay Path For Costly Cell & Gene Therapies

House Budget Committee Health Care Task Force Chair Michael Burgess (R-TX) is advocating a new value-based “warranty” payment approach for costly cell and gene therapies under which the therapy’s high upfront cost would essentially be mortgaged across payers as patients switch plans in subsequent years. The therapy’s initial high cost and the resulting long-term benefits would be shared across plans, but the drug maker would be on the hook to refund the cost if the therapy doesn’t work. Burgess highlights...
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IDP Issue: 
Inside Drug Pricing - 04/22/2024
IDP Volume: 
Vol. 7, No. 17
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Burgess Floats ‘Warranty’ Value-Based Pay Path For Costly Cell & Gene Therapies

House Budget Committee Health Care Task Force Chair Michael Burgess (R-TX) is advocating a new value-based “warranty” payment approach for costly cell and gene therapies under which the therapy’s high upfront cost would essentially be mortgaged across payers as patients switch plans in subsequent years. The therapy’s initial high cost and the resulting long-term benefits would be shared across plans, but the drug maker would be on the hook to refund the cost if the therapy doesn’t work. Burgess highlights...
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ICER Requests Public Input To Identify Drugs For Price Hike Report

The Institute for Clinical and Economic Review (ICER) has released the official procedures for conducting its sixth assessment of major drugs that experienced substantial price increases without adequate evidence to justify the increases. The drug pricing watchdog will identify 10 drugs with net price hikes that have generated the largest increase in drug spending at the federal level and is seeking public input for an additional three drugs that have experienced similar price increases over the same timeframe but won’t...
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IDP Issue: 
Inside Drug Pricing - 04/22/2024
IDP Volume: 
Vol. 7, No. 17
Author: 

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