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What We're Reading: Senate Passes FDA Funding; Florida Medicaid Demonstration; New HCV Drug
August 04, 2017 – Alison Rodriguez
What We're Reading: Part D Premiums; Molina Exits Some Exchanges; Gene Editing Success
August 03, 2017 – AJMC Staff
ICER Seeks Comments for Proposed Changes for Orphan Drugs Assessments
August 02, 2017 – Alison Rodriguez
Lung CT Changes in COPD Patients Affects the Human Lung Microbiome
August 02, 2017 – Alison Rodriguez
Accelerated Approval for Nivolumab for DNA RepairóDeficient Advanced CRC
August 02, 2017 – Surabhi Dangi-Garimella, PhD
What We're Reading: Drug User Fees; Premiums Rising 30% or More; Shoring Up ACA Markets
August 02, 2017 – AJMC Staff
Enasidenib Approved for IDH2-Mutated Patients With Relapsed/Refractory AML
August 01, 2017 – Surabhi Dangi-Garimella, PhD
FDA to Convene Committee Seeking Patient Engagement Feedback
August 01, 2017 – Christina Mattina
Bipartisan Group Reveals Proposals for Stabilizing the Healthcare Market
August 01, 2017 – Laura Joszt

What We're Reading: Senate Passes FDA Funding; Florida Medicaid Demonstration; New HCV Drug

Alison Rodriguez

FDA Drug User Fees Reauthorized

The Senate passed a bill that will continue to finance the FDA through fees paid by drug manufacturers. According to The New York Times, the bill now goes to President Donald Trump, who is expected to sign it; the House approved the bill on July 12. The fees help pay for the federal review of prescription drugs and medical devices. The Senate also approved, by a 94-1 vote, a bill that will provide people with terminal illnesses better access to experimental treatments.

 

CMS Approves Florida Medicaid Demonstration

Florida’s capitated Medicaid managed care program and a fund to help pay for charity care were both approved for a 5-year extension by CMS. The demonstration was set up under the Medicaid section 1115 waiver. CMS announced that the Trump administration will fund the hospital low-income pool with $1.5 billion annually. The agreement represents the new administration’s willingness to provide more flexibility to states—the Obama administration had not wanted to provide as much funding for the low-income pool because the state had the option of expanding Medicaid under the Affordable Care Act, but did not.

 

New HCV With Price Well Below Competition

The FDA has approved a drug that can treat all forms of the hepatitis C virus (HCV) through a course as short as 8 weeks. The AP reported that the approval of Mavyret means there are now 8 drugs available to treat HCV. AbbVie announced Mavyret’s list price will be $26,400 for 8 weeks of treatment. $39,600 for 12 weeks, and $52,800 for 16 weeks. This places the treatment’s price well below others on the market.

 
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