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News
Emicizumab as a Potential Treatment Pathway for Select Hemophilia B Cases
11/22/2024
Lisa Kuhns, PhD, MD
New research highlights the potential of emicizumab, traditionally used to treat hemophilia A (HA), as a promising alternative therapy for certain hemophilia B (HB) genotypes.
New research highlights the potential of emicizumab, traditionally used to treat hemophilia A (HA), as a promising alternative therapy for certain hemophilia B (HB) genotypes.
New research highlights the...
11/22/2024
First Report Managed Care
News
Revolutionary Single-Dose Gene Therapy Offers New Hope for Adults with Hemophilia B
11/08/2024
Lisa Kuhns, PhD, MD
A groundbreaking gene therapy for hemophilia B has shown remarkable success in reducing bleeding episodes and improving the quality of life for adult patients, according to a recent international phase III clinical trial.
A groundbreaking gene therapy for hemophilia B has shown remarkable success in reducing bleeding episodes and improving the quality of life for adult patients, according to a recent international phase III clinical trial.
A groundbreaking gene therapy...
11/08/2024
First Report Managed Care
News
Advances in Factor IX Therapy Offer New Hope for Hemophilia B Treatment
10/23/2024
Lisa Kuhns, PhD, MD
New factor IX therapies promise improved treatment for hemophilia B.
New factor IX therapies promise improved treatment for hemophilia B.
New factor IX therapies promise...
10/23/2024
First Report Managed Care
News
New Guidance Addresses Management of Patients With Congenital Hemophilia
10/09/2024
Jolynn Tumolo
New guidelines from the International Society on Thrombosis and Haemostasis strongly recommend prophylactic treatment over episodic for patients with severe and moderately severe hemophilia A and B, with conditional recommendations for other...
New guidelines from the International Society on Thrombosis and Haemostasis strongly recommend prophylactic treatment over episodic for patients with severe and moderately severe hemophilia A and B, with conditional recommendations for other...
New guidelines from the...
10/09/2024
First Report Managed Care
News
New 4F-PCC Proves Effective in Rapid Reversal of Anticoagulation for Urgent Surgery, Clinical Trial Finds
09/10/2024
Lisa Kuhns, PhD, MD
An investigational 4-factor prothrombin complex concentrate (4F-PCC) is as effective and safe as an FDA-approved 4F-PCC for rapidly reversing vitamin K antagonist (VKA) anticoagulation in patients requiring urgent surgery, according to a...
An investigational 4-factor prothrombin complex concentrate (4F-PCC) is as effective and safe as an FDA-approved 4F-PCC for rapidly reversing vitamin K antagonist (VKA) anticoagulation in patients requiring urgent surgery, according to a...
An investigational 4-factor...
09/10/2024
First Report Managed Care
News
Fitusiran Prophylaxis Shows Promise for Protection Against Bleeding for Patients With Hemophilia A or B
06/05/2024
Grace Taylor, MS, MA
A phase 3 study evaluated the efficacy and safety of fitusiran in males with hemophilia A or B who were receiving bypassing agent (BPA)/clotting factor concentrate (CFC) prophylaxis.
A phase 3 study evaluated the efficacy and safety of fitusiran in males with hemophilia A or B who were receiving bypassing agent (BPA)/clotting factor concentrate (CFC) prophylaxis.
A phase 3 study evaluated the...
06/05/2024
First Report Managed Care
News
Study Finds No Treatment-Related Adverse Events in Boys Treated With Purified FIX Concentrate
05/09/2024
Jolynn Tumolo
Purified factor IX (FIX) concentrate was effective in treating and preventing bleeding episodes in real-world pediatric patients 6 years and younger with hemophilia B, according to a study published in the Journal of Blood Medicine.
Purified factor IX (FIX) concentrate was effective in treating and preventing bleeding episodes in real-world pediatric patients 6 years and younger with hemophilia B, according to a study published in the Journal of Blood Medicine.
Purified factor IX (FIX)...
05/09/2024
First Report Managed Care
News
Rebalancing Coagulation Pathways and Human Factor 9 Gene Knock-In Strategy Identified for Hemophilia B
04/25/2024

Grace Taylor

Grace Taylor
A study published in Molecular Therapy Nucleic Acids highlights a treatment strategy for treating hemophilia B by combining rebalancing coagulation pathways and human factor 9 (hF9) gene knock-in (KI) using a lipid nanoparticle and...
A study published in Molecular Therapy Nucleic Acids highlights a treatment strategy for treating hemophilia B by combining rebalancing coagulation pathways and human factor 9 (hF9) gene knock-in (KI) using a lipid nanoparticle and...
A study published in Molecular...
04/25/2024
First Report Managed Care
News
Antibody Test Determines Eligibility for Hemophilia Gene Therapy
12/11/2023
Jolynn Tumolo
The US Food and Drug Administration’s recent approval of the AAV5 DetectCDx test marked the agency’s first-ever approval of a companion diagnostic test for a gene therapy product.
The US Food and Drug Administration’s recent approval of the AAV5 DetectCDx test marked the agency’s first-ever approval of a companion diagnostic test for a gene therapy product.
The US Food and Drug...
12/11/2023
First Report Managed Care
News
Patient Education on AAV Vectors for Hemophilia Essential to Prevent ‘Buyer’s Remorse’
11/10/2023
Jolynn Tumolo
Having long served as the model disorders for the development of gene therapy, hemophilia A (HA) and hemophilia B (HB) are currently benefitting from the role with the emergence of adeno-associated viral (AAV) vectors, according to a review...
Having long served as the model disorders for the development of gene therapy, hemophilia A (HA) and hemophilia B (HB) are currently benefitting from the role with the emergence of adeno-associated viral (AAV) vectors, according to a review...
Having long served as the model...
11/10/2023
First Report Managed Care

Behind the Bill

Behind the Bill
SCOTUS Takes on the Nondelegation Doctrine: Surprising Reactions and What They Mean for Agency Power
04/02/2025
Katie Hayes, MJ
The Supreme Court recently heard arguments in Federal Communication Commission (FCC) v Consumers’ Research, a case that I covered in February and one that could dramatically reshape federal agency authority through the nondelegation...
The Supreme Court recently heard arguments in Federal Communication Commission (FCC) v Consumers’ Research, a case that I covered in February and one that could dramatically reshape federal agency authority through the nondelegation...
The Supreme Court recently heard...
04/02/2025
First Report Managed Care
Behind the Bill
Dr Oz’s Prescription for Making Medicaid “Viable at Every Level”
03/26/2025
Katie Hayes, MJ
On Tuesday, March 25, 2025, the Senate Finance Committee voted to advance Dr Mehmet Oz in his confirmation as the next head of the Centers for Medicare and Medicaid Services (CMS).1 The full Senate vote is expected “soon” (whatever that...
On Tuesday, March 25, 2025, the Senate Finance Committee voted to advance Dr Mehmet Oz in his confirmation as the next head of the Centers for Medicare and Medicaid Services (CMS).1 The full Senate vote is expected “soon” (whatever that...
On Tuesday, March 25, 2025, the...
03/26/2025
First Report Managed Care
Behind the Bill
The $880 Billion Question Continues: Dr Oz's Confirmation and the Future of Medicaid
03/19/2025
Katie Hayes, MJ
Last week, I explored the $880 billion question facing Congress—whether lawmakers could achieve their budget goals without cutting Medicaid. This week, that question took center stage as Dr Mehmet Oz, President Trump's nominee to lead the...
Last week, I explored the $880 billion question facing Congress—whether lawmakers could achieve their budget goals without cutting Medicaid. This week, that question took center stage as Dr Mehmet Oz, President Trump's nominee to lead the...
Last week, I explored the $880...
03/19/2025
First Report Managed Care
Behind the Bill
The $880 Billion Question: Can Congress Cut Spending Without Touching Medicaid?
03/12/2025
Katie Hayes, MJ
I’d like to step away from administrative law for a moment to provide a quick update on Medicaid. With news coming from all sides, what does the future of Medicaid actually look like? The House of Representatives narrowly passed a budget...
I’d like to step away from administrative law for a moment to provide a quick update on Medicaid. With news coming from all sides, what does the future of Medicaid actually look like? The House of Representatives narrowly passed a budget...
I’d like to step away from...
03/12/2025
First Report Managed Care
Behind the Bill
RFK Jr’s Public Comment Ban: The Silent Shift in Health Care Rulemaking
03/05/2025
Katie Hayes, MJ
The erosion of administrative law continues, and with it, the dismantling of decades-long precedent. In June, the Supreme Court overturned a 40-year-old doctrine that allowed federal agencies to interpret their own ambiguous statutes. Later...
The erosion of administrative law continues, and with it, the dismantling of decades-long precedent. In June, the Supreme Court overturned a 40-year-old doctrine that allowed federal agencies to interpret their own ambiguous statutes. Later...
The erosion of administrative...
03/05/2025
First Report Managed Care
Behind the Bill
Prevention Over Pills? The First 2 Weeks of Health Care’s New Direction
02/26/2025
Katie Hayes, MJ
The dust has barely settled from Robert F Kennedy Jr’s confirmation as Secretary of Health and Human Services (HHS), but the changes are already coming fast and furious—a key theme of the Trump Administration’s actions within the last several...
The dust has barely settled from Robert F Kennedy Jr’s confirmation as Secretary of Health and Human Services (HHS), but the changes are already coming fast and furious—a key theme of the Trump Administration’s actions within the last several...
The dust has barely settled from...
02/26/2025
First Report Managed Care
Behind the Bill
The Nondelegation Doctrine: The Next Constitutional Showdown (Part 2)
02/19/2025
Katie Hayes, MJ
Last week, I explored the potential revival of the nondelegation doctrine through Federal Communication Commission v Consumers’ Research. Today, I want to examine what this could mean for health care regulation by considering the parallels...
Last week, I explored the potential revival of the nondelegation doctrine through Federal Communication Commission v Consumers’ Research. Today, I want to examine what this could mean for health care regulation by considering the parallels...
Last week, I explored the...
02/19/2025
First Report Managed Care
Behind the Bill
The Nondelegation Doctrine: The Next Constitutional Showdown (Part 1)
02/12/2025
Katie Hayes, MJ
Just when you thought the dust had settled from the Chevron decision, the Supreme Court is gearing up to hear arguments in Federal Communications Commission v Consumers' Research next month, potentially reviving the long-dormant nondelegation...
Just when you thought the dust had settled from the Chevron decision, the Supreme Court is gearing up to hear arguments in Federal Communications Commission v Consumers' Research next month, potentially reviving the long-dormant nondelegation...
Just when you thought the dust...
02/12/2025
First Report Managed Care
Behind the Bill
No, President Trump Did Not Actually Sign an Executive Order That Would Increase Drug Costs for Beneficiaries
02/05/2025
Katie Hayes, MJ
On inauguration day, President Trump issued an executive order rescinding several Biden-era health care initiatives, including 3 experimental drug pricing models developed by the Center for Medicare and Medicaid Innovation (CMMI). Oh boy did...
On inauguration day, President Trump issued an executive order rescinding several Biden-era health care initiatives, including 3 experimental drug pricing models developed by the Center for Medicare and Medicaid Innovation (CMMI). Oh boy did...
On inauguration day, President...
02/05/2025
First Report Managed Care
Behind the Bill
Robert F. Kennedy Jr’s Confirmation and the Unexpected Turn in the Drug Pricing Debate
01/29/2025
Katie Hayes, MJ
The Plot Thickens in Drug Pricing Drama Just when you thought the drug pricing debate couldn't get more interesting, Robert F. Kennedy Jr adds an unexpected twist. During closed-door Senate meetings, President Trump’s US Department of...
The Plot Thickens in Drug Pricing Drama Just when you thought the drug pricing debate couldn't get more interesting, Robert F. Kennedy Jr adds an unexpected twist. During closed-door Senate meetings, President Trump’s US Department of...
The Plot Thickens in Drug...
01/29/2025
First Report Managed Care

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Videos
Analyzing Patient Selection and the Utility of CNS Prophylaxis for Patients With DLBCL
04/20/2023
In a debate at the 2023 Great Debates & Updates in Hematologic Malignancies conference in New York, New York, Elizabeth A. Brem, MD, analyzed the role of central nervous system prophylaxis for patients with DLBCL.
In a debate at the 2023 Great Debates & Updates in Hematologic Malignancies conference in New York, New York, Elizabeth A. Brem, MD, analyzed the role of central nervous system prophylaxis for patients with DLBCL.
In a debate at the 2023 Great...
04/20/2023
Oncology
News
Thousands Face Medicaid Coverage Disruptions in South Dakota and North Carolina
05/18/2023
Arielle Zionts
Now that the public health emergency has expired, individuals may lose coverage but then requalify several months later in states which have recently approved Medicaid expansion.
Now that the public health emergency has expired, individuals may lose coverage but then requalify several months later in states which have recently approved Medicaid expansion.
Now that the public health...
05/18/2023
First Report Managed Care
News
Digital Therapeutics "Viable Solution" for Mental Health Needs
06/07/2023
Jolynn Tumolo
“The participants were willing to utilize digital therapeutics if available, and even preferred this type of support compared to actually visiting a clinic,” researchers wrote.
“The participants were willing to utilize digital therapeutics if available, and even preferred this type of support compared to actually visiting a clinic,” researchers wrote.
“The participants were willing...
06/07/2023
First Report Managed Care
News
First Gene Therapy for Severe Hemophilia A Is Approved
06/29/2023
Amanda Balbi
This approval comes after a safety and effectiveness trial showed that the treatment improved participants’ annualized bleeding rate after 3 years.
This approval comes after a safety and effectiveness trial showed that the treatment improved participants’ annualized bleeding rate after 3 years.
This approval comes after a...
06/29/2023
First Report Managed Care
Stock image of a doctor holding a phone
Commentary
Prescription Digital Therapeutics: Ongoing Efforts to Expand Awareness, Integrate Into Clinical Practice
07/28/2023
Yvette C. Terrie, BS Pharm, RPh
Yvette Terrie shares digital therapeutic updates regarding FDA approvals, recent and upcoming clinical trials, and current industry regulations.
Yvette Terrie shares digital therapeutic updates regarding FDA approvals, recent and upcoming clinical trials, and current industry regulations.
Yvette Terrie shares digital...
07/28/2023
First Report Managed Care

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