- Hypertrophic Cardiomyopathy (HCM)
- Eyecare
- Urothelial Carcinoma
- Hemophilia
- Heart Failure
- Vaccines
- Neonatal Care
- NSCLC
- Type II Inflammation
- Substance Use Disorder
- Gene Therapy
- Lung Cancer
- Spinal Muscular Atrophy
- HIV
- Post-Acute Care
- Liver Disease
- Asthma
- Atrial Fibrillation
- COVID-19
- Cardiovascular Diseases
- Prescription Digital Therapeutics
- Reproductive Health
- The Improving Patient Access Podcast
- Blood Cancer
- Ulcerative Colitis
- Respiratory Conditions
- Multiple Sclerosis
- Digital Health
- Population Health
- Sleep Disorders
- Biosimilars
- Plaque Psoriasis
- Leukemia and Lymphoma
- Oncology
- Pediatrics
- Urology
- Obstetrics-Gynecology & Women's Health
- Opioids
- Solid Tumors
- Autoimmune Diseases
- Dermatology
- Diabetes
- Mental Health
Weekend Reading: FDA’s Rollout of Plasma EUA Draws Skepticism
Scientists react negatively to FDA's handling of the Emergency Use Authorization for convalescent plasma in COVID-19.
Sunday’s announcement from FDA of an Emergency Use Authorization (EUA) for the use of blood plasma from those recovered from coronavirus disease 2019 (COVID-19), as a treatment for patients soon after COVID-19 symptoms appear, brought intense reaction from scientists, on Twitter and beyond.
Even physicians who favor studies of convalescent plasma as a treatment for COVID-19 winced at the scene of President Donald Trump announcing a “major therapeutic breakthrough,” with HHS Secretary Alex Azar and especially FDA Commissioner Stephen Hahn, MD, in tow. Not lost on anyone was the fact that days earlier, Trump had accused a mythical FDA “deep state” of moving too slowly on COVID-19. In particular, Hahn’s claim Sunday that plasma with certain antibodies had produced a 35% reduction in mortality rate raised questions, because the source supporting that statement was not immediately clear. STAT News reported that an FDA staff member whose name was left off a memo tempered his enthusiasm.
Ashish Jha, MD, director of Harvard’s Global Health Institute, tweeted that while FDA had the authority to issue the EUA and the “data might even meet the criteria,” the “hyperbole” and overselling of the evidence by Hahn was “very disappointing” and would make clinical trials more challenging. FDA’s credibility took a “big hit,” Jha said.
Meanwhile, former Commissioner Scott Gottlieb, MD, offered his former colleagues a partial defense, saying he firmly rejected Trump’s claims that FDA was “slow walking” coronavirus treatments. Gottlieb tweeted that he was “confident in the science part of the evaluation,” from FDA. He continued: “The way the public part was handled will erode precious public confidence. You earn public confidence in small drops and you lose it in buckets.”
In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
Listen
Inflation Reduction Act: Reforms to Patient Cost-Sharing
September 18th 2023Lower out-of-pocket costs for patients might put upward pressure on drug prices, as manufacturers face less price sensitivity, note Matthew Majewski and Rhett Johnson of Charles River Associates. But they also note that upward pressure on price is likely to be limited to the inflation rate as any additional price increase would need to be paid back to CMS in the form of inflation rebates.
Read More
Spending climbed by 2.7% in 2021. In 2020, it soared by 10.3%, fueled by federal government spending in response to the pandemic. The blizzard of calculations of 2021 healthcare spending by CMS’ actuaries also provides further evidence that utilization of healthcare services bounced back in 2021.
Read More
Talking PIE, the Act, Before Thanksgiving
November 23rd 2022AMCP CEO Susan A. Cantrell spoke with Managed Healthcare Executive® about Preapproval Information Exchange (PIE) Act of 2022, which would allow drug manufacturers to share information about a drug with payers before the drug is approved. Cantrell says passage of the PIE Act would speed up patient access to new medications.
Read More
Inflation Reduction Act and the Impact on Pharmaceutical Pricing and Investment Decisions
November 21st 2022The reference to “maximum fair price” in the act bodes poorly for manufacturers and suggests more of a take-it-or-leave-it situation rather than a negotiation where clinical evidence would be the prevailing factor in determining price.
Read More
