FDA Updates for the Week of Oct. 31, 2022
November 5th 2022The FDA has approved a hepatitis B therapy for adolescents and an oral MEK inhibitor to treat blood cancers. The regulatory agency has granted priority review for an adult RSV vaccine but extended the review for a Pompe disease therapy. Additionally, CytoDyn has withdrawn its BLA for an HIV therapy.
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They Are Still There. Barriers to HIV Testing and Care.
November 1st 2022In a conversation with Managed Healthcare Executive®, Genoa Healthcare Sales Director Jennifer Finocchiaro discusses social determinants of health, the LGBTQ+ community and the demographic contours of the HIV/AIDS epidemic.
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Price and End Points. For Cancer Drugs, There Is a Disconnect, Research Finds
October 31st 2022Overall survival is considered a more definitive end point. But according to Vinay Prasad, M.D., M.P.H., and colleagues , drugs approved based on progression-free survival and overall response rate were priced higher than those approved based on overall survival.
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FDA Updates for Week of Oct. 24, 2022
October 29th 2022The FDA approved two new novel cancer treatments: a bispecific antibody for multiple myeloma and a regimen of two drugs for liver cancer. The agency also granted priority review to two therapies. One is a novel therapy for C. difficile and the other is for a acute myeloid leukemia drug. The FDA has postponed an advisory committee meeting for an OTC birth control pill and accepted an NDA for new dry eye therapy. Additionally, Genmab submitted applications for a bispecific therapy for large B-cell lymphoma.
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Express Scripts Enters Prescription Drug Contract with Centene
October 27th 2022Cigna’s Express Scripts will now manage Centene’s pharmacy benefit services to make prescription medications more accessible and affordable for customers. The multi-year partnership is slated to officially begin Jan. 1, 2024.
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3 More Cities Pass Medicare for All This Week
October 26th 2022Three more cities join the 100-plus others that have endorsed the Medicare for All legislation. City Councils in Denver, Colorado, Gainesville, Florida, and Kent, Ohio passed the resolution in support of the universal program that ends for-profit healthcare.
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Doug Chaet of Value Evolutions Sees Value-based Care Programs as Just That: an Evolution
October 18th 2022Managing Editor of Managed Healthcare Executive, Peter Wehrwein, speaks with President of Value Evolutions and MHE Editorial Advisory Board Member, Doug Chaet, FACHE, about value-based care's current standing and CMS value-based trends vs commercial payer trends.
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Why Value-based Contracts Are Still the Exception, per Chester "Bernie" Good at UPMC
October 17th 2022Chester "Bernie" Good, senior medical director for the Center for Value Based Pharmacy Initiatives at UPMC Health Plan, gets in depth on value-based contracts and shares the results of the 2019 contract between UPMC and AstraZeneca for Brilinta. Good addressed value-based contracts last week at AMCP Nexus 2022 conference in National Harbor, Maryland.
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FDA Updates for Week of Oct. 10, 2022
October 15th 2022In COVID-19 news, the FDA has authorized updated boosters for younger children. The FDA also approved an at-home heart failure therapy, but issued a CRL for a Parkinson’s therapy. The agency has assigned PDUFDA dates for several BLA, including a hemophilia A gene therapy and Eylea for retinopathy in premature infants. Regulators have also announced an Adderall shortage. Additionally, a nonprofit company has begun the application process for OTC version of naloxone.
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Will Keytruda and Opdivo Finally Get Some Price Competition? | AMCP Nexus 2022
October 14th 2022EQRx has said it will price its PD-1/PDL-1 inhibitor 40% below the price of the entrenched PD-1/PDL-1 inhibitors, says Bhavesh Shah of Boston Medical Center Health System. But there are obstacles looming, including the development of combination therapies.
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How to Make Accumulator, Maximizer Programs More Acceptable to Your Patients l AMCP Nexus 2022
October 14th 2022Julie Kendle, Director, Clinical Pharmacy Director, Clinical Pharmacy at IPD Analytics addresses tips on improving accumulators and ways for PBMs or payers to make their accumulator and maximizer programs more acceptable to patients. Kendle spoke at this year's AMCP Nexus meeting in National Harbor, Maryland.
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Accumulators, Maximizers Exacerbate Healthcare Disparities, Says Janssen Research | AMCP Nexus 2022
October 13th 2022Research by Janssen shows that non-White patients are disproportionately affected by the accumulators and maximizers that PBMs use to blunt the financial consequences of copay assistance cards.
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The Inflation Reduction Act: Bad Medicine for Inflation and Innovation
October 13th 2022Marc Samuels and Lindsay Bealor Greenleaf of ADVI Health, LLC, say right now may not be the best time to move forward with this law as it could increase inflation through 2024. Samuels is CEO and founder of ADVI Health and is a member of MHE's editorial advisory board. Greenleaf is vice president and head of policy and reimbursement at ADVI.
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What You Need To Know About Medicare Part B Step Therapy: AMCP Nexus 2022
October 12th 2022Yuqian Liu, Pharm.D., and Michelle Booth, Pharm.D., of Magellan Rx Management, discuss the background and consequences of step therapy in Medicare Part B in an interview prior to their session at the AMCP Nexus 2022 meeting in National Harbor, Maryland.
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The former Baltimore city health commissioner has been criticized for some of her views on COVID-19 mandates. In her talk opening the AMCP Nexus 2022 meeting, Wen said that if public health officials don’t take into account public attitudes, it could affect the ability to deal with future public health emergencies.
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FDA Updates for Week of October 3, 2022
October 8th 2022The FDA uses real-world data to show how Boostrix prevents infections in infants. The agency also approves a label expansion for Oxlumo, a new administration method for Trogarzo, and accepts an sBLA for Takhzyro. In COVID-19 news, Eiger won’t submit EUA for COVID-19 treatment. Additionally, an OIG reports finds many accelerated approvals have delayed confirmatory trials.
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