News Briefs

News Briefs

June 10, 2021

HHS said on June 9 that the U.S. government will procure approximately 1.7 million courses of Merck & Co.’s investigational antiviral treatment for COVID-19, molnupiravir (MK-4482), pending emergency use authorization or approval from the FDA. The treatment — which is designed to induce viral genome copying errors to prevent the virus from replicating in the human body — is currently being studied in a Phase III trial for its potential to reduce the risk of hospitalization or death in patients who have COVID-19 symptoms for five days or less and are at high risk for severe illness. It has also “demonstrated broad-spectrum activity against other viruses such as influenza, Ebola, and Venezuelan Equine Encephalitis virus,” HHS said.

HHS said on June 9 that the U.S. government will procure approximately 1.7 million courses of Merck & Co.’s investigational antiviral treatment for COVID-19, molnupiravir (MK-4482), pending emergency use authorization or approval from the FDA. The treatment — which is designed to induce viral genome copying errors to prevent the virus from replicating in the human body — is currently being studied in a Phase III trial for its potential to reduce the risk of hospitalization or death in patients who have COVID-19 symptoms for five days or less and are at high risk for severe illness. It has also “demonstrated broad-spectrum activity against other viruses such as influenza, Ebola, and Venezuelan Equine Encephalitis virus,” HHS said.

The White House, HHS and the FDA on June 8 released a report containing several policy recommendations to address “vulnerabilities in U.S. pharmaceutical supply chains” that the COVID-19 pandemic revealed. For its part, HHS will make an initial commitment of about $60 million, sourced from the Defense Production Act appropriation in the American Rescue Plan, “to develop novel platform technologies to increase domestic manufacturing capacity for API [active pharmaceutical ingredients].” The report’s overall policy recommendations, meanwhile, are based on four main themes: boosting local production and fostering international cooperation; promoting research and development that establishes innovative manufacturing processes and production technologies to strengthen supply chain resilience; creating robust quality management maturity to ensure consistent and reliable drug manufacturing and quality performance; and leveraging data to improve supply chain resilience.

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News Briefs

June 10, 2021

✦ HHS said on June 9 that the U.S. government will procure approximately 1.7 million courses of Merck & Co.’s investigational antiviral treatment for COVID-19, molnupiravir (MK-4482), pending emergency use authorization or approval from the FDA. The treatment — which is designed to induce viral genome copying errors to prevent the virus from replicating in the human body — is currently being studied in a Phase III trial for its potential to reduce the risk of hospitalization or death in patients who have COVID-19 symptoms for five days or less and are at high risk for severe illness. It has also “demonstrated broad-spectrum activity against other viruses such as influenza, Ebola, and Venezuelan Equine Encephalitis virus,” HHS said.

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News Briefs

June 10, 2021

The U.S. Supreme Court denied a petition from Novartis AG’s Sandoz unit to review the 2020 Federal Circuit decision to uphold two patents of Amgen Inc.’s Enbrel (etanercept). The FDA approved Sandoz’s Enbrel biosimilar, which is known as Erelzi (etanercept-szzs), on Aug. 30, 2016, but the Supreme Court’s decision means Enbrel biosimilars will not be able to launch until 2029. The FDA approved another Enbrel biosimilar, Samsung Bioepis Co., Ltd.’s Eticovo (etanercept-ykro), on April 25, 2019. Novartis says that estimates indicate that a biosimilar of Enbrel could save the U.S. health care system around $1 billion per year.

The U.S. Supreme Court denied a petition from Novartis AG’s Sandoz unit to review the 2020 Federal Circuit decision to uphold two patents of Amgen Inc.’s Enbrel (etanercept). The FDA approved Sandoz’s Enbrel biosimilar, which is known as Erelzi (etanercept-szzs), on Aug. 30, 2016, but the Supreme Court’s decision means Enbrel biosimilars will not be able to launch until 2029. The FDA approved another Enbrel biosimilar, Samsung Bioepis Co., Ltd.’s Eticovo (etanercept-ykro), on April 25, 2019. Novartis says that estimates indicate that a biosimilar of Enbrel could save the U.S. health care system around $1 billion per year.

Viatris Inc. expects the FDA to approve two of its insulin products as interchangeable biosimilars this summer, the company said during its May 10 conference call to report first-quarter 2021 earnings. The company — formed in 2020 through the combination of Mylan N.V. and Pfizer’s Upjohn business — said its insulin glargine, whose reference drug is Sanofi’s Toujeo, and insulin aspart, whose reference drug is Novo Nordisk’s NovoLog/NovoRapid, are on track to be approved as interchangeable in July. As of early June, the FDA has approved 29 biosimilars, but none have the interchangeable designation. Insulins became eligible for biosimilar status when the FDA transitioned certain protein products approved under the Federal Food, Drug, and Cosmetic Act to the Public Health Service Act on March 23, 2020.

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News Briefs

June 4, 2021

The Oklahoma Supreme Court ruled on June 1 that the Oklahoma Health Care Authority (OHCA) cannot create a managed care program as part of the state’s voter-approved Medicaid expansion — on the same day that enrollment for the expanded Medicaid program began. The decision is the result of a suit brought by medical professional associations including the Oklahoma State Medical Association and groups representing dentists, pediatricians, osteopaths and anesthesiologists. The court held that OHCA acted improperly in awarding MCO contracts to payers because “the Legislature has not authorized the creation of the SoonerSelect [Medicaid managed care] program.” For now, the state is obliged to avoid a capitated model for the program, as the authorizing initiative “in no way authorize[s] this course of action. The OHCA, through an RFP process and competitive bidding, awarded contracts to MCOs without legislative authorization or required rules in place. In effect, the OHCA moved ahead without the required legislative authorization.” OHCA in January selected four MCOs to begin serving enrollees in October.

The Oklahoma Supreme Court ruled on June 1 that the Oklahoma Health Care Authority (OHCA) cannot create a managed care program as part of the state’s voter-approved Medicaid expansion — on the same day that enrollment for the expanded Medicaid program began. The decision is the result of a suit brought by medical professional associations including the Oklahoma State Medical Association and groups representing dentists, pediatricians, osteopaths and anesthesiologists. The court held that OHCA acted improperly in awarding MCO contracts to payers because “the Legislature has not authorized the creation of the SoonerSelect [Medicaid managed care] program.” For now, the state is obliged to avoid a capitated model for the program, as the authorizing initiative “in no way authorize[s] this course of action. The OHCA, through an RFP process and competitive bidding, awarded contracts to MCOs without legislative authorization or required rules in place. In effect, the OHCA moved ahead without the required legislative authorization.” OHCA in January selected four MCOs to begin serving enrollees in October.

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News Briefs

June 4, 2021

✦ The Oklahoma Supreme Court ruled on June 1 that the Oklahoma Health Care Authority (OHCA) cannot create a managed care program as part of the state’s voter-approved Medicaid expansion — on the same day that enrollment for the expanded Medicaid program began. The decision is the result of a suit brought by medical professional associations including the Oklahoma State Medical Association and groups representing dentists, pediatricians, osteopaths and anesthesiologists. The court held that OHCA acted improperly in awarding MCO contracts to payers because “the Legislature has not authorized the creation of the SoonerSelect [Medicaid managed care] program.” For now, the state is obliged to avoid a capitated model for the program, as the authorizing initiative “in no way authorize[s] this course of action. The OHCA, through an RFP process and competitive bidding, awarded contracts to MCOs without legislative authorization or required rules in place. In effect, the OHCA moved ahead without the required legislative authorization.” OHCA in January selected four MCOs to begin serving enrollees in October.

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June 3, 2021

President Joe Biden’s 2022 fiscal year budget plan includes multiple health care-related asks aimed at improving Medicare, Medicaid and Affordable Care Act coverage. The budget calls for, among other things, lowering the Medicare eligibility age to 60, enhancing access to supplemental benefits such as dental and hearing in Medicare, and providing “premium-free, Medicaid-like coverage” through a federal public option in states that have not expanded Medicaid, while financial incentives would remain in place to ensure states keep their existing expansions.

President Joe Biden’s 2022 fiscal year budget plan includes multiple health care-related asks aimed at improving Medicare, Medicaid and Affordable Care Act coverage. The budget calls for, among other things, lowering the Medicare eligibility age to 60, enhancing access to supplemental benefits such as dental and hearing in Medicare, and providing “premium-free, Medicaid-like coverage” through a federal public option in states that have not expanded Medicaid, while financial incentives would remain in place to ensure states keep their existing expansions.

The Senate on May 25 confirmed Chiquita Brooks-LaSure as the new administrator for CMS. The Obama-era policy adviser, who was most recently a managing director with professional services firm Manatt, will be instrumental in carrying out President Joe Biden’s goals of building on the Affordable Care Act (ACA) to improve coverage and controlling prescription drug costs. Matt Eyles, president and CEO of America’s Health Insurance Plans, said the insurer trade group looks forward to “working with Brooks- LaSure to strengthen and improve Medicare, Medicaid, and ACA marketplace coverage.”

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