Today's News and Commentary

About Covid-19

U.S. government to buy 1.5 mln more Novavax COVID vaccine doses “The U.S. government has agreed to buy 1.5 million more doses of Novavax Inc COVID-19 vaccine, the company said on Monday, adding that the modified agreement includes funds for development of an updated vaccine by fall this year.
Sales of the company's vaccine have been hurt by a global supply glut and waning demand, with Novavax cutting its full-year revenue forecast for the shots twice last year.”

About health insurance/insurers

Projected Savings Medicare Beneficiaries Need for Health Expenses Remained High in 2022 “To have a 90 percent chance of meeting their health care spending needs in retirement, a man will need to have saved $166,000, and a woman will need to have saved $197,000. Couples enrolled in a Medigap plan with average premiums, meanwhile, will need to have saved $212,000 to have a 50 percent chance of covering their medical expenditures in retirement and $318,000 to have a 90 percent chance.” 

Biden Administration Allowing State Medicaid Funds to Cover Groceries, Nutritional Care “The Biden administration has started allowing state Medicaid funds to be used to pay for groceries and dietary advice in an effort to promote better overall health and wellness among the population and to decrease the need for expensive medical interventions.”

AFFORDABILITY SOLUTIONS FOR THE HEALTH OF AMERICA From the BCBSA.
”We recommend policymakers take action in three areas to address the root causes of rising costs:
1. Improve competition among health care providers
2. Enhance consumer access to lower-cost prescription drugs
3. Ensure patients receive high-quality care delivered at the right place and the right time
The solutions outlined here by the Blue Cross Blue Shield Association (BCBSA) will reduce health care costs for consumers, patients, and taxpayers by approximately $767 billion over 10 years.” [Emphasis in original]
Read the short paper for more details in each category.

About pharma

 FDA Accepts Sandoz BLA for Biosimilar Referencing Amgen’s Prolia and Xgeva “The FDA has accepted Sandoz’s Biologics License Application (BLA) for its biosimilar candidate denosumab to treat osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, giant cell tumor of the bone, hypercalcemia of malignancy refractory to bisphosphonate therapy and to prevent skeletal related complications in cancer that has spread to the bone.” 

Assessment of FDA-Approved Drugs Not Recommended for Use or Reimbursement in Other Countries, 2017-2020 “In this cross-sectional study of all 206 new US drug approvals in 2017 through 2020, 47 drugs were refused marketing authorization or not recommended for reimbursement in other countries due to unfavorable benefit-to-risk profiles, uncertain clinical benefit, or unacceptably high price. The median US cost for these drugs was $115 281 per patient per year.”

US Food and Drug Administration Approval of Drugs Not Meeting Pivotal Trial Primary End Points, 2018-2021 “Between 2018 and 2021, the FDA approved 210 new drugs, 21 (10.0%) based on pivotal studies with null findings for 1 or more primary efficacy end points... These 21 drugs were approved for 21 unique clinical indications. Of these drugs, 11 (52.4%) were first in class, 10 (47.6%) received orphan designation, and 13 (61.9%) received an expedited review designation. Before approval, an advisory committee was convened for 3 (14.3%) of the drugs.”

About the public’s health

 The Use of Opioids in the Management of Chronic Pain: Synopsis of the 2022 Updated U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guideline Focus on the information in the Table.

 9 in 10 employers plan to change health and wellbeing vendors in next two years, WTW survey finds “…the survey of 232 U.S. employers found nearly nine in 10 respondents (88%) are planning to make changes to their vendor partnerships either this year or next. Such changes include adding, enhancing or ending various solutions and services, or working with a different vendor in the foreseeable future.”

Millennials with chronic health conditions have higher utilization rates than older generations: UnitedHealthcare report “Individuals aged 27 to 42 in 2023 with chronic health issues are using healthcare services at a significantly higher rate than older generations, according to a new white paper from UnitedHealthcare and the nonprofit Health Action Council…”
Among the findings:
—”Compared to Generation X (born 1965–1980), millennials (1981–1996) are 106 percent more likely to go to the hospital for diabetes-related issues, 55 percent more likely to visit the emergency room or urgent care for hypertension, and are 31 percent more likely to visit the ED/UC and 29 percent more likely to visit the hospital for obesity-related issues.
—Utilization rates for emergency, urgent and virtual care per 1,000 individuals:
Generation Alpha: 564.8
Generation Z: 709.1
Millennial: 761.2
Generation X: 664.2
Baby boomer: 514.7”
• Generation Alpha (born since 2013)
• Generation Z (born 1997–2012)
• Millennials (born 1981–1996)
• Generation X (born 1965–1980)
• Baby Boomers (born 1946–1964)

About healthcare IT

 ONC debuts first cohort of qualified networks in TEFCA, including Epic, eHealth Exchange “On Monday, the HHS unveiled the first six networks that have been approved to be onboarded as qualified health information networks, or QHINs, under TEFCA, the government’s framework for a nationwide health information exchange.
It’s been about a year since the Office of the National Coordinator for Health IT released TEFCA, or the Trusted Exchange Framework and Common Agreement. Now, Epic, CommonWell Health Alliance, eHealth Exchange, Health Gorilla, Kno2 and Konza — organizations that collectively cover a significant swath of American health records — have committed to become eligible and go live within TEFCA in 12 months.”

About health technology

 FDA Clears bioMérieux’s 15-Disease Point of Care Respiratory Test “The FDA has granted 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for bioMérieux’s point-of-care Biofire Spotfire system and accompanying R Panel which detects 15 common bacteria, viruses and viral subtypes, including COVID-19.
The system, which delivers results in about 15 minutes during a patient visit, is designed to be used by non-laboratory personnel and can be expanded to include up to four testing modules.”

About healthcare finance

 CVS Health to offer bonds to finance purchase of Signify Health “CVS Health has issued a prospectus for senior notes that will be used for general corporate purposes, as well as help fund its ~$8B acquisition of Signify Health.”