End of the COVID-19 PHE Imperils Access to Cancer Drugs for Rural Patients
Rule changes during the COVID-19 public health emergency (PHE) allowed cancer patients to have their drugs delivered to their home. With the end of the PHE, this change reverts back to pre-pandemic rules, which will force patients to pick up their medications every few months. This poses significant problems for rural patients, some of whom will have to drive 500 miles for their medications.
Real-World Data Study Characterizes Long-Term Outcomes in Patients Hospitalized with COVID-19
COVID-19 has long-term repercussions for patients who recover, but these effects are poorly characterized. In a newly published study in The Lancet, researchers examined the health outcomes of patients 6 months after being discharged from a hospital in Wuhan, China for COVID-19. The study, which examined data from 2469 patients, found that many patients experienced muscle weakness, sleep disturbances, or mental health issues.
US FDA Approves Paxlovid for High-Risk Adults
The US Food and Drug Administration (FDA) approved Pfizer’s Paxlovid for patients at high risk of severe COVID-19 this week. The move is based on a randomized clinical trial that found that unvaccinated patients who had not been infected by COVID-19 before were 86% less likely to be hospitalized if given Paxlovid early in the disease. However, some experts have expressed concern over whether these results will translate to people who are up-to-date on their vaccinations.
US Runs Out of J&J’s COVID-19 Vaccine
The US Centers for Disease Control and Prevention (CDC) has announced that the US is officially out of J&J’s COVID-19 vaccine. The final batches of the vaccine expired earlier this month and now the agency is ordering all remaining vials to be disposed of. The vaccine’s administration has long been restricted to certain groups with limited access to the more widely used mRNA vaccines.
WHO: The COVID-19 Pandemic Is Over
The World Health Organization (WHO) has announced the end of the COVID-19 public health emergency (PHE). The move comes after reported deaths and hospitalizations for the disease have plummeted in recent months. PHE status as declared by the WHO won’t immediately rescind healthcare policy changes in all nations, but countries are already set to end their own PHEs, triggering massive changes to Medicare enrollment in the US.
Responding to Next Public Health Emergency With Real-World Data
The COVID-19 pandemic spurred a sea change in the real-world data (RWD) landscape, bolstering its utilization and recognition. Eventually, another public health crisis will emerge, and by continuing to support the development of RWD resources and utilization, we can rise to the challenge even more quickly. Learn more about how The MITRE Corporation helped during the pandemic and how it is planning for the next public health emergency.
The End of the COVID-19 PHE Draws Near
The COVID-19 public health emergency (PHE) is set to expire in the US next week, leaving much up in the air. The pandemic-era pause on Medicare redeterminations will hit patients soon, kicking millions off of healthcare coverage. In addition, vaccines and treatments for COVID will hit the private market, although uninsured Americans will still have access to the drugs free of charge.
Biden Administration to Provide Free COVID-19 Vaccines to Uninsured People
The Biden administration is finalizing its plan to make COVID-19 vaccines, tests, and treatment free for uninsured people as the vaccines enter the commercial market. Once fully commercialize, prices for the mRNA-based shots from Moderna and Pfizer/BioNTech are set to spike to $100+. To curb this, the administration will prepare a stockpile of vaccines and therapeutics.
FDA Plans to Authorize Additional Omicron Booster for Select Populations
A report by the Washington Post indicates that the US Food and Drug Administration is set to approve another round of boosters for adults 65 and up. The approval will also include adults who are immunocompromised. Boosters will be available for these patients for free 4 months after their last booster.
FDA Adcomm Recommends Paxlovid for Mild-to-Moderate COVID-19
Pfizer’s Paxlovid has received a nod from the US Food and Drug Administration’s (FDA’s) Antimicrobial Drug Advisory Committee for use in mild-to-moderate cases of COVID-19 in adults. The 16-1 vote came after Pfizer’s previous request for full approval hit a roadblock last year when the agency extended the review period.
US FDA Issues Emergency Use Authorization for First At-Home COVID and Flu Combo Test Kit
After a winter hallmarked by coexiting waves of COVID-19, seasonal flu, and RSV, the US Food and Drug Administration has given the Lucira COVID and Flu Home Test emergency use authorization (EUA). The at-home test kit is the first of its kind approved by the agency, simultaneously testing for COVID-19 and the flu in patients experiencing respiratory symptoms characteristic of either disease.
Pfizer and BioNTech Apply for FDA Emergency Use Authorization of Omicron Booster in Children
Pfizer and BioNTech have applied for emergency use authorization from the US Food and Drug Administration for their Omicron-targeted bivalent COVID-19 vaccine in children 4 and under (to 6 months). The application specifically is for the vaccine as a second booster, or fourth dose, as it is already approved for young children as a third dose.
Moderna CEO Will Testify Before Senate Committee Headed by Sanders Over COVID Vaccine Price Hike
Stéphane Bancel, CEO of Moderna, will speak before a US Senate committee headed by Sen. Bernie Sanders (I-VT) over planned price hikes for the company’s COVID-19 vaccine. The shot, which the US federal government paid around $30 per dose for during the pandemic, will jump in price to $130 as it enters the market.
Moderna and Pfizer COVID-19 Vaccine 4X Price Increase Worries UK and US Lawmakers
As the COVID-19 pandemic inches closer to its endemic phase, Moderna and Pfizer are gearing up to nearly quadruple the price of their mRNA-based vaccines. This has drawn concern and ire from politicians in the UK and US, with four members of the UK Parliament penning a letter urging them to reconsider due to the proposed price hike’s impact on the NHS.
US Senators Blast Moderna for COVID Vaccine Price Hikes
Moderna is drawing heat from some US lawmakers and political leaders over its plans to spike prices of its COVID-19 vaccine to $110-130 per shot. The planned price hike, which is higher than the original price increases floated last fall, was lambasted by senators like Bernie Sanders (I-VT), Elizabeth Warren (D-MA), and Peter Welch (D-VT).
Millions of Medicaid Beneficiaries Likely to Lose Coverage When Continuous Enrollment Ends
Medicaid enrollees must reapply every year in a complicated process fraught with hidden pitfalls that could sink one’s coverage. This [...]
Pfizer and China in Deadlock Over High Paxlovid Price Amid COVID Surge
As China struggles with a massive surge in cases following the end of its COVID Zero policy, the nation’s officials are at odds with Pfizer over the cost of its COVID-19 pill Paxlovid. Critics of big pharma argue that the middle of an outbreak is not the time to be playing hardball, but representatives contend that the nation shouldn’t pay less than significantly poorer countries.
Moderna Eyes ~$120 COVID-19 Vaccine Price Tag
Moderna is looking to price its mRNA COVID-19 vaccine between $110 and $130 per shot, according Moderna CEO Stephane Bancel in an interview on Monday. The US government currently pays a discounted price of $26 per dose, but as the contract and the public health emergency comes to an end, most vaccine manufacturers are gearing up for price hikes.
Report Finds Medicare Part B Lab Test Spending Jumped $1.3 Billion in 2021
A newly released report by the Office of the Inspector General (OIG) found that Medicare Part B spending on lab testing jumped by $1.3 billion in 2021 from 2020. This 17% increase brought the total spending on laboratory tests to $9.3 billion. A key driver of the spike comes from mass utilization of COVID-19 testing.
ICER Cuts Price Recommendation for Paxlovid
The Institute for Clinical and Economic Review has issued a change to its suggested US price for Paxlovid, Pfizer’s antiviral drug for COVID-19, dropping it to between $563 and $906. The institute formerly recommended a price range of $3,600 to $5,800 for a round of treatment. The change was made based on new evidence regarding the drug’s ability to reduce hospitalizations among more widespread immunity to the virus in the nation.
Real-World Data Shows Bivalent COVID-19 Boosters Reduce Hospitalizations and Urgent Care Utilization for Older Adults
Two recently published studies have found that inoculation with the new bivalent COVID-19 mRNA boosters by Moderna and Pfizer reduce the rate of hospitalization and urgent care visits. Older adults were particularly protected by the shots, which boasted an efficacy against hospitalization of 83% and 73% compared to unvaccinated older adults and those only receiving two or more doses of the original vaccines, respectively
EMA Emergency Task Force Recommends Bivalent COVID-19 Vaccines for Initial Inoculations
An Emergency Task Force (ETF) of the European Medicines Agency (EMA) has announced that it supports the use of bivalent mRNA COVID-19 vaccines for primary inoculations. The vaccines, which contain mRNA from the original SARS-CoV-2 and the Omicron BA.4/BA.5 strains, were previously only used as boosters for those who have already been vaccinated with one of the original versions of the shots.
Real-World Data Study Supports Use of Paxlovid for COVID-19 in High-Risk Patients
A newly-published real-world study in the Journal of the American College of Clinical Pharmacy finds new data supporting the use of Paxlovid in high-risk COVID-19 patients. The retrospective study followed patients administered the combination therapy at a single medical center, finding that the drug was well-tolerated and helped improve health outcomes for people at-risk for severe COVID-19.
Medicaid Directors Tell US Congress That Uncertainty around Public Health Emergency Status is Too Much
The uncertainty building around the COVID-19 public health emergency (PHE) in the US is becoming too much for Medicaid to bear, according to a coalition of Medicaid directors. The association told congress that the tenuous status of the Medicaid continuous enrollment requirement during the PHE is undermining efforts to provide care to patients. As a result, the organization put forward a list of requests.
Bivalent COVID-19 Boosters Bolster Efficacy of Original Versions, Real-World Data Study Finds
Newly released data from the US Centers for Disease Control and Prevention (CDC) show that patients vaccinated with the new wave of bivalent COVID-19 boosters had better protection than those that have only taken the original versions. Moreover, results from the real-world data (RWD) study show that the bivalent boosters appear to work better the longer its been since the previous administration.
