FDA approved updated versions of the Covid-19 vaccines made by Moderna and Pfizer as hospitalizations rise.
The vaccines are approved for those 12 years and up and are authorized under emergency use for those six months and up. A different vaccine made by Novavax is currently under review with the FDA for use in ages 12 and up.
Health experts will meet this week to discuss recommendations for using the new vaccines and are expected to be available by mid-September.
For these shots to reach the public, the CDC has to make an official recommendation, which could come as soon as Tuesday.
In June, US health officials told drugmakers to reformulate shots in time for fall that would protect against the XBB.1.5 subvariant that accounted for about 40% of Covid infections at the time.
Pfizer and Moderna have both said their updated shots also protect against EG.5, currently the most widely circulating variant.
The Food and Drug Administration has issued a one-year delay on the final enhanced drug distribution security requirements under the Drug Supply Chain Security Act (DSCSA). Those requirements were set to take effect in November. The new date will be Nov. 27, 2024.
The decision to delay the DSCSA requirements was made after several advocates warned the FDA that the supply chain was not ready to comply. The extended time aims to allow each sector of the pharmaceutical supply chain time to develop the systems and processes necessary for efficient transactions. Read more.
According to the Centers for Disease Control, new COVID vaccines are expected in September. Vaccines from Moderna, Pfizer and Novavax will be designed to target omicron subvariant XBB.1.5.
Those vaccines still need approvals from the Food and Drug Administration and the CDC, which will form eligibility guidelines.
The arrival of updated vaccines offers some peace of mind to Americans as the U.S. sees an increase in COVID cases and hospitalizations. The current surge appears to be fueled by newer strains of the virus like EG.5, or Eris, an omicron subvariant that accounted for 17.3% of all cases as of last week, according to the CDC.
But the efficacy of the new COVID vaccine boosters is unknown against another new omicron strain of the virus called BA.2.86, which has been identified in a very small number of cases in the U.S., U.K., Denmark and Israel. Read more.
To order your vaccine program supplies from API Warehouse, like gloves and syringes, click here.
Moderna’s updated COVID-19 vaccine is effective against Eris variant
In this Weekly Rx Roundup, Moderna reports an initial study data showed its updated COVID-19 vaccine to be effective against the “Eris” and “Fornax” subvariants in humans.
The company expects the updated shot to be available, pending approval from the FDA, in the coming weeks for the fall vaccination season.
Pfizer has reported that its updated COVID-19 shot showed success at neutralizing activity against the Eris subvariant in a study conducted on mice. Pfizer has yet to complete its study in humans.
Eris, the nickname for EG.5, is a sub-lineage of the still-dominant Omicron variant. EG.5 accounted for about more than 17% of COVID-19 cases in the U.S., according to the latest government data. Infections from Fornax, officially known as FL 1.5.1, are also rising across the country.
Two big PBM stories in this Weekly Rx Roundup
Shares of CVS Health plunged 8% on Thursday after Blue Shield of California said it will drop the company’s pharmacy benefit management services and instead partner with Mark Cuban’s Cost Plus Drugs company and Amazon Pharmacy to save on drug costs for its nearly 5 million members.
The announcement hints at the potential for health insurers to abandon the traditional pharmacy benefit manager, or PBM, system and sent shares of other companies that offer PBM services lower.
CVS Health’s Caremark has been Blue Shield’s PBM partner for more than 15 years.
The other big story is that the United States Tenth Circuit Court of Appeals on Tuesday issued an unfavorable decision in the Pharmaceutical Care Management Association (PCMA) v.Mulready appeal.
The decision overturns Oklahoma’s effort to regulate pharmaceutical benefit managers (PBMs) – and likely would have implications for other states as well. The ruling allowing PBMs to escape certain state regulation by hiding behind the alleged preemption of that law by federal ERISA and Medicare Part D laws.
“The Tenth Circuit decision is inconsistent with what other federal courts have decided, and it departs from the Supreme Court’s unanimous Rutledge decision, which clearly held that PBMs can’t hide behind ERISA. It must be overturned,” said B. Douglas Hoey, CEO of the National Community Pharmacists Association.
AAP is following this story closely and will keep you updated as it unfolds.
After more than three years, the COVID-19 public health emergency ended Thursday.
While many Americans may not initially notice the sunsetting of the declaration, they are likely to feel it if they come down with COVID-19 or suspect they might have it. They could have to start paying for testing and treatment that they’ve grown used to being free during the pandemic. Just how much depends on the type of health coverage they have. Get the testing and vaccine details here.
FDA Advisory panel votes unanimously in favor of making Opill birth control an OTC
Advisers to the Food and Drug Administration on Wednesday voted unanimously to recommend making a birth control pill available without a prescription.
The 17-0 vote by two advisory panels came despite concerns from agency officials about the quality of the data used to support switching Opill from prescription to over the counter. The agency did not have concerns about the safety and effectiveness of the drug.
The FDA is not required to follow the recommendation but the panel’s opinion will weigh heavily on the FDA’s final decision, which is expected later this summer. Read more here.
FDA approves Rexulti for the treatment of agitation associated with Alzheimer disease dementia (AAD)
It is now the first FDA-approved treatment indicated for AAD in the U.S. According to John J. Miller, MD, Editor in Chief of Psychiatric Times. “Baby boomers are retiring and Alzheimer disease is on the rise, and AAD in one of the most difficult complications of dementia. Meanwhile, the need for treatments of Alzheimer disease and dementia remains huge and largely unaddressed. This approval parallels nicely with recent drug development and research working on decreasing disease progression by removing amyloid plaque with monoclonal antibodies and improving cognitive function.” Read more.
A group of pricey breakthrough prescription drugs are poised to shake up the market this year — including an Alzheimer’s treatment that could be approved today by the FDA.
Why it matters: Though the drugs offer hope to patients with hard-to-treat conditions like Alzheimer’s or sickle cell disease, or who struggle with obesity, their potentially eye-popping prices are sure to create dilemmas for insurers, government programs and patients themselves.
The big picture: The approvals could fuel already-contentious debates around affordability and equity, giving ammunition both to those who say innovation doesn’t come cheap and others who contend medical advances are meaningless if patients can’t access them.
Although some of the drugs could be transformative, “they will create choices that need to be made and they will also create potential burdens, particularly on the most vulnerable, on people who are the least well-insured and people who live in states or happen to have insurance coverage that is the least generous,” said Rena Conti, a professor at Boston University’s Questrom School of Business.
None of the drugs would be subject to the price controls that congressional Democrats included in the Inflation Reduction Act.
Driving the news: The FDA is expected to today decide whether to approve Eisai and Biogen’s lecanemab, a treatment for Alzheimer’s disease, setting into motion another round of debate over how much the drug should cost and whether Medicare should cover it.
It would become the second FDA-approved Alzheimer’s treatment targeting amyloid plaques that are believed to contribute to the development of the disease. But it isn’t likely to cause as much controversy as Biogen’s Aduhelm did when it was approved in 2021.
Biogen initially priced that drug at $56,000 a year, drawing outrage from critics and presenting big questions about how Medicare could absorb the large spending spike if millions of beneficiaries tried to get it.
If lecanemab is approved, experts will be closely watching both its list price and whether the FDA limits its use to subgroups of Alzheimer’s patients. Both factors will be crucial in determining potential spending on the drug.
A cost-effective price would be between $8,500 and $20,600 a year, the Institute for Clinical and Economic Review said last month.
State of play: The drug pipeline is brimming with other experimental cures that could make headlines this year.
Data for another promising Alzheimer’s treatment by Eli Lilly that is similar to lecanemab is expected midyear, per a recent Cowen research note, and Medicare will almost certainly have to revisit its coverage policy for the entire class of drugs.
Several multi-million dollar gene therapies have already been approved. But this year the pipeline includes two treatments for sickle cell disease, which has a much larger patient population.
Clinical trial results for Eli Lilly’s obesity drug candidate are also expected in April, potentially ushering a new entrant to what could become a booming market. Disputes over coverage of obesity drugs already on the market will almost certainty continue.
Between the lines: Some novel drugs present an inherent dilemma: They’re worth a lot of money because of the way they can dramatically improve patients’ lives. Even so, manufacturers can still price these drugs well above what experts say they’re worth.
Gene therapies may cost millions per patient. Other drugs could cost much less per course, but cater to enormous patient populations or may require long-term use.
In any scenario, the expense could present complex problems to federal and state health programs, private insurers and patients who wind up on the hook for out-of-pocket costs.
“We’re fortunate there are so many treatments in the pipeline that promise to transform the quality of care for people with devastating diseases. While we recognize there are concerns about cost, the facts point to a health care system that can sustain this incredible innovation over the long haul,” said Priscilla VanderVeer, vice president of public affairs at PhRMA.
Yes, but: The final cost burden hinges on several factors, starting with where manufacturers set the launch price.
Two of the largest U.S. pharmacy chains, CVS Health and Walgreen Co., announced agreements in principle Wednesday to pay about $5 billion each to settle lawsuits nationwide over the toll of opioids, and a lawyer said Walmart is in discussions for a deal.
Together, the developments amount to what could be the last round of huge settlements after years of litigation over the drug industry’s role in an overdose crisis that has been linked to more than 500,000 deaths in the U.S. over the past two decades. Read more.
The FDA has issued an emergency use authorization (EUA) for a booster dose of the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) in adults aged 18 years and older.1 The booster dose should be administered at least 6 months following the completion of a primary vaccination series with an authorized or approved COVID-19 vaccine. It can be administered to patients who do not have access to an authorized bivalent COVID-19 booster, in whom a bivalent booster would not be clinically appropriate, or who chose to receive the Novavax booster because they would not otherwise receive a COVID-19 booster dose. Read more.
Drug-related deaths are soaring among older Americans, driven by factors including unintentional misuse of prescription medications, self-medicating to treat pain, recreational drug use and social isolation.
In just a decade, the drug-related death rate doubled for those 65 years and older, climbing from 4.2 deaths per 100,000 in 2008-2010, to 8.4 deaths per 100,000 in 2018-2020, according to a report on senior health by United Health Foundation, which is part of UnitedHealth Group, earlier this year. The report drew on statistics from the Centers for Disease Control and Prevention. “It’s a really sad finding,” says Rhonda Randall, D.O., chief medical officer at UnitedHealthcare. “There’s a misperception that seniors may be exempt from this problem.” Read more.
The Food and Drug Administration announced Wednesday that it had granted emergency use authorization for updated COVID-19 vaccine boosters for Americans as young as 5 years old, and the Centers for Disease Control and Prevention officially signed off on their use. The boosters can be given at least two months after their previous shot of the vaccine. Read more.
The Novavax COVID-19 Vaccine has received an expansion of the emergency use authorization (EUA) from the FDA. The expanded EUA allows the vaccine to be administered as a two dose primary series for children aged 12 through 17. The vaccine was previously authorized under an EUA for adults 18+. Read more about the announcement.
Millions of Americans will soon have access to lower cost hearing aids, thanks to a final rule from the FDA aiming to improve access to them. The rule creates a category of OTC hearing aids, which allows a patient, ages 18+, with mild to moderate hearing impairment to purchase a hearing aid from a pharmacy or online retailer without a medical exam, prescription, or adjustment by an audiologist. Read more.
Humira may face competition from multiple generics in 2023. But, immunology medications aren’t the only biosimilars coming into the market in the next few years. Cardinal Health has compiled a report of more than 40 other biosimilars that we may see by 2030. Read Cardinal’s report here.
The Food and Drug Administration on Wednesday authorized a Covid-19 vaccine developed by Novavax, a biotechnology company in Maryland that received significant federal funding to produce the shot.
The vaccine will be a new option for Americans as vaccination rates stagnate. The vaccine is authorized as a primary immunization series for adults, rather than a booster. However, the shots can’t be administered until the CDC signs off on the recommendation later this month. Read more.
01 March 2022, Berlin: The drug Paxlovid against Covid-19 from the manufacturer Pfizer is lying on a table. Photo: Fabian Sommer/dpa (Photo by Fabian Sommer/picture alliance via Getty Images)
It’s a win for pharmacies, which had been pushing for the FDA to allow them to prescribe the medication, saying that it would ultimately expand access to the antivirals.
Paxlovid is authorized for the treatment of “mild-to-moderate” COVID-19 in adults and pediatric patients that have tested positive and are considered to be at high risk of developing severe disease.
