As a dozen Humira Biosimilars are set to enter the market this year, it seems to be unlikely that they will drive down drug costs in the future.

 was published by Goodroot to examine these new biosimilars and it was projected that they will gain up to 5% market share in the first year, and reaching a maximum of 20-25% by 2026.

However, the unlikely chance they will drive down drug costs in the future is mainly due to competing companies in the biosimilars market, as well as a few other barriers.

In 2023, 12 biosimilar products are expected to enter the market and compete with AbbVie’s Humira.

Humira, produced by AbbVie for a variety of conditions including rheumatoid arthritis, is the highest-grossing drug of all time with $21 billion in annual global sales as of 2021. The cost to a patient and their insurer for the drug is often more than $80,000 annually.

However, AbbVie's patent expired in 2016 and legal maneuvering delayed biosimilars from reaching the market until agreements were struck to allow the sale of Humira biosimilars in 2023.

Now, with the introduction of competing biosimilars into the market, AbbVie is likely to increase their rebate above their current range for Humira’s net cost after discount to remain competitive in the marketplace and retain preferred status on most PBM formularies. They will also likely increase rebates for Skyrizi and Rinvoq to maintain a preferred position for all three products on formularies, the analysis said.

RemedyOne president Ralph Pisano, RPh, said in a Goodroot press release, "AbbVie, by our estimates, likely paid over $5 billion in rebates to pharmacy benefit managers (PBMs) in 2021. By increasing their rebates just 10%, AbbVie can match the net cost of biosimilar manufacturers, who also have to pay AbbVie royalties that effectively create a floor to how far they can lower prices."

He said Abbvie's rebate agreements with PBMs and plans "flat out stipulate that they cannot provide an advantage, such as lower out-of-pocket costs, for biosimilars on the patient's benefit."

Lastly, Pisano added that "given the challenging nature of conditions Humira treats, such as Crohn's disease, doctors will be reluctant to switch patients who have achieved stability on Humira to another medication, even if it offers cost savings."

The analysis shared potential payer strategies for biosimilars to Humira in overcoming this barrier.

Offer both Humira and biosimilars at parity.


Some payers will continue to take a Humira rebate, allow access to lower cost biosimilars, and negotiate rebates with the biosimilar manufacturers. According to Goodroot, both OptumRx and Express Scripts have already opted for this strategy — and this will most likely be the leading strategy, given the concessions AbbVie has already made in contracting to allow both brand and biosimilars to coexist.


Humira Payers have the option to give up the Humira rebate and choose a biosimilar product with a lower net cost. While this is less likely, integrated health plans may be able to shift market share to lowest cost biosimilars.

Prefer Humira and disadvantage biosimilars.


Other payers may continue to take Humira rebate and block access to lower cost biosimilars. This is the least likely option and too fraught with potential higher out-of-pocket costs for patients.

While market share for autoimmune treatments has historically been dominated by Humira, competition will largely depend on the economics dictated by AbbVie, Goodroot suggests. If they increase their rebate, it will be nearly impossible for biosimilars to make the cost impact that many are hopeful for.

Though, there may be a tipping point in biosimilar pricing where difference in the net cost will be significant enough to force payers to make their PBMs prefer the biosimilars. It's suggested that this lower net price must be coupled with a significant shift in market share to make up for the loss of Humira rebate.

Articles

It's Unlikely that Humira Biosimilars Will Drive Down Drug Costs

 Orserdu (elacestrant) to treat postmenopausal women or adult men with advanced or metastatic breast cancer. It is indicated for patients with ER-positive, HER2-negative, ESR1-mutated disease with disease progression following at least one line of endocrine therapy.

Developed by Stemline Therapeutics (a subsidiary of Menarini Group), Orserdu is an oral selective estrogen receptor degrader (SERD). SERDs work by blocking the effects of estrogen on hormone receptor-positive breast cancer cells. ESR1 mutations are present in up to 40% of ER+, HER2- advanced or metastatic breast cancers.

In a press release, Stemline indicated that Orserdu will be available soon and the company will offer financial assistance.

Approval was based on data from the phase 3 EMERALD study, a multicenter trial that enrolled 478 postmenopausal women and men with ER-positive, HER2-negative advanced or metastatic breast cancer of which 228 patients had ESR1 mutations. The study compared Orserdu with AstraZeneca’s Faslodex (fulvestrant), the only other FDA-approved SERD, plus letrozole, anastrozole, exemestane.

In the 228 (48%) patients with ESR1 mutations, median progression-free survival was 3.8 months in the Orserdu arm and 1.9 months in the Faslodex arm. An exploratory analysis of progression-free survival in the 250 (52%) patients without ESR1 mutations showed a hazard ratio of 0.86, indicating that the improvement in the intent-to-treat population was primarily attributed to the results seen in the ESR1 mutated population.

The most common adverse events were musculoskeletal pain, nausea, increased cholesterol, increased AST, increased triglycerides, fatigue, decreased hemoglobin, vomiting, increased ALT, decreased sodium, increased creatinine, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flush, and dyspepsia.

In December 2022, additional data from the EMERALD study were 

 at the San Antonio Breast Cancer Symposium (SABCS). Orserdu demonstrated progression-free survival of 8.6 months versus standard of care endocrine therapy.

“This suggests elacestrant may have the potential to become a new standard of care as a monotherapy endocrine sequencing option in ER+, HER2- advanced breast cancer after progression on CDK4/6i, before moving to combination therapies,” Virginia Kaklamani, MD, DSc, breast medical oncologist and professor of medicine, UT Health San Antonio, MD Anderson Cancer Center, said in a press release at the time.

The FDA also approved the Guardant360 CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with Orserdu.

This article originally appeared in Formulary Watch. 

Elacestrant, now with the brand name Orserdu, is an oral selective estrogen receptor degrader (SERD), which works by blocking the effects of estrogen on hormone receptor-positive breast cancer cells.

FDA Approves Orserdu for Metastatic Breast Cancer

So far, the federal government has been the only paying customer for COVID-19 vaccines. But that is about to end, and prices of the shots are about to soar five- to sixfold.

The price the federal government has been paying for the COVID-19 shots has been inching up, but average price for all shots purchased by the government from Pfizer and Moderna comes out to $20.69, according to 

calculations by the Kaiser Family Foundation.

Individuals with insurance or who are covered by Medicare or Medicaid will be insulated from the price hikes because of a variety laws and related rules barring out-of-pocket costs for COVID-19 vaccination. But insurers and government payers will be shouldering the additional costs associated with the higher price — and that could mean higher premiums.

Using slightly lower prices than the $110 to $130 range suggested by Pfizer and Moderna, the Kaiser Family Foundation estimated that if half of the adults in the U.S. (129 million) received one dose of a vaccine at the new higher prices, the total cost will be between $12.4 billion and $14.8 billion. Those amounts are about half of what the federal government spent buying 1.2 billion doses of COVID-19 vaccine from July 2020 through July 2022, according to Kaiser’s figures.

Some lawmakers have objected to the price hikes. In letter last year to Pfizer CEO Albert Bourla, Sen. Elizabeth Warren of Massachusetts and then Sen.-elect Peter Welch of Vermont noted that the company’s price hikes would bring in an additional $2.5 to $3 billion in annual revenue, “marking yet another massive corporate payday from the ongoing pandemic.”

This article originally appeared in Managed Healthcare Executive. 

Pfizer Inc. and Moderna Inc. have indicated that they are going to price their shots at between $110 and $130. The shots should still be free to individuals because of rules barring out-of-pocket costs for such vaccinations.

COVID-19 Vaccine Prices Set to Surge

A study aimed to quantify the burden of current childhood 

 in the United States in association with smoke from indoor gas stoves.

In light of recent growing public concerns over the safety of indoor gas stoves used for cooking that seems to have become a media frenzy, this study found that only 12% of current childhood asthma is attributed to smoke from gas stoves, which is about the same percentage for childhood asthma attributed to second-hand smoke.

Gas stoves, the subject of research regarding a role in climate and health effects, was the topic of an interview earlier this month with a federal official who suggested they may need to be regulated In turn, gas stoves quickly became a “fodder for partisan influencers and campaign merchandise,” noted 

International Journal of Environmental Research and Public Health,

 researchers said they quantified gas stove use and current childhood asthma at a national and state level, which had never been done before.

The researchers used a population attributable fraction (PAF) model, an epidemiologic measure used to examine the public health impact of exposures in populations.

They reviewed previously published studies to update effect-size estimates; out of 357 studies published since January 4, 2013, 27 full manuscripts related to gas cooking and children were included in the analysis. None reported new links between gas stove use and childhood asthma specifically in North America or Europe.

Researchers then used the previous effect sizes in these past analyses for the current study (odds ratio [OR] = 1.34; 95% CI = 1.12–1.57).

Additionally, the researchers estimated the proportion of children aged 18 and older exposed to gas stove smoke in the United States and certain states using the 2019 American Housing Survey (AHS).

The study found that 12.7% (95% CI, 6.3%-19.3%) of current childhood asthma is attributable to gas stove use. At the state level, Illinois experienced the highest burden (21.1%), followed by California (20.1%), New York (18.8%), Massachusetts (15.4%), and Pennsylvania (13.5%). Texas, Colorado, and Ohio experienced about a 10% burden. In contrast, Florida experienced the lowest burden (3%).

State-level PAFs varied due to various levels of exposure to gas stoves among children. For example, in Illinois, approximately 79.1% of households with children cook with gas, whereas in Florida, that percentage is only 9%. Furthermore, states with a higher percentage of children living in households with gas stoves had a higher proportion of current childhood asthma attributable to gas stove use.

Two interventions proposed by the researchers are replacing gas cooking with alternative, cleaner methods, such as electric cooking, and reducing exposure using a ventilation source, such as a range hood, although high-efficiency range hoods are not practical in all households, such as apartments.

Study strengths include using peer-reviewed effect sizes and existing PAF models.

Despite a growing gas stove public health concern, this study suggests that gas stove smoke makes up a small percentage of asthma cases in children, and interventions to curb these cases should be considered as part of a much larger asthma prevention strategy.

“Further research is needed to quantify the burden experienced at the county levels, as well as the impacts of implementing mitigation strategies through intervention studies,” wrote the researchers.

This article originally appeared in AJMC.

1. Gruenwald T, Seals BA, Knibbs LD, Hosgood HD. Population attributable fraction of gas stoves and childhood asthma in the United States. 

. 2022;20(1):75. doi:10.3390/ijerph20010075

A study aims to quantify the burden of current childhood asthma in the United States in association with smoke from indoor gas stoves.

Study Finds Gas Stove Smoke Accounts for 12% of Childhood Asthma in the US

 form Janet Woodcock, MD, principal deputy commissioner for the office of the commissioner at the FDA, the Agency has reached the conclusion that “a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.” This means that FDA does not believe that the existing regulatory frameworks for foods and supplements are appropriate for cannabidiol (CBD). As such, FDA has also denied three 

 (NPA; Washington, D.C.) that have asked the Agency to conduct rulemaking that would allow CBD to be marketed as a dietary supplement.

FDA is citing concerns about safety of long-term use when it comes to liver function and the male reproductive system, as well as the need for additional safeguards such as CBD content limits, and minimum purchase age to mitigate risk of ingestion by children. “The FDA’s existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products,” the statement reads. “Under the law, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive.”

As a result of this conclusion, recently introduced 

 the FD&C to exempt CBD and other hemp-derived cannabinoids from the drug preclusion clause may no longer be possible based on new recommendations from FDA. The Agency has long rejected CBD as a dietary ingredient because under existing regulation, it falls under drug preclusion, meaning that because a pharmaceutical company is investigating it as a drug, it cannot be used as a dietary ingredient. If the laws were changed, or FDA changed its rulemaking to exempt CBD from drug preclusion, nothing should prevent it from going through the same channels as other novel ingredients.

“The first takeaway is that FDA did not come out and say CBD products currently sold in the market should be removed or that CBD products are dangerous. They acknowledge that there is room for CBD products in the marketplace,” explains Ashish Talati, partner, Amin, Talati, Wasserman LLP to 

. “What the industry was hoping for FDA to say is that they will initiate rulemaking to allow marketing of CBD products. Instead, the agency kicked the can so to speak and said a new regulatory pathway is needed for CBD. I don’t think a new regulatory pathway is needed as all the risk management reasons that FDA gave such as prevention of contaminants, CBD content limits etc. can be adequately addressed via existing regulations aimed at ensuring the safety and quality of products.”

Industry is staunchly expressing its disappointment in FDA’s decision, taking issue with its claims of inadequate safety and robustness of the current frameworks to regulate CBD.

“We were extremely disappointed today with the FDA’s announcement concerning the regulation of CBD. When it comes to the safety of CBD, the FDA gets it wrong,” says Jonathan Miller, general counsel of the U.S. Hemp Roundtable, in a press release. “Contrary to the FDA’s continued assertions regarding the safety of CBD, there is clear, established evidence of safety over the years. CBD products have been sold at retail for nearly a decade with no significant safety issues. The Roundtable recently met with the FDA and shared a broad range of safety studies showing that standard CBD serving sizes are safe, while the FDA continues to rely on pharmaceutical studies that show risk at significantly larger doses that are not commonly found in CBD products sold at retail.”

A number of brands have conducted toxicological studies to achieve an independent conclusion of GRAS (generally recognized as safe), including 

“It seems that no level of safety evidence will be good enough for FDA,” says Steve Mister, president and CEO of CRN in his own statement. “During the last four years, FDA has repeatedly disregarded evidence demonstrating safety that is relevant to CBD at the levels commonly used in supplements and continues to rely heavily on safety concerns related to high dosage Epidiolex to support the agency’s inaction.”

Industry advocates are also criticizing FDA’s years of inaction, only to ask Congress to act. “FDA has had ample time to consider scientific evidence and develop a regulatory pathway for CBD within the existing legal framework,” states Mister. “Since Congress enacted the 2018 Farm Bill, FDA’s inaction and indecision have frustrated consumer interest in having safe and beneficial CBD products available to them and allowed a ‘gray’ CBD marketplace to emerge without meaningful oversight. The agency’s ‘punt’ to Congress, asking it to intervene after four years, is a further disservice to consumers and responsible industry.”

“This is an astonishing dereliction of duty, especially compared to the agility and professionalism the agency showed it was capable of during the pandemic,” says Daniel Fabricant, president and CEO of NPA. “After more than a decade of promises, hearings, data sharing, market proliferation, and states filling the regulatory vacuum, the FDA’s Dietary Supplement Office claims it cannot do what Congress authorized, which is to regulate dietary supplements under the law.”

Industry agrees that existing regulations under the Dietary Supplement Health and Education Act (DSHEA) and the Federal Food, Drug, and Cosmetic Act (FD&C) are comprehensive enough to address FDA’s concerns. “FDA noted that a new regulatory pathway would benefit consumers by providing clear labels, prevention of contaminants, CBD content limits, and limits on use in certain populations—all this can and should be addressed through the existing dietary supplement NDIN process once FDA creates a legal pathway for CBD in dietary supplements,” says Mister.

“With all of these tools in place as part of the existing, well-established pathways, the FDA’s decision is unwise,” states Miller. “To the extent FDA believes its current resources are not sufficient to implement and enforce existing requirements, the Roundtable supports additional appropriations to assist FDA in its compliance efforts.”

"FDA cannot – via a citizen petition response – undermine the Federal Food, Drug, and Cosmetic Act’s direction and authority to initiate rulemaking to address the exclusory provisions and to let the New Dietary Ingredients (NDI) notification pathway serve its essential function, which is to require sponsors to demonstrate the safety of new ingredients before going to market. Therefore, we have concerns about FDA’s sweeping action today and the precedent it sets for future NDI submissions," said Scott Melville, president and CEO of CHPA, in a statement. "There is a legal process to evaluate the safety of new dietary ingredients, and this is not it. We look forward to working with Congress to explore modernization of the Dietary Supplement Health and Education Act (DSHEA) and to ensure that the NDI process works as was originally intended.”

Advocates also questions the logic of FDA’s arguments. If the question of CBD’s legality as a dietary ingredient hinges on the drug preclusion clause, then why is safety a factor in its consideration? Without drug preclusion CBD should be able to go through the NDIN process like any other novel dietary ingredient. “In essence, FDA is saying ‘it is because we say it is’—without support for that view in the statute,” says Mister. “As we have continued to point out, nothing is stopping FDA from using its rulemaking authority for CBD, other than FDA itself. Instead, FDA suggests Congress must fix this issue when FDA has had the authority to address it all along.”

The fear for industry is that devising an alternative regulatory pathway for CBD and other cannabinoids would give FDA new and far-reaching authority.

“When you read between the lines of today’s FDA statement, the agency appears to be saying that it would prefer to defy and attack DSHEA and develop different regulatory paths for ingredients at its own discretion,” says Fabricant. “That could include requiring premarket approval, unnecessary testing, or who knows what. That is an especially dangerous precedent not only for CBD but for the entire natural products industry and ingredients like hemp that clearly fall under the agency’s jurisdiction.”

FDA concludes that existing regulatory frameworks for foods and supplements are not appropriate for cannabidiol, will work with Congress on a new way forward. News release. FDA. January 26, 2023. Accessed January 27, 2023. 

https://www.fda.gov/news-events/press-announcements/fda-concludes-existing-regulatory-frameworks-foods-and-supplements-are-not-appropriate-cannabidiol

The agency intends to work with Congress to create a pathway that balances the desire for access with regulatory oversight and risk management.

FDA: CBD Requires Separate Regulatory Pathway from Dietary Supplements, Food

A new study has found that predominantly White neighborhoods had more green spaces, fewer dilapidated buildings, and more single-family homes compared with neighborhoods with mostly Black residents or other minoritized racial or ethnic groups.

This observational study was published in 

“Large datasets on determinants of health can help us better understand the associations between past and present policies—including racist and antiracist policies—and neighborhood health outcomes,” said corresponding author, Elaine O. Nsoesie, PhD, MS, associate professor of global health at Boston University School of Public Health, in a statement.

Using satellite images and neighborhood demographics, the researchers of this study aimed to identify an association between built environment and neighborhood racial composition and health.

The data for this study included 164 million Google Street View images from November 1-30, 2019. Race, ethnicity, and socioeconomic information came from the 2019 American Community Service 5-year estimates, and information on health outcomes came from the CDC’s 2020 Population Level Analysis and Community Estimates data set, which surveyed residents 18 years and older from May 23 to November 16, 2022.

The study included 59,231 urban census tracts and observed 5 neighborhood characteristics: dilapidated buildings, green spaces, crosswalks, multifamily homes, and single-lane roads. The census tract was 1160,595 (0.4%) American Indian and Alaska Native; 53,321,345 (19.5%) Hispanic; 462,259 (0.2%) Native Hawaiian and other Pacific Islander; 17,166,370 (6.3%) non-Hispanic Asian; 35,958,480 (13.2%) non-Hispanic Black; and 158,043,260 (57.7%) non-Hispanic White residents.

The largest inequities were associated with green spaces and multifamily homes. Predominantly Black neighborhoods had 2% (

 < .001) less green space than White neighborhoods, and other racial minority neighborhoods had 11% (

 < .001)less green space. Additionally, compared with White neighborhoods, neighborhoods with racial minorities other than Black had 17% (

Compared with White neighborhoods, all other neighborhoods had more dilapidated buildings. Minoritized racial and ethnic groups other than Black had an average 6% (

 < .001) more dilapidated buildings, and predominantly Black neighborhoods had less than 1% (

 = .03) more dilapidated buildings compared with predominantly White neighborhoods.

Neighborhoods with predominantly Black residents had the highest rates of sleeping problems (total effect size, 7.66%; 95% CI, 7.57%-7.75%; 

 < .001) and diabetes (total effect size, 4.95%; 95% CI, 4.88%-5.03%; 

 < .001), followed by neighborhoods with predominantly minoritized groups other than Black residents. Predominantly Black neighborhoods also had a higher prevalence of asthma (total effect size, 1.40%; 95% CI, 1.37%-1.43%; 

 < .001) compared with predominantly White neighborhoods. 

Compared with other neighborhoods, predominantly White neighborhoods had fewer dilapidated buildings, more green space, and fewer crosswalks. Neighborhoods with predominantly minoritized racial or ethnic groups other than Black residents had more dilapidated buildings than predominantly White neighborhoods. Furthermore, a built environment was associated with structural racism and redlining of neighborhoods, resulting in segregated communities, poor housing conditions, unwalkable neighborhoods, and other disadvantages for people of color that determine social detriments of health.

"Our findings really demonstrate the path-dependent nature of inequality and racial disparities,” said study co-lead author Ahyoung Cho, a racial data/policy tracker at CAR and a political science PhD student at Boston University, in a statement.

 “It is critical to develop appropriate policies to address structural racism.”

This article originally appeared in AJMC. 

1. Yang Y, Cho A, Nguyen Q, Nsoesie EO. Association of neighborhood racial and ethnic composition and historical redlining with built environment indicators derived from street view images in the US. 

. 2023;6(1). doi:10.1001/jamanetworkopen.2022.51201

2. Across the US, white neighborhoods have more greenery, fewer dilapidated buildings, fewer multi-family homes. News Release; EurkAlert! January 20 2023. Accessed February 1 2023. 

Geographical data could potentially yield insight on racial and ethnic health disparities in the United States. An analysis of the large dataset could help identify any potential causes for observed inequities.

Racial Discrepancies Among US Residential Areas Might Have Implications for Health Effects

COVID-19 during the first 6 months of pregnancy, with the Omicron variant specifically, was found to increase the risk of maternal morbidity and severe complications among symptomatic, unvaccinated women, according to a paper published in 

“As it is very difficult to predict who is going to develop severe symptoms and complications with the exception of overweight women or women with obesity, universal vaccination is key during pregnancy,” the study authors wrote.

A team of investigators from the United Kingdom, the United States, Pakistan, Argentina, and other countries enrolled 4,618 pregnant women in a prospective, observational study in order to understand the maternal and perinatal outcomes of COVID-19 during pregnancy as well as vaccine effectiveness against the omicron variant.

The women were recruited from 41 hospitals across 18 countries, the study authors explained. These hospitals, they noted, are part of a “worldwide network of research institutions that provide routine care to several thousand women and newborn babies every year.” They also acknowledged that these hospitals were not selected to represent underlying populations, but instead to allow the investigators to enroll the maximum number of diagnosed and non-diagnosed women in the shortest possible timeframe.

The study authors matched each woman with laboratory-confirmed COVID-19 with 2 unmatched women without a COVID-19 diagnosis. These women were enrolled from the day after the World Health Organization declared omicron a variant of concern, Nov. 27, 2021, and June 30, 2022. The investigators included live and stillborn singleton and multiple births, as well as newborns with congenital abnormalities, they said. They were included in follow-up data until the time of hospital discharge.

A third of the women enrolled (1,545 women) had COVID-19 diagnosis from 36.7 weeks, while the remaining two-thirds did not have a COVID-19 diagnosis, the study authors said. Despite similar demographic characteristics, the study authors noted smokers among the 2 groups (8 percent among the COVID-19-diagnosed participants; 6 percent among the otherwise healthy participants), people who were overweight or with obesity (49 percent vs. 47 percent), and those who had slightly fewer pre-existing morbidities (18 percent vs. 20 percent).

The study authors determined that women with a COVID-19 diagnosis had an increased risk for maternal morbidity and mortality index (MMMI) and severe perinatal morbidity and mortality index (SPMMI) compared to their non-COVID-19-diagnosed counterparts. Additionally, this group had an increased risk for severe neonatal morbidity index (SNMI) but it was lower, the investigators reported.

In looking at the impact of vaccination, the study authors observed that unvaccinated women with COVID-19 diagnosis had a greater risk of MMMI. Additionally, severe cases of COVID-19 symptoms in unvaccinated women increased the risk of severe maternal complications, perinatal complications, and referral, ICU admission, or death, the study authors found.

A majority (63 percent) of the participants had at least a single dose of any COVID-19 vaccine, the study authors said, while about half (54 percent) had either complete or booster doses of the vaccine. The study authors determined that vaccine effectiveness – that is, all vaccines combined – for severe complications from COVID-19 for all women with a complete regimen was 48 percent, and 76 percent following a booster dose. Furthermore, for women with a COVID-19 diagnosis, vaccine effectiveness of all vaccines combined for participants with a complete regimen was 74 percent, and reached 91 percent following a booster dose, the study authors said.

“COVID-19 in pregnancy, during the first 6 months of omicron as the variant of concern, was associated with increased risk of severe maternal morbidity and mortality, especially among symptomatic and unvaccinated women,” the study authors concluded. “Women with complete or boosted vaccine doses had reduced risk for severe symptoms, complications, and death. Vaccination coverage among pregnant women remains a priority.”

This article originally appeared in Contagion Live.

1. Villar, J et al. Pregnancy outcomes and vaccine effectiveness during the period of omicron as the variant of concern, INTERCOVID-2022: a multinational, observational study. 

2023. https://doi.org/10.1016/S0140-6736(22)02467-9

“Vaccination coverage among pregnant women remains a priority,” the researchers wrote.

COVID-19 Variant, Omicron, Connected to Worse Maternal Outcome in Pregnant Women

Lauren Biscaldi is the Managing Editor of Drug Topics. 

Adalimumab-atto (Amjevita), the first FDA approved adalimumab (Humira) biosimilar, is now available in the United States, according to a press release from manufacturer Amgen.

According to the 2016 FDA approval announcement, adalimumab-atto is approved to treat moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active Crohn disease, moderately to severely active ulcerative colitis, and moderate to severe plaque psoriasis in adults.

 The medication is also approved for treatment of moderately to severely active polyarticular juvenile idiopathic arthritis in pediatric patients aged 4 years and older.

At the time of its approval, adalimumab-atto was the fourth biosimilar medication approved by the FDA. The approval was based on an evidence review including the structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data.

Adalimumab-atto 40 mg is available at 2 prices: $3288 and $1557 for a 2-week supply of medication—a discount of 5% and 55%, respectively, compared with adalimumab.

 According to Amgen, the company’s goal “is to provide broad access for patients by offering 2 options to health plans and pharmacy benefit managers.”

“Biosimilars are extensively studied, FDA-approved treatments that have the potential to reduce costs to the health care system,” said Steven Taylor, president and CEO at the Arthritis Foundation. “[Adalimumab-atto] provides another treatment option for patients and their doctors.”

Several other adalimumab biosimilars are set to launch in the United States in July.

1. Amjevita (adalimumab-atto), first biosimilar to humira, now available in the United States. News release. Amgen. January 31, 2023. Accessed January 31, 2023. https://www.amgen.com/newsroom/press-releases/2023/01/amjevita-adalimumabatto-first-biosimilar-to-humira-now-available-in-the-united-states

2. FDA approves Amjevita, a biosimilar to Humira. News release. FDA. September 23, 2016. Accessed January 31, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-amjevita-biosimilar-humira

3. Mandowara K. Amgen launches biosimilar version of AbbVie’s Humira. Reuters. Published January 31, 2023. Accessed January 31, 2023. https://www.reuters.com/business/healthcare-pharmaceuticals/amgen-launches-biosimilar-version-abbvies-humira-2023-01-31/

Adalimumab-atto was first approved by the FDA in 2016.

First Adalimumab Biosimilar Launches in US Market

President Joe Biden told Congress on Monday that he will end the twin national emergencies for addressing COVID-19 on May 11, shifting the development of vaccines and treatments away from government involvement and back to drugmakers.

In addition, drugmakers and insurance companies will start billing for vaccines and treatments, which, until now, were available at no cost. Pfizer, the maker of the antiretroviral nirmatrelvir plus ritonavir (Paxlovid), could charge as much as $130 per dose.

The Trump administration declared a public health emergency (PHE) on January 31, 2020, and a national emergency followed in March. The emergencies have been repeatedly extended by Biden since he took office in January 2021.

The Biden administration has said it would give 60 days notice before ending the PHE, and the deadline for that notice was approaching next week. The national emergency was set to end March 1 and the PHE on April 11; they will both be extended to end May 11.

House Republicans have sought to end both emergencies immediately, but the White House warned that such a move would create chaos.

"To be clear, continuation of these emergency declarations until May 11 does not impose any restriction at all on individual conduct with regard to COVID-19. They do not impose mask mandates or vaccine mandates. They do not restrict school or business operations. They do not require the use of any medicines or tests in response to cases of COVID-19," according to a statement from the Office of Management and Budget.

 reported that Republican-controlled House is scheduled to hear several pandemic-related bills this week.

According to the CDC, more than 1.1 million people in the United States have died from COVID-19 since 2020, including about 3700 last week.

Only 15% of Americans have received the recommended, updated booster that has been offered since last fall, according to the Associated Press.

With the end of the emergency, hospitals and health systems will no longer have some of the flexibilities they had during the height of the pandemic, although some have been extended by Congress.

As part of the $1.7 billion spending bill passed in December, telehealth benefits expanded or created by necessity of the COVID-19 crisis were given a reprieve until 2024. In addition, Medicare is allowed to cover oral antiviral drugs like Paxlovid, even if they are under an emergency use authorization, through the end of 2024.

1. LaFraniere S, Weiland N. U.S. plans to end public health emergency for COVID in May. 

The public health emergency, which was set to end April 11, and the national emergency, which was set to end March 1, will be ended on May 11 by the Biden administration. 

COVID-19 National Emergencies to End in May

Drugmakers use copay assistance programs to shield patients from out-of-pocket expenses — and build market share for their products in the process. But pharmacy benefit managers have cried foul, saying the copay programs undercut formularies and wind up increasing the use of expensive drugs that are not any better than less expensive ones. They have pushed back with “copay adjustment programs,” especially “copay accumulators,” which are designed to blunt the effect of the copay assistance programs by not counting their value toward patient deductibles.

, a healthcare consulting firm in Washington, D.C., more than 80% of the people covered by commercial insurance belong to plans that have implemented a copay accumulator and more than 70% are in plans with copay maximizers, a version of the accumulators designed to even out patient out-of-pocket costs.

Many patient groups and professional organizers are opposed to accumulator programs. In August 2022, three patient groups — the HIV and Hepatitis Policy Institute, the Diabetes Patient Advocacy Coalition and the Diabetes Leadership Council — filed a lawsuit challenging a Trump administration decision that allowed pharmacy benefit managers to continue to use accumulator and maximizers.

State regulators and legislatures have also gotten involved. According to Avalere, as of January 2023, 16 states (Arizona, Arkansas, Connecticut, Delaware, Georgia, Illinois, Kentucky, Louisiana, Maine, New York, North Carolina, Oklahoma, Tennessee, Virginia, Washington and West Virginia) had banned accumulators in state-regulated health plans. The bans are not just nibbling at the edges. Avalere estimates that as of Jan. 1, 2024, about 13% of the commercial payer market will be operating under laws that ban accumulators.

Sixteen states have banned a pharmacy benefit management practice that involves not counting the value of drug copay assistance from manufacturers toward patient deductibles.

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States Move to Ban Accumulators