For details about specific variants and monoclonal antibody resistance, review the Antiviral Resistance information in each of the Fact Sheets listed above. Effective for services furnished on or after May 6, 2021, the Medicare payment rate for administering COVID-19 monoclonal antibody products through infusion in a patients home or residence is approximately $750. Future US, Inc. Full 7th Floor, 130 West 42nd Street, These collaborations can yield transformational results. Early in the drug development process, scientists used HEK293T trained to produce the protein to test whether the drug would, in fact, bind to it, Bowie said. A conversation with Isabella Oyier and Abdoulaye Djimd. But the antiviral drug has some downsides. Monoclonal antibodies are just like the antibodies the body makes when it sees SARS-CoV-2, except theyre designed in a laboratory to bind to specific parts of the spike protein. Since then, the cells have become commonplace in research labs, thanks in part to the fact that they can replicate indefinitely, ensuring they never run out. Medicare will only cover and pay for bamlanivimab (administered alone) if it was furnished, consistent with the terms of the EUA, between November 10, 2020 - April 16, 2021. CMS identified specific code(s) for each COVID-19 monoclonal antibody product and specific administration code(s) for Medicare payment: Eli Lilly and CompanysAntibody Bamlanivimab (LY-CoV555). and transmitted securely. These medicines have the potential to treat infected patients or prevent infection of essential health care and public health professionals on the front line of this pandemic. We allow Medicare-enrolled immunizers including, but not limited to, pharmacies working with the U.S., infusion centers, and home health agencies to bill directly and get direct payment from the Medicare Program for vaccinating Medicare SNF residents. Sotrovimab, a recombinant human monoclonal antibody (mAb) against SARS-CoV-2, had US FDA Emergency Use Authorization (EUA) for the treatment of high-risk outpatients with mild-to-moderate COVID-19 treatment. The right medications for COVID-19 can help. Key takeaways: Monoclonal antibodies are made in a lab but work like the antibodies our immune system makes. This rate applies to all providers and suppliers not paid reasonable cost for furnishing these products. Clinical trials have not yet tested the option of taking both Paxlovid and monoclonal antibodies simultaneously. Effective January 1 of the year after that in which the EUA declaration ends: On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. So far, a study in petri dishes that has not yet been peer reviewed suggests that bebtelovimab is also effective against the newer Omicron subvariants, BA.2.12.1, BA.4, and BA.5, but its unclear how it will perform against future variants and subvariants. The treatment can also shorten how long COVID-19 symptoms last. The FDA issued emergency use authorization forEli Lillys monoclonal antibody, called bamlanivimab, andRegeneron is waiting for FDAs green lightfor its antibody treatment. Pharmacists: 0.50 contact hour (0.05 CEUs) Still, he emphasizes, The most important thing is vaccination and boosters, and taking reasonable precautions, he says. Richard Harth A novel plant-made monoclonal antibody enhances the synergetic potency of an antibody cocktail against the SARS-CoV-2 Omicron variant. To receive monoclonal antibodies for treatment, you must have a positive test for COVID-19, have symptoms of COVID-19 and be within 10 days of when your symptoms began. We are best placed to answer the questions that impact us most." The .gov means its official. The infusion takes about an hour. Monoclonal antibodies are man-made antibodies. What are monoclonal antibodies? Meet the innovators training the next generation of African data experts, Uninformative research is the global health crisis youve never heard of, To support innovators in Africa, create an environment where African R&D thrives. The treatment that Mr. Trump called a cure for Covid-19 is a cocktail of two monoclonal antibodies manufactured by Regeneron. [Deep knowledge, daily. These findings are incredibly encouraging, considering the limitations of current tools such as seasonal malaria chemoprevention and an approved vaccine (RTS,S), which have a more complex dosing regimen and lower efficacy. Dont bill for USG-purchased products. The average drop in SBP was 9.2 mmHg for those patients. The FDA authorized the use of these monoclonal antibody therapies to treat mild-to-moderate COVID-19 in adults and pediatric patients when both of these apply: The patient has a positive COVID-19 test result. Some studies are focused on the impact of these drugs . The ACE2 receptor is expressed in various tissues throughout the body, including the lungs, heart, kidneys and intestines, which may contribute to the diverse symptoms and complications associated with COVID-19. Graphic by Jason DreesDownload Full Image. Its important for researchers to continue regularly testing the efficacy of monoclonal antibodies against new variants, he says. Inpatient locations, such as inpatient hospitals, inpatient psychiatric hospitals, long-term care hospitals, and inpatient rehabilitation hospitals, would never qualify as the home or residence for purposes of HCPCS codes M0241, M0244, M0246, M0248, or M0223. The Achilles heel of the monoclonal antibodies is that most of them target the same part of the virusthe spike proteinto help block entry into the cell, says Cutrell. by contributing institutions or for the use of any information through the EurekAlert system. We geographically adjust the rate based on where you furnish the service. Providers and suppliers should use Q0245 and M0245 or M0246 to bill for administering bamlanivimab and etesevimab for PEP. Unfortunately, there will likely be a shortage of the antibodies in the early going of approvals. For COVID-19, scientists made several mAbs that bind to the spike protein on the virus's surface. A very old line of cells is helping scientists determine just how well certain coronavirus treatments work. In an additional clinical study, which the foundation is co-funding with the NIH, that same monoclonal antibody is being evaluated for effectiveness in children ages 5 months to 5 years in Kenya. These self-assembling molecules are up to 10,000 times more potent than a monoclonal antibody and can attack several parts of a virus at once. A sign directs the public to a site in Miami that had been administering monoclonal antibody treatments for covid-19. Disclaimer: AAAS and EurekAlert! Under the terms of the EUA, tocilizumab may only be infused in the hospital setting, in limited clinical situations. Monoclonal antibodies are laboratory-made molecules that can mimic the immune system's ability to fight off pathogens, including SARS-CoV-2 and other viruses. [2]On July 30, 2021, the FDA revised the EUA for REGEN-COV (casirivimab and imdevimab, administered together) to allow its use for post-exposure prophylaxis (PEP) in certain adult and pediatric patients. If funders and governments can support private companies that are willing to invest in discovering and advancing novel approaches that will drive down the cost of these treatments, countless lives could be saved. By blocking the virus's entry into human cells, reducing viral load and triggering the immune system to fight off the infection, monoclonal antibodies can help reduce the severity of COVID-19. AstraZeneca and Moderna both used the HEK293T cell line in early studies on their vaccines. Findings from this study may have implications for patient safety. 1 0 obj Remdesivir is an antiviral drug approved by the FDA for the treatment of COVID-19 in hospitalized adults and hospitalized pediatric patients at least 12 years of age. That protein is unique to SARS-CoV-2, the virus that causes Covid-19, making it an excellent target for drugs and vaccines. The second antibody was identified in a mouse that was biologically engineered to have a human immune system. They can then design the mAb to target a particular virus or a specific part of the infection process. If you are eligible, you will be contacted by a Nebraska Medicine case manager. On January 26, 2023,the FDA announced that EVUSHELD isntcurrently authorized for emergency use in the U.S. x][s~w0RzwsM6NB&@k>.m^i(;?~uE?w?V.>WwU?~}|P*izP//_w The study also underscores the potential of plant-based monoclonal antibody expression platforms in therapeutic development against the ever-evolving SARS-CoV-2 pandemic. The company showed slides with detailed data from 275 infected . This rate reflects updated information about the costs involved in furnishing these complex products in a patients home. Monoclonal antibodies (mAbs) have revolutionized the treatment of several human diseases, including cancer and autoimmunity and inflammatory conditions, and represent a new frontier for the treatment of infectious diseases. They would offer almost instant neutralization for viral infections, and likely provide a much less problematic recovery for those with symptoms. Monoclon Antib Immunodiagn Immunother. Your browser appears to be unsupported. Finally, plant-based expression systems can be rapidly reprogrammed to produce new therapeutics in response to emerging pathogens such as SARS-CoV-2, making them an attractive option for pandemic response. This makes a hospital visit less likely. Antibodies that bind to the spike protein are called neutralizing antibodies, because theyre able to prevent SARS-CoV-2 from entering cells and replicating, thus neutralizing the infection. When the SARS-CoV-2 virus enters the body, it breaks into the cells and uses them to replicate itself. These rates dont apply if Medicare pays you for preventive vaccines and their administration at reasonable cost (for example, Federally Qualified Health Centers (FQHCs), Rural Health Clinics (RHCs), and Hospital-based Renal Dialysis Facilities). On January 24, 2022, the FDA announced that, REGEN-COV (casirivimab and imdevimab, administered together) (EUA issued November 21, 2020, latest update January 24, 2022). The study highlights the potential of synergizing antibody cocktails with the addition of monoclonal antibodies that do not directly hinder ACE2 binding to the receptor-binding domain. This version of the article was originally published onLive Science. However, many COVID-19 treatments are currently in short supply, while others arent effective against omicron. What promise do these drugs hold? CMS expects health care providers to maintain appropriate medical documentation that supports the medical necessity of the service, including: Documentation that supports that the provider met the terms of the approvals or EUAs. In such partnerships, nonprofit organizations like the foundation can identify and fund research efforts that private companies may not know are needed, or may not be able to take on by themselves due to the risk of failure, costs, and other constraints. To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. means youve safely connected to the .gov website. For an optimal experience visit our site on another browser. The NIH Treatment Guidelines recommend Paxlovid as the first option for non-hospitalized patients at high risk of severe COVID-19 outcomes. The FDA recommends this option for patients who cant get vaccinated because theyre allergic to the shots ingredients or are immunocompromised severely enough that they wont mount a sufficient response to the vaccine. stream In addition, when a Multabody targets different parts of a virus, it is much harder for that virus to escape: Even if one part of the virus changes, the other parts can still be attacked by the Multabody and the virus can be stopped in its tracks. Because of this, the cells are considered immortalized.. Regenerons two antibodiesare targeted to the spike protein of SARS-CoV-2 the protrusions on the surface of virus that give it a crown-like look and are critical for infecting human cells. The spike proteins protruding from the virus surface act as a type of key to unlock those cells. Epub 2022 Aug 3. These medicines are the fastest-growing class of drugs and have been used to treat a range of illnesses and diseasesincluding cancer and autoimmune/inflammatory diseasesand have become better known in recent years as a treatment for mild to moderate COVID-19. https:// We know that once these monoclonal antibodies are available, they will protect children from malaria and RSVnow we need to work hard to make them available as fast as possible. The binding of the virus to ACE2 is a crucial step in the process of viral entry into host cells, and this interaction is targeted by many antiviral therapies, including most monoclonal antibodies. Antibodies and COVID-19. Hear expert insights on the role and timing of monoclonal antibody treatments for COVID-19, including specific considerations related to omicron and its subvariants. Heres how you know. eEw'e7c*xcU|UE Medicare also pays for treatment to address major complications: For COVID-19 monoclonal antibody products administered before May 6, 2021, the Medicare payment rate is approximately $310. If you do not have a doctor or health care professional, the Test to Treat program can help you get tested and receive treatment if it is appropriate. It will likely be through multiple approaches, including the kinds of investments that are being made now, by the foundation and others, to put us on that path. Association of Subcutaneous or Intravenous Administration of Casirivimab and Imdevimab Monoclonal Antibodies With Clinical Outcomes in Adults With COVID-19. They can do more. They work like the natural antibodies your body makes to fight illness. That part of the virus has been mutating with each variant. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> 1991-2023 Bill & Melinda Gates Foundation. 8600 Rockville Pike The monoclonal antibody made by GlaxoSmithKline and Vir Biotechnology is authorized for people 12 and up who are at risk of getting severely sick from COVID-19 within 10 days of their symptoms . Once the infusion is complete, you will be monitored for another hour. Thenew researchhas been selected for the cover of the current issue of Plant Biology Journal. When the immune system identifies a pathogen like SARS-CoV-2, it begins to churn out antibodies: proteins that recognize and bind to specific proteins found on the virus. Read theoriginal article. What is fetal tissue research? Such innovation would provide immediate protection that could last for months. More than 3,500 Nebraska Medicine patients have been screened to receive monoclonal antibodies since November 2020. 2022 Jun 17;6(6):CD014945. And if given to a person with a compromised immune system before theyre exposed to the virus, they may even prevent infection. IE 11 is not supported. Our foundation doesnt need to make a profit, so we can absorb some of that risk and partner with the for-profit sector to invest in novel solutions. If you become infected with COVID-19, there are treatment options that may help reduce how sick you become. World Health Organization (WHO) . It's designed to block the infectivity of SARS-CoV-2, the virus that causes COVID-19. Effective for IV injection services furnished on or after February 11, 2022 (such as the administration of bebtelovimab), the Medicare payment rate for administering these COVID-19 monoclonal antibody products, authorized or approved by the FDA, is approximately $350.50. 3 0 obj "This network will allow us to test the safety and efficacy of monoclonal antibodies and other preventive measures to help identify how best to reduce the level of SARS-CoV-2 infection and ultimately end the COVID-19 pandemic." Monoclonal antibodies are laboratory-made versions of proteins naturally produced by the immune system in response . This might be a lifesaving intervention in people who are unable to mount a strong natural immune response to the virus those over 65 or with existing conditions that make them more vulnerable. COVID-19 is once again surging throughout the U.S., but deaths from the disease dont seem to be following suit. Get the most current list of billing codes, payment allowances, and effective dates for currently authorized monoclonal antibody products. Thats beneficial to scientists studying Covid-19 treatments and vaccines, said Kriegstein, who is not involved with Regenerons research, because the cells can be taught to produce the viruss so-called spike protein. Benefits of antiviral therapy. FOIA treatments known as monoclonal antibodies. Noninferiority of Subcutaneous Versus Intravenous Casirivimab/Imdevimab for Outpatient Treatment of SARS-CoV-2 in a Real-World Setting. The FDA authorized the following investigational monoclonal antibody product underEUA for pre-exposure prophylaxis of COVID-19: EVUSHELDTM(tixagevimab co-packaged with cilgavimab) (EUA issued December 8, 2021, latest update January 26, 2023). Antibodies to SARS-CoV-2, the virus that causes COVID-19, can be detected in the blood of people who have recovered from COVID-19 or people who have been vaccinated against COVID-19.Getting a vaccine is safer than getting COVID-19, and vaccination against COVID-19 is recommended for everyone 5 years of age and older. It also provides informative data analysis, and is essential for identifying . This rate applies to all providers and suppliers not paid reasonable cost for furnishing these products. Photo by Soumyabrata Roy/NurPhoto via Getty Images, Jacqueline Kirchner focuses on biologics under the. And this is a perfect example.. Regenerons and Eli Lillys products are both delivered by intravenous injection, after which the patient must be monitored by health care professionals. The goal of this therapy is to help prevent hospitalizations, reduce viral loads, and lessen symptom severity. 2023 Feb;25(1):e14006. Trump received an intravenous infusion of the antibodies from the drug company last week as part of his treatment for the illness. Note: On April 16, 2021, the FDA revoked the EUA for bamlanivimab when administered alone. Hundreds of thousands of people infected with Covid-19 have been treated with antibodies since one was first authorized in the Fall of 2020. The Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory agencies around the world are evaluating monoclonal antibodies for use as a therapy to treat COVID-19 . At the time, these proteins, which are made in a lab and can provide passive immunity, were the best and only treatment for the disease. While there are four classes of monoclonal antibodies, nearly all successful mAb therapies for COVID-19 have relied on class 1 or 2. In the specific case of malaria monoclonal antibody treatments, further innovation is needed to make them even more potent, which could help drive down the cost and make them available to older children and adults who might be particularly vulnerable to certain diseases, such as pregnant women and migrant workers. Unable to load your collection due to an error, Unable to load your delegates due to an error. "We are in a lucky position to know with certainty that a monoclonal antibody will protect children from malaria and RSVnow we need to work hard to make them available as fast as possible . See theEUAfor more information. Those antibodies are synthesized outside the body and then infused . Get provider enrollment information. Providers and suppliers who administer REGEN-COV for PEP should use M0243 or M0244 for administering the first dose and M0240 or M0241 for administering subsequent repeat doses. Scientists make monoclonal antibodies, or mAbs, in a lab. Monoclonal antibodies (mAbs) can be created in the lab by recombinant DNA technology to mimic those antibodies naturally generated by the immune system. Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the . As with payments for administering other COVID-19 monoclonal antibodies, the separate Medicare payment amount of $450 per infusion of ACTEMRA applies to all hospitals not paid reasonable cost for furnishing these products consistent with the FDA approval or EUA. In a world where monoclonal antibodies may not be readily available to the extent we truly need, it is the best way to protect yourself, your loved ones and your community. The effect of these alterations may be to increase or decrease infectivity. If your hospice patients Medicare Advantage plan participates in the Hospice Benefit Component of the Value-Based Insurance Design (VBID) Model, submit claims for administering COVID-19 monoclonal antibody products to the Medicare Advantage Plan. Recorded PODCAST. But by March 2022, new subvariants of Omicron had taken over, and on April 5, the FDA announced that even sotrovimab was no longer effective. After the Food and Drug Administration pulled its authorization of two COVID-19 antibody drugs because the treatments are highly unlikely to . National Library of Medicine Accessibility The new rate reflects updated information about the costs involved in administering monoclonal antibody products for different types of providers and suppliersand the resources necessary to ensure providers administer the products safely and appropriately. One way SARS-CoV-2 can accomplish this is by modifying the spike proteins ACE2 receptor-binding domain through mutation. Heres what we know about how well the monoclonal antibodies are working, and who might benefit from them. Although the Food and Drug Administration gave these treatments like Regeneron emergency use authorization in 2020, the criteria for who is eligible to receive them has expanded. JacquelineKirchner:Monoclonal antibodies are expensive to produce. The method highlighted in the study uses transient expression in tobacco plants to develop and produce a monoclonal antibody, or mAb. Therefore, the other option for the treatment of the patient with COVID-19 was the use of monoclonal antibodies. To find out if these treatments are right for you, you can start by checking the online COVID-19 information sites at the CDC, FDA, or NIH. A more potent antibody can be given at a lower dose, reducing the cost per dose. WebMD does not provide medical advice, diagnosis or treatment. The FDA approval and EUA for ACTEMRA also allows for 2 infusions for the same patient in limited situations. Can I get a different vaccine booster dose than what I originally received? Nevertheless, the virus can sometimes manage to outmaneuver such therapies. Paxlovid and monoclonal antibodies are important, but secondary., 1 in 5 U.S. To ensure access during the PHE, Medicare covers and pays for COVID-19 monoclonal antibodies under the COVID-19 vaccine benefit. Careers. 2022 Aug;41(4):210-213. doi: 10.1089/mab.2022.0008. The work of developing any solutions in global health, especially drugs and treatments, is rewarding but also takes time. The name of the provider who ordered or decided to administer the infusion or injection, even in cases where providers use roster billing to submit claims for these services, Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs), Through the end of the calendar year in which the EUA declaration ends for monoclonal antibody products used for post-exposure prophylaxis or for treatment of COVID-19, Permanently for covered monoclonal antibody products used as pre-exposure prophylaxis for prevention of COVID-19. See the, Fact Sheet for Health Care Providers EUA of Bebtelovimab, EVUSHELD (tixagevimab co-packaged with cilgavimab), administered as 2 separate consecutive intramuscular injection, (not currently authorized in any U.S. region), Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (12 years of age and older weighing at least 40kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for whom vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), 600 mg, Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (12 years of age and older weighing at least 40kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for whom vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), includes injection and post administration monitoring, Injection, tixagevimab and cilgavimab, for the pre-exposure prophylaxis only, for certain adults and pediatric individuals (12 years of age and older weighing at least 40kg) with no known sars-cov-2 exposure, who either have moderate to severely compromised immune systems or for whom vaccination with any available covid-19 vaccine is not recommended due to a history of severe adverse reaction to a covid-19 vaccine(s) and/or covid-19 vaccine component(s), includes injection and post administration monitoring in the home or residence; this includes a beneficiarys home that has been made provider-based to the hospital during the covid-19 public health emergency, Intravenous injection, bebtelovimab, includes injection and post administration monitoring, Intravenous injection, bebtelovimab, includes injection and post administration monitoring in the home or residence; this includes a beneficiarys home that has been made provider-based, CMS will pay you for monoclonal antibody products usedfor post-exposure prophylaxis or for treatment of COVID-19 as biological products paid under, When you administermonoclonal antibodies for post-exposure prophylaxis or for treatment of COVID-19, CMS will pay you under the applicable payment system, using the appropriate coding and payment rates, similar to the way we pay for administering other complex biological products, CMS will continue to pay for covered monoclonal antibody products and their administration when used as pre-exposure prophylaxis for prevention of COVID-19 under the Part B vaccine benefit even after the EUA declaration ends, The FDA approval and EUA for ACTEMRA also allows for 2 infusions for the same patient in limited situations. CMS pays for tocilizumab based on the number of units administered, so you should include the total number of units administered on the claim per day. Effective for services furnished on or after February 11, 2022, the Medicare payment rate for administering COVID-19 monoclonal antibody products through IV injection (such as bebtelovimab) in a patients home or residence is approximately $550.50. In 2022, a National Institutes of Health (NIH) clinical trial found that a single dose of a certain monoclonal antibody was 88% effective in protecting people in two rural communities in MaliKalifabougou and Torododuring a six-month malaria season. 7500 Security Boulevard, Baltimore, MD 21244, An official website of the United States government, ACTEMRA (tocilizumab) (EUA issued June, 24 2021, latest update December 21, 2022). Key messages - We do not know whether antibodies (the body's natural defence against disease) made in a laboratory and all the same as one another (monoclonal) and designed to target COVID-19, are an effective treatment for COVID-19 because we assessed only six studies exploring different treatments in different types of patients. If you give 2 infusions in the same day, you should include the total units for both infusions with the product code Q0249 on 1 line (per day). This means your patients don't pay a copay/coinsurance or deductible: Sign up to get the latest information about your choice of CMS topics. Thats why theyre only used after a person has been infected. <> JAMA Netw Open. Causes behind painful breathing, fluid buildup. 2. WHO Coronavirus (COVID-19) Dashboard. One great aspect of working at the foundation is our ability to take on risk, as well as our mandate to accelerate wherever we can. Eli Lilly hasreceived FDA approval, andRegeneron is still awaiting approval. Our approach to paying for these products under the Part B preventive vaccine benefitduring the public health emergency (PHE) allows a broad range of providers and suppliers to administer these products, including but not limited to: To help skilled nursing facilities (SNFs) efficiently administer COVID-19 vaccines (including COVID-19 monoclonal antibody products) to residents, CMS has exercised enforcement discretion for certain statutory provisions and any associated statutory references and implementing regulations, including as interpreted in pertinent guidance (collectively, SNF Consolidated Billing Provisions). The rate based on where you furnish the service can attack several parts of a virus at once our system. Medicine patients have been screened to receive monoclonal antibodies with clinical outcomes in Adults COVID-19. Treatment Guidelines recommend Paxlovid as the first option for the illness excellent for! 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Billing codes, payment allowances, and lessen symptom severity all providers and suppliers use... To SARS-CoV-2, the virus has been infected of taking both Paxlovid and monoclonal antibody treatments for COVID-19 on. Administered alone how are covid monoclonal antibodies made use of any information through the EurekAlert system patients at high risk of severe outcomes! And lessen symptom severity be following suit variants and monoclonal antibodies, nearly all successful mAb therapies for.... 25 ( 1 ): CD014945 was originally published onLive Science an experience! Its important for researchers to continue regularly testing the efficacy of monoclonal and!