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Clinical Insights: March 9, 2022

Posted on March 9, 2022 By RxStrategies, Inc. -

Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy marketplace. Contact us to learn more.

New Drug Approval

Carvykti™ (ciltacabtagene autoleucel) – New Orphan Drug Approval – February 28, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) has approved Carvykti™ (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The approval is based on data from the pivotal CARTITUDE-1 study, which included patients who had received a median of six prior treatment regimens (range, 3-18), and had previously received a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. In December 2017, Janssen entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialize ciltacabtagene autoleucel. <Read More>

 Vonjo™ (pacritinib) Capsules – New Orphan Drug Approval – February 28, 2022 – CTI BioPharma Corp. announced the U.S. Food and Drug Administration (FDA) has approved Vonjo™ (pacritinib) for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. Vonjo™ is a novel oral kinase inhibitor with specificity for JAK2 and IRAK1, without inhibiting JAK1. The recommended dosage of Vonjo™ is 200 mg orally twice daily. Vonjo™ is the first approved therapy that specifically addresses the needs of patients with cytopenic myelofibrosis. <Read More>

Norliqva® (amlodipine besylate) Oral Solution – New Drug Approval – February 28, 2022 – The U.S. Food and Drug Administration has approved CMP Pharma, Inc.’s  Norliqva® (amlodipine) oral solution for the treatment of:  1) Hypertension in adults and children 6 years and older, to lower blood pressure and 2) Coronary artery disease [Chronic Stable Angina, Vasospastic Angina (Prinzmetal’s or Variant Angina) and Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction <40%.]…Norliqva® is supplied as a peppermint flavored oral solution containing 1 mg/mL amlodipine as the besylate salt. It is administered once daily. <Read More>

New Indication/Dosage/Formulation Approval

No new update.

New/Updated Drug Shortage

March 04, 2022

March 03, 2022

March 02, 2022

March 01, 2022

New Drug Recall and Safety Alerts

Sodium Acetate Injection, USP by Fresenius Kabi – New Voluntary Recall – March 7, 2022 – Fresenius Kabi USA is voluntarily recalling seven lots of Sodium Acetate Injection, USP, 400 mEq/100 mL (4 mEq/mL), 100 mL fill in a 100 mL vial to the user level due to the presence of particulate matter found in reserve and/or stability sample vials. Microscopic and elemental analyses determined the presence of particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose. <Read More>

Sodium Chloride 0.9% for Injection USP 250ML in Excel by B. Braun Medical Inc. – New Voluntary Recall – March 2, 2022 – B. Braun Medical Inc. (B. Braun) is voluntarily recalling five (5) lots of 0.9% Sodium Chloride for Injection USP 250ML in Excel within the United States to the hospital/user level. The voluntary recall has been initiated due to fluid leakage or low fill volume of the respective containers. The biggest risk with a slow leak in any intravenous solution preparation is a break in sterility which poses a risk for the patient being exposed to a bacterial or fungal infection. There is a remote probability this could lead to bloodstream infection. B. Braun has not received any reports of adverse events related to this recall. <Read More>

New Generic/Biosimilar Approval and Launch

Releuko™ (filgrastim-ayow) Injection – New Biosimilar Approval – March 1, 2022 – Amneal Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approval of the Biologics License Application (BLA) for filgrastim-ayow, a biosimilar referencing Neupogen®. The product will be marketed under the proprietary name Releuko™. Releuko™ was developed in collaboration with Kashiv Biosciences, LLC located in Chicago, Illinois. It is used to treat neutropenia (low neutrophils which are a type of white blood cells that fight infection) which is commonly experienced by patients undergoing chemotherapy. Amneal expects to launch Releuko™ in the third quarter of 2022, along with a full patient support program. <Read More>

Clinical and Pharmacy News

GoodRx to Acquire Pharmacy Services Platform for $150M – March 7, 2022 – GoodRx has entered a definitive agreement to acquire VitaCare Prescription Services, a digital pharmacy services platform. Under the agreement, GoodRx will acquire the platform from TherapeuticsMD for $150 million, with an additional $7 million consideration contingent upon its financial performance through 2023. The platform is designed to help patients understand their coverage and find savings opportunities for brand medications. <Read More>

Five Key Sessions at the American Pharmacists Association Annual Meeting and Exposition – March 7, 2022 – The annual conference includes presentations with educational opportunities related to community pharmacies, health system pharmacies, pharmacy law, public health, and more. Pharmacy Times® will cover the upcoming American Pharmacists Association (APhA) Annual Meeting and Exposition in San Antonio, Texas, from March 18, 2022, through March 21, 2022. The annual meeting includes sessions with educational opportunities about community pharmacies, health system pharmacies, pharmacy law, public health, and more. There are 2 keynote sessions. <Read More>

Let’s Do This! A Call to Action for Test to Treat in Pharmacy – March 7, 2022 – President Biden’s recent State of the Union address included a pharmacy Test to Treat initiative for COVID-19. I’ve long been an advocate for pharmacists’ ability to evaluate and prescribe, so hearing President Biden announce a pharmacy test to treat initiative for COVID-19 during his State of the Union address was a thrill! The COVID-19 pandemic brought national attention to pharmacy and what we can do to serve our communities, and this felt like a great continuation of that narrative in the national spotlight. Pharmacists are ready for test to treat, but there are a few steps that need to happen before this can become a reality… <Read More>

AMA Statement on “Test to Treat” Does Not Align Well With Patients’ Interests – March 7, 2022 – During his State of the Union Address last week, President Biden announced a plan to make it easier for people to get access to the new antiviral drug Paxlovid. This drug, if taken during the first 3 to 5 days of a symptomatic COVID infection, is 89 percent effective in preventing the case from progressing to hospitalization or death. Under the plan, dubbed “test to treat,” people with symptoms may go to a designated pharmacy, community health center, nursing home, or supermarket, where a pharmacist can perform the test for COVID and, if it returns positive, prescribe the antiviral drug to the patient at the same time. This is a positive move…Unfortunately, the American Medical Association (AMA) poured cold water on the idea in a statement it released on March 4… <Read More>

‘Test-To-Treat’ Program Too Narrow, Risky, Medical Groups Say – March 7, 2022 – The American Pharmacists Association and American Medical Association have expressed concerns about the scope and safety of the White House’s “test-to-treat” program. The initiative, announced March 1, involves using pharmacy-based clinics as “one-stop shops” where people who receive a positive COVID-19 test result can be seen by a clinician and receive antiviral therapy, all in one visit. The White House said hundreds of one-stop sites will be made available nationwide in March. The American Pharmacists Association said the program should be expanded to include more pharmacies…The American Medical Association called the initiative “well intentioned” and praised the Biden administration for working to make antivirals broadly available. However, the group said the current plan is “extremely risky” as pharmacy-based clinics usually treat simple illnesses. <Read More>

FDA Expands Access to Mifepristone to Mail-Order and Community Pharmacies – March 7, 2022 – In December 2021, FDA permanently lifted a major restriction on medication abortions that had been temporarily lifted earlier in the COVID-19 pandemic. Prior to the pandemic, patients were required to pick up mifepristone in person from a certified prescriber. In 2020, FDA temporarily lifted this in-person requirement. The new change from FDA will permanently allow any certified mail-order or brick-and-mortar pharmacy to dispense the drug with a prescription. “We know that previous restrictions on dispensing have limited providers in their ability to provide this service because they didn’t have the capacity to also have an in-house pharmacy,” said Sally Rafie, PharmD, BCPS, APh, NCMP, FCCP, a pharmacist specialist at UC San Diego Health and founder of the Birth Control Pharmacist project. <Read More>

Learning from Patient Text Messaging to Optimize Opioid Prescribing and Reduce Misuse – March 7, 2022 – CDER investigates the utility of a text messaging app to obtain patient-reported information that can help FDA improve opioid prescription guidelines for surgical patients. The nonmedical use of physician-prescribed opioids is the second most common type of illicit drug use in the US. Opioid prescription rates for patients experiencing acute pain (e.g., those recovering from surgery) are especially high in the US, where it has been estimated that the median number of tablets prescribed for common surgical procedures is 20, compared with a median of one tablet in other countries, and that between 42% and 71% of opioids prescribed for acute pain remain unused. Such unused drugs may become available for misuse and abuse, perpetuating the opioid crisis. <Read More>

AMA Statement on Administration’s Test-to-Treat COVID-19 Plan – March 4, 2022 – “While the administration laid out promising plans earlier this week to combat COVID-19 and put measures in place to prevent future pandemics, the pharmacy-based clinic component of the test-to-treat plan flaunts patient safety and risks significant negative health outcomes. This approach, though well intentioned in that it attempted to increase access to care for patients without a primary care physician, oversimplifies challenging prescribing decisions by omitting knowledge of a patient’s medical history, the complexity of drug interactions, and managing possible negative reactions. <Read More>

Updated CDC Prescription Opioid Guidelines Appear More Flexible and Patient-Centric, But Fall Short – March 4, 2022 – Over the past quarter-century, the opioid epidemic has taken nearly 600,000 lives. Drug overdoses now kill more than 100,000 Americans a year, which is more than vehicle crash and gun deaths combined…The Centers for Disease Control and Prevention (CDC) has issued an updated set of prescription opioid guidelines that accounts to some degree for the changing landscape of the opioid crisis. The recommendations acknowledge the importance of a more patient-centric approach to pain management. Nonetheless, the guidelines fall short. They continue to underplay the outsized role illicit opioids play, and don’t adequately tackle the multifaceted nature of the prescription opioid problem, which goes beyond the doctor, patient, and the pharmaceutical industry. The problem also includes payer coverage policies. <Read More>

Counseling Pearls: Allergic Asthma Treatment – March 4, 2022 – Allergic asthma can be a complicated and confusing diagnosis. When it comes to treating allergic asthma, “the pharmacist is in the ideal position to ensure the patient understands their condition, how to avoid triggers, how to manage an attack, and how medications work,” Kashmira Govind, a pharmacist for the Farr Institute, explained. “This is especially important for patients with newly diagnosed asthma. It is a complicated and confusing diagnosis.” <Read More>

Home Infusion: Interest Still High, Inventory Still Low – March 4, 2022 – A handful of recently announced deals underscores the continued appetite for home infusion companies propelled by the COVID-19 pandemic, say M&A analysts. Option Care Health recently announced it acquired Wasatch Infusion and entered into an agreement to acquire Specialty Pharmacy Nursing Network. “Option Care has been doing deals for 20 years and I don’t think that’s going to stop – they continue to fill out their geographic footprint,” said Michael Patton, managing director with Provident Healthcare Partners. “There’s just not as much inventory as there was.” <Read More>

I’m Used to my Patients’ Prior Auth Hassles. Then came Mom’s. – March 4, 2022 – As a family physician, the best part of my job is caring for my patients and serving as their partner in a lifelong quest for wellness. Their well-being means everything to me, and I am humbled that they have placed their trust in me. But as we all know, physicians today face an onslaught of administrative hassles that steal our time with our patients as well as our families. These burdens are major sources of frustration and burnout, especially when they hinder delivery of the best patient care we can provide. My firsthand experience with pharmacy-related prior authorization illustrates the time-consuming and potentially dangerous nature of this aspect of utilization management. My mom, who will turn 92 this year, takes several generic medications each day and has remained stable while doing so for nearly a decade. But an updated benefit plan that took effect in January imposed wholly unexpected prior-authorization requirements that threatened to deprive her of these vitally important medications for an uncertain length of time. <Read More>

New Tools, New Data, New Pandemic Plan – March 4, 2022 – The president’s new National COVID-19 Pandemic Preparedness Plan provides a framework for getting back to normal, experts said. On Feb. 25, the CDC lifted most of its mask mandates, and at the State of the Union Address, President Joe Biden mentioned his plan as a path forward. That plan was released on March 2 by the White House COVID-19 Response Team and Xavier Becerra, the secretary of the Department of Health and Human Services. While many people are pleased to see restrictions lifted and excited for an opportunity to return to normal activities, others are feeling a sense of déjà vu. Although fewer new cases are being reported now, there are still about 60,000 new cases per day, which was more than June 2021, when many restrictions were lifted last year, just before the country was hit hard by the delta wave. <Read More>

No Approval for Lenacapavir Due to Vial Compatibility Issues – March 3, 2022 – The FDA issued a complete response letter (CRL) for the New Drug Application (NDA) for lenacapavir, an investigational, long-acting HIV-1 treatment for people with multidrug-resistant (MDR) HIV-1 infection. Lenacapavir, a capsid inhibitor, is being developed by Gilead Sciences. In the CRL, the FDA cited issues with Chemistry Manufacturing and Controls. The agency is concerned that the medication is not compatible with the proposed borosilicate glass vial, which contains boron trioxide to prevent cracking. The agency had put a clinical hold on the trials of lenacapavir in December 2021 because of this concern. <Read More>

Military Members, Families And Retirees Get Simplified Access To Abbott’s Freestyle® Libre 2 System Through Tricare® – March 3, 2022 – Abbott announced that its FreeStyle® Libre 2 flash glucose monitoring system (CGM) is now available as a brand-name formulary pharmacy benefit to military members, their families and retirees with Tricare® health coverage. This will make it easier for Tricare® members to access industry-leading monitoring technology1 to manage their diabetes. Previously, FreeStyle® Libre 2 was only available to Tricare® members by a prescription fulfilled through durable medical equipment companies. <Read More>

Children Affected by Educational Disruptions Experience Mental Health Declines – March 3, 2022 – During spring to fall 2020 related visits to emergency departments declined compared with a year earlier, study results show. Children who were more vulnerable to missed detection related to mental health issues when school was disrupted during the COVID-19 pandemic were more likely to experience disproportionate mental health declines, the results of a study published in Psychiatric Research & Clinical Practice showed. During spring to fall 2020 mental health-related emergency department (MH-ED) visits declined 25.5% compared with a year earlier. The greatest reduction was seen during spring at 42.8% and fall at 26.5%, with a lesser reduction during summer of 2.6%. <Read More>

President Outlines Plans to Fight Cancer, Curb COVID-19, Cut Prescription Drug Prices – March 2, 2022 – Continuing to control the spread of COVID-19, cutting prescription drug prices, curbing substance use disorder and developing a new federal agency that will work to improve the health of all Americans—in part by fighting cancer head-on—are among the key health initiatives President Joe Biden laid out in his State of the Union address on March 1. Although he gave few specific details on many of those initiatives, Mr. Biden said he will work toward keeping Americans healthy, lowering costs, boosting the economy and ensuring care for everyone. <Read More>

Drug Misuse is Not Exclusive to the Opioid Epidemic, Suggests Study – March 2, 2022 – Drug misuse is not exclusive to the opioid epidemic, according to a recent West Virginia University study. Every year, about 50,000 people in the United States are admitted to the emergency room due to misuse of a common over-the-counter pain medication – acetaminophen. With that in mind, Mark Garofoli, director of experiential learning at the WVU School of Pharmacy, spearheaded research that revealed that the public’s knowledge and perceptions of OTC pain meds is lacking. In a survey of 1,174 West Virginians, 85% of respondents answered two-thirds of questions about OTC pain meds incorrectly. <Read More>

Biocon Biologics Acquires Viatris’ Biosimilar Portfolio – March 1, 2022 – As part of a new partnership between the companies, Biocon Biologics announced that it will acquire Viatris’ entire biosimilar portfolio for up to $3.3 billion, according to a statement by Biocon. Overall, Viatris will receive up-front payments of $2.3 billion and compulsorily convertible preference shares in Biocon Biologics, which are valued at $1 billion. The transactions have been approved by the Boards of Directors from both companies. <Read More>

FTC Lets PBMs off the Hook: For Now it Won’t Pursue a Formal Inquiry on Alleged PBM Anti-Competitive Practices – March 1, 2022 – Despite statements by the Chair of the Federal Trade Commission (FTC), Lina Khan, and the Secretary of Health and Human Services (HHS), Xavier Becerra, that they would formally scrutinize anti-competitive practices by pharmacy benefit managers (PBMs), both agencies have yet to do so. Though the FTC Chair Khan wishes to proceed with an inquiry into certain alleged anti-competitive practices by PBMs – including their possible role in squeezing pharmacies, driving up drug list prices, and increasing patients’ out-of-pocket costs – she doesn’t have enough support among her colleagues. <Read More>

Registration Opens for the National Association of Specialty Pharmacy 2022 Annual Meeting & Expo – March 1, 2022 – The National Association of Specialty Pharmacy (NASP), the only industry association in the U.S. whose membership includes all specialty pharmacy stakeholders, opened registration for the NASP 2022 Annual Meeting & Expo, to be held September 19-22, 2022, at the Gaylord Palms Resort & Convention Center in Orlando, Florida. NASP members, industry thought leaders and health care veterans from around the country will come together once again to shape and change the future of specialty pharmacy and the patient journey. <Read More>

340B in the News

AHA Urges HHS to Ensure Hospitals Have Access to 340B Program – March 4, 2022 – On behalf of our nearly 2,000 340B member hospitals, the American Hospital Association (AHA) is again writing to urge that the Department of Health and Human Services (HHS) ensure hospitals participating in the 340B Drug Pricing Program do not lose access to the program as a result of changes in patterns of patient care due to the COVID-19 public health emergency (PHE). The COVID-19 pandemic has ravaged the United States, with nearly 80 million people infected and over 920,000 people dead through mid-February 2022. Our nation’s hospitals and health systems have been on the front lines of this devastating virus and have collectively cared for nearly 4.5 million patients hospitalized with COVID-19. Like many hospitals throughout the country, a number of 340B hospitals have endured immense financial and operational challenges, including mandatory shutdowns of non-emergent procedures to make way for increased demand for COVID-19 care. For some 340B hospitals, these challenges have led to changes in their payer mix during the PHE that put their access to the 340B program at risk. <Read More>

Lawmakers Work to Protect 340B Entities From PBM Practices – March 3, 2022 – Supporters of a bipartisan initiative in Colorado to restrict discriminatory pharmacy benefit manager (PBM) practices say the contracting practices of PBMs and other third-party payers is reducing medication access for 340B-covered patients. House Bill 1122, sponsored by Rep. Perry Will (R – New Castle), would prohibit PBMs from reimbursing a pharmacy for a prescription drug at an amount lower than that drug’s average national acquisition cost. This would address low medication reimbursement rates that numerous community health centers across Colorado are experiencing. The House Health and Insurance Committee discussed the bill on Wednesday, with a committee vote still pending. <Read More>

Overserved: Drug Manufacturers Attempt to Cut Off Contract Pharmacies’ Access to 340B Program – March 2, 2022 – Recent litigation between the federal government and drug manufacturers will surely impact how covered entities and contract pharmacies under the 340B Drug Discount Program (the 340B Program) operate going forward. A federal appeal is underway over drug manufacturers’ ability to add conditions and, in some cases, cut off sales to contract pharmacies operating under the 340B Program. While litigation continues, the Health Resources and Services Administration (HRSA) and the United States Congress may have to confront gaps pointed out under select provisions within the 340B Program – the long-term effect of which will most certainly affect how drug manufacturers, covered entities, and contract pharmacies interact going forward. <Read More>

Opinion: Hospitals are Pocketing Dollars Intended for Charity Care – March 1, 2022 – Hospitals are places of healing and should not harm those who seek care, especially uninsured and low-income patients. These patients are harmed when they are not able to pay for expensive medical care or costly prescriptions. They often go untreated. My faith teaches me this is wrong: everyone is made in the image of God and deserves health care, regardless of how much money they have…The federal government created a well-intentioned program that provided drug discounts to hospitals, the savings from which were intended to be used to provide charity care. The program, known as the 340B Drug Pricing Program, intended to help make health care affordable for uninsured and low-income patients seeking care at a community health center and nonprofit hospitals. It has not worked. <Read More>

The Controversy Surrounding 340B Program – February 28, 2022 – Prescription drug prices have faced a lot of controversy over the past few years, most recently with the federal 340(B) program. Under Section 340(B) of the Public Health Service Act, drug manufacturers who participate agree to provide a discount to eligible hospitals and other “covered entities” who serve low-income individuals not covered by Medicare and Medicaid. The purpose is to pass along the discount to these uninsured individuals. Hospitals which maintain their own in-house pharmacies easily participate. However, some hospitals have contracted outside private pharmacies to provide pharmaceutical coverage for their 340(B) eligible patients based on guidance from the Health Resources and Services Administration (HRSA) in 1996. In 2010, HRSA regulations began to allow providers to contract more than one pharmacy and still remain eligible for the 340(B) discount. <Read More>