Clinical Insights: February 9, 2021

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

    New Drug Approval

    BreyanziTM (lisocabtagene maraleucel) – New Drug Approval – February 5, 2021 – The U.S. Food and Drug Administration approved BreyanziTM (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment. BreyanziTM, a chimeric antigen receptor (CAR) T cell therapy, is the third gene therapy approved by the FDA for certain types of non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL). BreyanziTM is not indicated for the treatment of patients with primary central nervous system lymphoma. <Read More>

    UkoniqTM (umbralisib) – New Accelerated Drug Approval – February 5, 2021 – The Food and Drug Administration granted accelerated approval to umbralisib (UkoniqTM, TG Therapeutics), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, for 1) Adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and 2) Adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. Approval was based on two single-arm cohorts of an open-label, multi-center, multi-cohort trial, UTX-TGR-205 (NCT02793583), in 69 patients with MZL who received at least one prior therapy, including an anti-CD20 containing regimen, and in 117 patients with FL after at least 2 prior systemic therapies. Patients received umbralisib 800 mg orally once daily until disease progression or unacceptable toxicity. <Read More>

    Tepmetko® (tepotinib) Tablets – New Accelerated Drug Approval – February 3, 2021 – The Food and Drug Administration granted accelerated approval to tepotinib (Tepmetko®, EMD Serono Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. Efficacy was demonstrated in the VISION trial (NCT02864992), a multicenter, non-randomized, open-label, multicohort study enrolling 152 patients with advanced or metastatic NSCLC with MET exon 14 skipping alterations. Patients received tepotinib 450 mg orally once daily until disease progression or unacceptable toxicity. <Read More>

    Posimir® (bupivacaine) Solution – New Drug Approval – February 2, 2021 – Durect Corporation announced that the U.S. Food and Drug Administration (FDA) has approved Posimer® (bupivacaine solution) for infiltration use in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression. The approval was based on positive data from a randomized, multicenter, assessor-blinded, placebo–controlled clinical trial in patients undergoing arthroscopic subacromial decompression surgery with an intact rotator cuff. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Gocovri® (amantadine hydrochloride) Extended-Release Capsules – New Approved Indication – February 1, 2021 – Adamas Pharmaceuticals, Inc., a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, announced it has received marketing authorization from the U.S. Food and Drug Administration (FDA) for a supplemental New Drug Application for Gocovri® (amantadine) extended release capsules, gaining a second indication for the product. Gocovri® is now approved as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes, in addition to its indication for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. <Read More>

    New/Updated Drug Shortage

    February 08, 2021

    February 05, 2021

    February 04, 2021

    February 03, 2021

    February 02, 2021

    New Drug Recall and Safety Alerts

    Enoxaparin Sodium Injection, USP by Apotex Corp. – New Voluntary Drug Recall – February 3, 2021 – Apotex Corp is voluntarily recalling two (2) batches of Enoxaparin Sodium Injection, USP to consumer level due to a packaging error resulting in some syringes barrels containing 150 mg/mL markings (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) on the syringe barrel and vice versa. The packaging error was discovered during a customer complaint investigation. To date, Apotex has not received any reports of adverse events related to use of these two batches. The affected product is manufactured by Gland Pharma Limited, Hyderabad, India. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Vancomycin Loading Dose May Not Affect MRSA Outcomes – February 8, 2021 – Using a loading dose of vancomycin in patients with methicillin-resistant Staphylococcus aureus (MRSA) bacteremia may not alter their clinical outcomes, a new study suggests. In a retrospective chart review of 359 patients with MRSA bacteremia, of whom 239 received a vancomycin loading dose of at least 20 mg/kg, researchers with ChristianaCare in Newark, Del., found no significant differences in clinical failure whether or not patients received the loading dose. Clinical failure was defined as either day 7 microbiological failure, or a switch to another anti-MRSA antibiotic or in-hospital mortality prior to blood culture clearance, according to the research presented at the 50th Critical Care Congress Virtual Event (abstract 51). <Read More>

    The Right Anticoagulation Dose in COVID-19? Final Answer Remains Elusive – February 8, 2021 – Early on in the COVID-19 pandemic, patient presentations and autopsy reports made it abundantly clear that abnormal coagulation and multiorgan clotting were key signatures of this disease. Interim results from an eagerly awaited international, multiplatform randomized trial were released recently, suggesting that moderately ill patients—but not those who require ICU-level care—can benefit from therapeutic-dose anticoagulation. Yet it remains unclear whether that’s the right approach to take as a routine strategy. <Read More>

    ASCO’s Early Breast Cancer Guidelines Updated to Include T-DM1 – February 6, 2021 – The approval of adotrastuzumab emtansine (T-DM1; KadcylaTM) prompted the American Society of Clinical Oncology (ASCO) to issue guidelines regarding the selection of optimal adjuvant chemotherapy and targeted therapy for early breast cancer. ASCO’s multidisciplinary group of experts (Expert Panel) developed the previous guidelines based on the 2016 Cancer Care Ontario (CCO) guidelines. After releasing the findings from the KATHERINE trial (NCT01772472) in 2019, the panel reviewed and updated the guidelines to add 2 additional clinical recommendations. KATHERINE focused on patients with HER2-positive early breast cancer and residual disease after neoadjuvant chemotherapy. The update addressed 2 clinical questions regarding the administration of T-DM1. <Read More>

    FDA Warns of Possible Serious CV Events, Cancer Linked to XeljanzTMFebruary 5, 2021 – The FDA issued an alert concerning an increased risk for serious cardiovascular (CV) events and malignancies with the Janus kinase inhibitor, tofacitinib (XeljanzTM, Pfizer), compared with tumor necrosis factor (TNF) inhibitors. Tofacitinib was first approved in 2012 to treat adults with rheumatoid arthritis (RA) who did not respond well to methotrexate. Since then, it has been granted indications for psoriatic arthritis and ulcerative colitis. Tofacitinib works by suppressing an overactive immune system. <Read More>

    High Court Rules on Reimbursement Opinion in Battle Between PBMs, Pharmacies – February 5, 2021 – In 2015, Arkansas passed Act 900, which requires pharmacy benefit managers (PBMs) to reimburse the state’s pharmacies at a price equal to or higher than the pharmacy’s wholesale cost…The Pharmaceutical Care Management Association (PCMA) sued Leslie Rutledge in her capacity as Arkansas attorney general, alleging that Act 900 is preempted by the Employee Retirement Income Security Act of 1974 (ERISA). A federal district court held that ERISA preempts Act 900, and the Eighth Circuit Court of Appeals affirmed the lower court decision. The US Supreme Court reversed both lower courts and remanded the case to be administered in accord with its opinion. Justice Sonia Sotomayor delivered the opinion of the court, in which all other members joined in an 8-0 opinion. Newly appointed Justice Amy Coney Barrett took no part in either consideration or decision of the case. Justice Clarence Thomas filed a concurring opinion. <Read More>

    NACDS Urges Congress to Recognize Critical Role of Pharmacies in Overcoming the Pandemic – February 5, 2021 – In a recent hearing of the US House of Representatives Committee on Energy and Commerce Subcommittee on Health, the National Association of Chain Drug Stores (NACDS) submitted a statement underscoring the critical role of pharmacies, pharmacists, and pharmacy teams in the coronavirus disease 2019 (COVID-19) response and recovery efforts taking place across the country…NACDS also noted that retail pharmacies across the country are ready and able to meet the demand of 100 million COVID-19 vaccine doses in 30 days, assuming the supply of vaccines allows for the endeavor. <Read More>

    Coronavirus (COVID-19) Update: FDA Continues Important Work to Support Medical Product Development to Address New Virus Variants – February 4, 2021 – As the public health agency responsible for regulating medical products, we must ensure that health care providers have the most up-to-date diagnostics, treatments and vaccines in their toolbox to fight this pandemic. We understand the need to adapt and pivot to support modification or development of these lifesaving tools as new variants of coronavirus are identified…We have been actively assessing the impact of new strains on authorized products and continue to work with medical product sponsors and our international partners to evaluate the impact that each variant may have on effectiveness or utility of authorized medical products. <Read More>

    Contributor: Optimizing Specialty Contracting to Control Costs and Improve Patient Outcomes – February 4, 2021 – To control the costs of managing a complex patient population, the market is turning to value-based contracting to drive positive outcomes. From 2017 to 2018, the use of specialty medicines among patients grew by 5%, more than twice the rate of other pharmaceuticals, and specialty drugs represented almost 50% of total prescription drug spending in 2020. As a strategy to control the costs associated with managing a complex patient population, the market is turning to value-based contracting, which links reimbursement or payment for a product to positive clinical outcomes. These trends have paved the way for an increase in limited distribution drugs (LDDs), or therapies only made available to a small number of specialty pharmacies, to give manufacturers greater oversight and control over the quality of patient care and support. <Read More>

    WHO Updates Pain Management Protocols for Children – February 3, 2021 – The World Health Organization has issued updated guidelines for the management of chronic pain in children and adolescents aged 0 to 19 years. The new guidelines focus on physical, psychological, and pharmacological interventions for both primary and secondary chronic pain, with the updates replacing two discontinued documents, “Ensuring balance in national policies on controlled substances,” (2011) and the WHO’s guidelines on “the pharmacological treatment of persisting pain in children with medical illnesses” (2012). <Read More>

    U.S. Supreme Court Decision Supports State Regulation of Pharmacy Benefit Managers – February 3, 2021 – The U.S. Supreme Court’s recent unanimous decision clears the way for state regulation of Pharmacy Benefit Managers (“PBMs”). Rutledge v. Pharm. Care Mgmt. Ass’n, 141 S. Ct. 474 (2020). At issue before the High Court was Arkansas’ Act 900, which requires PBMs to reimburse Arkansas pharmacies at a price equal to or higher than that which the pharmacy paid for the medication to a wholesaler. Arkansas is one of numerous states around the country that passed legislation regulating PBMs in the interest of pharmacies and patients’ access to care. The Arkansas statute was challenged by the Pharmaceutical Care Management Association (“PCMA”), which represents the 11 largest PBMs in the country, as preempted by the 1974 Employee Retirement Income Security Act (“ERISA”). Reversing the Eight Circuit decision, the High Court found Arkansas’ Act 900 not preempted by the federal statute. For states like New York, where PBM practices are largely unregulated, this landmark ruling supports the adoption of new laws that will help pharmacies stay afloat. <Read More>

    APhA Urges Biden Administration to Use Retired Pharmacists and Pharmacy Technicians in COVID-19 Vaccination Campaign – February 2, 2021 – The American Pharmacists Association asked the Biden administration to include recently retired pharmacists and pharmacy technicians in its campaign to vaccinate 100 million Americans against COVID-19 during the administration’s first 100 days. The request was made in a joint letter signed by APhA and nine other pharmacy organizations. Several times during the pandemic, the US Department of Health and Human Services affirmed that pharmacists have the authority during the pandemic to order and administer COVID vaccines and administer pediatric vaccinations across the country. The federal government also gave pharmacy technicians the authority to administer COVID vaccines under the supervision of a pharmacist. <Read More>

    Biden Administration Rescinds New Guidelines on Opioid Use Disorder Treatment – February 2 , 2021 – The Biden administration has rescinded practice guidelines issued in the waning days of the Trump administration that would have made it easier for physicians to provide treatment for opioid use disorder in their offices. Under the guidelines from the U.S. Department of Health and Human Services (HHS), physicians with a Drug Enforcement Administration registration number no longer would have been required to take an eight-hour training course and apply for a separate waiver to prescribe buprenorphine for the treatment of opioid use disorder. The guidelines were applauded by physicians as a way to improve access to treatment as deaths due to opioid overdoses are skyrocketing. <Read More>

    No Time to Put Down Your Guard; CDC Adjusts Some COVID-19 Vaccination Guidelines  – February 2, 2021 – “If this pandemic were a stock, we might be wanting to sell, but it’s important to recognize that these numbers could potentially rise again,” he said. “While these [downward] trends are encouraging, I want to stress that the numbers nationally are still high.” In fact, they are the highest they’ve been since the pandemic began. The pandemic is not over, he said, offering this sobering statistic: “About 16,500 of every 1 million people diagnosed with COVID-19 will die.” The emergence of variants of SARS-CoV-2 is especially troubling, Butler said, at a briefing sponsored by the Infectious Diseases Society of America, because they appear more contagious, and there are concerns about the efficacy of the messenger RNA (mRNA) vaccines. Although still highly efficacious, the mRNA vaccines are more effective against the original strain (95% vs. about 65%). <Read More>

    Working Together to Distinguish Hospital, Health System Specialty Pharmacy Services – February 2, 2021 – As an increasing number of health systems strive to enhance patient care through in-house specialty pharmacies, a tremendous opportunity exists to come together and demonstrate how our services drive superior clinical outcomes and quality of life for patients. Yet today, getting health systems to align around clinical and operational benchmarks and practice standards that are meaningful to other stakeholders remains an opportunity. As a result, the performance of health system specialty pharmacies (HSSPs) continues to be defined by the standards accrediting bodies and payers use to assess traditional mail-order specialty pharmacies (SPs). But these standards don’t account for the unique capabilities and characteristics that enable health systems to deliver differentiated care and results. <Read More>

    Fact Sheet: President Biden Announces Increased Vaccine Supply, Initial Launch of the Federal Retail Pharmacy Program, and Expansion of FEMA Reimbursement to States – February 2, 2021 – As the U.S. surpasses 26 million COVID-19 infections, President Biden took additional steps to implement his comprehensive National Strategy to combat the COVID-19 pandemic. These steps include increasing the vaccine supply to states, Tribes, and territories and increasing funding to jurisdictions to help turn vaccines into vaccinations. And, the President announced that starting next week, the first phase of the federal pharmacy program will launch and select pharmacies nationwide will start offering vaccinations for their communities. <Read More>

    Influenza Vaccine Trials Could Give Insights into Testing COVID-19 Interventions – February 2, 2021 – Three ongoing trials studying the cardiovascular outcomes of influenza vaccines could provide insight into testing novel interventions against coronavirus disease 2019 (COVID-19), according to an article published in the Journal of American College of Cardiology. In addition to the findings of the clinical trials, researchers said seasonal influenza vaccine development and production could inform future efforts at developing and evaluating vaccine strategies for COVID-19. The World Health Organization estimates that as many as 650,000 people die annually from influenza, making it a top 10 cause of death among people of all ages and especially among those with 1 or more comorbidities, such as cardiovascular disease. Because of these risks, clinical guidelines recommend annual vaccinations to reduce the risk of flu-like illness. <Read More>

    What Are the Latest COVID-19 Treatment Recommendations? – February 2, 2021 – Since the beginning of the coronavirus disease 2019 (COVID-19) pandemic, several antivirals and other medications with antiviral properties have been explored as potential treatment options for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection…Both the Infectious Diseases Society of America (IDSA) and the National Institutes of Health (NIH) published practice guidelines that have undergone several updates. These guidelines recommend the use of remdesivir (VekluryTM) as first-line antiviral therapy in patients hospitalized with severe disease.1,2 Recommended remdesivir dosing for adults is a 200-mg loading dose, followed by 100 mg every 24 hours, for a total of 5 days (10 days may be considered for patients with slow response). Dexamethasone, a common corticosteroid, is recommended to be given in combination with remdesivir for patients requiring oxygen supplementation at a daily dose of 6 mg for 10 days. <Read More>

    340B in the News 

    New Swipes at Rx Industry Despite Stable Costs – February 8, 2021 – On the last full day of President Trump’s tumultuous presidency, CMS released a proposal to dramatically restrict access to Part D drugs for patients with serious medical conditions…This might explain another 11th-hour swipe at the industry by the Trump administration.  On December 30, the HHS released an advisory opinion arguing that manufacturers are required to deliver discounts under the 340B program to “contract pharmacies” that are acting as agents of 340B covered entities.  The opinion cited increased hesitancy of manufacturers to provide drugs to contract pharmacies and follows on a hospital industry-backed letter signed by 243 Members of Congress urging HHS to stop manufacturers from withholding 340B drug discounts to contract pharmacies. <Read More>

    Hospital Practices Increase Costs of Medicines for Patients & Employers, New Report Shows – February 4, 2021 – A new report from the Pharmaceutical Research and Manufacturers of America (PhRMA) uncovers the system of incentives that lead hospitals to drive up costs for patients and employers by marking up the price of medicines. While the supply chain for medicines purchased at pharmacies has been well documented, little information is available about the distribution and pricing of medicines administered in the hospital outpatient setting…Congress created the 340B program to help vulnerable patients access medicines at safety-net hospitals and certain clinics. However, the program has evolved to financially benefit large hospital systems, for-profit pharmacies and other middlemen at the expense of patients. Hospitals buy deeply discounted medicines and then charge both uninsured patients and health plans higher prices, pocketing the difference. The ability to generate a profit has spurred 340B hospitals to purchase independent physician offices to expand the program and bring in more profit by registering these entities as 340B offsite outpatient sites. This consolidation has contributed to explosive growth in the program. The number of registered 340B offsite outpatient sites increased from 34 in 1994 to more than 28,000 in 2020, but there has not been similar growth in care for vulnerable patients. <Read More>

    AstraZeneca Sues HHS over Drug Pricing Program Advisory Opinion Regarding Contract Pharmacies – February 2, 2021 – On January 12, 2021, AstraZeneca Pharmaceuticals LP filed a complaint in Delaware federal court against the Department of Health and Human Services (HHS) for issuing an invalid Advisory Opinion…Despite the guidance, AstraZeneca restricted the amount of contractor relationships it would recognize. On October 1, 2020, AstraZeneca announced it would only recognize one arrangement per covered hospital that does not maintain an on-site pharmacy. In response to AstraZeneca and other major pharmaceutical groups halting their drug discounts, the American Hospital Association and four other hospital organizations sued HHS for failing to enforce the 340B Drug Pricing Program requirements. <Read More>

    Will Democrats Squeeze Down Drug Prices? – February 1, 2021 – With Democrats controlling Congress and the White House, expectations are high that policy makers will revise certain coverage and payment policies. Jill Wechsler reports…Pharma companies are concerned, though, that changes in Medicaid best price could affect rate calculations for hospitals under the federal 340B drug discount program. An escalating dispute between manufacturers and CMS over revised rules and policies governing this program has generated lawsuits and eroded industry participation. At issue is whether manufacturers must offer discounted 340B prices to pharmacies that dispense drugs for certain hospitals, a practice that pharma companies claim greatly expands the volume of discounts beyond its original intent.8,9 Look for the “340B wars” to be an early test for the new leadership at HHS. <Read More>

    PhRMA Sues Over “Unconstitutional” 340B Rule – January 31, 2021 – In late January, the Pharmaceutical Research and Manufacturers of America (PhRMA) sued the United States Department of Health and Human Services (HHS) in federal court over the 340B Drug Pricing Program Administrative Dispute Resolution (ADR). In its filing, PhRMA has argued that the regulation is arbitrary and capricious, is not the product of reasoned decision-making, and is unconstitutional. PhRMA contends that the ADR final rule “further distorts an already broken program” and that it is burdensome and hampers the manufacturers’ ability to address program requirement violations by covered entities. PhRMA also believes that when finalizing the rule, the Trump Administration did not address concerns that were raised by stakeholders when the rule was initially proposed in 2016, nor did it update the rule to account for changes that have occurred in the program and the United States healthcare system overall since that time. <Read More>