Clinical Insights: March 23, 2021

    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

    Ponvory™ (ponesimod) Tablets – New Drug Approval – March 19, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) approved Ponvory™ (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Ponvory™ offers MS patients superior efficacy in reducing annualized relapse rates compared to an established oral therapy and a proven safety profile backed by over a decade of cumulative clinical research. <Read More>

    Kimyrsa™ (oritavancin) for Injection – New Drug Approval – March 15, 2021 – Melinta Therapeutics, LLC (Melinta), a commercial-stage company focused on the development and commercialization of novel antibiotics, announced that the U.S. Food and Drug Administration (FDA) has approved Kimyrsa™ (oritavancin)  for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of designated Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA). Kimyrsa™ is a lipoglycopeptide antibiotic that delivers a complete course of therapy for ABSSSI in a single, one hour 1,200 mg infusion. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Fabrazyme® (agalsidase beta) – New Expanded Indication Approval – March 12, 2021 – Fabrazyme is the only FDA-approved enzyme replacement therapy for Fabry disease with long-term efficacy and safety data. In a real-world observational study, the estimated mean eGFR slope was -1.5 mL/min/1.73 m2/year in the Fabrazyme-treated group and -3.2 mL/min/1.73 m2/year in the untreated group for a treatment difference of 1.7 mL/min/1.73 m2/year. Long-term clinical study found 28 percent (14 of 51 patients) Fabrazyme®-treated patients experienced a clinically significant event (renal, cardiac, cerebrovascular or death) compared to 42 percent (13 of 31 patients) placebo-treated patients. Results from a real-world, observational study and a clinical trial on long-term treatment with Fabrazyme® (agalsidase beta) for people living with Fabry disease are now included in FDA-approved label. Fabrazyme® was granted accelerated approval by the FDA in 2003 and is the first approved treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease. <Read More>

    New/Updated Drug Shortage

    March 19, 2021

    March 18, 2021

    March 17, 2021

    March 16, 2021

    March 15, 2021

    New Drug Recall and Safety Alerts

    No new update.

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    IDSA’s Latest COVID-19 Treatment Guidelines – March 21, 2021 – As the medical community’s knowledge of COVID-19 has grown, guidelines for treating it have evolved concurrently. The Infectious Diseases Society of America’s (IDSA) COVID-19 Treatment and Management Guidelines Expert Panel recently updated guidelines based on landmark studies incorporating ivermectin, tocilizumab, and other monoclonal antibodies. A press briefing featuring 2 co-chairs of the guidelines panel shed light on the new guidelines and what led to them. <Read More>

    Community Pharmacies Positioned to be the Epicenter of Care – March 19, 2021 – Community pharmacists have an essential role to play during this phase of the crisis that could further entrench them as the epicenter of care in the communities they serve. As declining COVID-19 case numbers and the rollout of new vaccines bring the end of the pandemic into clearer view, community pharmacists have an essential role to play during this phase of the crisis that could further entrench them as the epicenter of care in the communities they serve. Pharmacists are well aware that they do far more for their communities than merely dispense prescriptions, but many patients still cling to that outdated conception of their local pharmacies. <Read More>

    Marie Bradley, PhD, MPharm, MSc.PH on Apixaban and Warfarin for Stroke Prevention in Patients With NVAF – March 18, 2021 – In patients of all ages with nonvalvular atrial fibrillation (NVAF), apixaban yielded better results than warfarin for stroke prevention with reduced risk of ischemic stroke, gastrointestinal bleeding, and intracranial hemorrhage, according to the results of a recent study. To examine the benefit risk of the 2 medications across various age groups, the researchers conducted a retrospective cohort study in the FDA Sentinel system.  After propensity score matching 55,038 patients with NVAF, who initiated apixaban and 55,038 who initiated warfarin between December 2012 and June 2018, were included. <Read More>

    After a Rollercoaster Year, Infusion Providers Urge Biden Administration to Prioritize Home-Based Care – March 18, 2021 – Just over one year ago, like so many other businesses across the country, Upstate HomeCare went from normal operations to shutdown mode virtually overnight as the COVID-19 pandemic slammed into the United States. Senior Vice President and CEO Greg LoPresti sent approximately 40% of the staff of his Clinton, N.Y.–based home health care service agency, which serves the Albany, Syracuse, Utica, Rochester and Buffalo regions, to work from home. Meanwhile, the staff who had to work in person—including drivers, nurses and pharmacists—needed to readjust their model of care. “Many of the core services we provided, like postsurgical home infusions, dried up overnight,” LoPresti said. “Meanwhile, we had more specialty and chronic care cases for patients with conditions like primary immunodeficiency and CIDP [chronic inflammatory demyelinating polyneuropathy]. <Read More>

    National Comprehensive Cancer Network (NCCN) Issues New Set of Guidelines for Biosimilar Use – March 18, 2021 – This month, a working group within the Pharmacy Directors Forum of the National Comprehensive Cancer Network (NCCN) has reviewed and highlighted “some of the potential challenges regarding adopting biosimilars into clinical practice,” making “several recommendations for the safe and efficient use of biosimilar medications in the clinical setting.” The group listed medication errors, financial toxicity for patients, and economic challenges for institutions/providers as potential risks when using biosimilar products in the care of patients. <Read More>

    White, Brown Bagging of Therapies Creates Extra Steps for Oncology Practices – March 18, 2021 – Pharmacists from the Cleveland Clinic discuss the impact of payer dispensing requirements, known as white bagging and brown bagging, on oncology practices and on patients. Getting oncology medications from the manufacturer to the patient is more complex than it used to be, and the process can be tough for clinics and patients, according to Cleveland Clinic pharmacists who discussed dispensing trends during the National Comprehensive Cancer Network’s Virtual Annual Conference. Heather Jones, PharmD, MS, and Michael E. Seabright, PharmD, BCOP, outlined the challenges clinics are having as practices such as “white bagging” and “brown bagging” become more common. Jones and Seabright are affiliated with Case Comprehensive Cancer Center/ University Hospitals Seidman Cancer Center and Cleveland Clinic Taussig Cancer Institute. <Read More>

    WHO Publishes New Clinical and Service Delivery Recommendations for HIV Prevention, Treatment and Care – March 17, 2021 – These guidelines provide new and updated recommendations on the use of point-of-care testing in children under 18 months of age and point-of-care tests to monitor treatment in people living with HIV; the treatment monitoring algorithm; and timing of antiretroviral therapy (ART) among people living with HIV who are being treated for tuberculosis. New recommendations outline key new actions that countries can take to improve the delivery of HIV testing, treatment and care services by providing greater options for differentiated approaches such as, supporting HIV treatment start in the community, ensuring that children are diagnosed and treated early, and that viral load treatment monitoring is more accessible, focused and triggers clinical action. <Read More>

    Insurers, PBMs Call on Congress to Get Rid of Delayed Part D Rebate Rule – March 17, 2021 – A collection of insurer and pharmacy benefit manager groups is not satisfied with just a one-year delay of the implementation of a controversial Medicare Part D rebate rule. The groups now want Congress to fully nix the rule hastily approved before the end of the Trump administration. “The rebate rule was and remains unsound policy,” according to a letter sent to congressional leaders Wednesday. “We believe it is imperative to block implementation of this rule to protect Medicare beneficiaries and taxpayers from unsustainable cost increases.” <Read More>

    Patient-First Approach Addresses Unique Needs of Patients With Rare Disorders – March 17, 2021 – Now more than ever, 30 million Americans living with a range of 7000 rare or orphan diseases require a high level of therapy adherence support. To optimize care during uncertain times, such as amid the current pandemic, a patient-first approach can enable pharmaceutical companies, pharmacists, physicians, and other members of the care team to better address compliance and adherence to treatment to impact the patient experience and improve outcomes. The focus on small patient populations includes targeted programs and services that deliver specialized expertise that goes well beyond the scope of capabilities provided by traditional, legacy care organizations that are simply built for scale. <Read More>

    Study Links Promotional Challenges to Patient Use of HIV Screenings in Pharmacies – March 17, 2021 – Results presented at the 2021 APhA Annual Meeting and Exposition cite advertising and marketing difficulties as main barrier to success of point-of-care service. Pharmacists might be able to increase the number of patients who seek point-of-care screening for HIV with improved advertisement and marketing for the service. A survey of Iowa pharmacists showed the difficulties of advertising and marketing as the main barrier for getting patients to receive point-of-care HIV screenings. <Read More>

    Pharmacist Charged in $4 Million Health Care Fraud and Kickback Scheme – March 17, 2021 – A New York man was arrested for his role in a conspiracy to commit health care fraud and to pay kickbacks and bribes to customers for expensive prescription orders in connection with more than $4 million in Medicare and Medicaid reimbursements. According to an indictment returned by a federal grand jury in the Eastern District of New York, Robert John Sabet, 44, of Brooklyn, was the owner of Brooklyn Chemists in Gravesend, Brooklyn, and Lucky Care Pharmacy in Flushing, Queens. Since September 2016, Sabet allegedly conspired to bill Medicare and Medicaid for expensive prescription drugs that were not eligible for reimbursement because, among other reasons, they were not needed or not dispensed. <Read More>

    Counseling Patients on Proper Use of CBD Products – March 17, 2021 – With a wide array of cannabidiol (CBD) and CBD extract products available without a prescription, pharmacists have an increasingly important role to play in counseling patients on which products may work for them and how they should be properly used. Cannabis plants are used to make both medical and recreational products, according to Danielle Fixen, PharmD, BCGP, BCPS, of the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, in a session at the virtual 2021 American Pharmacists Association (APhA) 2021 Annual Meeting and Exposition. Cannabis, or marijuana, contains higher concentration of tetrahydrocannabinol (THC), whereas CBD is easier to extract and has lower amounts or no THC. <Read More>

    APhA: NBC News Story Illustrates the Need for Fundamental Pharmacy Payment Reform – March 17, 2021 – The NBC News story, “Overworked, understaffed: Pharmacists say industry in crisis puts patient safety at risk,” is a compelling demonstration of the need for fundamental payment reform in pharmacy, according to Scott J. Knoer, executive vice president and chief executive officer of the American Pharmacists Association (APhA). <Read More>

    Clinics, Home Infusion Spur Chemotherapy Savings – March 16, 2021 – With the right mix of people and processes, many chemotherapy treatments can be safely transitioned from inpatient to outpatient settings, reducing inpatient stays and saving institutions hundreds of thousands of dollars in drug costs, according to a presentation at the Association of Community Cancer Centers 2020 Virtual National Oncology Conference. <Read More> 

    Overworked, Understaffed: Pharmacists say Industry in Crisis Puts Patient Safety at Risk – March 16, 2021 – From the moment Marilyn Jerominski walks into her pharmacy every morning, her time is in demand. As pharmacy manager of a busy 24-hour Walgreens in Palm Desert, California, she is responsible for the safety and accuracy of the thousands of prescriptions the store dispenses every week. “There’s so much stress,” Jerominski said. “You’re not only running to the drive-thru but to the front, to the vaccination station to give a vaccination, then to the phone. … It’s almost impossible for any human to keep that momentum day in and out.”  <Read More>

    Bipartisan Bill Cracks Down on Pharmacy Benefit Managers, Should Result in Lower Drug Costs – March 16, 2021 – The state Assembly unanimously passed a bill Tuesday to remove Wisconsin from the few remaining states that do not regulate Pharmacy Benefit Managers, commonly known as PBMs, from banning pharmacies from offering cheaper drugs not covered by someone’s insurance plan. The bill, which already cleared the Senate, now heads to Governor Tony Evers who is expected to sign it into law. PBMs are currently able to operate largely as they wish. Thad Schumacher, owner of Fitchburg Family Pharmacy, said Tuesday the bill would allow him to suggest generic drugs in cases where it would cost less than a customer’s co-pay. <Read More>

    Apha House of Delegates Debates Health Inequities, Harassment, National Pharmacy Organization Unity – March 16, 2021 – At its Monday, March 15, 2021 business session, members of the APhA House of Delegates (HOD) considered policies salient to both pharmacy and the nation at large, including abuse of power and harassment in the profession, anti-racism, and social determinants of health. The session also included discussion on medications for opioid-use disorder and a proposal to unify national pharmacy organizations. <Read More>

    McKesson Expands Integrated Pharmacy Services for Specialty Clinics – March 16, 2021 – McKesson Corporation, a global healthcare company, announces a new collaboration with Vanderbilt Health Rx Solutions (VHRxS), a national leader in specialty pharmacy strategy and implementation, to offer VHRxS’s full suite of specialty pharmacy consulting services to McKesson’s health system clients. This new, specialized offering from VHRxS will complement the experience of McKesson, which has offered industry-leading pharmacy services for more than 40 years, by bringing the expertise of VHRxS, which was founded by Vanderbilt University Medical Center to advance the mission of health systems specialty pharmacies nationwide. <Read More>

    CVS 2021 Trend Report Illustrates how Pharmacy has Transformed During COVID-19 Era – March 16, 2021 – Each year, the CVS Trend Report analyzes the forces that impact care the most and forecasts where the health care industry is heading. The emergence of COVID-19 in the past year has caused a shift in many different aspects of the health care model, forcing many different challenges to be addressed throughout… CVS labeled 2021 as the Year of the Pharmacist and the report predicts that pharmacists will continue to be the most frequent health care touchpoint in the coming year after their major role in the COVID-19 pandemic. One way CVS Health hopes to see pharmacists help more people is in the social determinants of health aspect, such as food insecurity. <Read More>

    340B in the News

    WNY Federally Qualified Health Centers Ask State to Reverse 340B Funding Cuts – March 20, 2021 – Administrators of Western New York’s federally qualified health centers, including Universal Primary Care facilities in Cuba, Houghton, Olean and Salamanca have called on the state to reverse or delay the 340B funding cuts. If the state’s plan to “carve-out” Medicaid prescription drugs is approved, the plan is expected to devastate 340B drug discount program providers. The 340B program allows safety net providers to purchase discounted drugs and use the savings to provide essential services, like housing aid and food assistance, for low-income New Yorkers. <Read More>

    340B Assists Patients and Institutions – March 19, 2021 – How much does this federal program affect the success of the health care parties involved? Congress enacted section 340B of the Public Health Service Act in 1992, 2 years after the Medicaid Drug Rebate Program of 1990, which ensured eligible state facilities received drug products at the lowest price possible. In 1992, Congress extended this relief beyond just Medicaid patients to any eligible health care facility treating a large volume of low-income patients.1 Low income is loosely defined. In some contracts, it is based on a variation of income threshold compared with the federal poverty line.2 Covered entities (CEs), also known as safety net facilities, must meet certain criteria to be eligible for these drastic discounts from manufacturers. <Read More>

    Judge Halts 340B Dispute Rule, Siding With Eli Lilly in Lawsuit Over Program – March 16, 2021 – A federal judge blocked the Biden administration from implementing a controversial rule to handle disputes over the 340B drug discount program, handing drugmakers a major win in an escalating feud over the program. The opinion, issued late Tuesday, grants a preliminary injunction sought by Eli Lilly, which sued the feds over the rule. The ruling comes as Lilly and several other drugmakers restricted sales of drugs discounted under the 340B program to contract pharmacies, which are third parties that dispense the products on behalf of the covered entities. <Read More>