Clinical Insights: June 1, 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

    Lumakras™ (sotorasib) – New Drug Approval – May 28, 2021 – The U.S. Food and Drug Administration approved Lumakras™ (sotorasib) as the first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation called KRAS G12C and who have received at least one prior systemic therapy. This is the first approved targeted therapy for tumors with any KRAS mutation, which accounts for approximately 25% of mutations in non-small cell lung cancers. KRAS G12C mutations represent about 13% of mutations in non-small cell lung cancers. <Read More>

    Myfembree® (relugolix, estradiol and norethindrone acetate) Tablets – New Drug Approval – May 26, 2021 – Myovant Sciences and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Myfembree® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg), the first once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. The approval is supported by efficacy and safety data from the Phase 3 LIBERTY 1 and LIBERTY 2 studies, which were published in the New England Journal of Medicine. Under the terms of their previously announced collaboration, Myovant and Pfizer will jointly commercialize Myfembree® in the U.S. Myfembree® is expected to be available in June 2021. <Read More>

    Camcevi® (leuprolide mesylate) Injection – New Drug Approval – May 26, 2021 – Taipei, Taiwan, May 26th, 2021 – Foresee Pharmaceuticals announced  that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Camcevi® 42 mg, a ready-to-use 6-month subcutaneous depot formulation of leuprolide mesylate, as a treatment of advanced prostate cancer. “The approval of Camcevi® 42 mg is a significant step toward our mission in improving the standard of care and the lives of patients,” said Dr. Ben Chien, founder and Chairman of Foresee. “It also demonstrates the success of Foresee’s pioneering Stabilized Injectable Formulation (SIF) technology. We want to thank the tireless work from the team and all stakeholders, which has made this approval possible. <Read More>

    Pylarify™ (piflufolastat F 18) Injection – New Drug Approval – May 26, 2021 – FDA has approved Pylarify™ (piflufolastat F 18) – a drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. With the approval of Pylarify™, certain men with prostate cancer will have greater access to PSMA-targeted PET imaging that can aid health care providers in assessing prostate cancer. Pylarify™ is indicated for patients with suspected prostate cancer metastasis (when cancer cells spread from the place where they first formed to another part of the body) who are potentially curable by surgery or other therapy. Pylarify™ is also indicated for patients with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (PSA) levels. Pylarify™ is a radioactive diagnostic agent that is administered in the form of an intravenous injection. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Yervoy® (ipilimumab) – New Expanded Indication – May 23, 2021 – Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has expanded the indication for Yervoy® (ipilimumab) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. Yervoy® was evaluated in two trials of pediatric patients: a dose-finding study in 33 patients aged two to 21 years with relapsed or refractory solid tumors and an open-label, single-arm trial in 12 adolescents (ages ranging from 12 to 16 years) with previously treated or untreated, unresectable Stage 3 or 4 malignant melanoma. The overall safety profile of Yervoy® in children and adolescents was consistent with the safety profile in adults, and similarities in disease between adult and pediatric patients 12 years and older allow for extrapolation of data. Based on a population pharmacokinetic analysis, exposure in adolescents 12 years and older is comparable to that in adults for the approved dose of 3 mg/kg, administered intravenously over 90 minutes every three weeks for a total of four doses. <Read More>

    New/Updated Drug Shortage

    May 28, 2021

    May 25, 2021

    May 24, 2021

    New Drug Recall and Safety Alerts

    No new update.

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Report Says Amazon Looks to Open Pharmacy Stores in U.S. – May 30, 2021 – Amazon.com is planning to launch brick-and-mortar pharmacies in the United States, most likely inside of Amazon-owned Whole Foods locations, Insider reported on Wednesday. Amazon is currently in the exploratory stage and any meaningful rollout could take more than a year, according to the news site. An Amazon spokesperson said the company does not comment on rumor or speculation, but added that Amazon Pharmacy is focused on making at-home pharmacy deliveries easier and more convenient for customers. <Read More>

    ACG Issues Guidelines for C. Diff Management in Adults – May 28, 2021 – In clinical guidelines issued by the American College of Gastroenterology and published online May 19 in the American Journal of Gastroenterology, recommendations are presented for the management of Clostridioides difficile infection (CDI) in adults. Colleen R. Kelly, M.D., from the Warren Alpert Medical School of Brown University in Providence, Rhode Island, and colleagues developed recommendations for prevention, diagnosis, and treatment of CDI in adults. <Read More>

    FMI, NGA Join Pharmacy Coalition Backing DIR Fee Reform – May 28, 2021 – FMI-The Food Industry Association (FMI) and the National Grocers Association (NGA) have joined a coalition of pharmacy industry trade groups endorsing new federal legislation to tighten control of pharmacy direct and indirect remuneration (DIR) fees. This week, the U.S. House of Representatives and Senate introduced the bipartisan Pharmacy DIR Reform to Reduce Senior Drug Costs Act, aimed at preventing drug benefit plans and pharmacy benefit managers (PBMs) from “clawing back” fees from pharmacies while raising price transparency. <Read More>

    NASP Applauds the Introduction of Bipartisan Legislation to Reduce Drug Costs and Support Medication Access for Seniors with Life-Threatening Specialized Conditions – May 27, 2021 – A bipartisan group of lawmakers in the U.S. House and Senate introduced legislation to rein in the high cost of prescription drugs and support the needs of specialty pharmacy patients living with life-altering and life-threatening specialty medical conditions. The Pharmacy DIR Reform to Reduce Senior Drug Costs Act will ensure that medication savings are passed along to seniors and that these savings are not otherwise used to manipulate drug costs under Medicare Part D or to disadvantage the specialty pharmacies serving patients who have such conditions as cancer, multiple sclerosis, hemophilia, or HIV. <Read More>

    Strategies for Boosting Biosimilar Uptake – May 27, 2021 – Use of biosimilars could increase if stakeholders, from manufacturers to payors and pharmacists, united to employ all the tools at their disposal, an expert told attendees of the 2021 virtual annual meeting of the Academy of Managed Care Pharmacy (AMCP). Hospitals and health systems that have taken part in comprehensive approaches to biosimilar utilization report enjoying full adoption of biosimilar use and saving millions of dollars every year, according to Catherine Pham, PharmD, MPH, a postdoctoral fellow in pharmacoeconomics and policy at Kaiser Permanente, in Los Angeles. <Read More>

    Specialty Pharmacists, Nurse Education Improve Pre-Infusion Vaccination Practices for Patients With MS – May 27, 2021 – Working together, specialty pharmacists and nurses at the University of Rochester Medical Center, in New York, improved pneumococcal vaccination practices among their patients with multiple sclerosis (MS) before starting infusion therapy, a new study shows. The CDC recommends that patients receiving disease-modifying therapy such as ocrelizumab (Ocrevus, Genentech) and rituximab first get pneumococcal vaccinations to ensure optimal immune response, said Kristin Reindel, PharmD, a PGY-2 specialty pharmacy administration and leadership resident at the medical center. However, specialty pharmacists and a clinical nurse educator with the hospital’s MS center became aware that some staff did not fully understand these recommendations. <Read More>

    Applying SP Expertise to Rare and Orphan Diseases – May 27, 2021 – Many stakeholders envision a world where genetic blindness, severe muscular dystrophy, cancer, sickle cell anemia, blood disorders and many other diseases are not simply treated but cured by gene therapies. Today, these novel drugs represent a paradigm shift in how payors and plan sponsors address the incidence and growing prevalence of some of these rare or orphan diseases among patient populations—and how they manage utilization and cover costs, which have led to sticker shock. <Read More>

    Bipartisan Bill Aims to Ensure Timely Access to Oral Oncology Drugs – May 27, 2021 – With the introduction of the Timely Access to Cancer Treatment (TACT) Act in Congress, Representatives Terri Sewell (D-AL) and Gus Bilirakis (R-FL) are aimed at removing red tape and accelerating patients’ access to necessary cancer treatments. According to a press release from Sewell’s office, the legislation would require that patients with cancer have access to oral oncology drugs within an acceptable time frame, defined as 72 hours of having the prescription submitted to the patient’s pharmacy benefits manager (PBM). “Doctors, not bureaucrats, best understand the needs of their patients and should be empowered with the tools needed to provide the best possible care—especially when time is of the essence,” Bilirakis said in a press release. <Read More>

    Pharmacy Coalition Praises Legislation to Relieve Patients and Pharmacies from Pharmacy DIR Fees – May 27, 2021 – With pharmacy access top-of-mind due to the pandemic and with drug-pricing concerns remaining a national policy priority, organizations representing pharmacies and pharmacists are lauding legislation to confront the serious issue of pharmacy direct and indirect remuneration (DIR) fees. The organizations stated: “DIR fees are exerting unnecessary and devastating pressures on patients, on pharmacies, and on communities – particularly the most vulnerable and the underserved. We welcome the introduction of the Pharmacy DIR Reform to Reduce Senior Drug Costs Act, and we urge its passage this year. <Read More>

    AGA Recommends Early Use of Biologics in Patients With Moderate-To-Severe Crohn’s Disease – May 27, 2021 – Crohn’s disease, a type of inflammatory bowel disease (IBD) that causes inflammation (pain and swelling) in the gastrointestinal tract, can cause daily health problems, frequent hospitalizations and surgery when not adequately controlled. While there is no cure for Crohn’s disease, there are treatments that can help patients live a symptom-free life. After a detailed review of available literature, the American Gastroenterological Association (AGA) has released new clinical guidelines outlining the benefits and risks of each drug currently available to Crohn’s patients. <Read More>

    After PD-1 Inhibitor Indications Are Withdrawn in SCLC, What Now? – May 26, 2021 – Martin J. Edelman, MD, chair of the Department of Hematology/Oncology and associate director for Translational Research at the Fox Chase Cancer Center in Philadelphia, Pennsylvania, discusses the nuances of rescinded indications in small-cell lung cancer. One of the big stories in oncology in 2021 has been the tale of “dangling approvals.” These are accelerated approvals that landed in limbo, after follow-up trials failed to confirm the results that caused FDA to allow these cancer drugs to reach the market for certain patients. FDA held 3 days of hearings in late April to weigh whether some therapies in this category should stay on the market.1,2 But in some cases, manufacturers voluntarily withdrew indications after talks with FDA. During the hearings, some manufacturers cited that fact that therapies were already incorporated in National Comprehensive Cancer Network (NCCN) Clinical Guidelines, and thus in use. <Read More>

    New Effort Standardizes BP Measurement Training at Health Care Schools – May 26, 2021 – The American Medical Association (AMA) announced a new effort aimed at ensuring future physicians and health care professionals in the U.S. are uniformly trained on how to consistently take accurate blood pressure (BP) measurements. “We know that inaccurate blood pressure measurements are linked to errors in diagnosing and treating high blood pressure, and may lead to more adverse outcomes, yet medical and health profession students are not currently receiving consistent training in BP measurement,” said AMA President Susan R. Bailey, M.D. “The AMA’s new series of online education modules addresses the current lack of a standardized curriculum on evidence-based blood pressure measurement techniques offered at health care schools nationwide, including medical, nursing, physician assistant, medical assistant, and pharmacy. We believe this step is critical given that the percentage of American adults who have their blood pressure under control is significantly declining.” <Read More>

    American Urological Association Announces Updates to Clinical Guidance for Renal Mass and Localized Renal Cancer – May 26, 2021 – The American Urological Association (AUA) announced amendments to its clinical guideline on Renal Masses and Localized Renal Cancer, originally published in 2013 and was updated in 2017, based on an additional literature search conducted through October 2020. A renal mass, or tumor, is an abnormal growth in the kidney. Some renal masses are benign (not cancerous) and some are malignant (cancerous). One in four renal masses are benign. Smaller masses are more likely to be benign. Larger masses are more likely to be cancerous. Kidney cancer — also called renal cancer — is a disease in which kidney cells become malignant (cancerous) and grow out of control, forming a tumor. Almost all kidney cancers first appear in the lining of tiny tubes (tubules) in the kidney. This type of kidney cancer is called renal cell carcinoma. <Read More>

    The ISSCR Releases Updated Guidelines for Stem Cell Research and Clinical Translation – May 26, 2021 – The International Society for Stem Cell Research (ISSCR)  released updated guidelines for stem cell research and its translation to medicine. The update reflects emerging advances including, stem cell-based embryo models, human embryo research, chimeras, organoids, and genome editing. “The 2021 update presents practical advice for oversight of research posing unique scientific and ethical issues for researchers and the public,” said Robin Lovell-Badge, PhD, FRS, Chair, ISSCR Guidelines task force and Senior Group Leader and Head of the Division of Stem Cell Biology and Developmental Genetics at The Francis Crick Institute, UK. “They provide confidence to researchers, clinicians, and the public alike that stem cell science can proceed responsibly, ethically, and remain responsive to public and patient interests,” he said. <Read More>
    A Rollercoaster Year for Home Infusion Rx – May 26, 2021 – Just over one year ago, like so many other businesses across the country, Upstate HomeCare went from normal operations to sequestered virtually overnight as the COVID-19 pandemic hit the United States. Senior Vice President and CEO Greg LoPresti sent approximately 40% of the staff of his Clinton, N.Y. home health care service agency, which serves the Albany, Syracuse, 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 care models. <Read More>

    Tip of the Week: Leveraging Comprehensive Medication Management to Build Revenue – May 26, 2021 – A single pharmacy manager can be opportunistic enough to incorporate new technologies and build relationships that can serve to impact revenue reimbursement schema. “Show me the money!” Well, we know that pharmacist reimbursement has historically been tied to prescription dispensing and medication order processing. However, things are changing, even if not as rapidly as we would like. Pharmacy personnel and leaders discuss various models, such as pharmaceutical care and medication therapy management, as avenues to reimbursement. While similar, each model has built upon its predecessors, and all have contributed to pharmacy revenue. Comprehensive medication management (CMM) also builds upon previous models, but has a stronger foundation in the value proposition, or the economic benefits from pharmacist participation, than other models and thus might move the needle a bit further. <Read More>

    Atrium Health Pharmacists Launch Anticoagulation Clinic for Cancer Patients – May 26, 2021 – A team of clinical pharmacists at Atrium Health, in North Carolina, have begun a specialized anticoagulation clinic to reduce the high risk for primary or recurrent venous thromboembolism (VTE) in patients with gastrointestinal, genitourinary and other types of cancer. In patients receiving outpatient chemotherapy, VTE is a leading cause of death. So far, the program’s introduction has been smooth and underscores the power of a collaborative approach to managing these high-risk patients, according to Kristyn DiSogra, PharmD, BCOP, a clinical pharmacist coordinator at Atrium Health Specialty Pharmacy Service. <Read More>

    What Pharmacists Should Know About Drug Diversion – May 26, 2021 – Ninety-two percent of hospital executives and providers surveyed by the BD Institute for Medication Management Excellence are optimistic that drug diversion can be controlled with adequate resources and attention. Yet it is no secret that drug diversion remains a multi-faceted, pervasive challenge that can endanger patients and clinicians, and even lead to financial penalties and reputational damage to health care systems. What will it take for hospitals to curb drug diversion, which has been referred to as a hidden epidemic within health care? During a recent roundtable discussion, industry leaders shared frontline insights on the biggest drug diversion challenges and the most promising opportunities for better detecting and mitigating risk. <Read More>

    Study Finds Physicians Support Pharmacy Dispensing to Expand Access to Medication Abortion – May 26, 2021 – In a new study published online in spring 2021 and in the July issue of the journal Contraception, University of Chicago Medicine investigators and colleagues interviewed primary care providers in Illinois about their interest in providing medication abortion care and found that lifting FDA restrictions on mifepristone to allow pharmacy dispensing could normalize medication abortion, facilitate its use in primary care facilities, and address disparities in reproductive health access. <Read More> 

    The Cost Equation for CSTDs – May 25, 2021 – Can a hospital make a sound economic evaluation when it comes to purchasing a closed system drug-transfer device (CSTD)? A group of Canadian researchers say no. They claim the literature addressing the economic impact of CSTDs is sparse, and the evidence in the handful of studies that do tackle the issue lacks robustness. But is there a potential for a comprehensive cost-effectiveness analysis of a disposable device that’s essential for preparing and administering hazardous drugs? Such data could be a major benefit to hospitals making the case to their C-suites for investing in the devices, which can cost hundreds of thousands of dollars per year for a high-volume cancer treatment center. <Read More>

    More Than 130 Healthcare Groups Express Support for Legislation Expanding Medicare Patients’ Access to Pharmacist Services – May 25, 2021 – More than 130 healthcare groups applauded the introduction of the Pharmacy and Medically Underserved Areas Enhancement Act (S. 1362, H.R. 2759), legislation that will ensure that Medicare beneficiaries in medically underserved areas have access to pharmacists’ primary care services. In a letter sent to the bill’s original sponsors—Sen. Chuck Grassley (R-IA), Sen. Bob Casey (D-PA), Sen. Sherrod Brown (D-OH), Rep. G.K. Butterfield (D-NC), and Rep. David McKinley (R-WV)—the healthcare groups, including rural health advocates, consumer groups, and pharmacy organizations, call for the removal of restrictions on seniors’ access to care. <Read More>

    Pharmacist Evaluation Improves Appropriate Antibiotic Prescriptions at Hospital Discharge – May 24, 2021 – Pharmacist review of patients’ antimicrobial prescriptions at the time of hospital discharge can significantly decrease inappropriate prescribing, a new study has found. In 2016, the Infectious Diseases Society of America published guidelines to stipulate recommendations for the implementation of antibiotic stewardship programs (ASPs) within health care settings (Clin Infect Dis 2016;62[10]:e51-e77). “Although many of the recommendations within the guidelines are directed towards the inpatient setting, studies have demonstrated a majority of antibiotic regimens are completed upon discharge,” said Amneh Fares, PharmD, a PGY-1 pharmacy resident at Memorial Regional Hospital, in Hollywood, Fla., who presented the results (poster A32) at the 2021 annual MAD-ID (Making a Difference in Infectious Disease) virtual meeting. <Read More>

    Miscarriages are Common Among Pharmacists – May 24, 2021 – Occupational exposure to certain medications and long hours standing may increase risk. According to national estimates, approximately 1 in 4 pregnancies end in miscarriage, which is defined as loss of the fetus prior to 20 weeks. Study results show that certain health care professionals, such as pharmacists, may be at increased occupational risk of miscarriage or stillbirth because of exposure to certain medications. Additionally, pharmacists typically work unusually long hours while standing and seldom have breaks, which can further increase the risk of miscarriage. <Read More>

    340B in the News

    340B Update: HRSA Issues Final Warning Letter to Pharmaceutical Manufacturers that Their Contract Pharmacy Actions Violate 340B Statute – May 26, 2021 – On 17 May 2021, the Acting Administrator of the Health Resources and Services Administration (HRSA), Diana Espinosa, sent letters to six pharmaceutical manufacturers stating that the manufacturers’ actions to limit access to 340B Program pricing for covered entities that dispense medications through contract pharmacies have resulted in overcharges and are in direct violation of the 340B statute. The letters order the manufacturers to immediately begin offering 340B pricing to covered entities through their contract pharmacy arrangements or be subject to civil monetary penalties. <Read More>   

    Eli Lilly Files Motion to Prevent Giving 340B Drug Discounts to Contract Pharmacies – May 25, 2021 – Eli Lilly has fired back at the Department of Health and Human Services, saying the agency has capitulated to political pressure from Congress to “come down on drug manufacturers” that disagreed with the government’s interpretation of the 340B law. Lilly has filed a motion for a preliminary injunction against a May 17 order from Health Resources and Service Administration Acting Administrator Diana Espinosa telling six drugmakers, including Eli Lilly, to immediately begin offering drugs at discounted prices under the 340B program. The drugmakers are under a June 1 deadline. If it is not met, they face civil monetary penalties. <Read More>