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Clinical Insights: December 1, 2021

Posted on December 1, 2021 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

Cytalux™ (pafolacianine) Injection – New Drug Approval – November 29, 2021 – The U.S. Food and Drug Administration approved Cytalux™ (pafolacianine), an imaging drug intended to assist surgeons in identifying ovarian cancer lesions. The drug is designed to improve the ability to locate additional ovarian cancerous tissue that is normally difficult to detect during surgery. Cytalux™ is indicated for use in adult patients with ovarian cancer to help identify cancerous lesions during surgery. The drug is a diagnostic agent that is administered in the form of an intravenous injection prior to surgery. <Read More>

Livtencity™ (maribavir) Tablets – New Drug Approval – November 23, 2021 – The U.S. Food and Drug Administration approved Livtencity™ (maribavir) as the first drug for treating adults and pediatric patients (12 years of age and older and weighing at least 35 kilograms) with post-transplant cytomegalovirus (CMV) infection/disease that does not respond (with or without genetic mutations that cause resistance) to available antiviral treatment for CMV. Livtencity™ works by preventing the activity of human cytomegalovirus enzyme pUL97, thus blocking virus replication. <Read More>

Fyarro™ (sirolimus protein-bound) Lyophilized Powder for Injectable Suspension – New Drug Approval – November 22, 2021 – Aadi Bioscience, Inc., a biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, announced that the U.S. Food and Drug Administration (FDA) has approved Fyarro™ (sirolimus protein-bound particles for injectable suspension) (albumin-bound) for intravenous use for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). Fyarro™ is the first and only FDA-approved treatment for advanced malignant PEComa in adults. <Read More>

New Indication/Dosage/Formulation Approval

Keytruda® (pembrolizumab) – New Expanded Indication – November 18, 2021 – Merck announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda®, Merck’s anti-PD-1 therapy, for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. The approval is based on data from the pivotal Phase 3 KEYNOTE-564 trial, in which Keytruda® demonstrated a statistically significant improvement in disease-free survival (DFS), reducing the risk of disease recurrence or death by 32% (HR=0.68 [95% CI, 0.53-0.87]; p=0.0010) compared to placebo. Median DFS has not been reached for either group. <Read More>

New/Updated Drug Shortage

November 30, 2021

November 29, 2021

November 23, 2021

November 22, 2021

New Drug Recall and Safety Alerts

Levetiracetam Injection, USP by Sagent Pharmaceuticals, Inc. – New Voluntary Drug Recall – November 22, 2021 – Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of four lots of Levetiracetam Injection, USP, to the user level. The lack of container closure integrity, found in reserve sample vials may result in a non-sterile product…Levetiracetam Injection, USP 500 mg per 5 mL, is used in the treatment of certain types of seizures and is packaged in a 5mL single-does vial. The Levetiracetam Injection, USP, label and affected lot numbers with Expiration Dates and NDC number can be found in the table below.  Product was distributed Nationwide from March to November  2021. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

Pharmacists See Opportunities in TikTok to Educate, Advocate – November 29, 2021 – As the app TikTok has exploded over the past 2 years, influencers have identified new ways to gain followers and expand their influence using the app’s short-video format. Among these influencers are a growing number of pharmacists and pharmacy students who are educating young viewers and advocating for the profession. Monthly users of the app have grown nearly 800% since January 2018, according to data released in August 2020 and reported by CNBC.  Over 100 million Americans are considered active monthly users, and over 50 million are daily users. The pandemic played a major role in this growth, with users in the United States skyrocketing from almost 39.9 million in October 2019 to almost 92 million in June 2020. <Read More>

How to Support Patients and Ensure Adherence to Specialty Therapies – November 29, 2021 – Specialty medications have become the fastest growing, largest segment of the total pharmacy market with innovative treatment options for cancer and a variety of chronic diseases. In fact, it’s estimated that 65% of newly launched medicines within the next 4 years will be specialty medications. With a promising pipeline of specialty therapies and more patients using them, we must look for ways to improve the journey patients navigate to access, afford, and adhere to these complex medications. Although specialty therapies have the potential to help people live healthier lives, their cost and complexity can create distinct challenges. <Read More>

How to Use Data to Transform Pharmacy Practice – November 29, 2021 – Tips to help community-based pharmacists use the data at their fingertips to better market and provide the enhanced pharmacy services that drive practice transformation. Community pharmacies are filled with meaningful data nearly every day. Data can be organized to tell stories when partnering with physicians, other health care professionals, and payers to expand community-based patient care. The COVID-19 pandemic is an example of how useful pharmacy data can be in identifying, sharing, and responding to the testing and vaccination needs of local communities and large populations. <Read More>

Biosimilar Industry Critiques Biden’s Drug Pricing Reforms – November 29, 2021 – Specialty tiers for biosimilars and reforms that address the proliferation of poor-quality patents would help lower costs and improve access, biosimilar industry veterans said. Price negotiations for biologics and forcing drug manufacturers to rebate CMS for drug costs that exceed rates of general inflation are options the federal government is considering to control drug spending. But these policies “are in lieu of addressing the root cause” of drug cost increases, and programs that disallow rebates paid by manufacturers to pharmacy benefit managers (PBMs) and payer plans would be more effective, argued a biosimilars manufacturer representative at the recent GRx+Biosims conference sponsored by the Association for Accessible Medicines. <Read More>

Study Finds Inconsistencies With GOLD Guidelines Regarding Diagnosis, Treatment of COPD – November 28, 2021 – The prevalence of chronic obstructive pulmonary disease (COPD) underdiagnosis, false diagnosis, and treatment in the primary care setting is high and often inconsistent with Global Initiative for the Chronic Obstructive Lung Disease (GOLD) guidelines. A study found that more than half of patients with chronic obstructive pulmonary disease (COPD) were underdiagnosed, more than half of patients with COPD who were correctly diagnosed were overtreated, and most patients with COPD taking inhaled drugs were falsely diagnosed when examined against Global Initiative for the Chronic Obstructive Lung Disease (GOLD) guidelines. <Read More>

Consider a Career Move to Remote Medication Therapy Management – November 26, 2021 – COVID-19 drastically changed the pharmacy work environment, including an expansion of telehealth services that has opened new opportunities for pharmacists to work remotely. There was a 154% increase in telehealth visits during the last week of March 2020 during the COVID-19 pandemic compared with the same period a year earlier, according to a CDC report. Telehealth is an effective way for pharmacists to provide services while enhancing patient care, evidence shows. One study evaluated the effect of a pharmacist telephone intervention on nonadherent patients with diabetes and hypertension who were enrolled in a Medicare Advantage plan. The study results showed that the pharmacist telephone intervention resulted in significantly better medication refill adherence, which was measured by proportion of days covered during the 6 months following the phone consult. <Read More>

COPD Awareness Month: Pharmacists’ Role in Helping Patients Breathe Better – November 26, 2021 – Pharmacists have the potential to make a positive impact by screening patients, providing counseling, encouraging beneficial interventions, and helping tailor patient regimens based on personalized needs. Over 16 million Americans suffer from chronic obstructive pulmonary disease (COPD) and it is the fourth leading cause of death in the United States. Psychiatric conditions, activity limitations, and complications from infection are all significant obstacles within this patient population. Millions of emergency department visits and thousands of hospitalizations are related to COPD, which substantially increases economic burden. <Read More>

National Diabetes Month: How Pharmacists Can Serve Impactful Roles in the Lives of Patients with Early-Onset T2DM – November 24, 2021 – November is nationally recognized as Diabetes Awareness Month. The primary goal for 2021 is for patients to become aware of their diabetes status and complete smaller healthy lifestyle changes to make a big difference in diabetes prevention and management. In the United States (US), there are more than 122 million people who have prediabetes or diabetes mellitus. Between 1999 to 2019 diabetes mellitus was the seventh leading cause of death. In 2018, the Centers for Disease Control and Prevention (CDC) estimated that 70% of those diagnosed with type 2 diabetes mellitus (T2DM) were 45 years of age or older. However, increased T2DM diagnoses are emerging among youth and young adult populations in the US with an estimate of around 5000 new cases each year, which warrants an increased need for awareness of early-onset T2DM. <Read More>

Should we Blame Pharmacies or the Government for Opioid-Related Deaths? – November 24, 2021 – A federal jury in Cleveland yesterday concluded that three major pharmacy chains had contributed to a “public nuisance” in two Ohio counties caused by an oversupply of prescription opioids. The verdict, which represents the first time that retailers have been held legally liable for the “opioid crisis,” followed two recent rulings in which a California judge and the Oklahoma Supreme Court rejected similar claims against drug manufacturers. <Read More>

Pharmacies Testing New Strategies to get Kids on Board With COVID-19 Shots – November 24, 2021 – About 3.1 million children ages 5-11 have received a dose of a COVID-19 vaccine as of Nov. 22, but many of them receive their shots with tears in their eyes, according to The Wall Street Journal. Pharmacists from around the country shared tips with the Journal on how to make young children more comfortable getting shots. Here are five tips they offered: 1) Don’t let young children see the needle, 2) Make the inoculation as quick as safely possible… <Read More>

Pharmacists Can Help Meet the Need for Increased Behavioral Health Medication Management – November 24, 2021 – Reports of depression, anxiety and stress have surged since the beginning of the COVID-19 pandemic in 2020. In a Kaiser Family Foundation (KFF) poll in February 2021, 4 out of 10 Americans reported that they were experiencing symptoms of anxiety disorder or depressive order, compared with 1 out of 10 in January 2019.1 The spike in adverse mental health symptoms has led to increased use of behavioral health medications. This, in turn, has resulted in more patient questions and concerns and an expanded need for monitoring to ensure that these medications do not interact poorly with other medications. <Read More>

Nevada Board Stuns Nonresident Pharmacists With New Requirements – November 24, 2021 – It is common for a board of pharmacy to require a nonresident pharmacy to be licensed in its state before allowing that pharmacy to deliver, mail, or ship a prescription drug to any of its residents. It also is becoming increasingly common for a board to require a pharmacist-in-charge to be designated and registered for a nonresident pharmacy to engage in such activity in that state. This process is understood by pharmacy practitioners engaged in cross-state dispensing and general pharmacy practice activity. Recent actions by the Nevada Board of Pharmacy, however, are not common and are causing confusion and dismay. After reviewing Nevada state law NRS 639.100(1)(a), the board has started issuing notices to nonresident pharmacies engaged in the pharmacy practice of compounding or dispensing prescription drugs for any controlled substance or “dangerous drug” for a Nevada patient. <Read More>

Stay Nimble in Rapidly Changing Market – November 24, 2021 – Managed care market dynamics are changing quickly, so pharmacy leaders need to be nimble and work with their managed care teams to maintain a competitive strategy, speakers said at the 2021 ASHP Conference for Pharmacy Leaders, held virtually. Mega-mergers have affected the market, with payors such as UnitedHealth Group joining forces with or acquiring pharmacy benefit managers and pharmacies. <Read More>

Walmart, Major Pharmacy Chains Fueled Opioid Crisis, Jury Finds – November 24, 2021 – A Cleveland jury concluded Walmart Inc., CVS Health Corp. and Walgreens Boots Alliance Inc. helped create a public-health crisis by failing to properly monitor opioid prescriptions, the drug industry’s latest loss in the expanding litigation over the painkillers. The federal-court panel backed claims by northeast Ohio’s Trumbull and Lake Counties that the pharmacy chains failed to create legally mandated monitoring systems to detect illegitimate opioid prescriptions. <Read More>

Updates on Possible Mitigation Strategies to Reduce the Risk of Nitrosamine Drug Substance-Related Impurities in Drug Products – November 18, 2021 – FDA issued a guidance for industry, Control of Nitrosamine Impurities in Human Drugs, in September 2020 to help ensure the safety of the U.S. drug supply by recommending steps manufacturers of active pharmaceutical ingredients (API) and drug products should take to detect and prevent objectionable levels of nitrosamine impurities in pharmaceutical products. The guidance also described conditions that may introduce nitrosamine impurities and described a three-step mitigation strategy. <Read More>

340B in the News

Supreme Court to Hear 340B Drug Discount Arguments – November 30, 2021 – The Supreme Court is scheduled to hear arguments in the case involving 340B payments for hospitals’ outpatient drugs. The American Hospital Association and several other organizations and health systems originally brought the case in 2018, after the Trump Administration issued a final payment rule that decreased the amount of reimbursement hospitals received from the 340B drug payment program by about 30%. The decision was upheld by the U.S. Court of Appeals in August 2020, prompting the AHA to request the Supreme Court to hear the case. In July, the Supreme Court agreed. <Read More>

Chevron Deference at Stake in Fight Over Payments for Hospital Drugs – November 29, 2021 – How much should we pay for drugs? That’s the question at the center of American Hospital Association v. Becerra, a sleeper of a case involving billions of dollars in federal spending and a chance to reshape two doctrines at the heart of administrative law. Drugs, money, and the law: Sounds sexy, right? Still, you could be forgiven for never having heard of the case, which will be argued on Tuesday. It arises out of a technical dispute over how Medicare, the federal program that insures 63 million elderly and disabled people, pays for some of the drugs that hospitals dispense to patients in outpatient departments — in particular, chemotherapy drugs and other expensive anti-cancer medications. <Read More>

Four Hospitals That Take Federal Money to Help Low-Income Patients do Less to Help Than Those That Don’t – November 26, 2021 – A new issue brief published by Pacific Research Institute finds four Michigan hospitals that take federal dollars from a government program to help low-income patients with drug costs assisted fewer at-risk people than hospitals who don’t use the program. The study also found the participating hospitals are more profitable than non-participating hospitals. <Read More>

Lilly (LLY) Up 4.7% Since Last Earnings Report: Can it Continue? – November 25, 2021 – A month has gone by since the last earnings report for Eli Lilly (LLY). Shares have added about 4.7% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Lilly due for a pullback? Before we dive into how investors and analysts have reacted as of late, let’s take a quick look at the most recent earnings report in order to get a better handle on the important catalysts… Among the growth products, Trulicity generated revenues worth $1.60 billion, up 45% year over year driven by higher demand and higher realized prices in the United States. The higher realized prices were due to a favorable segment mix, including lower utilization in the 340B program and modest list price increases, which were partially offset by increased rebates to maintain access. Ex-U.S. sales rose driven by increased volume, which offset the impact of lower realized prices. <Read More>

Community Access National Network Releases Sixth & Final Policy Report on 340B Drug Pricing Program – November 23, 2021 – The 340B Drug Pricing Program has no doubt added benefit for patients and providers, alike. The measure of this benefit, however, is shrouded by uncertainty over the lack of transparency and accountability, decline in hospital charity care, as well as the explosive middleman growth in contract pharmacies and pharmacy benefit managers. Twenty-nine years after the program’s inception, it is now unclear to both regulators and patients, both qualitatively and quantitatively, if the Congressional intent is being met. <Read More>