Clinical Insights: July 20, 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

    Rezurock™ (belumosudil) Tablets – New Drug Approval – July 16, 2021 – The Food and Drug Administration approved belumosudil (Rezurock™, Kadmon Pharmaceuticals, LLC), a kinase inhibitor, for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy. Efficacy was evaluated in KD025-213 (NCT03640481), a randomized, open-label, multicenter dose-ranging trial that included 65 patients with chronic GVHD who were treated with belumosudil 200 mg taken orally once daily. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Prograf™ (tacrolimus) – New Approved Indication – July 16, 2021 – The U.S. Food and Drug Administration approved a new use for Prograf™ (tacrolimus) based on a non-interventional (observational) study providing real-world evidence (RWE) of effectiveness. FDA approved Prograf for use in combination with other immunosuppressant drugs to prevent organ rejection in adult and pediatric patients receiving lung transplantation. Prograf™, originally approved to prevent organ rejection in patients receiving liver transplants, was later approved to prevent organ rejection for kidney and heart transplants as well. The drug has also been routinely used in clinical practice for patients receiving lung transplants. This action marks the first approval of an immunosuppressant drug to prevent rejection in adults and pediatric patients who receive lung transplants. Prograf™ is the only approved immunosuppressant drug product for this population. <Read More>

    Darzalex Faspro® (daratumumab and hyaluronidase-fihj) – New Approved Indication – July 12, 2021 –  The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) approval of Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. The approval follows the regulatory submission to the FDA in November 2020 and marks the sixth indication for Darzalex Faspro® in the treatment of multiple myeloma. Findings from the Phase 3 APOLLO study were presented at the 2020 American Society of Hematology (ASH) Annual Meeting and were recently published in The Lancet Oncology. <Read More>

    Padcev® (enfortumab vedotin-ejfv) Lyophilized Powder for Injection – New Approved Indication – July 9, 2021 – Astellas Pharma Inc. and Seagen Inc. announced the U.S. Food and Drug Administration (FDA) granted Padcev® (enfortumab vedotin-ejfv) regular approval in the U.S., in addition to approving a new indication for adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. Cisplatin-ineligible patients typically have limited treatment options and a poor prognosis. <Read More>   

    New/Updated Drug Shortage

    July 16, 2021

    July 15, 2021

    July 14, 2021

    July 12, 2021

    New Drug Recall and Safety Alerts

    Neutrogena® and Aveeno® Aerosol Sunscreen Products by Johnson & Johnson Consumer Inc. – New Voluntary Recall – July 14, 2021 – Johnson & Johnson Consumer Inc. (JJCI) is voluntarily recalling all lots of five Neutrogena® and Aveeno® aerosol sunscreen product lines to the consumer level. Internal testing identified low levels of benzene in some samples of the products. Consumers should stop using the affected products and follow the instructions set forth below. <Read More>

    All Sterile Compounded Drug Products by Innoveix Pharmaceuticals, Inc. – New Voluntary Recall – July 12, 2021 – Innoveix Pharmaceuticals, Inc. is voluntarily recalling the following lots of sterile compounded drug products, within expiry.  The products are being recalled due to a lack of assurance of sterility. These concerns arose following a routine inspection of the pharmacy by FDA. Administration of a drug product intended to be sterile, that is not sterile, could result in serious infections which may be life-threatening. To date, Innoveix Pharmaceuticals, Inc. has not received any reports of adverse events related to this recall.  This voluntary recall is being conducted out of an abundance of caution and to promote patient safety, which is the pharmacy’s highest priority. <Read More>

    New Generic/Biosimilar Approval and Launch

    Feraheme® (ferumoxytol injection) – New Approved Generic Launch – July 16, 2021 – Sandoz, a global leader in generic and biosimilar medicines, announced the immediate US availability of generic Ferumoxytol, an intravenous medicine used to treat iron deficiency anemia (IDA). Ferumoxytol, a generic equivalent to AMAG Pharmaceuticals’ Feraheme® (ferumoxytol injection), is approved to treat IDA in adult patients who have an intolerance to oral iron or have had an unsatisfactory response to oral iron, or who have chronic kidney disease. The overall global IV iron market is over a one billion dollar market and continues to grow. <Read More>

    Clinical and Pharmacy News

    When Arbitrary Policies Collide With Patient Care – July 19, 2021 – The news came through when Aaron Newcomb, DO, was on vacation. A few patients called the office to say that the local pharmacy refused to fill their prescriptions for pain, anxiety and opioid-use disorder (OUD). One was a long-term female patient covered by Medicare who Dr. Newcomb had been treating for a few years for chronic pain and anxiety. She was stable, the medications hadn’t changed, but the large national chain “all of a sudden” told her that her physician had been blacklisted and refused to fill her medicine. Later that day, Dr. Newcomb received a letter from the chain stating it would not fill any of his controlled-substance prescriptions. Dr. Newcomb cares for thousands of patients at a small federally qualified health center in downstate Illinois. As a board-certified physician in family medicine and addiction medicine, he is one of only a few doctors in his area who treats patients with chronic pain and substance-use disorders. His practice is set up not far from where he did his residency at Southern Illinois University. <Read More>

    Reforming Pharmacy Direct and Indirect Remuneration in the Medicare Part D Program – July 19, 2021 – Recently, the National Community Pharmacists Association (NCPA) filed a lawsuit against the US Department of Health and Human Services (HHS), claiming that the pharmacy direct and indirect remuneration (DIR) fees in the Medicare Part D program are driving small, independently owned pharmacies out of business. In the lawsuit, the NCPA takes issue with HHS’s current definition of “negotiated prices” and its permission for pharmacy reimbursement to be adjusted months after a patient has paid cost sharing for drugs based on the list price (without taking into account the reimbursement adjustment after the point of sale). <Read More>   

    After PD-1 Inhibitor Indications are Withdrawn in SCLC, What Now? – July 18, 2021 – ”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 prompted the FDA to allow these cancer drugs to reach the market for certain patients. The FDA held 3 days of hearings in late April to weigh whether some therapies in this category should stay on the market. However, in some cases, manufacturers voluntarily withdrew indications after talks with the agency. During the hearings, some manufacturers cited the fact that their therapies were already incorporated into the National Comprehensive Cancer Network (NCCN) clinical guidelines, and thus in use. Two such cases involved the PD-1 inhibitors nivolumab (Opdivo™), from Bristol Myers Squibb, and pembrolizumab (Keytruda™), from Merck. <Read More>

    Health System Specialty Pharmacies Provide Rapid Access to Medications – July 16, 2021 – Integrated specialty pharmacies working in health-system clinics can help speed the time it takes for patients to gain access to needed medications, pharmacists with Mass General Brigham, in Boston, have shown. In a retrospective chart review of 121 patients being prescribed specialty medications from an ambulatory autoimmune/allergy practice, the median time to dispense from prescription receipt was four days for the health-system specialty pharmacy and 13 days (P<0.001) for an outside specialty pharmacy. <Read More>

    Hospitals Blast Unitedhealth Profits – July 16, 2021 – UnitedHealth Group’s most recent earnings stem from “not paying for healthcare,” American Hospital Association president and CEO Rick Pollack wrote in a July 15 blog post. In the second quarter of 2021, UnitedHealth posted $4.3 billion in profit, down nearly 36 percent from $6.6 billion a year prior. Mr. Pollack argued these profits were earned from deferred care during the pandemic, as well as new policies from the health insurer, including coverage restrictions around specialty pharmacy, hospital outpatient surgeries and hospital-based lab and radiology services. <Read More>

    Strategies for Improving Adherence With Oral Oncolytics – July 16, 2021 – The use of oral oncolytics has become a common in cancer care with more than 115 FDA-approved therapies for managing malignancy. Adherence to these medications, however, can be challenging for patients. In a session of the virtual American Society of Health-System Pharmacists Specialty Pharmacy Conference, presenter Eve Segal, PharmD, BCOP, lead clinical pharmacist, University of Washington Medical Center/Seattle Cancer Care Alliance, discussed advantages to oral oncolytics, as well as a need for pharmacists to understand barriers to adherence faced by patients who are prescribed these medications. Segal also offered strategies for improving adherence for patients taking these medications. <Read More>

    WHO Publishes New Consolidated HIV Guidelines for Prevention, Treatment, Service Delivery & Monitoring – July 16, 2021 – WHO launched updated Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach. This publication brings together important clinical and programmatic updates produced by WHO since 2016 and provides comprehensive, evidence-informed recommendations and good practice statements within a public health, rights-based and person-centred approach. These guidelines bring in the most recent guidance on HIV testing strategies – the entry point for HIV prevention and treatment – and include comprehensive guidance on infant diagnosis. Key recommendations are presented on rapid antiretroviral therapy (ART) initiation and the use of dolutegravir. Updated recommendations are included on the timing of ART for people with TB, and the use of point-of-care technologies for treatment monitoring. <Read More>

    Build Connections to Children With Asthma – July 16, 2021 – In 2015, the CDC found that pediatric asthma’s overall prevalence in the United States was 8.4% and was approximately 10% among school-aged children and adolescents aged 6 to 19 years. Asthma often causes them to miss school or extracurricular activities and creates a burden for parents who must miss work when their children are having breathing difficulties. Over the long term, 75% of children with asthma may accumulate abnormal lung growth patterns and irreversible airflow obstruction that follow them into adulthood. That impaired lung function can also alter their response to treatment. For approximately 60% of children with asthma, medication, primarily in the form of inhalers, can control the condition. For the rest, stepped-up care is needed. Pharmacists can find teachable moments to help children help themselves. <Read More>   

    Understand the Basic Characteristics of Hemophilia A and B – July 16, 2021 – A multidisciplinary team of health care professionals, including pharmacists, can work together to treat patients with the bleeding disorder. Hemophilia is an inherited bleeding disorder in which the blood lacks clotting factors, which work with platelets to stop bleeding at the site of an injury. As a result, bleeding may last longer, and individuals with hemophilia are also more susceptible to internal bleeding. There are 2 major types of hemophilia. <Read More>

    Legal Tools to Protect Specialty Pharmacies – July 16, 2021 – In today’s complicated pharmacy benefits landscape, with increasing dominance by a collection of vertically integrated payor and pharmacy benefit manager (PBM) networks, hospital and health-system specialty pharmacies have some legal tools that they can use to address challenges, such as network access, mandatory white-bagging policies and payor activities in the 340B space. That was the message from Jesse Mr. Dresser, Esq, an attorney with the health care law firm Frier Levitt LLC, in a session on legal conundrums in specialty pharmacy held during the 2021 ASHP Specialty Pharmacy Conference, held virtually. <Read More>

    Integrated Health-System Specialty Pharmacy Care Model Associated With Lower Oncology Medical Expenses – July 16, 2021 – Research presented at the 2021 American Society of Health-System Pharmacists (ASHP) Specialty Pharmacy Conference suggests overall medical expenses for oncology patients were significantly improved by using an integrated health-system specialty pharmacy (HSSP) care model. This model was associated with a $911 mean per member per month (PMPM, P<.05) decrease in total medical expense. According to the investigators, this is due to reduced hospital outpatient visits, free standing physician office visits, and emergency department (ED) visits. <Read More>   

    ACG Issues New Guidelines on C. difficile Management – July 16, 2021 – The American College of Gastroenterology issued new guidelines on the management of Clostridioides difficile infection (CDI), with recommendations reflecting developments from the availability of biologics to the growing use of fecal microbiota transplantation (FMT) (AM J Gastroenterol 2021;116[6]:1124-1147). “These guidelines are a step forward in our understanding of C. difficile,” commented Sahil Khanna, MBBS, MS, a professor of medicine at Mayo Clinic in Rochester, Minn., who was not involved in the guideline development. <Read More>

    WHO Releases First Guidelines on Hepatitis C Virus Self-Testing – July 15, 2021 – New guidelines from WHO strongly recommend offering self-testing for hepatitis C virus (HCV) as an additional approach to HCV testing services. WHO releases the new guidelines – its first on HCV self-testing – during the International AIDS Society Conference 2021. WHO set a goal to eliminate HCV as a public health problem by 2030 in its Global health sector strategy on viral hepatitis (2016–2021), with targets to diagnose 90% of those with HCV and to treat 80% of those diagnosed. However, as of 2019 only an estimated 21% of the 58 million people with chronic HCV infection globally were diagnosed. And, despite recent advances in highly effective and affordable direct-acting antiviral (DAA) treatment, only 9.4 million (62% of those diagnosed) were treated with DAAs between 2015 and 2019. In many settings people from key populations, particularly men who have sex with men and people who inject drugs, have high rates of HCV infection but do not benefit from testing and treatment. WHO’s guidance on HCV self-testing is meant to support the efforts of national programmes to reach people who may not otherwise test. <Read More>

    Could There Be a Cure for Peanut Allergies in Children? – July 15, 2021 – If your young child has a life-threatening peanut allergy, ongoing research suggests that they may be able to grow up and do the unthinkable: Eat and enjoy a peanut butter and jelly sandwich. A treatment program designed for peanut-allergic preschoolers and babies has proven effective at helping children overcome their food allergy, says allergist Sandra Hong, MD. It is a life-changing – and perhaps life-saving – outcome. <Read More>

    Emergency Department-Administered, High-Dose Buprenorphine May Enhance Opioid Use Disorder Treatment Outcomes – July 15, 2021 – High-dose buprenorphine therapy, provided under emergency department care, is safe and well tolerated in people with opioid use disorder experiencing opioid withdrawal symptoms, according to a study supported by the National Institutes of Health’s National Institute on Drug Abuse (NIDA) through the Helping to End Addiction Long-term Initiative, or the NIH HEAL Initiative. Lower doses of buprenorphine, a medication approved by the U.S. Food and Drug Administration to treat opioid use disorder, are the current standard of care. However, elevated doses of the medication may provide a critical extended period of withdrawal relief to people after being discharged from the emergency department that may help them navigate barriers to obtaining medications as well as accessing care for the treatment of opioid use disorder. <Read More>

    Health System Pharmacy Services Are Positioned to Drive Access, Care for Patients Seeking HIV Post-Exposure Prophylaxis – July 15, 2021 – The implementation of a priority alert system can enable integrated health system specialty pharmacies to provide access to HIV post-exposure prophylaxis (PEP) to those who need it, including sexual assault victims and others, according to a poster presented at the virtual American Society of Health-System Pharmacists Specialty Pharmacy Conference. Many sexual assault survivors and patients exposed to blood borne pathogens present to emergency departments to seek care and prevention of HIV infection, according to researchers at Trellis Rx. Because of their existing infrastructure and integrated services, health system specialty pharmacies are uniquely able to handle the complex and urgent needs of these patients. <Read More>

    Study Finds Flu Shots Protect Against Some Severe COVID-19 Symptoms – July 15, 2021 – The flu vaccine may provide some protection against severe symptoms of COVID-19, with a new study finding lower intensive care unit (ICU) admissions, sepsis, and stroke rates. An analysis of patient data presented at the European Congress of Clinical Microbiology & Infectious Diseases found that the annual flu shot reduces the risk of stroke, sepsis, and deep vein thrombosis (DVT) in patients with COVID-19. Individuals with COVID-19 who had been vaccinated against the flu were also less likely to visit emergency departments (ED) and to be admitted to the ICU. <Read More>

    Migraine-Specific Biologics Treat Severe Headaches – July 15, 2021 – Migraines are very common, with about 15.3% of Americans 18 years or older reporting a severe headache in the previous 3 months; that figure has remained stable for several decades. Migraines are recurrent headaches of moderate to severe intensity that tend to interfere with daily life functions. Symptoms include gastrointestinal problems, nausea, sensitivity to light, and vomiting. Migraines are caused by the activation of trigeminal sensory nerves leading to a release of neuropeptides, such as calcitonin gene-related peptide (CGRP), neurokinin A, pituitary adenylate cyclase-activating polypeptide, and substance P. In recent years, biologics have been introduced to the market that are approved for migraine prophylaxis by targeting CGRP. The approved agents (eptinezumab, erenumab, fremanezumab, and galcanezumab) work by binding directly to the CGRP ligand or receptor. <Read More>

    Implementing Ambulatory Workload Metrics into Workspace Brings Benefits to Pharmacists, Technicians – July 15, 2021 – Developing an ambulatory workload tool for pharmacists and pharmacy technicians will show an increased percentage of ambulatory pharmacist time captured, according to a poster presentation at the American Society of Health-System Pharmacists (ASHP) Specialty Pharmacy Conference. The objective of the study was to design and implement a useful tool to record ambulatory metrics that is reportable and can be easily integrated into the clinical workflow. <Read More>

    Survey: One-Third of Consumers Would Ignore Laws Against Buying From Online Pharmacies – July 15, 2021 – According to a new survey from the Alliance for Safe Online Pharmacies (ASOP) Global Foundation, almost half of Americans gamble with their lives to buy medication from online sources—even though the overwhelming majority of them operate illegally. That’s just one of the alarming findings from the organization’s 2021 survey of American perceptions and use of online pharmacies, which was commissioned from Abacus Data. There are approximately 35,000 online pharmacies across the world, and 95% of them are rogue and unregulated. The products they sell are often counterfeit, tainted, or substandard and can harm patients or even kill them. Further, the survey revealed that consumers can’t distinguish safe, legal sites from sites operating in violation of U.S. law. <Read More>

    Communicating With Care and Compassion: A Key to Unlocking Health Care Disparity – July 15, 2021 – Diversity, equity, inclusion, and belonging are important elements that can affect the work of health care providers in a dramatic way, according to a session at the American Society of Health-System Pharmacists (ASHP) Specialty Pharmacy Conference. Michael Wolcott, PharmD, PhD, BCIDPS, BCPS, director of Educational Resources and Scholarship at University of North Carolina (UNC) School of Dentistry/UNC School of Pharmacy/Duke University Hospital, defined diversity, equity, inclusion, and belonging and how our attitudes and behaviors toward people or associated stereotypes without any awareness can cause negative implicit bias. <Read More>

    ACI Panelists Discuss Misaligned Incentives in the Biosimilars Market – July 15, 2021 – Health care consumers are routinely blitzed with advertisements by drug companies, so how are they to find out about biosimilars? And further, providers and payers aren’t necessarily going to agree on what drugs should be prescribed to patients. Should they be lowest-cost or should the manufacturer with the most reliable supply chain be granted preference on formulary? A panel of industry experts moderated by an economist addressed these issues in a recent talk at the American Conference Institute’s 2021 Summit on Biosimilars and Innovator Biologics. “The thing that sometimes is indicative of our market is that with so many different stakeholders, incentives are not always aligned,” said Ali Ahmed, senior vice president of biosimilars at Fresenius Kabi. <Read More>

    Adoption of Biosimilars in Health Systems Faces Challenges and a Promising Future – July 15, 2021 – The use of biosimilar medications is projected to increase over the next few years. In a session at the virtual Association of Health-System Pharmacists Specialty Conference, presenters provided an overview of biosimilar therapies, discussed a robust pipeline of biosimilar products, and offered strategies for the adoption of biosimilars in health systems. 67Biosimilar agents are highly similar to biological reference products that have been approved by the FDA, but demonstrate no clinically meaningful safety, purity, and potency differences, according to presenter Shubha Bhat, PharmD, MS, BCACP, clinical pharmacist, gastroenterology at Cleveland Clinic in Ohio. To date, Bhat said, the FDA has approved a total of 29 biosimilars for 9 reference products, with 68% of these therapies currently available on the market. Additionally, the pipeline for biosimilar products in the United States includes at least 26 candidates in phase 3 trials for 13 reference therapies. <Read More>

    Revised Opportunistic Infections Guidelines Include Updates on Several Diseases and Immunizations – July 14, 2021 – The U.S. Department of Health and Human Services (HHS) recently published two updates to its Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV (OI Guidelines) which include new information about the management of four infectious diseases – cytomegalovirus (CMV), cryptococcosis, coccidioidomycosis, and bartonellosis – in people with HIV. These updates incorporate the latest available information about the diagnosis and treatment of these infections in particular patient populations, as well as toxicities of certain antiviral medications used to treat CMV. The latest version of the guidelines also includes updates to HHS recommendations concerning immunizations for preventable diseases in adults and adolescents with HIV. <Read More>   

    Addressing the Unmet Needs of Helicobacter pylori Treatment Through Alternative Treatment Options and Antimicrobial Stewardship – July 14, 2021 – Gastric cancer is the third most common cause of cancer death worldwide and is associated with Helicobacter pylori, which is classified as a human carcinogen by the International Agency for Research on Cancer. Chronic infection with H pylori has been demonstrated to cause noncardia gastric carcinoma and low-grade B-cell gastric mucosa-associated lymphoid tissue (MALT) lymphoma. Over 850,000 deaths were attributed to gastric cancer in 2017. This rate is expected to increase because of increasing life expectancy in developing countries and increased risk in younger generations. Globally, up to 89% of noncardia gastric cancers are attributable to H pylori, which is a total of around 780,000 cases and 6.2% of all cancers worldwide. <Read More>   

    What’s New In Accreditation For Specialty – July 14, 2021 – Executives from two leading specialty pharmacy accreditation organizations shared the latest information on new and reorganized standards and credentials, along with advice for specialty pharmacies on managing the accreditation process, during the ASHP 2021 virtual Specialty Pharmacy Conference. In 2019, ASHP began revising its Telehealth Pharmacy Practice (TPP) standard, which has become relevant to many pharmacies over the past year. The new edition will be published “very soon,” said Lynnae Mahaney, BSPharm, MBA, ASHP’s senior director of pharmacy accreditation. <Read More>

    Equal but Not the Same—2021 Update on Influenza Vaccines – July 14, 2021 – As COVID-19 vaccination efforts continue, it is more important than ever for pharmacists to be equipped with the knowledge and resources to bust the myths surrounding vaccinations, particularly in preparation for the upcoming influenza season, which is expected to occur from October 2021 to May 2022. Infection can be caused by both A and B strains of the influenza virus. Annual flu vaccines protect against the A and B strains that research has predicted to be the most prevalent in the upcoming season. However, much like the COVID-19 vaccines, not all influenza vaccines are created equal. Understanding the key differences between the available flu vaccinations can help pharmacists make the most appropriate vaccine recommendations for their patients. <Read More>

    Specialty Pharmacists Are Essential Patient Advocates – July 14, 2021 – In addition to providing necessary education for patients receiving treatments for complex diseases, specialty pharmacists can work as advocates within the difficult to access health care system, said presenter Georgeanne Vartorella, MD, founder and president of Patient Advocacy MD, in the keynote address at the American Society of Health-System Pharmacists (ASHP) Specialty Pharmacist Conference. Helping her parents navigate through long, terminal illnesses opened her eyes to the importance of patient advocates, Vartorella said. New advancements in tools and technology have empowered patients to engage as informed participants, but Vartorella said major obstacles still exist within the health care system. <Read More>

    U.S. Pharmacies Strike First Deals With Counties Over Opioids – July 14, 2021 – Pharmacy operators Walgreens Boots Alliance Inc(WBA.O), CVS Health Corp(CVS.N), Rite Aid Corp(RAD.N) and Walmart Inc(WMT.N) have agreed to pay a combined $26 million to settle claims by two New York counties that they fueled an opioid addiction epidemic. The settlements are the first reached by pharmacies in the ongoing nationwide litigation over opioids. The pharmacies did not admit wrongdoing. Suffolk County’s legislature approved the deals on Monday, while Nassau County’s legislature is expected to vote on final approval next month. <Read More>

    When Humira™ Finally Faces Biosimilar Competition, Losses for AbbVie May Not Be as Steep as Expected, Say Analysts – July 14, 2021 – A new analysis bodes well for AbbVie’s Humira™ (adalimumab) profits, as it vigorously attempts to fend off competition from biosimilar competitors to one of the leading treatments for rheumatoid arthritis and other autoimmune diseases. In fact, AbbVie has battled new biosimilar competitions so aggressively, that a recent investigative report from the House Committee on Oversight and Reform describes a “cold and heartless” methodology to keep competitors away from its franchise, according to The Center for Biosimilars®. The scathing congressional report says that AbbVie has raised the price of Humira™ 27 times. A 40mg/mL syringe is now priced at $2,984 — $77,586 annually — which works out to be a 470% increase in price from when the drug launched in 2003. <Read More>

    FDA Notifies Amgen of Misbranding of its Biological Product, Neulasta™, Due to False or Misleading Promotional Communications About the Product’s Benefit – July 14, 2021 – The Food and Drug Administration (FDA) has issued an untitled letter to Amgen Inc. for the misbranding of its biological product, Neulasta™ (pegfilgrastim) injection, for subcutaneous use, resulting from a false or misleading promotional communication. Amgen Inc. released a promotional communication that makes false or misleading claims and representations about the benefit of Neulasta™ when administered through the Onpro™ on-body injector compared to a prefilled syringe. Neulasta™ is the reference product for all FDA-licensed biosimilar pegfilgrastim products, which are only available as a prefilled syringe. <Read More>

    CHEST Releases Expert Guidelines For Lung Cancer Screening – July 14, 2021 – The American College of Chest Physicians® (CHEST) recently released a new clinical guideline, Screening for Lung Cancer: CHEST Guideline and Expert Panel Report. The guideline contains 16 evidence-based recommendations and an update of the evidence base for the benefits, harms, and implementation of low-dose chest computed tomography (CT) screening. Lung cancer is by far the leading cause of cancer death among both men and women, making up almost 25% of all cancer deaths. Evidence suggests that low-dose CT screening for lung cancer can reduce cancer-related deaths in the group that is screened. The new guidelines provide recommendations on the selection of screen-eligible individuals, the quality of imaging and image interpretation, the management of screen detected findings and the effectiveness of smoking cessation interventions. <Read More>

    Pharmacists Show Their Skill In Easing Biosimilar Switches – July 14, 2021 – Managing biosimilar adoption and utilization has become almost a specialty in itself for many health-system pharmacists, experts told attendees at the ASHP 2021 virtual Specialty Pharmacy Conference. “There are multiple challenges, including regulatory issues, unique formulary management considerations, forecasting coverage and reimbursement, and education of providers, which are very different when it comes to biosimilars compared with small-molecule product or originator biologics,” said Isha Rana, PharmD, a pharmacy administrative specialist in formulary management and drug information at Houston Methodist, who presented at the ASHP meeting. <Read More>

    Treatment, Management Guidelines for 6 Forms of Vasculitis Released – July 13, 2021 – Treatment options for patients with these rare diseases have expanded in recent years, but rheumatologists may have limited experience with systemic vasculitis. Three new guidelines have been released for the treatment and management of systemic vasculitis, a group of about 20 rare diseases involving the inflammation of blood vessels and other presentations. The 3 guidelines cover 6 forms of vasculitis; a fourth guideline on Kawasaki disease will be released soon, according to the American College of Rheumatology (ACR) and the Vasculitis Foundation (VF). The guidelines are the first produced and endorsed by the 2 organizations. Although the diseases are similar, they may differ in regard to which organs are affected and which therapy is most suitable. <Read More>

    Sanofi, Lilly, Novo and a Trio of PBMs Face Racketeering Claims Over Pricey Insulin Drugs – July 13, 2021 – Diabetes giants Sanofi, Eli Lilly and Novo Nordisk, plus a trio of pharmacy benefit managers will have to face racketeering charges over claims they systematically hiked the price of insulin drugs. U.S. District Judge Brian Martinotti on Friday denied motions by the defendants—which also include PBM bigwigs OptumRx, Caremark and Express Scripts—to scrap claims under the Racketeer Influenced and Corrupt Organizations (RICO) Act. Martinotti did drop antitrust claims under the Robinson-Patman Act, meant to stop distributors from charging different prices to retailers, and the Sherman Antitrust Act, which more broadly targets monopolies. <Read More>

    Generic Drug Price Tags: Too High. And Too Low. Competition Can Help Create an In-Between – July 13, 2021 – Low prices and some gaming of regulations can drive out competitors and create monopolies that allow generic makers to jack up their prices. Experience has shown that it often takes multiple generics to achieve the promised-for downward pressure on prices. The good news is that generic drug prices are continuing to decrease. As for the rest of the news about generics and biosimilars and their practices, it is complicated. For some classes of drugs, generics remain a price-lowering, cost-saving success. For others, prices are so low that manufacturers may leave the marketplace, creating an opportunity for monopoly pricing. For still others, there is an untapped opportunity for cost savings. “You cannot look at the generic drug and biosimilar markets as homogenous marketplaces,” says Martin VanTrieste, president and CEO of Civica Rx, a nonprofit company formed in 2018 to manufacture generic drugs. <Read More>

    Ketamine a Reasonable Rescue Sedative in ICU – July 13, 2021 – Continuous infusion (CI) ketamine is a reasonable alternative for ICU patients failing to respond to traditional sedative and analgesic regimens, a study has concluded. When patients refractory to other sedative agents are switched to CI ketamine, there is an increase in the proportion of time spent within goal pain and sedation ranges and a reduction in the use of other sedatives, according to pharmacists at medical centers and university hospitals across the country who undertook this large multicenter, retrospective observational study. <Read More>

    HHS Issues Much Anticipated Updates to Provider Relief Fund Deadlines and Reporting Requirements – July 13, 2021 – Pharmacies across the country were pleasantly surprised with the release of updated reporting requirements and deadlines in connection with funds received from the CARES Act Provider Relief Fund (PRF). On June 11, 2021, the Department of Health and Human Services (HHS) issued the revised post-payment notice of reporting requirements that supersedes all prior versions of the notice. The updated requirements reflect the Health Resources and Services Administration’s focus on giving providers equitable amounts of time for use of these funds, maintaining effective safeguards for taxpayer dollars, and incorporating feedback from providers requesting more flexibility and clarity about PRF reporting. <Read More>

    Individuals With Advanced HIV May Not Achieve Viral Clearance of SARS-CoV-2, Leading to Extensive Mutations – July 13, 2021 – Growing evidence suggests that failure to clear SARS-CoV-2 infection in patients with advanced HIV can create conditions leading to the evolution of dangerous viral mutations, according to data presented at the 2021 European Congress on Clinical Microbiology & Infectious Diseases (ECCMID). Further, the investigators said their findings suggest the beta SARS-CoV-2 variant, first identified in South Africa, leads to more severe disease in patients living with HIV. <Read More>  

    How Multi-Lingual Labels and Education Can Help Independent Pharmacies Better Serve Patients – July 13, 2021 – Independent pharmacies comprise a shrinking 35% of all retail pharmacies, predominantly serving patients in smaller cities and towns with 50,000 or fewer residents. Just as the retail pharmacy industry has changed in recent decades, these smaller communities are 97% more racially and ethnically diverse than they were in 1980. These demographic changes have increased the diversity of languages spoken in rural and non-metropolitan areas, in addition to the growth of the number of residents. With a larger population of limited English proficiency (LEP) residents, a few state legislatures have passed laws requiring pharmacies to print prescription labels in languages other than English when requested by the patient. The major potential benefits of such laws are clear: fewer patient medication-related errors and greater adherence to treatment plans due to better understanding of instructions. The latter of which is especially important considering patients with LEP tend to have a lower medication adherence rate than English proficient patients. <Read More>

    340B in the News

    Regulating Drugs at a Discount – July 17, 2021 – Prescription drugs are significantly more expensive in the United States than other countries. To reduce the costs of medicines for uninsured, low-income, or other vulnerable patients, Congress established what has come to be known as the “340B program.” The program gets its name from the legislation that created it—Section 340B of the Public Health Service Act, enacted in 1992. That section requires drug manufacturers that participate in Medicaid to sell drugs to certain “covered entities”—such as rural treatment centers, children’s hospitals, and hospitals that serve a disproportionately high number of low-income patients—at an estimated 25 to 50 percent discount. <Read More>

    Legal Tools to Protect Specialty Pharmacies – July 16, 2021 – In today’s complicated pharmacy benefits landscape, with increasing dominance by a collection of vertically integrated payor and pharmacy benefit manager (PBM) networks, hospital and health-system specialty pharmacies have some legal tools that they can use to address challenges, such as network access, mandatory white-bagging policies and payor activities in the 340B space. That was the message from Jesse Mr. Dresser, Esq, an attorney with the health care law firm Frier Levitt LLC, in a session on legal conundrums in specialty pharmacy held during the 2021 ASHP Specialty Pharmacy Conference, held virtually. <Read More>

    ASHP Survey of Specialty Pharmacies Highlights Concerns Over Access to Payer Networks, Interest in Serving New Populations – July 15, 2021 – The American Society of Health-System Pharmacists’ (ASHP) first annual survey of health-system specialty pharmacies (HSSPs) offered insights into the concerns of specialty pharmacists and provided an opportunity for professionals in the field to outline a potential future for specialty pharmacy. Presented at the 2021 ASHP Specialty Pharmacy Conference, the results of the survey indicated anxieties over reimbursement, pride in patient satisfaction, and an interest in serving new populations…When asked to select their top 3 challenges in the coming year, 82.9% of respondents indicated that access to payer networks was of critical concern. Frequently cited concerns also included changes to the 340B Drug Pricing Program (42.9%), shrinking reimbursement from payers (40%), and access to limited distribution drugs (34.3%). <Read More>