Clinical Insights: September 21, 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

    Exkivity™ (mobocertinib) Capsules – New Drug Approval – September 15, 2021 – The Food and Drug Administration granted accelerated approval to mobocertinib (Exkivity™, Takeda Pharmaceuticals, Inc.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. The FDA also approved the Oncomine™ Dx Target Test (Life Technologies Corporation) as a companion diagnostic device to select patients with the above mutations for mobocertinib treatment. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Brukinsa® (zanubrutinib) Capsules – New Approved Indication – September 14, 2021 – BeiGene, Ltd., a global biotechnology company focused on developing and commercializing innovative medicines worldwide, announced that Brukinsa® (zanubrutinib) has received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. This accelerated approval is based on overall response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. <Read More>

    New/Updated Drug Shortage

    September 16, 2021

    September 14, 2021

    September 13, 2021

    New Drug Recall and Safety Alerts

    Chantix® (Varenicline) Tablets by Pfizer – New Expanded Voluntary Recall – September 16, 2021 – Pfizer is voluntarily recalling all lots of Chantix® 0.5 mg and 1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. As alternative suppliers have been approved in the United States, Pfizer is undertaking this precautionary measure. Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline. <Read More>

    Ruzurgi® (amifampridine) by Jacobus Pharmaceutical Company Inc. – New Voluntary Recall – September 13, 2021 – Jacobus Pharmaceutical Company Inc. is voluntarily recalling 3 lots of Ruzurgi® (amifampridine) 10 mg tablets to the consumer level. The products have been found to be contaminated with yeast, mold, and aerobic bacteria based on laboratory test results. Oral products heavily contaminated with yeast, mold, and aerobic bacteria may result in serious and life-threatening infections. The use of the defective product in patients with underlying immunosuppressive conditions such as Lambert Eaton Syndrome (LEMS) increases the concern for serious infections. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    How Specialty Pharmacies Connect the Dots for Patient-Centered Care – September 20, 2021 – Specialty pharmacists are able to coordinate services and address social determinants of health, leading to improved medication adherence and health outcomes. Specialty pharmacies play a pivotal role in ensuring patients have access to the proper medications and resources necessary to stay adherent. They have evolved to handle the complexity and costs of specialty pharmaceuticals while at the same time managing reimbursement and providing individualized clinical support to patients. Within the concept of patient-centered care, these pharmacies function as the lynchpin bringing together manufacturers, providers, payers, and caregivers to streamline a process aimed at achieving optimal health outcomes for patients. And the value of specialty pharmacies has become especially evident during a pandemic that has disrupted daily life and exacerbated many of the social determinants of health that prevent patients from staying healthy. <Read More>

    IVIG Therapy May Fight Parvovirus-Associated Pure Red Cell Aplasia – September 20, 2021 – Intravenous immunoglobulin (IVIG) therapy can be used to promote antibody formation against parvovirus-associated pure red cell aplasia (PRCA) and helps compliance with antiretroviral therapy (ART) and proton pump inhibitors (PPI), which helps manage anemia, new study results show. IVIG therapy is often used as a treatment and can reverse PRCA with antibodies that protect against parvovirus, with a regimen of doses as low as 400 mg/kg over a 2-to-5-day period. A routine immunohistochemical staining is crucial to determine whether an individual has parvovirus, because of an individual testing negative with a polymerase chain reaction (PCR) test and positive with an immunohistochemical staining, investigators said. <Read More>

    Rare Disease Care: The Benefits of a Specialty Pharmacy – September 20, 2021 – When a biopharma company develops a therapy for a rare or complex disease, selecting a specialty pharmacy to partner with is an important choice. Choosing one that regularly works with patients who have rare and complex diseases means the specialty pharmacy will be familiar with the challenges a biopharma company faces during the orphan drug commercialization process, whether clinical or logistical. An experienced specialty pharmacy also knows how to help biopharma companies meet patient-related needs, including medication adherence and emotional support. <Read More>

    FDA Alerts Patients and Health Care Professionals Not to Use Compounded Products Intended to be Sterile From Prescription Labs Inc. Dba Greenpark Compounding Pharmacy – September 17, 2021 – FDA is alerting patients and health care professionals not to use compounded products intended to be sterile, produced and distributed nationwide by Prescription Labs Inc. doing business as Greenpark Compounding Pharmacy, Houston, Texas, due to lack of sterility assurance. Administration of non-sterile products intended to be sterile may result in serious and potentially life-threatening infections or death. Health care professionals and patients should immediately check their medical supplies, quarantine any products marketed as sterile from Greenpark Compounding Pharmacy, and not administer or provide them to patients. <Read More>

    FDA Advisory Committee Recommends COVID-19 Vaccine Booster for People at High Risk for Serious Disease – September 17, 2021 – The FDA’s Vaccines and Related Biological Products Advisory Committee voted against recommending a booster of the COVID-19 vaccine (Comirnaty™, Pfizer-BioNTech) in people ages 16 years and older. Instead, the committee recommended the booster for those ages 65 and older and people who are at high risk for serious disease. Before adjourning, the members provided clarification about whom they thought should also receive a booster—those at occupational risk for COVID-19. <Read More>

    Seven Retail Pharmacy Business Trends You Should Know! – September 17, 2021 – Being in the pharmacy industry, it is essential to know the retail pharmacy business trends. Not just in pharmacy but in any industry, keeping up with the ongoing trends is a must…During the pandemic, the online pharmacy got more exposure as people were more concerned about their health and getting infected with the virus. The essentials like face masks, gloves, sanitizers, necessary medications, etc. had high demand in the market. Sadly, the trend slowed down with the decrease in COVID cases. Still, there’s something that might have not caught your attention. The emerging pharma industry trends shaping the retail pharmacy apps and stores. Here in this article, you will read about Pharmacy trends that will help you in growing your online pharmacy business. <Read More>

    Establishing Specialty Pharmacy Beyond US Borders: Opportunities and Challenges – September 17, 2021 – The United States, the European Union (EU), and Canada are currently the world leaders in specialty pharmacy. IQVIA’s global use of medicine report states that by 2023, developed markets will see a growth in specialty spending from $336 billion in 2018 to nearly $505 billion and the specialty share of total pharmaceutical spending will reach 50%, since the majority of new drugs have been and will continue to be in specialty groups…The question is: “Do we expect to see specialty pharmacy expanding beyond these regions?” <Read More>

    CDC to Invest $2.1 Billion to Protect Patients and Healthcare Workers from COVID-19 and Future Infectious Diseases – September 17, 2021 – The Biden-Harris Administration announced a $2.1 billion investment to improve infection prevention and control activities across the U.S. public health and healthcare sectors. The Biden-Harris Administration, working through the Centers for Disease Control and Prevention (CDC), is investing American Rescue Plan funding to strengthen and equip state, local, and territorial public health departments and other partner organizations with the resources needed to better fight infections in U.S. healthcare facilities, including COVID-19 and other known and emerging infectious diseases. The funding is a commitment that will allow the United States to expand public health and improve the quality of healthcare in our country, including addressing healthcare-related inequities. <Read More>

    Ochsner Reports Progress for Ida-Hit Hospitals, Decline in COVID-19 Patients – September 16, 2021 – After being pummeled by Hurricane Ida almost three weeks ago, Ochsner hospitals in Southeast Louisiana are nearly recovered from the storm as the health system’s COVID-19 patient census declines dramatically. Ochsner’s Chief Operating Officer Mike Hulefeld said the system’s Southeast Louisiana facilities have made “great progress” toward restoring their care operations in the weeks since Ida made landfall on Sunday, August 29. “Our St. Charles Medical Center in Luling is back 100% fully operational, whether it’s ICU care, inpatient mental health, med-surg,” Hulefeld said. “The emergency department never closed.” <Read More>

    Practice Behavior Changes After Approval of Durvalumab in Review of Insurance Claims – September 16, 2021 – Oncology practices in the United States have changed since 2018 as durvalumab became available for patients with unresectable stage 3 non-small cell lung cancer (NSCLC), according to a study presented at the IASLC 2021 World Conference on Lung Cancer. After the results from the PACIFIC trial on durvalumab from 2018 were published, the FDA approved durvalumab for unresectable stage 3 NSCLC, according to a press release. Dr. Jason Liu and his colleagues hoped to assess the use of maintenance durvalumab based on patient and physician characteristics among individuals with stage 3 NSCLC in the United States. <Read More>

    Stemming the Rising Tide of Insulin Prices – September 16, 2021 – States are putting caps on prices, and Semglee®, the first interchangeable biosimilar in the United States, may exert some downward pressure. More than 30 million Americans have diabetes, according to the American Diabetes Association, and many rely on insulin. But insulin prices have been rising in recent years, and that has put many people with diabetes at risk because the price leads to people skipping doses or not taking insulin altogether. The latest figures from the American Action Forum show that the price of insulin rose 14% a year, on average, between 2012 and 2018, and the past few years have followed this growth trajectory. Many patients, policy makers and experts blame companies that manufacture insulin for dialing up the price of an established therapy. Sally Pipes, president and CEO of the Pacific Research Institute, a California-based think tank that favors free markets and limited government, says it’s easy to point the finger at pharmaceutical companies, but she finds fault elsewhere: in a dysfunctional market for insulin and many other prescription drugs and in pharmacy benefit managers. <Read More>

    New CLL Data Point to ‘Durable, Lasting Response’ – September 16, 2021 – A series of studies and trials conducted in chronic lymphocytic leukemia (CLL) suggest that an increasing proportion of patients are surviving without disease progression for extended periods. The durable responses, including undetectable minimal residual disease (uMRD) status, have been impressive. At the 2021 meeting of the American Society of Clinical Oncology (ASCO), new data from the CAPTIVATE trial were the latest to suggest new therapies are altering the prognosis of CLL. <Read More>

    Why Pharmacists Need to Practice at the Top of Their Licensure – September 16, 2021 – Pharmacists have an important role in improving patient health in their communities, but to reach their full potential, they must practice at the top of their licensure by expanding their services from just medication dispensing to chronic disease management, point-of-care testing, patient education, and medication therapy management. In recent years, pharmacists have increasingly become recognized as essential contributors to patient care and community health. This is because pharmacist involvement in care has been proven to result in better outcomes for patients with diabetes, hypertension, and cardiovascular disease. <Read More>

    Pharmacists Authorized to Order and Administer COVID-19 Therapeutics Under PREP Act Declaration – September 16, 2021 – The Department of Health and Human Services amended the COVID-19 Public Readiness and Emergency Preparedness (PREP) Act declaration to allow licensed pharmacists to order and administer selected COVID-19 therapeutics, including subcutaneous monoclonal antibodies (mAbs). The amendment broadly addresses COVID-19 therapeutics given orally, subcutaneously or intramuscularly, including current and future medications that are approved, authorized, cleared or licensed to treat/prevent COVID-19. Licensed pharmacists, licensed or registered pharmacy interns, and qualified pharmacy technicians who meet the criteria in the amendment are also authorized to administer certain COVID-19 therapeutics, according to the HHS. <Read More>

    FDA Authorizes Bamlanivimab and Etesevimab Monoclonal Antibody Therapy for Post-Exposure Prophylaxis (Prevention) for COVID-19 – September 16, 2021 – The U.S. Food and Drug Administration revised the emergency use authorization (EUA) for bamlanivimab and etesevimab, administered together, to include emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. Bamlanivimab and etesevimab are monoclonal antibodies. Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens, such as viruses like SARS-CoV-2. In this revision of the EUA, bamlanivimab and etesevimab, administered together, are authorized for use after exposure to the virus and are not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus. Health care providers should review the fact sheet for detailed information about use of this therapy for post-exposure prophylaxis. <Read More>

    NCCN Guidelines add PSMA-PET Imaging Modalities for Prostate Cancer – September 15, 2021 – The NCCN has added Ga 68– and F 18–based PSMA-PET imaging modalities to its clinical practice guidelines for prostate cancer. “The updated guidelines will encourage clinicians to use PSMA-PET as a primary imaging modality in patients and will deliver the benefit of a more streamlined approach. We look forward to having access to this functional form of imaging as new products come into the market,” Oliver Sartor, MD, Medical Director at Tulane Cancer Center, stated in a news release from Telix pharmaceuticals, a manufacturer of PSMA-PET imaging products. <Read More>

    Going Beyond Rebates to Real Value – September 15, 2021 – When PBMs focus too much on chasing rebates, they may miss out on the critical elements that provide true economic value to healthcare organizations and employers, Thatcher Sloan, vice president, practice leader, at Confidio, said during his presentation at the 2021 Pharmacy Benefit Management Institute® Annual National Conference. Sloan told attendees of the hybrid conference (virtual and in person) on Tuesday about Confidio’s net economic value assessment of PBMs that that factors in how effective their formularies are in driving prescription to the most cost-effectiveness choices and the rigor of their utilization management. Applying formulary effectiveness and utilization management effectiveness to a PBM can paint a truer picture of how well it is managing drug costs, said Sloan. <Read More>

    Vedolizumab May Be Safer Biologic Option for Older Adults – September 15, 2021 – Data from over 1,500 older adults with inflammatory bowel disease suggest vedolizumab (Entyvio®, Millennium Pharmaceuticals) may be a slightly safer option for this age group than anti–tumor necrosis factor (TNF) agents. The results showed there were 50% fewer infection-related hospitalizations among older patients who started vedolizumab than for those who received an anti-TNF drug. “While some research has suggested equivalent safety profiles among older patients on vedolizumab and anti-TNFs, this current study corroborates contrasting retrospective studies, which point to a better safety profile for vedolizumab,” said Sasha Taleban, MD, an associate professor and the director of the IBD Program at the University of Arizona College of Medicine–Tucson, and an expert on aging and IBD. He was not involved with the research. <Read More>

    Break up PBM Oligopolies, APhA Tells FTC – September 15, 2021 – Vertically merged pharmacy benefit managers (PBMs) use their highly concentrated market power to dominate, deceive, and maybe even defraud, American Pharmacists Association (APhA) CEO and Executive Vice President Scott Knoer told Federal Trade Commission (FTC) leaders at a roundtable. It’s time for the FTC to break up these massive conglomerates, he said. Knoer told the FTC that three PBMs process 75% of prescription drug claims; they operate their own mail-service, specialty, and retail pharmacies; and increasingly, they vertically merge with insurance companies. The consolidation has created oligopolies that engage in destructive, anticompetitive conduct, he said. <Read More>

    FDA Advances Data, IT Modernization Efforts with New Office of Digital Transformation – September 15, 2021 – The U.S. Food and Drug Administration announced the reorganization of the agency’s information technology (IT), data management and cybersecurity functions into the new Office of Digital Transformation (ODT). The office has been realigned to report directly to the FDA commissioner, elevating the office and its functions to agency-level. This reorganization will advance the agency’s information technology transformation with improved data and IT competencies that improve agency operations to support the public health mission. <Read More>   

    How Employers Plan to Tame the Health Cost Rebound – September 15, 2021 – The deferral of non-essential health care by Americans during the COVID-19 pandemic lowered costs for employers, but the rate of people accessing health care and the costs that come with that are expected to pick back up. According to the Business Group on Health’s “2022 Large Employers’ Health Care Strategy and Plan Design Survey,” top concerns for employers include expanding access to mental health care, monitoring trends in health care delivery and preparing for an uptick in health care spending. <Read More>

    Kentucky Federal Court Temporarily Bars CVS from Imposing Block on Interventional Pain Doctor’s Prescriptions – September 15, 2021 – In mid-August, the Eastern District of Kentucky granted a preliminary injunction in favor of an interventional pain management physician (Physician) against CVS Pharmacy (CVS) based on allegations that CVS was refusing to fill the Physician’s prescriptions. Specifically, the Physician and his practice, Interventional Pain Specialists, PLC (Practice), asserted that CVS refused to fill prescriptions for both controlled and non-controlled substances issued by the Physician and Practice, affecting nearly 300 patients in Northern Kentucky, Indiana, and Ohio. In the preliminary injunction motion, the Physician and Practice claimed tortious interference with a contractual and business relationship; the underlying complaint also includes a claim for defamation per se. <Read More> 

    Updates in Sequencing Treatment for Early Multiple Myeloma Relapse – September 15, 2021 – The future landscape of multiple myeloma (MM) depends on the type of relapse, as each combination therapy can be specific to a certain set of patients, according to a presentation at the Society of Hematologic Oncology (SOHO) 2021 Annual Meeting. Presenter Maria-Victoria Mateos, MD, PhD, University Hospital of Salamanca-IBSAL, Salamanca, Spain, discussed how optimal sequencing in MM has changed from those outlined in the older EU guidelines. The new guidelines for relapsed/refractory MM (RRMM) are modeled around CD38-based and non-CD38-based regimens, according to Mateos. “The new response criteria are applicable to all patients,” Mateos added. <Read More>

    NIH Builds Large Nationwide Study Population of Tens Of Thousands to Support Research on Long-Term Effects of COVID-19 – September 15, 2021 – The National Institutes of Health awarded nearly $470 million to build a national study population of diverse research volunteers and support large-scale studies on the long-term effects of COVID-19. The NIH REsearching COVID to Enhance Recovery (RECOVER) Initiative(link is external) made the parent award to New York University (NYU) Langone Health, New York City, which will make multiple sub-awards to more than 100 researchers at more than 30 institutions and serves as the RECOVER Clinical Science Core. This major new award to NYU Langone supports new studies of COVID-19 survivors and leverages existing long-running large cohort studies with an expansion of their research focus. This combined population of research participants from new and existing cohorts, called a meta-cohort, will comprise the RECOVER Cohort. <Read More> This funding was supported by the American Rescue Plan. <Read More> 

    Tuberculosis Preventive Treatment in People Living With HIV—Is the Glass Half Empty or Half Full? – September 14, 2021 – The most recent World Health Organization Global Tuberculosis (TB) Report suggests that 50% of people living with HIV (PLHIV) newly enrolled in HIV care initiated tuberculosis preventive treatment (TPT) in 2019. TPT is an essential intervention to prevent TB disease among people infected with Mycobacterium tuberculosis—some 25% of the world’s population. Without TPT, it is estimated that up to 10% of individuals will progress to TB disease. Among PLHIV, the prognosis is worse. Of the approximately 1.4 million annual deaths from TB, 200,000 occur among PLHIV, who experience TB at rates more than 30 times higher than people living without HIV. <Read More>   

    Challenges and Opportunities Facing Independent Community Pharmacies – September 14, 2021 – Despite long-standing challenges, independent community pharmacies continue to fight on the front lines of the pandemic and prioritize the health of their patients. AmerisourceBergen (AB) and Good Neighbor Pharmacy (GNP) are committed to fighting for independents in Washington and in the states to improve and expand pharmacy practice. During ThoughtSpot 2021, Beth Mitchell, senior director, government affairs, AmerisourceBergen, and Brian Nightengale, president, Good Neighbor Pharmacy, sat down with Drug Topics® to discuss current federal and state legislation affecting independent pharmacies, how pharmacists can support policies that will help advance the profession, and the ways that AB and GNP are investing and advocating on behalf of customers to protect their long-term viability. <Read More>

    Become Familiar with VTE Treatment and Anticoagulation Management – September 14, 2021 – The American College of Chest Physicians (CHEST) has been developing and publishing guidelines related to venous thromboembolism (VTE) management for more than 30 years. These clinical practice recommendations guide clinicians and physicians through the prophylaxis and treatment of VTE by covering aspects from initial management through secondary prevention and risk reduction of postthrombotic syndrome. CHEST’s most recent publication, the 10th edition of the Antithrombotic Guideline, contains updated recommendations on 12 topics that were in the ninth edition and addresses 3 new topics. These new guidelines also contain 4 new guidance statements that did not appear in the ninth edition (2012) or first update (2016), and 8 statements have been substantially modified in recent years because of new evidence. <Read More>

    Why People Think Ivermectin Can Treat COVID, and How the Medication Really Works – September 14, 2021 – Ivermectin continues to make headlines in the U.S. after COVID-19 patients and their loved ones insist on being treated with the anti-parasitic drug. QAnon supporter Veronica Wolski, who once filmed herself confronting Staples employees over their mask policy, died on Monday of COVID-19 after her supporters demanded that she be treated with ivermectin…But why do so many people outside the medical community insist that ivermectin works against COVID-19? Doctors break it—and the data—down. <Read More>

    Smaller PBMs and Insourcing Are Finding a Place in a Market Dominated by Major Players – September 14, 2021 – Many midsize health plans contract with the large PBMs that dominate the market and are owned by their rivals, such as CVS Health and Cigna, noted Javier Gonzalez, Pharm.D., chief growth officer at Abarca, a PBM based in Aventura, Florida, and San Juan, Puerto Rico, said this morning at the second day of the Annual National Conference of the Pharmacy Benefit Management Institute® in Orlando, Florida. Is that wise? Now midsize plans are “starting to think about their competitive landscape,” Gonzalez said. By contracting with the PBMs, “they are putting revenue dollars in their competitors.” PBMs owned by CVS Health, UnitedHealthcare and Cigna control almost 80% of the market, and the five largest PBMs together hold about 90% of the market. But venture capital and private equity investors are supporting new PBMs that rely heavily on technology, noted Gonzalez. <Read More>

    The Societal Case for Pharmacist Provider Status – September 14, 2021 – Beyond the benefits to the pharmacist profession, granting provider status to pharmacists addresses the larger societal problem of growing physician shortages. Every profession advocates for itself—that’s to be expected. But when a profession seeks to address a significant societal problem, it stands a better chance of gaining favor. Such is the case today, as there is an opportunity for pharmacists to help address a significant and worsening societal problem of another profession—the physician shortage. Using projected changes in population size and age, Xiaoming Zhang of the Cleveland Clinic Foundation and his fellow researchers developed demand and supply models to forecast the physician shortage or surplus by state, concluding that the United States will face a shortage of 139,160 physicians by 2030. <Read More>

    340B in the News

    AAMC Comments on 2022 Outpatient Prospective Payment System Proposed Rule – September 17, 2021 – The AAMC submitted comments on Sept. 15 regarding the Centers for Medicare & Medicaid Services’ (CMS’) Calendar Year (CY) 2022 Outpatient Prospective Payment System (OPPS) proposed rule…The CMS proposed to continue paying for separately payable drugs reimbursed under the OPPS and acquired through the 340B program at average sales price minus 22.5%. The AAMC urged the CMS not to continue the reimbursement reductions for 340B-acquired drugs and requested that the agency provide greater transparency in how it calculates and implements the budget neutrality adjustment. <Read More>

    AAMC, Hospital Groups Submit Merits Brief in 340B Case – September 17, 2021 – The AAMC and other plaintiffs submitted a merits brief to the U.S. Supreme Court in American Hospital Association v. Becerra, the case that challenges an estimated annual $1.6 billion reduction made by the Centers for Medicare & Medicaid Services (CMS) to payments for certain outpatient drugs to 340B hospitals under the Outpatient Prospective Payment System. The U.S. District Court for the District of Columbia found that the CMS had exceeded its statutory authority, but that decision was overturned by a 2-1 decision of the U.S. Court of Appeals for the District of Columbia Circuit. The decision of the appeals court relied on Chevron, which is a principle established by the Supreme Court that gives deference to actions of federal agencies when a statute is ambiguous and an agency’s action is not unreasonable. In July, the U.S. Supreme Court agreed to hear the case. <Read More>

    Report Shows 340B Non-Profit Charity Hospitals Make “a Handsome Profit” on Cancer Drugs – September 14, 2021 – A new report discussing the results of an examination of price transparency data of novel cancer drugs, published earlier by the Community Oncology Alliance (COA), suggests that the nation’s so-called non-profit 340B charity hospitals make “a handsome profit” by charging privately insured patients 3.8 times their costs to acquire cancer drugs. In the report, the Community Oncology Alliance calls for 340B program reforms that ensure discounts benefit patients, not hospitals. The report finds that hospitals participating in the 340B Drug Pricing Program charge an average of 3.8 times their acquisition costs for pricey cancer drugs and do not provide lower prices for uninsured or cash-paying customers. One drug used to treat anemia caused by chemotherapy, Epoetin alfa (Epogen®; Amgen), was priced at 11 times its cost to the hospital. <Read More>