Clinical Insights: November 2, 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

    No new update.

    New Indication/Dosage/Formulation Approval

    No new update.

    New/Updated Drug Shortage

    November 01, 2021

    October 29, 2021

    October 28, 2021

    October 27, 2021

    October 26, 2021

    New Drug Recall and Safety Alerts

    Pepaxto® (INN melphalan flufenamide) by Oncopeptides – New Voluntary Recall – October 22, 2021 – Oncopeptides AB, a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, announces that the company has decided to withdraw Pepaxto® (INN melphalan flufenamide) from the market in the US, following the phase 3 OCEAN study, which showed an overall survival in the ITT population with a HR of 1.104. The decision has been made after interactions and dialogue with the US Food and Drug Administration, FDA. Pepaxto® was granted accelerated approval on February 26th 2021. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    A New Frontier in the Fight Against Rare Disease – November 1, 2021 – Rare disease specialty pharmacies offer customizable pharmacy and patient services to make it easier for people living with rare, complex, and often isolating conditions to access the therapy, care, and resources they need. Approximately 30 million people in the United States—1 in 10 Americans—have been diagnosed with a rare disease, approximately two-thirds of whom are children.1 Rare disease drugs and cell or gene therapies to treat these conditions offer new hope for people living with a rare condition and are among the fastest growing areas of the drug pipeline. Although these treatments have the potential to save lives, they also represent the most dynamic and costly area in medicine. Complex in their administration, handling and care, these high-touch therapies require customized management and services beyond what traditional pharmacies can provide. <Read More>

    Pharmacies Face Drug Shortages Amid Global Supply Chain Bottlenecks – November 1, 2021 – The pandemic has exacerbated drug shortages, and pharmacies across the country have reported struggling to keep enough medications in stock. UVA Health in Charlottesville told CBS News its pharmacy technicians are filling single-dose drug orders for nearly 700 patients. Roche’s anti-inflammatory drug Actemra, which is needed by both chemotherapy patients and COVID-19 patients, has been particularly short at the health system, CBS News reported. The system decided to reserve it for chemotherapy patients and deny it to COVID-19 patients. “It does mean that some patients are getting the drug that I would not ideally want to give them,” said Patrick Jackson, MD, an infectious disease physician at UVA Health, told CBS News. The American Society of Health-System Pharmacists told CBS News that three of the top five shortages are drugs used for chemotherapy, heart conditions and antibiotics. <Read More>

    Kaiser Pharmacists, Therapists in Hawaii Vote in Favor of Strike – October 30, 2021 – Kaiser pharmacists and therapists on Maui and other islands voted this week to authorize a strike, citing concerns over wages in bargaining and working conditions made worse by the pandemic. More than 1,500 pharmacists, physical therapists, occupational therapists and speech-language pathologists in Hawaii and California faced the question of whether to strike during voting that took place from Sunday through Thursday. Results provided to The Maui News on Friday showed that Hawaii employees voted overwhelmingly for the strike — 94 percent in favor among the United Pharmacists of Hawaii (with 89 percent turnout) and 87 percent of physical and occupational therapists in favor (with 93 percent turnout). <Read More>

    Merck’s Keytruda® Close to Becoming Top-Selling Drug in the World – October 29, 2021 – Merck’s cancer drug Keytruda® is catching up to AbbVie’s Humira® as the highest selling drug in the world. Merck reported Oct. 28 that Keytruda® brought in a record $4.5 billion in revenue in the third quarter, a 22 percent increase from 2020. Keytruda®, which has been approved to treat 30 types of cancer, is currently the second best-selling drug in the world, bringing in $14.4 billion in sales in 2020. AbbVie’s Humira®, a rheumatoid arthritis treatment, is the top-selling drug in the world, bringing in $19.8 billion in 2020. And while Keytruda®‘s patent doesn’t expire until 2028, the FDA in October approved the first interchangeable biosimilar for Humira. <Read More>

    Pharmacy Chain Operator Giant Eagle Settles Ohio Opioid Lawsuits Mid-Trial – October 29, 2021 – Regional pharmacy chain operator Giant Eagle Inc on Friday said it had agreed to settle lawsuits accusing it of fueling the opioid epidemic in several Ohio communities, including two counties that had taken it and three larger rivals to trial. The settlement came during the fourth week of a trial in federal court in Cleveland over claims by the Ohio counties of Lake and Trumbull against Giant Eagle, Walgreens Boots Alliance Inc, CVS Health Corp and Walmart Inc. The settlement resolves claims against Giant Eagle in 10 lawsuits by those counties and others in Ohio, the company and the plaintiffs’ lawyers said in a joint statement. It operates grocery stores and pharmacies in five states including Ohio. <Read More>

    To Help Lower Diabetics’ Out-of-Pocket Insulin Costs, States Step in To Fill the Gap Left by the Federal Government’s Inaction – October 29, 2021 – In an effort to fight the growing diabetes epidemic in the U.S., Colorado has taken its first step towards making the life-saving drug more affordable for those who struggle to pay for it. Led by Governor Jared Polis, the state of Colorado has become the second U.S. state to pass legislation capping out-of-pocket costs for insulin—legislation that officials in several other states are now working to implement. On Tuesday, July 5th, Governor Jared Polis signed the bill (HB19-1045), which establishes a $100 per month cap on out-of-pocket costs for all diabetics starting January 1st, 2022. The cap will be phased in overtime, with patients able to opt for yearly insulin dosage at a set rate of $50 per month. The new law follows a similar insulin access initiative passed last year in Illinois. <Read More>

    New CDC Study: Vaccination Offers Higher Protection than Previous COVID-19 Infection – October 29, 2021 – The CDC published new science reinforcing that vaccination is the best protection against COVID-19. In a new MMWR examining more than 7,000 people across 9 states who were hospitalized with COVID-like illness, CDC found that those who were unvaccinated and had a recent infection were 5 times more likely to have COVID-19 than those who were recently fully vaccinated and did not have a prior infection. The data demonstrate that vaccination can provide a higher, more robust, and more consistent level of immunity to protect people from hospitalization for COVID-19 than infection alone for at least 6 months. <Read More>

    Certified Pharmacy Technicians Help Your Business Thrive – October 29, 2021 – As a pharmacist, it’s important to consider the benefits of certification for pharmacy technicians. When it comes to running a pharmacy, employee qualifications and skills can make or break the business. This is especially true today, as pharmacy technicians take on more responsibilities than ever before. In fact, according to the National Healthcareer Association (NHA) 2021 Industry Outlook, 43% of employers report that pharmacy technicians have more responsibility this year compared to last. The assumption could be made that this growth is attributed to the COVID-19 pandemic, but expectations are that this growth will continue long after the pandemic. <Read More>

    FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age – October 29, 2021 – The U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. The authorization was based on the FDA’s thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group. <Read More>

    New California Law Prohibits Chain Community Pharmacy Productivity Quotas for Pharmacists and Pharmacy Technicians – October 28, 2021 – Last year, The New York Times published an article titled “How Chaos at Chain Pharmacies is Putting Patients at Risk.” The article described how many pharmacists in large chain pharmacies “struggle to fill prescriptions, give flu shots, tend the drive-through, answer phones, work the register, counsel patients and call doctors and insurance companies … all the while racing to meet corporate performance metrics that they characterized as unreasonable and unsafe in an industry squeezed to do more with less.” Recent documents and data obtained by investigative reporters for an NBC News article entitled “Overworked, Understaffed: Pharmacists Say Industry In Crisis Puts Patient Safety At Risk” also alleges that large, publicly-traded pharmacy chains impose performance quotas on licensed pharmacists and pharmacy technicians that place at risk the health and well-being of patients. For itself, the California Pharmacy Association has stated  that “benchmarks and quotas are not conducive to the clinical practice of pharmacy and may actually inhibit a pharmacist’s care for their patients.” <Read More>   

    Coping With Burnout in the Pharmacy – October 28, 2021 – Mitigating the likelihood of pharmacy staff burnout requires a multifactorial approach. With millions of health care professionals heroically fighting COVID-19 on the front lines, battle fatigue has surely kicked in for some. This battle fatigue transcends mere tiredness and is more specifically referred to as burnout. As a concept, burnout was first proffered by a clinical psychologist named Herbert Freudenberger, who volunteered at a free clinic in the 1970s and observed that the demands of the job left many of the workers feeling emotionally drained, resulting in frustration, fatigue, and cynicism. <Read More>

    Simplifying the Complexity of Value-Based Contracting: Present, Future Implications in Specialty Pharmacy – October 28, 2021 – The state of value-based contracting in specialty pharmacy was addressed in a panel discussion at Asembia 2021 Specialty Pharmacy Summit in Las Vegas, with speakers touching on the essentials of such agreements, how to optimally integrate them, and future considerations for the pharmaceutical marketplace. The current integration and future implications of value-based contracting (VBC) in specialty pharmacy signal a shift for payers, providers, and the pharmaceutical industry, and stakeholders must strategically position themselves to excel in a changing market, according to panelists in a session at Asembia 2021 Specialty Pharmacy Summit in Las Vegas. <Read More>

    Generics and Biosimilars Have Critical Differences – October 28, 2021 – Generic drugs and biosimilars serve similar purposes: They are both unbranded versions of existing medications typically provided at a lower cost. However, there are some critical differences between the 2 categories that are worth examining and remembering. Generic medicines are chemically derived drugs designed to be equivalent to an existing, authorized originator. Only the inactive ingredients of a generic are allowed to differ from the originator. Because the chemical entities at the core of these drugs are exact copies of the originators, their performance in patients is predictable, and these chemicals are relatively uncomplicated to synthesize. By contrast, biosimilars are developed to be similar to biological medicines that have already been approved and whose patent has expired. The active ingredient of the biosimilar and the originator are functionally the same, but there could be minor differences because of production methods and the complexity of the molecules involved. <Read More>

    Novartis Under New DOJ Scrutiny Over Potential Kickback Allegations – October 28, 2021 – A little more than a year after Novartis’ generics unit Sandoz paid the U.S. government $195 million to settle price-fixing charges, the company is once again in the crosshairs of a federal investigation. This time over its blockbuster cardiovascular drug, Entresto®. Buried in its quarterly financial earnings report (page 36) released earlier this week, Novartis noted that it is the subject of a DOJ inquiry over the company’s marketing and pricing of Entresto® over the past five years, receiving a Civil Investigative Demand from the government. The Swiss pharma giant specifically noted that the government is seeking information regarding “remuneration provided to healthcare professionals,” meaning kickbacks paid to the doctors to prescribe the drug. <Read More>

    ACC, AHA Release Long-Awaited Chest Pain Guidelines – October 28, 2021 – The American Heart Association (AHA) and American College of Cardiology (ACC) have unveiled new guidelines designed to help clinicians evaluate the source and symptoms of chest pain while improving patient outcomes and reducing healthcare costs. The guidelines, published in Circulation and the Journal of the American College of Cardiology, have been in development for several years now. This represents the first time the AHA and ACC have collaborated on a comprehensive document focused on the evaluation and diagnosis of chest pain. <Read More>

    Healthcare Providers Say Anthem Blue Cross is Behind on Billions of Dollars in Payments – October 28, 2021 – According to hospital officials in multiple states, Anthem Blue Cross is behind on billions of dollars in payments to hospitals because of new reimbursement rules, computer problems, and mishandled claims—this according to an article in Kaiser Health News published on October 6, 2021 available here. An Anthem spokesperson was quoted, saying “[w]e recognize there have been some challenges” and “[w]e apologize for any delays or inconvenience this may have caused.” Hospitals cite a variety of causes to the payment delays and denials, including “new layers of document requirements, prior-authorization hurdles for routine procedures and requirements that doctors themselves—not support staffers—speak to insurance gatekeepers.” <Read More>

    Abstract Demonstrates Safety Events Reduced Through Notifying Pharmacies of Discontinued Prescriptions – October 28, 2021 – An abstract presented at the American College of Cardiology Quality Summit Virtual showed that there are several methods that can be used to alert community pharmacy staff about canceled medications, potentially avoiding nearly 200 safety events over 2 months. The study sought to highlight the issues with the correct routing of discontinued medications, which increases the risk of medication safety events. This issue continues to grow as many prescriptions are sent to pharmacies via electronic health record systems. “Currently there is no ideal way to notify a pharmacy that a clinician has discontinued medication for a patient, often leading to a discontinued medication or incorrect dose to be refilled and causing confusion for the patient,” said study author Jeffrey A. Goss, FNP-c, MSN. <Read More>

    CVS Returns to the Military Tricare Pharmacy Network. Walmart’s Out – October 28, 2021 – Military community beneficiaries who use Walmart and Sam’s Club pharmacies will have to go elsewhere to fill their prescriptions, as those pharmacies leave the Tricare network as of Dec. 15. “Walmart declined several opportunities to offer more highly competitive discounts to continue to serve Tricare beneficiaries,” said Express Scripts officials, in a statement to Military Times. Express Scripts is the contractor that manages the Tricare Pharmacy Program, which serves 9.6 million active duty, retirees and family members. <Read More>

    CDC Launches New Education Campaigns Aimed at Preventing Drug Overdose Deaths – October 27, 2021 – To save more lives from drug overdose, the Centers of Disease Control and Prevention (CDC) recently launched four complementary education campaigns intended to reach young adults ages 18—34 years. The campaigns provide information about the prevalence and dangers of fentanyl, the risks and consequences of mixing drugs, the life-saving power of naloxone, and the importance of reducing stigma around drug use to support treatment and recovery. CDC spoke directly with young adults who reported using drugs, as well as peer recovery professionals, to develop the campaigns. Each campaign includes new resources on all four topics to help people make informed decisions, get the help they need, and ultimately reduce the rise in drug overdoses and overdose deaths. <Read More>

    Asembia 2021: Specialty is a Growing Share of the Pharma Market. PBMs, Health Systems Are Vying for That Larger Slice of the Pie – October 27, 2021 – Pharma industry experts Adam Fein, Ph.D., and Doug Long, MBA, described the growth of specialty pharmacy and the competition for that part of the pharma market during the opening presentation at the Asembia 2021 Specialty Pharmacy Summit in Las Vegas. Specialty pharmacy, once a niche in the pharmaceutical industry, is on a trajectory to account for more than half of the industry’s revenues and that growth has set off some fierce competition for control of the specialty drug pricing and distribution, industry experts said at the Asembia 2021 Specialty Pharmacy Summit in Las Vegas. “Specialty drugs today are about 40% of the entire pharmacy industry’s revenues,” said Adam. <Read More>

    An Interchangeable Biosimilars vs Authorized Biologics Battle May be Looming – October 27, 2021 – Competitors in the field of adalimumab and insulin products may soon include “authorized biologics” in addition to biosimilars and interchangeable biosimilars, a pharmacy expert explains at the Academy of Managed Care Pharmacy Nexus 2021 meeting. The FDA has approved 2 interchangeable biosimilars—biosimilars that pharmacists could substitute interchangeably with reference drugs—since July 2021, but manufacturer-developers are seeking interchangeable status for about 7 other biosimilars, according to Jeff Casberg, MS, RPh, vice president of Clinical Development for IPD Analytics. Casberg participated in a presentation on interchangeable biosimilars at the recent Academy of Managed Care Pharmacy Nexus 2021 meeting in Denver, Colorado. <Read More>

    FDA, NIH, And 15 Private Organizations Join Forces to Increase Effective Gene Therapies for Rare Diseases – October 27, 2021 – The U.S. Food and Drug Administration, the National Institutes of Health, 10 pharmaceutical companies and five non-profit organizations have partnered to accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease. While there are approximately 7,000 rare diseases, only two heritable diseases currently have FDA-approved gene therapies. The newly launched Bespoke Gene Therapy Consortium (BGTC), part of the NIH Accelerating Medicines Partnership (AMP) program and project-managed by the Foundation for the National Institutes of Health (FNIH), aims to optimize and streamline the gene therapy development process to help fill the unmet medical needs of people with rare diseases. <Read More>

    AHF to Protest PBM Abuse by United Healthcare and its OptumRx PBM – October 26, 2021 – Healthcare advocates from across the country will join AIDS Healthcare Foundation (AHF) to protest unethical charges by United Healthcare and its OptumRx pharmacy benefits manager to independent and specialty pharmacies providing the sensitive, lifesaving medical needs of individuals living with HIV and other critical illnesses. United Healthcare, one of the nation’s largest medical insurance companies, who in 2020 made over $15 billion in profit, has disproportionality impacted access to care for those living with critical illnesses by adding arbitrary penalties and fees to small, independent pharmacies, which has resulted in many patients not having their medicines covered at their pharmacy of choice, thus causing many to fall out of care. <Read More>

    Strategies for Aligning and Integrating Infusion Services Across the Health System – October 26, 2021 – Aligning infusion care services under pharmacist leadership can be a win-win strategy for any health system, no matter how large or small, said experts at the 2021 ASHP Conference for Pharmacy Leaders, held virtually. Nancy Palamara, PharmD, the vice president for diagnostics and therapeutics at Holy Name Medical Center, in Teaneck, N.J., polled session attendees as to who at their institution has operational oversight of the outpatient infusion center and all of its staff. The most common response was a nurse manager (35%), followed by a nonclinical manager (15%), pharmacist (4%) and physician (2%); 31% of respondents said oversight was handled by a mix of those roles, while 13% did not know. <Read More>

    Little Things Can Cause Big Issues in Patient Care – October 26, 2021 – The patient—a woman with a neuroendocrine tumor—had waited at Baystate Medical Center’s infusion center for three hours. The lanreotide (Somatuline® Depot, Ipsen) injection for her tumor treatment had not arrived from the out-of-state third-party pharmacy as mandated by her insurance. No one at the hospital could trace it. The drug was reordered and the patient’s treatment had to be rescheduled. Although she received her treatment, the delay could have compromised her care. <Read More>

    PBMs’ Drug Formularies are Rapidly Shrinking, Research Shows – October 26, 2021 – The share of drugs covered by insurers is dropping at an increasingly fast pace, leaving many Americans with prescriptions their health plans don’t cover, according to research released Oct. 26 by GoodRx. GoodRx analyzed Medicare Part D data, examining coverage from an average of 3,707 plans from 2010 to 2021. On average, the share of covered drugs dropped by 18 percentage points from 2010 to 2021. The average plan covered 73 percent of prescribed drugs in 2010 but just 55 percent in 2021. The report said commercial plans likely saw an even steeper decrease in coverage. <Read More>

    What 5 Pharmacy Execs Would Tell Parents Unsure About Vaccinating Young Children Against COVID-19 – October 26, 2021 – Approval for the use of Pfizer’s COVID-19 vaccine in children ages 5-11 is expected soon, as the White House on Oct. 20 detailed its plan for quickly vaccinating this age group. Many parents are apprehensive about vaccinating their young children against COVID-19, so Becker’s gathered advice on the matter from chief pharmacy officers at health systems across the country. Susan Mashni, PharmD. Senior Vice President and Chief Pharmacy Officer at Mount Sinai (New York City): The CDC and FDA are in agreement that the Pfizer COVID-19 vaccine is both safe and effective in children 5 through 11…There is a lower dose for children, and a smaller needle, and our pediatric providers are anxiously awaiting the opportunity to provide this important protection against COVID-19 to children — both patients and their own children alike! As always, talk with your child’s pediatrician about any of your concerns about the vaccine. I feel very comfortable suggesting to my friends and family to have their kids immunized against COVID with the pediatric Pfizer vaccine. <Read More>

    Amazon Pharmacy: An industry disruptor—or a Misfire? – October 26, 2021 – Last year, Amazon announced the launch of Amazon Pharmacy, a move that many analysts thought could be disruptive in the pharmaceutical industry. But after its first year, some experts say Amazon Pharmacy is indistinguishable from other mail order pharmacies—though the company could be making moves to change that, Erin Brodwin reports for STAT+. Currently, Amazon Pharmacy provides discounts on prescription drugs through its subscription program, Amazon Prime, and allows customers to track their orders through Prime, Brodwin reports. It also allows customers paying with cash to price-shop their prescriptions through a partnership with Inside Rx, which allows Amazon to reference prices from Express Scripts. <Read More>

    Many Nonvalvular AFib Patients Skip DOAC Therapy Altogether – October 25, 2021 – One in ten patients with nonvalvular atrial fibrillation (NVAF) prescribed direct oral anticoagulants (DOACs) failed to take their first prescription, according to a new study published in the Journal of Managed Care + Specialty Pharmacy. DOACs are commonly prescribed to limit the risk of stroke among NVAF patients, the study’s authors explained, and nonadherence can have grave consequences for those individuals. However, they added, few studies have examined nonadherence rates found in real-world data. The team tracked data from 12,257 patients with NVAF who were treated from January 2009 to December 2015 in Spain. Fifty-three percent of the patients were men, and the mean patient age was 74.6 years old. Overall, primary nonadherence, defined as never collecting their first prescription, was seen in 10.4% of those patients. <Read More>

    Two New PBM Launches Aim to Bring Greater Transparency to the Market – October 25, 2021 – Two new pharmacy benefit management startups are aiming to inject greater price transparency into the market. The Purchaser Business Group on Health has announced Emsana Health, with its first business arm launching as EmsanaRx, a PBM. As PBGH is a coalition of 40 large employers, the company says its PBM solution is “built by employers, for employers.” Emsana Health aims to serve as an “innovation studio” that will develop new products and solutions designed with input from PBGH’s employer members. “Our members have asked us to use our unique position in the market and deep expertise with large employers to help them develop solutions for the pain points that aren’t being addressed by the status quo and to reshape the health care market so it delivers for them and the employees they cover,” said Elizabeth Mitchell, president and CEO of PBGH and chair of the Emsana Health board, in a statement. <Read More>

    Pharmacies Play Key Role as Center of Immunization Services – October 25, 2021 – Public recognition of their role has increased exponentially during the COVID-19 pandemic. The COVID-19 pandemic has made clear the essential role pharmacists play in immunizations, and as booster shots and the flu season approach, patients will continue to turn to pharmacists for necessary vaccines, according to a panel of experts in a recent Pharmacy Times® webcast. The webcast participants discussed the opportunities that pharmacists have to expand their services through immunizations. <Read More>

    Annual Report to the Nation Part 2: Patient Economic Burden of Cancer Care More Than $21 Billion in the United States in 2019 – October 25, 2021 – Part 2 of the latest Annual Report to the Nation on the Status of Cancer finds that cancer patients in the United States shoulder a large amount of cancer care costs. In 2019, the national patient economic burden associated with cancer care was $21.09 billion, made up of patient out-of-pocket costs of $16.22 billion and patient time costs of $4.87 billion. Patient time costs reflect the value of time that patients spend traveling to and from health care, waiting for care, and receiving care, according to the report. The report, appearing October 26, 2021, in JNCI: The Journal of the National Cancer Institute, is the most comprehensive examination of patient economic burden for cancer care to date and includes information on patient out-of-pocket spending by cancer site, stage of disease at diagnosis, and phase of care. <Read More>

    Use of Stimulants in Older Adults Associated With Higher Risk for Cardiovascular Events in First Month – October 25, 2021 – New research led by Mina Tadrous, Assistant Professor, Leslie Dan Faculty of Pharmacy, University of Toronto shows that use of prescription stimulant medications in older adults increased the risk of a cardiovascular events by 40 per cent within the first thirty days of medication use. The study was published in JAMA Network Open and is one of the first studies to explore the connection between cardiovascular (CV) events among older patients despite their increased baseline risk and the increasing use of stimulants to treat multiple conditions in this group including depression, poststroke recovery, motor function, and fatigue. <Read More>

    CDC Issues Orders Operationalizing the President’s Safer, More Stringent International Travel System – October 25, 2021 – The Centers for Disease Control and Prevention (CDC) is issuing orders to implement the new travel policy announced by the Biden administration to safely resume global travel to the United States while protecting the health and safety of American communities from COVID-19. These Orders put in place a stringent and consistent global international travel policy that is guided by public health. The announcement means that on November 8, non-U.S. citizens who are not immigrants to the United States will be required to be fully vaccinated and provide proof of their vaccination status to fly to the United States. There will be very limited exceptions to this vaccination requirement for certain non-U.S. citizens who are not immigrants, including children under the age of 18. <Read More>

    340B in the News

    Eli Lilly Serves up a Win Over Biden’s HHS in Drug Discount Court Case – November 1, 2021 – In the battle over a growing federal drug discount program and whether pharma companies can unilaterally change what entities receive certain discounts, the industry was just dealt a win from a US district court. The Indiana court ruled that a letter from HHS to drugmakers in May, which said their unilateral changes to the discounts were illegal, is “arbitrary and capricious.” Now HRSA, which runs the 340B drug discount program, has to come up with further consideration/action consistent with the opinion…However, the opinion also makes clear that “the statute, correctly construed, does not permit drug manufacturers, such as Lilly, to impose unilateral extra statutory restrictions on its offer to sell 340B drugs to covered entities utilizing multiple contract pharmacy arrangements,” judge Sarah Evans Barker wrote. <Read More>

    Federal Judge Rules HHS’ Efforts to Punish Pharma Over 340B Restrictions ‘Arbitrary and Capricious’ – November 1, 2021 – The pharmaceutical industry scored a muted win in its long-running feud with the Department of Health and Human Services (HHS) over 340B program discounts Friday when a federal court judge granted Eli Lilly’s bid to vacate two administrative actions aimed at drugmakers. U.S. District Court Judge Sarah Evans Barker ruled that a December advisory opinion from HHS’ Office of the General Counsel and a May enforcement letter from the Health Resources and Services Administration (HRSA) were “arbitrary and capricious” and in violation of the Administrative Procedures Act. But while Barker ordered the two actions to be set aside and vacated, she also specified that HHS did not exceed its statutory authority or act unconstitutionally in regard to the May enforcement letter. <Read More>

    Investigating if 340B Led to Improved Care in Underserved Populations – October 28, 2021 – In the years since its inception, debates around the 340B program have centered on whether savings actually benefit the underserved as intended. A new paper in The American Journal of Managed Care® analyzed secondary data on 340B participation and uncompensated care provision from general acute care and critical access hospitals between 2003 and 2015. The 340B drug pricing program was first established in 1992 and allows participating hospitals to manufacture discounts on drugs used in an outpatient setting. In years since, federal agencies have clarified savings from the program should be directed at improving care for underserved patients. One method of doing this is providing uncompensated care, or charity care and other unreimbursed care, to uninsured or underinsured patients. In the years since its inception, debates around the program have centered on whether savings actually benefit the underserved as intended. <Read More>

    Boehringer Ingelheim Latest to Take on HHS Over 340B Drug Pricing Program – October 27, 2021 – Pharmaceutical manufacturer Boehringer Ingelheim Pharmaceuticals Inc. (BI) filed suit against the Department of Health and Human Services (HHS), the Health Resources and Services Administration (HRSA), and their leaders on Monday over the 340B drug pricing program. The program is a provision of federal health care law requiring drug makers to provide certain drug dispensing entities with discounts. The District of Columbia lawsuit seeks a binding declaration that the 340B statute does not require the company to provide discounted drugs to contract pharmacies. <Read More>

    Unraveling the Growing Influence of Consolidation, 340B, and Industry in Specialty Pharmacy – October 27, 2021 – Panelists of the opening session at Asembia 2021 Specialty Pharmacy Summit in Las Vegas address emerging shifts in specialty pharmacy, its impact on the health care system, and future implications post pandemic. As the number of pharmacy locations with specialty pharmacy accreditation more than tripled in the United States from 2015 to 2020, the financial and structural impact of specialty drugs on the health care system continues to expand…For an average buy-and-bill drug in a hospital, the manufacturer gets about 20% of the revenue that the insurer pays and the rest gets absorbed due to both the markups and 340B, added Fein. Focusing on the 340B drug pricing program, roughly half of all US pharmacies are now 340B contract pharmacies. In addition to hospitals and clinics who receive a majority of 340B funding, retail and mail pharmacies now receive a large share of these dollars as well, despite pharmacies not being covered entities. “If you just look at a share of purchases by list prices, excluding all discounts and everything, 340B is more than 13% of all dollars in retail and mail pharmacy.” <Read More>

    Lilly Reports Robust Third-Quarter 2021 Financial Results as Pipeline Success Strengthens Future Growth Potential – October 26, 2021 –  Eli Lilly and Company announced financial results for the third quarter of 2021. “Lilly demonstrated strong performance again this quarter. Revenue attributable to our newer medicines grew more than 35 percent and represented nearly 60 percent of our core business, an important indicator of our long-term growth potential,” said David A. Ricks, Lilly’s chairman and CEO. “…Revenue in the U.S. increased 26 percent, to $3.990 billion, driven by a 22 percent increase in volume and a 4 percent increase due to higher realized prices. The company recognized U.S. revenue of $392.9 million in the third quarter of 2021 for COVID-19 therapies. Excluding that revenue, revenue in the U.S. increased by 14 percent. The increase in U.S. volume was driven by certain key growth products…Higher realized prices in the U.S. during the third quarter of 2021 were driven by lower utilization in the 340B segment, unfavorable changes to estimates for rebates and discounts for Trulicity® in the third quarter of 2020, and modest list price increases, partially offset by increased rebates to maintain access for products across the business. <Read More>

    Community Access National Network Releases Second Policy Report on 340B Drug Pricing Program – October 26, 2021 – All public-private partnerships require transparency to instill confidence in program function, private business operations, and government accountability. Transparency is an essential part of the equation; it brings us more accountability and more effective programs. It helps to identify areas of improvement in operations or enforcement, as well as limiting waste, fraud, and abuse. The 340B Drug Discount Program is no exception because transparency ensures investments into patient access to medications for critically vulnerable populations are reaching patients. Transparency – in every programmatic aspect – serves the public interest and is, frankly, just good government. It builds confidence in the efficacy of the program and good will of the participating entities. <Read More>