Clinical Insights: October 26, 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

    Dupixent® (dupilumab) Injection – New Expanded Indication Approval – October 20, 2021 – The U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) as an add-on maintenance treatment of patients aged 6 to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma. “This FDA approval brings new hope for children who may be suffering from life-threatening asthma attacks and poor lung function, affecting their ability to breathe, potentially into adulthood,” says Naimish Patel, M.D. Head of Global Development in Immunology and Inflammation at Sanofi. “Dupixent® has helped to make a difference to the lives of many patients and families across three diseases with underlying type 2 inflammation, with more than 300,000 patients treated globally. We now have the opportunity to offer a safe and effective option to children as young as 6 years of age living with certain types of moderate-to-severe asthma.” <Read More>

    Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide) – New Approved Strength and New Approved Expanded Indication – October 18, 2021 – Gilead Sciences, Inc. announced the U.S. Food and Drug Administration (FDA) approved a new low-dose tablet dosage form of Biktarvy® (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy. The approval of this supplemental New Drug Application (sNDA) expands the indication for Biktarvy® to include younger children living with HIV-1 infection and will help to close the gap between HIV treatment options available for adults and children. <Read More>

    New/Updated Drug Shortage

    October 25, 2021

    October 22, 2021

    October 21, 2021

    October 20, 2021

    New Drug Recall and Safety Alerts

    Cubicin® (Daptomycin for Injection) 500 mg – New Voluntary Recall – October 20, 2021 – Merck is voluntarily recalling one lot of Cubicin® (daptomycin for injection) 500mg for intravenous use, Lot 934778, Exp June 2022. Because treatment with Cubicin® is likely to be initiated at a hospital or other monitored healthcare setting, the recall is being conducted to the user level, including hospital and administering institutions. Approximately 22,000 vials are affected by this recall. The recall has been initiated following receipt of a customer complaint reporting that a piece of glass was found in a vial of Cubicin® after reconstitution. <Read More>

    Methocarbamol 500mg by Bryant Ranch Prepack – New Voluntary Recall – October 18, 2021 – Bryant Ranch Prepack is voluntarily recalling 1 lot of Methocarbamol 500mg, Tablets to the consumer level. The bottles labeled as Methocarbamol 500mg Tablets have been found to contain Methocarbamol 750mg Tablets. Risk Statement: If a patient takes a 750mg Tablet of Methocarbamol instead of the prescribed 500mg Tablets, it potentially could result in Excessive Central Nervous System depression which may result in nausea, sedation, fainting, falls, seizure, coma, and death. Bryant Ranch Prepack has not received any reports of adverse events related to this recall. <Read More>

    New Generic/Biosimilar Approval and Launch

    Cyltezo® – New Approved Biosimilar for Humira®October 18, 2021 – The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo® (adalimumab-adbm), originally approved in August 2017, is both biosimilar to, and interchangeable with (may be substituted for), its reference product Humira® (adalimumab) for Cyltezo®’s approved uses. Cyltezo® is the second interchangeable biosimilar product approved by the agency and the first interchangeable monoclonal antibody. Once on the market, approved biosimilar and interchangeable biosimilar products can play a role in facilitating access to treatments for many serious health conditions. <Read More>

    Clinical and Pharmacy News

    Walmart Must Pay Pharmacist $27.5M for Denying Her Breaks, Overtime Pay – October 25, 2021 – The District Court of Central California on Oct. 20 awarded $27.5 million to Afrouz Nikmanesh, PharmD, after she filed a class-action lawsuit against Walmart, her former employer. The pharmacist originally filed the case in Orange County Superior Court in 2015. It was later moved to the District Court of Central California, according to Courthouse News Service. In her complaint, Dr. Nikmanesh said Walmart denied her breaks and overtime wages, gave her inaccurate wage statements and terminated her employment wrongfully. She also said the retail giant forced her to study for and take an immunization certification exam but did not compensate her for this off-the-clock work. <Read More>

    ISMP, TJC Urge Safer Smart Pump Practices – October 25, 2021 – Although “smart” programmable IV pumps have become commonplace across hospitals and health systems, simply having the technology in place does not necessarily mean the brains of the device—namely, dose error reduction software (DERS)—are being adequately used. “There is room for improvement in monitoring of DERS use and in addressing the causes of non-utilization,” said Robert Campbell, PharmD, the clinical director of the Standards Interpretation Group and director of Medication Management, the Joint Commission, in Oakbrook Terrace, Ill. <Read More>

    Large Employer Group Launches New Pharmacy Benefit Management Business – October 25, 2021 – A nonprofit coalition of nearly 40 private employers, including U.S. retailers Walmart and Costco, said on Monday it has launched a new company that would offer pharmacy benefit management (PBM) services for employers. With the COVID-19 pandemic weighing severely on people’s emotional and physical wellbeing, companies have been looking to broaden their offerings to support their employees. EmsanaRx, the PBM unit of the coalition Purchaser Business Group on Health (PBGH), will provide employers a fixed price per prescription as well as guidance from a clinical pharmacist account manager. <Read More>

    Increasing Data Transparency in Pharmacy – October 25, 2021 – Pharmacy touches nearly everyone, and medications have the ability to deliver miracles every day. But in today’s system, medications are approved (or not), and often prescribed, largely based on “pay for placement” and multiple layers of rebates and fees, not clinical evidence revealing which drug would be most effective for a specific patient. And, because of the numerous and dramatic rebates and fees on the back end, a patient has no insight into the bottom-line net cost of the medication. This growing problem is exacerbated as the prevalence of high-deductible health plans grows and patient cost sharing increases. <Read More>

    Survey: US Pharmacists Have Homework to Do on Biosimilar Interchangeability – October 23, 2021 – Pharmacists have limited awareness of concepts underlying FDA approval of the interchangeable designation for biosimilars, according to survey findings presented at the Academy of Managed Care Pharmacy (AMCP) Nexus 2021 meeting. Just 20% correctly answered that based on FDA approval of interchangeable status, a pharmacist can substitute a biosimilar for a reference drug without consulting with the prescribing physician. Slightly more than half (53%) correctly answered that it is “appropriate for a pharmacist to dispense an interchangeable biosimilar in place of its reference product without authorization from the prescriber if consistent with state law.” <Read More>

    Antineoplastic Extravasation Prevention, Management – October 22, 2021 – Although infiltration can be defined as the inadvertent leakage of an irritant, extravasation is defined as the inadvertent leakage of a vesicant from the vein into surrounding tissue. During cancer treatment, extravasation is the accidental leakage of chemotherapy from the vein into surrounding tissue. Rates are not clearly defined and no centralized database of chemotherapy extravasation events exists, but some literature reports overall incidence as ranging from 0.1% to 6.5%. The damage potential from antineoplastic therapy extravasation ranges from mild toxicity, such as local pain and erythema, to severe toxicity including tissue necrosis. Because of the potential for severe tissue injury, it is imperative that preventive measures are taken and extravasation is identified and managed quickly. <Read More>

    Youngsters With ADHD Often Don’t Receive Best Treatment – October 22, 2021 – Families of young kids with ADHD should get parenting-skills therapy before other treatments When a 4- or 5-year-old is diagnosed with attention-deficit/hyperactivity disorder, the pediatrician is supposed to recommend a specific therapy to improve parents’ skill at handling the child’s behavior. The therapy, called Parent Training in Behavior Management, is backed by scientific evidence that shows it’s the best starting point for treating young kids with ADHD. The evidence has led the American Academy of Pediatrics to endorse the therapy in its clinical practice guidelines. But it’s not usually the first treatment offered to families, according to a Stanford Medicine study based on reviews of patient charts that published recently in JAMA Pediatrics. <Read More>

    Team Collaboration Crucial in Delivering Safe, Effective Ig Therapy – October 22, 2021 – The current edition of the Immunoglobulin National Society’s  (IgNS) “Immunoglobulin Therapy Standards of Practice” emphasizes the essential collaborative role that “pharmacists, nurses and prescribers play in the care of patients receiving immune globulin therapy,” Stacey Ness, PharmD, CSP, IgCP, MSCS, AAHIVP, the president of the IgNS, said at the organization’s 10th national conference, held this week. Dr. Ness, who is also vice president of clinical services for Managed Health Care Associates, described how the implementation of Ig standards can work in clinical practice to ensure optimal outcomes in patients who have a broad range of immunodeficiencies and other conditions. <Read More>

    How Tech-Enabled Pharmacy Can Help Reinvent the Pharmacy Experience – October 22, 2021 – The current retail pharmacy environment has relegated pharmacists to relatively mundane tasks—faxing documents, verifying medication, and answering the phone—rather than balancing those activities with the complex decision-making and patient care that pharmacists are trained to do. In fact, given today’s overburdened health care system, patients need pharmacists to practice at the top of their license. However, the outmoded technology used in many pharmacies keeps pharmacists behind the scenes, tethered to slow, intermittent communication with the rest of the patient’s care team. <Read More>

    Help Get the Right Medications at the Right Time – October 22, 2021 – Other health care stakeholders can learn from pharmacists’ patient-centered perspective in addressing high out-of-pocket costs. When discussing how to address high out-of-pocket health care costs, we should focus on what matters most: the patient, particularly the one at the pharmacy counter. This is more than an academic exercise for me. My interest in pharmacy began when I observed the health benefits that my own family members experienced thanks to medications dispensed by a pharmacist. Medications increase life expectancy and quality of life for millions of Americans. Research from the National Pharmaceutical Council found that physicians perceived medications as the most important contributor to improved patient outcomes for eight debilitating medical conditions over a 20-year period — more than any other medical innovation. <Read More>

    23andMe Expands Into Telehealth Care With Lemonaid Purchase – October 22, 2021 – Consumer DNA testing giant 23andMe Holding Co. agreed to purchase telehealth upstart and drug-delivery service Lemonaid Health Inc. in a bid to make its personalized genetics approach part of patients’ primary care. 23andMe will pay $400 million for Lemonaid, with 25% of the purchase price in cash and the rest in stock, according to a statement Friday. The acquisition is expected to close by the end of the year. <Read More>

    A Helping Hand From Leadership Boosts Biosimilars – October 21, 2021 – Corporate pharmacy support composed of clinical and financial resources, promotion of best practices, and enhanced communication with the C-suite significantly boosted biosimilar conversion rates and doubled drug savings during a pilot program within a large health system. Such a program can address many of the operational challenges associated with efforts to increase biosimilar use across multiple care sites, according to investigators from Community Health Systems (CHS), based in Franklin, Tenn., who described the program during the 2021 ACCP virtual poster symposium (abstract 182). <Read More>

    Four Health Insurance Leaders Share Their Top Goals for the Year Ahead – October 20, 2021 – Four health insurance executives recently shared their top goals and priorities as they lead their organizations out of the pandemic. Here is what they told Becker’s: Susan Diamond, CFO of Humana: Certainly the number one thing is just navigating the challenges caused by COVID. It’s certainly a challenging time, not only for our associates and our members and our partners but also investors. A lot of my time right now is just spent continuing to look for ways to support each of those constituency groups. And obviously that will continue until everything returns to a more normal state.  As the new CFO within a public company, I’m spending a lot of time getting to know the investors. I am committed to providing transparency for them, and again, in this environment, if you listened to our second-quarter call, that can be challenging — just trying to help them understand the range of complexities we’re managing and giving them visibility into our emerging experience. <Read More>

    Panel: Biosimilar Acceptance may be Greater Among Payers Than Previously Thought – October 20, 2021 – A panel discussion at AMCP Nexus 2021 explored the current biosimilar landscape and level of uptake, with survey results showing payers are accepting of biosimilars and that a majority support nonmedical switching. Payers were found to be more accepting of biosimilars than expected, according to survey results presented during a panel discussion at the Academy of Managed Care Pharmacy’s 2021 Nexus meeting. The panel discussed the current trajectory of biosimilar adoption, barriers to adoption, and how coverage of biosimilar is anticipated to evolve in the coming years. <Read More>

    Express Scripts Puts Insulin Biosimilar Semglee® on Preferred Formulary – October 20, 2021 – Express Scripts will prefer the first Food and Drug Administration-approved interchangeable biosimilar product, a move it says will lead to millions in savings. Semglee®, which was developed by Viatris, was approved by the FDA in late July. Express Scripts will move the product to its National Preferred Formulary, which reaches 28 million members. By making the change, the pharmacy benefit manager estimates it could achieve $20 million in savings in 2022. In addition, Express Scripts said Sanofi’s biologic insulin injection Lantus® will be excluded from its National Preferred Formulary. <Read More>

    FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines – October 20, 2021 – The U.S. Food and Drug Administration took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The agency is amending the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose as follows:  The use of a single booster dose of the Moderna COVID-19 Vaccine that may be administered at least 6 months after completion of the primary series to individuals: 1) 65 years of age and older, 2) 18 through 64 years of age at high risk of severe COVID-19, or 3) 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2. <Read More>

    APhA Statement on Administration Plan to Vaccinate Children Aged 5 to 11 Against COVID-19 – October 20, 2021 – The American Pharmacists Association supports the Biden administration’s efforts to implement a comprehensive plan to vaccinate children aged 5 to 11 against COVID-19. After authorization from the FDA and CDC, it will take everyone in the immunization neighborhood to get the job done – pharmacists, pharmacy interns, pharmacy technicians, public health, physicians, nurses, and other trusted community stakeholders. The vaccines are safe and effective, and the data clearly shows that the overwhelming majority of cases, hospitalizations and deaths are occurring among the unvaccinated. <Read More>

    Pharmacy Leaders Must Stay Nimble, Competitive in Rapidly Changing Managed Care Market – October 20, 2021 – Managed care market dynamics are changing quickly, so hospital and health-system pharmacy leaders need to be nimble and work with their managed care teams to maintain a competitive strategy, speakers said at the 2021 ASHP Conference for Pharmacy Leaders, held virtually. Unprecedented mega-mergers have impacted the market, with payors such as UnitedHealth Group joining forces with or acquiring pharmacy benefit managers and pharmacies, said Paul Spencer, MBA, the vice president of managed care and revenue cycle for Froedtert Health, in Milwaukee. <Read More>

    New Shorter Treatment Regimen Found to be Safer, More Effective at Treating Drug-Resistant TB – October 20, 2021 – A new all-oral six-month treatment regimen is safer and more effective at treating rifampicin-resistant tuberculosis (RR-TB) than the current accepted standard of care, according to results announced at the 52nd Union World Conference on Lung Health. These results, which are not yet peer-reviewed, signal the start of a new chapter for people with drug-resistant (DR)-TB who currently face lengthy treatment regimens of up to 20 months that can include painful injections and up to 20 pills a day that can cause severe side-effects. These grueling regimens only cure one in two patients and can have a catastrophic effect on people’s physical and mental health, as well as their financial and social lives. <Read More>

    National Pharmacy Week, American Pharmacists Month Have Been Celebrated for Nearly a Century – October 20, 2021 – The first “National Pharmaceutical Week” was proposed at the 1924 annual meeting of the American Pharmaceutical Association (APhA) by Robert J. Ruth, a pharmacist from North Carolina. One year later in 1925, the inaugural week celebrating pharmacy was held from October 11 to 17. Ruth envisioned this would be a week to commemorate the contributions made by pharmacists to their patients and communities. The original intent of this week was to remind pharmacists of their responsibility to the public to uphold a standard of ethics. Seventy-nine years later, the APhA expanded the week into a month-long celebration. <Read More>

    What are the Newest Drugs for Treating Psoriatic Arthritis? – October 19, 2021 – Almost one-third of people with psoriasis develop PsA. The condition most commonly develops in people ages 30–50 years. The onset may be gradual and mild, or it may be more sudden with severe symptoms. Rheumatologists and dermatologists are typically those who treat PsA. Treatment aims to reduce pain and swelling, help the joints work correctly, and prevent ongoing joint damage. This article looks at newly approved drugs for treating PsA, some medications still in clinical trials, and other treatments for the condition. <Read More>

    New ESMO Clinical Practice Guideline for Managing Metastatic Breast Cancer Released – October 19, 2021 – The much-anticipated ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer has been published in Annals of Oncology. Amidst public information and support initiatives taking place worldwide on the occasion of Breast Cancer Awareness Month, the publication marks a milestone for the translation of recent research achievements into practical improvements to patient care in the era of precision medicine. With clinical trial evidence on novel therapeutic approaches now sufficiently robust to inform oncologists’ routine decision-making processes, the newly released guideline encompasses all major developments of the last few years to offer a comprehensive picture of the state of the art in advanced breast cancer management. <Read More>

    Low-Dose Aspirin has Limited Benefits in Adults Without Heart Disease: Yale Experts Explain Why Talking to a Doctor can Help – October 19, 2021 – Decades of research has shown the benefits of aspirin to reduce the chances of having a heart attack, stroke, or colon cancer. Now the preliminary guidelines suggest that adults who may be prone to cardiovascular disease may benefit more from blood pressure management or statins. The U.S. Prevention Services Task Force (USPSTF), an independent panel of U.S. experts, issued draft guidelines on the primary prevention of heart attack and stroke. Currently under review, the USPSTF report could alter the 2016 recommendations by discouraging adults over the age of 60 — specifically those without known cardiovascular disease—from a low-dose aspirin regimen. Rohan Khera, MD, MS, an assistant professor at the Yale School of Medicine and Erica Spatz, MD, MHS, director of the Preventive Cardiovascular Health Program, associate professor at the Yale School of Medicine, and associate professor of epidemiology at the Yale School of Public Health, discuss emerging guidance on the overall benefit of aspirin therapy among older adults. <Read More>

    National Association of Specialty Pharmacy Announces New Board of Directors Chairman and Members – October 19, 2021 – The National Association of Specialty Pharmacy (NASP), a 501(c)(6) non-profit trade organization representing all stakeholders in the specialty pharmacy industry, announced the appointment of Kyle Skiermont, PharmD, as Chairman of its Board of Directors. Skiermont, who joined the NASP Board in 2016, succeeds Michael Einodshofer, RPh, MBA. “It has been a great honor to have served as Chairman,” said Einodshofer. “I am incredibly proud of our accomplishments during my term. Despite the pandemic, we increased our overall membership and attracted new corporate members both large and small on our journey to be the unified voice of specialty pharmacy.   I’m excited to transition the Chairman role to Kyle, who undoubtedly will continue to expand NASP’s influence on clinical practice standards, specialty certification, education, and advocacy.” <Read More>

    Eight Tips for CSTD Implementation – October 19, 2021 – Implementing closed system drug-transfer devices (CSTDs) can be a daunting task, with challenges ranging from device selection to justifying the investment during budget negotiations with the C-suite. Fortunately, there are lessons learned from facilities that already have rolled out the technology. Here are eight tips to keep in mind if your facility has not yet jumped on the CSTD train. 1) Don’t over-emphasize cost. Budget dollars have typically played an outsized role in discussions of CSTDs, said Patricia C. Kienle, RPh, MPA, the director of accreditation and medication safety for Cardinal Health. “If money wasn’t the issue, nobody would be talking about this. We’d all be doing it. But people need to be safe,” added Ms. Kienle, also a member of the USP Compounding Expert Committee. “So, remember that USP <800> requires CSTD use for administration of [certain] antineoplastics when the dosage form allows.” (It also “recommends” use of the device in preparing the drugs.) <Read More>

    Adapting to a Remote Pharmacy Workforce Post-Pandemic – October 19, 2021 – Many aspects of health-system pharmacy are likely to stay remote even after the COVID-19 pandemic is over, according to attendees at the 2021 ASHP Conference for Pharmacy Leaders, held virtually. In a session on managing remote teams, 82% of participants surveyed said their pharmacy had staff performing work from home during the past year, and 71% said these arrangements have been ongoing and/or they are planning to continue work-from-home arrangements. Session attendees were asked which hospital pharmacy functions they would be most willing to have performed remotely: acute care rounding or clinical work, order verification, patient onboarding to a new drug therapy, or all of the above. <Read More>

    American Pharmacists Month: You Stand by us all – October 19, 2021 – As we reach the midpoint of American Pharmacists Month, we must continuously honor the pharmacists who do heroic work every day in the face of incredible pressures. Pharmacy workforce shortages exist in almost every area of the country. Corporations can seem insufficiently responsive to the stresses of pharmacy practice. Patients may aggressively challenge the professional judgment of pharmacists and other pharmacy personnel. A toxic mixture of vaccine misinformation and disinformation fuels distrust. Keeping up-to-date with the rapidly evolving vaccine guidance from government authorities can be difficult. We recognize these problems and are thankful for your invaluable work. <Read More>

    Reinventing Health Care: The Aetna Connected Plan With CVS Health™ is Helping Deliver Cost-Effective, Accessible and Easy Health Care – October 19, 2021 – The Aetna Connected Plan with CVS Health™ is a first-of-its-kind plan offering that will deliver the unique CVS Health and Aetna capabilities in the Columbus market to help members access care when and where they need it – and at a lower cost than a traditional plan. The plan combines the country’s largest independent primary care practice – Central Ohio Primary Care (COPC) network, with Aetna’s Broad Local Network in Columbus with access to expanded services at CVS pharmacy. <Read More>

    340B in the News

    AHF Praises HRSA for Recent Action to Defend Vital 340B Program – October 21, 2021 – AIDS Healthcare Foundation (AHF) welcomed and praised recent action taken to defend the 340B drug pricing program by the U.S. Health Resources & Services Administration (HRSA). On September 22, 2021, HRSA referred six drug manufacturers to the U.S. Health and Human Services Department of the Office of the Inspector General (HHS OIG) for their refusal to offer 340B discounts to 340B covered entities. 340B has helped provide low-cost medications and better health outcomes for millions of Americans and the nonprofit clinics and hospitals that serve them. The companies being referred are AstraZeneca, Eli Lilly, Novartis, Novo Nordisk, United Therapeutics, and Sanofi. The move is a significant step in the fight to protect the program from drug companies who have refused to comply with requests from HRSA to resume offering 340B pricing to contract pharmacies. HRSA previously warned each of the manufacturers in letters dated May 17 that their refusal to offer discounts through contract pharmacies “have resulted in overcharges and are in direct violation of the 340B statute.” <Read More>

    340B Price Restriction Development – HRSA Moves 340B ADR Complaints Forward – October 21, 2021 – Recently, HRSA verbally confirmed that it has assigned Administrative Dispute Resolution (ADR) panelists, a key development to move a handful of pending ADR complaints forward. Those complaints contain allegations that drug manufacturers violated the 340B statute by restricting access to 340B pricing in contract pharmacies. The panel assignment is good news for Covered Entities (CEs) because ADR will likely be a valuable process to recoup the significant lost 340B opportunities stemming from recent manufacturer restrictions. <Read More>

    Hospital Specialty Pharmacies can be Supported Through 340B Program Participation – October 19, 2021 – Actively managing participation in the federal 340B Drug Pricing Program can further support hospitals and health systems’ specialty pharmacy services through achieved savings, a panel of experts said during the 2021 ASHP Conference for Pharmacy Leaders, held virtually. But to understand the need for maximizing 340B savings, it’s important to understand the overall market pressures that health system–based specialty pharmacies are facing, noted Allison Bystriansky, MBA, a regional account director for Acentrus Specialty. It is expected that specialty prescription revenues will represent almost half of total prescription drug revenue by 2025, she said, citing statistics from the 2021 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers released by the Drug Channels Institute. <Read More>

    MDRP and 340B: Updates From Last Week – October 19, 2021- On October 13, 2021, the in-person portion of the annual informaconnect Medicaid Drug Rebate Program (MDRP) Conference concluded in New Brunswick, New Jersey.  A day earlier, on October 12, 2021, a joint hearing was held in Novartis Pharms. Corp. v. Espinosa, et al., 1:21-cv-01479-DLF (D.D.C.) and United Therapeutics Corp. v. Espinosa et al., 1:21-cv-01686-DLF (D.D.C.) to consider the question of whether manufacturers may restrict the circumstances under which they offer the 340B ceiling price through contract pharmacy arrangements.  We provide highlights from both events below. <Read More>