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Clinical Insights: April 6, 2022

Posted on April 6, 2022 By RxStrategies, Inc. -

Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy marketplace. Contact us to learn more.

New Drug Approval

Tlando™ (testosterone) Capsules – New Drug Approval – March 28, 2022 – Antares Pharma, Inc., a specialty pharmaceutical company, announced that the U.S. Food and Drug Administration granted final approval for Tlando™ (testosterone undecanoate), an oral treatment for testosterone replacement therapy (“TRT”) indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, “The FDA approval of Tlando™ brings to market an oral formulation of testosterone that we believe will prove beneficial to physicians and their patients. <Read More>

New Indication/Dosage/Formulation Approval

Yescarta® (axicabtagene ciloleucel) Suspension for Intravenous Infusion – New Approved Indication – April 1, 2022 – Kite, a Gilead Company announced the U.S. Food and Drug Administration (FDA) has approved Yescarta® (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Yescarta® demonstrated a clinically meaningful and statistically significant improvement in event-free survival (EFS; hazard ratio 0.398; P< 0.0001) over the current standard of care (SOC) that has been in place for decades. EFS was determined by blinded central review and defined as the time from randomization to the earliest date of disease progression, commencement of new lymphoma therapy, or death from any cause. <Read More>

 Triumeq® PD (abacavir, dolutegravir and lamivudine) – New Approved Dosage Form – March 30, 2022 – ViiV Healthcare, the global specialist HIV company majority-owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. (Pfizer) and Shionogi B.V. (Shionogi) as shareholders, has announced that the U.S. Food and Drug Administration (FDA) has approved a new drug application (NDA) for a dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine for the treatment of pediatric patients weighing 10kgs to <25 kgs with human immunodeficiency virus type 1 (HIV-1). In addition, a supplemental new drug application (sNDA) has been approved for Triumeq® tablet, lowering the minimum weight that a child with human immunodeficiency virus type 1 (HIV-1) can be prescribed this medicine to 25kgs from 40kgs. <Read More>

Ozempic® 2.0mg (once-weekly semaglutide subcutaneous injection) – New Approved Indication – March 28, 2022 – Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved a 2.0 mg dose of Ozempic® (once-weekly semaglutide subcutaneous injection), a glucagon-like peptide-1 (GLP-1) analogue for the treatment of adults with type 2 diabetes. Ozempic® is now approved in the US at 0.5 mg,1.0 mg and 2.0 mg doses for the treatment of type 2 diabetes in adults. Further, Ozempic® is indicated to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes and known heart disease. <Read More>

 Fintepla® (fenfluramine) Oral Solution – New Approved Indication – March 28, 2022 – UCB (Euronext: UCB), a global biopharmaceutical company, announced that Fintepla® (fenfluramine) oral solution CIV has been approved in the United States, by the U.S. Food and Drug Administration (FDA) for the treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age and older.  Additionally, the FDA has granted pediatric exclusivity for the product. It is already approved for the treatment of seizures associated with Dravet syndrome in patients two years of age and older in the US and EU. Fenfluramine for LGS is available in the US through a restricted distribution program, called the Risk Evaluation and Mitigation Strategy (REMS) Program. <Read More>

Cabenuva™ (Cabotegravir, Rilpivirine) Injection – New Labeling Revision – March 23, 2022 – ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, announced that the US Food and Drug Administration (FDA) approved a label update for Cabenuva™ (cabotegravir, rilpivirine) making the oral lead-in with cabotegravir and rilpivirine tablets optional. Oral cabotegravir and rilpivirine can be taken for a month to assess tolerability to the medicines prior to initiating cabotegravir and rilpivirine injections, a regimen co-developed as part of a collaboration with the Janssen Pharmaceutical Companies of Johnson & Johnson, but this oral lead-in is now optional after clinical trial data demonstrated similar safety and efficacy profiles for both initiation methods (with or without the oral lead-in). <Read More>

New/Updated Drug Shortage

April 05, 2022

April 01, 2022

March 31, 2022

March 30, 2022

New Drug Recall and Safety Alerts

IDArubicin Hydrochloride Injection USP 5 mg/5 mL by Teva – New Voluntary Recall – March 29, 2022 – Teva Pharmaceuticals has initiated a voluntary nationwide recall of lot 31329657B of IDArubicin Hydrochloride Injection USP 5 mg/5 mL vial, to the user level in the United States. This voluntary recall is initiated based on an internal inspection that found particulate matter in one vial of the product identified as silica and iron oxide. No other vials have been observed to contain this defect. To date, Teva has received no product quality complaints or adverse event reports of this nature for the subject recall lot. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

Fire on the Mountain: Addressing Pharmacy Staff Burnout – April 5, 2022 – The entire pharmacy profession and all those interested in medication safety need to coalesce around the need for systemic change in community pharmacy workplace environments. Authors’ note: This commentary includes lyrics from Fire on the Mountain by the Grateful Dead in 1978. The song was written as California hills were engulfed in flames and the message has been suggested to be: “How come we’re doing the same old same old when disaster is at hand?” We think this song speaks to where community pharmacy practice is today. Why do we continue to practice in workplaces that we know compromise our own health and the health of our patients? “Almost ablaze still you don’t feel the heat…It takes all you got just to stay on the beat” <Read More>

Public Health and Pharmacy Intersect, Providing Opportunities – April 4, 2022 – Pharmacists are making waves in public health practice. Throughout much of United States history—and certainly until the 1950s—the community drugstore served as a “primary gathering place–a hangout for school kids and a social center for adults—all drawn there by the sweet confections of the soda fountain,” reported the Chicago Tribune in 1985. The neighborhood pharmacy’s role as a gathering spot also firmly placed the pharmacist as the most accessible health care provider, explained Mitch Rothholz, RPh, chief of governance and state affiliates and executive director at the American Pharmacists Association (APhA). In fact, a 2022 study revealed patients go to their community pharmacies “almost twice as often as they visit their physicians or other [qualified health providers].” <Read More>

Extended-Duration Prophylaxis With Letermovir May Reduce CMV Reactivation in HSCT – April 4, 2022 – Extended-duration prophylactic therapy with letermovir (Prevymis™, Merck) may reduce cytomegalovirus (CMV) reactivation in allogeneic hematopoietic stem cell transplant (HSCT) patients, according to a small study presented at the 2022 Hematology/Oncology Pharmacy Association annual conference. Despite advances in diagnosis and treatment, CMV reactivation remains a common complication, and the most common clinically significant infection, among HSCT recipients. Letermovir was approved for CMV prophylaxis in HSCT patients in November 2017, following the results of a phase 3 trial demonstrating that it resulted in a significantly lower risk for clinically significant CMV infection than placebo, without significant toxicities. <Read More>

How Rapidly Did Hospitals Adopt COVID-19 Recommended Procedures? – April 4, 2022 – Hospitals and other healthcare facilities are notoriously slow to adopt new treatments or practices, with one study estimating this time lag to be as great as 17 years. However, the outbreak of the highly infectious COVID-19 respiratory virus called for new standard operating procedures to be implemented immediately. A new study, published in JAMA, sought to assess the rapidity and fidelity with which academic medical centers adopted COVID-19 procedural evidence into practice. The survey study was co-led by Thomas Jefferson University and the University of California, San Francisco (UCSF). <Read More>

CMS Rolls Out Free At-Home COVID-19 Tests for Part B, Medicare Advantage Beneficiaries – April 4, 2022 – Medicare beneficiaries in Part B can now get at-home COVID-19 tests from participating pharmacies and providers. The Centers for Medicare and Medicaid Services announced Monday that beneficiaries can get up to eight at-home tests at participating pharmacy chains such as CVS, Rite Aid, Costco and Walmart and other providers, a few months after the Biden administration required private insurers to reimburse customers for tests. “This is all part of our strategy to ramp up access to easy-to-use, at-home tests free of charge,” said Health and Human Services Secretary Xavier Becerra in a statement Monday. <Read More>

Software a Big Time-Saver in Drug Diversion Detection – April 4, 2022 – A software-based analytics tool that enhances monitoring and auditing improved the effectiveness of a healthcare system’s drug diversion surveillance program, according to a presentation at the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually. Within six months, the application led to an increase in document reconciliation and significant reductions in time spent to complete audits and investigations, JoAnne Myhre, CPhT, FMSHP, the drug diversion program manager at Allina Health System in Minneapolis, and her colleagues reported. <Read More>

Pharmacist’s Fundamental Responsibilities and Rights – April 4, 2022 – The American Pharmacists Association (APhA) and the National Alliance of State Pharmacy Associations (NASPA) call for support of the Pharmacist’s Fundamental Responsibilities and Rights (Fundamentals), a set of principles focused on pharmacists’ responsibilities and the workplace expectations needed to fulfill those responsibilities. The Fundamentals serve as a road map to engage in meaningful discussion about the pharmacy practice workplace across practice settings. Recognized organizations (e.g., national and state professional associations, pharmacy and pharmacy-related companies, single and multiunit independent pharmacies, hospital/health systems, and the pharmaceutical industry) are invited to support the Fundamentals by completing an online attestation. At this time, individual support is not being sought. <Read More>

Pharmacy Industry Voices Opposition to California’s Effort to Prohibit Discriminatory PBM Practices – April 4, 2022 – Sen. Richard Pan (D-Sacramento) is sponsoring a bill that would prevent pharmacy benefit managers (PBMs) from discriminating against 340B-covered entities for which they’re statutorily required to provide discounted prescription drugs. While the Senate Health Committee recently voted to advance the bill, pushing it closer to a full Senate floor vote, drug manufacturers voiced their concern over the legislation during a hearing, saying it doesn’t align with the program’s original requirements and unfairly restricts their ability to impose what they consider to be reasonable price constraints. <Read More>

Medical Therapy and Guideline Updates for Peripheral Arterial Disease – April 3, 2022 – Multiple approaches can be taken to optimize medical therapy in patients with PAD. A session presented at the American College of Cardiology Scientific Sessions 2022 on treatments for peripheral arterial disease (PAD) highlights the promising future of therapy for cardiovascular health. Connie Ng Hess, MD, MHS, provided updates on PCSK9 inhibitors (PCKS9i) and anticoagulation treatments as well as the risk of major cardiovascular events (MACE) and how to optimize the common risk factors in PAD: lifestyle modification, diabetes risk, lipid risk, and thrombotic risk. <Read More>

Why White Bagging is a Symptom of High Drug Costs, and What States are Doing – April 3, 2022 – Many oncologists oppose white bagging because they prefer to be able to adjust doses during a visit based on lab reports taken that day. The rise of white bagging is wreaking havoc for patients and has spurred legislation in several states, according to 2 experts who said their oncology practices refuse to take part in the practice. With white bagging, pharmacy benefit managers (PBMs) require certain high-cost drugs to be shipped from their own specialty pharmacies to practices, where clinicians then administer the drugs to patients—assuming the drugs arrive safely and no dose changes are needed. But the real issue, according to a third expert on Friday’s panel on PBM practices during the National Comprehensive Cancer Network (NCCN) annual meeting, is that payers are determined to do something about rising drug costs. <Read More>

Biosimilars for Oncology Gaining Ground – April 1, 2022 – Biosimilars for oncology are gaining ground, with more payors implementing strategies to cover them and large projected savings for health plans, health systems and patients, speakers said during a panel discussion at the AMCP 2022 annual meeting. Biosimilars are defined as biologic products approved by the FDA based on demonstrating they are highly similar to an FDA-approved biologic product, also known as the reference product, said Yuqian Liu, PharmD, the director of specialty clinical solutions at Magellan Rx Management. Legislation enacted in 2010 created a regulatory pathway for FDA approval of biosimilars, but patent litigations prevented most biosimilars from entering the market immediately, she said. <Read More>

Value-Based Contracting Likely to Continue Evolving – April 1, 2022 – Value-based contracts (VBCs) can provide opportunities for manufacturers to evaluate clinically appropriate outcomes not studied in clinical trials, while offering attractive pricing for payors, speakers said during a panel discussion at the AMCP 2022 annual meeting. They offered insight into this continuing evolving marketplace and advice for plans on how to pursue such contracts. VBCs are agreements between the manufacturer and a payor, with the goal of improving quality of care, managing utilization and reducing price, said Mahsa Salsabili, PharmD, PhD, a pharmacoeconomics specialist with the University of Massachusetts Chan Medical School, in Worcester. The amount reimbursed to the payor is linked to an agreed-upon clinical, utilization or other intermediary end point, she said. <Read More>

Double Antibiotic Coverage Does Not Improve Outcomes in Febrile Neutropenia – April 1, 2022 – Early empirical double coverage with an aminoglycoside added to cefepime for the initial management of febrile neutropenia offers no significant difference in outcomes compared with monotherapy, according to a new study presented at the 2022 annual meeting of the Hematology/Oncology Pharmacy Association. Guidelines for high-risk febrile neutropenia management, including those from the Infectious Diseases Society of America (IDSA) and the National Comprehensive Cancer Network (NCCN), recommend monotherapy with an antipseudomonal beta-lactam in patients with febrile neutropenia—but with some caveats, said Amber B. Clemmons, PharmD, BCOP, a professor of pharmacy at the University of Georgia (UGA) College of Pharmacy, in Athens. <Read More>

Financial Health Spotlight: The Real Costs of Managing Metastatic Prostate Cancer – April 1, 2022 – About 7 percent of prostate cancer cases are metastatic. This means the cancer has spread from the prostate into other parts of the body. Prostate cancer usually metastasizes to bones. Treatment for any type of cancer can be financially overwhelming. Treating advanced cancer piles on the expenses at a time when your primary concern is comfort and recovery, whether it is your own or that of your loved one. Here, we’ll give you some tips on managing treatment decisions for metastatic prostate cancer and what you can expect it to cost. <Read More>

New Heart Failure Guidelines Add Another Type of Meds to Treatment Recommendations – April 1, 2022 – The American College of Cardiology, the American Heart Association and the Heart Failure Society of America released new guidelines Friday that add a fourth class of medication to the recommended treatment plan for people who have a condition called heart failure with reduced ejection fraction. Heart failure is caused by weakened muscles that lower the heart’s ability to properly squeeze and pump blood. Nearly 6.2 million Americans have it, according to the US Centers for Disease Control and Prevention. Heart disease is the leading cause of death for both men and women in the US, accounting for almost 400,000 deaths a year as of 2018, and heart failure accounts for 8.5% of those deaths. <Read More>

Pharmacists’ Scope of Practice Grows Despite Physicians’ Objections – April 1, 2022 – A growing number of states have moved to expand what pharmacists can do to include treating a range of conditions, such as strep and flu, for which there are rapid point-of-care tests, Kaiser Health News reported March 31.  More than a dozen states have OK’d pharmacists to test and treat people for things like urinary tract infections, strep and flu, according to the National Alliance of State Pharmacy Associations. Pharmacists typically have this ability through annual collaborative practice agreements with local physicians that are subject to state approval. A smaller number of states have looked to further expand pharmacists’ roles, allowing them to prescribe medications for a range of conditions outside of these agreements. <Read More>

Concentrated Saline Improves Severe Traumatic Brain Injury in Children – March 31, 2022 – When people think about traumatic brain injury, or TBI, most picture professional football players, their bodies slamming hard against the ground. But severe brain trauma—due to motor vehicle accidents, falls from heights, gun shots or domestic abuse—is also a serious problem in children, leading to thousands of deaths annually and a lifetime of disabilities in those who survive. A new study from the University of Pittsburgh, published in JAMA Network Open earlier this month, was the first to compare effectiveness of two therapies that reduce brain swelling in kids with TBI. The data, collected as part of an international clinical trial with thousands of pediatric patients, showed that a concentrated mixture of salt and water is more effective at reducing pressure in the skull and preventing serious brain damage than the traditionally used sugary solution called mannitol. <Read More>

AHA Urges FTC, Justice Department to Update Merger Guidelines – March 31, 2022 – The American Hospital Association is prompting the Federal Trade Commission and the U.S. Department of Justice to update its merger guidelines, in response to a request by the two federal agencies for comments and suggestions regarding how to overhaul the merger rules. The FTC and DOJ have solicited suggestions about modernizing the guidelines in ways that better detect and prevent anti-competitive deals. In a March 30 letter to the agencies, the AHA floated two proposed revisions: that antitrust enforcers should address defects in the economic models used to evaluate hospital transactions, and that guidelines should enable antitrust agencies to account for the better care coordination that can be achieved through mergers. <Read More>

Digital Therapeutics Hold Promise for Behavioral Health – March 31, 2022 – Digital therapeutics could serve as effective complementary therapies for behavioral health conditions, or even stand-alone therapies for mild conditions. But to date, few health plans cover them as the search for more robust outcomes data continues, speakers said during the AMCP 2022 Annual Meeting. Digital therapeutics are evidence-based interventions using high-quality software programs to prevent, manage or treat medical disorders or diseases. Ten such products have been cleared by the FDA for use in the management of behavioral health disorders, said Michael Angelini, PharmD, BCPP, a professor of pharmacy practice at Massachusetts College of Pharmacy and Health Sciences in Boston. <Read More>

Remote Clinical Oncology Pharmacists Beneficial to Community Clinics, Study Shows – March 31, 2022 – Remote clinical oncology pharmacists can provide financial and patient care support to community-based oncology practices that have been affected by staffing shortages or where telepharmacy might be necessary, new research shows. Speaking at the 2022 Hematology/Oncology Pharmacy Association annual conference, Melissa Carroll, PharmD, a senior clinical pharmacist at McKesson and the U.S. Oncology Network, outlined a review program that employed three remote clinical pharmacist services at four community oncology practices in the United States. <Read More>

Clinical Outcomes of Oral Anticancer Regimens in NSCLC Patients Managed in an Integrated Health-System Specialty Pharmacy Program – March 31, 2022 – Pharmacist interactions provide significant benefits for patients with non-small cell lung cancer treated with oral oncolytics. Non-small cell lung cancer (NSCLC) treatments are rapidly evolving and there is an increasing number of oral oncology medications available for patients. The use of oral therapies present new challenges compared with intravenous (IV) therapy. Adherence with IV therapy is ensured at each infusion in which staff prepare, deliver, observe, and document each treatment. With oral therapy, patients are responsible for taking their medication at home, where there is a risk for missed or forgotten doses, taking doses earlier or later than recommended, and not refilling medications. <Read More>

A Simple Solution Would Make COVID Antivirals More Accessible, Pharmacists Say – March 31, 2022 – People in the U.S. who suspect they have COVID may now be able to get tested and treated much more quickly, thanks to a new federal program announced by President Joe Biden in his March 1 State of the Union address. The initiative, known as Test to Treat, allows people to take a COVID test at certain pharmacies and other sites—or send in the results of an at-home test—and receive a prescription for antiviral pills from medical providers at the same location. <Read More>

CDC Weighs Removing Dosing Limits for Opioids – March 30, 2022 – Federal health officials are considering a plan to update restrictions on opioid prescribing as pain management groups push for changes to help people with chronic illnesses get their medication. The U.S. Centers for Disease Control and Prevention is finalizing new federal clinical practice guidelines on opioid prescribing that will remove a recommended ceiling on opioid doses and urges physicians to use “non-opioid therapies” to treat chronic and acute pain, such as physical therapy, yoga and acupuncture. The draft guidelines, once finalized, would be the first major revision of the federal agency’s opioid prescribing guidelines in more than five years. Pain management groups, which have aggressively pushed to update the CDC’s 2016 prescribing guidelines, said they see progress in revisions to the rules. <Read More>

Walgreens Turns to Robots to Fill Prescriptions, As Pharmacists Take on More Responsibilities – March 30, 2022 – Walgreens Boots Alliance is opening robot-powered micro-fulfillment centers across the U.S. to fill customers’ prescriptions as the role of stores and pharmacists change. The drugstore chain plans to open 22 facilities across the country. By 2025, as much as half of Walgreens’ total prescription volume could be filled at the automated hubs, said Rex Swords, who oversees the network of facilities as Walgreens’ group president of centralized services, operations and planning. <Read More>

CVS Reaches $484M Settlement With Florida Over Opioid Case – March 30, 2022 – CVS Health will pay the state of Florida $484 million to settle claims related to opioid prescriptions at its pharmacies. The settlement will resolve claims dating back more than a decade, according to the announcement from CVS. The settlement amount will be paid over the course of 18 years. “Putting these claims behind us is in the best interest of all parties and helps sharpen our focus on delivering a personalized, connected health care experience for the millions of consumers who rely on us,” said Thomas Moriarty, chief policy and external affairs officer and general counsel at CVS Health, in a statement. <Read More>

Arkansas Health Care Group Asks to Intervene, Says Overturning Lawsuit Could Lead to Higher Drug Prices for Patients – March 29, 2022 – Community Health Centers of Arkansas said in its filing Monday that if the law is overturned, it will negatively impact the ability of its member community health centers to provide care to the approximately 240,000 low-income patients it serves on an annual basis. The nonprofit organization that represents 12 community health centers filed its request in federal court Monday to intervene in the lawsuit filed last October by Pharmaceutical Research and Manufacturers of America (PhRMA). The lawsuit seeks to overturn a state law passed in 2021 that requires drugs discounted under the federal 340B Drug Pricing Program to be extended to contract pharmacies. <Read More>

CDC Recommends Additional Boosters for Certain Individuals – March 29, 2022 – Data continue to show the importance of vaccination and booster doses to protect individuals both from infection and severe outcomes of COVID-19. For adults and adolescents eligible for a first booster dose, these shots are safe and provide substantial benefit. During the recent Omicron surge, those who were boosted were 21-times less likely to die from COVID-19 compared to those who were unvaccinated, and 7-times less likely to be hospitalized. CDC continues to recommend that all eligible adults, adolescents, and children 5 and older be up to date on their COVID-19 vaccines, which includes getting an initial booster when eligible. Following FDA’s regulatory action, CDC is updating its recommendations to allow certain immunocompromised individuals and people over the age of 50 who received an initial booster dose at least 4 months ago to be eligible for another mRNA booster to increase their protection against severe disease from COVID-19. Separately and in addition, based on newly published data, adults who received a primary vaccine and booster dose of Johnson & Johnson’s Janssen COVID-19 vaccine at least 4 months ago may now receive a second booster dose using an mRNA COVID-19 vaccine. <Read More>

Pfizer Agrees to Supply UNICEF With up to 4 Million Courses of Oral COVID-19 Treatments – March 23, 2022 – Pfizer has announced that it will supply UNICEF with up to 4 million treatment courses of its COVID-19 oral treatment Paxlovid™ to 95 low- and middle-income countries, pending authorisation or approval. The deal is part of Pfizer’s comprehensive strategy to work toward providing global equitable access of its COVID-19 oral treatment. Paxlovid™ is a coronavirus main protease inhibitor – also known as SARS-CoV-2 3CL protease inhibitor – therapy. The drug was developed to be given to patients orally, meaning it can be prescribed at the first sign of infection or at first awareness of an exposure, pending the clinical success of the rest of the EPIC development programme and subject to regulatory authorisation. <Read More>

340B in the News

HRSA Calls for Boehringer Ingelheim to be Fined Over 340B Contract Pharmacy Restrictions – March 31, 2022 – The Health Resources and Services Administration (HRSA) has called for drugmaker Boehringer Ingelheim to be fined for its move to restrict sales of 340B-discounted products to contract pharmacies. The decision, outlined in a letter to the drugmaker, comes as the administration is fighting with five pharmaceutical companies over similar restrictions. The drugmakers have argued in court, with mixed results, that HRSA does not have the authority to issues warnings or fines and didn’t give proper notice. Boehringer announced back in July 2021 that it will cut off sales of 340B products to contract pharmacies with some limited exceptions. HRSA wrote to the drugmaker in October that the move violated the 340B federal statute, which requires manufacturers to honor purchases regardless of how they are dispensed. <Read More>

HHS Seeks to Fine Boehringer Ingelheim for Curtailing 340B Discounts – March 30, 2022 – HHS is seeking to penalize Boehringer Ingelheim for reducing 340B discounts, the department said in a March 29 letter to the drugmaker. In the letter, HHS reminded Boehringer Ingelheim of a 2021 letter in which the department instructed the drugmaker to comply with its 340B statutory obligations and offer its covered outpatient drugs at or below the ceiling price to entities covered by the program and their contract pharmacies. HHS said Boehringer Ingelheim’s refusal to comply will result in the drugmaker paying monetary penalties. The department referred the issue to its Office of the Inspector General for further disciplinary action. The drugmaker implemented its 340B policy in 2021 to ensure the 340B program “supports care for the most vulnerable of patients as it was intended to do — rather than benefit for-profit contract pharmacies,” a Boehringer Ingelheim spokesperson said in a statement sent to Becker’s March 30. <Read More>