Clinical Insights: December 29, 2020

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

    New Drug Approval

    Gemtesa® (vibegron) Tablets – New Drug Approval – December 23, 2020 – Urovant Sciences announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg GEMTESA® (vibegron), a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. This approval marks the first new oral branded OAB medication approved by the FDA since 2012, and it is the first product approval for Urovant Sciences. <Read More> 

    EbangaTM (ansuvimab-zykl) – New Drug Approval – December 21, 2020 – Ridgeback Biotherapeutics LP (“Ridgeback”), a biotechnology company experienced in antiviral drug development, announced that the U.S. Food and Drug Administration (“FDA”) approved EbangaTM for the treatment of Ebola. EbangaTM is now approved for treatment of infection caused by Zaire ebolavirus in adult and pediatric patients (including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection). EbangaTM is the only FDA approved, single injection Ebola treatment which is available in a lyophilized form. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Tagrisso® (osimertinib) Tablets – New Approved Indication – December 21, 2020 – AstraZeneca’s Tagrisso® (osimertinib) has been approved in the US for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumour resection with curative intent. Tagrisso® is indicated for EGFRm patients whose tumours have exon 19 deletions or exon 21 L858R mutations as detected by an approved test. The approval was granted under the US Food and Drug Administration’s (FDA) Real-Time Oncology Review (RTOR) pilot program. Five other countries participated in a concurrent submission and review process through FDA’s Project Orbis. <Read More>

    New/Updated Drug Shortage

    December 28, 2020

    December 23, 2020

    December 22, 2020

    New Drug Recall and Safety Alerts

    Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% by Sunstar Americas Inc. – Voluntary Drug Recall Expansion – December 28, 2020 – Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 12/31/2020 – 9/30/2022 to the consumer level. This product may be contaminated with the bacteria Burkholderia lata. This is an expansion of the recall initially announced on October 27, 2020. Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Antibiotic Stewardship Policy Offers Strategies for Inpatient, Outpatient Pediatrics – December 28, 2020 – Antibiotics are among the most commonly used medications in pediatric inpatient and outpatient settings, with a significant proportion of antibiotic use considered unnecessary. Antibiotic stewardship is dedicated to using antibiotics only when necessary, and using the appropriate spectrum of activity, dose, route and duration of therapy to optimize clinical outcomes while minimizing harm. Growing evidence demonstrates that antibiotic stewardship programs (ASPs) reduce antibiotic overuse while improving patient outcomes. A new policy statement from the AAP Committee on Infectious Diseases and Pediatric Infectious Diseases Society discusses the rationale for inpatient and outpatient ASPs; personnel, infrastructure and activities required; approaches to evaluating effectiveness; and gaps in knowledge that require further investigation. <Read More>

    States Deviate From CDC Guidelines on Vaccine Distribution – December 28, 2020 – Several states are straying from the CDC’s national guidelines for COVID-19 vaccine prioritization, including Texas, which is prioritizing residents 65 and older and adults with serious medical conditions in its next round of vaccinations, according to the Houston Chronicle. The CDC’s guidelines say Americans over age 75 and front-line essential workers such as agricultural workers and teachers should be prioritized in the second round. “The focus on people who are age 65 and older or who have comorbidities will protect the most vulnerable populations,” Imelda Garcia, chair of Texas’ vaccine advisory panel, told the Houston Chronicle. “This approach ensures that Texans at the most severe risk from COVID-19 can be protected across races and ethnicities and regardless of where they work.” <Read More>

    Rebate Rule Will Hold Middlemen Accountable – December 28, 2020 – COVID-19 has exposed a variety of inadequacies in America’s healthcare system that leave our most vulnerable populations at risk. First and foremost is the cost of prescription medications, a significant barrier to high-quality care for seniors living on fixed incomes and those who have lost jobs or seen wages decline. As such, it is critical for the incoming Biden administration to prioritize lowering drug prices. And while it may be tempting to ignore the policies of the current administration, ongoing efforts to rein in drug middlemen, primarily Pharmacy Benefit Managers (PBMs), have proven effective and must remain a cornerstone of President-elect Biden’s healthcare agenda. PBMs deny consumers low prices and greater choice through complicated kickback schemes, and policymakers must work to restrict these arrangements that prevent patients from being able to afford the medicines they need. <Read More>

    Pandemic Delays FDA Decision on Biocon’s Bevacizumab Application – December 26, 2020 – For Bengaluru, Karnataka, India–based Biocon Biologics, the pandemic has interrupted the FDA review process for its planned bevacizumab biosimilar. Biocon has been informed by the FDA that a decision on its biologics license application (BLA) for the bevacizumab biosimilar candidate MYL-14020, referencing Avastin, has been deferred while the agency awaits an opportunity to inspect the company’s manufacturing facility. Biocon announced in March 2020 that the FDA had accepted its BLA for MYL-14020. The anticipated decision date at the time was December 27, 2020. A European application for approval also has been filed, but Biocon did not provide an update on that progress. <Read More>

    The Role of Antimicrobial Stewardship in the Treatment of C difficile – December 26, 2020 – Biologics have traditionally been used to treat patients with cancer and various inflammatory diseases. More recently, biologics have emerged as a novel treatment modality in recurrent Clostridioides difficile infection (CDI). Currently, the recommended first-line treatment of CDI includes oral antibiotics vancomycin and fidaxomicin. However, comprehensive management of CDI cannot be achieved with antibiotics alone, as they disrupt the normal gut flora and do not target Clostridioides difficile spores. Fidaxomicin and fecal microbiota transplant (FMT) have been favored in the management and prevention of recurrent CDI due to their theorized ability to combat microbiota dysbiosis. With mounting evidence of the correlation among antibiotic use, host microbiota dysbiosis, and recurrent CDI, biologics and novel strategies may also play a key role in CDI therapy. <Read More>

    IDSA Guidance on the Treatment of Antimicrobial Resistant Gram-Negative Infections – December 25, 2020 – Antimicrobial-resistant (AMR) bacteria pose grave threats to global public health. In the United States, AMR organisms are estimated to cause an estimated 2.8 million infections per year, resulting in more than 35,000 deaths…The Infectious Diseases Society of America (IDSA) identified the development and dissemination of timely practice recommendations as a top initiative in its 2019 Strategic Plan. The just-released IDSA Guidance on the Treatment of Antimicrobial Resistant Gram-Negative Infections offers practical recommendations for antibiotic management of ESBL-E, CRE, and DTR P aeruginosa infections. <Read More> 

    Acute Coronary Syndrome Is a Medical Emergency – December 25, 2020 – Cardiovascular diseases affect millions of people globally each year, and many affected individuals must be treated both at onset and continuously after. With cardiovascular diseases accounting for approximately one-third of all deaths worldwide—and approximately 7.5 million of those deaths due to ischemic heart disease—the entire health care team must manage patients diagnosed with cardiovascular-related conditions that lead to ischemic heart disease carefully to ensure long-term, relatively symptom–free survival. Acute coronary syndrome (ACS) is an umbrella term encompassing 3 common cardiovascular-related conditions that lead to ischemic heart disease: non–ST-segment elevation myocardial infarction (NSTEMI), ST-segment elevation myocardial infarction (STEMI), and unstable angina. <Read More>

    HHS Report Acknowledges Pharmacy’s Role in Advancing Hypertension Control – December 24, 2020 – Following the US Department of Health & Human Services’ release of The Surgeon General’s Call to Action to Control Hypertension, which acknowledges pharmacists as integral members of the hypertension care team, the National Association of Chain Drug Stores (NACDS) released a statement on the importance of this report in continuing the momentum of recognizing the role of pharmacists in the battle against chronic diseases. The report acknowledges community pharmacies’ and pharmacists’ critical and unique roles in improving hypertension control and supporting patients throughout the country. Additionally, the NACDS said that individuals facing these chronic disease states are often medically underserved and suffer from disparities within the health care system. <Read More>

    Proper Procedures Are Essential for Handling Hazardous Agents – December 24, 2020 – With a national survey of nurses finding that more than 50% have been exposed to hazardous agents, proper safety procedures and education about handling these agents is essential. In a recent Directions in Oncology Pharmacy® Practice Pearls video, a panel of experts discussed potential harmful effects and best practices for handling hazardous agents. Moderator Jeffrey Lombardo, PharmD, BCOP, director of pharmacy business development at Catholic Health in Buffalo, New York, said health care workers risk exposure to hazardous agents during receipt, transport, storage, compounding, distribution, administration, and disposal of these substances. Furthermore, he said, many exposures occur in situations without monitoring requirements, making it necessary to preemptively establish best practices. <Read More>

    Tofacitinib Tested as Monotherapy for Psoriatic Arthritis – December 24, 2020 – Results from the first randomized control trial of tofacitinib monotherapy for psoriatic arthritis, an extension substudy of a long-term tofacitinib-methotrexate combination trial, suggest that some patients can discontinue methotrexate from the combination treatment without exacerbation of disease activity or reduction in health-related quality of life. Peter Nash, MD, Griffith University, Brisbane, Queensland, Australia, and colleagues note that the 2019 European League Against Rheumatology (EULAR) guidelines recommend continuing methotrexate with advanced therapies in patients who tolerate it, and reducing the dosage in patients demonstrating good response to biological treatment, particularly if there are concerns with toxicity. <Read More>

    ACC/AHA Clarify When AF Patients With Mitral Stenosis Should—And Should Not—Take DOACs – December 24, 2020 – Experts from leading cardiology societies have updated atrial fibrillation performance measures to incorporate a clarification that valvular atrial fibrillation refers to patients with moderate or severe mitral stenosis or a mechanical heart valve. The distinction between valvular and nonvalvular atrial fibrillation (AF) has been a persistent point of confusion for clinicians, with trials for both nonvitamin K oral anticoagulants and direct-acting anticoagulants using varying definitions. Variation has also existed between North American and European guidelines. Valvular AF calls for treatment with long-term anticoagulation with warfarin. <Read More>

    CDC to Require Negative COVID-19 Test for Air Travelers from the United Kingdom to the U.S. – December 24, 2020 – President Trump is taking another step to protect the health of the American people by requiring air passengers arriving from the United Kingdom (U.K.) to test negative, via PCR or Antigen test, no more than 72 hours before departure from the U.K. to the United States. The public health authorities in the United Kingdom recently announced the discovery of a new variant of SARS-CoV-2.  Viruses constantly change through mutation, and preliminary analysis in the U.K. suggests that this new variant may be up to 70% more transmissible than previously circulating variants. <Read More>

    Pharmacist Contributions to Patient Care in Cervical and Endometrial Cancers: From Prevention to Metastatic Disease – December 23, 2020 – In a live 2020 Directions in Oncology Pharmacy® conference session titled Cervical and Endometrial Cancers: A Pharmacist’s Review of the New and Emerging Treatment Paradigm for Patients With Advanced or Metastatic Disease, Judith A. Smith, PharmD, BCOP, CPHQ, FCCP, FHOPA, FISOPP, provided an update on the management of cervical and endometrial cancers…Dr Smith reviewed the pharmacist’s role in disease prevention based on risk factors for cervical and endometrial cancers. The human papillomavirus (HPV) vaccination is recommended in male and female patients aged 11 to 12 years and is also approved in adult patients to prevent cervical cancer. Pharmacists can assist in offering vaccinations and providing recommendations on other lifestyle modifications, such as weight management support and smoking cessation. <Read More>

    Techs Play an Essential Role in Telepharmacy – December 23, 2020 – Any pharmacist can attest to the importance of having hard-working, responsible, and trustworthy pharmacy technicians on the team. Techs are the lifeblood of pharmacies. From filling and dispensing prescriptions in an efficient manner to taking care of odd jobs around pharmacies, techs keep things running smoothly while freeing up pharmacists to focus on clinical duties. Although techs are a vital part of the pharmacy team in any setting, their importance reaches its apex in the telepharmacy setting. For that reason, let’s examine the role of the tech in a telepharmacy, how that role differs from the traditional pharmacy setting, and how telepharmacy provides an elevated role beyond what is typically available for techs. <Read More>

    Media Statement from CDC Director Robert R. Redfield on Vaccine Milestone – December 23, 2020 – The United States achieved an early but important milestone – jurisdictions have now reported that more than 1 million people have received their first dose of COVID-19 vaccine since administration began 10 days ago. With cases of COVID-19 continuing to surge nationwide, this achievement comes at a critical time and will help to protect those on the frontlines – our healthcare providers treating COVID-19 patients – as well as our most vulnerable: elder individuals living in nursing homes and assisted living facilities. While we celebrate this historic milestone, we also acknowledge the challenging path ahead. There is currently a limited supply of COVID-19 vaccine in the U.S., but supply will increase in the weeks and months to come. The goal is for everyone to be able to easily get vaccinated against COVID-19 as soon as large enough quantities are available. <Read More>

    FDA Takes Further Steps to Confront Opioid Crisis Through Risk Evaluation and Mitigation Strategy Programs – December 23, 2020 – While our efforts to combat COVID-19 remain at the forefront of our day-to-day activities, the U.S. Food and Drug Administration also continues its work on a number of important public health issues and, in particular, the opioid crisis. We remain committed to using all facets of our regulatory authority to lessen the impact of opioid addiction, misuse, and abuse while also striking a careful balance between patient access and safety to ensure that patients suffering from significant pain have access to appropriate medication. To that end, the FDA has been and continues to address this public health crisis on a number of fronts, including efforts to: 1) Decrease unnecessary exposure to prescription opioids and prevent new addiction; 2) Support the treatment of those with opioid use disorder; 3) Foster the development of new and effective pain therapies; and 4) Take action against those who contribute to the illegal importation and sale of opioid products. <Read More>

    NCCN Recommends Zanubrutinib as First-Line, Second-Line Therapy in CLL, SLL – December 23, 2020 – The National Comprehensive Cancer Network (NCCN) recommended zanubrutinib, approved by the FDA for the treatment of adult patients with mantle cell lymphoma, as a first-line and second-line therapy for treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The National Comprehensive Cancer Network (NCCN) recommended zanubrutinib, a tyrosine kinase inhibitor sold as Brukinsa (BeiGene), for treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). <Read More>

    Scalp Cooling in ESMO’S Clinical Practice Guidelines to help Prevent Chemotherapy-induced Alopecia – December 23, 2020 – Patients receiving anticancer treatment need help to prevent and alleviate adverse events while coping with the disease itself. Treatment may affect skin, nails, and hair, all integral components of overall health, appearance, and, as a result, a sense of self. Chemotherapy-induced alopecia, which usually starts 1–3 weeks after initiating anticancer therapy and is one of the most reported unpredictable adverse events experienced by cancer patients and survivors, generally results in diffuse grade 2 alopecia on the entire scalp. In addition, patients might also experience diffuse partial alopecia or patchy, unevenly distributed alopecia…In contrast, scalp cooling has been frequently been described as safe, effective, and generally well tolerated. <Read More> 

    PhRMa is Granted Temporary Injunction Against Favored Nation Rule – December 23, 2020 – Judge Catherine Blake of the U.S. District Court for the District of Maryland granted PhRMA and others a temporary restraining order regarding the administration’s most favored nation rule that was supposed to go into effect on January 1, 2021. The move pleased both PhRMA and the American Hospital Association. “Hospitals and health systems have very deep concerns about the substance and legality of this model, and the AHA filed a Declaration with this lawsuit expressing how the model could negatively impact hospitals, health systems and the patients they care for,” said AHA Executive Vice President Tom Nickels. <Read More>

    FDA Authorizes Marketing of New Device Designed to Remove Dead Pancreatic Tissue – December 23, 2020 – The U.S. Food and Drug Administration authorized marketing of the EndoRotor System to resect (cut out) and remove necrotic (dead) tissue for patients with walled-off pancreatic necrosis (WOPN), a potentially deadly condition which can occur several weeks after an episode of severe acute pancreatitis, often requiring tissue removal. “This device has shown its potential to provide a minimally invasive way to remove harmful necrotic pancreatic tissue in patients with walled-off pancreatic necrosis, which occurs in about 15 percent of patients with severe pancreatitis,” said Charles Viviano, M.D., Ph.D., acting director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the FDA’s Center for Devices and Radiological Health. <Read More>

    New Guidelines Call for Less Use of Surgery to Treat Heart Valve Disease – December 22, 2020 – People with heart valve disease have a growing number of treatment options that could allow them to avoid surgery except in the most severe cases, according to new guidelines. The recommendations, meant to advise health care providers and developed jointly by the American Heart Association and American College of Cardiology, call for the use of less invasive treatment for conditions that make it difficult for heart valves to open and close normally, disrupting heart blood flow. People with severe valve disease should be evaluated by a specialized team to determine the best treatment, according to the guidelines co-published in the AHA journal Circulation and in the Journal of the American College of Cardiology. The new guidelines are an update of those last published in 2017. <Read More>

    AMCP Sets a Course for Biosimilar Promotion – December 22, 2020 – The Academy of Managed Care Pharmacy (AMCP) has kicked off an effort to promote biosimilar use by developing strategies and consensus at a 2-day summit involving various stakeholders. “AMCP is dedicated to continue partnering with managed care pharmacy stakeholders to implement these strategies and advocate for biologic to be accepted as safe and effective therapeutic options, as well as increase access to them,” said AMCP CEO Susan Cantrell, RPh, CAE. <Read More>

    Survey Finds Younger Generations Have Least Amount of Trust in COVID-19 Vaccine – December 22, 2020 – As the first vaccines for the coronavirus disease 2019 (COVID-19) begin rolling out, pharmacists and other health care providers are working to ensure that as many Americans as possible receive the 2-dose vaccination. However, a new survey has found that younger individuals are significantly less likely to get the vaccine compared with older generations. According to the survey results, 56% of Americans say they do not plan to get the vaccine once available. Of those, 35% do not trust vaccines in general, 28% are not confident in the development and approval process, and 24% are concerned about adverse effects (AEs). Combating these concerns should be a major goal for health experts as more vaccines are approved and the broader public is able to receive them. <Read More>

    American College Of Cardiology Shares New Guidelines for Treating Patients With Anticoagulant and Antiplatelet Therapy – December 22, 2020 – The American College of Cardiology (ACC) is celebrating the holiday season with a new gift for cardiologists: antithrombotic therapy recommendations for patients with atherosclerotic cardiovascular disease (ASCVD) and concomitant atrial fibrillation (AFib) or venous thromboembolism (VTE). The guidance, published in the Journal of the American College of Cardiology, “highlights the challenges with choosing optimal antithrombotic regimen for patients needing an anticoagulant and antiplatelet therapy, including the increased risk of major bleeding associated with triple antithrombotic therapy.” <Read More>

    Essential Updates in Acute Graft-Versus-Host Disease – December 22, 2020 – In a live 2020 Directions in Oncology Pharmacy® conference session titled Acute Graft- Versus-Host Disease: Innovative Strategies in Risk Assessment, Prevention, and Treatment, Katie S. Gatwood, PharmD, BCOP, provided an update on research in the past decade that has led to improvements in the diagnosis, risk stratification, prevention, and treatment of acute graft-versus-host disease (aGVHD). Approximately 30,000 patients undergo allogeneic hematopoietic stem cell transplant (HSCT) annually in the United States, with approximately 20% to 85% developing aGVHD that affects the skin, gut, or liver. <Read More> 

    CMS Pricing Transparency Rule Looms: Is Your Hospital Ready? – December 22, 2020 – The final countdown has begun. U.S. hospitals now have only days to go before publicly disclosing their standard charges for items and services under the Centers for Medicare & Medicaid Services’ (CMS’s) new price transparency mandate, which aims to lower both patient and overall health care costs by increasing competition among hospitals. Starting Jan. 1, failure to comply with the new rule could bring swift CMS enforcement action, including civil penalties of up to $300 per day per hospital. Health and Human Services Secretary Alex Azar said that the new transparency initiative “may be a more significant change to American health care markets than any other single thing we’ve done, by shining light on the costs of our shadowy system and finally putting the American patient in control.” <Read More>

    Retailers in Mad Rush to Hire, Bring Back Pharmacists – December 22, 2020 – pharmacists and technicians to administer COVID-19 vaccines, according to The Wall Street Journal. Walgreens plans to hire 8,000 to 9,000 pharmacists and other healthcare workers nationwide. CVS Health is hiring thousands of healthcare professionals on short-term and permanent status, although the company declined to specify how many. This fall, the chains agreed to work with the government to deliver the vaccine to long-term care facilities. Smaller chains and grocery stores are also looking to ramp up their pharmacy workforces. Hy-Vee, the grocery chain based in West Des Moines, Iowa, aims to add 1,000 more pharmacy technicians to its current rank of 1,300. The chain is focusing on former pharmacy workers in its hiring efforts, especially those in rural areas who have left work or whose employers closed. Hy-Vee is also looking to retain its current pharmacy tech workforce, as competitors approach them with sign-on bonuses. <Read More>

    AIDS Healthcare Foundation Protests Amgen Pricing for Orphan Drugs – December 22, 2020 – The AIDS Healthcare Foundation in Los Angeles on Tuesday staged a socially distant protest at Amgen headquarters in Thousand Oaks in response to the biotech giant’s refusal to sell orphan drugs to nonprofit entities at a reduced price…“At a time when the U.S. health system is under tremendous stress from the COVID-19 pandemic, this enormously wealthy drug company has decided to make it worse,” John Hassell, national director of advocacy for AHF, said in a statement. “AHF calls on the U.S. Department of Health and Human Services to do its job and stop this callous drug industry attack on the U.S. health care safety net. Nonprofit health care entities depend on savings from the 340B Drug Discount Program to provide essential lifesaving services to needy under-insured patients all over the country.“ <Read More> 

    Department of Justice Files Nationwide Lawsuit Against Walmart Inc. for Controlled Substances Act Violations – December 22, 2020 – In a civil complaint, the Department of Justice has alleged that Walmart Inc. unlawfully dispensed controlled substances from pharmacies it operated across the country and unlawfully distributed controlled substances to those pharmacies throughout the height of the prescription opioid crisis. The complaint alleges that this unlawful conduct resulted in hundreds of thousands of violations of the Controlled Substances Act (CSA).  The Justice Department seeks civil penalties, which could total in the billions of dollars, and injunctive relief. <Read More>

    FDA Warns Companies Illegally Selling CBD Products – December 22, 2020 – The U.S. Food and Drug Administration issued five warning letters to companies for selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). All five warning letters address the illegal marketing of unapproved CBD products claiming to treat medical conditions. The warning letters include CBD products that are especially concerning from a public health perspective due to the route of administration, including nasal, ophthalmic and inhalation. In addition, they address violations relating to the addition of CBD to food, and the impermissible marketing of CBD products as dietary supplements. Two of the letters also address CBD products illegally marketed for pets, including a product for use in the eye. <Read More> 

    340B in the News

    MDRP: CMS Final Rule on Value-Based Purchasing, Line Extension Definition, PBM Accumulator Programs – December 24, 2020 – On December 21, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule that materially modifies current Medicaid Drug Rebate Program (MDRP) regulations, largely finalizing the proposed rule dated June 17, 2020. The Final Rule will be effective on March 1, 2021, 60 days after publication in the Federal Register, which is scheduled for December 31, 2020. Effectiveness after January 20, 2021 (inauguration) means that the Final Rule will likely be subject to the “freeze” an incoming administration typically imposes on regulations that are not yet effective…CMS states in the preamble to the Final Rule that “the changes made by this final rule will not have a significant impact on best price, AMP or Medicaid drug rebates that would impact either Medicare Part B payment allowances or 340B pricing…because manufacturers will continue to be required to report a non-VBP best price when reporting multiple best prices generated from a VBP arrangement, and that non-VBP best price will be used to calculate the 340B ceiling price.” CMS further “would expect manufacturers to make adjustments to their 340B ceiling prices as they have done in the past consistent with any changes to the MDRP pricing metrics.” <Read More> 

    To Keep Drug Costs Down and Fairness Up, Stop the Abuses of 340B – December 23, 2020 – Hospitals and pharmacies are abusing a federal program meant to help low-income patients. New research from consulting firm Berkeley Research Group reports that these bad actors are lining their own pockets with discounts on prescription drugs at the expense of millions of disadvantaged American patients. This exploitative behavior is unacceptable under any circumstances, especially now in the midst of twin medical and economic crises. Our lawmakers mustn’t let this abuse continue. <Read More>

    ACG Develops First Guideline for Irritable Bowel Syndrome – December 22, 2020 – In a new American College of Gastroenterology clinical guideline, published online Dec. 14 in The American Journal of Gastroenterology, recommendations are presented for diagnostic testing and therapeutic options for patients with irritable bowel syndrome (IBS). Brian E. Lacy, Ph.D., M.D., from the Mayo Clinic in Jacksonville, Florida, and colleagues developed the first clinical guideline for the management of IBS. After a comprehensive literature search, 25 clinically important questions were assessed; nine focused on diagnostic testing and 16 focused on therapeutic options. <Read More>

    Trump Administration Finalizes Policy on ‘Value-Based’ Drug Deals – December 22, 2020 – The Trump administration on finalized a rule meant to make it easier for state Medicaid programs, commercial insurers and drugmakers to enter into “value-based” arrangements tying prescription drug payments to clinical outcomes. The rule overhauls existing regulations that made structuring value-based payments difficult, the Centers for Medicare and Medicaid Services said. Under these types of deals, payers negotiate prices with drugmakers based on outcomes and evidence-based measures like reduced hospitalizations or lab visits, and aren’t accountable for the full price if those measures aren’t met. The changes are effective in January 2022. CMS estimates that value-based drug deals emerging in the wake of the final rule could save federal and state governments up to $228 million through 2025…Hospitals, drugmakers, insurers and Medicaid officials said its implementation timeline was too quick. Some said the rule could result in higher administrative burden for healthcare companies or less copay assistance for commercially insured patients. Pharmaceutical companies, meanwhile, warned it could have ripple effects lowering the price they’re allowed to charge hospitals in the 340B drug discount program. <Read More> 

    340B Update: Recent Supreme Court Ruling May Curtail 340B Program Discriminatory Pricing – December 22, 2020 – The U.S. Supreme Court recently issued a unanimous decision in Rutledge v. Pharmaceutical Care Management Ass’n, which supports the validity of state statutes that regulate reimbursement rates pharmacy benefit managers (PBMs) pay to pharmacies. Specifically, the Supreme Court’s ruling upheld Arkansas’s Act 900 (the Act) requiring PBMs to reimburse pharmacies at a rate equal to or greater than the pharmacies’ acquisition costs, concluding that the Act was not preempted by the Employee Retirement Income Security Act of 1974 (ERISA), even though it regulates the price at which PBMs must reimburse pharmacies for drugs covered by prescription drug plans. Rutledge is a significant win for pharmacies and health care providers with pharmacy operations, and particularly health care providers participating in the 340B Drug Discount Program (the 340B Program). In recent years, numerous states have enacted laws prohibiting PBMs from imposing a discriminatory two-tier pricing model for drugs purchased under the 340B Program. The Rutledge opinion supports the validity of these state laws.  <Read More> 

    HRSA Implements Administrative Dispute Resolution Process for 340B Program – December 21, 2020 – On December 10, 2020, HRSA issued a final rule (the Final Rule) implementing the 340B Drug Pricing Program administrative dispute resolution (ADR) process–an overdue mandate from the Affordable Care Act. Under the Final Rule, disputes will be resolved by three-person ADR Panels, consisting of individuals from HRSA, CMS, and HHS Office of the General Counsel (HHS OGC). The process will be governed by the Federal Rules of Civil Procedure (FRCP), to the extent possible, and the outcome will constitute a final agency decision that is precedential and binding. Claims may be brought by manufacturers, covered entities, and associations or organizations representing covered entities. <Read More>