Clinical Insights: November 24, 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

    ZokinvyTM (lonafarnib) Capsules – New Drug Approval – November 20, 2020 – The U.S. Food and Drug Administration approved ZokinvyTM (lonafarnib) capsules to reduce the risk of death due to Hutchinson-Gilford progeria syndrome and for the treatment of certain processing-deficient progeroid laminopathies in patients one year of age and older. ZokinvyTM is not approved for use in patients with other progeroid syndromes or laminopathies. “Hutchinson-Gilford progeria syndrome and progeroid laminopathies are rare genetic diseases that cause premature aging and death and have a debilitating effect on people’s lives,” said Hylton V. Joffe, M.D., M.M.Sc, director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    ImfinziTM (durvalumab) Injection – New Approved Dosing Option – November 18, 2020 – AstraZeneca’s ImfinziTM (durvalumab) has been approved in the US for an additional dosing option, a 1,500mg fixed dose every four weeks, in the approved indications of unresectable Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy (CRT) and previously treated advanced bladder cancer. This new option is consistent with the approved ImfinziTM dosing in extensive-stage small cell lung cancer (ES-SCLC) and will be available to patients weighing more than 30kg as an alternative to the approved weight-based dosing of 10mg/kg every two weeks. <Read More>

    Vimpat® (lacosamide) – New Approved Indication – November 17, 2020 – UCB, a global pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved Vimpat® (lacosamide) CV as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures (PGTCS) in patients four years of age and older and Vimpat® injection for intravenous use in children four years of age and older. PGTCS is a type of seizure that occurs all over the brain, affecting both sides of the brain from the start, causing muscles to stiffen and convulsions to occur for up to a few minutes. <Read More>

    New/Updated Drug Shortage

    November 20, 2020

    November 19, 2020

    November 18, 2020

    November 17, 2020

    New Drug Recall and Safety Alerts

    Dexmedetomidine Hydrochloride Injection by Fresenius Kabi – New Drug Recall – November 19, 2020 – Fresenius Kabi USA is voluntarily recalling a single lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to a trace amount of lidocaine present in the lot. This recall is being performed to the user level. To date, no adverse drug experience reports have been received for the recalled lot. Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy could result in a potentially life-threatening allergic reaction. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention – November 23, 2020 – The U.S. Food and Drug Administration expanded the approved indication for XofluzaTM (baloxavir marboxil) to include post-exposure prevention of influenza (flu) for patients 12 years of age and older after contact with an individual who has the flu. XofluzaTM, previously available only in tablet form, is also now available as granules for mixing in water. XofluzaTM was originally approved in 2018 for treating uncomplicated flu in patients 12 years of age and older who have been symptomatic for no more than 48 hours. <Read More>

    Society for Immunotherapy of Cancer Publishes Clinical Practice Guideline on Immunotherapy for the Treatment of Acute Leukemia – November 23, 2020 – The Society for Immunotherapy of Cancer (SITC), the world’s leading member-driven organization dedicated solely to cancer immunotherapy, has published a clinical practice guideline specific to the use of immunotherapy for acute leukemia, a type of blood cancer. “The Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of acute leukemia,” was developed by an expert panel of leaders in the fields of hematology, oncology, hematopathology, oncology nursing and cancer patient advocacy from across the United States. This immunotherapy-specific guideline provides hematologists, oncologists, and other advanced practice providers a clinical roadmap to provide optimal care for patients who have acute leukemia. <Read More>

    States Roll Back Rule Forcing NPs to Practice With Physician Oversight – November 23, 2020 – In most places, laws dictate that nurse practitioners (NPs) must work under the supervision of physicians. While their educational background is different, their duties are fairly similar. Now, 22 states, plus Washington DC, the Indian Health Care Services, and the VA Health Care Services, currently allow NPs to practice without physician oversight. In a recent interview with Oncology Nursing News, Sophia L. Thomas, DNP, APRN, FNP-BC, PPCNP-BC, FNAP, FAANP, president of the American Association of Nurse Practitioners (AANP) explained that this advancement of the NP profession is far overdue, and she hopes that more states catch on. “In oncology, nurse practitioners are an integral part of the health care team,” Thomas said. <Read More>

    National Comprehensive Cancer Network® Adds Inqovi® (decitabine and cedazuridine) Tablets to its Clinical Practice Guidelines in Oncology for Myelodysplastic Syndromes – November 23, 2020 – Taiho Oncology, Inc. announced that the FDA approved hypomethylating agent Inqovi® (decitabine and cedazuridine) 35 mg/100 mg tablets, for oral use, has been included in the latest National Comprehensive Cancer Network® Clinical Practice Guidelines (NCCN Guidelines®) in Oncology for Myelodysplastic Syndromes (MDS). The NCCN Guidelines now include a category 2a recommendation that oral decitabine and cedazuridine (DEC-C) could be considered as a substitution for intravenous decitabine in the treatment of adult patients with MDS. <Read More>

    U.S. Infectious Disease Group Backs Gilead’s Remdesivir for COVID-19 Treatment – November 23, 2020 – The top U.S. infectious disease medical association said on Monday that Gilead Sciences Inc’s antiviral drug remdesivir should be used for hospitalized COVID-19 patients despite a World Health Organization (WHO) recommendation last week against its use. The Infectious Diseases Society of America (IDSA) in updated guidelines said its experts back the drug for use in severe COVID-19 patients based on a clinical trial showing it reduced hospital stays. The WHO study that led to its recommendation against the drug suggested it had no benefit in saving lives or reducing the need for mechanical breathing assistance. <Read More>

    COVID-19 and Substance Use Compound Challenges – November 23, 2020 – As the coronavirus disease 2019 (COVID-19) pandemic continues, pharmacists and other health care professionals have had to contend simultaneously with the continuing substance use epidemic. In a Pharmacy Times® webinar titled “The Impact on Substance Misuse During the COVID-19 Pandemic,” participants discussed specific challenges for pharmacists and best practices for tackling the 2 problems. Alcohol sales have increased, and data have shown the growing use of nonprescribed fentanyl, methamphetamine, and cocaine across the country, according to moderator Tyler Davis, PharmD, a senior advisor of pharmacy professional practice standards at CVS Health. Jeffrey Bratberg, PharmD, FAPhA, agreed that this is a major issue, adding that there were more than 72,000 opioid over- dose–related deaths in 2019, many of which were related to polysubstance use. <Read More>

    Techs Matter More Than Ever – November 23, 2020 – Now that the 2020 influenza season has officially kicked off, Americans are looking to pharmacy professionals to help with vaccinations while they also prepare for a highly anticipated coronavirus disease 2019 (COVID-19) vaccine. Some may be surprised, however, to see which pharmacy professionals are being called to the helm during this time of need. CVS Health recently announced that it will be hiring more than 10,000 full- and part-time licensed pharmacy technicians (techs) who can help dispense medications and administer COVID-19 tests.1 These workforce changes are being made in preparation for the next phase of the pandemic, as the number of daily cases continues to rise apace. “Our pharmacy teams continue to play a critical role in the nation’s pandemic response. Authorization for trained pharmacy technicians to administer COVID-19 vaccines, under the supervision of immunization-certified pharmacists, will expand capacity throughout the US to efficiently and safely vaccinate millions of Americans,” Ryan Rumbarger, senior vice president of retail store operations at CVS Pharmacy said in an interview. <Read More>

    HHS Issues Final Rule Ending Pharmacy Benefit Manager Drug Rebates to Insurers – November 21, 2020 – The Department of Health and Human Services finalized a rule ending protections that allow pharmacy benefit managers to pass along Medicare Part D prescription rebates to insurers. The final rule excludes safe harbor protections under the Anti-Kickback Statute for rebates paid by drug manufacturers to PBMs, and creates new safe harbor protections for these rebates to be passed directly to consumers at the pharmacy counter. HHS Secretary Alex Azar said the move that will create incentives to lower list prices and reduce out-of-pocket spending on prescription drugs. Savings to patients may be nearly 30%, the average difference between the list price of a drug and the net price after a rebate, HHS said. <Read More>

    Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 – November 21, 2020 – The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions. <Read More>

    FDA Offers New Q&A on Biosimilars and Interchangeable Products – November 20, 2020 – In a draft questions and answers guidance issued Thursday, the US Food and Drug Administration (FDA) offers insights into how it will handle certain aspects of submissions and labeling for interchangeable biosimilars. When finalized, FDA will move the questions and answers from the draft guidance to its companion final questions and answers guidance on biosimilar development. In the first of four questions and answers in the draft guidance, FDA explains how it anticipates handling applications for interchangeable biosimilars that include data to support licensure as a biosimilar but not as an interchangeable product. <Read More>

    Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate – November 20, 2020 – The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH. “The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. I want to assure the American people that the FDA’s process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and stands ready to do so as soon as an EUA request is submitted.  While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible. <Read More>

    Amazon Launches Online Pharmacy in the US – November 20, 2020 – Tech giant Amazon has made a foray into the healthcare sector with the launch of its own online pharmacy service in the US. Amazon Pharmacy will allow customers to order commonly used medications, including both generic and prescription medications. The online pharmacy will allow customers to manage prescriptions, with Amazon Prime members able to receive two-day deliveries on orders for medications. <Read More>

    50.6 Million U.S. Adults Currently Use Tobacco Products – November 19, 2020 – Findings from a Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report show that approximately 1 in 5 U.S. adults reported currently using a tobacco product in 2019, with about 80% of those adults reporting that they use combustible products such as cigarettes. To assess recent national estimates of tobacco product use among U.S. adults 18 years or older, CDC analyzed data from the 2019 National Health Interview Survey. The survey measured use of five tobacco products: cigarettes, cigars (cigars, cigarillos, or filtered little cigars), pipes (regular pipes, water pipes, or hookahs), e-cigarettes, and smokeless tobacco (chewing tobacco, snuff, dip, snus, or dissolvable tobacco)…“The battle against tobacco use in this country is far from over,” said CDC Director Robert R. Redfield, MD. “Tobacco use remains the leading cause of preventable disease and death in the United States.” <Read More>

    WHO Guideline Development Group Advises Against Use of Remdesivir for COVID-19 – November 19, 2020 – The antiviral drug remdesivir is not suggested for patients admitted to hospital with covid-19, regardless of how severely ill they are, because there is currently no evidence that it improves survival or the need for ventilation, say a WHO Guideline Development Group (GDG) panel of international experts in The BMJ. The recommendation is part of a living guideline, developed by the World Health Organization with the methodological support of MAGIC Evidence Ecosystem Foundation, to provide trustworthy guidance on the management of covid-19 and help doctors make better decisions with their patients. <Read More>

    Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19 – November 19, 2020 – The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). <Read More>

    NCPA, NACDS Applaud HHS for Including Pharmacies in the COVID-19 Vaccine Program – November 19, 2020 – Following the announcement from the Department of Health and Human Services (HHS) regarding the US government’s partnerships with national and regional chain pharmacies and independent pharmacies to maximize access to coronavirus disease 2019 (COVID-19) vaccines, the National Association of Chain Drug Stores (NACDS) and the National Community Pharmacists Association (NCPA) both released statements applauding the decision. The HHS announcement explained that the partnerships with pharmacy chains allow for the coverage of approximately 60% of pharmacies throughout the country, whereas the partnerships with independent pharmacies will allow for wider coverage, especially in traditionally underserved areas. <Read More>

    ACR Updates Guidelines on Management of Rheumatoid Arthritis – November 18, 2020 – The American College of Rheumatology (ACR) has released its updated guidelines for the Management of Rheumatoid Arthritis (RA) at ACR Convergence, the ACR’s annual meeting. The comprehensive, clinical recommendations for pharmacologic treatment of RA includes important updates to the previous guideline released in 2015. Rheumatoid arthritis (RA) is the most common type of chronic inflammatory arthritis. In RA, the immune system, the body’s defense system against disease and injury, is not working properly. RA commonly causes pain and swelling in the wrist and small joints of the hand and feet but can affect almost all joints. Treatments for RA can stop joint pain and swelling and may also prevent joint damage. Early treatment will give patients with RA better long-term results. <Read More>

    Specialty Pharmacy Rotations Address Education Gaps, Expand Career Horizons – November 18, 2020 – Residency programs in specialty pharmacy are relatively new, emerging in response to dramatic growth in the specialty sector. Education in the classroom has also lagged behind the demand for specialty pharmacy expertise. These gaps in pharmacy curriculum have been discussed at industry meetings, including Asembia and other forums. Among the organizations recognizing the need for exposure to specialty pharmacy is the American Society of Health-System Pharmacists (ASHP), whose Section of Specialty Pharmacy Practitioners—Section Advisory Group on Workforce Development has developed extensive guidance for an elective rotation in health system specialty pharmacy, touching on pharmacy operations and a range of disease states. <Read More>

    Pharmacy Quality Solutions Industry Report Compares Trend, Comfort Levels of 2019 and 2020 – November 18, 2020 – Pharmacy Quality Solutions (PQS) has released its latest report that tracks trends and comfort levels that have changed among consumers, pharmacies, and payers from 2019 to 2020 as it relates to pharmacist-provided services and value-based performance programs. The 4-section report covers consumer perceptions, pharmacy readiness for outcomes-based measurement, payer challenges and opportunities with performance improvement, and the special report on coronavirus disease 2019 testing and treatment insights that was previously released in May 2020. <Read More>

    Vaccine Coverage, Pricing, and Reimbursement in the U.S. – November 18, 2020 – Several COVID-19 vaccines are now in phase 3 trials, and $10 billion in government money has been invested in the research, development, manufacturing, and distribution of vaccines. As part of this effort, the federal government has paid in advance for hundreds of millions of doses of multiple COVID-19 vaccines and, in some cases, has the option to purchase more. These government-purchased doses will be distributed for free to providers who will then administer the vaccine(s) under the Centers for Disease Control and Prevention’s (CDC) COVID-19 Vaccination Program.1 Once distributed, individuals will be able to get COVID-19 vaccine(s) without having to pay any cost sharing, due, in part, to changes made by Congress and CMS to the laws and regulations that typically govern insurance coverage for vaccines. <Read More>

    Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home – November 17, 2020 – The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. <Read More>

    Pharmacy Technician Certification Board (PTCB) Reaches Milestone with 1,000 Compounded Sterile Preparation Technician (CSPT) Certifications Granted – November 17, 2020 – Less than 3 years since launching its Compounded Sterile Preparation Technician® (CSPT®) Certification Program, the Pharmacy Technician Certification Board (PTCB), the nation’s leading credentialing organization for pharmacy technicians, has granted its 1,000th CSPT credential. Pharmacy technicians across the US are assuming more advanced roles in many areas of pharmacy, including in sterile compounding, the preparation of medications in a sterile environment to prevent contamination. By earning their CSPT Certification, technicians demonstrate their specialized knowledge and skills, and their commitment to ensuring safety and regulatory compliance in sterile compounding. <Read More>

    Amid Concerns About Declining Childhood Vaccination Rates, Measles Surges Globally – November 17, 2020 – Even before the COVID-19 pandemic drowned out every other public health issue, global measles cases reached a 23-year high, according a new World Health Organization (WHO) and CDC publication released on November 13. In 2019, there were a reported 869,770 measles cases leading to 207,500 deaths. The death rate was 50% higher than it was in 2016. Now, amid a worldwide coronavirus-related decline in childhood vaccinations, the agencies warn that global immunization partners must act quickly to reverse the trend. The WHO/CDC publication—Progress Toward Regional Measles Elimination—Worldwide, 2000–2019—aims to support the achievement of regional measles elimination goals, development of additional strategies to help countries strengthen routine immunization systems, identification and closing of immunity gaps, and improvement of case-based surveillance. <Read More>

    The Importance of Provider Status for Pharmacists – November 17, 2020 – Throughout the coronavirus disease 2019 (COVID-19) global pandemic, we have—rightly —seen an outpouring of support for frontline workers risking their lives for the benefit of others. Companies, schools, and community organizations have offered support through donations and free services. In New York and cities around the world, residents regularly cheered their health care heroes from their homes to thank them for their work addressing this crisis on the frontlines… Because they are trusted by patients, readily accessible in most American communities, and are highly skilled, pharmacists are vital to our COVID-19 recovery. However, unlike their acute and physician office counterparts, pharmacists’ legal capacity to assess, prescribe, and administer biological products varies from state to state. <Read More>

    340B in the News

    American Hospital Association and PhRMA Question Legality of Most Favored Nation Model – November 23, 2020 – The Centers for Medicare and Medicaid Services has announced changes to the way providers are paid for drugs in a Most Favored Nation Model. The interim final rule with a comment period that was released on Friday would lower prescription drug costs by paying no more for Medicare Part B drugs and biologicals than the lowest price that drug manufacturers receive in other similar countries. The MFN Model would focus on a set of 50 Medicare Part B drugs that encompass a high percentage of Medicare Part B drug spending…”Hospitals would have to absorb losses while drug companies are free to continue their trend of charging exorbitant prices,” said Tom Nickels, AHA executive vice president. “Instead of holding drug companies accountable for drug prices, it slashes reimbursement to hospitals for drugs. In addition to the continued concerns we have expressed about the impact this model has on the 340B drug pricing program, we strongly question whether attempting to institute such a sweeping and controversial policy in an interim final rule is legally permissible.” <Read More>

    Community Health Groups Oppose Medicaid ‘Carve-Out’ – November 23, 2020 – Community health groups across New York are warning about a change to the state’s Medicaid program. More than 35 community health groups have joined the Save New York’s Safety Net coalition. The movement is targeting a drug “carve-out” and resulting changes to the 340B drug discount program they say will decimate essential services for the medically underserved and low-income New Yorkers. Perry Junjulas is Executive Director of the Albany Damien Center, which serves people living with HIV and AIDS. “This is actually a federal program that has allowed agencies like the Albany Damien Center and other community based organizations and federally qualified health centers, to be able to purchase drugs at cost, and be able to use some of the savings that is captured through the resale of those medications, to provide services to persons who are the most vulnerable in our community. New York state, in an effort to balance the budget, and also get some more money into Medicaid, has instituted a change in April, that will effectively take all of these savings away from the agencies who need them the most. There are about two dozen groups across the state where this Medicaid drug carve-out will become a catastrophic effect for, because this is about a quarter to 30% of our agency’s budgets.” <Read More>

    Schumer Looks to Help Nathan Littauer – November 21, 2020 – Hospitals already feeling the crunch against new expenses to combat the coronavirus and falling revenues as non-essential procedures and appointments declined amidst the pandemic, could face another financial squeeze if federal lawmakers within the next month do not extend the Medicaid Disproportionate Share Payments program…Another federal program, the 340B Drug Pricing Program, is also in danger, according to Fadale. The program aimed at keeping patient care affordable by supporting hospitals that care for populations largely covered by Medicare, Medicaid or no insurance. The program allows eligible healthcare providers to prescribe medications at a heavily discounted purchase price while available insurance provides set reimbursement rates for the medication, allowing the institution to retain the difference between the purchase price and reimbursement amount. <Read More>

    Unconscionable Drug Company Efforts Threaten Communities Hit Hardest by COVID-19 – November 20, 2020 – When America’s hospitals are struggling to provide care to people with low incomes, the uninsured and the underserved, some pharmaceutical companies are undermining a program that provides these safety-net providers with the resources they need to serve their communities. If the drug companies are successful, our hospital systems — UCLA Health in Los Angeles and UW Medicine in Seattle — together stand to lose more than $110 million in funds annually that we use to provide care to our patients who are most in need. And we are not alone in this struggle, as safety-net hospitals, community health centers, rural clinics, and other providers caring for underserved communities throughout the country could lose billions. The crisis is caused by pharmaceutical industry attacks on what is known as the 340B drug pricing program. Congress created 340B to help hospitals serving large numbers of low-income patients to stretch scarce federal resources as far as possible to support essential services. <Read More>

    Attack on Low-Cost Prescription Program Inexcusable – November 20, 2020 – At a time when the need for access to affordable, high-quality health care has never been more apparent, we find it abhorrent that some drug companies are trying to find ways to do away with a low-cost prescription program that helps hospitals and clinics that serve rural and poor communities. And we’re glad to once again see U.S. Rep. David McKinley, R-1st District, West Virginia, at the lead to combat this threat. “Protecting access to prescription drugs for underserved communities should be a top priority,” McKinley said. “Yet, recent actions taken by big pharmaceutical companies and middlemen could jeopardize the ability of hospitals to provide critical services.” <Read More>

    Changes to 340B Pharmacy Program Will Hurt New York’s Community Health Centers | Opinion – November 19, 2020 – More than 2.5 million New Yorkers are at risk of losing health services right now. Few people know it. Unless the state halts proposed changes to a pharmacy program called 340B, community health centers like Sun River Health will lose over $100 million a year and be forced to eliminate services. Low income communities will be singularly affected because these are the areas in which community health centers and other safety net providers are located. In the midst of the pandemic, the proposed changes would be catastrophic since the very patients who will bear the brunt of these cuts are those most impacted by COVID-19. <Read More>

    Nine Latest Lawsuits Involving Hospitals – November 19, 2020 – The following hospital lawsuits and settlements were reported in the past month, beginning with the most recent. 1) Montana health system sued over oncologist’s sudden absence – A class-action lawsuit filed Nov. 13 against St. Peter’s Health in Helena, Mont., claims patients of Tom Weiner, MD, an oncologist at the hospital, weren’t notified before his unexplained absence in late October, resulting in gaps in their care…9) Hospitals denied full court review in lawsuit over 340B cuts – Hospitals suing HHS over a policy that will cut Medicare outpatient drug payments by nearly 30 percent at 340B hospitals failed to persuade a full appeals court to rehear the case. <Read More>

    Celebrating the Power of Rural Health Care – November 19, 2020 – Every year, the third Thursday in November is celebrated as National Rural Health Day. This is a time to recognize and celebrate the nearly one in five Americans who live in rural communities, the health care organizations and providers that serve these rural populations and the community members who help make their towns healthier. “It’s been a hard year” is a statement that rings true for most of us. For those in the health care industry, COVID-19 has posed a fair share of challenges, especially in rural health settings. While it’s important to recognize the disruption of COVID-19, and the many other concerns facing rural health (hospitals continuing to close at alarming rates, the 340B drug pricing program and broadband access to name a few), I also want to shine a light on some of the positive things that showcase the true power of rural health. <Read More>

    Consider Adopting Biosimilars Into Clinical Practice – November 19, 2020 – The number of biosimilar agents available for use in clinical practice continues to increase. As such, institutions are replacing innovator biologics with their biosimilars, often to take advantage of the financial benefits, which can be quite significant for an organization. One analysis estimated that biosimilar approvals will reduce direct spending on biologic drugs by $54 billion between 2017 and 2026.1 When introducing biosimilars into clinical practice, key considerations include acceptance by patients, demonstration of a positive financial analysis, selection of biosimilars most suited to the organization, and buy-in from physiciansOne of the major reasons for an organization to use biosimilars is the financial benefits. Before switching to biosimilars, it is important to assess the magnitude of these financial benefits at an organization. The benefits reported by other institutions may not necessarily carry over to one’s facility. In performing the analysis, one needs to determine the cost savings potential of biosimilars when used in the in-patient setting along with their revenue generation potential in the outpatient setting. In the outpatient setting, the organization’s payer mix determines the type and amount of reimbursement and can vary among institutions. The Centers for Medicare & Medicaid Services (CMS) reimburses biosimilars at their average selling price (ASP), plus 6% of the ASP of the innovator biologic. Hence, there is an incentive to use a biosimilar.8 For innovator biologics and biosimilars acquired under the 340B drug pricing program, reimbursement is at ASP minus 22.5%. In the in-patient setting, diagnosis-related groups are used by the CMS, which makes cost a key factor for using biosimilars.8 Some biosimilars may have pass-through status, which must also be factored into the analysis. Reimbursement from private payers will vary in type and amount between institutions and must be evaluated as well. Given the complexity surrounding reimbursement in the health care environment, it is important for a pharmacy department to work with the organization’s revenue cycle team in doing this analysis. <Read More>

    Drug Manufacturers Risk Lives by Refusing to Honor Prescription Drug Program – November 19, 2020 – Eastern Shore Rural Health System Inc. low-income patients are threatened by prescription drug manufacturers who are violating the federal 340B discount drug program statute and have abruptly stopped shipping discounted drugs to health centers’ contracted pharmacies. At Eastern Shore Rural Health 4,791 patients are uninsured or underinsured and 20,069 are at or below 200% of poverty (for example a family of four with a total income of $52,400 is at 200% of poverty). Across the country, millions of patients’ lives are at stake and health center operations and budgets face possible devastation amid an overwhelming public health pandemic. Community Health Centers like Eastern Shore Rural Health rely on this program to make medications affordable for patients, and to generate savings used to expand access to other services. Over the past two years, Rural Health has used 340B savings to add eight dental chairs, expand behavioral health services, and add 12 providers to staff. <Read More>