Clinical Insights: January 19, 2021

    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

    No new update.

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Enhertu® (fam-trastuzumab deruxtecan-nxki) Injection – New Approved Indication – January 15, 2021 – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca’s Enhertu® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. <Read More>

    Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Injection – New Approved Indication – January 15, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) approval of Darzalex Faspro® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis. Darzalex Faspro® is the first and only FDA-approved treatment for patients with this blood cell disorder that is associated with the production of an abnormal protein, which leads to the deterioration of vital organs, most notably the heart, kidneys and liver. This indication is approved under accelerated approval and is based on the hematologic complete response rate (hemCR) measure. <Read More>

    Xalkori® (crizotinib) Capsules – New Approved Indication – January 14, 2021 – Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Xalkori® (crizotinib) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. The safety and efficacy of Xalkori®  have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. ALCL is a rare form of non-Hodgkin lymphoma (NHL) and accounts for approximately 30% of cases of NHL in young people. Approximately 90% of ALCL cases in young people are ALK-positive. <Read More>

    New/Updated Drug Shortage

    January 15, 2021

    January 14, 2021

    January 13, 2021

    January 12, 2021

    January 11, 2021

    New Drug Recall and Safety Alerts

    No new update.

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Review Examines Use of Biologics in Atopic, Inflammatory Diseases – January 16, 2021 – A recent review explores the use of biologics in atopic and inflammatory conditions as well as lingering research gaps. A recent review highlighted different biologic therapies that are used or are being investigated for the treatment of several atopic diseases. The authors of the review, published in Allergologie Select, also discussed hypersensitivity reactions and as well as current research gaps that future investigators should address. Biologics are used to treat a number of atopic and inflammatory conditions, including bronchial asthma, urticaria, atopic dermatitis, chronic rhinosinusitis with nasal polyps (CRSwNP), hereditary angioedema, atopic dermatitis (AD), as well as rheumatoid arthritis and psoriatic arthritis. <Read More>

    Anticholinergic Use for 3 Months or Longer Increases Dementia Risk by About 46% – January 15, 2021 – Investigators conducted a systematic literature review and meta-analysis assessing the impact of 3 months or longer anticholinergic use on the risk of multiple subtypes of incident dementia. Anticholinergic use for 3 months or longer increases dementia risk by about 46% compared with nonuse, according to a recent review and meta-analysis published in Neurourology and Urodynamics. The investigators of the review saw a similar relationship with drugs many urologists use to treat overactive bladder. <Read More>

    Some Big U.S. Pharmacies Will Not Check ID Before Administering COVID-19 Vaccines – January 15, 2021 – Many U.S. pharmacies, including those inside Kroger Co supermarkets and the drugstore chain of CVS Health Corp, say they will not be checking IDs before administering COVID-19 vaccines, leaving the door open to those who do not meet states’ guidelines to jump the line. While the United States has distributed more than 30 million vaccine doses, a little over 11 million had been administered as of Thursday, a lag that prompted U.S. health secretary Alex Azar to call on states to begin vaccinating the vulnerable older population and those with certain chronic health conditions to get more vaccines into arms. <Read More>

    “Pharmacy Deserts” Could Become Vaccine Deserts – January 15, 2021 – Millions of Americans who live in “pharmacy deserts” could have extra trouble accessing coronavirus vaccines quickly, according to a new analysis by GoodRx. Why it matters: Places without nearby pharmacies, or with a large population-to-pharmacy ratio, may need to rely on mass vaccination sites or other measures to avoid falling behind. The big picture: Pharmacies will play a huge role in the vaccine rollout, especially as shots become more available to the general population. But if people have to drive far to get a shot, or if pharmacies can’t keep up with local demand, that could leave millions of Americans vulnerable to the virus for longer than people in better-served areas. <Read More>

    Wisconsin Suspends License of Pharmacist Accused of Spoiling Vaccine – January 15, 2021 – A state board has suspended the license of a Wisconsin pharmacist accused of ruining more than 500 doses of COVID-19 vaccine because he thought it was unsafe. Steven Brandenburg was working at Advocate Aurora Health in Grafton, about 20 miles north of Milwaukee, when he was arrested following an investigation into the 57 spoiled vials of the Moderna vaccine. He has not been criminally charged. The Wisconsin Pharmacy Examining Board said in its order that Brandenburg cannot practice pharmacy while the suspension is in place. It said Brandenburg agreed to the action “in order to focus” on possible charges against him. <Read More>

    Acute Coronary Syndromes: Summary of Updated NICE Guidance – January 15, 2021 – What you need to know: 1) Prasugrel is recommended as dual anti-platelet therapy in combination with aspirin for people with ST-elevation myocardial infarction being treated with primary percutaneous coronary intervention (PCI). 2) Prasugrel or ticagrelor are recommended as dual anti-platelet therapy in combination with aspirin for people with non-ST-elevation myocardial infarction or unstable angina being treated with PCI. 3) In people with acute coronary syndromes treated with PCI, who have a separate indication for oral anticoagulation (eg, atrial fibrillation), use clopidogrel and oral anticoagulant for up to one year. Do not use prasugrel or ticagrelor, and avoid long-term addition of aspirin. <Read More>

    ISMP Provides Recommendations for Avoiding COVID-19 Vaccination Administration Errors – January 15, 2021 – The Institute for Safe Medication Practices (ISMP) is providing recommendations for avoiding mistakes when administering coronavirus disease 2019 (COVID-19) vaccines. Published as guidance for health care providers, the recommendations focus on dilution errors, vaccine and monoclonal antibody mix-ups, waste of doses, administering immunizations to the wrong age group, errors with scheduling the second dose, and allergic reactions. <Read More>

    FDA Issues New Prescribing Guidelines for Synthetic Opioid Fentanyl – January 15, 2021 – The federal Food and Drug Administration (FDA) has issued new prescribing guidelines for synthetic opioid painkillers, which specifically focus on transmucosal immediate-release fentanyl (TIRF) drugs.  TIRF medications contain the powerful synthetic opioid that is supposed to be reserved for pain management in patients with terminal cancer.  To be prescribed a TIRF drug, patients have to be opioid tolerant. In recent years, there has been growing evidence that fentanyl has made its way to the streets and is commonly being mixed with other deadly drugs, including cocaine and heroin.  This has caused the overdose rate to skyrocket.  Thus, it is important to regulate more closely how this synthetic is being distributed legally to patients in order to also get it off the streets. <Read More>

    Pharmacy Chains Ready to Supply COVID-19 Vaccines – January 15, 2021 – Now that federal guidelines have expanded COVID-19 vaccine eligibility to include people over 65 and those of all ages with underlying health conditions, drug stores say they are ready, willing and able to start giving the shots. There’s just one slight glitch: supply. But with two vaccines already available and others moving toward emergency use authorization, experts say supply will likely soon catch up with demand. <Read More>

    APhA: President-Elect Biden’s COVID Plan is a Strong Start to Rescue the Country From the Pandemic – January 14, 2021 – Statement of Scott J. Knoer, executive vice president and CEO of the American Pharmacists Association:  “President-Elect Biden’s plan to address COVID-19 is a strong start to rescue the country from the pandemic. It not only allocates billions of dollars to launch a sweeping national plan for vaccination and testing, it also invests in public health workers for outreach and contact tracing, addresses health disparities, protects residents of long term care facilities and workers in essential industries, and proposes billions for the administration of the vaccines. <Read More>

    NICE Guideline on Long COVID – January 13, 2021 – As the global COVID-19 pandemic has progressed, evidence has emerged that some patients are experiencing prolonged multiorgan symptoms and complications beyond the initial period of acute infection and illness. The list of persisting and new symptoms reported by patients is extensive, including chronic cough, shortness of breath, chest tightness, cognitive dysfunction, and extreme fatigue. Termed long COVID or post-COVID-19 syndrome, the implications and consequences of such ongoing clinical manifestations are a growing health concern…In the guideline, two definitions of postacute COVID-19 are given: (1) ongoing symptomatic COVID-19 for people who still have symptoms between 4 and 12 weeks after the start of acute symptoms; and (2) post-COVID-19 syndrome for people who still have symptoms for more than 12 weeks after the start of acute symptoms. <Read More>

    New Clinical Practice Guidelines on Diagnosis, Management of von Willebrand Disease – January 13, 2021 – The American Society of Hematology (ASH), the International Society on Thrombosis and Haemostasis (ISTH), National Hemophilia Foundation (NHF), and World Federation of Hemophilia (WFH) have developed joint clinical practice guidelines on the diagnosis and management of von Willebrand Disease (VWD), the world’s most common inherited bleeding disorder. The guidelines were published in Blood Advances. <Read More>

    Walgreens Makes Majority Investment in Pharmacy Automation Services Provider – January 13, 2021 – Walgreens Boots Alliance acquired the majority share of pharmacy automation technology company iA, the companies announced Jan. 12. Walgreens Boots Alliance’s investment will foster the expansion of iA’s pharmacy automation software, developing technology that makes medication dispensing labor more efficient and centralized so pharmacists can spend more time delivering front-line care to patients. <Read More>

    Pharmacies Say They Could Do More To Distribute Vaccines. States Are Listening. – January 13, 2021 – Retail pharmacies are stepping in to help speed up Covid-19 vaccinations much earlier than anticipated after calls for states to take more advantage of their networks and experience. Independent and chain drug stores weren’t supposed to take a large role in distributing the vaccines until later stages, when doses will be much more widely available. But the halting rollout so far has sent governors scrambling for alternatives to hospital systems and local health departments, which have been handling most vaccinations so far. <Read More>

    PBM Lobby Sues To Block HHS Rule Denying PBMs Drugmaker Rebates – January 12, 2021 – The Pharmaceutical Care Management Association, a national group that represents pharmacy benefit managers, filed a lawsuit Jan. 12 challenging a rebate rule passed by HHS last November. The rule eliminates rebates drugmakers pay to pharmacy benefit managers. It was intended by HHS to simplify the drug-pricing system and to pass discounts to consumers. Drugmakers have supported the rule, but most pharmacy benefit managers oppose it. PCMA argues that the rule will drastically increase Medicare Part D premiums and costs for taxpayers. <Read More>

    Why Won’t Physicians Prescribe New Antibiotics? – January 12, 2021 – A roundtable that was convened in 1965 by Max Finland and his 7 colleagues emphatically endorsed the need for new antibiotics.1 The problem pathogens were predominantly gram-negative, such as Pseudomonas, Klebsiella, and Proteus species. The roundtable members also recognized the emerging problems associated with methicillin-resistant Staphylococcus aureus (MRSA). Approximately 50 years later, not a lot had changed when the Infectious Diseases Society of America (IDSA) established the “10 × ‘20” campaign to encourage the development of new antimicrobials. In the ensuing years, this target was achieved, as the FDA approved 19 new antibiotics. Apart from bedaquiline (Sirturo, Janssen)—a drug for multidrug-resistant (MDR) tuberculosis—no new pathways or novel agents were created, however. <Read More> 

    Understanding Prehospital Vasopressors: Dopamine, Epinephrine or Norepinephrine? – January 12, 2021 – Managing hypotension in the field can be tricky. While only about 1-2% of EMS patients (non-trauma) present with hypotension and shock, this small subset of patients carries an in-hospital mortality rate between 33-52%. This means that vasopressors are not used often, but they are used on the sickest of patients. A practical understanding of what common vasopressors do, both the good and the bad, is important in guiding clinical treatment decisions. <Read More>

    CDC Expands Negative COVID-19 Test Requirement to All Air Passengers Entering the United States – January 12, 2021 – The Centers for Disease Control and Prevention is expanding the requirement for a negative COVID-19 test to all air passengers entering the United States.  Testing before and after travel is a critical layer to slow the introduction and spread of COVID-19. This strategy is consistent with the current phase of the pandemic and more efficiently protects the health of Americans. Variants of the SARS-CoV-2 virus continue to emerge in countries around the world, and there is evidence of increased transmissibility of some of these variants.  With the US already in surge status, the testing requirement for air passengers will help slow the spread of the virus as we work to vaccinate the American public. <Read More>

    Updated Evidence For Optimal Management of C. diff Infection – January 11, 2021 – Evidence continues to accumulate on the increased relative efficacy of some therapies for Clostridioides difficile infection (CDI), especially with respect to the prevention of recurrent infection. There are 4 agents approved for managing CDI: 2 older antibiotics, metronidazole and vancomycin, and 2 newer options, the antibiotic fidaxomicin (Dificid, Merck) and a newer monoclonal antibody against toxin B, 1 of the 2 major C. difficile toxins (bezlotoxumab [Zinplava, Merck]). Four additional agents are in phase 1 to 3 clinical trials. Bezlotoxumab is given along with one of the standard-of-care antibiotics to reduce the risk for CDI recurrence by augmenting the host endogenous antibody response against C. difficile toxin B. <Read More>

    Early Flu Antiviral Use Reduces Hospitalizations – January 11, 2021 – A study published in the International Journal of Infectious Diseases found early administration of Oseltamivir (Tamiflu) has a beneficial impact in reducing 30-day readmissions and mortality in adult influenza patients when compared to a delayed administration after hospital admission or untreated patients and should be considered in all patients who require hospitalisation. These Australian researchers concluded by saying ‘The beneficial effect of Oseltamivir in reducing readmissions could be related to a reduction in the incidence of secondary complications of influenza such as bacterial pneumonia or fewer exacerbations of underlying chronic medical conditions.’ <Read More>

    New Asthma Management Guidelines Primer with Dr. Anne Dixon – January 11, 2021 – New guideline updates from the National Asthma Education and Prevention Program delivered a litany of key recommendations for clinicians managing asthma, a condition has seen steady growth in both new cases and therapeutic options over the last decade. The National Institutes of Health (NIH)-supported guidelines, published in December 2020, entailed 6 major changes to asthma management determined by an expert panel based off a six-year old needs assessment. Overall, the panel provided 19 new recommendations on the subject of management—an indication of how far the field has grown in so few years. <Read More>

    340B in the News 

    340B Administrative Dispute Resolution Goes Live Amid a Flurry of 340B Litigation – January 18, 2021 – The U.S. Department of Health and Human’s Services (HHS) Health Resources and Services Administration’s (HRSA) long-awaited administrative dispute resolution (ADR) final rule went into effect last week, on January 13, 2021. The ADR regulations, which have lingered in HHS since 2010, arrive amid increasing tensions and a flood of 340B-related litigation between covered entities, manufacturers, and HHS. <Read More> 

    United States: Summary: “Examining HRSA’s Oversight of the 340B Drug Pricing Program” Energy & Commerce Hearing – Oversight and Investigations Subcommittee – January 14, 2021 – The 340B Program continues to experience some long-standing vulnerabilities that impede the effective oversight and operation of the program. Two in particular stand out: (1) the lack of transparency that prevents accurate payments by 340B providers, State Medicaid programs, and pharmaceutical manufacturers, and (2) a lack of clarity regarding program rules that creates uncertainty and results in uneven program implementation and limited accountability. In response to these vulnerabilities, OIG makes two recommendations: (1) increase transparency to allow payment accuracy and, (2) clarify rules to ensure that the program operates as intended. As to the first point, the lack of transparency in ceiling prices impedes 340B providers and Medicaid programs from ensuring that they have paid the correct amount for 340B-purchased drugs, and it also hinders States’ efforts to pay providers correctly and to claim correct Medicaid rebates from manufacturers. With respect to 340B program rule clarifications, HRSA should clarify the definition of an “eligible patient” under the program in light of increasingly complex contract pharmacy arrangements, and the agency should also issue guidance clarifying how the program should apply to uninsured patients, as 340B providers are not currently required to use savings from the program for any particular purpose. To the extent HRSA does not have the regulatory authority to pursue these recommendations, Congress should provide authorizing legislation. <Read More> 

    Sanofi, Eli Lilly Pile on Challenges to HHS’s Drug Discount Push – January 14, 2021 – Lawsuits are piling up against an HHS advisory opinion that drugmakers must provide steep discounts to pharmacies in contract with low-income health providers. Eli Lilly and Co., Sanofi-Aventis U.S. LLC, and AstraZeneca Pharmaceuticals LP are asking federal courts to strike down an opinion that calls on drug manufacturers to give contract pharmacies the same discounts they provide to health institutions under the 340B drug pricing program. The opinion, by Department of Health and Human Services General Counsel Robert Charrow, isn’t legally binding. But companies allege it’s unlawful and puts them on the hook for honoring a practice they say falls beyond the scope of the program. They also fear that a newly established alternative dispute resolution board for 340B spats will rely on the opinion when making its decisions. <Read More>

    340B Saga Continues With Drug Company Lawsuits – January 14, 2021 – At least three drug companies have filed separate suits against the U.S. Department of Health and Human Services (HHS) over an advisory opinion the HHS Office of Inspector General (OIG) issued Dec. 30 stating that drug manufacturers are obligated to provide 340B pricing for outpatient drugs dispensed by contract pharmacies on behalf of hospitals and clinics that qualify for the discounts. Indianapolis-based Eli Lilly and Co. filed a complaint for declaratory and injunctive relief in the U.S. District Court for the Southern District of Indiana. The complaint asks the court to declare that the OIG decision violates the Administrative Procedure Act because it was issued without following proper procedure and exceeds statutory authority, and that Lilly isn’t required to offer the 340B discounts to contract pharmacies. It also asks the court to enjoin enforcement of the OIG decision. <Read More>

    Nevada Shelves Program Cuts in Victory for HIV Patients: Federal 340B Changes Forestalled – January 13, 2021 – AIDS Healthcare Foundation (AHF) and a coalition of nonprofit HIV providers and the people they serve throughout Nevada welcomed news that the Nevada Department of Health and Human Services (DHHS) Division of Public and Behavioral Health (DPBH) has delayed plans to roll out major changes to the state’s 340B Drug Pricing Program, a federally administered, privately funded program that HIV nonprofits rely on and use to deliver crucial, lifesaving care and services to Nevadans living with HIV or AIDS. According to a letter issued by the Nevada Medication Assistance Program (NMAP letter) yesterday, NMAP, which was to begin rolling out the changes on January 18, 2021 “… will be temporarily postponing any changes to the program through April 1, 2021, if not longer. This delay will allow DPBH additional time to review the impact of community partners using the federal 340B program and the program income received directly to them and the impact of rebate revenue received at NMAP.” <Read More>

    Drugmakers Sue HHS Over 340B Advisory Opinion in Feud Over Contract Pharmacy Access – January 13, 2021 – Drug companies AstraZeneca, Eli Lilly and Sanofi filed separate lawsuits seeking to preserve their ability to restrict offering 340B-discounted drugs to contract pharmacies. The lawsuits, filed in different federal courts, seek to get rid of an advisory opinion filed by the Department of Health and Human Services’ (HHS’) general counsel that says drug companies must offer 340B drugs to contract pharmacies, which are third-party entities that dispense drugs on behalf of hospitals participating in the program. The drug companies argue that the advisory opinion contracts the statute for the 340B program, which requires manufacturers to offer discounted products to safety net hospitals and other providers in exchange for participation in Medicare and Medicaid. <Read More>

    HHS Issues Advisory Opinion on Contract Pharmacies Under the 340B Program – January 12, 2021 – On Dec.30, 2020, the Department of Health and Human Services (HHS) Office of the General Counsel released an advisory opinion concluding that drug manufacturers are obligated to deliver discounts under the 340B Drug Pricing Program on covered outpatient drugs when contract pharmacies are acting as agents of 340B covered entities…In the advisory opinion, the HHS Office of the General Counsel asserts that the plain meaning of Section 340B requires manufacturers to sell covered drugs to covered entities at or below the ceiling price. This requirement is independent of whether or not a contract pharmacy is used to dispense the prescription drugs. The HHS Office of the General Counsel maintains that this plain meaning is also supported by the purpose and history of the 340B program. Last, the HHS Office of the General Counsel maintains that the risk of diversion and duplicate discounts will not be increased through the use of contract pharmacies. <Read More> 

    Around the Nation: Tennessee Received CMS’ OK on Plan to Turn Medicaid Into Block Grant Program – January 11, 2021 – Tennessee Gov. Bill Lee (R) on Friday announced the Trump administration has approved a 10-year demonstration program to turn the state’s Medicaid program into a block grant program, making Tennessee the first state in the United States to get CMS’ approval to receive a lump sum of funding for its Medicaid program, in today’s bite-sized hospital and health industry news from the District of Columbia, Ohio, and Tennessee… District of Columbia: HHS’ Office of General Counsel (OGC) late last month in an advisory opinion said drug manufacturers are required to provide discounts to community health centers, safety net hospitals, and other entities covered under the federal 340B Drug Pricing Program. Last year, some drugmakers began implementing new contract conditions or imposing restrictions on the discounts. <Read More> 

    Medi-Cal Rx: California to Transition Medi-Cal Pharmacy Benefits to Fee-For-Service – January 11, 2021 – On April 1, 2021, the California Department of Health Care Services (“DHCS”) will be transitioning all Medi-Cal pharmacy benefits from managed care to fee-for-service (“FFS”).  This new system to administer FFS pharmacy benefits is being called “Medi-Cal Rx” and was developed by DHCS in response California Governor Gavin Newsom’s January 7, 2019 executive order (the “Order”), which instructed DHCS to transition all Medi-Cal pharmacy benefits to FFS by January 1, 2021… Medi-Cal Rx will likely impact billing and reimbursement for prescription drugs under the 340B Drug Pricing Program (the “340B Program”).  The 340B Program requires pharmaceutical manufacturers to offer covered outpatient drugs to eligible “safety net” health care facilities, clinics, and hospitals (termed “covered entities”) at a discounted price.  For 340B Program claims under Medi-Cal Rx, the reimbursement is the covered entity’s actual drug acquisition cost plus the appropriate professional dispensing fee. <Read More>   

    Contract Pharmacies and the 340B Drug Discount Program: New Litigation and an Advisory Opinion Point to Ongoing Skirmishes on the 340B Battlefield – January 11, 2021 – On December 11, 2020, five hospital groups, including the American Hospital Association (“AHA”), and an organization of hospital pharmacists representing participants in the 340B drug pricing program (“340B Program”), filed a federal lawsuit (the “340B Program Litigation”) against the U.S. Department of Health and Human Services (“HHS”) over HHS’ alleged failure to enforce 340B Program requirements that obligate pharmaceutical manufacturers to provide 340B Program prescription drug discounts to pharmacies contracted by 340B Program-participating hospitals to dispense 340B Program drugs. <Read More>