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New Drug Approval
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New Generic/Biosimilar Approval and Launch
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Clinical and Pharmacy News
US Insulin Prices Drastically Higher Than Other High-Income Countries – October 12, 2020 – The price of insulin is more than 8 times higher in the United States than in 32 other high-income comparison countries combined, according to a study by the RAND Corporation. Over the past decade, insulin prices have skyrocketed, with a previous study showing that annual insulin spending among adults with employer-sponsored health insurance doubling from $1432 to $2853 between 2012 and 2016, despite a 50% rebate. Another federal analysis found that the average wholesale acquisition price for rapid-, long-, and short-acting insulin increased by 15% to 17% per year from 2012 to 2016. <Read More>
Mallinckrodt Files for Chapter 11 Bankruptcy – October 12, 2020 – Mallinckrodt has filed for Chapter 11 bankruptcy for all of its U.S. subsidiaries and some international subsidiaries, the company said Oct. 12. The bankruptcy restructuring will reduce the company’s total debt by about $1.3 billion and resolve opioid-related claims and litigation involving its drug Acthar. “After many months of deliberation, negotiation and consideration of alternatives, Mallinckrodt’s management and board of directors determined that implementing a Chapter 11 restructuring provides the best opportunity to maximize the value of the enterprise and position the company for the future in light of the current challenges it faces,” said Mark Trudeau, Mallinckrodt’s CEO. <Read More>
Study: Single Dose Radiotherapy Equally Effective as Conventional Radiotherapy for Most Breast Cancer Cases – October 12, 2020 – For most women with early stage breast cancer, researchers have found that a single dose of targeted radiotherapy during surgery is just as effective as conventional radiotherapy, which typically requires several hospital visits after surgery. This approach, called targeted intraoperative radiotherapy (IORT), is restricted only to the area around the tumor and is given immediately following surgery. Conventional radiotherapy approaches involve doses to the entire breast over several days. According to the study findings, IORT is associated with an approximately 80% chance of avoiding a full course of conventional radiotherapy, fewer adverse effects, and no difference in survival or the likelihood of the cancer returning. <Read More>
NIH Testing New Blood-based COVID-19 Treatment – October 12, 2020 – The National Institutes of Health has begun studying remdesivir in combination with a highly concentrated solution of COVID-19 antibodies to see if it can reduce the risk of patients developing more serious illness. The solution is called anti-coronavirus hyperimmune intravenous immunoglobulin, or hIVIG. It’s a more-concentrated convalescent plasma that contains several times the amount of antibodies than are typically found in the plasma of people who have recovered from COVID-19, the NIH said. Anti-coronavirus hIVIG may be a more sustainable treatment for COVID-19 patients, as convalescent plasma must be used within 24 hours, whereas anti-coronavirus hIVIG can be stored for as long as three years, The Wall Street Journal reported. <Read More>
Clashing Medications can put Older Adults at Risk, Yet Many Have not had Pharmacist Check for Safety Concerns – October 9, 2020 – A new poll has found that most people over 50 years of age have not connected with a pharmacist to check for potential clashes among their prescription drugs, non-prescription drugs, and supplements, or the potential to save money by switching to lower-cost options. The findings come from the National Poll on Health Aging based at the University of Michigan’s Institute for Healthcare Policy and Innovation with support from AARP and Michigan Medicine, which draws on responses from a national sample of more than 2000 adults between 50 and 80 years of age who answered a wide range of questions online. The poll found that approximately two-thirds of older adults rely on at least 2 prescription drugs and more than half take 2 or more non-prescription drugs or supplements. Further, 2 in 10 take 5 or more prescription drugs. <Read More>
Rutledge v PCMA Arguments: Thumbs Up or Thumbs Down? – October 9, 2020 – Finally, oral arguments in Rutledge v PCMA were heard this week. The pharmacy community has been eagerly awaiting the showdown at the U.S. Supreme Court on this case involving the state of Arkansas against the Pharmaceutical Care Management Association, the association representing pharmacy benefit managers (PBMs). This case is pivotal to curbing the abusive practices of PBMs across the country. The legal question involves ERISA, which is the Employee Retirement Income Security Act of 1974. ERISA is intended to provide nationwide, consistent standards and requirements for employee retirement and health plans by preempting (or preventing) states from passing laws and regulations affecting employee retirement and health plans. The question for the Supreme Court is whether ERISA’s broad preemption extends to state laws covering the dealings between PBMs and pharmacies. All eight current justices heard the case by telephone, and the audio was broadcasted live. It was all very orderly. Arkansas gave brief opening remarks, and then the justices each had 3 minutes or so to ask questions. <Read More>
Study Shows Unique Cardioprotective Properties of an Old Drug – October 9, 2020 – A drug costing less than 2 euros per dose could reduce the long term consequences of a heart attack, benefitting millions of patients. Metoprolol, a member of the beta-blocker class of drugs that has been in use for more than 40 years, has been found to have unique cardioprotective properties. This is the conclusion of a study carried out by scientists at the Centro Nacional de Investigaciones Cardiovasculares (CNIC), Fundación Jiménez Díaz University Hospital, and the Cardiovascular Disease Research Network (CIBERCV). The study, performed in sophisticated experimental mouse models, shows that the cardioprotective effect of metoprolol during a heart attack is not shared by other beta-blockers commonly administered by intravenous injection, such as atenolol and propranolol. <Read More>
NACDS: HHS Report Acknowledges the Pharmacy’s Role in Advancing Hypertension Control – October 9, 2020 – Following the release of The Surgeon General’s Call to Action to Control Hypertension by the Department of Health and Human Services (HHS) that 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. Additionally, the NACDS explained that those facing these chronic disease states are often medically underserved and suffering from disparities within the health care system. <Read More>
Neuropsychiatric Effects of ADT Often Overlooked – October 8, 2020 – Although the physiologic adverse effects of androgen-deprivation therapy (ADT), such as hot flashes, fatigue, osteoporosis, and sexual dysfunction, are regularly discussed with patients, the neurocognitive complications (such as depression, cognitive decline, and dementia) are often overlooked. Despite the reportedly strong association between ADT for prostate cancer and several psychological adverse effects, clinical guidelines to address these issues are lacking. Recently, Siebert et al performed a systematic review of the literature to demonstrate the strength of existing data and to offer recommendations regarding identification and management of neuropsychiatric adverse effects of ADT. <Read More>
Fibrate Rx Works in Cholangiopathic Itch – October 8, 2020 – Treatment with bezafibrate proved superior to placebo in a small randomized trial for short-term relief of moderate to severe cholestasis-associated pruritus in patients with fibrosing cholangiopathies. The primary endpoint of a more than 50% reduction in severe or moderate pruritus at 21 days was achieved by 45% of patients in the arm given the lipid-lowering drug bezafibrate versus 11% in those receiving placebo (P=0.003), according to Ulrich Beuers, MD, of the Tytgat Institute for Liver and Intestinal Research at Amsterdam University Medical Center in the Netherlands, and colleagues. <Read More>
ASH Releases Clinical Practice Guidelines on the use of Preventive Anticoagulation in Patients with COVID-19 – October 8, 2020 – ASH released new guidelines to help clinicians prevent serious blood clotting complications affecting COVID-19 patients. The recommendations suggest that clinicians should use a standard prophylactic anticoagulant dose over higher doses to prevent clotting in patients who have been hospitalized with COVID-19, including those in intensive care. <Read More>
FDA Releases New Guidelines for COVID-19 Vaccine Approval: What to Know – October 8, 2020 – The Food and Drug Administration (FDA) released tough new guidelines Tuesday outlining what’s required for the emergency authorization of a COVID-19 vaccine. The stricter guidance makes it unlikely that a vaccine could be approved — even for emergency use — before Election Day on Nov. 3, something President Trump has been pushing for. Herschel Nachlis, PhD, a research assistant professor of government and a policy fellow in the Nelson A. Rockefeller Center for Public Policy and the Social Sciences at Dartmouth College, says the FDA’s new guidelines are a “win” for the FDA, vaccine makers, and the American public. <Read More>
Pharmacists Garner Priority COVID-19 Vaccination in new Recommendations – October 8, 2020 – The new National Academies of Sciences, Engineering, and Medicine’s (NASEM) COVID-19 vaccine recommendations identify pharmacists as one of the essential groups that should be the first to receive the vaccines when they are available. NASEM’s “Framework for Equitable Allocation of COVID-19 Vaccine” report, developed by the Committee on Equitable Allocation of Vaccine for the Novel Coronavirus, will inform the work of federal agencies that will determine how COVID-19 vaccine(s) will be allocated in the US. <Read More>
Mandates Fail to Increase HPV Vaccination Rates, Coverage – October 8, 2020 – Human papillomavirus (HPV) vaccination mandates fall short of ensuring both higher levels of uptake and equal uptakes of the vaccine across socioeconomic and racial-ethnic groups, according to a recent study published in SSM-Population Health. The findings of this study could potentially affect the distribution and uptake of the coronavirus disease 2019 (COVID-19) vaccine, according to author Andrea Polonijo, PhD . If the vaccine is unable to reach people at all socioeconomic and racial backgrounds, it will not be effective in ending the pandemic, according to the study. Investigators used 2008-09 and 2011-13 data from the National Immunization Survey-Teen in order to gain a nationally representative sample. Polonijo found that receiving a recommendation from a provider greatly increased the odds that a teen got their first HPV shot. <Read More>
How Specialty Pharmacy Will Thrive in the Value Era – October 8, 2020 – The era of fee-for-service health care is nearing an end. In its place, value-based initiatives seek to improve patient outcomes, reduce cost, and increase transparency in health care. These changes represent significant opportunity for specialty pharmacies to demonstrate their ability to create sustainable value across the health care continuum. <Read More>
Expert Recognizes Expansion of HCC Treatment Options During Liver Cancer Awareness Month – October 7, 2020 – In an interview with Targeted Oncology, David J. Pinato, MD, PhD, reviewed how the treatment landscape of hepatocellular carcinoma has evolved over the years and the challenges that clinicians and researchers currently face in the field. Following the approval of the first systemic therapy, sorafenib (NexavarÒ), in 2007, the treatment landscape of hepatocellular carcinoma (HCC) has been enriched by a number of first- and second-line therapeutic options, including tyrosine kinase inhibitors (TKIs) and immunotherapy agents. <Read More>
Consolidative High-Dose Therapy, Autologous Stem Cell Transplant After R-CHOP for Follicular Lymphoma Does not Improve Survival – October 7, 2020 – Consolidative high-dose therapy and autologous stem cell transplantation (HDT/ASCT) should not be offered to patients with follicular lymphoma who are in their first remission after having initially received treatment with Rituxan (rituximab) plus the chemotherapies cyclophosphamide, doxorubicin and vincristine in addition to the steroid prednisone (R-CHOP), according to the authors of a recent study published in Blood Advances. <Read More>
Provider Status for Pharmacists: It’s About Time – October 7, 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. Pharmacists have been central health care heroes in the frontline fight against the spread of COVID-19. Throughout the pandemic, pharmacists have played a critical role in the COVID-19 response in several ways. These efforts include standing up mobile testing facilities, working alongside their colleagues to draft protocols and response plans, reinforcing messages about how to control the spread in their communities, providing curbside delivery, conducting virtual consultations, and compounding hand sanitizers. <Read More>
340B in the News
A Few Bad Apples are Destroying a Vital Drug Program for the Underserved – October 8, 2020 – COVID-19 has swept through the United States, leaving death and devastation in its wake and preying on vulnerable populations the most. As the data pour in, we continue to see a widening wealth gap — lower-income workers are being laid off at much higher rates — and increasing disparities in the death toll among underserved communities. As such, it is imperative that programs that protect these at-risk populations work effectively. Unfortunately, many do not, and the 340B Program administered by the Health Resources and Services Administration (HRSA) is one of the worst offenders. Although it was originally designed to assist patients in low-income and underserved rural and urban areas, it has been transformed into a large and reliable income stream for for-profit healthcare middlemen and pharmacy chains, who are actively stealing discounts from patients in order to pad their own pockets. <Read More>
New Analysis Shows Contract Pharmacies Financially Gain From 340B Program With no Clear Benefit to Patients – October 8, 2020 – The Berkeley Research Group (BRG) published an analysis of historical trends in 340B contract pharmacy arrangements. The findings conclude that the growth in the number of these arrangements is fueling explosive growth in the program at large and driving the 340B program farther and farther away from its original intended goal of providing discounted medicines to safety-net entities treating uninsured and vulnerable patients. <Read More>
Double-Dippers Drive up Drug Costs – October 7, 2020 – In searching for answers to why drug costs are high, we only need look at problems our own government has created. One of the biggest culprits distorting prices is the once obscure “340B Drug Pricing Program.” Created in 1992, it requires drugmakers to offer steep discounts to certain safety net clinics and hospitals to help them “stretch scarce federal resources.” The original intent was to reduce drug costs for uninsured and vulnerable patients by passing the discounts along to them. But this program has little oversight or accountability and no transparency or requirements that the generous 340B discounts be shared with the patients the program was intended to help. <Read More>
Hospital Groups Concerned by Prescription Drug Change – October 5, 2020 – A change in Medicaid funding for prescription drugs could cost New York safety net hospitals big in the state budget, industry groups warned state officials last week in a letter. Leading hospital associations in the state are urging the Department of Health and Governor Andrew Cuomo to reverse the provision, which switches the Medicaid pharmacy benefit from Medicaid managed care to fee-for-service. This, in turn, will lead to New York’s safety net, or 340B hospitals, to be reimbursed for the drugs at cost, meaning they can no longer draw down the cost of those when purchasing them. “This is a significant loss coming at the worst possible time for our safety net hospitals and their communities,” the groups wrote in the letter. <Read More>