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Clinical Insights: April 20, 2021

Posted on April 20, 2021 By RxStrategies, Inc. - ,

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

New Drug Approval

Nextstellis® (drospirenone and estetrol) Tablets – New Drug Approval – April 16, 2021 – Mayne Pharma Group Limited and Mithra Pharmaceuticals, SA are very pleased to announce that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for the novel combined oral contraceptive Nextstellis® (3 mg drospirenone (DRSP) and 14.2 mg of estetrol (E4) tablets). Mayne Pharma anticipates the commercial launch of Nextstellis® by the end of June 2021. Developed by Mithra, Nextstellis® is the first and only contraceptive pill containing estetrol, a native estrogen, now produced from a plant source. Estetrol is the first new estrogen introduced in the US in more than 50 years. <Read More>

New Formulation Approval

No new update.

New Indication/Dosage Approval

Trodelvy® (sacituzumab govitecan-hziy) Injection – New Approved Indication – April 13, 2021 – Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Trodelvy® (sacituzumab govitecan-hziy) for use in adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor. The accelerated approval was based on data from the international Phase 2, single-arm TROPHY study. Of the 112 patients who were evaluable for efficacy, 27.7% of those treated with Trodelvy responded to treatment, with 5.4% experiencing a complete response and 22.3% experiencing a partial response. The median duration of response was 7.2 months (95% CI: 4.7-8.6). <Read More>

Xolair® (omalizumab) Subcutaneous Injection – New Approved Indication – April 13, 2021 – Roche announced that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection across all approved U.S. indications. Xolair® is the only FDA-approved biologic designed to target and block immunoglobulin E (IgE) for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria (CIU) and nasal polyps. <Read More> 

Trodelvy® (sacituzumab govitecan-hziy) Injection – New Approved Indication – April 7, 2021 – Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Trodelvy® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. The approval is supported by data from the Phase 3 ASCENT study, in which Trodelvy® demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival (PFS)), extending median PFS to 4.8 months from 1.7 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; p<0.0001). Trodelvy also extended median overall survival (OS) to 11.8 months vs. 6.9 months (HR: 0.51; 95% CI: 0.41-0.62; p<0.0001), representing a 49% reduction in the risk of death. <Read More> 

New/Updated Drug Shortage

April 16, 2021

April 15, 2021

April 13, 2021

April 12, 2021

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

What Allergies Cause Asthma? – April 19, 2021 – With allergy season under way, pharmacists can help patients identify triggers and coach them on how to manage. For those with allergies, the immune system treats these as if they are harmful substances, causing a cascade of events including inflammation and the production of immune response modulators. Asthma attacks can be triggered by allergies. Allergic asthma is the most common type of asthma. An allergic response causes histamines and immunoglobulin E (IgE) to be released. Too much IgE can cause inflammation of the airways, resulting in an asthma attack. The most significant allergens for individuals with allergic asthma are those that are inhaled. Respiratory allergies occur in about 24.4 million individuals in the United States. Food allergies can cause asthma, though that is rare. About 4.8 million children suffer from food allergies. <Read More>

Pharmacy’s Steps for Addressing Vaccine Inequities – April 19, 2021 – The first wave of COVID-19 vaccine distribution exposed racial and ethnic disparities in access to health care in America—disparities that were already exposed by the pandemic itself. By late February, reports from all over the country and national data showed that the distribution rates of COVID-19 vaccination were much lower among Black and Latinx Americans than whites. Whether the opening of mass vaccination sites announced in March will ease this vaccination gap for minorities remains to be seen. But several health systems have taken a proactive approach. Whether it’s providing transportation to vaccination sites or conducting registration drives for people with limited access to the internet, these pharmacist-coordinated efforts show the profession is willing to do its part. <Read More>

NCCN Guidelines for RCC Add Frontline Lenvatinib/Pembrolizumab as Preferred Treatment Option – April 17, 2021 – Recent updates to the National Comprehensive Cancer Network’s (NCCN) guidelines for renal cell carcinoma (RCC) reflect quick integration of new agents and combination regimens to provide patients with RCC with more treatment options and the most up-to-date options. Incorporated into the latest guidelines update, released March 23, 2021, are the use of lenvatinib (Lenvimaä) and pembrolizumab (Keytrudaä) as frontline systemic therapy for patients with clear cell RCC, both for favorable and poor-/intermediate-risk disease. The combination received a preferred, category 1 recommendation from the NCCN. <Read More>

Study: Step Therapy Contributes to Biosimilar Utilization – April 17, 2021 – Study authors measured savings, conversions to biosimilars, and payer policies for 3 originator brands. Using commercial and public payer data, investigators observed that payer utilization management policies such as step therapy contributed to a sizeable movement toward biosimilar use, according to a poster presentation at AMCP 2021. “Payers equipped with proactive utilization management strategies for oncology biosimilars were able to capitalize on early utilization shifts to the less expensive biosimilar products,” the authors concluded. They conducted a retrospective claims analysis for patients with cancer enrolled in commercial and Medicare plans between June 2019 and June 2020. <Read More>

Update of the WHO Guidance on the Treatment of Drug Susceptible Tuberculosis – April 16, 2021 – The World Health Organization (WHO) is convening a Guideline Development Group (GDG) to advise on updates needed to its recommendations on the treatment of drug susceptible tuberculosis (TB). Drug susceptible TB affects approximately 7 million people annually. It is currently treated with four first line TB medicines for a period of six months. Approximately 85% of patients who take the six-month regimen will have a successful treatment outcome. Ensuring access to effective treatment is a key component of the End TB Strategy, which includes a priority indicator that 90% or more of patients should have a successful treatment outcome. <Read More>

Incoming HOPA President Outlines Organization’s Future – April 16, 2021 – Incoming Hematology/Oncology Pharmacy Association (HOPA) president Larry W. Buie, PharmD, BCOP, FASHP, outlined his plan for the future of the organization in a presentation at the virtual 2021 HOPA Annual Conference. He placed specific emphasis on the importance of expanding HOPA’s reach, committing to diversity, equity, and inclusion, and developing the HOPA collaborative research program. Buie discussed a number of ways to potentially expand the organization’s reach, including through HOPA’s task force on student engagement, which is examining how HOPA can collaborate with pharmacy schools to teach pharmacy students about oncology earlier in their careers. <Read More>

Understanding Specialty Pharmacy (Part 1) – April 16, 2021 – Overall growth in specialty pharmacy today is significantly outpacing traditional pharmacies and soon will make up approximately half of total pharmacy spend. The field of specialty pharmacy is exactly what it sounds like—it is a unique, rapidly growing segment of the pharmacy industry that primarily focuses on the dispensing of high-cost, high-touch medications. High cost, in this instance, typically refers to therapies that cost upwards of $700 per month for a patient—simple enough, right? Defining “high touch” is a little bit more obscure. Think of it as analogous to being considered “high maintenance”. For our purposes, this translates to medications that require extra time, attention, and/or resources from most or all the stakeholders associated with it from production to consumption, namely manufacturers, wholesalers, prescribers, payers, pharmacies, and patients. Specialty medications are also “special” in that they often tend to treat disease states that affect smaller patient populations than those most often seen at traditional retail pharmacies. For example, according to the American Heart Association, in 2020 an estimated 918 million individuals globally are living with a diagnosis and/or are being treated for hypertension. Conversely, according to the National Multiple Sclerosis Society, only 2.8 million people worldwide suffer from multiple sclerosis, a common disease state targeted by specialty medications. <Read More>

Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab – April 16, 2021 – The U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use. Therefore, the agency determined that the criteria for issuance of an authorization are no longer met and has revoked the EUA. <Read More>

Pharmacy Automation is Critical to Win the Fight Against COVID-19 – April 16, 2021 – Technology is key in supporting and freeing up time for pharmacists to meet vaccination efforts and increased demands in providing community care. Since March 2020, the way that Americans use and view the country’s health care system has changed radically. The onset of the coronavirus disease 2019 (COVID-19) pandemic resulted in vast shifts, which limited the capability to use hospitals for much of anything other than COVID-19-related admissions. The health care industry’s primary function became administering COVID-19 tests, and the ability to secure these appointments was extremely limited, based on lab capabilities, patient volume, and test quantities. <Read More>

NIH Closes Enrollment in Trial Comparing COVID-19 Treatment Regimens – April 15, 2021 – The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced that the fourth iteration of the Adaptive COVID-19 Treatment Trial (ACTT-4) has closed to enrollment because the study met pre-defined futility criteria indicating that neither treatment regimen studied is likely significantly better than the other. The NIAID-sponsored trial aimed to determine which of two drug combinations—baricitinib plus remdesivir or dexamethasone plus remdesivir — was more effective at preventing adults hospitalized with COVID-19 on supplemental oxygen from progressing to requiring mechanical ventilation or death, among other outcomes. <Read More>

Updates for Second Generation BTK Inhibitors in R/R Mantle Cell Lymphoma – April 15, 2021 – Selection of any BTK inhibitors for mantle cell lymphoma should consider factors such as cardiovascular or bleeding risks, predisposition for gastrointestinal adverse effects, and potential medication nonadherence. Second generation Bruton’s tyrosine kinase (BTK) inhibitors showed promise for patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) in short-term follow up, as well as fewer off-target adverse effects (AEs), according to Andrea LeVoir, PharmD, BCOP, a clinical pharmacy specialist in lymphoma for Memorial Sloan Kettering Cancer Center. LeVoir presented data supporting these results on Thursday at the virtual Hematology/Oncology Pharmacy Association Annual Conference 2021. <Read More>

Holding Third Parties Liable for Their Role in Perpetuating the Opioid Crisis – April 15, 2021 – While the country has been focused on the tragic losses and economic fallout from the coronavirus pandemic, another plague, a man-made one 20 years in the making, continues to quietly rage in the background: the opioid crisis. The opioid epidemic was a perfect storm, caused by years of over-promotion, over-prescription and dangerous marketing campaigns. Integral to this “perfect storm” was not just the drug manufacturers’ conduct, but also third parties, such as private equity and consulting companies, who all played critical roles. Unfortunately, this crisis has taken a turn for the worse. Authorities nationwide have reported upticks in opioid overdose deaths, which sadly have been exacerbated by social distancing measures and the reduction in critical government funds as attention is turned to fighting COVID-19. <Read More>

Transgender Women Urgently Need More HIV Prevention and Treatment Services, New CDC Data Show – April 15, 2021 – A CDC report released in advance of National Transgender HIV Testing Day found that 4 in 10 transgender women surveyed in seven major U.S. cities have HIV. The report, one of the most comprehensive surveys of transgender women in the United States to date, also revealed that nearly two-thirds of African American/Black transgender women and more than one-third of Hispanic/Latina transgender women surveyed have HIV. These findings demonstrate the pressing need for scaled-up HIV prevention and care strategies for transgender women. CDC is actively working to address disparities through strategic program funding and partnerships throughout the nation. <Read More>

Bills to Lower Prescription Drug Costs and Boost Biosimilars Sent to Biden’s Desk – April 15, 2021 – The U.S. House of Representatives yesterday approved two bills meant to lower prescription drug prices and sent them on to President Joe Biden for approval. The Advancing Education on Biosimilars Act and the Ensuring Innovation Act were introduced by U.S. Senator Bill Cassidy, M.D. (R-LA) and broadly aim to improve the current market for cheaper generic drugs.
The Advancing Education on Biosimilars Act chiefly targets education. It was introduced by Cassidy and Senator Maggie Hassan (D-NH). Generally, the bill calls for the creation and maintenance of a website “to provide educational materials for health care providers, patients, and caregivers, regarding the meaning of the terms, and the standards for review and licensing of, biological products, including biosimilar biological products and interchangeable biosimilar biological products.” <Read More>

New Models for Practicing at the Top of Your License – April 15, 2021 – Clinical pharmacists practicing at the top of their license have the opportunity to close provider shortage gaps and improve the quality of patient care, based on the experiences of several innovative states that have implemented advanced practice models. Pharmacists from New Mexico, North Carolina and Illinois are serving as examples of how this practice approach has evolved in recent years, along with the services covered, the unique roles advanced practice pharmacists perform, and current and future challenges to the model. <Read More>

How Can Medicare Part D Keep Up With a More Complex, Costly Landscape? – April 14, 2021 – Compared with when Medicare Part D launched, therapies today are more expensive. A panel at the Academy of Managed Care Pharmacy 2021 meeting discussed how the benefit needs to adapt to keep up with the future. Sixteen years in, how is Medicare Part D performing and what does its future look like? A keynote discussion at the Academy of Managed Care Pharmacy 2021 meeting looked at the past and future of the program, created by the 2003 Medicare Modernization Act, including some of the challenges it faces in a landscape of higher-cost therapies that did not exist when the benefit rolled out. According to the Kaiser Family Foundation, 46 million of the more than 60 million people covered by Medicare were enrolled in Part D plans in 2020, which may be used in either traditional Medicare or in Medicare Advantage. <Read More>

Consumers in Pain Over High Prescription Prices, Ready to Take Action and in Need of Better Tools, According to Survey by Scripta Insights – April 14, 2021 –  It’s no secret prescription drugs are pricey. So, it’s not surprising that “Expensive, Necessary and Cost(ly)” are the first three words that come to mind when people think about prescription drugs. That’s according to the results of an online survey released by Scripta Insights, a cloud-based healthcare IT solution that helps self-insured employers contain their pharmacy benefit spend, while helping members get The Right Meds at the Best Price™. Scripta Insights released results of an online survey that explores consumers’ attitudes and behaviors around prescription drug pricing in America. Scripta is a cloud-based healthcare IT solution that helps self-insured employers contain their pharmacy benefit spend, while helping members get The Right Meds at the Best Price™. Scripta surveyed 372 respondents, ages 18-60+, in Q1 2021 to delve deeper into American attitudes and behaviors around prescription drug pricing. All respondents have health insurance through their employer and take one or more prescription drugs on a regular monthly basis. <Read More>

Certified Technicians Play a Feature Role in COVID-19 Response, Vaccinations – April 14, 2021 – Before the COVID-19 pandemic, pharmacy technicians spent most of their shifts helping patients, billing insurance, stocking the pharmacy area, dispensing prescriptions, and other administrative duties. However, COVID-19 quickly changed that. In Harlan, Iowa, a rural community located in the western part of the state with a population of fewer than 5000, the Harlan Hy-Vee Pharmacy is a staple in the community and has become even more so during the COVID-19 pandemic. Kristen Lund, a full-time certified technician at the pharmacy, describes Harlan as a small and friendly community. “We know a large majority of our patients, and their families, by name,” she said. In fact, the pharmacy has a reputation for sending personalized birthday cards to patients every year. It’s this level of patient care that goes above and beyond as well as strong relationships with patients that have positioned the pharmacy as a trusted place within the tight-knit community. <Read More>

Hematology/Oncology Pharmacists Report Experiencing High Levels of Burnout – April 14, 2021 – A new national survey has shown that occupational burnout is highly prevalent among hematology/oncology pharmacists. Results of the survey were presented by lead poster author Allison P. Golbach, PGY2 oncology resident at the Mayo Clinic in Rochester, Minnesota, during the virtual Hematology/Oncology Pharmacy Association (HOPA) Annual Conference 2021. According to survey results, 61.8% of 550 HOPA members reported symptoms of burnout as defined by a high score on the emotional exhaustion (EE) or depersonalization (DP) scale of the Maslach Burnout Inventory (MBI). High levels of burnout for these categories were defined by scores of 27 or greater for EE, and 10 or greater for DP.1 According to Golbach, the study results were consistent with previous studies on burnout in pharmacists. <Read More>

Applying Specialty Drug Expertise to Gene Therapies for Rare and Orphan Diseases – April 14, 2021 – Many stakeholders envision a world where genetic blindness, severe muscular dystrophy, cancer, sickle cell anemia, blood disorders and many other diseases are not simply treated but cured by gene therapies. Today, these novel drugs represent a paradigm shift in how payors and plan sponsors address the incidence and growing prevalence of some of these rare or orphan diseases among patient populations—and how they manage utilization and cover costs, which have led to sticker shock. For example, a new spinal muscular atrophy gene therapy, onasemnogene abeparvovec-xioi (Zolgensma™, AveXis Inc.), has a one-time price of $2.12 million. <Read More>

FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19 – April 14, 2021 – During this worldwide public health emergency, the FDA has used a variety of tools to oversee facilities that manufacture FDA-regulated products. These tools include record requests in advance of or in lieu of a drug facility inspection, relying on information from trusted regulatory partners, and remote interactive evaluations (such as remote livestreaming video of operations, teleconferences and screen sharing). We have used some or all of these approaches to evaluate facilities for human and animal medical products during the public health emergency when inspections of drug facilities were not possible due to travel or quarantine restrictions. <Read More>

NORC: Pricing Transparency Could Aid Biosimilar Uptake – April 14, 2021 – How you define biosimilar savings depends on whom you ask. The payer may be very happy with a rebate deal obtained from a biologics manufacturer that cuts costs on an originator biologic by 20%, but the patient who has to pay a higher out-of-pocket for an originator vs a biosimilar (eg, $1000 vs $500) may not be very happy with that outcome. And yet the 20% price discount may have been secured only because of the threat of a new biosimilar entering the market. Investigators from NORC, a University of Chicago independent research center, talked to patients, providers, group purchasing organizations (GPOs), and payers about the lack of transparency and hidden deal-making that often goes into the pricing and availability of biosimilars. <Read More>

As Part of Revamp, Ohio Medicaid Hires Watchdog for State-Run Pharmacy Benefits Manager – April 14, 2021 – Bedeviled for years by pharmacy benefit managers making hundreds of millions from Ohio, the state Medicaid department completed its revamp of the entire PBM setup Wednesday by awarding a contract costing 25% less than estimated. Indianapolis firm Myers and Stauffer will be paid an average of $1.5 million a year under a two-year pact that has an additional six optional years. The price tag if the deal remains in place for the entire eight years would be $12 million. The new firm — which already manages the National Average Drug Acquisition Cost database for the federal government — essentially will act as a watchdog on a state-run PBM. <Read More>

Reported STDs Reach All-time High for 6th Consecutive Year – April 13, 2021 – New data published by the Centers for Disease Control and Prevention (CDC) show that reported annual cases of sexually transmitted diseases (STDs) in the United States continued to climb in 2019, reaching an all-time high for the sixth consecutive year. The newly released 2019 STD Surveillance Report found: 1) 2.5 million reported cases of chlamydia, gonorrhea, and syphilis, the three most commonly reported STDs in 2019, 2) A nearly 30% increase in these reportable STDs between 2015 and 2019, 3) The sharpest increase was in cases of syphilis among newborns (i.e., congenital syphilis), which nearly quadrupled between 2015 and 2019. <Read More>

Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine – April 13, 2021 – As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given. <Read More>

How Employers are Rethinking the Pharmacy Benefit to Address Specialty Drugs – April 13, 2021 – As growing numbers of specialty drugs come through the development pipeline, employers are finding new strategies to manage the associated costs, a new report from Willis Towers Watson shows. Katie Asch, senior director and U.S. consulting pharmacy practice lead at WTW, told Fierce Healthcare that two-thirds of new drug approvals are for specialty drug products. In addition, these products are gaining approval for additional indications, Asch said. For example, Sanofi’s Dupixent™ was launched as a drug to treat eczema but has since been approved for asthma, she said…For instance, utilization management tools like prior authorization can ensure patients are taking drugs appropriately, while copay assistance programs can manage individual costs. <Read More>

Pharmacy First Earns URAC Accreditation as a Credentials Verification Organization – April 13, 2021 – The first and only firm of its kind to achieve this distinction, Pharmacy First is setting a new bar for excellence in the pharmacy industry. With a mission to provide the best, most comprehensive suite of services for community pharmacies, Pharmacy First proudly announces it has achieved URAC accreditation as a Credentials Verification Organization (CVO). Pharmacy First, a pharmacy services administrative organization (PSAO) serving thousands of independent pharmacies across the United States, is the first and only PSAO to earn this prestigious distinction. Completing the rigorous URAC accreditation process demonstrates Pharmacy First’s commitment to better healthcare and supporting pharmacies in improving quality, efficiency and patient outcomes. <Read More>

Three Changes Coming to Drug Pricing – April 13, 2021 – Pounded by both sides of the political aisle, pharmaceutical companies know what it feels like to be whipsawed by opposite ends of the American reimbursement system. Two weeks after the November election, President Trump announced a new model for federal drug pricing that was supposed to begin in January. Shortly after taking office, though, President Biden halted, if not canceled, many of those changes for at least a year. Though some pharma companies saw the Biden blockage as a cause for celebration — a kind of stay of execution — I believe some form of policy change regarding drug pricing is inevitable. Pharma companies should not use the legislative delay as justification to avoid what is sure to come. This breather should be used to take a step back and really consider: Where is the U.S. healthcare system headed for pharmaceutical pricing? What is likely to be done? <Read More>

Independent Pharmacies Serving Lower-Income, Minority Communities Report Shortage of COVID-19 Vaccine Supplies – April 13, 2021 – Nearly half of independent pharmacists surveyed by the National Community Pharmacists Association (NCPA) are not getting enough or any doses of the COVID-19 vaccine. Forty-seven percent of the respondents reported serving populations with a significant minority population. According to the survey, which received 515 responses between April 1 and April 7, 2021, 48% of independent pharmacists report inadequate supply as the most pressing issue in their vaccine rollout. Further, 22% report patient reluctance as an issue in their vaccine distribution. <Read More>

AmerisourceBergen Launches Accelerate Specialty Network – Nation’s First Specialty-Focused Pharmacy Services Administration Organization – April 13, 2021 – Global healthcare company AmerisourceBergen launched the Accelerate Specialty Network (Accelerate), the nation’s first specialty-focused Pharmacy Services Administration Organization (PSAO) that leverages AmerisourceBergen’s proven, data-driven PSAO strategy to enhance managed care access and optimize business performance for community-based specialty pharmacies. Accelerate members include accredited health system specialty pharmacies, independent specialty pharmacies and medically integrated dispensing practices. “As specialty pharmaceutical development continues its upward trajectory, the need for higher-touch care coordination for patients will also rise. More and more, patients want to find that care on their own terms,” said Willis Chandler, President of Health Systems & Specialty Services at AmerisourceBergen. “Over the years, payors have narrowed their networks to contain costs and outcomes, but that has dictated where patients can go to get their specialty medications. Accelerate was built to work with payors to help promote and enable accessible community-based pharmaceutical care.” <Read More>

Artificial Intelligence Identifies Novel Multiple Sclerosis Subtypes – April 12, 2021 – A new study published in Nature Communications used artificial intelligence (AI) to identify 3 new multiple sclerosis (MS) subtypes, which may help identify which individuals are more likely to have disease progression, according to the authors. Further, these new subtypes could assist in more effective targeted treatments. MS is a neurological condition that arises when the immune system mistakenly attacks the myelin sheaths that wrap around nerves in the brain and spinal cord, resulting in the disruption of electrical signals in the nervous system. It is classified as either relapsing MS, in which nerves are damaged, repaired, and damaged again, or progressive MS, in which nerve damage is continual and unrecovered, resulting in worsening disability. <Read More>

Insurance, Physician Barriers Impede Wider Adoption of Biosimilars – April 12, 2021 – Since 2015, the US Food and Drug Administration (FDA) has approved 29 biosimilar products, with some biologics having between four and five biosimilars now available. When FDA approved the country’s first biosimilar, Zarxioä (filgrastim-sndz), the prospect that these products could help address the high cost of biologics and patient access issues seemed promising. However, the reality five years later is that uptake of biosimilars appears to be slow and inconsistent across medical specialties. <Read More>

APhA Announces 2021 Immunization Champion Award Winners – April 12, 2021 – The American Pharmacists Association (APhA) has selected eight recipients of its 2021 Immunization Champion Awards, recognizing individuals and organizations who have made extraordinary contributions toward improved vaccination rates within their communities. “The APhA Immunization Champion Awards program helps us tell the story regarding pharmacists’ and the pharmacy teams’ contributions to and impact on the health of communities and as valued members of the immunization neighborhood,” according to Mitchel Rothholz, RPh, MBA, APhA Chief Governance & State Affiliates and Executive Director, APhA Foundation. <Read More>

How Pharmacists Contribute Meaningfully in Primary Health Care – April 12, 2021 – Evidence is growing that health care delivered by teams is superior to services delivered by a single practitioner. Published in the Journal of the American Board of Family Medicine — University of Minnesota, University of North Carolina, American Board of Family Medicine and the American Academy of Family Physicians researchers compared key elements from the practice of a pharmacist providing comprehensive medication management to the foundational components defined for primary care. Based on a common health care team framework — the Four C’s of Primary Care (first contact, continuity, comprehensiveness, and coordination) — this team has, for the first time, articulated the impact of comprehensive medication management services delivered by pharmacists. <Read More>

How Pharmacists can Protect Patients from Outdated COVID-19 Treatment – April 12, 2021 – The pharmacist is the last barrier between a patient and a drug, which is why it’s critical for pharmacists to check for allergies, potential drug interactions, patient understanding of how to use the drug, and whether the prescription is appropriate for the diagnosis. Hydroxychloroquine is an ineffective and potentially dangerous treatment for COVID-19, yet prescriptions for patients with the virus continue. Protecting people from this misguided therapy means pharmacists must take a stand and question the prescribed treatment. When hydroxychloroquine came to the attention of the American public in 2020, it was commonly described as a malaria treatment. Besides being used to prevent malaria, it is often prescribed to treat autoimmune disorders including lupus and rheumatoid arthritis. Millions of Americans living with these chronic disorders depend on the drug to manage their symptoms. <Read More>

340B in the News

Biosimilars Advance in the Oncology Space – April 12, 2021 – Hospital reimbursement deals slow the adoption of biosimilars in oncology, but cost concerns contribute to the incentives to use these agents. When it comes to biosimilars, recent months have seen important developments in oncology. These have included new findings on oncologists’ willingness to prescribe biosimilars and fresh pursuits among companies that hope to carve out a niche in the oncology biosimilars space. Many health institutions are focused on getting oncologists to prescribe more biosimilars, because these lower-cost agents are comparable to the originator products they reference in terms of safety and efficacy, but biosimilars also have the potential to save money for health institutions and patients and also broaden access to medicine, simply by being cheaper than higher-priced reference products. However, the key is getting oncologists to change their prescribing habits… Other factors also influence whether hospitals use originators or biosimilars, such as the 340B Drug Pricing Program, which is designed to improve patient access to drugs but, because of its compensation structure, often incentivizes hospitals to use the most expensive drugs, according to Okon. <Read More>

New York State Delays Changes to 340B Drug Discount Program – April 12, 2021 – Local healthcare providers and non-profits are breathing a collective sigh of relief after the state agreed to delay plans to overhaul the federal 340B drug discount program, which requires drugmakers to give medication to certain providers at discounted rates. Advocates long warned that changes to the program would have wreaked havoc on vulnerable populations — including individuals living with HIV/AIDS as well as homeless folks. Organizations impacted by the program include community health non-profits, homeless shelter providers, and safety net hospitals, which offer services to individuals regardless of ability to pay. <Read More>