Clinical Insights: August 3, 2021

    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

    Twyneo® (tretinoin and benzoyl peroxide) Cream – New Drug Approval – July 27, 2021 – Sol-Gel Technologies, Ltd., a dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, announced that the Food and Drug Administration (FDA) has approved its first proprietary drug product, Twyneo® (tretinoin/benzoyl peroxide) cream, 0.1%/3%, indicated for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older. Twyneo® uses Sol-Gel’s patented technology to entrap tretinoin, a retinoid, and benzoyl peroxide within silica-based microcapsules to stabilize tretinoin from being degraded by benzoyl peroxide and to slowly release each of the active drug ingredients over time to provide a favorable efficacy and safety profile. Twyneo® is patent protected until 2038. Sol-Gel has partnered with Galderma to commercialize Twyneo® in the U.S. Sol-Gel expects to receive a regulatory milestone payment in conjunction with this approval and retains the option to regain U.S. commercialization rights five years following first commercialization in the U.S. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Nucala™ (mepolizumab) Injection – New Approved Indication – July 29, 2021 – GlaxoSmithKline plc (GSK) announced that the US Food and Drug Administration (FDA) has approved Nucala™ (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). This new indication for mepolizumab is for the add-on maintenance treatment of CRSwNP in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. <Read More>

    Uptravi® (selexipag) Tablets and Injection – New Approved Dosage Form – July 29, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Uptravi® (selexipag) injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients with WHO functional class (FC) II–III, who are temporarily unable to take oral therapy. Uptravi® IV is a therapeutic option that will allow patients to avoid short-term treatment interruptions and stay on Uptravi® therapy, as uninterrupted treatment is considered key for individuals with PAH. Uptravi® tablets were first approved by the FDA in 2015 to delay disease progression and reduce the risk of hospitalization for PAH. <Read More>

    Botox® (onabotulinumtoxinA) Injection – New Approved Indication – July 28, 2021 – Allergan, an AbbVie company, announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion of Botox® to include eight new muscles for the treatment of upper limb spasticity in adults. The new muscles for treatment include additional muscles of the elbow and forearm (brachialis, brachioradialis, pronator teres, and pronator quadratus), as well as intrinsic hand muscles (lumbricals and interossei) and thumb muscles (flexor pollicis brevis and opponens pollicis). The label now includes the use of ultrasound as a muscle localization technique in adult spasticity. <Read More>

    Shingrix™ (Zoster vaccine recombinant, adjuvanted) – New Expanded indication – July 26, 2021 – GlaxoSmithKline plc announced that the US Food and Drug Administration (FDA) has approved Shingrix™ (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 18 years and older who are or who will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. Immunocompromised individuals are at greater risk of shingles and associated complications than immunocompetent individuals. Shingrix™, a non-live, recombinant sub-unit adjuvanted vaccine, given intramuscularly in two doses, was initially approved by FDA in 2017 for the prevention of shingles in adults 50 years of age or older. Shingrix™ is not indicated for prevention of primary varicella infection (chickenpox). The approval for this new population expands the number of people who can be protected against shingles by Shingrix™. <Read More>

    Keytruda™ (pembrolizumab) Injection – New Approved Indication – July 26, 2021 – The Food and Drug Administration approved pembrolizumab (Keytruda™, Merck) for high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. FDA also granted regular approval to pembrolizumab in combination with chemotherapy for patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA approved test. FDA granted accelerated approval to pembrolizumab for this indication in November 2020. The following trial was the basis of the neoadjuvant and adjuvant approval, as well as the confirmatory trial for the accelerated approval. <Read More>

    Bydureon BCise® (exenatide extended-release) – New Expanded Indication – July 23, 2021 – AstraZeneca’s Bydureon BCise® (exenatide extended-release), once-weekly injectable suspension has been approved in the US for the treatment of type 2 diabetes (T2D); to improve glycemic control in pediatric patients (10 to 17 years) as an adjunct to diet and exercise. The approval by the US Food and Drug Administration (FDA) is the first regulatory approval for a once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) in this population, supported by the positive results of the BCB114 Phase III trial in youth with T2D between 10 and <18 years of age; which showed on top of standard of care exenatide extended-release significantly improved glycemic control compared to placebo in pediatrics. <Read More>

    New/Updated Drug Shortage

    July 30, 2021

    July 27, 2021

    July 26, 2021

    New Drug Recall and Safety Alerts

    No new update.

    New Generic/Biosimilar Approval and Launch

    Semglee® (insulin glargine-yfgn) Injection – New Biosimilar Approval – July 28, 2021 – The U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee® (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog. Semglee® (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S. for the treatment of diabetes. Approval of these insulin products can provide patients with additional safe, high-quality and potentially cost-effective options for treating diabetes. <Read More>

    Clinical and Pharmacy News

    FDA Gives Breakthrough Status to Biofourmis’ Heart Failure Dtx – August 2, 2021 – Boston-based Biofourmis claimed the accolade for its BiovitalsHF prescription digital therapeutic (DTx), which is used to make sure that patients who have heart failure with reduce ejection fraction (HFrEF) get the right drug treatment in accordance with clinical guidelines. Biofourmis’ chief executive and founder Kuldeep Singh Rajput said it is a significant step for the advancement of the digital therapeutic category, as well as for patients with heart failure. Breakthrough device designation can speed up the development of new medical devices, making them available to patients sooner – a key consideration for Biofourmis as BiovitalsHF is currently under review by the US regulator. <Read More>

    Telehealth, Enriching Residents During Pandemic – August 2, 2021 – Using video appointments to manage stem cell transplant patients and employing innovative approaches to ensure PGY-1 oncology residents get the most out of their rotations are among the strategies that pharmacists have used to counter challenges brought on by COVID-19. One positive change in health care accelerated by the COVID-19 pandemic that is expected to linger is a transition to telehealth, said Julianna Merten, PharmD, BCPS, BCOP, an ambulatory care pharmacist with Mayo Clinic in Rochester, Minn. <Read More>

    Not So Different: Should Biosimilar Variations Be Concerning? – August 1, 2021 – Although the European Union has been in the biosimilars game longer than the United States, both are considered leaders in biosimilar use. Generics were the first copycat drugs, however, there are lessons to be learned from this experience. But biologics, which are made from living organisms, are not as simple to copy as generics are. There will be minute differences between biosimilars and originator biologics, and there will even be small differences between different batches of the same originator biologic. We now have reliable tests for determining whether these differences are clinically significant or not. But what does our experience so far with biosimilars and originators tell us about these differences? We sat down with Paul Cornes, BM, BCH, MA, MRCP, FRCR, a consultant oncologist and biosimilars expert… <Read More>

    How Immunoglobulin (Ivig) Therapy is Changing the Health Care Industry – August 1, 2021 – Did you know that a component of your blood could be used to create life-saving medicine for someone else? Many people who have chronic diseases or illnesses rely on immunoglobulin therapy, also known as IVIg or SCIg, a drug that is made from plasma. IVIg is administered intravenously, which means “into a vein,” and SCIg is administered subcutaneously, which means “under the skin.” Both methods are effective but are prescribed for different reasons. A patient’s physician will carefully consider their medical situation, medical history, response to treatment, compliance with therapy, and lifestyle to determine which route will be a better option. <Read More>

    Senate Takes Aim at Pharma’s Patent Schemes, Pay-For-Delay Deals in Renewed Drug Pricing Crackdown – July 30, 2021 – Earlier this month, groups lobbying for lower prescription drug prices called on Congress to enact long-awaited reforms and stressed the urgency of the movement. Given the change of the guard in Washington, D.C. and the fresh momentum to address anti-competitive practices, the groups told Congress that it “has a unique and time-limited window for crafting meaningful drug pricing reform this year.” Answering the call on Thursday was the Senate Judiciary Committee, which voted unanimously to advance four pieces of legislation which would help rein in the cost of prescription drugs. <Read More>

    FDA Requests Additional Study to Support Approval of Tenapanor for Patients With CKD – July 30, 2021 – The FDA has issued a complete response letter (CRL) to Ardelyx stating that an additional clinical trial is needed to support approval of tenapanor, the company’s novel treatment for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. Ardelyx previously submitted a new drug application (NDA) to the FDA hoping to obtain approval of tenapanor in this setting; however, the CRL explained that the data in the NDA left the FDA “unclear of the clinical significance”of the treatment. According to Ardelyx, the CRL did not identify any issues in other key areas, such as safety; clinical pharmacology/biopharmaceutics; chemistry, manufacturing and control; or nonclinical items. <Read More>

    FDA Authorizes REGEN-COV™ Monoclonal Antibody Therapy for Post-Exposure Prophylaxis (Prevention) for COVID-19 – July 30, 2021 – The U.S. Food and Drug Administration revised the emergency use authorization (EUA) for REGEN-COV™ (casirivimab and imdevimab, administered together) authorizing REGEN-COV for emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. REGEN-COV™ is not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus — only after exposure to the virus. REGEN-COV™ also remains authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. <Read More>

    NICE Publishes New Rapid Guideline to Diagnose and Treat Rare Blood Clotting Condition Associated With COVID-19 Vaccination – July 29, 2021 – NICE has published a new rapid COVID-19 guideline to help healthcare staff identify and treat patients who develop the rare syndrome vaccine-induced immune thrombocytopenia and thrombosis (VITT) after receiving COVID-19 vaccinations. Thrombocytopenia is a condition where a person has a low platelet count, while thrombosis is the formation of blood clots. Although extremely rare, with only 14.2 cases occurring per million doses of COVID-19 vaccine, this condition can be very serious and requires swift diagnosis and urgent treatment. <Read More>

    Five Key Things Pharmacists Need to Know As Insulin Biosimilars Come to Market – July 29, 2021 – The FDA approved the first interchangeable biosimilar in the United States on July 28 for Viatris’ Semglee® (insulin glargine-yfgn), achieving a much-anticipated milestone since the development of the Biologics Price Competition and Innovation Act. The approval could disrupt one of the oldest, costliest and most commonly used biologic products on the market: insulin. The availability of insulin biosimilars can bring high-quality, lower cost treatment options for pharmacists, physicians, payers, and patients alike. As the first interchangeable biosimilar that is also the first to be primarily dispensed at retail pharmacies, retail pharmacists may now be in a position to make decisions on whether to fill prescriptions with the reference products or the biosimilar products. <Read More>

    How Tech-Driven Hubs in Specialty Pharmacy Can Improve the Patient Experience – July 29, 2021 – The use of specialty drugs in the U.S. has skyrocketed in recent years driven primarily by an increase in chronic condition diagnosis and the number of new medications on the market. Krishnanjan Alaparthi explores how tech-driven hub services can help manage the complexities of specialty pharma. It’s estimated specialty medications account for 75% of the approximately 7,000 prescription drugs currently in development, and by 2022, more than 60% of the 600 drugs expected to gain FDA approval will be specialty medications. <Read More>

    Hospital Drug Spending Will Go Up 3% Next Year, Vizient Predicts – July 29, 2021 – Total pharmaceutical spend for hospitals and health systems will increase by 3.1 percent in 2022, Vizient projected in its pharmacy market outlook, released July 28. Vizient, a healthcare services company and group purchasing organization, developed its pharmacy market outlook by analyzing its member hospitals’ pharmaceutical purchase data. The data analysis period was April 2020 through March 2021. <Read More>

    Establishing Workflow for In-clinic, Home Administration of Cabotegravir-rilpivirine Injections for HIV-1 – July 29, 2021 – The development and operationalization of the workflow within both the clinic and the pharmacy are critical to properly implement a new and novel medication therapy, such as cabotegravir-rilpivirine, for patient initiation and management during treatment, according to a poster presentation at the American Society of Health-System Pharmacists (ASHP) Specialty Pharmacy Conference. A long-acting monthly intramuscular injection, cabotegravir-rilpivirine was recently approved by the FDA for the treatment of HIV type-1 (HIV-1) and is the first injectable approved by the FDA for the treatment of this disease type. Additionally, the therapy needs to be administered by a health care professional either in the patient’s home or at the clinic. <Read More>

    FDA Authorizes Baricitinib Alone as COVID-19 Treatment – July 29, 2021 – The FDA revised the emergency use authorization (EUA) for baricitinib (Olumiant™, Lilly) to enable its use alone for the treatment of COVID-19 in hospitalized adults and pediatric patients as young as 24 months. Under the revised EUA, baricitinib does not have to be administered with remdesivir (Veklury™, Gilead). Baricitinib alone can be given to hospitalized adults and children with COVID-19 who require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. <Read More>

    Clozapine Risk Evaluation and Mitigation Strategy (REMS) Requirements Will change on November 15, 2021 – July 29, 2021 – CPMG and FDA continue to work to ensure that patients relying on clozapine have continued access to this medication and appropriate management of associated risks. FDA approved a modification to the Clozapine REMS. The modification to Clozapine REMS will go into effect on November 15, 2021. Important changes include: 1) All prescribers and pharmacies must be re-certified by November 15, 2021, or they will no longer be able to prescribe/dispense clozapine 2) Prescribers must re-enroll their patients who will continue clozapine by November 15, 2021. Patients who are not re-enrolled by that day will no longer be able to receive clozapine… <Read More>

    Labeling and Packaging Issues Contribute to Dose, Quantity Errors – July 29, 2021 – Companies and practitioners should take important steps to protect patients from these mistakes. Two labeling and packaging errors are worth noting to protect patients. Dosing error with sacubitril-valsartan:  A dispensing error occurred when a pharmacist misinterpreted a prescription for sacubitril-valsartan (Entresto), a product used to treat heart failure that contains different amounts of sacubitril and valsartan (ie, 24/26 mg, 49/51 mg, and 97/103 mg). The prescription listed the strength as 100 mg, which the patient was supposed to take twice daily. However, none of the 3 available strengths of sacubitril-valsartan include a 100-mg strength. The pharmacist dispensed what he thought was closest to the strength prescribed, the 97/103-mg product, and instructed the patient to take the medication twice daily. <Read More>

    Opinion: How Will Semglee® Interchangeable Insulin Affect Access and Affordability? – July 29, 2021 – Six years after the first biosimilar launched in the United States, at long last we have an interchangeable biosimilar available. The first interchangeability designation was granted to Biocon Biologics and Viatris’ Semglee® (insulin glargine-yfgn) this week, referencing the long-acting insulin Lantus®, which may allow pharmacists to substitute the biosimilar at the counter without consulting the prescribing physician, per state laws. Although the concept of interchangeability may not seem like a groundbreaking idea, the ability to substitute Semglee® at the pharmacy could enable faster uptake and broader adoption of retail biosimilars in the United States. <Read More>

    Drug-Pricing Practice Could be Banned to Help Pay for Infrastructure Bill – July 29, 2021 – There’s a push to ban a drug pricing scheme that advocates say will save the federal government money and help pay for a $1.2 trillion federal infrastructure bill. Some states — including Ohio, Georgia, Louisiana, Pennsylvania, Virginia, Arkansas, New York and Kentucky — have already banned the pricing practice in their Medicaid programs after The Columbus Dispatch reported apparent abuses in 2018. But it’s hard to say how much banning “spread pricing” will save taxpayers. Pharmacy benefit managers, or PBMs, are powerful middlemen that manage prescription benefits on behalf of payers such as insurance companies and Medicaid managed-care plans. They decide which drugs are covered. They negotiate big, often-secret rebates from drugmakers. And they decide how much to pay the pharmacies that dispense them. PBMs engage in spread pricing when they pay pharmacies less for drugs than they bill payers. “Spread” refers to the difference, or the amount the PBM pockets. <Read More>

    Experts: Unified Global Approach Needed to Address NAFLD/NASH – July 29, 2021 – A new report from 8 professional societies has highlighted the dangers of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) and issued a call to action to create a unified, international response to NAFLD and NASH. As the incidence and prevalence of NAFLD and NASH increase, there is a growing need to develop and implement effective screening, diagnosis, and treatment strategies worldwide, the authors explained. Traditionally, patients with NAFLD and NASH are treated by hepatologists, but new noninvasive diagnostic procedures have made it more likely that other providers will see these patients. Experts wrote that past research has shown that specialists and primary care providers (PCPs) need more education about NAFLD and NASH in order to effectively treat them and that there are signification gaps between guidance and clinical practice. <Read More>

    Practical Application of the Safe to Touch 2020 Consensus Conference on Hazardous Drug Surface Contamination – July 29, 2021 – In September 2020, the Safe to Touch Consensus Conference on Hazardous Drug Surface Contamination was convened, bringing together subject matter experts in the field of hazardous drugs (HDs) to develop consensus statements and corresponding recommendations regarding surface contamination. During Safe to Touch, authoritative speakers virtually presented to a conference expert panel and an audience of approximately 25 reaction panel members on a variety of HD topics including the impact of HDs on health, the current regulatory and standards environment, and commercially available surface contamination monitoring systems. <Read More>

    Pfizer Signals Waning Interest in Biosimilars – July 28, 2021 – Pfizer Inc. appears to be deprioritizing investment in biosimilars despite some commercial success in the area with a portfolio of oncology drugs. The company is more interested in investing in innovative therapeutics, biopharmaceuticals group president Angela Hwang said during the company’s second quarter sales and earnings call on 28 July. “Since we’ve made this pivot to a pure play, sort of innovation focus in our pipeline, we are really now looking at that biosimilar portfolio vis-à-vis other investments in breakthrough therapies that we have to make,” she said. “We will continue to look for opportunities, but I would say, at this point, it’s going to be more opportunistic and that we’re really looking at our investments in our development programs to be competitive,” she added. <Read More>

    AHF Calls on Federal Gov’t to Protect Pharmacies Protesting PBMs – July 28, 2021 – In response to growing monopolistic behavior in the pharmacy and health care industries, particularly by pharmacy benefit managers (PBMs)—just three of which control 75% of the US market and abuse independent and mom and pop pharmacies all over the country—AIDS Healthcare Foundation (AHF) is calling on the federal government to protect pharmacies that protest PBM strong-arming and abuses from retaliation or being dropped from their networks. AHF’s call for federal government protections against PBM abuse comes on the heels of a damning article in the Columbus Dispatch (“’I just see fraud all over this’: Insiders detail how clawbacks drive up drug prices, hurt pharmacies,” July 15, 2021 Darrell Rowland, reporter) that carefully chronicled how PBMs, which act as middlemen between insurance companies and pharmacies, have grown so powerful and emboldened that they now dictate what pharmacies patients can use. <Read More>

    New Agents Making a Mark Against Genitourinary Cancers – July 28, 2021 – Patients treated with adjuvant nivolumab after surgery for advanced high-risk muscle-invasive urothelial cancer (MIUC) had improved survival rates compared with patients given placebo in the phase 3 CheckMate 274 trial (abstract 391). “Nivolumab is the first systemic immunotherapy to demonstrate a clinically meaningful improvement in outcomes when administered as adjuvant therapy to patients with muscle-invasive urothelial carcinoma,” said presenter Dean F. Bajorin, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center, in New York City. <Read More>

    H-E-B Tops J.D. Power Pharmacy Rankings – July 28, 2021 – Texas retailer H-E-B has ranked highest among brick-and-mortar supermarket pharmacies, with a score of 896, according to the J.D. Power 2021 U.S. Pharmacy Study. Wegmans Food Markets, previously top ranked for three consecutive years, came in second, with a score of 892, and Ahold Delhaize USA banner Stop & Shop was third, with a score of 885. <Read More>

    ASHP Foundation Awards Grant to Projects Evaluating Telehealth, MRC-ICU Scoring Tool – July 28, 2021 – The ASHP Foundation awarded funding to Illeana Rodriques Nazario, PharmD, assistant professor at the University of Puerto Rico; and Andrea Newsome, PharmD, MSCR, clinical assistant professor at the University of Georgia College of Pharmacy, through the Optimizing Technology Solutions Innovation Grant Program. Both researchers received $30,000 to fund projects that demonstrate the ways that new and emerging technologies can assist in the safe and effective use of medications. Nazario’s project intends to examine the feasibility and acceptability of clinical pharmacy services delivered through telehealth at a team-based rheumatology clinic, with the goal of enhancing access to care. Newsome’s project will utilize machine learning methodology to optimize the Medication Regimen Complexity (MRC)-ICU Scoring Tool, which uses predictive analytics to connect patient-level data to individualized pharmacist resource predictions to improve patient outcomes and reduce health care costs through the optimization of the pharmacist-to-patient ratio. <Read More>

    FDA Alerts Patients and Health Care Professionals About Clinical Trial Results Showing an Increased Risk of Death Associated With Pepaxto® (Melphalan Flufenamide) – July 28, 2021 – FDA is alerting patients and health care professionals that a clinical trial (OCEAN, Study OP-103) evaluating Pepaxto® (melphalan flufenamide) with dexamethasone to treat patients with multiple myeloma showed an increased risk of death. The trial compared Pepaxto® with low-dose dexamethasone to pomalidomide with low-dose dexamethasone in patients with relapsed or refractory (resistant) multiple myeloma following 2-4 lines of prior therapy and in patients who were resistant to lenalidomide in the last line of therapy. FDA encourages health care professionals to review patients’ progress on Pepaxto® and discuss the risks of continued administration with each patient in the context of other treatments. Patients currently receiving Pepaxto® should also discuss with their health care professional the risks and benefits of receiving Pepaxto®. <Read More>

    First Appropriate Use Guidance Published for Alzheimer’s Drug Aduhelm™ – July 27, 2021 – Clinical experts have published the first set of clinical guidelines for appropriately using the newly approved Alzheimer’s drug aducanumab — brand name Aduhelm™. Although a leading eldercare physicians group has recommended against prescribing Aduhelm to the nursing home population, clinicians may use their own discretion in recommending the drug to patients. The Food and Drug Administration has restricted its use to patients with early disease, mild cognitive impairment or mild dementia due to Alzheimer’s. The newly published clinical guidelines fill the gaps between the FDA’s prescribing information and “real-world implementation of this treatment,” said first author Jeffrey Cummings, M.D., Sc.D., of the Chambers-Grundy Center for Transformative Neuroscience at the University of Nevada Las Vegas. <Read More>

    NCCN Adds Rylaze™ to Clinical Practice Guidelines for Acute Lymphoblastic Leukemia – July 27, 2021 – Asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze™) has been added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for the treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL), announced Jazz Pharmaceuticals, developer of the agent, in a press release. The addition of the treatment strategy follows the FDA’s approval of asparaginase to be used as a component of a multi-agent chemotherapeutic regimen administered by intramuscular injection for the treatment of ALL and lymphoblastic lymphoma (LBL) in adult and pediatric patients aged 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase. <Read More>

    Seven Habits of Effective COVID-19 Rx Managers – July 27, 2021 – The extraordinary amount of scientific activity marshalled to fight COVID-19 has led to a full pipeline of medications and vaccines—and an opportunity for pharmacists to help deliver the potentially lifesaving treatments to the right patients. At the Academy of Managed Care Pharmacy’s 2021 virtual annual meeting, G. Caleb Alexander, MD, MS, a professor of epidemiology and medicine at Johns Hopkins Bloomberg School of Public Health, in Baltimore, proposed guiding principles to help pharmacists navigate the evolving landscape of COVID-19 medical management. <Read More>

    ASTRO Issues Clinical Guideline on Radiation Therapy for Soft Tissue Sarcoma in Adults – July 27, 2021 – A new clinical guideline from the American Society for Radiation Oncology (ASTRO) provides guidance on the use of radiation therapy to treat adult patients with soft tissue sarcoma (STS). Recommendations outline optimal radiation dosing, techniques and treatment planning for patients with localized, operable STS of the trunk (i.e., chest wall, abdominal wall) and extremities (i.e., arms, legs), with a focus on preserving long-term functionality through individualized care. The guideline additionally addresses the role of radiation therapy for retroperitoneal sarcoma. The guideline, ASTRO’s first for sarcoma, is published in Practical Radiation Oncology. <Read More>

    Sixty-Four Healthcare Groups Back Mandatory Vaccines for Hospital Workers – July 27, 2021 – As COVID-19 cases rise and the delta variant spreads, dozens of hospitals and health systems have announced vaccination mandates for employees. Below are 64 healthcare groups, including national associations and medical societies, that have released statements in July supporting this requirement for healthcare workers. <Read More>

    Training Program Helps Pharmacists Provide Diabetes Care – July 27, 2021 – Pharmacists can help patients manage diabetes, which was the seventh-leading cause of death in the United States in 2020, according to the CDC. Approximately 34.2 million US adults have diabetes, and 1 in 5 do not know they have it, according to the CDC.1 The majority of cases are type 2 diabetes, and approximately 5% to 10% are type 1. To effectively help patients, pharmacists must possess diabetes-related knowledge and skills. The American Pharmacists Association (APhA) has developed a certificate training program specifically focused on providing pharmacists with the tools needed to engage in effective, evidence-based diabetes care.2 The primary goal of the program is to inform pharmacists of best practices for incorporating diabetes education and management. Pharmacists can work collaboratively with patients to make the best use of medication therapies and achieve optimal therapeutic outcomes. <Read More>

    CDC Updates Mask Guidance as COVID-19 Cases Soar – July 27, 2021 – The CDC updated its mask guidance recommending that everyone wear a mask indoors in public places regardless of vaccination status if they are in an area with substantial or high transmission. The CDC also recommended universal indoor masking for all teachers, staff, students and visitors to kindergarten through 12th grade schools, regardless of vaccination status, until vaccines are authorized and widely available to all children and vaccination rates are sufficient to control transmission. This is a change to recommendations just released earlier this month, but she said it was necessary to enable in-person learning. <Read More>

    Ohio Leads the Way in Pharmacy Reform, Will Other States Follow? – July 27, 2021 – The United Pharmacy Association (URPhA) is in its infancy and just like any baby, it’s growing daily and finding its way. This baby is lucky to have been born in Ohio, because it is Ohio that’s leading the way in pharmacy reform. Ohio Attorney General Dave Yost has been taking on pharmacy benefit managers (PBMs) for the past 2 years. Yost has twice sued PBMs for overcharging the state of Ohio by billing state agencies more for prescriptions than was paid to the pharmacies that dispensed them. He has called for legislative reforms and it doesn’t look like he’s ready to stop battling with PBMs any time soon. <Read More>

    340B in the News

    Gilead to Lower PrEP Reimbursement to Clinics – July 28, 2021 – HIV advocates are concerned that upcoming changes to Gilead Sciences Inc.’s Advancing Access program mean that there will be less money available to local providers for related virus prevention. Gilead produces PrEP, or pre-exposure prophylaxis, which refers to two antiviral medications — under the brand names of Truvada™, which was approved by the federal Food and Drug Administration in 2012, and Descovy™, which was approved in 2019 — that are taken by HIV-negative people to prevent HIV infection… in April, Gilead announced changes to how much it will reimburse clinics as part of the program. The reason is that clinics participate in a federal program called 340B, which requires drug wholesalers to charge clinics at a discounted rate from the retail price. And so what was happening, according to Health Affairs, was that Gilead was reimbursing clinics approximately $1,900 per bottle of Truvada™ or Descovy™, while under 340B, clinics were paying wholesalers only hundreds of dollars per bottle and pocketing the rest. <Read More>

    Supreme Court Agrees to Hear Two Medicare Payment Cases Next Term with Significant Financial Implications for Hospitals – July 26, 2021 – The U.S. Supreme Court granted petitions to hear two cases related to Medicare payments for health care providers. The Court will consider a hospital appeal of a Ninth Circuit decision that vacated part of a Centers for Medicare & Medicaid Services (CMS) rule addressing the calculation of Medicare Disproportionate Share Hospital (DSH) payments. Empire Health Found. v. Azar, Nos. 18-35845, 18-35872 (9th Cir. May 5, 2020). The Court will also consider an appeal by hospital groups and hospital co-plaintiffs of a D.C. Circuit decision upholding reduced Medicare payment rates for drugs to certain hospitals participating in the 340B drug pricing program. Amer. Hosp. Ass’n v, et al. v. Azar, No. 19-5048 (D.C. Cir July 31, 2020). Both cases will give the Court an opportunity to consider the level of deference granted to CMS related to setting Medicare payment rates. The Court will hear the cases during its next term, which begins October 2021, but is not expected to issue decisions in the cases until next year. <Read More>