Clinical Insights: July 13, 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

    Padcev™ (enfortumab vedotin-ejfv) – New Drug Approval – July 9, 2021 – The Food and Drug Administration approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma US, Inc.), a Nectin-4-directed antibody and microtubule inhibitor conjugate, for adult patients with locally advanced or metastatic urothelial cancer who:  1) have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand (PD-L1) inhibitor and platinum-containing chemotherapy, or 2) are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. <Read More>

    Kerendia™ (finerenone) Tablets – New Drug Approval – July 9, 2021 – FDA has approved Kerendia (finerenone) tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes…The efficacy of Kerendia to improve kidney and heart outcomes was evaluated in a randomized, multicenter, double-blind, placebo-controlled study in adults with chronic kidney disease associated with type 2 diabetes. In this study, 5,674 patients were randomly assigned to receive either Kerendia or a placebo. <Read More>

    New Formulation Approval

    No new update.

    New Indication/Dosage Approval

    Keytruda® (pembrolizumab) – New Indication Withdrawal – July 1, 2021 – Merck announced that the company plans to voluntarily withdraw the U.S. accelerated approval indication for Keytruda® for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [combined positive score (CPS ≥1)] as determined by a U.S. Food and Drug Administration (FDA)-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, human epidermal growth factor receptor 2 (HER2)/neu-targeted therapy. <Read More>

    Solosec® (secnidazole) Oral Granules – New Approved Indication – July 1, 2021 – Lupin Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application to expand the use of Solosec® (secnidazole) to include the treatment of trichomoniasis in adults. Trichomoniasis is the most common non-viral, curable sexually transmitted infection (STI) in the U.S., affecting an estimated three to five million people every year. Solosec® was approved in the U.S. in 2017 for the treatment of bacterial vaginosis (BV) in adult women. The supplemental approval makes Solosec® the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV. <Read More>

    New/Updated Drug Shortage

    July 09, 2021

    July 08, 2021

    July 07, 2021

    July 06, 2021

    New Drug Recall and Safety Alerts

    Chantix® (varenicline) Tablets by Pfizer – New Drug Recall – July 2, 2021 – FDA is alerting patients and health care professionals to Pfizer’s voluntary recall of nine lots of the smoking cessation drug, varenicline (brand name Chantix®), to the warehouse level. The company is recalling varenicline because it may contain levels of a nitrosamine impurity, called N-nitroso-varenicline, above FDA’s acceptable intake limit. N-nitroso-varenicline may be associated with a potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. An increased cancer risk would be associated with long-term use, and the health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline. <Read More>

    New Generic/Biosimilar Approval and Launch

    No new update.

    Clinical and Pharmacy News

    Malignant Hyperthermia Requires Rapid Attention – July 12, 2021 – Malignant hyperthermia (MH) is an inherited disorder related to the musculoskeletal system that puts affected individuals at risk of life-threatening adverse reactions when exposed to potent volatile inhalation anesthetics during surgery. These anesthetics can include desflurane, isoflurane, sevoflurane, and succinylcholine. MH occurs in the general population in 1 of 100,000 administered anesthetics. Some patients have been given anesthetics before without experiencing the symptoms or complications of MH, and they may experience it without warning after another surgery and exposure to anesthetic gases. <Read More>

    Oncology Overview: Taking a Closer Look at Nivolumab Immunotherapy – July 12, 2021 – Nivolumab (Opdivo™; Bristol Myers Squibb) is an immunotherapy that is FDA approved for 11 cancer indications, with the most recent approval for use in combination with certain chemotherapy for the initial treatment of gastric cancer. This latest action marks an important milestone as the first FDA-approved immunotherapy for first-line treatment of gastric cancer. Pharmacists can play an important role in managing patients receiving nivolumab therapy. <Read More>

    Why the Pharmaceutical Industry has ‘Mixed Views’ on Biden’s Latest Executive Order – July 12, 2021 – The American Pharmacists Association “has mixed views” on the executive order President Joe Biden signed July 9 to address competition among drugmakers, hospitals, health insurers and hearing aid manufacturers. The executive order directs the FDA to work with states and tribal programs to import prescription drugs from Canada. In addition to its drug importation guidance, the order asks the Federal Trade Commission to ban “pay for delay” agreements, under which makers of brand name drugs pay generic drugmakers to keep out of a market. It also calls on HHS to increase support for generic and biosimilar drugs and to create a plan within 45 days to address high drug prices and price gouging. <Read More>

    What’s New In Accreditation For Specialty – July 12, 2021 – Executives from two leading specialty pharmacy accreditation organizations shared the latest information on new and reorganized standards and credentials, along with advice for specialty pharmacies on managing the accreditation process, during the ASHP 2021 virtual Specialty Pharmacy Conference. In 2019, ASHP began revising its Telehealth Pharmacy Practice (TPP) standard, which has become relevant to many pharmacies over the past year. The new edition will be published “very soon,” said Lynnae Mahaney, BSPharm, MBA, ASHP’s senior director of pharmacy accreditation. <Read More>

    Moving Beyond the Spreadsheet in Measuring Pharmacy Benefit Value – July 12, 2021 – Many experts have stated that the prescription drug chain is complex and confusing. However, there seems to be a growing divergence of messages in the marketplace on how the pharmacy benefit is valued. Adding to the complexity is finding an authentic and transparent calculation to measure value tangibly. For example, is the value measured or modeled by the lowest net drug cost on a per prescription or per member per month basis, by total health care costs spend reduction when the benefit includes medical and pharmacy combined under one insurer, or by clinical pharmacy programs with inferred medical savings? <Read More>

    ‘Corporate Vampires Suck’ Ads by AHF Skewer CVS – July 10, 2021 – In response to the growing consolidation and increasingly monopolistic behavior in the pharmacy and health care industries, AIDS Healthcare Foundation (AHF) is launching a new advocacy campaign to take on health and pharmacy giant CVS, the sixth largest corporation in the world over its anti-competitive business model which squeezes many independent and mom-and-pop pharmacies, some to the point of forcing their closure. The campaign, ‘CVS: Corporate Vampires Suck’ targets CVS over its fierce anti-competitive behavior, specifically regarding its refusal to allow patients any choice in their pharmacy services. CVS’s currently forces most of its health plan patients from providers like Aetna—which CVS purchased for $69 billion in cash and stock in 2018—to obtain their lifesaving medications by mail order or drop shipment. <Read More>

    APhA Responds to Executive Order on Promoting Competition in the American Economy – July 9, 2021 – The American Pharmacists Association (APhA) issued the following statement in response to the Executive Order on Promoting Competition in the American Economy:  APhA has mixed views on the Executive Order. On the one hand, it contains important directives that could increase access to care through pharmacies and pharmacists. However, APhA opposes the inclusion of prescription drug importation as a potential means to reduce drug costs due to our continued concerns about patient safety and the integrity of the drug supply chain. APhA applauds the Executive Order’s call to vigorously enforce antitrust laws and recognition that the law allows them to challenge prior bad mergers, particularly in healthcare markets. Pharmacy benefit manager (PBM) practices have led to increases in patients’ drug prices at the pharmacy counter through use of direct and indirect remuneration (“DIR”) fees and other “clawback” mechanisms, delaying prescribed treatments through patient steering and prior authorization, and limiting options for patients by controlling access to insurance networks. <Read More>

    U.S. HIV Infections Have Fallen 75%, but Not for Everyone – July 9, 2021 – The annual number of HIV infections diagnosed in the United States has declined nearly 75% since the peak of the epidemic in the mid-1980s, according to the CDC. However, the study epidemiologists noted that disparities exist and, in some cases, have grown worse over recent years (MMWR Morb Mortal Wkly Rep 2021;70[22]:801-806). “This is the first study to present the estimated annual number of new HIV infections in the U.S. from 1981 to 2019 in one publication,” said Karin A. Bosh, PhD, an epidemiologist and lead author, CDC’s Division of HIV/AIDS Prevention. Mathematical modeling was used to turn data reported to the CDC’s National HIV Surveillance System into estimates of annual HIV incidence among people 13 years of age and older. <Read More>

    Costco Prescription Distribution System Could Have Saved Medicare $2.6 Billion, Study Finds – July 9, 2021 – PBMs keep copays higher on the same generic drugs. Medicare spent billions of dollars more than Costco on the same generic drugs, according to a research letter published by JAMA Internal Medicine. More precisely, Medicare overspent by $2.6 billion in 2018, a bigger gap than overspending seen the year prior. This finding comes from researchers who developed data from 184 generic drugs commonly prescribed in 30-day or 90-day supplies. The data only included generic drugs because manufacturers do not pay rebates to pharmacy benefit managers (PBM) or plans. The team from the University of Southern California compared the amount Medicare pays for these commonly prescribed generic prescriptions in Part D with prices for the same drugs available at Costco to patients without insurance…Compared to the Costco member price, Medicare overspent on 43.2% of all 30-day and 90-day prescription fills for the 184 products included in 2018. Overspending was most common on 90-day fills (52.9%). <Read More>

    Appeals Court Urged to Let North Dakota’s Laws Regulating Pharmacy Benefit Managers Stand – July 9, 2021 – A bipartisan group of 34 AGs, led by Minnesota AG Keith Ellison, filed an amicus brief in the U.S. Court of Appeals for the Eighth Circuit in support of North Dakota’s position in Pharmaceutical Care Management Association (“PMCA”) v. Wehbi, where North Dakota argued that states have the right to regulate pharmacy benefit managers (“PBMs”) and that this right is not preempted by either the Employee Retirement Income Security Act (“ERISA”) or by Medicare. <Read More>

    The Contribution of RWE to the Management of Relapsed/Refractory Multiple Myeloma – July 9, 2021 – in determining safety and efficacy, randomized controlled trials (RCTs) are considered the gold standard. RCTs can evaluate cause and effect and minimize bias through their prospective design, randomization, predefined end points, and minimization of confounders. However, it is difficult to determine potential benefits for those who were excluded from trials. Real-world data (RWD) and real-world evidence (RWE) are other forms of evidence that complement RCT data. The FDA defines RWD as “the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.” <Read More>

    Three New Guidelines Released for Treatment and Management of Systemic Vasculitis – July 9, 2021 – The American College of Rheumatology (ACR), in partnership with the Vasculitis Foundation (VF), released three new guidelines for the treatment and management of systemic vasculitis. Vasculitis is a group of about 20 rare diseases that have inflammation of blood vessels in common, which can restrict blood flow and damage vital organs. The three guidelines cover six forms of vasculitis, and a fourth guideline on Kawasaki disease will be released in the coming weeks. <Read More>

    Big PBM Decision Undergoes its First Test – July 9, 2021 – The stakes appear to be pretty high. After a unanimous ruling in a related case in December, the U.S. Supreme Court has reopened a case regarding sweeping regulations of powerful middlemen known as pharmacy benefit managers — and 30 state attorneys general and many others are joining the fray. Pharmacy benefit managers, or PBMs, are powerful, secretive companies that contract with insurance companies and government entities such as Medicaid to manage prescription-drug benefits. The biggest PBMs — CVS Caremark, OptumRx and ExpressScripts — say they use their size and sophistication to save money for the plans with which they contract. But their critics say they use a lack of transparency to reap huge profits and drive community pharmacies out of business. <Read More>

    What the NBA “Bubble” can Teach us About COVID-19 – July 8, 2021 – Professional basketball players run, jump, sweat and bump each other every day on indoor hardcourts, and might seem like perfect targets for highly transmissible SARS-CoV-2. But in 2020, the National Basketball Association (NBA) ventured to protect its players from infection while completing its season. And it succeeded. Athletes and other participants who tested positive for infections but who followed Centers for Disease Control and Prevention (CDC) guidelines to isolate for 10 days after a positive test or when COVID-19 symptoms first appeared did not pass on their infections, according to a recently published study. In JAMA Internal Medicine, researchers published an investigation of the NBA “bubble” campus in Orlando, Florida, that allowed teams to play against each other with only limited contact with the outside world. <Read More>

    Antibiotic Use Study Informs Hospital-Based Stewardship Program – July 8, 2021 – A medication-use evaluation of ceftolozane-tazobactam (Zerbaxa™, Merck) and ceftazidime-avibactam (Avycaz™, AbbVie) in a Florida Veterans Affairs hospital found a significant reduction in susceptibility for Pseudomonas aeruginosa over time. The findings demonstrate the importance of evaluating antibiotic use patterns in hospitals, and how such data can allow for better informed decisions regarding antibiotic stewardship programs, according to a presentation at the MAD-ID (Making a Difference in Infectious Diseases) virtual 2021 meeting (poster A17). <Read More>

    FDA Narrows Recommendation for New Alzheimer Drug – July 8, 2021 – Following its approval of aducanumab (Aduhelm™, Biogen) for the treatment of Alzheimer disease in June 2021, officials with the FDA have now recommended that it only be given to adults with mild symptoms. “Alzheimer’s disease is a devastating illness that can have a profound impact on the lives of people diagnosed with the disease as well as their loved ones,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, in an FDA press release. “Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s.” <Read More>

    Moderna COVID-19 Vaccine Efficacious Against Variants – July 8, 2021 – The Moderna messenger RNA (mRNA) vaccine against COVID-19 appears to be effective against the variant virus strains, including the new Delta variant first identified in India. However, the efficacy is less than against the original SARS-CoV-2. <Read More>

    NASP Releases Agenda for the NASP 2021 Annual Meeting & Expo – July 8, 2021 – The National Association of Specialty Pharmacy (NASP), a nonprofit organization representing all specialty pharmacy industry stakeholders, announces this year’s agenda and keynote speakers for the live and in-person NASP 2021 Annual Meeting & Expo, September 27-30, 2021 at the Marriott Marquis, in Washington, DC. Pre-conference workshops will be held on Monday, September 27th, with the NASP 2021 Annual Meeting & Expo sessions and events taking place over the next three days – Tuesday, September 28th through Thursday, September 30th. <Read More>

    Cigna Offers $500 Incentive for Switching to Biosimilars – July 8, 2021 – Citing the slow uptake of biosimilars, insurer Cigna is offering incentives for switching from biologic treatments to biosimilar versions. It is also moving two approved biosimilars for Remicade™ — Avsola™ and Inflectra™ — to preferred status. Biologic medicines represent only 2% of prescriptions, but accounted for 43% of the total invoice-level medicine spending at $211 billion in the US in 2019, Steve Miller, MD, chief clinical officer for Cigna wrote in an article on the company’s website. Plus, specialty drugs accounted for more than half of the total pharmacy spend last year, driven largely by biologic medicines for inflammatory conditions and new treatments for cancer and rare diseases. <Read More>

    NIH Study Associates COVID-19 Surges with Mortality Increases for Patients – July 8, 2021 – A new study authored by scientists at the National Institutes of Health, in collaboration with colleagues at the Centers for Disease Control and Prevention and Harvard University, Boston, and Emory University, Atlanta, suggests that one in four COVID-19 deaths in U.S. hospitals may have been attributed to hospitals strained by surging caseloads. Published in the Annals of Internal Medicine, the analysis looked at data from 150,000 COVID-19 inpatients from 558 U.S. hospitals from March to August of 2020. More than half of those admissions were patients arriving at hospitals during peak COVID-19 surges. <Read More>

    Annual Report to the Nation: Rapid Decrease in Lung Cancer and Melanoma Deaths Lead Overall Continued Decline in Cancer Death Rate – July 8, 2021 – Overall cancer death rates continue to decline in men and women for all racial and ethnic groups in the United States, according to the latest Annual Report to the Nation on the Status of Cancer. During 2001 to 2018, declines in lung cancer death rates accelerated, and death rates for melanoma declined considerably in more recent years, reflecting a substantial increase in survival for metastatic melanoma. However, the report finds that for several other major cancers, including prostate, colorectal and female breast cancers, previous declining trends in death rates slowed or disappeared. <Read More>

    Joint CDC and FDA Statement on Vaccine Boosters – July 8, 2021 – The United States is fortunate to have highly effective vaccines that are widely available for those aged 12 and up. People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country such as Delta. People who are not vaccinated remain at risk. Virtually all COVID-19 hospitalizations and deaths are among those who are unvaccinated. We encourage Americans who have not yet been vaccinated to get vaccinated as soon as possible to protect themselves and their community. Americans who have been fully vaccinated do not need a booster shot at this time. FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary. <Read More>

    Pharmacist-Led Sun Safety Education Can Expand Skin Cancer Awareness – July 8, 2021 – Skin cancer is diagnosed more each year than all cancers combined, making it the most common cancer in the United States. Ultraviolet (UV) radiation from the sun is responsible for 90% of diagnosed nonmelanoma skin cancer (NMSC). Skin cancer can be prevented by reducing sun exposure and has a 99% 5-year survival rate when detected early. Pharmacists often provide counseling regarding photosensitivity, a common drug adverse effect and are well-versed in over-the-counter products that prevent and treat sunburn. Their position is ideal to educate the public on skin cancer prevention. <Read More>

    Patient Advocacy Organizations Join Forces to Endorse BIOSIM Act – July 7, 2021 – To improve biosimilar utilization, 28 patient advocacy organizations penned a letter of endorsement for HR 2815, a House bill that aims to increase Medicare reimbursement for health systems that prescribe biosimilars to patients. The 60 Plus Association, Allergy and Asthma Network, CancerCare, and Texas Business Group on Health were among the organizations throwing their support behind HR 2815, also known as the Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act. The bill, cosponsored by Representatives Kurt Schrader (D-OR) and Adam Kinzinger (R-IL), would revise the Medicare payment policy to increase a physician’s reimbursement for biosimilars from the average sales price (ASP) of the biosimilar plus 6% to the ASP of the biosimilar plus 8%, providing physicians more of an incentive to prescribe a biosimilar over a reference product. <Read More>

    CAMH Releases Updated National Clinical Guidelines for Treatment of Opioid Use Disorder – July 7, 2021 – As more evidence emerges that opioid overdose deaths have increased dramatically since the onset of COVID-19, the Centre for Addiction and Mental Health (CAMH), in collaboration with subject matter experts and medical regulatory authorities across Canada, have now released updated national clinical guidelines for the treatment of opioid use disorder. Opioid Agonist Therapy: A Synthesis of Canadian Guidelines for Treating Opioid Use Disorder, harmonizes existing provincial and national guidelines, evidence-based practices, and expert opinions into one document aimed at providing consistent and high-quality care to people with opioid use disorder. <Read More>

    Tip of the Week: Avail Employees of Tools that can Improve Patient Safety – July 7, 2021 – Technology and technological breakthroughs abound. Some individuals use technology primarily to play games and share pictures of pets, while others use it to help solve complex problems that plague entire human populations. Health information technology is becoming available an accelerated pace, yet its uptake by end-users can be a bit slower. It might take more time to train individuals on how to effectively employ a new technology and convince them of its merit than engineers to develop the technology. <Read More>   

    Adults With ADHD at Higher Risk of Many Physical Conditions, Finds Study – July 7, 2021 – Adults with ADHD are at higher risk of a wide range of physical conditions, including nervous system, respiratory, musculoskeletal, and metabolic diseases, according to a large register-based study from Karolinska Institute in Sweden published in The Lancet Psychiatry. ADHD is a common neuropsychiatric disorder characterised by inattention, impulsiveness and hyperactivity, and commonly treated with stimulant therapy (methylphenidates or amphetamines). <Read More>

    Pharmacy Exec in Deadly U.S. Meningitis Outbreak Gets Stiffer, 14-1/2 Year Prison Term – July 7, 2021 – A founder of a Massachusetts compounding pharmacy whose mold-tainted drugs sparked a deadly U.S. fungal meningitis outbreak in 2012 was resentenced on Wednesday to 14-1/2 years in prison after a federal appeals court overturned his earlier 9-year term. U.S. District Judge Richard Stearns in Boston said the appellate court at least implicitly deemed as too light the original sentence for Barry Cadden, the co-founder and former president of the now-defunct New England Compounding Center (NECC). <Read More>

    AMA Says CDC Opioid Guideline Still Harming Pain Patients – July 6, 2021 – It was nearly three years ago that the American Medical Association took its first public stand against the CDC’s controversial opioid prescribing guideline. The AMA’s House of Delegates adopted resolutions calling for an end to the “misapplication” and “inappropriate use” of the guideline by many states, doctors, pharmacists and insurers who imposed hard limits on the amount of opioid medication patients could get, if they could get it at all. Many were left in excruciating pain. Last year, the AMA went even further, with a 17-page letter to the CDC warning that it was “clear that the CDC Guideline has harmed many patients.” Even the CDC acknowledged the 2016 guideline “has been inappropriately cited to justify hard limits or cutting off opioids” and that cancer and surgery patients were suffering as a result. <Read More>

    Requirements Related to Surprise Billing; Part 1: Policy Update – July 6, 2021 – The US Departments of Health and Human Services (HHS), Treasury and Labor, and the Office of Personnel Management issued an Interim Final Rule with comment (IFR) implementing portions of the No Surprises Act, legislation enacted in December 2020 that bars surprise billing beginning January 1, 2022. Under the law, payers and providers (including hospitals, facilities, individual practitioners and air ambulance providers) are prohibited from billing patients more than in-network cost-sharing amounts in certain circumstances. The prohibition applies to both emergency care and certain non-emergency situations where patients do not have the ability to choose an in-network provider. <Read More>

    JAK Inhibitors, IL-6 Blockers for COVID-19: Where Do They Fit? – July 6, 2021 – Another Janus kinase (JAK) inhibitor appears effective in reducing death and respiratory failure in patients hospitalized with COVID-19 pneumonia. STOP-COVID, a double-blind, placebo-controlled study, evaluated the safety and efficacy of tofacitinib (Xeljanz™, Pfizer) in 289 hospitalized adults with COVID-19 pneumonia who were not receiving ventilation. Patients from 15 hospitals in Brazil were randomly assigned to receive either tofacitinib 10 mg twice daily plus standard of care or placebo twice daily plus standard of care for up to 14 days or until hospital discharge. <Read More>

    Study Reveals Inflammatory Proteins May Slow Cognitive Decline in Aging Adults – July 6, 2021 – A new study published in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association found that elevated levels of 2 chemical mediators of inflammation, or cytokines, are connected with slower cognitive decline in aging adults. “These are totally unexpected results,” said study co-senior author, Rudolph Tanzi, PhD, vice chair of Neurology and co-director of the Henry and Allison McCance Center for Brain Health at Massachusetts General Hospital (MGH), in a press release. The study authors said that these findings could be used to help identify healthy people who are at risk for the condition before they have symptoms. <Read More>

    Using Store-and-Forward Teledermatology to Evaluate Potential Skin Cancers – July 6, 2021 – Telemedicine increases health care accessibility and convenience while preventing excessive gathering of patients in hospitals or other medical offices. The “store-and-forward” method involves the physician forwarding a patient’s clinical history and findings to a specialist, who reviews and responds with a report later. This system of health care communication was found to be useful to evaluate the incidence of nonmelanoma skin cancer (NMSC), NMSC precursors, and melanoma. Pharmacists’ vast health care knowledge and community accessibility makes them ideal patient liaisons. A study published in the Journal of the American Pharmacists Association in September 2020 used a direct-to-consumer, store-and forward teledermatology with dermoscopy using the pharmacist as the patient’s point-of-contact. <Read More>

    Pharmacists Show Their Skill in Easing Biosimilar Switches – July 6, 2021 – Managing biosimilar adoption and utilization has become almost a specialty in itself for many health-system pharmacists, experts told attendees at the ASHP 2021 virtual Specialty Pharmacy Conference. “There are multiple challenges, including regulatory issues, unique formulary management considerations, forecasting coverage and reimbursement, and education of providers, which are very different when it comes to biosimilars compared with small-molecule product or originator biologics,” said Isha Rana, PharmD, a pharmacy administrative specialist in formulary management and drug information at Houston Methodist, who presented at the ASHP meeting. <Read More>

    BioMatrix Specialty Pharmacy Acquires InfuCare Home Infusion Pharmacy – July 6, 2021 – BioMatrix Specialty Pharmacy announced the acquisition of InfuCare LTD, in Tyler, Texas. This infusion focused specialty pharmacy adds a brick-and-mortar location in a key geographic area, expands the organization’s national footprint, and provides access to additional covered lives in one of the nation’s largest states. The acquisition is the latest of several transactions that have positioned BioMatrix as one of the largest privately held specialty pharmacies in the United States. <Read More>

    Tuberville Supports Greater Accountability for Pharmacy Benefit Managers – July 7, 2021 – Last week, Sen. Tommy Tuberville, R-Alabama, authored an op-ed in the Washington Times on helping patients and independent pharmacies by bringing greater transparency to the practices of large pharmacy benefit managers. “Our great country was founded on hard work and competition,” Tuberville wrote. “That sense of grit is the main principle in our free-market economy where consumers have choice, because competition breeds choice, better quality, and better prices for customers. But not everywhere. Unfortunately, most Americans don’t have that choice when it comes to prescription drugs,” Tuberville wrote. “The prices of life-saving medications keep going up. According to the AARP, prescription drug prices are rising even faster than inflation. Americans’ spending on medicines jumped 200% between 2000 and 2020. It’s time the American people start to question why this is happening.” <Read More>

    Fifty-Six Percent Rate of Compounding SOP Adherence ‘Crazy’ – July 2, 2021 – The USP’s sterile compounding standards have been in place for nearly two decades, and most large health systems, home infusion providers, specialty pharmacies and other practice sites that perform compounding employ technology to safeguard the sterile drug workflow process, according to field surveyors and other regulators. But have compounders reached the optimal level of compliance? That’s what the Institute for Safe Medication Practices (ISMP) wanted to know. So last July, ISMP launched a Pulse Check survey. More than 600 pharmacists, technicians and others allied with pharmacy responded. <Read More>

    340B in the News

    [Free Webinar] 340B… Or Not 340B: Oversight, Compliance and Enforcement – July 15th, 9:00 am – 10:00 am PT – July 15, 2021 – The 340B Program has gained national attention over the last decade, in part due to the opportunities it provides to generate revenue for participating entities without risk of significant enforcement penalties for non-compliance… This program will address key elements of 340B Program participation that are regulated outside of the 340B Program and the 340B Statute, the intersection of these elements with the 340B Program, and 340B covered-entity compliance obligations and enforcement consequences. It will also review “best practices” for covered entities participating in the 340B Program to evaluate risks and compliance with these elements. <Read More>

    340B Update: Supreme Court Accepts Certiorari in 340B Payment Reduction Case – July 9, 2021 – On 2 July 2021, the Supreme Court announced that it has accepted the American Hospital Association’s (AHA) petition for certiorari in American Hospital Association v. Becerra. At issue is the Centers for Medicare and Medicaid Services’ (CMS) nearly 30 percent cut to payments for specified covered outpatient drugs (SCODs) under the Medicare Outpatient Prospective Payment System (OPPS) for certain hospitals participating in the 340B Drug Pricing Program (340B Program), which provider groups have been challenging in court since 2017. Notably, the Supreme Court’s grant of certiorari comes as CMS is expected to release any day now the CY 2022 OPPS proposed rule, which could either reverse or continue the payment cuts. Provider groups have been urging CMS to reverse the payment reductions as part of the CY 2022 OPPS proposed rule. This client alert provides an overview of these developments and what to expect next. <Read More>

    Boehringer Ingelheim Latest Drugmaker to Limit 340B Discounts – July 7, 2021 – Boehringer Ingelheim has become the latest drugmaker to limit discounts to hospitals that use contract pharmacies to dispense 340B-discounted drugs. The German drugmaker sent a letter June 30 to 340B hospitals saying that it will stop giving 340B discounts to drugs dispensed through contract pharmacies as of Aug. 1. It joins Eli Lilly, Novo Nordisk, Novartis, Sanofi, AstraZeneca and United Therapeutics in enacting such a policy. Boehringer Ingelheim did outline a few exceptions to its new policy, including that any hospital that doesn’t have an in-house pharmacy capable of dispensing 340B drugs can designate a single contract pharmacy location to get the discounts, and that contract pharmacies that are wholly owned by a 340B hospital are still eligible for discounts. <Read More>

    Supreme Court to Decide Legality of Drug Payment Cuts to 340B Hospitals – July 7, 2021 – Provider groups have expressed support for a Supreme Court decision to hear a challenge to the Department of Health and Human Services’ move to cut hospital reimbursement in the 340B drug payment program. On July 2, the Supreme Court agreed to hear the case of the American Hospital Association et al versus Xavier Becerra, secretary of HHS. The court is expected to hear the case during its next session, which begins in October. At question is whether HHS has the legal authority to make the adjustments to Medicare Part B reimbursement under the Outpatient Prospective Payment System. <Read More>