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Clinical Insights: May 4, 2022

Posted on May 4, 2022 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

Cuvrior™ (trientine tetrahydrochloride) Tablets – New Drug Approval – May 2, 2022 – Orphalan SA, an international orphan drug development and commercialisation company, announces approval of Cuvrior™, a new salt of trientine (trientine tetrahydrochloride) by the United States Food and Drug Administration (FDA). Cuvrior™ is approved for the treatment of adult patients with stable Wilson’s disease who are de-coppered and tolerant to penicillamine. Penicillamine is currently approved as a first-line treatment of Wilson’s disease in the US with about one third of patients developing intolerance. <Read More>

Camzyos™ (mavacamten) Capsules – New Drug Approval – April 28, 2022 – Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Camzyos™ (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms. Camzyos is the first and only FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of obstructive HCM. “This is a first-in-class medicine specifically for patients living with symptomatic obstructive HCM,” said Milind Desai, M.D., MBA, director of the Hypertrophic Cardiomyopathy Center and director of clinical operations in Cleveland Clinic’s Heart Vascular & Thoracic Institute. <Read More>

Vivjoa™ (oteseconazole) Capsules – New Drug Approval – April 26, 2022 – The U.S. Food and Drug Administration (FDA) approved Vivjoa™ (oteseconazole capsules), an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential. Vivjoa™ is the first and only FDA-approved medication for this condition and provides sustained efficacy demonstrated by significant long-term reduction of RVVC recurrence through 50 weeks versus comparators. Vivjoa™ is the first FDA-approved product for Mycovia Pharmaceuticals, Inc. (Mycovia), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies. <Read More>

Epsolay® (benzoyl peroxide) Cream – New Drug Approval – April 25, 2022 – 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 the Food and Drug Administration (FDA) approval of its drug product, Epsolay®, a proprietary cream formulation of benzoyl peroxide, 5%, for the treatment of inflammatory lesions of rosacea in adults. The benzoyl peroxide in Epsolay® is encapsulated within silica-based patented microcapsules. The silica-based shell is designed to slowly release benzoyl peroxide over time to provide a favorable efficacy and safety profile. <Read More>

New Indication/Dosage/Formulation Approval

Qelbree® (viloxazine hydrochloride) Extended Release Capsules – New Expanded Population – April 29, 2022 – Supernus Pharmaceuticals, Inc., a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Qelbree® (viloxazine extended-release capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in adult patients aged 18 and older. The FDA has now approved Qelbree® for the treatment of ADHD in children (starting at age 6), adolescents and adults. <Read More>

Ultomiris® (ravulizumab-cwvz) Injection – New Approved Indication – April 27, 2022 – Ultomiris® (ravulizumab-cwvz) has been approved in the US for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive, which represents 80% of people living with the disease. The approval by the Food and Drug Administration (FDA) was based on positive results from the CHAMPION-MG Phase III trial, in which Ultomiris® was superior to placebo in the primary endpoint of change from baseline in the Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL) total score at Week 26, a patient-reported scale that assesses patients’ abilities to perform daily activities. This FDA action marks the first and only approval for a long-acting C5 complement inhibitor for the treatment of gMG. <Read More>

Caplyta® (lumateperone) Capsules – New Approved Indication – April 26, 2022 – Intra-Cellular Therapies, Inc., a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, announced that the U.S. Food and Drug Administration (FDA) approved Caplyta® for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate. “Caplyta® is the only medication approved by the FDA to treat depressive disorders associated with bipolar I or bipolar II as both monotherapy and adjunctive therapy with lithium or valproate. Caplyta® has shown a consistent favorable profile on weight, cardiometabolic parameters and extrapyramidal symptoms (movement disturbances)…,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. <Read More>

New/Updated Drug Shortage

May 03, 2022

May 02, 2022

April 29, 2022

April 27, 2022

April 26, 2022

New Drug Recall and Safety Alerts

Compounded Drugs by Drug Depot, LLC, dba APS Pharmacy – New Voluntary Recall – April 26, 2022 – FDA is alerting patients, health care professionals, veterinarians, and animal owners/caretakers about a voluntary recall by Drug Depot, LLC, doing business as APS Pharmacy, of certain unexpired compounded drugs due to a lack of sterility assurance. Administration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening infections. APS Pharmacy, located in Palm Harbor, Florida, which compounds drugs intended for human use and drugs intended for animal (veterinary) use, initiated the voluntary nationwide recall via a recall letter dated March 15, 2022. The company has sent recall letters to all patients and animal owners who received the recalled drugs, and they are contacting all customers via telephone calls and emails as part of their recall strategy. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

PrEP Access in the United States: The Role of Telehealth – May 3, 2022 – Uptake of pre-exposure prophylaxis (PrEP)—a preventive medication that reduces the risk of acquiring HIV through sex and injection drug use, has been slow, despite its high efficacy and recommended use for those at risk. Furthermore, disparities in access and use exist along racial, ethnic, and gender lines. The Centers for Disease Control and Prevention (CDC) estimates that in 2020 about 300,800 people were prescribed PrEP, representing only 25% of those with an indicated need for the medication. The use of telehealth to provide PrEP and associated services (“tele-PrEP”) is a trend that began before the COVID-19 pandemic but we find it has increased for some providers along with the growing use of telehealth generally. However, little is known about the tele-PrEP environment. <Read More>

 Pharmacists Play an Essential Role in Patients’ Access to Contraception – May 3, 2022 – Until recently, a pharmacist’s responsibilities were almost exclusively confined to counting pills, attaching a label to the prescription bottle, and handing out the medication. At most, they would counsel patients whose prescriptions were somewhat complicated. However, as health care in the United States has advanced, pharmacists have gained a more active role. Some of their new responsibilities include providing comprehensive medication reviews to patients, conducting research, and administering vaccinations. Idaho is the most progressive jurisdiction in the United States in terms of the scope of a pharmacist’s practice <Read More>

Drug Plan Prices Touted During Medicare Open Enrollment Can Rise Within a Month – May 3, 2022 – Something strange happened between the time Linda Griffith signed up for a new Medicare prescription drug plan during last fall’s enrollment period and when she tried to fill her first prescription in January. She picked a Humana drug plan for its low prices, with help from her longtime insurance agent and the Medicare Plan Finder, an online pricing tool for comparing a dizzying array of options. But instead of the $70.09 she expected to pay for her dextroamphetamine, used to treat attention-deficit/hyperactivity disorder, her pharmacist told her she owed $275.90… As early as three weeks after Medicare’s drug plan enrollment period ends on Dec. 7, insurance plans can change what they charge members for drugs — and they can do it repeatedly <Read More>

Opportunities and Ideas to Make a Difference With Pediatric Patients – May 2, 2022 – Educating patients can be especially rewarding with children. Part of what pharmacists do for patients is educate them, and this can be especially rewarding and important when the patients are children. Children account for 22% of the US population, and nearly all of them receive medical care before reaching the age of 18. Pharmacists have a significant opportunity to engage with these patients and have a substantial impact on their use of medications. When interacting with children, it is important to remember to include the caregiver and address all their concerns. The child’s age also affects how involved they can be in their treatment. <Read More>

U.S. Attorney Announces Settlement of Fraud Lawsuit Against Online Pharmacy for Overdispensing Insulin – May 2, 2022 – Damian Williams, the United States Attorney for the Southern District of New York, and Scott J. Lampert, Special Agent-in-Charge of the U.S. Department of Health and Human Services Office of the Inspector General (“HHS-OIG”) New York Regional Office, announced that the United States filed and settled a healthcare fraud lawsuit against online retail pharmacy PillPack, LLC (“PillPack”), a wholly-owned subsidiary of Amazon.com, Inc.  The settlement resolves allegations that PillPack improperly billed Government healthcare programs (“GHPs”), including Medicare and Medicaid, for more insulin pens than patients needed according to their prescriptions and falsely under-reported the days-of-supply of insulin dispensed. <Read More>

 Five Ways Pharmacists Can Increase Engagement, Improve Services – May 2, 2022 – The scope of pharmaceutical care is continuing to evolve beyond medication dispensing. Two years since the beginning of the pandemic, most chain and independent pharmacy professionals operate at the top of their licenses, delivering clinical services such as flu and COVID-19 vaccinations, medication therapy management (MTM), and more. Given projected physician shortfalls of up to 139,000 by 2033, and the fact that 44 million Americans live in physician “deserts,” this trend is expected to continue. But with new opportunities for pharmacy professionals come challenges, such as ensuring optimal reimbursement and compensation, collaboration with health plans, and accountability for patient outcomes. Improving patient engagement and pharmacy enablement will help to ease many of these challenges and boost revenues in 2022. <Read More>

Top 10 Financial Tips for Pharmacy Students – April 29, 2022 – Most pharmacy schools don’t teach personal finance, so it’s up to you to set yourself up for success by taking control of your money while you’re still a student. In average, pharmacists today are graduating with more than $170,000 in student loan debt. Figuring out how to tackle that debt, on top of other financial priorities like making a down payment on a home or planning for retirement, is not easy. Most pharmacy schools don’t teach personal finance, so it’s up to you to set yourself up for success by taking control of your money while you’re still a student. Here are 10 tips to help you get started… <Read More>

How Pharmacies Can Defend Against PBM Audits – April 29, 2022 – Pharmacy benefits managers, or PBMs, are a double-edged sword for many pharmacies. On the one hand, PBMs work between pharmacies and health insurance companies, and drug manufacturers, drastically reducing the headaches that come with negotiating with these parties. PBMs also provide more experienced advocacy on the pharmacy’s behalf during the negotiations that take place in the industry. On the other hand, PBMs possess lots of power, have little accountability, and stand between the pharmacy and the companies that pay the pharmacy. <Read More>

 NASP Thanks Biden Administration for Reducing Out-of-Pocket Drug Costs for Seniors and Taking Initial Steps to Address Pharmacy DIR Fees – April 29, 2022 – The Biden Administration released a final regulation for the Medicare Advantage (MA) and Medicare Part D programs, including important reforms affecting seniors and pharmacies.  The National Association of Specialty Pharmacy’s (NASP) President and CEO Sheila Arquette, RPh applauds the Centers for Medicare and Medicaid Services (CMS) for taking steps in the rule to significantly reduce out of pocket drug costs for all Medicare beneficiaries through initial pharmacy DIR reforms, although also expresses disappointment that CMS delayed implementation of these critical reforms until January 2024.   NASP also calls on Congress to further bolster the rule by establishing statutory protections that will support patient access to their pharmacies and ensure fair performance evaluations of specialty pharmacies. <Read More>

 Pharmacy-Driven Probiotic Protocol Reduces Rates of C Diff Infection in an Inpatient Setting – April 28, 2022 – Patients taking high-risk antibiotics and a probiotic capsule had a lower risk of healthcare-associated C diff infections. Multiple antibiotic use can compound the risk of developing Clostridium difficile infection in a hospital setting. Efforts to minimize these risks have focused on 2 strategies: first, minimizing exposure to pathogens and second, minimizing infection susceptibility. Probiotics may, according to research published in Clinical Infectious Diseases, “offer another complimentary approach and aim to improve a patient’s defenses to [C diff infection].” <Read More>

U.S. Case of Human Avian Influenza A(H5) Virus Reported – April 28, 2022 – A person has tested positive for avian influenza A(H5) virus (H5 bird flu) in the U.S., as reported by Colorado and confirmed by CDC. This case occurred in a person who had direct exposure to poultry and was involved in the culling (depopulating) of  poultry with presumptive H5N1 bird flu. The patient reported fatigue for a few days as their only symptom and has since recovered. The patient is being isolated and treated with the influenza antiviral drug oseltamivir. While it is possible the detection of H5 bird flu in this specimen is a result of surface contamination of the nasal membrane, that can’t be determined at this point and the positive test result meets the criteria for an H5 case. The appropriate public health response at this time is to assume this is an infection and take actions to contain and treat. <Read More>

 CDC Press Release: Hypertensive Disorders in Pregnancy Affect 1 in 7 Hospital Deliveries – April 28, 2022 – The prevalence of hypertensive disorders in pregnancy (HDP) among delivery hospitalizations increased from about 13% in 2017 to 16% in 2019, affecting at least 1 in 7 delivery hospitalizations during this period, according to a CDC report. About a third of those who died during hospital delivery had a hypertensive disorder of pregnancy documented. HDP are common and can cause severe complications for pregnant people, such as heart attacks and strokes, and are a leading cause of pregnancy-related death in the United States. It includes both pregnancy-associated hypertension that begins during or after pregnancy, and chronic hypertension that begins before pregnancy and continues during pregnancy. <Read More>

Physician Leaders Wave Red Flag on Automated Pharmacy Technology – April 28, 2022 – As retail pharmacy chains rely on automated technology to fill prescriptions, a group of physician leaders is waving a red flag, stating that this technology has serious consequences for patient safety and the future of pharmacy. Becker’s spoke to former pharmacist and current physician Matthew Sewell, MD, PharmD, and physician Purvi S. Parikh, MD, about what they call the dangers of automated technology. Dr. Sewell and Dr. Parikh are both members of Physicians for Patient Protection, a nonprofit, patient advocacy group, and Dr. Parikh sits on its board. The group has more than 12,000 members who advocate for patient safety, physician-led care and truth and transparency in the industry. <Read More>

FDA Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars to Prevent Youth Initiation, Significantly Reduce Tobacco-Related Disease and Death – April 28, 2022 – The U.S. Food and Drug Administration is announcing proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors (other than tobacco) in  cigars. These actions have the potential to significantly reduce disease and death from combusted tobacco product use, the leading cause of preventable death in the U.S., by reducing youth experimentation and addiction, and increasing the number of smokers that quit…These proposed product standards are based on clear science and evidence establishing the addictiveness and harm of these products and build on the Family Smoking Prevention and Tobacco Control Act, which prohibited all characterizing flavors (other than tobacco and menthol) in cigarettes in 2009. <Read More>

ADHD Clinical Practice Guidelines ‘Long Overdue’ – April 28, 2022 – There is a growing concern among clinicians that many people – predominantly children, but also adults – are not receiving the care they require for both diagnosed and undiagnosed attention deficit hyperactivity disorder (ADHD). Dr John Kramer, Chair of RACGP Specific Interests ADHD, ASD and Neurodiversity, is part of the ADHD Guidelines Development Group. He told newsGP that new guidelines are ‘long overdue. It’s 20 years since there’s been any official guidelines in Australia for the management of ADHD and, in that time, much greater awareness of the condition has developed,’ Dr Kramer said. <Read More>

CMS Targets Reforms to Benchmarks to Kick-Start Flat ACO Participation – April 28, 2022 – The Biden administration wants to change how benchmark payments to accountable care organizations are calculated to make it easier for providers in the Medicare Shared Savings Program (MSSP) to qualify for savings. Leaders in the Centers for Medicare & Medicaid Services (CMS) outlined several changes they are pursuing to get more providers involved in value-based care in an article in The New England Journal of Medicine Thursday. CMS officials said the agency is looking into how to better calculate ACO benchmarks to better adjust for savings and to improve equity. The goal of the reforms is to reverse a slide in participation in the Medicare Shared Savings Program—which oversees ACOs—and to target smaller providers that treat patients in underserved areas. <Read More>

Seven Habits of Highly Effective Surface Samplers – April 27, 2022 – Staff working in specialty pharmacies, home infusion clinics, health systems and other care settings that handle hazardous drugs (HDs) may think their efforts to prevent surface contamination are working. But studies and practical experience suggest that even the best prevention efforts may fall short. So, here are seven steps for ensuring your facility’s HD strategies have the best chance for success, based on interviews with two safe-handling veterans… <Read More>

 J&J Files Lawsuit Against Several Pharmacies and Distributors Over Counterfeit HIV Medication – April 27, 2022 – Johnson & Johnson is on the attack against distributors and pharmacies that have allegedly sold counterfeit HIV medication being advertised as their product. The case, which was filed in the Eastern District of New York earlier this month, is against four entities including Safe Chain Solutions, LLC, ProPharma Distribution LLC, Scripts Wholesale Inc. and I Care Pharmacy 14, Inc. J&J alleges that they received a series of complaints from patients who found that their prescribed bottles of Symtuza®, which is used to treat HIV, contained the wrong pills inside the bottles, and that there were different drugs instead. An investigation conducted by Janssen claimed that these bottles were counterfeits, as the process controls at its packaging plant make it impossible for genuine Symtuza® bottles to contain anything but Symtuza® pills. <Read More>

Mississippi Pharmacist Sentenced to 10 Years in $180M Fraud Scheme – April 27, 2022 – A Mississippi pharmacist was sentenced to 10 years in prison over his role in an $180 million fraud scheme, the Justice Department said April 26. Mitchell Barrett was a licensed pharmacist and co-owner of compounding pharmacies. He participated in a scheme to defraud Tricare by paying kickbacks to distributors for the referral of medically unnecessary prescriptions, prosecutors said. Mr. Barrett and his co-conspirators submitted $180 million in fraudulent billings to federal and private insurers as a result of the scheme. <Read More>

Specialized Cancer Hospitals Hike Drug Costs by up to 630%, Study Finds – April 27, 2022 – While patients often seek treatment at big, fancy hospitals, in part because they are designated as National Cancer Institute centers, these institutions provide a sticker-shock surprise for those receiving their specialized care: They jack up the already sky-high cost of prescription cancer drugs with markups going up from 120% to 630% above what they pay for the medications. Those are the findings of researchers at the Harvard and Yale medical schools and elsewhere as reported in the Journal of the American Medical Association’s Internal Medicine publication. <Read More>

New York Enacts Legislation Regulating Pharmacy Benefit Managers – April 27, 2022 – New York recently enacted legislation, SB 3762, requiring Pharmacy Benefit Managers (“PBMs”) doing business in New York to register and then become licensed with the New York Department of Financial Services (“DFS”). The law was signed by the Governor on December 31, 2021 and became effective on March 31, 2022… Under the new law as amended, PBMs are required to register with the DFS and pay a fee of $4,000 by June 1, 2022. The new PBM registration requirement expires on December 31, 2022. Thereafter, all PBMs doing business in New York must be licensed by January 1, 2023, and licenses shall expire 36 months after date of issue. <Read More>

 Well Health, OSIS Partner to Bring Patient Communications Tech to Community Health Centers – April 27, 2022 – Well Health is teaming up with a technology services organization to provide community health centers and Federally Qualified Health Centers (FQHCs) more advanced patient communications technologies, making it easier for doctors to text with their patients. Well Health’s patient communication platform enables conversations between patients and their providers through secure messaging in the patient’s preferred channel—SMS/texting, email or phone—and preferred language, with 19 languages available for use. Well Health offers accessible digital patient engagement with a simple SMS/texting solution that does not require an app download, internet access or even a password. <Read More>

340B in the News

Unpacking Past, Future Hurdles in 340B Drug Pricing – May 3, 2022 – In his talk, “340B At 30 And The Impending Cliff On The Road To 40,” Tim Paine outlines how the program came to be and what needs to happen to improve future implementation. In a session on the 340B drug pricing program presented at this year’s Asembia Specialty Pharmacy Summit, Tim Paine, principal consultant at Blue Fin Group, outlined how the program came to be, where it stands now at age 30, and what the future might hold for it. The program was first established in 1992 and allows participating hospitals to manufacture discounts on drugs used in an outpatient setting. In other words, it was designed based on qualifications for inpatient metrics, but for an outpatient benefit, Paine said. In the years since its inception, debates have centered on whether savings actually benefit the underserved as intended, while numerous court cases have shaped its current interpretation. <Read More>

Grassley Seeks Update From HHS Inspector General on 340B Drug Pricing Program Referrals – May 2, 2022 – Sen. Chuck Grassley (R-Iowa) sent a letter to the Department of Health & Human Services (HHS) Office of Inspector General (OIG) asking for an update on seven drug manufacturer referrals for 340B Drug Pricing Program (340B Program) non-compliance…“Living in rural Iowa, I understand the importance of access to health care close to home,” Grassley said. “I’ve heard from Iowa hospitals and pharmacists about how drug manufacturers have ended 340B Program pricing at contract pharmacies and placed administrative burdens on health care providers. It’s important to understand what the inspector general is doing to take action following referrals by HRSA.” <Read More>

Senate Bill 355 Would Divert Patient Savings to For-Profit Businesses – April 30, 2022 – Our state legislature passed reforms to ensure safe school environments for the immunocompromised through good immunization policies. Recently Connecticut passed a law allowing patients to utilize assistance programs to lower their out-of-pocket expenses. That is why it is alarming to see these same lawmakers consider legislation that would divert savings intended for patients into the pockets of for-profit businesses. In 1992, Congress created the 340B Drug Discount program to stretch limited resources and help patients access life-saving health care…And while this program has good intentions, unfortunately the hospitals have seen it as a piggy bank during the past thirty years, abusing and expanding the program to where it is currently unrecognizable. And some states are trying to exacerbate the program. Connecticut’s SB 355 would make it even worse. <Read More>

Financial Losses, Challenges Persist for Hospitals, Health Systems – April 27, 2022 – Hospitals and health systems have faced massive financial losses throughout the COVID-19 pandemic and continue to experience staffing shortages, rising expenses, and supply chain issues, a new report from the American Hospital Association (AHA) detailed. Hospitals and health systems have been efficient in keeping up with COVID-19 surges since the onset of the pandemic. Facilities have expanded treatment capacity, hired additional staff, and maintained patient access to critical services and programs, AHA said. However, as a result, hospitals have experienced billions of dollars in losses. According to AHA, more than a third of hospitals have negative operating margins… A heightened need for the COVID-19 drug Remdesivir was also a driving factor behind the rising drug expenses. In addition, drug manufacturers denied 340B drug pricing to eligible hospitals through contracted pharmacies, leading many hospitals to lose millions of dollars in 340B drug savings. <Read More>

Pharma Companies Making 340B Restrictions Continue to Pile up – April 27, 2022 – The 340B drug pricing program requires drugmakers participating in Medicaid to sell outpatient drugs at discounted rates to healthcare organizations that serve vulnerable communities, or many uninsured and low-income patients. The program has seen significant growth since it was first signed into law in 1992. The March 15 enactment of the Consolidated Appropriations Act of 2022 permitted certain hospitals to be reinstated into the program if they met specified criteria. Drugmakers have reworked their 340B operations over the last few years as lawsuits target constraining them from what they see as a ballooning portion of the prescription drug market. The number of hospitals participating in the 340B drug pricing program increased from 591 in 2005 to 2,479 in October 2017. IQVIA reported that the program grew by $13 billion, or 16%, to $94 billion in 2021.  <Read More>