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Clinical Insights: February 29, 2024

Posted on February 29, 2024 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/Vaccine Approval

Amtagvi™ (lifileucel) Suspension for Intravenous Infusion –New Orphan Drug Approval  –February 16, 2024 – The U.S. Food and Drug Administration approved Amtagvi™ (lifileucel), the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies (a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor). <Read More> 

Aurlumyn™ (iloprost) Injection – New Orphan Drug Approval – February 13, 2024 – The U.S. Food and Drug Administration approved Aurlumyn™ (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. “This approval provides patients with the first-ever treatment option for severe frostbite,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. “Having this new option provides physicians with a tool that will help prevent the lifechanging amputation of one’s frostbitten fingers or toes.” <Read More>

New Indication/Dosage/Formulation Approval

Biktarvy® (bictegravir, emtricitabine and tenofovir alafenamide) Tablets – New Label Expansion – February 23, 2024 – Gilead Sciences, Inc. (Nasdaq: GILD) announced the U.S. Food and Drug Administration (FDA) approved a new, expanded indication for Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to treat people with HIV (PWH) who have suppressed viral loads with known or suspected M184V/I resistance, a common form of treatment resistance. HIV treatment resistance is permanent and irreversible, which can jeopardize future treatment options for PWH. The M184V/I resistance mutation has been found to be present in a range (22-63%) of PWH with pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs) across various HIV subtypes. <Read More>

Imbruvica® (ibrutinib) Capsules, Tablets and Oral Suspension – New Label Expansion – February 22, 2024 – Johnson & Johnson, in collaboration with its alliance partner, Pharmacyclics LLC, an AbbVie Company, announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for Imbruvica® (ibrutinib) with an oral suspension formulation for adult patients in the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); Waldenström’s macroglobulinemia (WM); and chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. “Some patients may have trouble swallowing medications, adding another layer of complexity to their treatment journey,” said Lisa Nodzon, PhD, ARNP, AOCNP at Moffitt Cancer Center. “Having multiple formulations of Imbruvica® offers prescribers another option when treating adults with CLL/SLL, WM, or cGVHD, which could make a difference in their daily lives.” <Read More>

Tecvayli® (teclistamab-cqyv) Injection – New Label Expansion – February 20, 2024 – Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Tecvayli® (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients with relapsed or refractory multiple myeloma (RRMM) who have achieved and maintained a complete response (CR) or better for a minimum of six months.1There is a continued unmet need for patients with multiple myeloma and this approval allows increased flexibility in dosing schedule for appropriate patients with a weight-based regimen. <Read More>

Xolair® (omalizumab) Injection – New Label Expansion – February 16, 2024 – The U.S. Food and Drug Administration approved Xolairâ (omalizumab) injection for immunoglobulin E-mediated food allergy in certain adults and children 1 year or older for the reduction of allergic reactions (Type I), including reducing the risk of anaphylaxis, that may occur with accidental exposure to one or more foods. Patients who take Xolair® must continue to avoid foods they are allergic to. Xolair® is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis. Xolair® was originally approved in 2003 for the treatment of moderate to severe persistent allergic asthma in certain patients. Xolair® is also approved to treat chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps in certain patients. <Read More>

Tagrisso® (osimertinib) Tablets – New Label Expansion – February 16, 2024 – AstraZeneca’s Tagrisso® has been approved in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). The approval following a Priority Review by the Food and Drug Administration (FDA) was based on the results from the FLAURA2 Phase III trial published in The New England Journal of Medicine. Tagrisso® with the addition of chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso® monotherapy which is the 1st-line global standard of care (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.49-0.79; p<0.0001). Median progression-free survival (PFS) by investigator assessment was 25.5 months for patients treated with Tagrisso® plus chemotherapy, an 8.8-month improvement versus Tagrisso® monotherapy (16.7 months). <Read More>

Tepmetko® (tepotinib) Tablets – New Label Expansion – February 15, 2024 – The Food and Drug Administration granted traditional approval to tepotinib (Tepmetko®, EMD Serono, Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. Tepotinib was previously granted accelerated approval for this indication on February 3, 2021, based on initial overall response rate (ORR) and duration of response (DOR) in the VISION trial (NCT02864992), a multicenter, non-randomized, open-label, multicohort study. <Read More>

Onivyde® (irinotecan liposomal) Injection – New label Expansion – February 13, 2024 – Ipsen (Euronext: IPN; ADR: IPSEY) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC). This is the second approval for an Onivyde® regimen in mPDAC, following the FDA’s approval in 2015 of Onivyde® plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy. <Read More>

New Drug Shortage

February 28, 2024

February 23, 2024

February 14, 2024

February 13, 2024

Updated Drug Shortage

February 27, 2024

February 26, 2024

February 23, 2024

February 22, 2024

February 21, 2024

New Drug Recall and Safety Alerts

Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment, Lubricant PM Ointment by Brassica Pharma Pvt. Ltd. – New Voluntary Recall – February 22, 2024 – Brassica Pharma Pvt. Ltd. is voluntarily recalling Eye Ointment products listed in the table below with expiration date ranging from February 2024 to September 2025. The products are being recalled due to lack of sterility assurance at the facility noted during an inspection conducted by the Food and Drug Administration (FDA). <Read More>

New Generic/Biosimilar Approval and Launch

Simlandi™ (adalimumab-ryvk) Injection – New Biosimilar Approval – February 23, 2024 – Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced that the U.S. Food and Drug Administration (FDA) has approved Simlandi™ (adalimumab-ryvk) injection, as an interchangeable biosimilar to Humira®, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis. In 2023, Humira® was one of the highest-grossing pharmaceutical products in the world, with sales in the U.S. of nearly $12.2 billion. Teva is Alvotech’s strategic partner for the exclusive commercialization of Simlandi™ in the United States. <Read More>

Clinical and Pharmacy News

Local Pharmacy Feeling Impact of Nationwide Cyberattack – February 27, 2024 – Pharmacies across the nation and in St. Joseph are working to fill essential medications after a cyberattack last Wednesday disrupted data transmission lines between insurance companies and pharmacies. The cybersecurity attack that took place on a major health tech platform, Change Healthcare, has complicated the process of billing through insurance companies, and local pharmacies are feeling the impact. JulieMarie Nickelson, a registered pharmacist at Roger’s Pharmacy, said when the cyber issue first happened, they experienced nearly 500 claims a day not going through for patients. “It’s improved since last Wednesday, but it’s definitely not resolved yet,” Nickelson said. There are many coupons that aren’t working; we have insurances where some claims are going through, but not others. So, we’re kind of at the mercy of what we call a ‘switch program,’ which is basically the intermediary between the pharmacy and the insurance company.” <Read More>

The Change Healthcare Cyberattack is Still Impacting Pharmacies. It’s a Bigger Deal Than You Think – February 26, 2024 – Pharmacies across the United States are still grappling with substantial disruptions following a cyberattack on UnitedHealth’s technology unit, Change Healthcare, as reported by multiple pharmacy chains through official statements and on various social media platforms. The attack led to a nationwide outage of a network designed to communicate data between healthcare providers and insurance companies. According to a filing last Thursday with the Securities and Exchange Commission (SEC), UnitedHealth discovered a “suspected nation-state associated cyber security threat actor” had access to subsidiary Change Healthcare’s systems on Wednesday. <Read More>

From Billionaire Mark Cuban to Independent Store Owners, Criticism for Pharmacy Benefit Managers is Plentiful – February 25, 2024 – At first glance, billionaire entrepreneur Mark Cuban may seem to have little in common with an independent pharmacy owner. But they have one shared adversary: pharmacy benefit managers. They claim the drug price negotiators are putting mom-and-pop drugstores out of business. Pharmacy benefit managers — known as PBMs — are third-­party intermediaries between drug manufacturers and insurance providers. PBMs reimburse pharmacies for the prescriptions customers buy with insurance, but independent pharmacy owners accuse them of reimbursing far less than the actual cost of medications. <Read More>

AI May Not Be So Smart When Payors Use It To Deny Medical Claims – February 23, 2024 – Concerns are growing about the increasing use of artificial intelligence to review—and in many cases deny—healthcare claims, sparking a congressional inquiry and lawsuits. Thirty-two legislators sent a letter to the Centers for Medicare & Medicaid Services (CMS) on Nov. 3, 2023, urging increased oversight of the use of these tools in Medicare Advantage (MA) plans. “In recent years, problems posed by prior authorization [PA] have been exacerbated by MA plans’ increasing use of AI or algorithmic software to assist in their coverage determinations in certain care settings, including inpatient hospital, skilled nursing facilities and home health,” wrote the representatives, led by Judy Chu (D-Calif.) and Jerrold Nadler (D-N.Y.). <Read More>

Taking Pharmacogenomics Guidelines to Heart – February 23, 2024 – Pharmacogenomics is a rapidly expanding field with new evidence and implications for cardiology practice, experts said during the ASHP 2023 Midyear Clinical Meeting & Exhibition, in Anaheim, Calif. Pharmacogenomics (also known as pharmacogenetics) explores how a person’s genes metabolize medications. The Clinical Pharmacogenetics Implementation Consortium (CPIC) has compiled information about nearly 200 drug–gene associations, many in common cardiology drug classes such as antiarrhythmics, antiplatelet/anticoagulants, beta-blockers and statins, said Jordan Baye, PharmD, MA, BCPS, an assistant professor of pharmacy practice at South Dakota State University, in Brookings. <Read More>

FDA Revises EUA for Paxlovid™ – February 21, 2024 – The FDA announced a revision to the emergency use authorization (EUA) for nirmatrelvir+ritonavir (Paxlovid™, Pfizer): Nirmatrelvir+ritonavir manufactured and labeled in accordance with the EUA currently in U.S. distribution will remain authorized for use through the labeled or extended expiration date, as applicable, or through March 8, 2024, whichever is earlier. EUA-labeled nirmatrelvir+ritonavir will no longer be authorized for emergency use after March 8, regardless of the labeled or extended expiration date. However, the nirmatrelvir+ritonavir EUA will continue to authorize emergency use of nirmatrelvir+ritonavir manufactured and labeled in accordance with the new drug application (NDA-labeled nirmatrelvir+ritonavir) for the treatment of mild to moderate COVID-19 in pediatric patients (>12 years of age weighing >40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. <Read More>

Medication Safety Tools, Pharmacy Technician Usage Up – February 20, 2024 – Health-system pharmacies’ use of technology to improve medication safety and to promote cleanroom compliance has risen, while other metrics such as pharmacist prescribing have remained relatively flat, according to results of the 2023 ASHP National Survey of Hospital Pharmacy Practice. There has been limited change from 2020 to 2023 in pharmacists’ ability to independently prescribe medications pursuant to a diagnosis, said Michael Ganio, PharmD, the senior director of pharmacy practice and quality at ASHP. One of five areas of focus through ASHP’s Practice Advancement Initiative (PAI) 2030—a list of recommendations to advance healthcare and pharmacy practice—was to increase authority for pharmacists to independently prescribe medications by 20% by 2024, he noted during a session at the ASHP 2023 Midyear Clinical Meeting & Exhibition, in Anaheim, Calif. <Read More>

Medicare Now Negotiating Price of Drug That Costs $7,100 in US Vs. $900 in Canada – February 6, 2024 – Sen. Bernie Sanders is once again taking the pharmaceutical industry to task, issuing a report Tuesday that highlights the cost of three blockbuster drugs that are far pricier in the US than in other countries. The differences are striking. The annual list price of Bristol Myers Squibb’s Eliquis®, a blood thinner that reduces the risk of stroke, is $7,100 in the US. But in Japan, it’s $940; in Canada, it’s $900; in Germany, it’s $770; in the United Kingdom, it’s $760; and in France, it’s $650. <Read More>

340B in the News

The 340B Hospital Overcharge Controversy: Unveiling the Need for Transparency and Regulation in Healthcare – February 20, 2024 – In a distressing revelation, Adventist Health System, a 340B hospital, has raised serious allegations against some of the world’s largest pharmaceutical companies. The hospital claims to have been drastically overcharged by these pharmaceutical giants in a federal drug discount program. This has sparked a wave of concerns about the fairness and transparency of the program and its impact on healthcare providers and patients alike. The allegations revolve around the intricate calculations used to provide medicines to the 340B program. This program necessitates drug manufacturers to offer discounts on all outpatient drugs used by hospitals and clinics primarily serving lower-income patients. In the United States, approximately 12,400 hospitals and clinics participate in this program. These numbers have expanded over the years, making it a substantial market for pharmaceutical companies. <Read More>

 

Alabama Health System Sues Humana to Recoup MA Payments After 340B Rate Revision – February 13, 2024 – Baptist Health has filed a lawsuit against Humana arguing the payer’s Medicare Advantage plans had underpaid for outpatient drugs purchased through the 340B Drug Pricing Program in light of a 2022 Supreme Court decision that amended rates set by the federal government. In 2018, the Department of Health and Human Services (HHS) cut outpatient drug payments to hospitals participating in the pricing program, which requires drug manufacturers to sell drugs at a discount to safety-net providers, by nearly 30%. The Supreme Court ruled the cut unlawful in 2022, leading HHS to issue a one-time lump sum repayment of about $9 billion to impacted hospitals across the nation. <Read More>