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Clinical Insights: January 24, 2024

Posted on January 24, 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

Balversa® (erdafitinib) Tablets – New Label Expansion – January 19, 2024 – The Food and Drug Administration approved erdafitinib (Balversa®, Janssen Biotech) for adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy. Erdafitinib is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. This approval amends the indication previously granted under accelerated approval for patients with mUC with susceptible FGFR3 or FGFR2 alterations after prior platinum-containing chemotherapy. <Read More>

Casgevy™ (exagamglogene autotemcel) Suspension for Intravenous Infusion – New Label Expansion – January 16, 2024 – Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that the U.S. Food and Drug Administration (FDA) has approved Casgevy™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited cell therapy, for the treatment of transfusion-dependent beta thalassemia (TDT) in patients 12 years and older. “On the heels of the historic FDA approval of Casgevy™ for sickle cell disease, it is exciting to now secure approval for TDT well ahead of the PDUFA date,” said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. “TDT patients deserve new, potentially curative treatment options, and we look forward to bringing Casgevy™ to eligible patients who are waiting.” <Read More>

New Indication/Dosage/Formulation Approval

No new update.

New Drug Shortage

January 12, 2024

Updated Drug Shortage

January 22, 2024

January 19, 2024

January 18, 2024

January 17, 2024

January 16, 2024

January 15, 2024

New Drug Recall and Safety Alerts

Multiple Eyedrops by Kilitch Healthcare India Limited – New Voluntary Recall Correction – January 22, 2024 – Kilitch Healthcare India Limited is issuing an amendment in the last Nationwide press release dated November 13, 2023 issued for nationwide recall of various eye drops. There are corrections in product NDC No for the below mentioned products. These products were distributed nationwide to wholesalers, retailers, and via the product distributor, Velocity Pharma LLC. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

All it Takes is a Conversation: Deprescribing Benzodiazepines in Older Adults – January 19, 2024 – Benzodiazepines have proven effective in managing anxiety and insomnia, but they heighten risk of falls, cognitive impairment, functional decline, and mortality among older adults. Prescribing medications and intensifying therapeutic regimens are often at the forefront of optimizing patient care. However, patients can accumulate a plethora of medications and such polypharmacy can cause adverse effects and even, potentially, the development of new conditions and diseases. Benzodiazepines have proven effective in managing anxiety and insomnia, but they heighten risk of falls, cognitive impairment, functional decline, and mortality among older adults, as well as avoidable hospitalizations. Regardless of their risks and the availability of safer first-line treatments for anxiety and insomnia, benzodiazepines are still one of the most commonly prescribed medication classes in the United States, being given to almost 10% of Medicare beneficiaries. <Read More>

How Specialty Pharmacies Can Increase Access Through Patient Financing – January 16, 2024 – More than 4 in 10 Americans are concerned that prescription drug costs will lead to bankruptcy or debt.1 One-third of respondents to the same study said the cost of their prescription medications rose last year. For those living with rare, chronic, or complex diseases who require specialty pharmaceuticals, cost-related concerns can be even greater. Specialty medications are costly, have a more complex benefit structure, and follow strict payer utilization management parameters that complicate patients’ ability to access prescribed therapy. For these reasons, it’s essential that health care providers across the patient journey demystify the costs of treatment and provide solutions to overcome the financial barriers, helping to ensure patients can access the care and treatments they want and need. <Read More>

Study Finds High HIV Viral Loads Associated With Higher Recombination Rates, May Influence Viral Evolution – January 12, 2024 – According to research published in Molecular Biology and Evolution, HIV populations in people with higher viral loads also have higher rates of viral recombination. In effect, it is easier for the virus to diversify when there are more viral loads of HIV in the blood. Due to HIV’s high rate of recombination—which allows the exchange of genetic information across strains of the virus and drives the evolution of HIV—it has been difficult to combat the virus. Further, recombination is an evolutionary driver and allows organisms to remove destructive mutations and instead combine helpful ones. According to the authors, understanding the factors that influence recombination rates in HIV can help broadly reveal the potential effects that recombination has on the viral evolution. <Read More>

Ninety Percent of Pain Patients Have Trouble Filling Opioid Prescriptions – January 11, 2024 – Nine out of ten pain patients with an opioid prescription in the United States experienced delays or problems in the past year getting their prescription filled at a pharmacy, according to a large new survey by Pain News Network.  Nearly 20% of patients were not able to get their opioid medication, even after contacting multiple pharmacies. Over 2,800 pain patients participated in PNN’s online survey. Many were so frustrated with pharmacists being unable or unwilling to fill their opioid prescriptions that they turned to other substances for pain relief or contemplated suicide. “My medication helps my pain be at a level I can tolerate. When I can’t get it, I honestly feel like ending my life due to the pain. I wish they’d stop to realize there are those of us with a legitimate need,” one patient told us. <Read More>

CVS Will Close Some Target Pharmacy Locations – January 11, 2024 – CVS will close dozens of pharmacies located inside of Target stores in early 2024, a company spokesperson said on Thursday. The closures come as retail pharmacy chains in the US face increasing difficulties with their prescriptions business, workforces and more. CVS will shutter the pharmacies between February and April of this year as part of the Rhode Island-based company’s plan to space out stores and pharmacies more, said Amy Thibault, spokesperson for CVS Pharmacy, in an email to CNN. The closures are “based on our evaluation of changes in population, consumer buying patterns and future health needs to ensure we have the right pharmacy format in the right locations for patients,” she said. <Read More>

AMCP Report Illustrates Benefits of Managed Care Pharmacy – January 10, 2024 – Due to the increasing prevalence of managed care pharmacies (MCPs) and the lack of widespread understanding of their benefits, the Academy of Managed Care Pharmacy (AMCP) released a report that aims to explain how delivering pharmacy benefits through a managed care organization (MCO) improves patient health, titled “Access, Affordability, and Outcomes: The Value of Managed Care Pharmacy.” Most people in the United States with private health insurance have their pharmacy benefits managed by an insurer through an MCP. Furthermore, MCP is the dominant method for Medicaid recipients to receive prescription benefits and is growing among Medicare patients. In 2022, 45% of Medicare patients were enrolled in an MCP Medicare Advantage Plan. <Read More>

Medicare Reimbursement Hits New Low – January 10, 2024 – Medicare historically reimburses hospitals below the cost of providing care to patients, but payments to hospitals fell to a record low in 2022, according to new data provided by the American Hospital Association. Four things to know:  1) An AHA analysis published Jan. 10 shows that Medicare paid 82 cents for every dollar hospitals spent on care for Medicare patients in 2022 — the most recent year for which data is available, 2) Medicare underpayments to hospitals hit $99.2 billion in 2022, almost two and a half times the amount in 2012, according to the report… <Read More>

340B in the News

Tracking Administrative Complexity Within the 340B Drug Pricing Program – January 16, 2024 – Part of the Public Health Service Act of 1992, the 340B Drug Pricing Program lowers drug costs and increases revenues for safety-net health care providers by allowing them to pay heavily discounted prices for prescription drugs, but get reimbursed at full cost. With revenues from the discounted drugs, these safety-net providers can offer discounts on drugs for their patients while also enhancing their care offerings to help achieve the 340B program’s goal of “reaching more eligible patients and providing more comprehensive services.” The 340B program has grown substantially in the last three decades to include more eligible hospitals and a dramatic expansion in the number of pharmacies contracted via the program to dispense drugs. In the first study of its kind, published in Health Affairs Scholar, the University of Minnesota School of Public Health (SPH) sheds light on a previously unexamined area of the 340B program’s growth: third-party administrators (TPAs). <Read More>

How Hospitals Hijacked a Drug Discount Program for the Poor – January 10, 2024 – Corporate greed is a powerful motivator. When our lawmakers draft legislation, they really ought to have a special committee to evaluate how corporations might exploit it. No such committee exists, though. And that’s one reason a program enacted in 1992 to give poor and underserved populations better access to costly prescription drugs has turned into a multibillion-dollar boondoggle for hospital mega-chains. It’s high time for Congress to restore the 340B drug discount program to its intended purpose. The 340B program allows hospitals, specified clinics, and other “safety net” providers to purchase outpatient prescription drugs at significant discounts. Theoretically, providers could pass along these savings to their underserved patients by charging them less for medications — or reinvesting in services and facilities for those in need. But nothing requires them to do that. So, very often, they don’t. Instead, they use the discounts to pad their profits. <Read More>

How Drug Manufacturers Can Mitigate Trends in Revenue Leakage – January 9, 2024 – The Gross-to-Net (GTN) gap for drug manufacturers in 2022 was $223 billion, a 33.5% increase from 2018, when the total sum of manufacturer GTN reductions for patent-protected, brand name drugs was $167 billion. Misapplied discounts are a major contributor to this growing revenue leakage, which puts financial pressure on drug manufacturers and makes it more difficult to keep down drug prices. This trend isn’t likely to abate soon: Multiple factors are aligning to intensify the impact of misapplied discounts on drug manufacturers over the next two years. For starters, the 340B program, created by Congress more than three decades ago to make drug rebates mandatory, has grown in popularity since the federal government in 2010 allowed an unlimited number of contract pharmacies to participate. <Read More>