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
Welireg™ (belzutifan) – New Drug Approval – December 14, 2023 – The Food and Drug Administration approved belzutifan (Welireg™, Merck & Co., Inc.) for patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI). <Read More>
iDose® TR (travoprost) Intracameral Implant – New Drug Approval – December 13, 2023 – Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for a single administration per eye of iDose® TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG). <Read More>
Iwilfin™ (eflornithine) Tablets – New Drug Approval – December 13, 2023 – The Food and Drug Administration approved eflornithine (Iwilfin™, USWM, LLC) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. This represents the first FDA approval of a therapy intended to reduce the risk of relapse in pediatric patients with HRNB. <Read More>
New Indication/Dosage/Formulation Approval
Cresemba® (isavuconazonium) – New Label Expansion – December 8, 2023 – Astellas Pharma US, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Cresemba® (isavuconazonium sulfate), an azole antifungal drug, for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients. Cresemba® for injection is approved for adults and now for pediatric patients 1 year of age and older. Cresemba® capsules are approved for adults and now for pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater. With this approval, Cresemba® is now the only azole antifungal therapy approved for the treatment of IA and IM in patients as young as one. <Read More>
New Drug Shortage
December 12, 2023
- Sodium Chloride 14.6% Injection (Currently in Shortage)
- Sodium Chloride 23.4% Injection (Currently in Shortage)
Updated Drug Shortage
December 19, 2023
- Azacitidine Injection (Currently in Shortage)
- Azacitidine Injection (Discontinuation)
December 13, 2023
- Somatropin Injection (Currently in Shortage)
New Drug Recall and Safety Alerts
No new update.
New Generic/Biosimilar Approval and Launch
No new update.
Clinical and Pharmacy News
Breaking Down Barriers: Why Biosimilars Face Resistance in the US Market – December 18, 2023 – Despite a boom of new, cost-efficient options for chronic conditions, prescriber and patient concern over clinical benefit persists. Through the recent introduction of 9 US Food and Drug Administration (FDA)-approved adalimumab (Humiraâ) biosimilars, with more in the pipeline, the US is experiencing a biosimilar boom. These drugs represent an opportunity to deliver more treatment options at a potential discount compared with reference biologics. On average, biosimilars cost about 50% less than the reference brand. This reduction in costs can benefit both the healthcare system and patients, especially those whose out-of-pocket payments are based on a drug’s list price. <Read More>
Medication Adherence to BTK Inhibitors Can Pose Challenges for Patients with CLL – December 18, 2023 – Although treatment is effective, AEs remain difficult for patients. In 2022, more than 20,000 people received a diagnosis of chronic lymphocytic leukemia (CLL), a disease that can be characterized by the progressive accumulation of leukemic cells in peripheral blood bone marrow and lymphoid tissue, explained Desi Kotis, PharmD, vice dean of clinical affairs and chief pharmacy executive at the University of California, San Francisco School of Pharmacy, in a recent Pharmacy Times panel discussion. Kotis explained further that survival for patients with low-risk disease is 97% at 5 years and 80% at 10 years; for high-risk disease, the survival rate at 5 years decreases to 55% and 26% at 10 years. <Read More>
Mark Cuban Cost Plus Drugs Teams up With 4th PBM Company – December 18, 2023 – Mark Cuban Cost Plus Drug Co. has announced a partnership with pharmacy benefit management company PCA Rx to bring members even more clarity about drug pricing, according to a Dec. 18 news release. The company is now the fourth PBM to team up with Cost Plus. Founded in 2020, PCA Rx provides claims processing, consultations, customized clinical services, data reporting and collection, key performance indicator analysis, and rebate administration. Its resources, combined with Cost Plus Drug Co.’s emphasis on drug pricing transparency, will allow the two to make strides in redefining “transparency in the healthcare sector, where opaque pricing models have been a major pain point for employers and their workforce,” according to the news release. <Read More>
Physicians Challenge Licensing Boards’ Limitations on Dispensing – December 18, 2023 – Unsuccessful arguments at trial court level are upheld on appeal. After legislators in Texas prohibited physicians from dispensing noncontrolled medications and those laws were enforced by licensing boards, physicians challenged the decision. Under Texas state law, only pharmacists licensed by the state may dispense noncontrolled prescription medication. The prohibition extends to physicians with 2 notable exceptions: first, where the patient has an “immediate need,” although this carve-out specifies that it does not permit a physician to operate a pharmacy in the sense of a traditional retail community pharmacy; and second, if the physician’s practice is located in certain rural portions of the state. This broad, overarching prohibition is referred to as the dispensing ban. <Read More>
Mistakes at Work Happen. For Pharmacists, it can End Their Career – December 17, 2023 – It’s every pharmacist’s worst fear: To come home from a busy day at work and realize that they failed to consult with a patient about a potentially dangerous interaction, or filled a prescription incorrectly. Workers at chain pharmacies across the US have told CNN that increased demand for prescriptions, shots and other services without sufficient staff to fulfill those orders has made it nearly impossible for the workers to do their jobs properly and has created potentially unsafe conditions for customers. Mistakes happen, especially when workers are burnt out and busy. But when a pharmacist errs, the implications can be both legal – pharmacists can be sued for malpractice – and lethal. Errors can cost lives, tie pharmacists up in prolonged court battles and cost them their livelihoods. <Read More>
Pharmacy Automation Can Be a Means to Drug Safety – December 14, 2023 – In the pharmacy, time is the ultimate value-add. Part of the pharmacist’s oath is to “assure optimal outcomes for all patients.” With this, the first and foremost priority is patient safety and ensuring that patients get the right medication at the right time. Yet, each year in the United States alone, 7000 people die due to a medication error. Beyond the risk to patients, there is also significant cost associated with medication errors: According to the World Health Organization, the global cost of medication errors is estimated to be $42 billion annually, or almost 1% of total health expenditures. <Read More>
Five Key Questions to Ask When Implementing Drug Diversion Monitoring Software – December 13, 2023 – Saint Luke’s Health System, in the Kansas City, Mo., region, implemented drug diversion monitoring software two years ago. The health system’s experience—including key questions to ask vendors—offers valuable lessons for other organizations investing in this vital component of diversion prevention, according to a session from the ASHP 2023 Midyear Clinical Meeting & Exhibition. Diversion surveillance “is a lot of tedious work and a lot of Excel spreadsheets, maybe some manual audits, and a lot of focus on the software,” acknowledged Della Bahmandar, PharmD, MBA, BCPS, BCSCP, the director of pharmacy at Saint Luke’s North Hospital. “But it’s so important for our patients, employees and community; the more at-risk behavior is recognized, the better we are.” <Read More>
What’s Wrong With Flavored Medicine? California Moves to Ban it. – December 13, 2023 – Gov. Gavin Newsom has been touting California as the “true freedom state,” but for a state that values freedom, its regulators don’t know how to leave anyone alone. The latest example of meddlesome state bureaucracy is too ridiculous to fathom: California’s Board of Pharmacy is implementing new rules that are stopping pharmacists from flavoring children’s medication. It’s been common practice for generations for pharmacists to add grape or other sweet flavors to antibiotics, flu syrups and various icky tasting medications to make it easier for young kids to tolerate their prescribed doses. <Read More>
340B in the News
Medicare Advantage Payors Have Not Redressed 340B Underpayments – December 13, 2023 – CMS recently published its remedy in response to the Supreme Court’s decision that CMS’s 340B outpatient drug payment policy violated the Medicare statute. Many hospitals that are 340B covered entities will now receive tens of millions of dollars in lump sum payments as reimbursement for what Medicare was required to pay 340B hospitals for outpatient drugs between January 1, 2018, and September 28, 2022. But unlike CMS, Medicare Advantage plans are refusing to compensate hospitals for 340B underpayments, leaving covered entities with millions of dollars of uncollected reimbursement for outpatient drugs provided to Medicare Advantage enrollees. <Read More>