Sherif Kamal’s Post

June Issue of Strategies Oncology magazine -  Solid information for Smart Decisions-  The theme this month is Assessing Cancer Drugs: Ongoing Challenges As usual, Strategies offers different perspectives on important issues. In This Issue: The Impact of Pharmacy Benefit Managers on Oncology Treatment  by Cindy Boyer, RN, PhD   Pharmacy Benefit Managers (PBMs), which are likely familiar to cancer care professionals but not necessarily to their patients, are third party companies that function as intermediaries between insurance providers and pharmaceutical manufacturers. PBMs were created in the 1960’s to create formularies and administer claim processes to assist insurers with drug spending. Over the years they have expanded. Today, PBMs create formularies and negotiate rebates (discounts paid by a drug manufacturer to a PBM) with manufacturers. They also create pharmacy networks, process claims, and review drug utilization. Some offer mail order pharmacy services. https://lnkd.in/gvUbNMcA #STRATEGIESONCOLOGYMAGAZINE #ONCOLOGY #cancercare #PBM

𝐀𝐥𝐝𝐞𝐲𝐫𝐚 𝐓𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜𝐬 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐬 𝐅𝐃𝐀 𝐀𝐜𝐜𝐞𝐩𝐭𝐚𝐧𝐜𝐞 𝐨𝐟 𝐑𝐞𝐩𝐫𝐨𝐱𝐚𝐥𝐚𝐩 𝐍𝐃𝐀 𝐟𝐨𝐫 𝐃𝐫𝐲 𝐄𝐲𝐞 𝐃𝐢𝐬𝐞𝐚𝐬𝐞 𝐚𝐧𝐝 𝐄𝐱𝐩𝐚𝐧𝐝𝐬 𝐀𝐛𝐛𝐕𝐢𝐞 𝐎𝐩𝐭𝐢𝐨𝐧 𝐀𝐠𝐫𝐞𝐞𝐦𝐞𝐧𝐭 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) Aldeyra Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for Reproxalap, an investigational therapy for the treatment of dry eye disease. The FDA has set the Prescription Drug User Fee Act (PDUFA) date for April 2, 2025. Alongside the FDA’s acceptance of the NDA, Aldeyra shared news of an expanded exclusive option agreement with AbbVie Inc., aimed at advancing the development and commercialization of Reproxalap. The FDA’s acceptance marks a critical milestone for Reproxalap, a first-in-class topical ocular therapy designed to address the signs and symptoms of dry eye disease. If approved, the therapy will bring a novel solution to a condition impacting millions of individuals worldwide. Under the expanded agreement, AbbVie retains the option to co-develop, manufacture, and commercialize Reproxalap in the United States. Should AbbVie exercise this option, it will make a $100 million upfront payment to Aldeyra, adjusted for $6 million in prior fees. Aldeyra could also receive up to $300 million in additional payments tied to regulatory and commercial milestones, including a $100 million payment upon FDA approval. Both companies have committed to pre-commercial activities, with costs shared at 60% AbbVie and 40% Aldeyra if the option is exercised. In the event of commercialization, profits and losses will be split at the same 60/40 ratio. Additionally, the expiration of AbbVie’s option has been extended to 10 business days following FDA approval, should it occur. Dr. Todd C. Brady Todd Brady, President and CEO of Aldeyra, commented: “FDA acceptance of the Reproxalap NDA is a significant step forward. Our collaboration with AbbVie underscores our shared dedication to bringing this innovative therapy to patients and clinicians as swiftly as possible.” #DryEyeDisease #Ophthalmology #AbbVieCollaboration #Reproxalap #FDAApproval #PharmaPartnership

A recent article "Standardization of key performance indicators and metrics for investigational drug services: Consensus recommendations among IDS specialists" by Mollys Schmidt, PharmD, BCPS, BCOP, CSP, Dr. Lisa Janssen Carlson, PharmD, BCOP, DPLA, Jennifer Murphy, PharmD, BCOP, Sapna Amin, PharmD, BCOP, Robi Lockhorst, PharmD, BCOP, BCPS and Kyle Luedtke, PharmD, published in American Journal of Health-System Pharmacy helps to establish practical guidance for investigational drug services metrics and site utility as applicable. The article is available here : This study aimed to establish practical guidance and utility for metrics in investigational drug services (IDS) due to the absence of consensus guidelines, which complicates tracking pharmacy productivity, establishing growth baselines, and benchmarking against peer institutions. Conducted by the metrics subgroup of the Hematology/Oncology Pharmacy Association (HOPA) IDS special interest group (SIG), the study involved three surveys sent to 75 SIG members to gather and standardize IDS metrics. The first survey identified current metrics, which were then categorized. Through consensus, standardized definitions were created for future surveys. The subsequent surveys refined and confirmed the top recommended metrics for IDS tracking. Out of the 75 recipients, the response rates ranged from 24% to 38%. From the surveys and subgroup consensus, five top metrics were identified: (1) active protocols, (2) dispenses, (3) new clinical trials initiated, (4) patients treated, and (5) clinical interventions. These metrics are intended to guide IDS sites in resource allocation and standardization efforts, facilitating consistent benchmarking across institutions. The recommendations aim to ensure IDS pharmacy staff have adequate resources and establish a foundation for standardizing metrics and improving institutional comparisons. ASHP FIP Hospital Pharmacy Section ONE FIP #pharmacyresearch

🌟 Introducing QUAPOS: Elevating Quality in Oncology Pharmacy Services 🌟 QUAPOS stands for "Quality Assurance in Pharmaceutical Oncology Services." Developed by the European Society of Oncology Pharmacy (ESOP) Global these guidelines aim to standardize and improve the quality of pharmaceutical services in oncology. Here's how QUAPOS makes a difference: 1. **Preparation of Cytotoxic Drugs**: Ensures medications are prepared safely and accurately. 2. **Handling and Administration**: Establishes protocols to protect healthcare workers and patients. 3. **Education and Training**: Provides comprehensive training for oncology pharmacists and healthcare professionals. 4. **Quality Management**: Implements systems to continuously monitor and improve service standards. 5. **Patient Safety**: Prioritizes safety through rigorous guidelines and adverse event management. 6. **Interdisciplinary Collaboration**: Promotes teamwork among pharmacists, oncologists, and nurses. By following QUAPOS guidelines, we ensure safe, effective, and high-quality care for oncology patients. Let's work together to enhance the standards of oncology treatments! #OncologyPharmacy #QUAPOS #ESOP #QualityCare #PatientSafety #PharmacyExcellence #HealthcareStandards

New Agios Pharma MDS Treatment Gains FDA 'Orphan Drug' Status Agios Pharmaceuticals has reached a significant milestone in the development of their new myelodysplastic syndrome (MDS) treatment, Tebapivat, with the FDA's recent designation of the drug as an 'orphan drug'. Tebapivat has shown promise in treating lower-risk MDS, which affects between 75,000 and 80,000 patients in the US and EU each year. The 'orphan drug' status facilitates several benefits for Agios, including additional tax credits, FDA fee exemptions, and the potential for a seven-year market exclusivity period post-approval. Agios' Chief Medical Officer, Dr. Sarah Gheuens, emphasized the significance of this designation after Agios wrapped the Phase 2a study of Tebapivat; with the company now proceeding with Phase 2b of the trial. The OxyDial team is closely following Agios’ progress, with this designation not only highlighting the company's dedication to fighting rare hematologic diseases, but also helping set the stage for the potentially transformative impacts on disease management and patient care. Read more: https://lnkd.in/eKAWFzTf #AgiosPharma #Tebapivat #MDS #ClinicalTrial #HematologyResearch #OrphanDrugDesignation

Takeda’s resurrection of the once-rejected #Eohilia appears to be paying off, with a survey of physicians finding the launch is in line with the rollout of Dupixent and is delaying the use of Regeneron and Sanofi’s big blockbuster drug.   The FDA rejected Eohilia, also called TAK-721 , in the chronic inflammatory disease eosinophilic esophagitis in 2021. Spherix Global Insights surveyed 75 U.S. physicians who treat #eosinophilic #esophagitis was found trial rates to be comparable to DUPIXENT® (dupilumab) HCP, which won FDA approval in the setting in 2022, at a similar point in its launch. More than half of the physicians had prescribed Eohilia and “the breadth of patient initiations” for Takeda’s drug surpassed that of #Dupixent, Spherix said. Projecting out to six months after launch suggests a user base comparable to that of Dupixent. Spherix expects Takeda’s market share to increase by fourfold. The forecasts reflect the potential for Eohilia to fill a gap in the toolkit for treating eosinophilic esophagitis

Government Must Empower NICE - National Institute for Health and Care Excellence to Unlock Access to Life-Saving Medicines for Severe Conditions The NICE - National Institute for Health and Care Excellence has decided to maintain its current valuation methods for medicines, despite concerns that patients with severe conditions are missing out on critical treatments. The Association of the British Pharmaceutical Industry (ABPI), led by Paul Catchpole, urges the government to reform funding constraints imposed by the 2024 Voluntary Scheme for Branded Medicines Pricing and Access, which they argue is restricting access to innovative therapies. While NICE - National Institute for Health and Care Excellence plans to reassess public opinion on medicine valuation, The Association of the British Pharmaceutical Industry (ABPI) is concerned that the two-year timeline will delay necessary reforms, leaving patients without access to potentially life-saving treatments. For more details please click the link! https://lnkd.in/duJjR_Ep #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

CMS PHARMA DRUG PRICE NEGOTIATIONS UPDATE: CMS offers Pharma more time and opportunities to submit counteroffers during price talks that may finalize in 2025. In August, the federal government announced the lower negotiated prices for 10 medications, which include therapies for Type 2 diabetes, blood clots and heart failure. The new prices — which are estimated to reduce healthcare costs by $7.5 billion — will go into effect Jan. 1, 2026. For the next phase, CMS will select up to 15 medications to undergo negotiations for lower list prices to take effect Jan. 1, 2027. Multiple cancer therapies are predicted to be chosen, and CMS will announce the selected drugs by February. In contrast to the first round of negotiations, CMS will hold up to 15 patient-focused roundtables and one town hall that weighs the clinical considerations, according to a 313-page final guidance published Oct. 2nd. #CMS #PHARMA #NEGOTIATIONS #UPDATE #AHCA

News from First Report Managed Care from Asembia AXS24: The specialty pharmacy pipeline was the subject of one of many informative sessions at the annual Asembia Summit this year. Key insights were shared about current drugs in the pipeline according to their drug designations, the phase of each drug’s development, and projected first launch dates after receiving FDA approval. Access the latest insights from Asembia's AXS24 Summit! #FirstReportManagedCare #FRMC #asembia2024 #axs24 #raredrugs #specialtydrugs #pharmaceuticalpipeline