A research team from CHOP and the Perelman School of Medicine at the University of Pennsylvania, supported by the National Institutes of Health, developed a customized gene therapy by utilizing the gene editing platform CRISPR.
Read morectDNA testing and treatment of stage 3 colon cancer
Clinical trial for stage 3 colon cancer shows promise.
Read moreNo Pain, No...Addiction?
On January 30, 2025, the United States FDA approved medication Journavx (suzetrigine), a first-in-class, non-opioid analgesic to treat moderate to severe acute pain in adults.
Read moreGene Therapy Summary 2019-2024 from a Reinsurance/Stop Loss Perspective
Summit Re sees increasing number of gene therapy cases.
Read moreMedicare Drug Price Negotiation
CMS initially selected ten drugs covered under Part D for the first cycle of negotiations with drug companies. These drugs include Januvia, NovoLog, Farigia, Enbrel, Jardiance, Stelara, Xarelto, Eilquis, Entresto, and Imbruvica. The new pricing will go into effect January 1, 2026. It is estimated that had the drug prices been in effect in 2023, it would have saved $6 billion in net covered prescription drug costs, or approximately 22 percent, across the 10 selected drugs. (Ref. Source 1) Click HERE to see the fact sheet.
On January 17, 2025, CMS announced the next 15 drugs for the second cycle of negotiations. These drugs include (1) Ozempic, Rybelsus, Wegovy; (2) Trelegy, Ellipta; (3) Xtandi; (4) Pomalyst; (5) Ibrance; (6) Ofev; (7) Linzess; (8) Calquence; (9) Austedo, Austedo XR; (10) Breo, Ellipta; (11) Tradjenta; (12) Xifaxan; (13) Vraylar; (14) Janumet, Janumet XR; (15) Otezla. (Ref. Source 1) If the selected drug companies agree to participate in the program, the new drug prices will go into effective January 1, 2027.
In addition to the new drug pricing, Medicare Part D beneficiaries will also benefit from the new $2000 out-of-pocket cap which went into effect January 1, 2025. For more information on the $2000 out-of-pocket cap, go to https://aspe.hhs.gov/reports/impact-ira-2000-cap.
References/Additional Information:
(2) https://www.cms.gov/files/document/factsheet-medicare-negotiation-selected-drug-list-ipay-2027.pdf
Brian Fehlhaber Retires from Summit Re
Senior Vice President Brian Fehlhaber has retired from Summit Re, effective January 3, 2025.
As you may know, Brian was one of the original founders of Summit Re in 1999, and he continued to shepherd the company’s reinsurance sales efforts through his last day. His contributions not only have helped Summit Re grow and thrive over the last 25 years, but he has also assisted so many clients and industry colleagues with their own strategic direction, both professionally and personally. Brian’s passion for the industry has been second to none, and his selfless and consultative approach has allowed Summit Re to differentiate itself in the industry. Brian has traveled more miles on Summit Re’s behalf than anyone else—perhaps even collectively—and we are exceedingly grateful for all he has done to promote our company and this industry.
Brian has left Summit with a very strong and capable sales team. Over the past few years, Brian has transitioned his direct responsibility for individual accounts so that he could focus his activities on strategic oversight. To that end, day-to-day client responsibilities are already well looked after. We appreciate the thoughtful care with which Brian has readied this company for his retirement.
We wish Brian the very best in this next phase!
Gene and Cell Therapy Update
November ushered in two new therapies, AUCATZYL® (obecabtagene autoleucel), a CAR-T therapy which was approved on 11/8/2024, and Kebilidi™ (eladocagene exuparvovec-tneq), a gene therapy which was approved on 11/13/2024.
Read moreNew Treatment for Uveal Melanoma: HEPZATO
Uveal melanoma is the most common primary intraocular malignancy, and while several local therapies can be offered for primary disease control such as plaque brachytherapy, proton therapy and enucleation, effective therapies to control distant disease have been limited.
Read morePfizer Voluntarily Withdraws All Lots of Sickle Cell Disease Treatment OXBRYTA® (voxelotor) from Worldwide Markets
Pfizer announced on September 25, 2024, that they are voluntarily withdrawing all lots of OXBRYTA (voxelotor) and discontinuing all active clinical trials and expanded access programs worldwide.
Read moreFDA Approves Tecelra, First T Cell Therapy for Solid Tumors
On August 2, 2024, the FDA granted accelerated approval for Tecelra (afamitresgene autoleucel) a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, 16 -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. Tecelra is contra-indicated in adults who are heterozygous or 52 homozygous for HLA-A*02:05P.[i]
Synovial sarcoma is an uncommon and aggressive cancer that can form in soft tissues such as muscles, fat, joint linings, and ligaments. It is often found in the arm, leg, or foot, and near joints such as the wrist or ankle. It can also form in soft tissues in the lung or abdomen. Although synovial sarcoma can affect people at any age, it is known to occur more commonly in adolescents and adults younger than 30.[ii] Adults with metastatic synovial sarcoma at diagnosis have a 5-year overall survival rate of 10%, versus 76% for those with localized disease at diagnosis.[iii]
Synovial sarcoma (SS) accounts for up to 10% of all soft-tissue sarcomas. In the US, 800-1000 new cases of SS are diagnosed annually. According to an analysis of the Surveillance, Epidemiology, and End Results (SEER) database study, the age-adjusted incidence rate of SS in the US is 0.177 per 100,000 (approximately 580 incident cases) with a prevalence rate of 0.65 per 100,000 (approximately 2129 prevalent cases).[iv]
Tecelra is an autologous T cell immunotherapy composed of a patient’s own T cells. T cells in Tecelra are modified to express a TCR that targets MAGE-A4 expressed by cancer cells in synovial sarcoma. After the patient undergoes leukapheresis, cells are sent for manufacturing. It takes about six weeks for the Tecelra to be returned to the provider, though that time may vary.
The patient is admitted to the hospital and receives a lymphodepleting chemotherapy regimen of fludarabine 30 mg/m2/day intravenously for four days starting on the seventh day before Tecelra infusion (Day-7 to Day -4), and cyclophosphamide 600 mg/m2/day intravenously for 3 days starting the seventh day before Tecelra infusion (Day -7 to Day -5). Tecelra is administered over an hour as a single intravenous infusion on Day 1. The patient will remain hospitalized for at least seven days after the infusion. The patient should plan to stay close to a healthcare facility for at least four weeks.[v]
The safety and effectiveness of Tecelra were evaluated in a multicenter, open-label clinical trial. Effectiveness was evaluated based on overall response rate and the duration of response to treatment with Tecelra. Among the 44 patients in the trial who received Tecelra, the overall response rate was 43.2% and the median duration of response was six months. Tecelra was approved under an accelerated approval pathway and a confirmatory trial is ongoing to verify Tecelra’s clinical benefit.[vi]
A Black Box Warning has been issued because patients may experience cytokine release syndrome. Patients may also exhibit Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS).
The current list price for Tecelra is $727,000. This does not include the pre-treatment or hospitalization costs associated with the administration of the therapy.
Article by Kathy Clark, RN, BSN, CMCN, Vice President, Director of Managed Care. For more information about how this may affect your plan, please contact your Summit ReSources care specialist. The following sources were used as reference material for this article:
[i] FDA Package Insert-Tecelra. https://www.fda.gov/media/180565/download?attachment. Accessed 8/12/2024.
[ii] National Cancer Institute. Synovial Sarcoma. https://www.cancer.gov/pediatric-adult-rare-tumor/rare-tumors/rare-soft-tissue-tumors/synovial-sarcoma#:~:text=Synovial%20sarcoma%20is%20a%20cancer,also%20be%20called%20malignant%20synovioma. Accessed 8/12/2024.
[iii]Blay JY, von Mehren M, Jones RL, Martin-Broto J, Stacchiotti S, Bauer S, Gelderblom H, Orbach D, Hindi N, Dei Tos A, Nathenson M. Synovial sarcoma: characteristics, challenges, and evolving therapeutic strategies. ESMO Open. 2023 Oct;8(5):101618. doi: 10.1016/j.esmoop.2023.101618. Epub 2023 Aug 23. PMID: 37625194; PMCID: PMC10470271. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10470271/ Accessed 8/12/2024.
[iv] Mangla A, Gasalberti DP. Synovial Cell Sarcoma. [Updated 2023 May 6]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. https://www.ncbi.nlm.nih.gov/books/NBK587366/. Accessed 8/12/2024.
[v] FDA Package Insert-Tecelra. https://www.fda.gov/media/180565/download?attachment. Accessed 8/12/2024.
[vi] FDA. FDA Approves First Gene Therapy to Treat Adults with Metastatic Synovial Sarcoma. https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-treat-adults-metastatic-synovial-sarcoma. Accessed 8/12/2024.