Last year, Oncology Insights brought you the most talked about topics in 2024. As we enter this new year, let us review these impactful and potentially practicing changing subjects that are likely to drive changes soon.  

Cancer treatments are making their way home 
For over 20 years, health care systems have safely transitioned cancer therapy from the hospital into the patient’s home. Cost is one of the biggest drivers for this site of care change. Between 2009 and 2012, Medicare beneficiaries paid an extra $4.05 million more in out-of-pocket cost for chemotherapy services provided in a hospital setting than they would have paid if the same care were provided in a community setting. Unfortunately, the higher cost does not translate into improved quality of care or outcomes. 

In May 2023, the US Food and Drug Administration (FDA) released a draft guidance created to increase clinical trial accrual and ease the movement of some or all clinical trial components to alternate locations including participant’s home. 

It is essential to meet the patient where they are most able to receive care while decreasing health care cost and maintaining quality of care. 

Cancer treatment is personal 
Precision medicine, or personalized medicine, has significantly affected oncology and grew out of a need to improve and individualize patient treatments. The FDA granted expanded indications to three targeted drugs directed towards a patient’s unique cancer characteristic. These targeted drugs include ciltacabtagene autoleucel, cilta-cel (Carvykti), idecabtagene vicleucel, ida-cel (Abecma), and fam-trastuzumab deruxtecan, T-Dxd (Enhertu). 

On Feb. 16, 2024, FDA granted accelerated approval to lifileucel (Amtagvi), the first cellular therapy to receive FDA approval for a solid tumor cancer. Lifileucel is a T cell immunotherapy composed of a patient’s own T cells, a type of cell that helps the immune system fight cancer. 

Personalized medicine is driving the present and future of cancer therapy pipeline, cost, and outcomes.

First in class bladder cancer therapy and BCG shortage 
On April 22, 2024, a new treatment for bladder cancer appeared when the FDA approved nogapendekin alfa inbakicept-pmln (NAI) (Anktiva). This novel agent is a first-in-class drug. The combined intravesical administration with Bacillus Calmette–Guerin (BCG) produces a synergistic effect that leads to greater bladder cancer cell death and a durable complete response.  

However, the global BCG shortage will limit uptake. In some cases, the length of therapy and cost for this first in class drug may far exceed that of the previously FDA approved and NCCN recommended therapies.  

As use of this novel agent is evaluated, consideration for administration in combination with BCG and in patients identified as most likely to benefit should be considered. 

Transformative treatment for small cell lung cancer 
On May 16, 2024 the FDA granted accelerated approval to intravenous tarlatamab (Imdelltra) for the treatment of adults with extensive stage small cell lung cancer (ES-SCLC).  

The wholesale acquisition cost (WAC) of tarlatamab is $31,500 for the first cycle and $30,000 for subsequent cycles for a total annual WAC of $391,500.5 In the DeLLphi-301 trial the median therapy duration was 5.5 months, which would equate to a WAC of about $179,000.  

Treatment options for SCLC are limited, so continued advancements are needed. However, tarlatamab follows the current high-cost trend seen with new to market agents. As more drugs with improved outcomes are approved, this moves us closer to the possibility of extended disease control and improved outcomes for this aggressive cancer. 

Cancer drugs top global drug sales 
Pembrolizumab (Keytruda), is a checkpoint inhibitor that binds PD1 receptor. This action blocks the ability of cancer cells to turn off immune system cells and avoid elimination. Pembrolizumab is projected to be the number one selling drug worldwide with sales of about $30 Billion in 2024. The annual wholesale acquisition cost (WAC) for the three cancer drugs in the top 10 best-selling drug list are $192,735 pembrolizumab, $198,500 nivolumab (Opdivo), and $222,941 daratumumab and hyaluronidase-fihj (Darzalex Faspro). 

Another event that will likely maintain the demand for two of the top sellers is reformulation from intravenous to subcutaneous preparations. 

Opportunities to manage high-cost cancer drugs may include dosing strategies, evaluation of evidence set up in published literature, and transition to lower cost administration sites.  

As drug prices continue to rise, an assessment of value and identification of methods to improve treatment benefit is vital to ensure resources are available to provide quality care.  

Oncology case management and navigation: How do they differ? 
Over the years, the Centers for Medicare and Medicaid (CMS), practices, and payers have incorporated case management and navigation services as part of the patient care plan. However, the distinction between case management and navigation services may be unclear. Case management is implemented by a health care professional, typically a nurse.  

The American Cancer Society defines patient navigators as those who help patients, families, and caregivers decrease barriers to accessing quality health care including financial and psychosocial resources. In general, a navigation team consists of clinical and non-clinical members and are typically employed by a health care, advocacy, and/or community-based organization. 

Case management and navigation have proven benefits in cancer care. However, studies using validated tools are needed to better quantify these contributions.  

Decoding cancer: How genetic and genomic testing advance treatment 
Genetic and genomic testing are used to find patient-specific characteristics that allow for customized care and personalized treatments.  

Genetics focuses on the study of genes inherited from family members across generations. Although a genetic test may find a mutation that significantly increases cancer risk, it does not guarantee that an individual will develop cancer. Genomic testing, also referred to as molecular or biomarker testing, focuses on genetic changes specifically within the cancer cell deoxyribonucleic acid (DNA). This approach is central to precision medicine, which tailors’ treatments to the individual characteristics of each patient’s disease.  

A recent study highlights the financial impact of selecting non-targeted therapies due to undetected mutations. Investigators found that the per patient costs associated with inadequate therapies were $6,455 $6,566 and $6,569 over the first 1 2 and 3 years of treatment, respectively. 

Genetic and genomic testing each play a crucial role in matching patients with treatments most likely to yield the best clinical outcomes. By embracing these advancements, payers, providers, and health care teams are better equipped to provide valuable and effective care for patients. 

As cancer care transforms, new knowledge applied, and approvals of novel therapies continue, we look forward to bringing these hot topics to you. 

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