Incorporating Value-Based Care Into Oncology

Seymour, Erlene; Souza, Jonas A. de; Fendrick, A. Mark

doi:10.1097/ppo.0000000000000459

Cited by 10 publications

(7 citation statements)

References 70 publications

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“…Furthermore, high-quality real-world evidence (RWE) could be leveraged to enable drug approvals in oncology (34,35), linking it to the value proposition of drugs (36)(37)(38). Regulatory bodies, such as the US Food and Drug Administration, have recently shown a willingness to expedite access to new cancer medicines by using RWE (39).…”

Section: Discussionmentioning

confidence: 99%

Correlation Between Early Endpoints and Overall Survival in Non-Small-Cell Lung Cancer: A Trial-Level Meta-Analysis

et al. 2021

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Early endpoints, such as progression-free survival (PFS), are increasingly used as surrogates for overall survival (OS) to accelerate approval of novel oncology agents. Compiling trial-level data from randomized controlled trials (RCTs) could help to develop a predictive framework to ascertain correlation trends between treatment effects for early and late endpoints. Through trial-level correlation and random-effects meta-regression analysis, we assessed the relationship between hazard ratio (HR) OS and (1) HR PFS and (2) odds ratio (OR) PFS at 4 and 6 months, stratified according to the mechanism of action of the investigational product. Using multiple source databases, we compiled a data set including 81 phase II–IV RCTs (35 drugs and 156 observations) of patients with non-small-cell lung cancer. Low-to-moderate correlations were generally observed between treatment effects for early endpoints (based on PFS) and HR OS across trials of agents with different mechanisms of action. Moderate correlations were seen between treatment effects for HR PFS and HR OS across all trials, and in the programmed cell death-1/programmed cell death ligand-1 and epidermal growth factor receptor trial subsets. Although these results constitute an important step, caution is advised, as there are some limitations to our evaluation, and an additional patient-level analysis would be needed to establish true surrogacy.

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Section: Discussionmentioning

confidence: 99%

Correlation Between Early Endpoints and Overall Survival in Non-Small-Cell Lung Cancer: A Trial-Level Meta-Analysis

et al. 2021

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“…Given that very short survival often is synonymous to active treatment in the last 30 days of life, oncologists can opt for palliative and supportive care rather than brain-directed therapy [ 6 ]. Supposing they choose brain-directed therapy, the challenge is to navigate a complex scenario of low-value care, potential overtreatment and futile, but costly procedures [ 7 , 8 ].…”

Section: Introductionmentioning

confidence: 99%

30-day mortality in patients treated for brain metastases: extracranial causes dominate

et al. 2022

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Background Established prognostic models, such as the diagnosis-specific graded prognostic assessment, were not designed to specifically address very short survival. Therefore, a brain metastases-specific 30-day mortality model may be relevant. We hypothesized that in-depth evaluation of a carefully defined cohort with short survival, arbitrarily defined as a maximum of 3 months, may provide signals and insights, which facilitate the development of a 30-day mortality model. Methods Retrospective analysis (2011–2021) of patients treated for brain metastases with different approaches. Risk factors for 30-day mortality from radiosurgery or other primary treatment were evaluated. Results The cause of death was unrelated to brain metastases in 61%. Treatment-related death (grade 5 toxicity) did not occur. Completely unexpected death was not observed, e.g. accident, suicide or sudden cardiac death. Logistic regression analysis showed 9 factors associated with 30-day mortality (each assigned 3–6 points) and a point sum was calculated for each patient. The point sum ranged from 0 (no risk factors for death within 30 days present) to 30. The results can be grouped into 3 or 4 risk categories. Eighty-three percent of patients in the highest risk group (> 16 points) died within 30 days, and none survived for more than 2 months. However, many cases of 30-day mortality (more than half) occurred in intermediate risk categories. Conclusion Extracranial tumor progression was the prevailing cause of 30-day mortality and few, if any deaths could be considered relatively unexpected when looking at the complete oncological picture. We were able to develop a multifactorial prediction model. However, the model’s performance was not fully satisfactory and it is not routinely applicable at this point in time, because external validation is needed to confirm our hypothesis-generating findings.

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“…Despite FA, many patients are not eligible for these grants (because of household size, income thresholds, or other factors) and incur high co-payments. Ultimately, caps on OOP cost, value-based insurance design, 21 and decreasing drug prices could help ease the overall burden on our patients and health care system. Drug cost distribution and the sources of FA are complicated.…”

Section: Jco Oncology Practice E143mentioning

confidence: 99%

How to Effectively Decrease Patient Co-Payments of High-Cost Drugs Through Innovation: Lessons From the Karmanos Specialty Pharmacy

Seymour

Daniel

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et al. 2022

JCO Oncology Practice

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PURPOSE: High-cost drugs impose a financial burden on patients with cancer. Karmanos Specialty Pharmacy (KSP) developed a process to automate financial assistance (FA) applications to decrease patient drug cost. We evaluate the outcomes of this program on cost to patients and payers. METHODS: This is an observational, retrospective study of the KSP claims data set from January to December 2019, accessed by 13 statewide cancer centers within Michigan. Drug cost of patients, payers, FA (funds to lower patient drug cost), and types of FA were obtained. A subset analysis was performed to determine drug delivery times. RESULTS: In 2019, 869 prescriptions and 1,722 prescription fills were provided to 463 patients through KSP. The total cost of drug claims was approximately $10 million US dollars (USD) among Medicare patients (58%), approximately $3.4 million USD for privately insured patients (20%), and approximately $3.7 million USD for Medicaid patients (22%). Twenty-seven percent of patients (22% of all prescription fills) required additional FA with initial total co-payment claims of $335,216 USD. $280,988 USD of FA was obtained, which substantially lowered total patient costs by 81%. $250,818 USD of FA obtained was from foundation grants (327 fills), and $21,441 USD from manufacturer co-pay cards (47 fills). An additional $12,260 USD (12 fills) from a Karmanos Patient Assistance Fund was used. There was high dependence on foundation grant assistance among Medicare patients (33% of claims). In a subset analysis, the median time from prescription written to delivery to the patient was < 7 days (0-56 days). CONCLUSION: Twenty-seven percent of patients (22% of prescriptions fills) in 2019 required additional FA for high-cost drugs. KSP substantially reduced patient cost by implementing an efficient process using additional pharmacy assistants to obtain FA.

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Incorporating Value-Based Care Into Oncology

Cited by 10 publications

References 70 publications

Correlation Between Early Endpoints and Overall Survival in Non-Small-Cell Lung Cancer: A Trial-Level Meta-Analysis

Correlation Between Early Endpoints and Overall Survival in Non-Small-Cell Lung Cancer: A Trial-Level Meta-Analysis

30-day mortality in patients treated for brain metastases: extracranial causes dominate

How to Effectively Decrease Patient Co-Payments of High-Cost Drugs Through Innovation: Lessons From the Karmanos Specialty Pharmacy

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