The Insurance Approval Process for Proton Radiation Therapy: A Significant Barrier to Patient Care

Ning, Matthew S.; Gomez, Daniel R.; Shah, Amit Kumar; Kim, Charissa; Palmer, Matthew; Thaker, Nikhil G.; Grosshans, David R.; Liao, Zhongxing; Chapman, Bhavana V.; Brooks, Eric D.; Tang, Chad; Rosenthal, D.I.; Garden, Adam S.; Frank, Steven J.; Gunn, G. Brandon

doi:10.1016/j.ijrobp.2018.12.019

Cited by 51 publications

(58 citation statements)

References 33 publications

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“…Our results are in line with recently published experiences from MD Anderson where a significant number of patients were denied PBT coverage by private insurance with a subsequent approval process that required a similar significant time and resource investment from the radiation department (42). The appeal process, as demonstrated by other institutions, also leads to significant delays to the start of proton treatment, with adult patients waiting an average of one month (42,43). Treatment delays have been previously demonstrated across various subsites to be detrimental to patient outcomes, including for gynecologic cancers and tumors of the head and neck (44)(45)(46).…”

Section: Discussionsupporting

confidence: 90%

“…More importantly, the insurance denials resulted in significant delays in patient care with most patients delayed by at least one month prior to their first treatment. Our results are in line with recently published experiences from MD Anderson where a significant number of patients were denied PBT coverage by private insurance with a subsequent approval process that required a similar significant time and resource investment from the radiation department (42). The appeal process, as demonstrated by other institutions, also leads to significant delays to the start of proton treatment, with adult patients waiting an average of one month (42,43).…”

Section: Discussionsupporting

confidence: 88%

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Early Experience of the World’s First Single-Room Gantry Mounted Active Scanning Proton Therapy System at an Integrated Cancer Center

Forsthoefel

Ballew

Unger

et al. 2020

Preprint

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Introduction Review the early experience with a single-room gantry mounted active scanning proton therapy system implemented in the modern era. Materials and Methods All patients treated with proton beam radiotherapy (PBT) were enrolled in an institutional review board-approved patient registry. Proton beam radiotherapy was delivered with a 250 MeV gantry mounted synchrocyclotron in a single-room integrated facility within the pre-existing cancer center. Demographic data, cancer diagnoses, treatment technique, and geographic patterns were obtained for all patients. Treatment plans were evaluated for mixed modality therapy. Insurance approval data was collected for all patients treated with PBT. Results A total of 132 patients were treated with PBT between March 2018 and June 2019. The most common oncologic subsites treated included the central nervous system (22%), gastrointestinal tract (20%), and genitourinary tract (20%). The most common histologies treated included prostate adenocarcinoma (19%), non-small cell lung cancer (10%), primary CNS gliomas (8%), and esophageal cancer (8%). Rationale for PBT treatment included limitation of dose to adjacent critical organs at risk (67%), reirradiation (19%), and patient comorbidities (11%). Patients received at least one x-ray fraction delivered as prescribed (36%) or less commonly due to unplanned machine downtime (34%). Concurrent systemic therapy was administered to 57 patients (43%). Twenty-six patients (20%) were initially denied insurance coverage and required peer-to-peers (65%), written appeals (12%), secondary insurance approval (12%), and comparison x-ray to proton plans (8%) for subsequent approval. Proton beam radiotherapy approval required a median of 17 days from insurance submission. Conclusion Incorporation of PBT into our existing cancer center allowed for multidisciplinary oncologic treatment of a diverse population of patients. Insurance coverage for PBT presents as a significant hurdle and improvements are needed to provide more timely access to necessary oncologic care.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionsupporting

confidence: 88%

Early Experience of the World’s First Single-Room Gantry Mounted Active Scanning Proton Therapy System at an Integrated Cancer Center

Forsthoefel

Ballew

Unger

et al. 2020

Preprint

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“…Among 903 patients with thoracic or head and neck cancer considered for PBT between 2013 and 2016 at the MD Anderson Proton Therapy Center in Houston, Texas, significant disparity between Medicare and private insurance coverage at initial request (91% vs 30%) was noted. 4 With 66% of patients approved at initial review, a final 87% approval rate was achieved, with 68% receiving approval after initial denial with a median time to approval of 21 days (interquartile range, 22 days). Contrary to what are often regarded as strong justifications for PBT, a prescribed dose 66 Gy and generation of a comparative intensity modulated radiation therapy (IMRT) plan demonstrating dosimetric benefits were associated with decreased likelihood of approvals during the appeals process, which is paradoxical and counterintuitive to principles of good radiation oncology practice.…”

Section: A Significant Barrier To Patient Carementioning

confidence: 99%

“…8 However, the 2 referenced studies demonstrate a clear unwillingness on the commercial payers' part to support fair evaluation of the relative merits of PBT through patient enrollment on phase 3 trials. 4,5 Others have developed pragmatic models to objectify the benefit of PBT in terms of toxicity profile at the individual patient level. 9 This single-index measurement for demonstrating the potential amount of toxicity reduction using PBT when compared with conventional photon-based RT has been recognized by the Health Insurance Board in the Netherlands to determine patient selection and reimbursement for PBT.…”

Section: Proton Beam Therapy At the Mayo Clinic And The University Ofmentioning

confidence: 99%

The Insurance Approval Process for Proton Beam Therapy Must Change: Prior Authorization Is Crippling Access to Appropriate Health Care

Sio

Mohindra

Regine

et al. 2019

International Journal of Radiation Oncology*Biology*Physics

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With almost 70 proton beam therapy (PBT) centers worldwide, of which 29 are operating in the US, and multiple centers under construction, 1 it is increasingly important that the insurance coverage process for PBT is standardized to allow seamless approval, minimizing delays and the burden on patients and providers. With over 30 years of the US Food and Drug Administrationeapproved practice and research, 2 PBT is not "experimental" or "investigational"; however, these terms are still commonly used in denial letters that are written by private insurance payers and thirdparty organizations that claim to provide medical benefit "management and solutions." The basis for their coverage and the evidence cited in their policies are often out of date and not peer reviewed by clinical experts in the field.

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“…However, insurance approval for proton radiotherapy remains challenging and could pose significant hurdles to the timely delivery of this treatment. 48 Other logistical hurdles to particle radiotherapy, such as upfront treatment cost, could also pose formidable barriers. Statistical modeling of the expected lifetime costs associated with proton therapy for pediatric medulloblastoma offers optimism, with some studies suggesting an eightfold reduction in costs given the reduced incidence of treatment-related adverse events.…”

Section: Considering the Cost-effectiveness Of Particle Therapymentioning

confidence: 99%

Efficacy and toxicity of particle radiotherapy in WHO grade II and grade III meningiomas: a systematic review

Jin

Meola

et al. 2019

Neurosurgical Focus

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OBJECTIVEAdjuvant radiotherapy has become a common addition to the management of high-grade meningiomas, as immediate treatment with radiation following resection has been associated with significantly improved outcomes. Recent investigations into particle therapy have expanded into the management of high-risk meningiomas. Here, the authors systematically review studies on the efficacy and utility of particle-based radiotherapy in the management of high-grade meningioma.METHODSA literature search was developed by first defining the population, intervention, comparison, outcomes, and study design (PICOS). A search strategy was designed for each of three electronic databases: PubMed, Embase, and Scopus. Data extraction was conducted in accordance with the PRISMA guidelines. Outcomes of interest included local disease control, overall survival, and toxicity, which were compared with historical data on photon-based therapies.RESULTSEleven retrospective studies including 240 patients with atypical (WHO grade II) and anaplastic (WHO grade III) meningioma undergoing particle radiation therapy were identified. Five of the 11 studies included in this systematic review focused specifically on WHO grade II and III meningiomas; the others also included WHO grade I meningioma. Across all of the studies, the median follow-up ranged from 6 to 145 months. Local control rates for high-grade meningiomas ranged from 46.7% to 86% by the last follow-up or at 5 years. Overall survival rates ranged from 0% to 100% with better prognoses for atypical than for malignant meningiomas. Radiation necrosis was the most common adverse effect of treatment, occurring in 3.9% of specified cases.CONCLUSIONSDespite the lack of randomized prospective trials, this review of existing retrospective studies suggests that particle therapy, whether an adjuvant or a stand-alone treatment, confers survival benefit with a relatively low risk for severe treatment-derived toxicity compared to standard photon-based therapy. However, additional controlled studies are needed.

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The Insurance Approval Process for Proton Radiation Therapy: A Significant Barrier to Patient Care

Cited by 51 publications

References 33 publications

Early Experience of the World’s First Single-Room Gantry Mounted Active Scanning Proton Therapy System at an Integrated Cancer Center

Early Experience of the World’s First Single-Room Gantry Mounted Active Scanning Proton Therapy System at an Integrated Cancer Center

The Insurance Approval Process for Proton Beam Therapy Must Change: Prior Authorization Is Crippling Access to Appropriate Health Care

Efficacy and toxicity of particle radiotherapy in WHO grade II and grade III meningiomas: a systematic review

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