Cost-Effectiveness Models of Proton Therapy for Head and Neck: Evaluating Quality and Methods to Date.

PURPOSE: Proton beam therapy (PBT) is associated with less toxicity relative to conventional photon radiotherapy for head-and-neck cancer (HNC). Upfront delivery costs are greater, but PBT can provide superior long-term value by minimizing treatment-related complications. Cost-effectiveness models (CEMs) estimate the relative value of novel technologies (such as PBT) as compared with the established standard of care. However, the uncertainties of CEMs can limit interpretation and applicability. This review serves to (1) assess the methodology and quality of pertinent CEMs in the existing literature, (2) evaluate their suitability for guiding clinical and economic strategies, and (3) discuss areas for improvement among future analyses. MATERIALS AND METHODS: PubMed was queried for CEMs specific to PBT for HNC. General characteristics, modeling information, and methodological approaches were extracted for each identified study. Reporting quality was assessed via the Consolidated Health Economic Evaluation Reporting Standards 24-item checklist, whereas methodologic quality was evaluated via the Philips checklist. The Cooper evidence hierarchy scale was employed to analyze parameter inputs referenced within each model. RESULTS: At the time of study, only 4 formal CEMs specific to PBT for HNC had been published (2005, 2013, 2018, 2020). The parameter inputs among these various Markov cohort models generally referenced older literature, excluding many clinically relevant complications and applying numerous hypothetical assumptions for toxicity states, incorporating inputs from theoretical complication-probability models because of limited availability of direct clinical evidence. Case numbers among study cohorts were low, and the structural design of some models inadequately reflected the natural history of HNC. Furthermore, cost inputs were incomplete and referenced historic figures. CONCLUSION: Contemporary CEMs are needed to incorporate modern estimates for toxicity risks and costs associated with PBT delivery, to provide a more accurate estimate of value, and to improve their clinical applicability with respect to PBT for HNC.

Strategic Operational Redesign for Successfully Navigating Prior Authorization Barriers at a Large-Volume Proton Therapy Center.

PURPOSE: Prior authorization (PA) can be a resource-intensive barrier to oncologic care. To improve patient access and reduce delays at our large, academic proton therapy center, we implemented a novel payor-focused strategy to efficiently navigate the PA process while eliminating physician burden and reducing inappropriate denials. METHODS: In 2017, business operations were redesigned to better reflect the insurance process: (1) certified medical dosimetrists (CMDs), with their unique treatment expertise, replaced our historical PA team to function as an effective interface among physicians, patients, and payors; (2) a structured, tiered timeline was implemented to hold payors accountable to PA deadlines; and (3) our PA team provided administrative leadership with requisite insurance knowledge. PA outcomes were compared 6 months before and after the intervention. RESULTS: After implementation of this multifaceted strategy, the median time to successful appeal (after initial denial of coverage) decreased from 30 to 18 days (P < .001), and the total number of overturned denials increased by 56%. Because of the efficiency of the CMDs, full-time equivalents on the PA team actually decreased by 44%, translating to a 34% reduction in team personnel expenses. Internal referrals increased by 29%, attributable to optimized communication and diminished administrative burden for providers. New treatment starts also increased, resulting in a 37% larger patient census on treatment. CONCLUSION: Incorporating payor-focused strategies can improve patient access in a cost-effective manner while decreasing time and administrative burden associated with the PA process. These operational concepts can be adapted for other oncologic practice settings facing analogous PA-related obstacles.

Commercial Insurance Coverage of Advanced Radiation Therapy Techniques Compared With American Society for Radiation Oncology Model Policies.

PURPOSE: This study aimed to compare and contrast the American Society for Radiation Oncology (ASTRO) model policies (MPs) for intensity modulated radiation therapy (IMRT), stereotactic radiosurgery (SRS), stereotactic ablative radiation therapy (SABR), and proton beam therapy (PBT) with the coverage policies constructed by 5 of the largest publicly available commercial insurers throughout the United States (ie, Aetna, Anthem, Cigna, Humana, and United Healthcare). METHODS AND MATERIALS: Appropriate indications for IMRT, SRS, SABR, and PBT by disease site (and particular clinical setting thereof) were extracted from the most recently published ASTRO MPs and published coverage policies (2019 editions) of the 5 carriers. After tabulation, concordance between ASTRO MPs and insurance policies were calculated for each modality. RESULTS: All 5 insurer policies supported IMRT for neoplasms of the central nervous system, head/neck, hepatopancreaticobiliary, anal, and prostate cancers. The least covered diseases were retroperitoneal tumors (n = 0 carriers) and bladder cancer (n = 1). For SRS, all carriers covered benign brain tumors, brain metastases, arteriovenous malformations, and trigeminal neuralgia. None of the insurance carriers covered SRS for medically refractory epilepsy. For SABR, primary liver, lung, and low- or intermediate-risk prostate cancer were covered by all insurers, and none allowed SABR for primary biliary neoplasms. Only one insurance carrier each covered SABR for primary/metastatic adrenal disease and primary renal cancer. All carriers approved PBT for ocular melanoma, skull base tumors, and pediatric malignancies. The ASTRO MPs listed 4 PBT scenarios (ie, spinal disease, retroperitoneal sarcoma, head/neck neoplasms, and patients with genetic radiosensitivity syndromes) not covered by any insurer. Concordance between insurance carriers and ASTRO MPs was 67.8% for IMRT, 72.0% for SRS, 58.4% for SABR, and 41.8% for PBT (P = .005). CONCLUSIONS: Coverage guidelines for IMRT, SRS, SABR, and PBT vary across 5 major insurance providers and may be substantially discordant compared with ASTRO coverage guidelines. There remain several specific areas where ongoing and future dialogues between ASTRO members, payers, and policymakers remain essential.

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

PURPOSE: Proton therapy is increasingly prescribed for cancer treatment, given its potential for improvements in clinical outcomes and toxicity reduction; however, insurance coverage continues to be a barrier to patient access. This study examined insurance approval and appeal outcomes at a large-volume proton therapy center to clarify the process and identify areas for improvement. METHODS AND MATERIALS: In 2013 to 2016, 1753 patients with thoracic or head and neck cancer were considered for proton therapy; 903 (553 thoracic, 350 head and neck) entered the insurance process. Rates of and times to approval and successful appeal after initial denial were calculated. Clinical factors were evaluated for association with insurance outcomes via logistic regression. RESULTS: Approval rates by Medicare (n = 538) and private insurance (n = 365) were 91% and 30% on initial request, at a median 3 days and 14 days from inquiry to determination. Of the 306 patients initially denied coverage, 276 appealed the decision, and denial was overturned for 189 patients (68%; median time, 21 days from initial inquiry). On multivariable analysis, Medicare (odds ratio [OR], 14.20; P < .001) was the strongest predictor of initial approval. Approval rates decreased from 2013 to 2014 versus 2015 to 2016 (OR 0.54; P = .001). For patients who appealed denial, multivariable analysis found no associations between approval and trial enrollment or tumor type. Submission of a comparison treatment plan (proton vs photon) indicating dosimetric advantage to normal tissues was associated with decreased likelihood of approval (OR 0.43; P = .006), as was a prescribed dose of ≥66 Gy (OR 0.48; P = .019). CONCLUSIONS: Despite an 87% ultimate approval rate for proton therapy, the insurance process is a resource-intensive barrier to patient access associated with significant time delays to cancer treatment. These findings, plus the lack of clinical correlates with insurance outcomes, highlight a need for increased efficiency, transparency, and collaboration among stakeholders to promote timely patient care and research.

Prevalence of Polycystic Ovary Syndrome Phenotypes Using Updated Criteria for Polycystic Ovarian Morphology: An Assessment of Over 100 Consecutive Women Self-reporting Features of Polycystic Ovary Syndrome.

The prevalence of polycystic ovary syndrome (PCOS) and its distinct clinical phenotypes were assessed using 3 sets of international diagnostic criteria in women self-reporting concerns over outward features of PCOS. Revised ultrasonographic criteria for polycystic ovaries (PCO) based on modern ultrasound technology were used. Of the participants, 53%, 62%, and 70% were diagnosed with PCOS using National Institutes of Health, Androgen Excess and PCOS Society, and Rotterdam criteria, respectively. Prevalence of Frank, Ovulatory, Normoandrogenic, and Non-PCO PCOS were 66%, 13%, 11%, and 9%, respectively. Frank PCOS was associated with the severest metabolic disturbances whereas metabolic profiles in Normoandrogenic PCOS did not differ from controls, supporting reduced health risks in women without androgen excess. Metabolic disturbances and hyperandrogenism were linked to excess adiposity across all the groups. Using updated criteria for PCO, the prevalence of Non-PCO PCOS and PCO alone in healthy women recruited from the general population was reduced compared to the previous reports.