Abstract
Introduction: Expert guidelines recommend investigational therapy as first-line treatment for many patients with acute myeloid leukemia (AML) given poor long-term outcomes with standard therapies. Delays in authorization for clinical trial participation—as required in some states such as ours—may lead to psychological stress, worsening of clinical status, increased healthcare resource utilization, and prolonged hospital length of stay. Moreover, this requirement may be a critical barrier to trial enrollment. To analyze the impact of the requirement for insurance authorization prior to treatment as part of a clinical trial, we completed a retrospective chart review evaluating the rate and time to insurance authorization for clinical trials for patients with newly diagnosed AML.
Methods: Via clinical trial authorization request records, we identified patients with high grade myeloid neoplasm (>10% blasts in the blood/marrow) or AML. We included newly diagnosed patients for whom a clinical trial request was made for treatment with intensive chemotherapy (e.g., a regimen with “7+3” or high-dose cytarabine backbone). Requests for lower intensity therapies or a hematopoietic cell transplant trials were excluded. We then recorded demographic features, insurance authorization status, payor type initial date of claim submission and date of authorization or denial. Separately, we identified the treatment regimen (“on trial”/investigational trial or “off trial”/standard of care), and treatment start date. Finally, we calculated Areas Deprivation Index (ADI) values as a marker of socioeconomic status (SES) corresponding to local addresses using local U.S. Census Data per the Neighborhood Atlas.
Results: We identified 325 insurance claims submitted for 314 unique patients (11 patients had claims submitted for 2 trials). Of these claims, 92% (298/325) were authorized with a median of 1 (range 0-35) calendar days and a median of 2 (range 1-26) business days. Eight percent (26/325) were closed prior to authorization or denial decision, and one (<1%) was ultimately denied. Three-quarters of authorized patients (229/298) were treated with the investigational therapy requested. However, 25% of authorized patients (77/298) were treated “off trial” with intensive chemotherapy and 2% (6/314) did not receive any intensive chemotherapy. Among the 26 patients with insurance authorization requests withdrawn prior to claim decision (reason for withdrawal was not recorded), 65% (17/26) received intensive chemotherapy treatment “off trial,” 31% (8/26) were approved via a different claim and treated on another intensive chemotherapy treatment trial, and one (4%) declined treatment. Patients with Medicare had a mean time to authorization of 2.09 business days versus Medicaid 3.1 business days versus private insurance 3.95 business days (p<0.01). Most patients were from higher area-level SES by ADI with 39% (121/314) from the highest and 29% (91/314) from the second highest quartile, while 14% (45/314) and 18% (57/314) were from the lowest two quartiles, respectively. Patients from the lowest ADI quartile versus highest ADI quartile had a non-statistically significant longer mean time to insurance authorization in both calendar days (3.5 calendar days vs. 2.9 calendar days; p=0.44) and business days (3.4 versus 3.1 business days; p=0.52). Patients who ultimately received insurance approval but were treated “off trial” had a non-statistically significant longer mean time to insurance approval compared to patients with insurance approval who were treated “on trial” in terms of calendar days (4.4 calendar days vs. 3.1 calendar days; p=0.33) and business days (4.0 business days vs. 3.2 business days; p=0.37).
Conclusion: Nearly all clinical trial insurance claims for newly diagnosed AML that were not withdrawn were authorized (99%), however only 75% of patients thought to benefit from trial participation actually received investigational therapy. This finding suggests that state-mandated requirements for insurance authorization prior to trial enrollment may prevent patients from accessing potentially life-saving therapies. Given that 99% of patients with newly diagnosed AML for whom trial approval was requested were approved for a treatment trial, and that even only a few days of delay in authorization of may decrease the overall likelihood of trial enrollment, the requirement for insurance approval for clinical trial represents should be reexamined.
