Search Results

Background: eviCore healthcare uses the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) to support its proprietary program for medical oncology drug management. All treatment regimens assigned NCCN Category of Evidence 1, 2A, or 2B are considered NCCN-adherent treatment selections in the eviCore program. The purpose of this study was to evaluate the pattern of NCCN adherence during the first year following program launch in regional payer markets. Methods: All cancer drug treatment authorization requests submitted in month 1 and month 12 following program launch for 4 regional third-party payers representing 13 different states were included, each of whom had management of high cost oncology drugs in place prior to eviCore program launch. Month 1 data were used as a surrogate for pre-program NCCN adherence, which is an overestimate as there is significant eviCore program impact on patients initiating therapy during that time. Requests with incomplete clinical data were excluded from analysis. Included requests were stratified by month 1 or month 12 from initial program launch date for each health plan. NCCN adherence was assigned based on the results of the clinical decision support and peer consultation processes utilized by eviCore to adjudicate the treatment request. NCCN adherence rate was calculated for each subgroup and a cumulative NCCN adherence rate for all included cases was calculated using weighted average accounting for volume differences by market. Results: There were 2,028 treatment regimen requests that were fully evaluable, with 1,285 occurring in month 1 and 743 occurring in month 12 following program launch. The rate of NCCN adherence increased for each health plan during the first program year, ranging from 69%–84% in month 1 and rising to 79%–91% in month 12. The weighted cumulative NCCN adherence during month 1 for all included plans was 75% and rose to 88% at month 12 following program launch. Conclusions: Use of clinical decision support supplemented by peer consultation is an effective means of increasing oncologists’ adherence to NCCN-recommended therapies across a broad range of regional provider markets. Additional study is warranted to determine whether this methodology can be applied to NCCN Categories of Preference to direct more patients toward preferred regimens with superior efficacy, safety, and affordability to further improve quality of care and lower total medical costs.

Background: Poly (ADP-ribose) polymerases (PARPs) are a highly conserved family of enzymes whose main function is to preserve genomic integrity following DNA damage. PARP inhibitors (PARPi) are increasingly used in cancers with deficiencies in homologous recombination. Clinical trials in breast and ovarian cancers have led to several FDA approvals in recent years, and their use in clinical practice is continuing to rise. It is thus necessary to assess their adverse event (AE) profile. Method: Literature search was performed using Ovid MEDLINE, EMBASE, CENTRAL, and Scopus (inception through October 26, 2018). Eligible studies were phase 3, randomized, controlled trials that compared single agent PARPi to placebo or standard treatment. Number of patients treated and AEs reported were recorded. Observed incidence of AE was reported with 95% CI. Heterogeneity was evaluated using Cochran Q statistic and I2 statistics quantified the proportion of heterogeneity not due to chance. Results: Databases revealed 869 references. Of these, 6 were eligible: 2 in breast cancer (OlympiAD, EMBRACA) and 4 in ovarian cancer (NOVA, ARIEL3, SOLO1, SOLO2). PARPi included niraparib (NOVA), olaparib (OlympiAD, SOLO1, SOLO2), rucaparib (ARIEL3), and talazoparib (EMBRACA). Of 1,685 patients who received PARPi, incidence of any AE, regardless of grade, was 98.5% (95% CI, 97.2–99.2%). Common AEs were: nausea (incidence rate, 68.9% and 95% CI, 58.7%–77.5%), fatigue (56.3%, 45.3%–66.8%), anemia (46.3%, 37.2%–55.8%), vomiting (33.7%, 29.5%–38.3%), neutropenia (24.7%, 15.3%–37.4%), headache (23.9%, 19.9%–28.4%), and reduced appetite (21.7%, 19.3%–24.3%). Myeloid neoplasms were rare (1.2%, 0.7%–1.9%). Incidence of grade 3 or higher AE was 44.3% (30.2%–59.5%) and often related to myelosuppression, specifically anemia (24.7%, 15.3%–37.4%), neutropenia (10.7%, 6.6%–16.9%), and thrombocytopenia (5.0%, 1.7%–14.0%). Incidence of serious AE was 24.3% (19.4%–29.9%); dose interruption occurred in 53.3% (41.2%–65.0%) and dose reduction occurred in 39.2% (23.6%–57.4%). 10% (7.4%–13.6%) of patients discontinued therapy due to AE. Death due to AE was rare; less than 1% (0.4%, 0.2%–0.8%) in all trials. Conclusion: Myelosuppression and gastrointestinal toxicities were the most commonly reported AE in 6 randomized phase 3 trials of PARPi for breast and ovarian cancers. Therapy was rarely discontinued due to AE. It remains to be seen whether these results will be reflected in clinical practice.