Evaluating the real-world effectiveness of belimumab in patients with SLE using SLE-related laboratory values and rheumatoid arthritis-derived disease activity measures: RAPID3, swollen joint count and tender joint count.

OBJECTIVE: To investigate the real-world impact of intravenous belimumab treatment among patients with SLE using rheumatoid arthritis-derived disease activity measures and SLE-related laboratory values. METHODS: This retrospective cohort study used US electronic medical record data from the United Rheumatology Normalised Integrated Community Evidence (UR-NICE) database. Adult patients with SLE who initiated intravenous belimumab between 1 January 2012 and 3 December 2019 (index), had 12 months of pre-index and 24 months of post-index clinical activity, and had ≥6 infusions of belimumab during the 24 months post-index were included. The primary outcome measure was time to first improvement of minimally important difference (MID) for Routine Assessment of Patient Index Data 3 (RAPID3), Patient Pain Index (PPI), swollen joint count, tender joint count (TJC), complement C3 and C4 and anti-double-stranded DNA antibodies during the on-treatment follow-up period of up to 24 months. The secondary outcome measure evaluated the trajectories of these outcome measures for up to 24 months of belimumab treatment. RESULTS: Of 495 patients included, between 21.0% and 52.1% had ≥1 record for each of the disease activity measures or laboratory values in the pre-index and post-index periods and were included in analyses for that measure. The proportion of patients achieving MID for each measure increased rapidly within 3 months, with continued gradual improvement throughout the remaining on-treatment period, up to 24 months. After 6 months, 52.3% and 55.3% of patients had achieved MID in RAPID3 and PPI, respectively. Outcome measure trajectories indicated improved disease activity with belimumab treatment, particularly in RAPID3, TJC and laboratory values. CONCLUSIONS: In this real-world effectiveness study, belimumab therapy for SLE resulted in clinically meaningful improvements in rheumatoid arthritis-derived disease activity measures within 3 months of treatment, with patients who remained on belimumab therapy experiencing improvement even up to 24 months of observation.

Impact of formulary-related pharmacy claim rejections of cariprazine on health care utilization and treatment patterns among patients with bipolar I disorder.

BACKGROUND: Formulary restrictions, intended to limit inappropriate medication use and decrease pharmacy costs, may prevent or delay patients with bipolar I disorder from initiating cariprazine, a dopamine D3-preferring D3/D2 and serotonin 5HT1A receptor partial agonist that is approved to treat manic/mixed or depressive episodes associated with bipolar I disorder. Little is known about the downstream consequences of formulary-related cariprazine prescription rejections. OBJECTIVE: To evaluate the impact of formulary-related cariprazine claim rejections on health care resource utilization (HCRU) and treatment patterns among patients newly prescribed cariprazine for bipolar I disorder. METHODS: Symphony Health Integrated Dataverse was used to identify commercially insured adults (aged ≥18 years) with bipolar I disorder and at least 1 pharmacy claim for cariprazine (rejected because of formulary restrictions or approved; date of the first claim is the index date) from March 2015 through October 2020. Formulary-related rejection reasons included noncoverage, prior authorization requirement, and step therapy requirement. Baseline characteristics were evaluated during the 12 months pre-index and balanced between rejected and approved cohorts using 1:2 propensity score matching. HCRU outcomes included all-cause and mental health (MH)-related hospitalizations, emergency department (ED) visits, and outpatient visits. Treatment patterns were analyzed descriptively and included treatment delay and atypical antipsychotic use. HCRU was reported per patient-year and compared between cohorts using rate ratios; 95% CIs and P values were calculated using nonparametric bootstrap procedures. RESULTS: The matched rejected and approved cohorts comprised 1,554 and 3,108 patients, respectively. The rejected cohort had 22% more all-cause and 24% more MH-related hospitalizations per patient-year vs the approved cohort (rate ratio [95% CI], all-cause: 1.22 [1.01-1.48], P = 0.024; MH-related: 1.24 [1.01-1.55], P = 0.044). ED and outpatient visits were numerically, but not significantly, greater in the rejected cohort. Of patients in the rejected cohort, 34.7% never received an atypical antipsychotic and 76.8% never received cariprazine. For those who later received cariprazine or another atypical antipsychotic, the average treatment delay was approximately 6 months (188 days) and approximately 4 months (123 days) after the initial rejection, respectively. CONCLUSIONS: Patients with bipolar I disorder and formulary-related cariprazine claim rejections experienced significantly more hospitalizations than patients whose initial claim was approved; ED and outpatient visits were similar between cohorts. Less than a quarter of patients whose initial claim was rejected later received cariprazine, and more than one-third never received any atypical antipsychotic. To our knowledge, this is the first study to evaluate the impact of formulary-related rejections of cariprazine on HCRU and treatment patterns in patients with bipolar I disorder.

Real-world economic burden of metastatic castration-resistant prostate cancer before and after first-line therapy initiation.

AIMS: To describe healthcare costs of patients with metastatic castration-resistant prostate cancer (mCRPC) initiating first-line (1 L) therapies from a US payer perspective. METHODS: Patients initiating a Flatiron oncologist-defined 1 L mCRPC therapy (index date) on or after mCRPC diagnosis were identified from linked electronic medical records/claims data from the Flatiron Metastatic Prostate Cancer (PC) Core Registry and Komodo's Healthcare Map. Patients were excluded if they initiated a clinical trial drug in 1 L, had <12 months of insurance eligibility prior to index, or no claims in Komodo's Healthcare Map for the Flatiron oncologist-defined index therapy. All-cause and PC-related total costs per-patient-per-month (PPPM), including costs for services and procedures from medical claims (i.e. medical costs) and costs from pharmacy claims (i.e. pharmacy costs), were described in the 12-month baseline period before 1 L therapy initiation (including the baseline pre- and post- mCRPC progression periods) and during 1 L therapy (follow-up). RESULTS: Among 459 patients with mCRPC (mean age 70 years, 57% White, 16% Black, 45% commercially-insured, 43% Medicare Advantage-insured, and 12% Medicaid-insured), average baseline all-cause total costs (PPPM) were $4,576 ($4,166 pre-mCRPC progression, $8,278 post-mCRPC progression). Average baseline PC-related total costs were $2,935 ($2,537 pre-mCRPC progression, $6,661 post-mCRPC progression). During an average 1 L duration of 8.5 months, mean total costs were $13,746 (all-cause) and $12,061 (PC-related) PPPM. The cost increase following 1 L therapy initiation was driven by higher PC-related outpatient and pharmacy costs. PC-related medical costs PPPM increased from $1,504 during baseline to $5,585 following 1 L mCRPC therapy initiation. LIMITATIONS: All analyses were descriptive; statistical testing was not performed. CONCLUSION: Incremental costs of progression to mCRPC are significant, with the majority of costs driven by higher PC-related costs. Using contemporary data, this study highlights the importance of utilizing effective therapies that slow progression and reduce healthcare resource demands despite the initial investment in treatment costs.