Association Between Oncology Clinical Pathway Utilization and Toxicity and Cost Outcomes in Patients With Metastatic Solid Tumors.

PURPOSE: This retrospective observational study compared cancer care toxicity and cost outcomes for patients with metastatic cancer with nine different cancer types prescribed on- versus off-pathway regimens. METHODS: This study used claims and authorization data from a national insurer between January 1, 2018, and October 31, 2021. Participants included adults with metastatic breast, lung, colorectal, pancreatic, melanoma, kidney, bladder, gastric, or uterine cancer, who were prescribed first-line anticancer regimens. Multivariable regressions were used to assess outcomes including counts of emergency room visits or hospitalizations, use of supportive care medications, immune-related adverse events (IRAEs), and health care costs. RESULTS: Of the 8,357 patients in the study, 5,453 (65.3%) were prescribed on-pathway regimens. The on-pathway proportion trended downward, from 74.3% in 2018 to 59.8% in 2021. The on- and off-pathway groups had a similar proportion of patients with treatment-related hospitalization (adjusted odds ratio [aOR], 1.080; P = .201) and IRAEs (aOR, 0.961; P = .497). More all-cause hospitalizations (aOR, 1.679; P = .013) were observed among patients with melanoma treated on-pathway. The on-pathway group had higher use of supportive care drugs in bladder cancer (aOR, 4.602; P < .001) and colorectal cancer (aOR, 4.465; P < .001), and lower use in breast (aOR, 0.668; P = .001) and lung cancer (aOR, 0.550; P < .001). On average, on-pathway patients incurred $17,589 less total health care cost (P < .001), and $22,543 lower chemotherapy cost (P < .001) than those from the off-pathway group. CONCLUSION: Our findings suggest that use of on-pathway regimens was associated with significant cost savings. Toxicity outcomes were variable by disease, but overall, there were similar numbers of treatment-related hospitalizations and IRAEs compared to off-pathway regimens. This cross-institutional study provides evidence to support the use of clinical pathway regimens for patients with metastatic cancer.

Cost Per Relapse Avoided for Ozanimod Versus Other Selected Disease-Modifying Therapies for Relapsing-Remitting Multiple Sclerosis in the United States.

INTRODUCTION: This study assessed the cost-effectiveness of ozanimod compared with commonly used disease-modifying therapies (DMTs) for relapsing-remitting multiple sclerosis (RRMS). METHODS: Annualized relapse rate (ARR) and safety data were obtained from a network meta-analysis (NMA) of clinical trials of RRMS treatments including ozanimod, fingolimod, dimethyl fumarate, teriflunomide, interferon beta-1a, interferon beta-1b, and glatiramer acetate. ARR-related number needed to treat (NNT) relative to placebo and annual total MS-related healthcare costs was used to estimate the incremental annual cost per relapse avoided with ozanimod vs each DMT. ARR and adverse event (AE) data were combined with drug costs and healthcare costs to manage relapses and AEs in order to estimate annual cost savings with ozanimod vs other DMTs, assuming a 1 million USD fixed treatment budget. RESULTS: Treatment with ozanimod was associated with lower incremental annual healthcare costs to avoid a relapse, ranging from $843,684 vs interferon beta-1a (30 µg; 95% confidence interval [CI] - $1,431,619, - $255,749) to $72,847 (95% CI - $153,444, $7750) vs fingolimod. Compared with all other DMTs, ozanimod was associated with overall healthcare cost savings ranging from $8257 vs interferon beta-1a (30 µg) to $2178 vs fingolimod. Compared with oral DMTs, ozanimod was associated with annual cost savings of $6199 with teriflunomide 7 mg, $4737 with teriflunomide 14 mg, $2178 with fingolimod, and $2793 with dimethyl fumarate. CONCLUSION: Treatment with ozanimod was associated with substantial reductions in annual drug costs and total MS-related healthcare costs to avoid relapses compared with other DMTs. In the fixed-budget analysis, ozanimod demonstrated a favorable cost-effective profile relative to other DMTs.

Effectiveness, safety and treatment adherence of biosimilar follow-on insulin in diabetes management.

AIM: To assess the change in HbA1c after initiation of biosimilar follow-on insulin (Basaglar) or reference insulin (Lantus) among patients with type 2 diabetes. We also compared treatment adherence, safety events and costs at 1 year after initiation of insulin. MATERIALS AND METHODS: Using claims data from a large US health plan during 2016-2020, we identified adults with type 2 diabetes who initiated either Basaglar or Lantus. Generalized linear regression modelling assessed the differences in outcomes between the two groups. A 0.4% margin was used to determine non-inferiority for HbA1c. RESULTS: The study included 1136 Basaglar users and 6304 Lantus users. Both Lantus and Basaglar groups showed more than 1% reduction in HbA1c over 6 months and over 12 months. Reduction in HbA1c with Basaglar was similar (non-inferior) to that with Lantus, with an adjusted difference of Basaglar to Lantus of 0.14% (95% CI -0.02 to 0.30) over 6 months and 0.17% (95% CI 0.02 to 0.32) over 12 months. Rates of adverse events were similar for both hypoglycaemia and vascular events. The Basaglar group showed higher adherence in terms of proportion of days covered (adjusted difference 0.06, 95% CI 0.04 to 0.08). Medical costs were similar, but the cost of Basaglar was lower (adjusted mean cost difference -$462, 95% CI -$556 to -$363) after adjustment. CONCLUSIONS: In patients with type 2 diabetes, Basaglar provided similar glycaemic control compared with Lantus, had a similar safety profile and lower drug costs, and showed more favourable adherence.

Immune checkpoint inhibitors: immune-related adverse events, healthcare utilization, and costs among commercial and Medicare Advantage patients.

BACKGROUND: Immune checkpoint inhibitors (ICI) are increasingly used across multiple cancer types and stages and little is known about real-world outcomes. This study sought to determine healthcare utilization, costs, immune-related adverse events (irAEs), and all-cause mortality of single-agent versus combination ICI in the USA. MATERIALS AND METHODS: This is a retrospective study conducted with 2016-2018 data from the HealthCore Integrated Research Database, consisting of commercial and Medicare-insured adult patients with a cancer diagnosis using ICI in the USA. Outcomes were healthcare utilization, costs, and irAEs (FDA-recognized and others) up to 1-year post-index between patients using ICI monotherapy (mono, PD-1/PD-L1 inhibitor) and combination therapy (combo, PD-1/PD-L1 with CTLA-4 inhibitors). RESULTS: In total, 9084 patients received monotherapy and 904 patients received combo therapy. Mean age 65 years for mono and 58 years for combo. Overall, the combo arm had higher rates of FDA-recognized irAEs (67.4% vs. 45.9%), especially endocrinopathies (27.7% vs 14.7%) and dermatitis (25.9% vs. 12.4%). All-cause mortality over 1-year follow-up was similar, 30.7% in mono vs 30.8% in combo arms. The combo group had higher rates of all-cause inpatient hospitalizations (55.4% mono vs 65.6% combo) and emergency department (ED) visits (33.7% mono vs 41.4% combo). IrAE-related hospitalizations were higher in combo (55.2% vs 42.1%). IrAE-related ED visits were 15.7% mono vs 22.7% combo. This increased toxicity and health care utilization was reflected in significant differences in healthcare costs. Stark differences were seen in all-cause medical costs as well as costs related to inpatient and ED utilization and costs attributed to irAEs. CONCLUSIONS: Higher rates of irAEs, healthcare utilization, and costs occur with combination immunotherapy. As further indications are approved for combination ICI, our study highlights the real-world tradeoffs involved with combination therapy regarding burdens of toxicity and increased healthcare utilization.

"I wanted to participate in my own care": Evaluation of a Patient Navigation Program.

INTRODUCTION: Patient navigation programs can help people overcome barriers to outpatient care. Patient experiences with these programs are not well understood. The goal of this study was to understand patient experiences and satisfaction with an emergency department (ED)-initiated patient navigation (ED-PN) intervention for US Medicaid-enrolled frequent ED users. METHODS: We conducted a mixed-methods evaluation of patient experiences and satisfaction with an ED-PN program for patients who visited the ED more than four times in the prior year. Participants were Medicaid-enrolled, English- or Spanish-speaking, New Haven-CT residents over the age of 18. Pre-post ED-PN intervention surveys and post-ED-PN individual interviews were conducted. We analyzed baseline and follow-up survey responses as proportions of total responses. Interviews were coded by multiple readers, and interview themes were identified by consensus. RESULTS: A total of 49 participants received ED-PN. Of those, 80% (39/49) completed the post-intervention survey. After receiving ED-PN, participants reported high satisfaction, fewer barriers to medical care, and increased confidence in their ability to coordinate and manage their medical care. Interviews were conducted until thematic saturation was reached. Four main themes emerged from 11 interviews: 1) PNs were perceived as effective navigators and advocates; 2) health-related social needs were frequent drivers of and barriers to healthcare; 3) primary care utilization depended on clinic accessibility and quality of relationships with providers and staff; and 4) the ED was viewed as providing convenient, comprehensive care for urgent needs. CONCLUSIONS: Medicaid-enrolled frequent ED users receiving ED-PN had high satisfaction and reported improved ability to manage their health conditions.

National estimates of case-mix, mortality, and economic outcomes among inpatient HIV/AIDS mono-infection and hepatitis C co-infection cases in the US.

RATIONALE, AIMS, AND OBJECTIVES: To assess inpatient clinical and economic outcomes for AIDS/HIV and Hepatitis C (HCV) co-infection in the United States from 2003 to 2014. METHOD: This historical cohort study utilized nationally representative hospital discharge data to investigate inpatient mortality, length of stay (LoS), and inflation-adjusted charges among adults (≥18 years). Outcomes were analysed via multivariable generalized linear models according to demographics, hospital and clinical characteristics, and AIDS/HIV or HCV sequelae. RESULTS: Overall, 17.8% of the 2.75 million estimated AIDS/HIV inpatient cases involved HCV from 2003 to 2014, averaging 48.5 ± 9.0 years of age and 68.0% being male. Advanced sequalae of AIDS and HCV incurred a LoS of 10.3 ± 11.9 days, charges of $88 789 ± 131 787, and a 16.9% mortality. Many cases involved noncompliance, tobacco use disorders, and substance abuse. Although mortality decreased over time, multivariable analyses indicated that poorer outcomes were generally associated with more advanced clinical conditions and AIDS-associated sequalae, although mixed results were observed for specific manifestations of HCV. Rural residence was independently associated with a 3.26 times higher adjusted odds of mortality from 2009 to 2014 for HIV/HCV co-infection (P < 0.001), although not for AIDS/HCV (OR = 1.38, P = 0.166). CONCLUSION: Given the systemic nature and modifiable risks inherent within coinfection, more proactive screening and intervention appear warranted, particularly within rural areas.

Overview of Prescription Opioid Deaths in the Oklahoma State Medicaid Population, 2012-2016.

BACKGROUND: Medicaid members are predisposed to unintentional prescription opioid overdose. However, little is known about their individual risk factors. OBJECTIVES: To describe demographic and clinical characteristics, medical utilization, opioid use, concurrent use of benzodiazepines, risk factors, and substances involved in death for Oklahoma's Medicaid members who died of unintentional prescription opioid poisoning. SUBJECTS: Decedents who were Medicaid eligible in Oklahoma during the year of death, had an opioid recorded in cause of death, and had ≥1 opioid prescription claim between January 1, 2011 and June 30, 2016 were cases. Controls were living Medicaid members and were matched 3:1 to cases through propensity score matching. MEASURES: Demographics, clinical characteristics, and medical/pharmacy utilization were examined in the 12 months before the index date. RESULTS: Of 639 members with fatal unintentional prescription opioid overdoses, 321 had ≥1 opioid prescription claim in the year before death; these were matched to 963 controls. Compared with controls, decedents had significantly greater proportions of nonopioid substance use disorders, opioid abuse/dependence, hepatitis, gastrointestinal bleeding, trauma not involving motor vehicle accidents, nonopioid poisonings, and mental illness disorders. Decedents had significantly higher daily morphine milligram equivalent doses (67.2±74.4 vs. 47.2±50.9 mg) and greater opioid/benzodiazepine overlap (70.4% vs. 35.9%). Benzodiazepines were involved in 29.3% of deaths. CONCLUSIONS: Several comorbidities indicative of opioid use disorder and greater exposure to opioids and concomitant benzodiazepines were associated with unintentional prescription opioid overdose fatalities. Prescribers and state agencies should be aware of these addressable patient-level factors among the Medicaid population. Targeting these factors with appropriate policy interventions and education may prevent future deaths.

Sustained Virologic Response and Costs Associated with Direct-Acting Antivirals for Chronic Hepatitis C Infection in Oklahoma Medicaid.

BACKGROUND: Outcomes involving newer direct-acting antiviral (DAA) hepatitis C virus (HCV) regimens have not been studied extensively among the Medicaid population. OBJECTIVE: To assess clinical (treatment failure) and economic outcomes for chronic HCV-infected Oklahoma Medicaid members following treatment with DAAs and to measure associations with patient, treatment, and clinical characteristics. METHODS: This cross-sectional study used Oklahoma Medicaid pharmacy and medical claims data for adult members who used a newer DAA agent and had reported a successful or failed sustained virological response rate 12 weeks after therapy completion (SVR12) from January 1, 2014, to June 30, 2016. Multivariable logistic and gamma regressions assessed predictors of SVR12 failure and costs controlling for member demographics (i.e., age, sex, race, rural residence); type of DAA and adherence; clinical characteristics (e.g., comorbid conditions, advanced liver disease); and the implementation of changes to a prior authorization program. RESULTS: Of 934 Medicaid members eligible for treatment with DAAs between January 1, 2014, and June 30, 2016, 906 received DAA treatment, 40.6% (368/906) had reported SVR12 outcomes, and 59.4% (n = 538) did not have a reported SVR recorded. Of those with reported SVR12 outcomes, patients were 53.1 ± 9.7 years of age, 51.1% were male, 8.4% had SVR12 failure, and each member had mean costs of $140,283 ± $52,779. Multivariable analyses indicated higher odds of SVR12 failure was independently associated with cirrhosis (OR [decompensated] = 6.69 and OR [compensated] = 3.52, P < 0.001), while males had higher odds of failure than females (OR = 3.34, P < 0.010). No significant difference in SVR12 failure was noted, according to DAA type or a medication adherence threshold of > 95%. Ledipasvir/sofosbuvir was independently associated with lower costs (exp[b] = 0.81; P < 0.001) compared with sofosbuvir, while higher costs were associated with decompensated cirrhosis (exp[b] = 1.22; P < 0.001) and treatment failure (exp[b] = 1.18, P < 0.010). In an analysis including members without reported SVR12 outcomes, decompensated and compensated cirrhosis had lower odds (P < 0.001) of no reported SVR12 from ambulatory clinic settings. CONCLUSIONS: Almost 60% of Medicaid members receiving DAA treatment did not have a final reported SVR12 outcome. Among those with viral load measurements, treatment success was high and both decompensated and compensated cirrhosis were independently associated with significantly higher odds of treatment failure. Addressing a loss to follow-up among HCV patients and curtailing the development of cirrhosis to improve treatment success may warrant interventions that improve access to care and remove barriers that impede treatment initiation and completion. DISCLOSURES: No outside funding supported this study. Pham, Keast, Holderread, Nesser, and Skrepnek disclose either employment by the Oklahoma Health Care Authority or contractual work for this employer. Pham discloses fellowship funding from Purdue Pharma unrelated to this study. Keast and Skrepnek disclose research grant funding from Gilead Sciences and Abbvie. Holderread also reports grant funding from Gilead Sciences and fees from PRIME Education. Thompson, Farmer, and Rathbun have nothing to disclose.

Incremental Effect of the Addition of Prescriber Restrictions on a State Medicaid's Pharmacy-Only Patient Review and Restriction Program.

BACKGROUND: Patient review and restriction programs (PRRPs), used by state Medicaid programs to limit potential abuse and misuse of opioids and related controlled medications, often restrict members to a single pharmacy for controlled medications. While most states use a restricted pharmacy access model, not all states include restricted prescriber access. Oklahoma Medicaid (MOK) added a restricted prescriber access feature to its PRRP in July 2014. OBJECTIVE: To evaluate the incremental effect that the addition of a prescriber restriction to MOK's pharmacy-only PRRP had on the pharmacy and resource utilization of the enrolled members. METHODS: MOK members with at least 6 months of enrollment in the pharmacy-only PRRP were restricted to a maximum of 3 prescribers for controlled substances in July 2014 and were identified as "cases." Using a propensity score method, cases were matched to controls from the MOK non-PRRP enrolled population based on demographics and baseline health care utilization. Data from January 1, 2014, through December 31, 2014, were evaluated. Each member's monthly health care resource utilization, defined in terms of medical and pharmacy costs, prescription counts, and opioid use per member per month (PMPM), was analyzed. A difference-indifferences (DID) regression estimated the change in resource utilization following the July 2014 policy change. RESULTS: This study included 378 controls and 126 cases after propensity matching. No differences were noted for daily morphine equivalents, benzodiazepine prescriptions, or maintenance prescriptions. There were decreases in mean PMPM use for both groups for short-acting opioid (SAO) claims (P < 0.001), overall opioid claims (P = 0.007 for controls and P < 0.001 for cases), prescribers (P = 0.01 for controls and P < 0.001 for cases), and number of pharmacies for cases (P < 0.001). DID analyses indicated that cases had a larger decrease in mean SAO claims (difference: -0.15, 95% CI: -0.25 to -0.04, P = 0.008); prescribers (difference: -0.25, 95% CI: -0.36 to -0.15, P < 0.001); and pharmacies (difference: -0.20, 95% CI: -0.28 to -0.13, P < 0.001) relative to controls. The difference for overall opioid claims was greater for cases than controls but did not reach statistical significance (difference: -0.12, 95% CI: -0.25 to 0.00, P = 0.050). CONCLUSIONS: Although there was no evidence that overall opioid claims were affected, the addition of prescriber restrictions may have resulted in an incremental change to SAO, prescriber, and pharmacy use in the PRPP population. Use of PRRPs may be an effective tool in reducing inappropriate use of prescription opioids within payer systems. The question remains whether these changes result in long-term changes to behavior outside the payer system. Future research into the effects of PRRPs on patient behavior beyond the payer system is needed. DISCLOSURES: No outside funding supported this research. All authors disclose either employment by the Oklahoma Health Care Authority or contractual work for this employer. In addition, Keast discloses unrelated funding through unrestricted research grants from Gilead Sciences and Purdue Pharma. Study concept and design were contributed by Keast and Pham, along with Teel and Nesser. Keast and Pham collected the data, along with Teel, and data interpretation was provided by Keast and Pham, with assistance from Teel and Nesser. The manuscript was written primarily by Keast, along with Pham and Teel, and revised by all the authors.