RESUMEN
BACKGROUND: Newer hepatitis C virus (HCV) treatments often provide high success rates with fewer adverse events, although the extent of all potential drug interactions is not fully known. OBJECTIVE: To assess outcomes of receiving HCV treatment and subsequent sustained virologic response (SVR) based on patient and clinical characteristics, including direct-acting antiviral (DAA) drug-drug interactions (DDIs), in Medicaid members with chronic HCV. METHODS: Comprehensive medical and pharmacy claims and prior authorization data were collected for HCV patients requesting treatment between January 2014 and June 2015. Outcomes of receiving treatment with DAAs and treatment failure based on SVR were analyzed according to demographics, prior/current HCV treatment, severity of DDIs, advancing liver disease, and comorbidities. Multivariable generalized linear models were employed, including a Bayesian sensitivity analysis. RESULTS: Among 3,412 Medicaid members with HCV, 13.6% received DAAs (n = 464), averaging 53.6 ± 10.0 years, with 52.8% female. Multivariable analyses indicated that higher odds of DAA treatment initiation were associated with older age, prior HCV treatment, and advancing liver disease. Some 4.8% of treatment failures occurred among 168 patients with reported SVRs, wherein a 3.218 times higher adjusted odds of treatment failure was associated with concomitant use of medications with DDIs classified as significant or potentially clinically significant by the University of Liverpool HEP Drug Interactions resource (P = 0.001). CONCLUSIONS: In a cohort of state Medicaid members with chronic HCV, a markedly higher adjusted odds of treatment failure was independently associated with DDIs classified as significant or potentially clinically significant, warranting continued inquiry and potential alternate treatments concerning conditions that require their use. DISCLOSURES: This research was funded by an unrestricted research grant by Gilead Sciences. During the course of this study, all authors were either employed by the Oklahoma HealthCare Authority or engaged in contractual work for this employer. Keast, Holderread, and Skrepnek report unrelated research grants from AbbVie, Otsuka, and Amgen. Keast and Skrepnek acknowledge funding from Purdue Pharma for an unrelated research fellowship grant. Posters based on this work were presented at HepDart 2015 on December 6-10, 2015, in Grand Wailea, HI, and at Academy of Managed Care Nexus 2015 on October 26-29, 2015, in Orlando, FL.
Asunto(s)
Antivirales/uso terapéutico , Hepacivirus/efectos de los fármacos , Hepatitis C Crónica/tratamiento farmacológico , Medicaid/organización & administración , Administración del Tratamiento Farmacológico/organización & administración , Adulto , Antivirales/farmacología , Teorema de Bayes , Estudios Transversales , Interacciones Farmacológicas , Femenino , Hepacivirus/aislamiento & purificación , Hepatitis C Crónica/virología , Humanos , Masculino , Persona de Mediana Edad , Oklahoma , Respuesta Virológica Sostenida , Insuficiencia del Tratamiento , Estados UnidosRESUMEN
OBJECTIVES: To describe roles for pharmacists to facilitate payer-initiated value-based contracts within state Medicaid programs. SUMMARY: According to the Centers for Medicare and Medicaid Services, prescription drug expenditures are expected to see the fastest annual growth in the health care sector over the next decade owing to a greater number of costly specialty medications and overall higher drug prices. Increased prescription costs make value-based contracts particularly compelling opportunities for payers. Pharmacists, as formulary subject-matter experts, have unique skills that are beneficial to value-based contract designs. Much like their role in formulary development, pharmacists' clinical knowledge of evidence-based medicine and cost-effective medication use ensures that contract negotiations are both clinically appropriate and address cost-savings components. Well designed value-based contracts can potentially improve the quality of care without increasing overall health care expenditures. Other potential benefits of value-based contracts include reducing waste, achieving cost predictability, and achieving fiscal responsibility for high-cost drugs while supporting patient access.
Asunto(s)
Costos de los Medicamentos , Medicaid/economía , Farmacéuticos/economía , Mecanismo de Reembolso/economía , Contratos , Humanos , Estados UnidosRESUMEN
OBJECTIVES: The market for chronic hepatitis C (HCV) treatment has changed rapidly. New treatments offer high cure rates, fewer adverse effects, and shorter treatments-but also increased costs per therapy. The objective of this study was to compare adherence and cost between HCV patients included in an enhanced prior authorization and management program (PAMP) versus no intervention in Medicaid members undergoing treatment. DESIGN: A retrospective study using longitudinal panel data assessed differences in adherence and costs associated with implementation of the PAMP from the payer perspective. The PAMP included case management, patient education, pharmacy counseling, and medication adherence. Multivariable generalized estimating equations were used to assess associations between program and outcomes. SETTING AND PARTICIPANTS: Patients with HCV enrolled in a state Medicaid program receiving or requesting HCV treatment from January 2014 to November 2015. OUTCOME MEASURES: Outcomes included medication adherence, treatment gaps, and pharmacy and total direct costs after controlling for demographic and clinical factors between those in the PAMP and those in the preintervention period. RESULTS: There were 384 Medicaid members included (156 pre-PAMP, 228 post-PAMP). Overall adherence was high regardless of PAMP intervention, although an adjusted 1.086-fold increase in medication possession ratio (MPR) was observed with the program and a 2.732-fold higher odds of adherence above 80% (P < 0.05). Members in the program had 0.358 times lower adjusted odds of a greater than 3-day treatment gap, and pharmacy-related costs were 0.940 times lower (P < 0.05); no difference was observed in total medical costs (P = 0.333). CONCLUSION: This enhanced Medicaid program was associated with increased adherence to HCV therapy, decreased treatment gaps, and decreased pharmacy-related costs compared with the preintervention period. Because challenges exist if patients fail HCV treatment or if viral resistance emerges, ensuring high adherence and persistence remains key. Continued work is needed to develop and assess enhanced management programs for this population.
Asunto(s)
Costos de los Medicamentos/estadística & datos numéricos , Hepatitis C Crónica/economía , Cumplimiento de la Medicación/estadística & datos numéricos , Administración del Tratamiento Farmacológico/economía , Autorización Previa/economía , Servicios Comunitarios de Farmacia/economía , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Farmacéuticos , Estudios Retrospectivos , Estados UnidosRESUMEN
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.