Relationship between patient copayments in Medicare Part D and vaccination claim status for herpes zoster and tetanus-diphtheria-acellular pertussis

Objective: To assess the relationship between copay amount and vaccination claim submission status for tetanus-diphtheria-acellular pertussis (Tdap) and herpes zoster (GSK study identifier: HO-14-14319).

Methods: Retrospective analyses were performed using vaccination administrative claims data in patients aged ≥65 years with ≥1 claim for Tdap or zoster vaccines between 2012 and 2014. To avoid confounding by other financial responsibility, analyses were conducted among patients in the copayment phase of insurance. The impact of patient copay amount on vaccination claim status (“canceled” vs. “paid”) was evaluated by logistic regression separately for Tdap and zoster, adjusting for patient and provider characteristics.

Results: A total of 81,027 (39.2% with canceled claims) and 346,417 patients (56.8% with canceled claims) were included in the Tdap and zoster analyses, respectively. Mean (standard deviation) copay for canceled vs. paid claims was $37.2 (18.4) vs. $31.1 (20.1) for Tdap and $64.9 (36.9) vs. $53.5 (38.8) for zoster. The adjusted odds ratios (ORs) for a canceled Tdap vaccine claim, compared with Objective: To assess the relationship between copay amount and vaccination claim submission status for tetanus-diphtheria-acellular pertussis (Tdap) and herpes zoster (GSK study identifier: HO-14-14319).

Methods: Retrospective analyses were performed using vaccination administrative claims data in patients aged ≥65 years with ≥1 claim for Tdap or zoster vaccines between 2012 and 2014. To avoid confounding by other financial responsibility, analyses were conducted among patients in the copayment phase of insurance. The impact of patient copay amount on vaccination claim status (“canceled” vs. “paid”) was evaluated by logistic regression separately for Tdap and zoster, adjusting for patient and provider characteristics.

Results: A total of 81,027 (39.2% with canceled claims) and 346,417 patients (56.8% with canceled claims) were included in the Tdap and zoster analyses, respectively. Mean (standard deviation) copay for canceled vs. paid claims was $37.2 (18.4) vs. $31.1 (20.1) for Tdap and $64.9 (36.9) vs. $53.5 (38.8) for zoster. The adjusted odds ratios (ORs) for a canceled Tdap vaccine claim, compared with $0 copay, were 1.19 ($1–25 copay), 1.76 ($26–50 copay), 2.42 ($51–75 copay) and 2.40 ($76–100 copay), all p?<?.001. The adjusted ORs for a canceled zoster vaccine claim, compared with $0 copay, were 1.02 ($1–25), 1.39 ($26–50), 1.66 ($51–75), 2.07 ($76–100) and 2.71 (>$100), all p?<?.001 except for $1–25 (p?=?.172).

Conclusions: High patient copay is a barrier to Tdap and zoster vaccinations in Medicare Part D patients. Providing vaccines at low or no copay may improve vaccination rates in these adults.

GSK study identifier: HO-14-14319.     

Burden of illness of hepatitis C from a managed care organization perspective

SUMMARY

Objectives: The objectives of this study were to: (1) determine the total hepatitis C virus (HCV)-related and total healthcare costs (HCV plus other co-morbidities) of patients with HCV in a managed care organization; (2) determine total healthcare costs of HCV patients with and without a human immunodeficiency virus (HIV) infection as a co-morbidity.

Methods: The study design was a retrospective analysis of a medical and pharmacy claims database of patients diagnosed with HCV in a 325000 member managed care organization. Patients diagnosed with HCV and 12 months of continuous eligibility in the managed care organization from January 1997 through December 1999 were included in the study. The main outcome measures of the study were the total healthcare costs and HCV-related healthcare costs and the impact of HIV as a co-morbidity on these costs.

Results: The study identified 614 patients meeting the inclusion criteria. The study population was 58% male and had a mean age of 46 (± 10.6)years. In patients receiving interferon-α, their median total healthcare costs exceeded $4600 and the median HCV-related costs exceeded $2470. The total healthcare costs of HCV patients with HIV as a co-morbidity were significantly larger than patients without this co-morbidity.

Conclusion: HCV represents a very important disease to managed care organizations. Patients with this disease require costly drug therapies and consume significant health care resources. Additional research is needed to more fully characterize future clinical and economic outcomes as new agents become available.     

丙型、丁型、庚型肝炎与原发性肝癌的相关因素分析

目的 探讨由RNA病毒引起的丙型、丁型、庚型肝炎与原发性肝癌(PLC)发生的关系。方法 采用免疫病理学观察,比较丙型肝炎病毒NS_5抗原(HCV-NS_5),丁型肝炎病毒抗原(HDVAg),庚型肝炎病毒NS_5抗原(HGV-NS_5)在肝细胞肝癌(HCC)组织中的表达特点。结果 在72例HCC中HCV-NS_5,HDVAg,HGV-NS_5的检出率分别为26.39％、19.44％、6.94％。总检出率为29.17％。3种病毒抗原信号在癌组织及癌旁组织中均有表达,虽其表达的主要部位有差异。3种病毒抗原的表达在HCC的分化程度方面无明显相关性,而与HCC患者的预后有一定的相关性。结论 HCV和HDV与PLC的发病关系密切,没有证据表明HGV是PLC发生的高危因素。     

Racial/ethnic disparities in measure calculations for Part D Star Ratings among Medicare beneficiaries with diabetes,hypertension, and/or hyperlipidemia

BackgroundPrevious literature reported racial/ethnic disparities in the measure assessment of diabetes medication adherence in the Medicare Part D Star Ratings program.ObjectiveThis study examined the likelihood of inclusion in measure calculation across racial/ethnic groups for adherence metrics in Part D Star Ratings among individuals with diabetes, hypertension, and/or hyperlipidemia.MethodsThis was a retrospective cross sectional analysis of a 10% random sample of 2017 Medicare claims linked to Area Health Resources Files. Inclusion in measure calculation was determined based on inclusion/exclusion criteria in adherence metrics for adherence medications for diabetes, hypertension, and hyperlipidemia in Part D Star Ratings developed by the Pharmacy Quality Alliance. Logistic regression and multinomial logistic regression were used to adjust for patient/community characteristics.ResultsThe study sample size was 2 707 216. Compared to Non-Hispanic White (White) beneficiaries, minorities were more likely to be excluded from measure calculation among individuals with 1 condition. For example, among individuals with hypertension, compared to White individuals, the adjusted odds ratios for exclusion for Black, Hispanic, Asian/Pacific Islander and other individuals were 1.46 (95% confidence interval, or CI = 1.42–1.50), 1.38 (95% CI = 1.33–1.43), 1.28 (95% CI = 1.21–1.35), and 1.08 (95% CI = 1.02–1.15), respectively. Among individuals with more than 1 chronic condition, minorities were more likely to be included in fewer calculations for medication adherence measures. For example, among individuals with all 3 conditions, the adjusted relative risk ratios for Black, compared to White, beneficiaries for being included in 0, 1, and 2 measures, versus all 3 measures, were 2.14 (95% CI = 1.99–2.30), 1.49 (95% CI = 1.41–1.56), 1.20 (95% CI = 1.18–1.23), respectively.ConclusionsCompared to White beneficiaries, racial/ethnic minorities are more likely to be excluded from the calculation for adherence measures among individuals with diabetes, hypertension, and/or hyperlipidemia. Future studies should examine whether such disparities exacerbate existing racial/ethnic disparities in health outcomes and devise solutions for these disparities.     

The lived experience of interferon-free treatments for hepatitis C: A thematic analysis

BackgroundInternational discourse concerning the evolution in hepatitis C virus (HCV) therapy has tended to focus on improving outcomes, shortened treatment length and reduced side-effects of interferon-free regimens. How these treatments are being understood and experienced by the people receiving them has so far been overlooked. This study therefore aimed to explore the lived experience of individuals taking interferon-free HCV therapies.MethodsData were generated through 16 semi-structured interviews with a purposive sample of eight participants, recruited from a university hospital in Scotland. The interviews took place between June 2015 and March 2016, before and after a period of interferon-free HCV treatment. The data were interrogated using a thematic analysis, underpinned by social phenomenological theory.ResultsThree overriding themes were identified. ‘Expectations and realisations’ characterised the influence that interferon continued to cast over interferon-free treatment, contrasting the practicalities of taking interferon-free therapy with preconceived notions. ‘An honour and a pleasure’ portrayed a positive experience of an undemanding therapy, yet among those with a history of drug use, was also positioned as a privilege, associated with feelings of luck and guilt. ‘Treatment needs’ illustrated the strategies participants used to search for treatment efficacy, and the value those with a significant history of drug use placed on support. One nonconforming case is then discussed to enhance rigour and trustworthiness.ConclusionThis is the first qualitative exploration of the experience of interferon-free HCV treatment reported globally. The results from this study suggest a cultural lag exists between the pharmacological developments which have been witnessed, and societal understandings of them. This has implications for the way services meet the needs of, and offer therapy to, HCV positive individuals.     

Treatment costs of hepatitis C infection among injection drug users in Canada, 2006-2026

Background

Canadian injection drug users (IDUs) are at high risk of hepatitis C virus infection (HCV). However, little is known about the costs associated with their HCV-related medical treatment. We estimated the medical costs of treating HCV-infected IDUs from 2006 to 2026.

Methods

We employed a Markov model of entry through birth or immigration to exposure-related behaviours or experiences, HCV infection, progression to HCV sequelae and mortality for active and ex-IDUs in Canada. We estimated direct and indirect treatment costs using data from the Ontario Case Costing Initiative (OCCI).

Result

Approximately 137,000 IDUs will suffer from HCV-related disease each year until 2026. Applying the OCCI cost data to the prevalence of HCV-related disease from 2006 to 2026 yielded an estimated cost of $3.96 billion CND to treat HCV-infected IDUs.

Conclusions

Substantial costs are associated with the treatment of HCV-related disease among Canadian IDUs. Given the lack of effective HCV prevention strategies in Canada, we must develop targeted evidence-based responses to prevent HCV transmission and ensure appropriate allocation of medical resources to meet the present and future treatment needs of HCV-infected IDUs.     

Mapping the hepatitis C cascade of care in people attending drug treatment services in England: A data linkage study

IntroductionHepatitis C (HCV) infection in England primarily affects people who inject drugs (PWID). We describe persons HCV tested, estimate incidence and establish the cascade of care (CoC) for people engaging with drug services.MethodsPersons testing for HCV in drug services in Sentinel Surveillance of Blood Borne Virus Testing (SSBBV) between 2008 and 2016 were linked with people attending drug services in the National Drug and Treatment Monitoring System (NDTMS). We describe risk characteristics, establish the CoC, and estimate HCV incidence in PWID diagnosed in drug services.ResultsOf 46,721 persons tested for anti-HCV in SSBBV in drug services, 29,773 (63.7%) linked to NDTMS. Of these, 9100 (30.6%) were antiV positive and anti-HCV positivity was 45.0% in persons reporting urgent housing problems and 43.8% in persons reporting ever injecting. Among persons anti-HCV positive, half had ≥1 positive anti-HCV test. For persons’ first anti-HCV positive between 2008 and 2013 (n = 3123), 74.9% were HCV RNA tested, of whom 71.2% were RNA positive, and of these, 14.0% had evidence of interferon-based treatment, with 52.8% achieving cure. Among PWID, HCV incidence was 8.7 per 100 person-years (95% CI: 8.1–9.2).ConclusionThrough record linkage of surveillance datasets, we estimated the HCV CoC for people attending drug services, providing a benchmark from which to monitor the impact of strategies to scale-up prevention, testing, and curative treatment with direct acting antivirals. Our study highlights wasteful repeated testing and poor linkage to care for this high risk population which need to be addressed.     

预防血液透析患者乙型肝炎与丙型肝炎病毒感染的效果观察

目的 采取有效措施预防维持性血液透析患者乙型肝炎、丙型肝炎病毒感染的发生.方法 观察2008年9月至2011年3月在本院行维持性血液透析患者,每6个月化验1次乙型肝炎五项、丙型肝炎抗体指标,共6次.结果 36例维持性血液透析患者未再出现新的乙型肝炎、丙型肝炎病毒感染病例.结论 采取有效措施可预防维持性血液透析患者乙型肝炎、丙型肝炎病毒感染的发生.     

长期血液透析患者丙型肝炎病毒感染的研究

目的　调查长期血液透析患者丙型肝炎感染状况。方法　用酶联免疫吸附试验 ( EL ISA)法和RT- PCR法检测 13 7例长期血液透析患者血清中的抗丙型肝炎病毒 ( HCV)和丙型肝炎病毒核糖核酸( HCVRNA) ,并且同时检测丙氨酸转氨酶 ( AL T)和天冬氨酸转氨酶 ( AST) ,计算其变动率。结果　 13 7例长期血液透析患者中仅抗 HCV阳性 8例 ,仅 HCVRNA阳性 15例 ,抗 HCV与 HCVRNA同时阳性者 2 4例 ,感染率3 4 .3 %。且透析时间 <2 a的 HCV感染率为 15 % ,透析时间 >2 a以上的其感染率增至 3 7.6%。结论　血透患者中 HCV的感染应引起重视 ,透析的年限越长 ,被 HCV感染的机率就越大。酶学指征的变动率不能作为长期透析患者 HCV感染的敏感指标     

丙型肝炎病毒感染者血清中自身抗体结果分析

目的 :观察丙型肝炎病毒 (HCV)感染者血清中自身抗体的变化情况。方法 :对85例HCV感染者血清标本测定抗核抗体(ANA)和可提取性核抗原 (ENA)抗体。结果 :HCV感染者ANA的检出率为24 7 % (21/85) ,明显高于正常对照组的2 5% (2/80)(x2=16.8,P<0 01)。抗ENA抗体阳性率为15 3% (13/85)与对照组比较差异有显著性 (x2=8.16,P<0 01)12 7 %。阳性主要有nRNP/Sm、SS-A、Scl-70、Jo-1、dsDNA等多种类型。结论 :自身免疫可能是HCV感染后肝组织损伤的重要因素     

Opportunistic assessment and treatment of people with hepatitis C virus infection admitted to hospital for other reasons: A prospective cohort study

BackgroundIt will be essential to find novel ways to access, diagnose and treat people with Hepatitis C Virus (HCV) infection in Australia to achieve HCV elimination.AimWe assessed the effectiveness of opportunistic HCV assessment and antiviral treatment in patients admitted to hospital for other reasons.MethodsPatients with HCV infection were referred from inpatient services at a tertiary referral centre in Sydney. Patients were assessed for HCV treatment with transient elastography (TE), HCV genotype and a clinical assessment and a summary letter was generated for all patients with a general practitioner (GP). Patients were offered treatment commencement at hospital discharge or after discharge with their GP, the infectious diseases clinic or with a gastroenterologist if they had cirrhosis. The primary outcome was the proportion of eligible patients who commenced treatment. We also undertook an intention to treat (ITT), modified intent to treat (mITT) analysis for virologic outcome (SVR12) and per protocol cure rates. An assessment of potential efficiency gains was undertaken.ResultsA total of 100 patients with a positive HCV antibody test were enrolled, of whom 70 were viraemic. The cohort included a high proportion of people who currently or previously injected drugs, indigenous patients and people previously lost to follow-up from other services. Treatment was initiated in 46 (66%) patients. The ITT was 80.4% (37/46) and mITT rate was 84.1% (37/44).The per-protocol SVR12 rate was 94.9%. Two subjects with genotype 3 and cirrhosis failed treatment, two subjects died and five were lost to follow up. The key barrier to uptake of DAA was incomplete assessment. Key inefficiencies of this model of care included referral of non-viraemic subjects, limited TE access and virologic test turnaround times.ConclusionThis model of care can complement the current efforts to increase HCV treatment in the community for those who do not access care elsewhere or are lost to follow-up.     

Outcomes of a nurse-led model of care for hepatitis C assessment and treatment with direct-acting antivirals in the custodial setting

BackgroundPeople in prison have been identified as an important population to prioritise for hepatitis C virus (HCV) treatment to achieve HCV elimination goals. We evaluated the efficacy of the New South Wales Justice Health and Forensic Mental Health Network Hepatitis Nurse Led Model of Care during the 12 months following the widespread availability of HCV direct acting antivirals (DAAs) in Australia.MethodsA retrospective cohort study was conducted of a network of 36 correctional centres across NSW from April 2016 to March 2017, with approximately 13 000 full time inmates. Population Health Nurses conducted initial clinical assessments and confirmatory testing. Patients were referred to a Hepatitis Clinical Nurse Consultant (CNC) for protocol-driven assessment, including transient elastography to assess hepatic fibrosis. The CNC then discussed the case with an Infectious Diseases physician and DAA therapies were prescribed. The total number of patients who commenced and completed treatment, and sustained virological response 12 weeks post treatment completion (SVR 12) were recorded.ResultsDuring the first 12 months of DAA treatment 698 patients were commenced on HCV treatment. Of those who were tested at the 12-week post treatment completion timepoint the per-protocol SVR12 (cure) rate was 92% (396/430), with 34 patients having a detectable viral load. 52 (7%) patients were released to freedom before completing treatment and a further 211 (30%) were released prior to SVR12 assessment. These outcomes indicate an intention-to-treat SVR 12 cure rate of 57% (396/698). There were no differences in demographic or treatment characteristics between those who underwent SVR12 testing and those released prior.ConclusionsTreatment for HCV can be delivered safely, efficiently and in high numbers in the prison setting using a nurse-led model of care. This will be an important component of the strategy to eliminate HCV infection as a public health concern by 2030.     

Vedroprevir in the management of hepatitis C virus infection

Introduction: Hepatitis C Virus (HCV) is a chronic infection of the liver and the leading cause of liver failure and liver transplantation worldwide. While prior HCV therapies were prolonged and had variable success rates, the advent of direct-acting antivirals (DAAs) has dramatically improved HCV therapy with minimal side effects, shorter treatment durations, and higher cure rates.

Areas covered: In this paper, we review the literature discussing the use of Vedroprevir (GS-9451) in treatment of HCV in a variety of patient populations. Articles accessible on MEDLINE/PubMed were reviewed to provide context on chemistry, pharmacology, and efficacy of Vedroprevir in HCV treatment.

Expert opinion: Vedroprevir is highly effective in reducing treatment duration in combination with other DAAs without compromising treatment success rates. GS-9451 is insufficient as HCV monotherapy due to low threshold for development of high level of resistance and must be combined with other DAAs to achieve sustained virologic response (SVR).