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Objective To assess adherence and persistence with first-line single-tablet regimen (STR) and multi-tablet regimen (MTR) antiretroviral therapy (ART) in newly treated HIV-1 patients. Methods Retrospective analysis of longitudinal pharmacy claims among US patients initiating ART between 1/1/2016 and 5/31/2016 (index date was defined by first ART claim for STRs, and fill date for the last therapy in the regimen for MTRs). Adherence was assessed over a 12-month period and reported as the proportion of adherent or non-adherent (defined as ≤5-day and > a 5-day gap between successive fills, respectively) patients. Sensitivity analysis using ≤7-day and ≤14-day gap thresholds to define adherence was performed. Persistence was assessed as the number of days on therapy from index until treatment discontinuation (>90 day gap in therapy). Kaplan–Meier curves and Cox Proportional Hazard models were generated to evaluate discontinuation rates. Assessments were performed on STRs vs MTRs overall and by regimen. Results Patients initiating ART (STR: n=10,623; MTR: n=2504) had a mean age of 42.8 years; 76.0% were male. STR patients were >2 times more likely to be adherent over 12 months than MTR patients (24.9% vs 11.7%, respectively). Patients using EVG/COBI/FTC/TAF had greater adherence than those using other STRs. Among MTRs, patients were more adherent with FTC/TDF+DTG (15.1%) than other MTRs. Persistence was also greater with STRs, with MTR patients being 61% more likely to discontinue therapy. Persistence was best for FTC/TAF-based regimens. Predictors of treatment discontinuation included younger age, female gender, and Medicare or Medicaid insurance type. Conclusion Patients receiving STRs were significantly less likely to discontinue therapy and were more adherent with their regimens, providing further evidence of greater adherence and persistence with STRs versus MTRs. However, there was a large proportion of patients who interrupted or discontinued treatment. Further research examining treatment patterns beyond first line is warranted.

In this chapter, we address the question of what health economic models represent. Are they realistic? And, does model realism matter? Or, is model usefulness in terms of informing pricing, reimbursement, and prescribing decisions all policymakers care about? The usefulness of models is circumscribed given that: (1) market failure is inherent in healthcare and (2) models oversimplify the preference structure underlying choices. We suggest, however, that models which employ the ceteris paribus clause can be useful in order to isolate factors that play a role in healthcare decision-making and ultimately characterize agents’ multiattribute utility functions through discrete choice experiments. As a result, policymakers gain important knowledge about decision criteria in the healthcare system.

With the inclusion of $US1.1 billion earmarked for comparative effectiveness research (CER) in the recently enacted stimulus package, the US government indicated it will play an important role in informing prescribing and reimbursement decisions. However, this sizable investment does beg four important questions: what is the nature of CER data; what methods are suitable for collecting CER data; who is (should be) responsible for collecting CER data; and how will (should) CER data be used by the federal government? Using three recent high-profile cases of drugs and drug classes, we assess the current state of federal- and state-funded CER in the US. From these cases we observe that evidence is gradually emerging as a filter for certain prescribing and coverage decisions. The first case indicates evidence should not be gathered and applied in a post hoc fashion after a reimbursement decision has already been reached. Case 2 suggests limitations associated with making inferences from systematic reviews when applying the evidence to the treatment of individual patients. Case 3 points to a comprehensive, but more costly and time-consuming, way of gathering data to inform prescribing and reimbursement decisions. Despite caveats, we argue that there is room for building a more systematic and better coordinated evidence base in the US, so that all stakeholders are better equipped to understand variation in clinical outcomes while promoting appropriate prescribing patterns. Accordingly, CER could help close the gap between what we know and what we do in pharmaceutical care. For the majority of cases in which CER is carried out, we favour a pluralistic system of CER analyses with a clearinghouse for systematic reviews conducted by multiple evidence-based practice centres, each uniquely suited to its constituency.

To examine health plan compliance with essential drug benefit regulations in California and Massachusetts and at the federal level.Health plan formulary review and analysis.We analyzed formularies from the 3 largest small group plans in California and Massachusetts, including each state's benchmark plan. With respect to both federal and state regulations, for each health plan, we examined whether the drug was covered, the designated patient cost sharing tier of the drug, and which conditions of reimbursement were applied to the drug.Most drugs included in state and federal mandates are covered by both benchmark and non-benchmark plans. However, health plans are not fully compliant with state and federal regulations. Significant differences among plans relate more to cost sharing and conditions of reimbursement, such as prior authorization, step edits, and quantity limits, than to drug coverage. CONCLUSIONS/POLICY IMPLICATIONS: Because health plans in California and Massachusetts are not fully compliant with state and federal mandates, they will have to adjust their formularies to meet minimum requirements. State policy makers need to balance competing aims of comprehensiveness of coverage and drug affordability. They must consider: (1) choice of benchmark plan -choice of a more generous benchmark plan implies less leverage for negotiating lower prices; and (2) breadth of state mandates which, if they exceed federal mandates, must be paid for by the states.

Although the US has lagged behind international developments in health technology assessment (HTA), renewed interest in HTA in the US has been fueled by the appropriation of $1.1 billion comparative effectiveness research (CER) in 2009 and the debate over health care reform.To inform CER practices in the US, we present case studies of HTA from England/Wales and Germany: contrasting methods; relevance to the US; and impact on innovation.The National Institute of Health and Clinical Excellence (NICE) was established in 1999 to inform trusts within the National Health Service of England and Wales. It uses cost-effectiveness analysis to guide the allocation resource across preventative and curative interventions. In Germany, the Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) was established in 2004 to inform reimbursement and pricing policies for the statutory sickness funds set by the Gemeinsamer Bundesaursschuss (G-BA). IQWiG evaluates competing technologies within specific therapeutic areas, placing more weight on clinical evidence and the relative efficiency of competing therapies.Although having deep political and cultural antecedents, differences between NICE and IQWiG can be explained by perspective: the former guiding resource allocation across an entire system (macro-evaluation), the latter focusing on efficiency within the bounds of a particular therapeutic area (micro-evaluation). Given the decentralized nature of the US health care system, and the relative powers of different medical specialties, the IQWiG model presents a more suitable case study to guided CER efforts in the US.