Assessing the Quality of Economic Evaluations of FDA Novel Drug Approvals: A Systematic Review.

OBJECTIVE: To systematically review and assess the quality of the novel drugs' economic evaluation literature in print during the drugs' early commercial availability following US regulatory approval. DATA SOURCES: MEDLINE and the United Kingdom National Health Service Economic Evaluation Database were searched from 1946 through December 2011 for economic evaluations of the 50 novel drugs approved by the FDA in 2008 and 2009. STUDY SELECTION AND DATA EXTRACTION: The inclusion criteria were English-language, peer-reviewed, original economic evaluations (cost-utility, cost-effectiveness, cost-minimization, and cost-benefit analyses). We extracted and analyzed data from 36 articles considering 19 of the 50 drugs. Two reviewers assessed each publication's quality using the Quality of Health Economic Studies (QHES) instrument and summarized study quality on a 100-point scale. DATA SYNTHESIS: Study quality had a mean of 70.0 ± 16.2 QHES points. The only study characteristics associated with QHES score (with P < 0.05) were having used modeling or advanced statistics, 75.1 versus 61.9 without; using quality-adjusted life years as an outcome, 75.9 versus 64.7 without; and cost-utility versus cost-minimization analysis, 75.9 versus 58.7. Studies most often satisfied quality aspects about stating study design choices and least often satisfied aspects about justifying design choices. CONCLUSION: The reviewed literature considered a minority of the 2008-2009 novel drugs and had mixed study quality. Cost-effectiveness stakeholders might benefit from efforts to improve the quality and quantity of literature examining novel drugs. Editors and reviewers may support quality improvement by stringently imposing economic evaluation guidelines about justifying study design choices.

Surgical specialty and preoperative medical consultation based on commercial health insurance claims.

BACKGROUND: Surgical patients are sometimes referred for preoperative evaluations by consultants in other medical specialties, although consultations are unnecessary for many patients, particularly for healthy patients undergoing low-risk surgeries. Surgical specialty has been shown to predict usage of preoperative consultations. However, evidence is generally limited regarding factors associated with preoperative consultations. This study evaluates surgical specialty and other predictors of preoperative consultations. METHODS: This retrospective cohort study analyzed surgery claims of 7400 privately insured patients in Washington, United States, from eight surgical specialties. We estimated log-Poisson generalized estimating equation models that regress whether a patient received a consultation on surgical specialty and covariates accounting for the data's hierarchical structure with patients nesting within surgeons, and surgeons nesting within provider organizations. Covariates include age, gender, Deyo comorbidity index, surgical risk, and geographic factors. RESULTS: Overall, 485 (6.6%) patients had a preoperative consultation. The incidence of preoperative consultation varied significantly by surgical specialty. Orthopedics, neurosurgery, and ophthalmology had 3.9 (95% CI 2.4, 6.5), 2.3 (95% CI 1.1, 4.5), and 2.3 (95% CI 1.1, 4.6) times greater adjusted likelihoods of preoperative consultation than general surgery, respectively. The adjusted likelihoods of consultation for gynecology, urology, otolaryngology, and vascular surgery were not statistically different from general surgery. The following covariates were associated with greater likelihood of preoperative consultation: greater age, higher surgical risk, having one or more comorbidities vs. none, and small rural towns vs. urban areas. More than 75% of all consultations were provided to patients with a Deyo comorbidity index of 0 or 1. Low surgical risk patients had 0.3 (95% CI 0.3, 0.5) times the likelihood of preoperative consultation of intermediate and high-risk patients overall. CONCLUSIONS: The likelihood of preoperative consultation varied fourfold (an absolute 9% points) across surgical specialties. Most consultations were provided to patients with low comorbidity and with low or intermediate surgical risk. To improve usage of preoperative consultations as an evidence-based practice, future research should determine how the health outcomes effects of preoperative consultations vary depending on comorbidity burden and surgical risk.

European Union-28: An annualised cost-of-illness model for venous thromboembolism.

Annual costs for venous thromboembolism (VTE) have been defined within the United States (US) demonstrating a large opportunity for cost savings. Costs for the European Union-28 (EU-28) have never been defined. A literature search was conducted to evaluate EU-28 cost sources. Median costs were defined for each cost input and costs were inflated to 2014 Euros (€) in the study country and adjusted for Purchasing Power Parity between EU countries. Adjusted costs were used to populate previously published cost-models based on adult incidence-based events. In the base model, annual expenditures for total, hospital-associated, preventable, and indirect costs were €1.5-2.2 billion, €1.0-1.5 billion, €0.5-1.1 billion and €0.2-0.3 billion, respectively (indirect costs: 12 % of expenditures). In the long-term attack rate model, total, hospital-associated, preventable, and indirect costs were €1.8-3.3 billion, €1.2-2.4 billion, €0.6-1.8 billion and €0.2-0.7 billion (indirect costs: 13 % of expenditures). In the multiway sensitivity analysis, annual expenditures for total, hospital-associated, preventable, and indirect costs were €3.0-8.5 billion, €2.2-6.2 billion, €1.1-4.6 billion and €0.5-1.4 billion (indirect costs: 22 % of expenditures). When the value of a premature life-lost increased slightly, aggregate costs rose considerably since these costs are higher than the direct medical costs. When evaluating the models aggregately for costs, the results suggests total, hospital-associated, preventable, and indirect costs ranging from €1.5-13.2 billion, €1.0-9.7 billion, €0.5-7.3 billion and €0.2-6.1 billion, respectively. Our study demonstrates that VTE costs have a large financial impact upon the EU-28's healthcare systems and that significant savings could be realised if better preventive measures are applied.

Venous thromboembolism: annualised United States models for total, hospital-acquired and preventable costs utilising long-term attack rates.

Healthcare reform is upon the United States (US) healthcare system. Prioritisation of preventative efforts will guide necessary transitions within the US healthcare system. While annual deep-vein thrombosis (DVT) costs have recently been defined at the US national level, annual pulmonary embolism (PE) and venous thromboembolism (VTE) costs have not yet been defined. A decision tree and cost model were developed to estimate US health care costs for total PE, total hospital-acquired PE, and total hospital-acquired "preventable" PE. The previously published DVT cost model was modified, updated and combined with the PE cost model to elucidate the same three categories of costs for VTE. Direct and indirect costs were also delineated. For VTE in the base model, annual cost ranges in 2011 US dollars for total, hospital- acquired, and hospital-acquired "preventable" costs and were $13.5-$27.2, $9.0-$18.2, and $4.5-$14.2 billion, respectively. The first sensitivity analysis, with higher incidence rates and costs, demonstrated annual US total, hospital-acquired, and hospital-acquired "preventable" VTE costs ranging from $32.1-$69.3, $23.7-$51.5, and $11.9-$39.3 billion, respectively. The second sensitivity analysis with long-term attack rates (LTAR) for recurrent events and post-thrombotic syndrome and chronic pulmonary thromboembolic hypertension demonstrated annual US total, hospital-acquired, and hospital-acquired "preventable" VTE costs ranging from $15.4-$34.4, $10.3-$25.4, and $5.1-$19.1 billion, respectively. PE costs comprised a majority of the VTE costs. Prioritisation of effective VTE preventative strategies will reduce significant costs, morbidity and mortality within the US healthcare system. The cost models may be utilised to estimate other countries' costs or VTE-specific disease states.