Optimizing Orthopaedic Trauma Implant Pricing Through a Data-Driven and Surgeon-Integrated Approach.

OBJECTIVE: To determine whether market-based pricing could be coupled with surgeon integration into negotiation strategies to achieve lower pricing levels for orthopaedic trauma implants. A secondary aim was to identify specific types of implants that may offer larger opportunities for cost savings. METHODS: Market pricing levels were reviewed from 2 industry implant databases. This information was used by surgeons and supply chain management at our institution to select appropriate target pricing levels (25th percentile) for commonly used orthopaedic trauma implants. Target price values were provided to the existing 12 vendors used by our institution with a clear expectation that vendors meet these thresholds. RESULTS: Benchmark modeling projected a potential savings of 20.0% over our prior annual spend on trauma implants. After 2 rounds of negotiation, savings amounted to 23.0% of prior annual spend. Total savings exceeded 1,000,000 USD with 11 of 12 vendors (91.7%) offering net savings. Total percent savings were highest for external fixators, drill bits, and K-wires. Plates and screws comprised the greatest proportion of our prior annual spend and achieved similar savings. CONCLUSION: A surgeon and supply chain coordinated effort led to major cost savings without a need for consolidation of vendors. LEVEL OF EVIDENCE: Economic Level IV. See Instructions for Authors for a complete description of levels of evidence.

A Stepwise Replicable Approach to Negotiating Value-driven Supply Chain Contracts for Orthobiologics.

INTRODUCTION: Orthobiologics are increasingly used to augment healing of tissues. Despite growing demand for orthobiologic products, many health systems do not enjoy substantial savings expected with high-volume purchases. The primary goal of this study was to evaluate an institutional program designed to (1) prioritize high-value orthobiologics and (2) incentivize vendor participation in value-driven contractual programs. METHODS: A three-step approach was used to reduce costs through optimization of orthobiologics supply chain. First, surgeons with orthobiologics expertise were engaged in key supply chain purchasing decisions. Second, eight orthobiologics formulary categories were defined. Capitated pricing expectations were established for each product category. Capitated pricing expectations were established for each product using institutional invoice data and market pricing data. In comparison with similar institutions, products offered by multiple vendors were priced at a lower benchmark (10th percentile of market price) than more rare products priced at the 25th percentile of the market price. Pricing expectations were transparent to vendors. Third, a competitive bidding process required vendors to submit pricing proposals for products. Clinicians and supply chain leaders jointly awarded contracts to vendors that met pricing expectations. RESULTS: Compared with our projected estimate of $423,946 savings using capitated product prices, our actual annual savings was $542,216. Seventy-nine percent of savings came from allograft products. Although the number of total vendors decreased from 14 to 11, each of the nine returning vendors received a larger, three-year institutional contract. Average pricing decreased across seven of the eight formulary categories. DISCUSSION: This study demonstrates a three-step replicable approach to increase institutional savings for orthobiologic products, engaging clinician experts, and strengthening relationships with select vendors. Vendor consolidation permits a symbiotic win-win relationship: Health systems achieve increased value by reducing unnecessary complexity of multiple contracts, and vendors obtain larger contracts with increased market share. LEVEL OF EVIDENCE: Level IV study.

Value Improvement by Assessing IR Care via Time-Driven Activity-Based Costing.

PURPOSE: To evaluate time-driven activity-based costing (TDABC) in interventional radiology for image-guided vascular malformation treatment as an example. MATERIALS AND METHODS: Retrospective analysis was performed on consecutive vascular malformation treatment cycles [67 venous malformations (VMs) and 11 arteriovenous malformations (AVMs)] in a university hospital in 2018. All activities were integrated with a process map, and spent resources were assigned accordingly. TDABC uses 2 parameters: (i) practical capacity cost rate, calculated as 80% of theoretical capacity, and (ii) time consumption of each resource determined by interviews (23 items). Thereby, the total costs were calculated. Treatment cycles were modified according to identified resource waste and TDABC-guided negotiations with health insurance. RESULTS: Total personnel time required was higher for AVM (1,191 min) than for VM (637 min) treatment. The interventional procedure comprised the major part (46%) of personnel time required in AVM, whereas it comprised 19% in VM treatment. Materials represented the major cost type in AVM (75%) and VM (45%) treatments. TDABC-based treatment process modification led to a decrease in personnel time need of 16% and 30% and a cost reduction of 5.5% and 15.7% for AVM and VM treatments, respectively. TDABC-guided cost reduction and TDABC-informed negotiations improved profit from -56% to +40% and from +41% to +69% for AVM and VM treatments, respectively. CONCLUSIONS: TDABC facilitated the precise costing of interventional radiologic treatment cycles and optimized internal processes, cost reduction, and revenues. Hence, TDABC is a promising tool to determine the denominator of interventional radiology's value.

Intra-arterial catheter-directed CT angiography for assessment of endovascular aortic aneurysm repair.

OBJECTIVE: To compare the efficacy and safety as well as associated image quality of catheter-directed CT angiography (CCTA) with a low dose of iodine contrast agent compared to intravenous CTA in patients undergoing endovascular aortic aneurysm repair (EVAR). METHODS: Retrospective data analysis of 92 patients undergoing EVAR between January 2009 and December 2017 was performed. Patients were divided in two groups; those receiving CTA (n = 59) after intravenous contrast agent application and those receiving CCTA (n = 33) via an intraarterial catheter placed in the descending aorta. Demographic and cardiovascular risk factors as well as renal function parameters before, immediately after and 6-60 months after EVAR were evaluated. As primary endpoint, changes in serum creatinine levels in the two groups were evaluated. Secondary endpoints encompassed complications associated with intraarterial catheter placement. Objective (signal-to-noise ratios) and subjective image quality (5-point Likert scale) were compared. RESULTS: Amount of contrast medium was significantly lower in CCTA compared to i.v. CTA (23 ± 7 ml vs. 119 ± 15 ml, p<0.0001). Patients undergoing catheter-directed CTA had higher baseline creatinine values compared to the group with intravenous iodine application (1.9 ± 0.6 mg/dl vs. 1.3 ± 0.5 mg/dl; p<0.0001). Follow-up serum creatinine levels however did not show significant alterations between the two groups (1.9 ± 0.4 mg/dl vs. 1.3 ± 0.5 mg/dl). No major complications were detected in the CCTA group. Signal-to-noise ratio (SNR) was comparable between i.v. CTA and CCTA (8.5 ± 4.6 vs. 7.7 ± 4.0; p = 0.37) and subjective image similarly revealed no differences with a good interobserver agreement (ICC = 0.647). CONCLUSIONS: Catheter-directed CTA is safe and provides comparable image quality with a substantial retrenchment of the needed amount of iodine-based contrast medium. However, no benefit of the reduced contrast medium protocol with respect to renal function was observed.

Information on new drugs at market entry: retrospective analysis of health technology assessment reports versus regulatory reports, journal publications, and registry reports.

BACKGROUND: When a new drug becomes available, patients and doctors require information on its benefits and harms. In 2011, Germany introduced the early benefit assessment of new drugs through the act on the reform of the market for medicinal products (AMNOG). At market entry, the pharmaceutical company responsible must submit a standardised dossier containing all available evidence of the drug's added benefit over an appropriate comparator treatment. The added benefit is mainly determined using patient relevant outcomes. The "dossier assessment" is generally performed by the Institute for Quality and Efficiency in Health Care (IQWiG) and then published online. It contains all relevant study information, including data from unpublished clinical study reports contained in the dossiers. The dossier assessment refers to the patient population for which the new drug is approved according to the summary of product characteristics. This patient population may comprise either the total populations investigated in the studies submitted to regulatory authorities in the drug approval process, or the specific subpopulations defined in the summary of product characteristics ("approved subpopulations"). OBJECTIVE: To determine the information gain from AMNOG documents compared with non-AMNOG documents for methods and results of studies available at market entry of new drugs. AMNOG documents comprise dossier assessments done by IQWiG and publicly available modules of company dossiers; non-AMNOG documents comprise conventional, publicly available sources-that is, European public assessment reports, journal publications, and registry reports. The analysis focused on the approved patient populations. DESIGN: Retrospective analysis. DATA SOURCES: All dossier assessments conducted by IQWiG between 1 January 2011 and 28 February 2013 in which the dossiers contained suitable studies allowing for a full early benefit assessment. We also considered all European public assessment reports, journal publications, and registry reports referring to these studies and included in the dossiers. DATA ANALYSIS: We assessed reporting quality for each study and each available document for eight methods and 11 results items (three baseline characteristics and eight patient relevant outcomes), and dichotomised them as "completely reported" or "incompletely reported (including items not reported at all)." For each document type we calculated the proportion of items with complete reporting for methods and results, for each item and overall, and compared the findings.Results 15 out of 27 dossiers were eligible for inclusion and contained 22 studies. The 15 dossier assessments contained 28 individual assessments of 15 total study populations and 13 approved subpopulations. European public assessment reports were available for all drugs. Journal publications were available for 14 out of 15 drugs and 21 out of 22 studies. A registry report in ClinicalTrials.gov was available for all drugs and studies; however, only 11 contained results. In the analysis of total study populations, the AMNOG documents reached the highest grade of completeness, with about 90% of methods and results items completely reported. In non-AMNOG documents, the rate was 75% for methods and 52% for results items; journal publications achieved the best rates, followed by European public assessment reports and registry reports. The analysis of approved subpopulations showed poorer complete reporting of results items, particularly in non-AMNOG documents (non-AMNOG versus AMNOG: 11% v 71% for overall results items and 5% v 70% for patient relevant outcomes). The main limitation of our analysis is the small sample size. CONCLUSION: Conventional, publicly available sources provide insufficient information on new drugs, especially on patient relevant outcomes in approved subpopulations. This type of information is largely available in AMNOG documents, albeit only partly in English. The AMNOG approach could be used internationally to develop a comprehensive publication model for clinical studies and thus represents a key open access measure.

The EHR-ARCHE project: satisfying clinical information needs in a Shared Electronic Health Record system based on IHE XDS and Archetypes.

PURPOSE: While contributing to an improved continuity of care, Shared Electronic Health Record (EHR) systems may also lead to information overload of healthcare providers. Document-oriented architectures, such as the commonly employed IHE XDS profile, which only support information retrieval at the level of documents, are particularly susceptible for this problem. The objective of the EHR-ARCHE project was to develop a methodology and a prototype to efficiently satisfy healthcare providers' information needs when accessing a patient's Shared EHR during a treatment situation. We especially aimed to investigate whether this objective can be reached by integrating EHR Archetypes into an IHE XDS environment. METHODS: Using methodical triangulation, we first analysed the information needs of healthcare providers, focusing on the treatment of diabetes patients as an exemplary application domain. We then designed ISO/EN 13606 Archetypes covering the identified information needs. To support a content-based search for fine-grained information items within EHR documents, we extended the IHE XDS environment with two additional actors. Finally, we conducted a formative and summative evaluation of our approach within a controlled study. RESULTS: We identified 446 frequently needed diabetes-specific information items, representing typical information needs of healthcare providers. We then created 128 Archetypes and 120 EHR documents for two fictive patients. All seven diabetes experts, who evaluated our approach, preferred the content-based search to a conventional XDS search. Success rates of finding relevant information was higher for the content-based search (100% versus 80%) and the latter was also more time-efficient (8-14min versus 20min or more). CONCLUSIONS: Our results show that for an efficient satisfaction of health care providers' information needs, a content-based search that rests upon the integration of Archetypes into an IHE XDS-based Shared EHR system is superior to a conventional metadata-based XDS search.

Clinical situations and information needs of physicians during treatment of diabetes mellitus patients: a triangulation study.

Physicians should have access to the information they need to provide the most effective health care. Medical knowledge and patient-oriented information is dynamic and expanding rapidly so there is a rising risk of information overload. We investigated the information needs of physicians during treatment of Diabetes mellitus patients, using a combination of interviews, observations, literature research and analysis of recorded medical information in hospitals as part of a methodical triangulation. 446 information items were identified, structured in a set of 9 main categories each, as well as 6 time windows, 10 clinical situations and 68 brief queries. The physician's information needs as identified in this study will now be used to develop sophisticated query tools to efficiently support finding of information in an electronic health record.