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Supplemental material, sj-docx-4-aop-10.1177_10600280231160437 for Critical Care Pharmacist Attitudes and Perceptions of Neuromuscular Blocker Infusions in ARDS by John W. Devlin, Sarah E. Train, Karen E. A. Burns, Anthony Massaro, Ting Ting Wu, Timothy Castor, John Vassaur, Kavitha Selvan, John P. Kress and Brian L. Erstad in Annals of Pharmacotherapy

Supplemental material, sj-docx-2-aop-10.1177_10600280231160437 for Critical Care Pharmacist Attitudes and Perceptions of Neuromuscular Blocker Infusions in ARDS by John W. Devlin, Sarah E. Train, Karen E. A. Burns, Anthony Massaro, Ting Ting Wu, Timothy Castor, John Vassaur, Kavitha Selvan, John P. Kress and Brian L. Erstad in Annals of Pharmacotherapy

Supplemental material, sj-docx-3-aop-10.1177_10600280231160437 for Critical Care Pharmacist Attitudes and Perceptions of Neuromuscular Blocker Infusions in ARDS by John W. Devlin, Sarah E. Train, Karen E. A. Burns, Anthony Massaro, Ting Ting Wu, Timothy Castor, John Vassaur, Kavitha Selvan, John P. Kress and Brian L. Erstad in Annals of Pharmacotherapy

Supplemental material, sj-docx-3-aop-10.1177_10600280231160437 for Critical Care Pharmacist Attitudes and Perceptions of Neuromuscular Blocker Infusions in ARDS by John W. Devlin, Sarah E. Train, Karen E. A. Burns, Anthony Massaro, Ting Ting Wu, Timothy Castor, John Vassaur, Kavitha Selvan, John P. Kress and Brian L. Erstad in Annals of Pharmacotherapy

Supplemental material, sj-docx-1-aop-10.1177_10600280231160437 for Critical Care Pharmacist Attitudes and Perceptions of Neuromuscular Blocker Infusions in ARDS by John W. Devlin, Sarah E. Train, Karen E. A. Burns, Anthony Massaro, Ting Ting Wu, Timothy Castor, John Vassaur, Kavitha Selvan, John P. Kress and Brian L. Erstad in Annals of Pharmacotherapy

Supplemental material, sj-docx-2-aop-10.1177_10600280231160437 for Critical Care Pharmacist Attitudes and Perceptions of Neuromuscular Blocker Infusions in ARDS by John W. Devlin, Sarah E. Train, Karen E. A. Burns, Anthony Massaro, Ting Ting Wu, Timothy Castor, John Vassaur, Kavitha Selvan, John P. Kress and Brian L. Erstad in Annals of Pharmacotherapy

Additional file 1: Pharmacokinetic and clinical trials involving low molecular weight heparin and unfractionated heparin.

Supplemental material, sj-pdf-1-aic-10.1177_0310057X20968573 for Dosing of neuromuscular blocking agents in patients with obesity: A narrative review by Brian L Erstad Jeffrey F Barletta in Anaesthesia and Intensive Care

Supplemental material, sj-docx-1-taw-10.1177_2042098621991279 for Association of immune-checkpoint inhibitors and the risk of immune-related colitis among elderly patients with advanced melanoma: real-world evidence from the SEER–Medicare database by Abdulaali R. Almutairi, Marion Slack, Brian L. Erstad, Ali McBride and Ivo Abraham in Therapeutic Advances in Drug Safety

Aims: Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. The second dimension (δ2) estimates prices on the basis of four willingness-to-pay (WTP) thresholds. We describe this dimension’s methodology and present a proof-of-concept application to the treatment of non-small cell lung cancer (NSCLC) with EGFR mutation with osimertinib. Materials and methods: Eight WTP scenarios based on four levels of real gross domestic product per capita (3xGDP/capita) and two market conditions (monopolistic versus competitive) were assumed. The incremental cost-utility ratio (ICUR) was applied to differently to both markets. In the monopolistic market, assuming no competitors, the cost/QALY ratio for a drug was used; whereas in the competitive market, assuming competitors, the incremental cost-utility ratio (ICUR) was applied. One-way sensitivity analyses were performed and predictive equations were specified to estimate the prices of treatment for the resulting eight WTP scenarios; for which subsequently the average and standard deviation were calculated. A gamma distribution was specified and Monte Carlo Simulation (MCS) was applied to estimate the dimension-specific price based on WTP (DSPWTP). A proof-of-concept exercise with osimertinib in NSCLC was performed for two hypothetical outcome-based contracts: 1-year (2019-2020) and 2-year (2019-2021). The 2018 wholesale acquisition cost (WAC) of $14,616 (30-day prescription) was used to estimate the DSPWTP for each contract. Results: The 1-year estimates averaged $4,654 (SD=$6,462) and the MCS yielded a DSPWTP of $4,547 or -68.89% of the 2018 WAC for a 30-day prescription. The 2-year estimates averaged $4,7667 (SD=$6,480) with the MCS generating a DSPWTP of $4,704 or -67.82% of the WAC. Conclusions: We demonstrated that WTP-based methods that include various WTP thresholds and market conditions generate price estimates across these thresholds and market conditions that can be integrated into our proposed Six Delta platform for outcome-based pricing/contracting.

Aims: Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. The fourth dimension (δ4) estimates prices on the basis of assessments of the safety of the drug using an ex ante analysis based on clinical trial data. We describe this dimension’s methodology and present a proof-of-concept application to the treatment of non-small cell lung cancer (NSCLC) with EGFR mutation with osimertinib. Materials and methods: The safety-based pricing dimension utilizes a four-step method: 1) pooling adverse events (AE), standardizing, estimating 95%CIs, and adjusting for time; 2) estimating correction factors and corrected probabilities of AEs; 3) estimating the probability of at least one adverse event (AE) occurring and leading to treatment discontinuation; and 4) estimating ranges for payback percentages and performing Monte Carlo Simulation to estimate a DSPSafety. A proof-of-concept exercise with osimertinib in NSCLC was performed for two hypothetical outcome-based contracts: 1-year (2019-2020) and 2-year (2019-2021). We estimated the DSPSafety based on the grade 3/4 AEs observed for osimertinib and standard of care. The 2018 wholesale acquisition cost (WAC) of osimertinib at $14,616 for a 30-day prescription was used. Results: AEs3/4 were retrieved from the FLAURA trial. In the 1-year contract, the DSPSafety of osimertinib was estimated at $14,627 (or +0.08% the 2018 WAC) for a 30-day prescription. In the 2-year contract, the DSPSafety of osimertinib was estimated at $14,516 (or −0.68% the 2018 WAC) for a 30-day prescription. Conclusions: We demonstrated that ex ante pricing methods-based paybacks for safety issues leading to treatment discontinuation can be integrated into our proposed Six Delta platform for outcome-based pricing/contracting.

Aims: Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. The first dimension (δ1) estimates prices on the basis of cost-effectiveness (CEA) and cost-utility analysis (CUA). We describe this dimension’s methodology and present a proof-of-concept application to the treatment of non-small cell lung cancer (NSCLC) with EGFR mutation with osimertinib. Materials and methods: CEA and CUA were performed using established methods. Probabilistic sensitivity analyses (PSA) were performed to generate cost-effectiveness acceptability curves (CEAC), specifically the PSA incremental cost-effectiveness (PSA ICER) and incremental cost-utility ratio generated CEACs (PSA ICUR). Price of treatment was estimated at three certainty levels (0%, turning point%, 100%). The marketed drug price at turning point was used to estimate prices at 0% and 100% certainty levels, as per PSA ICER and PSA ICUR-generated CEACs. The resulting prices were pooled, inflated, and simulated by Monte Carlo Simulation (MCS) methods to estimate the dimension-specific price based on CEA and CUA (DSPCEA/CUA). A proof-of-concept exercise with osimertinib in NSCLC was performed for two hypothetical outcome-based contracts: 1-year (2019-2020) and 2-years (2019-2021). Results: Turning points were estimated at the 50% certainty level in both PSA ICER and ICUR-generated CEACS. At these points, the wholesale acquisition cost for osimertinib was $14,616 (30-day prescription); inflated by 0.44% for 1-year and by 0.72% for 2-year contracts. Additional prices at 0% and 100% certainty levels were quantified based on the PSA ICER and ICUR-generated CEACs. The MCS yielded a DSPCEA/CUA of $16,391 for the 1-year contract and a DSPCEA/CUA at $16,677 for the 2-year contract for a 30-day prescription. Conclusions: We demonstrated that conventional CEA and CUA methods generate price estimates at varying levels of certainty that can be integrated into our proposed Six Delta platform for outcome-based pricing/contracting.

Additional file 2. Clinical and pharmacokinetic studies involving sedatives.

Aims: Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. The fifth dimension (δ5) estimates prices on the basis of the risk of efficacy failure of a drug. We describe this dimension’s methodology and present a proof-of-concept application to the treatment of non-small cell lung cancer (NSCLC) with EGFR mutation with osimertinib. Materials and methods: The risk of efficacy failure pricing dimension utilizes a seven-step method: 1) defining risk; 2) extracting data; 3) predicting models; 4) performing Monte Carlo Simulation (MCS) to estimate risk of efficacy failure; 5) estimating ranges for a payback; 6) adjusting for medical inflation; and 7) performing Monte Carlo Simulation (MCS) to estimate the DSPRisk of efficacy failure. A proof-of-concept exercise with osimertinib in NSCLC was performed for two hypothetical outcome-based contracts: 1-year (2019-2020) and 2-year (2019-2021). We estimated the risk of efficacy failure for osimertinib in terms of overall and progression-free survival versus standard of care. We used the estimated risk to estimate the price reduction on the wholesale acquisition cost (WAC) for the two hypothetical contracts: a 1-year (2019–2020) and 2-year contract (2019–2021). From this we estimated the DSPRisk of efficacy failure. Results: Based on the risk of OS and PFS efficacy failure for osimertinib in OS and PFS, in the 1-year contract, the DSPRisk of efficacy failure was estimated at $12,652 (or −13.44% the 2018 WAC) for a 30-day prescription. For the 2-year contract (2019-2021), the DSPRisk of efficacy failure was estimated at $13,019 (or −10.93% the 2018 WAC). Conclusions: We demonstrated that pricing methods based on risk of efficacy failure methods can be integrated into our proposed Six Delta platform for outcome-based pricing/contracting.

Aims: Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. The third dimension (δ3) estimates prices on the basis of international drug price referencing methods. We describe this dimension’s methodology and present a proof-of-concept application to the treatment of non-small cell lung cancer (NSCLC) with EGFR mutation with osimertinib. Materials and methods: The reference-based pricing dimension utilizes a six-step method: 1) selecting foreign countries based on a set of four criteria (drug is available in the foreign country, price information is available in the foreign country, foreign countries are members within the organization for Economic Co-operation and Development, pricing methods in the foreign countries involve value assessment); 2) adjusting for exchange rates; 3) generating reference price (RP) scenarios; 4) adjusting with the medical inflation rate; 5) pooling all generated RP scenarios and calculating average and standard deviation (SD); 6) and Monte Carlo Simulation (MCS) to estimate the dimension-specific DSPReference. A proof-of-concept exercise with osimertinib in NSCLC was performed for two hypothetical outcome-based contracts: 1-year (2019-2020) and 2-year (2019-2021). Results: The United Kingdom and Canada met the four criteria. For the osimertinib 1-year contract price, the average of eight RP scenarios, adjusted for inflation by 0.44%, was $8,892 (SD=$2,606) for a 30-day prescription. MCS yielded a DSPReference estimate of $9,395 or -35.72% of the wholesale acquisition cost (WAC) of $14,616. For the 2-year contract, the average, adjusted for inflation by 0.72%, was $8,928 (SD=$2,610). MCS yielded a DSPReference estimate of $9,442 or -35.40% of the WAC of $14,616. Conclusions: We demonstrated that international price referencing methods can be integrated into our proposed Six Delta platform for outcome-based pricing/contracting.

Supplemental material, _Online_Data_Supplement for Clinical Pharmacist–Led Impact on Inappropriate Albumin Utilization and Associated Costs in General Ward Patients by Mitchell S. Buckley, Sumit K. Agarwal, Jake M. Lansburg, Brian J. Kopp and Brian L. Erstad in Annals of Pharmacotherapy

Additional file 1. Hypothetical examples of initial doses in three male patients with different weights using ideal body weight, adjusted body weight and actual body weight. For each example, height is estimated to be 5’9” and adjusted body weight is calculated using a correction factor of 0.4.

Aims: Six Delta is a six-dimensional independent platform for outcome-based pricing/contracting. The sixth dimension (δ6) estimates prices on the basis of adherence to the prescribed regimen, whereby manufacturers provide payers with adherence-enhancing programs and whereby payers implement these programs and provide adherence data to the manufacturer. We describe this dimension’s methodology and present a proof-of-concept application to the treatment of non-small cell lung cancer (NSCLC) with EGFR mutation with osimertinib. Materials and methods: We propose two paybacks based on adherence: in-advance (based on clinical trial data) and in-arrear (based on real-world data). The risk of efficacy failure pricing dimension utilizes a seven-step method: 1) defining efficacy endpoints; 2) extracting data; 3) predicting models; 4) estimating in-advance and in-arrear paybacks; 5) suggesting ranges for in-advance and in-arrear paybacks; 6) adjusting for medical inflation; and 7) performing Monte Carlo Simulation (MCS) to estimate the DSPAdherence. A proof-of-concept exercise with osimertinib in NSCLC was performed for two hypothetical outcome-based contracts: 1-year (2019-2020) and 2-year (2019-2021). The 2018 wholesale acquisition cost (WAC) for a 30-day prescription was used and inflated as needed. Herein, the DSPAdherence is estimated exclusively in terms of in-advance payback because real-world data about osimertinib are not yet available and thus the in-arrear payback cannot yet be estimated. Results: For the 1-year contract, the average price for osimertinib was $13,798 (SD=$1,265) and the DSPAdherence was $13,785 (or -5.69% of the 2018 WAC) for a 30-day prescription. For the 2-year contract, the average price was $12,555 (SD=$2,847) and the DSPAdherence was $12,582 (or -13.92% of the 2018 WAC). Conclusions: We demonstrated that adherence-based pricing methods can be integrated into our proposed Six Delta platform for outcome-based pricing/contracting. The proof-of-concept exercise needs to be expanded with the in-arrear pricing method based on real world data to be secured.

Supplemental material, _Online_Data_Supplement_Revised_Clean_copy for Clinical Pharmacist–Led Impact on Inappropriate Albumin Use and Costs in the Critically Ill by Mitchell S. Buckley, Kristen D. Knutson, Sumit K. Agarwal, Jake M. Lansburg, Laura M. Wicks, Rajeev C. Saggar, Emily C. Richards, Brian J. Kopp and Brian L. Erstad in Annals of Pharmacotherapy

Successful management of a pandemic or disaster requires implementation of preexisting plans to minimize loss of life and maintain control. Managing the expected surges in intensive care capacity requires strategic planning from a systems perspective and includes focused intensive care abilities and requirements as well as all individuals and organizations involved in hospital and regional planning. The suggestions in this article are important for all involved in a large-scale disaster or pandemic, including front-line clinicians, hospital administrators, and public health or government officials. Specifically, this article focuses on surge logistics—those elements that provide the capability to deliver mass critical care.The Surge Capacity topic panel developed 23 key questions focused on the following domains: systems issues; equipment, supplies, and pharmaceuticals; staffing; and informatics. Literature searches were conducted to identify studies upon which evidence-based recommendations could be made.This article presents 22 suggestions pertaining to surge capacity mass critical care, including requirements for equipment, supplies, and pharmaceuticals; staff preparation and organization; methods of mitigating overwhelming patient loads; the role of deployable critical care services; and the use of transportation assets to support the surge response.