Characterizing UncertaintyDetermini

Characterizing Uncertainty<br><br>Deterministic sensitivity and scenario analyses should be provided with the submitted BIA to inform decision makers of the sensitivity of the model to specific assumptions. Probabilistic sensitivity analyses may be considered but are not required.<br><br>Validation<br><br>The validity of the model should be assessed and documented.<br><br>Input and Data Source Recommendations<br>Estimation of the Current Size of the Market<br><br>When estimating the size of the market, analysts may develop their models based on either population (epidemiological) data or claims data, or in some instances, both. Population data is best used for a novel drug entering a new market, while claims data is usually used for a novel drug entering a more mature market. For transparency and completeness, claims data-based models should provide an estimate of the number of active beneficiaries based on the number of claims for both the Reference and New Drug scenarios.<br><br>Selection of Relevant Comparators<br><br>The comparators used in the budget impact model should reflect drug-based treatment strategies used to treat the same indication(s) as the new drug. For transparency, the costs for concomitant medicines should be listed separately in the model. Non-drug alternatives are excluded from the base-case analysis but should be mentioned in the report and can be included in the scenario analysis if they are expected to have a significant impact. The relevant treatment strategies identified should align with those used in the economic evaluation submitted with the BIA, if possible.<br><br>Forecasting of the Market Under the Reference Scenario<br><br>Analysts should use published forecasts to anticipate changes in the market. The forecasts should take expected changes to the market over the time horizon into consideration using available data. These changes include, but are not limited to, anticipated market growth and market distribution of the treatment strategies expected to be available.<br><br>Forecasting of the Market Under the New Drug Scenario<br><br>To forecast changes under the New Drug Scenario, analysts should use verifiable market intelligence on how the reimbursement of the new drug will affect the market. Markets where the new drug is currently reimbursed should be consulted to inform the forecasting process. Analysts should estimate the anticipated growth of the market, the expected market share of the new drug, the effect of any restrictions to access to the new drug on the market size or market share, and how the new drug will affect the market share of all relevant treatment strategies. These factors should be considered for the entire time horizon and data supporting these estimates should be provided and explained.<br><br>Estimating Drug Costs<br><br>To estimate the cost of each treatment strategy, analysts should obtain reimbursement prices from the best available source(s), such as the drug plan formulary, public drug plan databases, and wholesaler pricing information. Additionally, analysts should include markups, dispensing fees, and patient co-payments according to the drug plan’s specifications. When comparing the cost per day of different treatment strategies, it is important to consider therapeutic equivalencies (i.e., the frequency of drug administration) and drug wastage (i.e., the number of drug units dispensed per prescription, rather than consumed). The BIA should address the impact of compliance and persistence with therapy on the cost of treatments, as required, based on the best available evidence. Analysts should consider whether any additional assumptions used in the accompanying economic evaluation are applicable for estimating drug costs.

不确定性的特征<br><br>应向提交的BIA提供确定性敏感性和情景分析，使决策者了解模型对具体假设的敏感性。可考虑概率灵敏度分析，但不需要。<br><br>验证<br><br>模型的有效性应进行评估和记录。<br><br>输入和数据源建议<br>对当前市场规模的估计<br><br>在估计市场规模时，分析师可能会根据人口（流行病学）数据或索赔数据，或在某些情况下，同时开发其模型。人口数据最好用于进入新市场的新型药物，而声称数据通常用于进入更成熟市场的新型药物。为了提高透明度和完整性，基于索赔数据的模型应根据参考和新药方案的索赔数量，提供主动受益人的估计数。<br><br>相关比较器的选择<br><br>预算影响模型中使用的比较器应反映用于治疗与新药相同的指示的药物治疗策略。为了提高透明度，应在模型中单独列出伴随药物的成本。非药物替代品被排除在基本案例分析之外，但应在报告中提及，如果预期会产生重大影响，则可列入情景分析。如果可能，确定的相关治疗战略应与提交国际投资局的经济评估中使用的策略一致。<br><br>参考情景下的市场预测<br><br>分析师应该使用已发布的预测来预测市场的变化。预测应利用现有数据考虑市场在时间范围内的预期变化。这些变化包括但不限于预期的市场增长和预期的治疗策略的市场分布。<br><br>新药情景下的市场预测<br><br>为了预测新药情景下的变化，分析师应使用可验证的市场情报来预测新药的报销将如何影响市场。应咨询目前报销新药的市场，以告知预测过程。分析师应估计市场的预期增长、新药的预期市场份额、任何限制获得新药对市场规模或市场份额的影响，以及新药将如何影响所有相关治疗策略的市场份额。应在整个时间范围内考虑这些因素，并提供和解释支持这些估计的数据。<br><br>估计药物成本<br><br>为了估算每个治疗策略的成本，分析师应从最佳可用来源（如药物计划配方、公共药物计划数据库和批发商定价信息）获取报销价格。此外，分析师应根据药物计划的规格包括加价、配药费和患者共同付款。在比较不同治疗策略的每天费用时，必须考虑治疗等价物（即药物管理频率）和药物浪费（即每个处方开出的药物单位数，而不是消费量）。BIA应根据现有最佳证据，根据需要解决遵守和坚持治疗对治疗费用的影响。分析师应考虑在随附的经济评估中使用的任何其他假设是否适用于估计药物成本。

Characterizing UncertaintyDeterministic sensitivity and scenario analyses should be provided with the submitted BIA to inform decision makers of the sensitivity of the model to specific assumptions. Probabilistic sensitivity analyses may be considered but are not required.ValidationThe validity of the model should be assessed and documented.Input and Data Source RecommendationsEstimation of the Current Size of the MarketWhen estimating the size of the market, analysts may develop their models based on either population (epidemiological) data or claims data, or in some instances, both. Population data is best used for a novel drug entering a new market, while claims data is usually used for a novel drug entering a more mature market. For transparency and completeness, claims data-based models should provide an estimate of the number of active beneficiaries based on the number of claims for both the Reference and New Drug scenarios.Selection of Relevant ComparatorsThe comparators used in the budget impact model should reflect drug-based treatment strategies used to treat the same indication(s) as the new drug. For transparency, the costs for concomitant medicines should be listed separately in the model. Non-drug alternatives are excluded from the base-case analysis but should be mentioned in the report and can be included in the scenario analysis if they are expected to have a significant impact. The relevant treatment strategies identified should align with those used in the economic evaluation submitted with the BIA, if possible.Forecasting of the Market Under the Reference ScenarioAnalysts should use published forecasts to anticipate changes in the market. The forecasts should take expected changes to the market over the time horizon into consideration using available data. These changes include, but are not limited to, anticipated market growth and market distribution of the treatment strategies expected to be available.Forecasting of the Market Under the New Drug ScenarioTo forecast changes under the New Drug Scenario, analysts should use verifiable market intelligence on how the reimbursement of the new drug will affect the market. Markets where the new drug is currently reimbursed should be consulted to inform the forecasting process. Analysts should estimate the anticipated growth of the market, the expected market share of the new drug, the effect of any restrictions to access to the new drug on the market size or market share, and how the new drug will affect the market share of all relevant treatment strategies. These factors should be considered for the entire time horizon and data supporting these estimates should be provided and explained.Estimating Drug CostsTo estimate the cost of each treatment strategy, analysts should obtain reimbursement prices from the best available source(s), such as the drug plan formulary, public drug plan databases, and wholesaler pricing information. Additionally, analysts should include markups, dispensing fees, and patient co-payments according to the drug plan’s specifications. When comparing the cost per day of different treatment strategies, it is important to consider therapeutic equivalencies (i.e., the frequency of drug administration) and drug wastage (i.e., the number of drug units dispensed per prescription, rather than consumed). The BIA should address the impact of compliance and persistence with therapy on the cost of treatments, as required, based on the best available evidence. Analysts should consider whether any additional assumptions used in the accompanying economic evaluation are applicable for estimating drug costs.<br>