Table 2

Recommendations on future unrelated medical costs by official guidelines for economic evaluation in different jurisdictions

Country/areaGuidelinesYearInclusion or exclusionRecommendations (if available)
Africa
South AfricaGuidelines for Pharmacoeconomic Evaluations of Medicines and Scheduled Substances2013Not specified
  • In general, indirect costs should not be included in the submission.

EgyptRecommendations for Reporting Pharmacoeconomic Evaluations in Egypt2013Not specified
  • Direct medical costs should be included.

  • Other direct non-medical and indirect costs paid by patients, including lost productivity costs, might be included only in the sensitivity analysis.

Latin America
BrazilMethodological Guidelines: Economic Evaluation of Health Technologies2014Not specified
  • The included cost components should be described in detail and separated by type of cost (medical-hospital rights, non-medical-hospital, indirect and intangible direct cost).

ColombiaManual Para la Elaboración de Evaluaciones Económicas en Salud2014Not specified
  • Direct costs for the healthcare system should be considered.

  • Indirect costs and direct non-medical costs should be excluded, such as productivity and other costs assumed by patients on the base case.

CubaMethodological Guidelines for Health Economic Evaluation2003Not specified
  • All relevant cost data should be clearly identified and explained in detail.

MexicoEconomic Assessment Study Guideline for Updating the National Formulary in Mexico2015Not specified
  • The suggested perspective only included the direct costs.

MERCOSUR (Argentina, Brazil, Paraguay, Uruguay)Guideline for Economic Evaluation of Health Technologies2015Not specified
  • The costs such as direct healthcare costs, indirect costs, patient and family costs and productivity loss should be appropriate for the chosen perspective.

North America
USAICER’s Base case for Economic Evaluations: Principles and Rationale2020Inclusion
  • In cases where an intervention that increases QALYs is not found to be cost effective, even with a zero-dollar price, a separate scenario analysis excluding unrelated (non-drug) healthcare costs will be presented.

USARecommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses Second Panel on Cost-Effectiveness in Health and Medicine2016Inclusion
  • The new recommendations suggest the inclusion of future costs (ie, that cost effectiveness analyses account for related or unrelated healthcare costs that occur during the additional life-years produced by an intervention).

USAAMCP Format for Formulary Submissions Guidance on Submission of Pre-approval and Post-approval Clinical and Economic Information and Evidence2019Not specified
  • The model should be disease-based and depict the costs of the product and other medical resources consumed within each clinical pathway, including the economic impact of adverse events.

CanadaGuidelines for the Economic Evaluation of Health Technologies: Canada fourth Edition2017Not specified
  • The evaluation should include all relevant resources and costs based on the perspective of funded healthcare payer.

Asia
China (Mainland)China Guidelines for Pharmacoeconomic Evaluations2020Exclusion
  • The costs unrelated to the target disease or the intervention can be excluded.

JapanGuideline for Preparing
Cost-Effectiveness Evaluation to the Central Social Insurance
Medical Council
2019Exclusion
  • Healthcare costs of each health state include only related costs that are directly affected by the selected technology and do not include unrelated costs.

MalaysiaPharmacoeconomic guidelines for Malaysia second edition2019Not specified
  • All direct costs relevant to the services borne by the payer.

Taiwan of ChinaGuidelines of Methodological Standards for Pharmacoeconomic Evaluations (V.1.1, draft)2008Exclusion
  • For the extended life-year cost, the costs those are not related to target disease should be excluded.

South KoreaKorean Guidelines for Pharmacoeconomic Evaluation
(Second and Updated Version)
2013Exclusion
  • All costs not including productivity costs, unrelated future medical cost should be considered.

IsraelGuidelines for the Submission of a Request to Include a Pharmaceutical Product in the National List of Health Services2010Not specified
  • The costs are direct and indirect medical costs.

  • If use of the new technology requires or spares spending on other medical technologies, these costs should be included in the calculation.

ThailandGuidelines for health technology assessment in Thailand (second edition)2014Not specified
  • The choice whether to include or exclude future unrelated costs will depend on the payer requirement and perspective.

Europe
AustriaGuidelines on Health Economic
Evaluation Consensus paper
2006Not specified
  • Fundamentally, all costs relevant to the chosen perspective must be determined and included in the analysis.

DenmarkThe Danish Approach to Standards for Economic Evaluation Methodologies1997Not specified
  • All relevant costs should be considered including direct, indirect and intangible costs

  • Indirect and intangible costs should be reported separately and valued on if they are considered relevant.

HungaryProfessional Healthcare Guideline on the Methodology of Health Technology Assessment2017Exclusion in base case. Inclusion in supplementary analysis
  • Costs generated due to diseases not related to the given health service, costs emerging in the life lengthened by the therapy but not due to the disease examined in the analysis, or other indirect costs cannot be presented, or, in justified cases, can be presented in additional analyses.

ItalyGuidance to applicants for the submission of pharmacoeconomic analysis within the Pricing and Reimbursement Dossier2020Not specified
  • In the base case, it is required to include the direct healthcare costs in line with the NHS perspective.

  • Indirect costs and non-health care costs could be considered in a supplementary analysis from the societal perspective.

Russian FederationGuidelines for Conducting a Comparative Clinical and Economic Evaluation of Drugs2016Not specified
  • Direct medical costs are mandatory.

  • Accounting for other types of costs remains at the discretion of researchers and different types of costs are indicated separately.

SpainSpanish Recommendations on Economic Evaluation of Health Technologies2010Not specifiedThe societal perspective is recommended considering all the related costs.
CroatiaThe Croatian Guideline for Health Technology Assessment Process and Reporting2011Not specified
  • Where measurable and relevant, indirect costs and costs falling outside of Croatian Institute for Health Insurance should be reported separately.

Baltic (Latvia, Lithuania, Estonia)Baltic Guideline for Economic Evaluation of Pharmaceuticals (Pharmacoeconomic Analysis)2002Not specified
  • The suggested perspective includes only direct healthcare costs.

  • If relevant, include all costs outside healthcare system, presented separately.

BelgiumBelgian Guidelines for Economic Evaluations and Budget Impact Analyses: Second Edition2015Exclusion in base case; Inclusion in supplementary analysis
  • Costs borne outside the healthcare sector should not be included in the Base case analysis;

  • If productivity losses, non-health care costs and/or unrelated healthcare costs are deemed important for a specific treatment, they may be presented in a separate analysis.

FranceChoices In Methods for Economic Evaluation2012Exclusion
  • Future costs independent of the interventions being studied are not considered

GermanyWorking Paper Cost Estimation2009Exclusion in base case; Inclusion in supplementary analysisSumming up the controversial discussion on future costs, the following recommendations apply:
  • Only future related costs should be considered in the base case.

  • In sensitivity analyses, total healthcare costs (related and unrelated healthcare costs) in life-years gained should also be calculated if possible.

IrelandGuidelines for the Economic Evaluation of Health Technologies in Ireland2019Not specified
  • Only direct costs relevant to the public-funded health and social care system should be included in the base case.

Nether- landsGuideline for Economic Evaluations in Healthcare2016Inclusion
  • If an intervention increases the life expectancy, ‘related’ costs and ‘non-related’ costs should both be considered in an economic evaluation of a life-lengthening intervention.

NorwayGuidelines for the Submission of Documentation for Single Technology Assessment Of Pharmaceuticals2018Exclusion
  • The health service costs related to future unrelated illness will not be taken into consideration.

PortugalGuidelines For Economic Drug Evaluation Studies1998Not specified
  • When the analysis adopts the perspective of society, the costs included will be the direct costs of providing healthcare, the costs of social services and other sectors related to healthcare and the costs borne by patients and their families.

SlovakGuidelines for Economic Evaluation of Healthcare Interventions2011Exclusion
  • Direct healthcare costs should be included. These encompass costs directly related to the treatment of the disease as well as direct healthcare costs related to the disease in life-years gained.

SloveniaRules on the Classification of Medicine on the List2013Not specified
  • The analysis should include direct health costs (total direct costs of drug and total direct costs of other healthcare procedures connected to changes in drug therapy) for all future years.

SwedenAssessment of Methods in Healthcare and Social Services2018Not specified
  • Which direct costs to include depends on the type of method that is being evaluated.

  • In certain cases, costs for sectors of society other than those delivering the services can be the most important for the analysis.

  • The most important indirect cost is the reduced productivity due to incapacity to work because of disease or social problem.

Czech RepublicCost-effectiveness Guidelines2017Exclusion
  • All relevant direct costs covered from health insurance company perspective (medical and non-medical) to the disease should be identified.

England & WalesGuide to the Methods of Technology Appraisal 20132013Exclusion
  • Costs related to the condition of interest and incurred in additional years of life gained as a result of treatment should be included in the reference-case analysis.

  • Costs considered to be unrelated to the condition or technology of interest should be excluded.

FinlandPreparing a Health Economic Evaluation to Be Attached to the Application for Reimbursement Status and Wholesale Price for A Medicinal Product2019Not specified
  • The calculation of costs must include, irrespective of the payer, all direct healthcare and comparable social welfare costs related to the therapies that are being compared.

PolandHealth Technology Assessment Guidelines V.3.02016Not specified
  • The suggested perspective only includes the consideration of direct medical costs.

ScotlandGuidance to Submitting Companies for Completion of New Product Assessment Form2020Exclusion
  • Costs should relate to resources that are under the control of the NHS.

  • When sensitivity analyses include non-NHS/social work costs, explicit methods of valuation are required.

Oceania
New ZealandPrescription for Pharmacoeconomic Analysis: Methods for Cost-Utility Analysis V.2.22015Exclusion
  • Indirect future healthcare costs including costs associated with patients living longer and hence consuming healthcare resources unrelated to their initial diagnosis or treatment should not be included.

AustraliaGuidelines for Preparing a Submission to the Pharmaceutical Benefits Advisory Committee2016Not specified
  • Healthcare resource costs should be considered including those incurred by the patient, and the public or private healthcare provider

  • AMCP, Academy of Managed Care Pharmacy; ICER, Institute for Clinical and Economic Review; NHS, National Health Service; QALYs, quality-adjusted life-years.