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Pharmacoeconomic Guidelines Around The World

Country/Region: United States of America

Published PE Recommendations
The AMCP Format for Formulary Submissions (Version 4.0, April, 2016)
PDF in English

Published PE Recommendations Source:
Academy of Managed Care Pharmacy

Additional Information:
1. Additional information related to the Format may be found at the link above, including the Format, Word versions of the Appendices, slides from the 4.0 release presentation, a link to a webinar providing a guided tour of key changed and enhancements, and a link to previous versions of the Format.
2. The AMCP Format for Formulary Submissions: Welcome to Version 4.0.
J Manag Care Spec Pharm, 2016 May;22(5): 444-446.

Last Webpage Update: Monday, June 20, 2016

Published PE Recommendations Key Features:

Key Features:  
Title and year of the documentThe AMCP Format for Formulary Submissions (Version 4.0, April 2016) 
Affiliation of authorsAMCP Format Executive Committee members (see Acknowledgements page for affiliations)  
Purpose of the documentFirst, it is intended to improve the timeliness, scope, quality and relevance of information available to a health system’s evaluators and ultimately to its P&T Committees. Second, the AMCP Format streamlines the data acquisition and review process for health system staff pharmacists. Also, support the informed selection of pharmaceuticals, biologics and vaccines by: a) Standardizing and communicating product and supporting program information requirements; b) Requiring projections of product impact on both the organization and its enrolled patient population; c) Requesting information on the value of products; and d) Making evidence and rationale supporting all choice(s) more clear, transparent and evaluable by decision makers. 
Standard reporting format includedYes 
Target audience of funding/ author's interestsHealth systems and those within the health systems who have responsibility for managing their formularies and analyzing data submitted by manufacturers in advance of coverage and reimbursement considerations. 
PerspectiveThe payer perspective is recommended for the primary analysis, with optional perspectives (i.e., societal, employer) conducted as secondary evaluations. 
IndicationInclusion of data to support product use in labeled and off-label indications is encouraged.  
Target populationYes, target population should be clearly defined in submission.  
Subgroup analysisYes, include clinical markers, diagnostic or genetic criteria, or other markers, if known, that can be used to identify appropriate subpopulations.  
Choice of comparatorExisting standard of care, best available, usual care or best supportive care 
Time horizonAlthough Suggested time horizons include 1-year, 5-year and over the course of the disease, the payer may choose an alternative time horizon. 
Assumptions requiredYes, documented with source citations 
Preferred analytical techniqueBoth cost-effectiveness analyses and budget impact models (BIM) are commonly presented in the Format. Analytical technique should be selected based on appropriateness of use in the condition or treatment being evaluated. QALY-based analyses are helpful when clinically appropriate and possible given the existing data inputs. BIM's provide useful information to decision makers related to the expected financial effects of product adoption from a payer perspective.  
Costs to be includedAll resources used that are relevant to the analysis and which are nontrivial in magnitude should be included in the base case analysis.  
Source of costsAll costs should be valued using payer-relevant sources where possible.  
ModelingYes, where direct primary or secondary empirical evaluation of effectiveness is not available or is limited to relatively short duration studies compared with the typical duration of the disease. 
Systematic review of evidencesYes, from best designed and least biased sources relevant to the question and population under study  
Preference for effectiveness over efficacyYes, evidences may be drawn from RCTs, observational data, systematic reviews, uncontrolled experiments, descriptive series and expert opinion and should include both benefits and harms of alternatives  
Preferred outcome measureAssess clinical events, life expectancy, and QALYs – with the latter two outcomes primarily relevant for lifetime timeframe analyses. 
Preferred method to derive utilityPreference measures used should be generic, however, not endorsing any particular generic preference-weighted instrument  
Equity issues statedYes  
Discounting costsWhen appropriate, adjustment for the time preference should be incorporated and should follow US PHS Panel recommendations. 
Discounting outcomesWhen appropriate, adjustment for the time preference should be incorporated and should follow US PHS Panel recommendations. 
Sensitivity analysis-parameters and rangeThe 3-5 parameters and 2-3 assumptions that have the greatest impact on the results should be identified. Probabilistic sensitivity analysis (PSA) and the generation of cost-effectiveness scatter plots and acceptability curves are recommended. Analysts should justify the distribution used for each parameter that is included in a PSA. The use of arbitrary lower and upper values is strongly discouraged. Use of generally accepted confidence intervals (95%) should be employed if parameter uncertainty is, at least largely, characterized by random error.  
Sensitivity analysis-methodsBoth univariate and PSA should be conducted. Comprehensive one-way sensitivity analysis of all parameters in the model is strongly recommended. including assessment of impacts on both incremental effectiveness (e.g., QALYs) and cost-effectiveness.   
Presenting resultsModels should be implemented in spreadsheet software. 1. Provide a figure displaying the structure of the model; 2. Provide a table listing all of the model inputs including probabilities, costs, and utility estimates if appropriate. Provide a range of values upon which sensitivity analyses are based for each input. 3. Provide an explicit list of model assumptions including assumptions about comparator interventions, clinical events, patient management, and costs.; 4. Present the disaggregated results in a table; 5. Present results of sensitivity analyses in figures or tables.  
Incremental analysisYes 
Total costs vs effectiveness (cost/effectiveness ratio)Yes 
Portability of results (Generalizability)Yes 
Financial impact analysisBIM are appropriate but financial analyses (e.g., drug cost only) are not directly relevant to value-based decision-making, 
Mandatory or recommended or voluntaryVoluntary, however many US payer organizations now require the Format as a core evidence communication resource to support payer decision making.  

Acknowledgement: The key features form was contributed by Jeff Lee and Kim Saverno and reviewed by Dan Malone and Susan Oh
Jeff Lee, PharmD, FCCP, Associate Professor, Pharmacy Practice, Lipscomb University College of Pharmacy, Nashville, TN
Kim Saverno, PhD, RPh, Research Lead, Comprehensive Health Insights, Humana, Inc., Austin, TX
Daniel C. Malone, RPh, PhD, Professor, College of Pharmacy, University of Arizona
Susan Oh, PharmD, MS, Assistant Director of Pharmacy Affairs, Academy of Managed Care Pharmacy

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