|
Key
Features: |
|
| Title and year of the Document | The AMCP Format for Formulary Submissions (Version 2.1, April 2005) |
| Affiliation of authors | FMCP staff and the Format Executive Committee |
| Main policy objective | First, 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. |
| Standard reporting format included | Yes, with the design of reference case. |
| Disclosure | No |
| Target audience of funding/ author’s interests | Health 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. |
| Perspective | The payer perspective is recommended for the primary analysis. AMCP Format welcomes a societal perspective analysis as a secondary evaluation. |
| Indication | Yes |
| Target population | Yes, need to be indicated |
| Subgroup analysis | Yes |
| Choice of comparator | Existing best available, viable or a do-nothing alternative |
| Time horizon | Suggested time horizons include 1-year, 5-year and over the course of the disease. The exact time horizon used will depend on the natural course of the disease. In some cases, multiple time horizons might be appropriate. |
| Assumptions required | Yes |
| Preferred analytical technique | CEA or CUA |
| Costs to be included | All resources used that are relevant to the analysis and which are nontrivial in magnitude should be included in the reference case |
| Source of costs | All costs should be valued at opportunity costs |
| Modeling | Yes, where direct primary or secondary empirical evaluation of effectiveness is not available |
| Systematic review of evidences | Yes, from best designed and least biased sources relevant to the question and population under study |
| Preference for effectiveness over efficacy | Yes, evidences may be drawn from RCTs, observational data, uncontrolled experiments, descriptive series and expert opinion and should include both benefits and harms of alternatives |
| Preferred outcome measure | QALYs |
| Preferred method to derive utility | Preference measures used should be generic, however, not endorsing any particular generic preference-weighted instrument |
| Equity issues stated | Yes |
| Discounting costs | When appropriate, adjustment for the time preference should be incorporated and should follow US PHS Panel recommendations. |
| Discounting outcomes | When appropriate, adjustment for the time preference should be incorporated and should follow US PHS Panel recommendations. |
| Sensitivity analysis-parameters and range | All uncertain parameters, high/low value, best/worst scenario, 95% CI, variable distribution. |
| Sensitivity analysis-methods | Comprehensive (all variables) one-way sensitivity analysis is highly recommended. |
| Presenting results | 1. Provide a figure displaying the structure of the model; 2. Provide a table listing all of the model inputs; 3. Provide an explicit list of model assumptions; 4. Present the disaggregated results in a table; |
| Incremental analysis | Yes |
| Total C/E | Yes |
| Portability of results (Generalizability) | Yes |
| Financial impact analysis | No |
| Mandatory or recommended or voluntary | Voluntary |
