# AMCP dossier editorial working templates — instructions

> **Editorial working files only.** These original RWEdnesdays worksheets do not reproduce the AMCP Format, are not official AMCP forms, and are not legal, regulatory, or compliance advice. Use the official AMCP Format 5.0 for requirements and obtain organizational review before external distribution.

## 1. Select the dossier state

| Field | Complete |
|---|---|
| Product / use | |
| Dossier type selected | A — Unapproved Product / B — Approved Product / C — Unapproved Use |
| Why this lifecycle state applies | |
| Current regulatory status and effective date | |
| Intended HCDM audience | |
| Communication pathway and requested scope | |
| External-distribution owner and internal reviewers | |
| Official AMCP Format 5.0 version checked | 5.0 (April 2024) |
| FDA payer-communication guidance status checked on | |
| Draft / working / internally approved / released | |

**Status rule:** mark each entry **approved/current**, **projected/pending**, or **unavailable**. Do not silently transform a forecast, a study in progress, or an unavailable datum into a current claim.

## 2. Evidence and claim trace

| Evidence ID | Dossier section | Exact draft claim or table output | Evidence type | Population / setting | Comparator | Source, version, access date | Key limitation / uncertainty | Content owner | Scientific / LRC reviewer | Decision |
|---|---|---|---|---|---|---|---|---|---|---|

Use one row for each externally meaningful claim. Link appendices, publications, protocols, SAPs, code lists, model files, and evidence tables by immutable version where possible.

## 3. RWE exhibit record

| Item | Complete |
|---|---|
| Research question and estimand | |
| Data source, coverage period, and population | |
| Protocol/SAP version and registration | |
| Exposure/comparator, outcome algorithms, and code-list version | |
| Time zero, eligibility, follow-up, censoring, and missing-data plan | |
| Confounding, selection, measurement, and transportability limitations | |
| Study result, uncertainty, and sensitivity analyses | |
| Reporting/protocol standards used | HARPER / STaRT-RWE / RECORD-PE / other: |
| Exhibit ID and linked evidence-trace rows | |

## 4. ITC/NMA evidence record

| Item | Complete |
|---|---|
| Decision question and target population | |
| Systematic review protocol/search date | |
| Evidence network and disconnected nodes | |
| Comparator and effect measure | |
| Transitivity / similarity judgment | |
| Heterogeneity and inconsistency checks | |
| Risk-of-bias / certainty assessment | |
| Model choice and sensitivity analyses | |
| Claim boundary; what the comparison does **not** establish | |
| Evidence ID(s) | |

## 5. Payer economic model record

| Item | Complete |
|---|---|
| Decision problem, perspective, population, comparator(s) | |
| Model type, structure, cycle length, and horizon | |
| Clinical / utilization / cost / utility inputs and source versions | |
| Current vs projected pricing and access assumptions | |
| Base case, scenario analyses, and probabilistic/deterministic uncertainty | |
| Calibration / face / external validation evidence | |
| Budget-impact plan characteristics and uptake assumptions | |
| Model file, run date, analyst, and QA record | |
| Claim boundary and limitations | |
| Evidence ID(s) | |

## 6. Change log and lifecycle transition

| Date | Version | Trigger | Affected section / evidence ID | What changed | Status impact | Claim / model output impact | Reviewer approval | Next action |
|---|---|---|---|---|---|---|---|---|

### Transition decision
- **A → B at initial FDA approval:** preserve the A version, retire A, create B, replace projected information with approved/current status, and link the approved label and first post-approval update.
- **B + C while a new use is under review:** limit C to the unapproved use(s) seeking approval; maintain a separate B record.
- **C after approval of a use:** retire C for that use or revise a multi-use C file; update B and log the transition.

## 7. Release readout

- [ ] Every claim and model output is linked to evidence and a version.
- [ ] Status labels distinguish approved/current, projected/pending, and unavailable.
- [ ] Unapproved-product/use wording has qualified legal/regulatory/compliance review.
- [ ] An approved-product response has an unsolicited HCDM-request record.
- [ ] The change log and distribution record are complete.
- [ ] Official AMCP Format and payer-specific requirements were checked for this release.