# Approved Product Dossier — editorial working template

> **For drafting only.** This original worksheet aligns to the B section family in AMCP Format 5.0 without reproducing AMCP text. It is not an AMCP form. Document the unsolicited HCDM request and obtain internal legal/regulatory/compliance review before external response.

## Dossier control

| Field | Complete |
|---|---|
| Product / sponsor / approved indication(s) | |
| Approved label version and effective date | |
| HCDM unsolicited request: date, requestor, scope, and record location | |
| Draft version / evidence cutoff / owner | |
| Intended distribution and controls | |
| Link to common instructions / evidence trace / change log | |

## 1.0B — Executive summary: clinical and economic value
> Each statement must link to a supporting location in Sections 2.0B–5.0B.

| Summary statement | Evidence ID | Supporting section | Key limitation / qualifier |
|---|---|---|---|
| Clinical benefit | | | |
| Comparative effectiveness | | | |
| Safety / tolerability | | | |
| Economic / budget implication | | | |
| Equity, access, or patient impact | | | |

## 2.0B — Product information and disease description
### 2.1B Product information
| Topic | Current approved / evidence-supported content | Evidence ID |
|---|---|---|
| Approved label and use | | |
| Dosing, administration, and site of care | | |
| Safety, monitoring, REMS, and operational requirements | | |
| Price / contracting assumptions and effective date | | |

### 2.2B Place of product in therapy
| Population / pathway | Comparator(s) | Current clinical rationale | Access / equity consideration | Evidence ID |
|---|---|---|---|---|

### 2.3B Evidence for companion diagnostic tests
- Test and intended use, analytic validity, clinical validity, clinical utility, economic implications, and supporting evidence IDs. Mark not applicable with a reason when no companion diagnostic is relevant:

## 3.0B — Clinical evidence
| Evidence ID | Study / design | Population / comparator | Endpoint / effect / uncertainty | Applicability and limitation |
|---|---|---|---|---|

### RWE and indirect-comparison review
- RWE protocol/SAP, data source, estimand, algorithm/version, and major bias limitations:
- ITC/NMA review: systematic review provenance, network, transitivity, heterogeneity/inconsistency, certainty, and conclusion boundary:
- Evidence synthesis: what is consistent, uncertain, or absent:

## 4.0B — Economic value and modeling report
### 4.1B Modeling overview
| Decision problem | Population | Comparator(s) | Perspective | Horizon | Model / source version |
|---|---|---|---|---|---|

### 4.2B Cost-effectiveness analysis
| Result | Base-case assumption | Uncertainty / scenario | Validation / QA | Evidence ID |
|---|---|---|---|---|

### 4.3B Budget impact model
| Plan characteristic | Uptake / displacement assumption | Cost inputs | Scenario | Limitation |
|---|---|---|---|---|

### 4.4B Modeling report and interactive model
- Model access/distribution process:
- Input provenance and update date:
- Validation/calibration and technical-report location:
- Reviewer questions / response log:

## 5.0B — Additional supporting evidence
- Guidelines, HTAs, and systematic reviews:
- Other clinical/economic/outcomes evidence:
- Health-disparity and quality-measure evidence:
- Patient-reported outcomes and patient-experience evidence:
- Evidence gaps and material uncertainties:

## 6.0B — Dossier appendices
- [ ] Reference list and evidence tables
- [ ] Economic model technical report / model access instructions
- [ ] Current prescribing information and patient information
- [ ] Supporting study materials and permitted appendices
- [ ] DTx appendices, if relevant
- [ ] Change log, unsolicited-request record, and distribution record

## Final internal check
- [ ] Executive-summary statements trace to Sections 2.0B–5.0B.
- [ ] Current/approved information is dated; off-label/unapproved-use material is identified and reviewed.
- [ ] Model inputs, results, uncertainty, and validation are visible.
- [ ] The complete dossier was reviewed against official AMCP Format 5.0 and payer-specific requirements.