heor-agent-mcp 1.2.2 → 1.3.2

package/dist/tools/htaDossierPrep.js

@@ -1,5 +1,6 @@
 import { z } from "zod";
 import { LiteratureResultSchema, RobResultsSchema, CEModelResultSchema, } from "../schemas/dossierInputSchemas.js";
+import { detectMismatch, extractTaNumber, findPrecedents, } from "../data/niceTaPrecedents.js";
 const DossierSchema = z.object({
     hta_body: z.enum(["nice", "ema", "fda", "iqwig", "has", "jca", "gvd"]),
     submission_type: z.enum([
@@ -91,7 +92,7 @@ const DossierSchema = z.object({
             .default([]),
         gvp_module: z.enum(["V", "VI", "VIII", "VIII_Addendum_I"]),
         gvp_revision: z.literal("rev_4"),
-        encepp_protocol_template: z.string().optional(),
+        encepp_study_category: z.string().optional(),
         rmp_implications: z.array(z.string()).default([]),
         fda_analogue: z.string().optional(),
         submission_obligations: z.array(z.string()).default([]),
@@ -266,8 +267,8 @@ function appendPvPlanSection(lines, pv) {
         lines.push(`**Alternatives:** ${pv.alternatives.map((c) => `\`${c}\``).join(", ")}`);
     }
     lines.push(`**GVP Module:** Module ${pv.gvp_module} (EMA GVP ${pv.gvp_revision.replace("_", " ")})`);
-    if (pv.encepp_protocol_template) {
-        lines.push(`**ENCePP template:** \`${pv.encepp_protocol_template}\``);
+    if (pv.encepp_study_category) {
+        lines.push(`**ENCePP category:** ${pv.encepp_study_category}`);
     }
     if (pv.fda_analogue) {
         lines.push(`**FDA analogue:** ${pv.fda_analogue}`);
@@ -674,6 +675,39 @@ export async function handleHtaDossierPrep(rawParams) {
     lines.push(`## ${params.hta_body.toUpperCase()} ${params.submission_type.toUpperCase()} Dossier Draft`);
     lines.push(`**Drug:** ${params.drug_name} | **Indication:** ${params.indication}`);
     lines.push(`**Template:** ${methodology}\n`);
+    // ── NICE TA precedent surfacing (closes the TA902/TA679 gap
+    //    revealed by the management benchmark — see design log #16).
+    //    For NICE submissions, we look up the canonical TA for the
+    //    drug-indication and emit it upfront. If the user passed a
+    //    different TA number anywhere in their evidence_summary
+    //    prose, we flag the mismatch with both URLs so the user
+    //    can choose the correct one rather than silently overriding.
+    if (params.hta_body === "nice") {
+        const matches = findPrecedents(params.drug_name, params.indication);
+        if (matches.length > 0) {
+            const top = matches[0];
+            lines.push(`### Relevant NICE Technology Appraisal`);
+            lines.push(`- **${top.ta_number}** — ${top.title}`);
+            lines.push(`- Date: ${top.date} · URL: ${top.url}`);
+            if (top.notes)
+                lines.push(`- ⚠️ ${top.notes}`);
+            lines.push("");
+            audit = addAssumption(audit, `Canonical NICE TA precedent surfaced: ${top.ta_number} (${top.title}).`);
+            // Scan user-supplied evidence prose for a competing TA number.
+            // This catches the "cite TA902 for HFrEF" prompt error pattern.
+            if (typeof params.evidence_summary === "string") {
+                const userTa = extractTaNumber(params.evidence_summary);
+                if (userTa) {
+                    const mismatch = detectMismatch(params.drug_name, params.indication, userTa);
+                    if (mismatch) {
+                        lines.push(`> ⚠️ **TA mismatch detected.** ${mismatch.explanation}`);
+                        lines.push("");
+                        audit = addWarning(audit, `User-supplied TA ${mismatch.user_supplied} does not match canonical ${mismatch.canonical} for "${params.drug_name} ${params.indication}".`);
+                    }
+                }
+            }
+        }
+    }
     const gaps = [];
     for (const sectionName of sections) {
         const { content, status } = buildSection(sectionName, params.drug_name, params.indication, params.evidence_summary);

package/dist/tools/htaDossierPrep.js.map

@@ -1 +1 @@
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package/dist/tools/jcaPicoScope.d.ts.map

@@ -1 +1 @@
-{"version":3,"file":"jcaPicoScope.d.ts","sourceRoot":"","sources":["../../src/tools/jcaPicoScope.ts"],"names":[],"mappings":"AAoBA,OAAO,KAAK,EAAE,UAAU,EAAE,MAAM,uBAAuB,CAAC;AAwCxD,wBAAsB,kBAAkB,CACtC,QAAQ,EAAE,OAAO,GAChB,OAAO,CAAC,UAAU,CAAC,CA0NrB;AAED,eAAO,MAAM,sBAAsB;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;CAqCzB,CAAC"}
+{"version":3,"file":"jcaPicoScope.d.ts","sourceRoot":"","sources":["../../src/tools/jcaPicoScope.ts"],"names":[],"mappings":"AAsBA,OAAO,KAAK,EAAE,UAAU,EAAE,MAAM,uBAAuB,CAAC;AAqDxD,wBAAsB,kBAAkB,CACtC,QAAQ,EAAE,OAAO,GAChB,OAAO,CAAC,UAAU,CAAC,CAsSrB;AAED,eAAO,MAAM,sBAAsB;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;CAqCzB,CAAC"}

package/dist/tools/jcaPicoScope.js

@@ -12,6 +12,7 @@ import { auditToMarkdown } from "../formatters/markdown.js";
 import { suggestForEnum } from "../util/didYouMean.js";
 import { buildScope } from "../jca/scopeBuilder.js";
 import { JCA_REVISION } from "../jca/countryRegistry.js";
+import { checkScopeEligibility } from "../jca/scopeEligibility.js";
 const DRUG_CLASSES = [
     "monoclonal_antibody",
     "small_molecule",
@@ -43,6 +44,15 @@ const JcaPicoScopeSchema = z
         .min(1)
         .default(["de", "fr", "it", "es", "nl"]),
     regulatory_context: z.enum(REG_CONTEXTS).default("post_authorisation"),
+    is_orphan: z
+        .boolean()
+        .optional()
+        .describe("Optional: orphan-designated medicinal product. Affects JCA scope eligibility (orphans enter scope 2028 vs 2030 for general medicinal products)."),
+    force_proceed_out_of_scope: z
+        .boolean()
+        .optional()
+        .default(false)
+        .describe("Override the JCA scope check. Default false. Set true to produce a JCA-style matrix anyway when the indication is not yet in JCA scope (e.g., for protocol-design or anticipatory market-access work). Output will carry an explicit out-of-scope warning either way."),
 })
     .strict();
 export async function handleJcaPicoScope(rawInput) {
@@ -76,7 +86,55 @@ export async function handleJcaPicoScope(rawInput) {
         jurisdictions: input.jurisdictions,
         regulatory_context: input.regulatory_context,
     });
+    // ── JCA scope eligibility check (Reg 2021/2282 phased rollout).
+    //    Closes the gap surfaced by Claude.ai during the management
+    //    benchmark — see design log #16. We compute eligibility against
+    //    the indication category that scopeBuilder already classified.
+    const eligibility = checkScopeEligibility({
+        indication_category: matrix.indication_category,
+        drug_class: input.drug_class,
+        is_orphan: input.is_orphan,
+    });
     audit = addAssumption(audit, `JCA scope produced for ${input.jurisdictions.join(", ")} (revision ${JCA_REVISION}). ${matrix.picos.length} consolidated PICO(s).`);
+    audit = addAssumption(audit, `JCA scope eligibility per Reg 2021/2282 Article 7: in_scope=${eligibility.in_scope} (phase: ${eligibility.phase}, in scope from ${eligibility.in_scope_from_year}).`);
+    // Out-of-scope short-circuit — refuse to produce a JCA matrix
+    // and explain why, unless the caller explicitly set
+    // force_proceed_out_of_scope=true (for anticipatory work).
+    if (!eligibility.in_scope && !input.force_proceed_out_of_scope) {
+        const refusalLines = [];
+        refusalLines.push(`# JCA Scope Eligibility Check — ${input.drug} (${input.indication})`);
+        refusalLines.push("");
+        refusalLines.push(`> ⚠️ **Not currently in JCA scope.** ${eligibility.explanation}`);
+        refusalLines.push("");
+        refusalLines.push(`**Indication category:** ${matrix.indication_category}`);
+        refusalLines.push(`**Drug class:** ${input.drug_class}`);
+        refusalLines.push(`**JCA phase that gates scope entry:** ${eligibility.phase}`);
+        refusalLines.push(`**In JCA scope from:** 13 January ${eligibility.in_scope_from_year}`);
+        refusalLines.push("");
+        refusalLines.push("## What to do instead");
+        refusalLines.push("Produce a **consolidated national-HTA PICO matrix** synthesising what each jurisdiction (G-BA/IQWiG, HAS, AIFA, AEMPS/RedETS, Zorginstituut, NICE) would require if the dossier were submitted today. This is what an MAH preparing for a future JCA dossier should compile now to anticipate consolidated PICOs at submission.");
+        refusalLines.push("");
+        refusalLines.push("To proceed anyway (e.g., for protocol-design or anticipatory market-access work), call this tool again with `force_proceed_out_of_scope: true`. The output will be labelled as out-of-scope.");
+        refusalLines.push("");
+        refusalLines.push("## References");
+        for (const r of eligibility.references)
+            refusalLines.push(`- ${r}`);
+        refusalLines.push("");
+        audit = addWarning(audit, `Refused to produce JCA PICO matrix: indication "${input.indication}" (${matrix.indication_category}) is not in JCA scope until ${eligibility.in_scope_from_year}.`);
+        refusalLines.push(auditToMarkdown(audit));
+        return {
+            content: refusalLines.join("\n"),
+            audit,
+            pico_matrix: null,
+            scope_eligibility: eligibility,
+        };
+    }
+    // If we got here either we're in scope, or the caller forced it.
+    // Either way, emit the matrix — but add an out-of-scope warning
+    // when forced, so downstream readers know.
+    if (!eligibility.in_scope && input.force_proceed_out_of_scope) {
+        audit = addWarning(audit, `JCA matrix produced under force_proceed_out_of_scope=true. Indication is not in JCA scope until ${eligibility.in_scope_from_year}. Output should be treated as anticipatory only.`);
+    }
     if (matrix.heterogeneity_warning) {
         audit = addWarning(audit, `Comparator heterogeneity: ${matrix.distinct_comparator_count} distinct comparators across jurisdictions. NMA / Bucher feasibility may be compromised.`);
     }

package/dist/tools/jcaPicoScope.js.map

@@ -1 +1 @@
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package/dist/tools/pvClassify.d.ts

@@ -3,7 +3,7 @@ export type { PvClassification } from "../pv/types.js";
 export declare function handlePvClassify(rawInput: unknown): Promise<ToolResult>;
 export declare const pvClassifyToolSchema: {
     readonly name: "pv.classify";
-    readonly description: "Classify a planned study into its EMA pharmacovigilance regulatory category (PASS imposed/voluntary, PAES, RMP Annex 4, DUS, active surveillance registry, pregnancy registry, spontaneous reporting, ICH E2E plan). Returns the matching GVP module + ENCePP protocol template + submission obligations + RMP implications + FDA analogue. Use BEFORE preparing an HTA dossier or before designing a post-authorisation study. Pass the structured `pv_classification` output to `hta_dossier` to populate its Pharmacovigilance Plan section.";
+    readonly description: "Classify a planned study into its EMA pharmacovigilance regulatory category (PASS imposed/voluntary, PAES, RMP Annex 4, DUS, active surveillance registry, pregnancy registry, spontaneous reporting, ICH E2E plan). Returns the matching GVP module + ENCePP study-category label (not a registered protocol ID — consult the ENCePP Code of Conduct checklist for templates) + submission obligations + RMP implications + FDA analogue. Use BEFORE preparing an HTA dossier or before designing a post-authorisation study. Pass the structured `pv_classification` output to `hta_dossier` to populate its Pharmacovigilance Plan section.";
     readonly annotations: {
         readonly title: "PV Study Classification";
         readonly readOnlyHint: true;

package/dist/tools/pvClassify.d.ts.map

@@ -1 +1 @@
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+{"version":3,"file":"pvClassify.d.ts","sourceRoot":"","sources":["../../src/tools/pvClassify.ts"],"names":[],"mappings":"AAuBA,OAAO,KAAK,EAAE,UAAU,EAAE,MAAM,uBAAuB,CAAC;AAExD,YAAY,EAAE,gBAAgB,EAAE,MAAM,gBAAgB,CAAC;AAiDvD,wBAAsB,gBAAgB,CAAC,QAAQ,EAAE,OAAO,GAAG,OAAO,CAAC,UAAU,CAAC,CAsK7E;AAED,eAAO,MAAM,oBAAoB;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;CAqCvB,CAAC"}

package/dist/tools/pvClassify.js

@@ -4,7 +4,7 @@
  * Maps a planned study's metadata onto its EMA GVP regulatory category
  * (PASS imposed/voluntary, PAES, RMP Annex 4, DUS, registry, pregnancy
  * registry, spontaneous reporting, ICH E2E plan) plus the matching GVP
- * module + ENCePP protocol template + RMP/FDA implications. Pure logic,
+ * module + ENCePP study-category label + RMP/FDA implications. Pure logic,
  * no I/O — modelled on itc_feasibility.
  *
  * See design log #11 for the decision tree and design rationale.
@@ -87,12 +87,17 @@ export async function handlePvClassify(rawInput) {
     if (input.population_includes_pregnant) {
         audit = addWarning(audit, "Pregnant population in scope — pregnancy registry obligations apply on top of any other classification.");
     }
+    // Surface advisory warnings from the decision tree (CMA SOB hint,
+    // contradictory-input detection, etc.)
+    for (const w of decision.advisory_warnings ?? []) {
+        audit = addWarning(audit, w);
+    }
     const classification = {
         primary_category: decision.primary_category,
         alternatives: decision.alternatives,
         gvp_module: mapping.gvp_module,
         gvp_revision: GVP_REVISION,
-        encepp_protocol_template: mapping.encepp_protocol_template,
+        encepp_study_category: mapping.encepp_study_category,
         rmp_implications: mapping.rmp_implications,
         fda_analogue: mapping.fda_analogue,
         submission_obligations: mapping.submission_obligations,
@@ -108,13 +113,21 @@ export async function handlePvClassify(rawInput) {
     lines.push("");
     lines.push("## GVP Module");
     lines.push(`Module ${mapping.gvp_module} (EMA GVP ${GVP_REVISION.replace("_", " ")})`);
-    if (mapping.encepp_protocol_template) {
-        lines.push(`ENCePP protocol template: \`${mapping.encepp_protocol_template}\``);
+    if (mapping.encepp_study_category) {
+        lines.push(`ENCePP study category: ${mapping.encepp_study_category}`);
+        lines.push(`*(Category label, not a registered template ID. Consult the [ENCePP Code of Conduct](https://www.encepp.eu/code_of_conduct/) checklist for protocol structure and the [EUPAS register](https://www.encepp.eu/encepp/studiesDatabase.jsp) for actual study protocols.)*`);
     }
     lines.push("");
     lines.push("## Rationale");
     lines.push(decision.rationale);
     lines.push("");
+    if (decision.advisory_warnings && decision.advisory_warnings.length > 0) {
+        lines.push("## ⚠️ Advisory Warnings");
+        for (const w of decision.advisory_warnings) {
+            lines.push(`- ${w}`);
+        }
+        lines.push("");
+    }
     lines.push("## Submission Obligations");
     for (const o of mapping.submission_obligations) {
         lines.push(`- ${o}`);
@@ -129,8 +142,8 @@ export async function handlePvClassify(rawInput) {
         lines.push("## US (FDA) Mapping — v1 stub");
         lines.push(`FDA analogue: ${mapping.fda_analogue ?? "not yet mapped"}. Full FDA REMS / Sentinel / FAERS integration is planned for v2 of this tool — for now this is an indicative mapping, not a regulatory-grade FDA classification.`);
         lines.push("");
-        lines.push("### CMS IRA note");
-        lines.push("**Inflation Reduction Act (CMS IRA) excludes pharmacovigilance cost data from Medicare drug-price negotiation calculations.** PV obligations recorded here do not enter the IRA negotiation threshold; track them separately in the regulatory budget, not the HEOR cost-effectiveness model.");
+        lines.push("### CMS IRA note (US jurisdiction)");
+        lines.push("PV study costs are typically tracked as regulatory obligations separate from HEOR cost-effectiveness modelling and are **not standard inputs to the IRA Maximum Fair Price calculation** under current CMS guidance. The IRA statute (P.L. 117-169) does not contain a specific carve-out for pharmacovigilance costs — track these in the regulatory budget rather than embedding them in the HEOR CEA, and verify the latest CMS implementation guidance before final pricing analyses.");
         lines.push("");
     }
     if (input.population_includes_pregnant) {
@@ -160,7 +173,7 @@ export async function handlePvClassify(rawInput) {
 }
 export const pvClassifyToolSchema = {
     name: "pv.classify",
-    description: "Classify a planned study into its EMA pharmacovigilance regulatory category (PASS imposed/voluntary, PAES, RMP Annex 4, DUS, active surveillance registry, pregnancy registry, spontaneous reporting, ICH E2E plan). Returns the matching GVP module + ENCePP protocol template + submission obligations + RMP implications + FDA analogue. Use BEFORE preparing an HTA dossier or before designing a post-authorisation study. Pass the structured `pv_classification` output to `hta_dossier` to populate its Pharmacovigilance Plan section.",
+    description: "Classify a planned study into its EMA pharmacovigilance regulatory category (PASS imposed/voluntary, PAES, RMP Annex 4, DUS, active surveillance registry, pregnancy registry, spontaneous reporting, ICH E2E plan). Returns the matching GVP module + ENCePP study-category label (not a registered protocol ID — consult the ENCePP Code of Conduct checklist for templates) + submission obligations + RMP implications + FDA analogue. Use BEFORE preparing an HTA dossier or before designing a post-authorisation study. Pass the structured `pv_classification` output to `hta_dossier` to populate its Pharmacovigilance Plan section.",
     annotations: {
         title: "PV Study Classification",
         readOnlyHint: true,

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+{"version":3,"file":"pvClassify.js","sourceRoot":"","sources":["../../src/tools/pvClassify.ts"],"names":[],"mappings":"AAAA;;;;;;;;;;GAUG;AACH,OAAO,EAAE,CAAC,EAAE,MAAM,KAAK,CAAC;AACxB,OAAO,EACL,aAAa,EACb,UAAU,EACV,iBAAiB,EACjB,cAAc,GACf,MAAM,qBAAqB,CAAC;AAC7B,OAAO,EAAE,eAAe,EAAE,MAAM,2BAA2B,CAAC;AAC5D,OAAO,EAAE,cAAc,EAAE,MAAM,uBAAuB,CAAC;AACvD,OAAO,EAAE,UAAU,EAAE,MAAM,uBAAuB,CAAC;AACnD,OAAO,EAAE,YAAY,EAAE,MAAM,EAAE,MAAM,qBAAqB,CAAC;AAM3D,MAAM,aAAa,GAAG;IACpB,KAAK;IACL,YAAY;IACZ,oBAAoB;IACpB,sBAAsB;IACtB,cAAc;IACd,UAAU;IACV,qBAAqB;IACrB,kBAAkB;IAClB,0BAA0B;IAC1B,qBAAqB;CACb,CAAC;AAEX,MAAM,kBAAkB,GAAG;IACzB,QAAQ;IACR,UAAU;IACV,eAAe;IACf,kBAAkB;IAClB,iBAAiB;IACjB,8BAA8B;CACtB,CAAC;AAEX,MAAM,mBAAmB,GAAG;IAC1B,mBAAmB;IACnB,oBAAoB;IACpB,sBAAsB;IACtB,sBAAsB;IACtB,gBAAgB;CACR,CAAC;AAEX,MAAM,aAAa,GAAG,CAAC,IAAI,EAAE,IAAI,EAAE,IAAI,EAAE,OAAO,EAAE,OAAO,CAAU,CAAC;AAEpE,MAAM,gBAAgB,GAAG,CAAC;KACvB,MAAM,CAAC;IACN,IAAI,EAAE,CAAC,CAAC,MAAM,EAAE,CAAC,GAAG,CAAC,CAAC,EAAE,kBAAkB,CAAC;IAC3C,UAAU,EAAE,CAAC,CAAC,MAAM,EAAE,CAAC,GAAG,CAAC,CAAC,EAAE,wBAAwB,CAAC;IACvD,YAAY,EAAE,CAAC,CAAC,IAAI,CAAC,aAAa,CAAC;IACnC,iBAAiB,EAAE,CAAC,CAAC,IAAI,CAAC,kBAAkB,CAAC;IAC7C,kBAAkB,EAAE,CAAC,CAAC,IAAI,CAAC,mBAAmB,CAAC;IAC/C,oBAAoB,EAAE,CAAC,CAAC,OAAO,EAAE,CAAC,OAAO,CAAC,KAAK,CAAC;IAChD,4BAA4B,EAAE,CAAC,CAAC,OAAO,EAAE,CAAC,OAAO,CAAC,KAAK,CAAC;IACxD,8BAA8B,EAAE,CAAC,CAAC,OAAO,EAAE,CAAC,OAAO,CAAC,KAAK,CAAC;IAC1D,aAAa,EAAE,CAAC,CAAC,OAAO,EAAE,CAAC,OAAO,CAAC,KAAK,CAAC;IACzC,aAAa,EAAE,CAAC,CAAC,KAAK,CAAC,CAAC,CAAC,IAAI,CAAC,aAAa,CAAC,CAAC,CAAC,OAAO,CAAC,CAAC,IAAI,CAAC,CAAC;CAC9D,CAAC;KACD,MAAM,EAAE,CAAC;AAEZ,MAAM,CAAC,KAAK,UAAU,gBAAgB,CAAC,QAAiB;IACtD,MAAM,MAAM,GAAG,gBAAgB,CAAC,SAAS,CAAC,QAAQ,CAAC,CAAC;IACpD,IAAI,CAAC,MAAM,CAAC,OAAO,EAAE,CAAC;QACpB,MAAM,QAAQ,GAAa,EAAE,CAAC;QAC9B,KAAK,MAAM,KAAK,IAAI,MAAM,CAAC,KAAK,CAAC,MAAM,EAAE,CAAC;YACxC,IACE,KAAK,CAAC,IAAI,KAAK,oBAAoB;gBACnC,OAAO,KAAK,CAAC,QAAQ,KAAK,QAAQ,EAClC,CAAC;gBACD,MAAM,WAAW,GAAG,cAAc,CAChC,KAAK,CAAC,QAAQ,EACd,KAAK,CAAC,OAA4B,CACnC,CAAC;gBACF,QAAQ,CAAC,IAAI,CACX,WAAW,KAAK,CAAC,IAAI,CAAC,IAAI,CAAC,GAAG,CAAC,MAAM,KAAK,CAAC,QAAQ,eAAgB,KAAK,CAAC,OAAoB,CAAC,IAAI,CAAC,IAAI,CAAC,IACtG,WAAW,CAAC,MAAM;oBAChB,CAAC,CAAC,iBAAiB,WAAW,CAAC,GAAG,CAAC,CAAC,CAAC,EAAE,EAAE,CAAC,IAAI,CAAC,GAAG,CAAC,CAAC,IAAI,CAAC,IAAI,CAAC,GAAG;oBACjE,CAAC,CAAC,EACN,EAAE,CACH,CAAC;YACJ,CAAC;iBAAM,CAAC;gBACN,QAAQ,CAAC,IAAI,CAAC,GAAG,KAAK,CAAC,IAAI,CAAC,IAAI,CAAC,GAAG,CAAC,IAAI,OAAO,KAAK,KAAK,CAAC,OAAO,EAAE,CAAC,CAAC;YACxE,CAAC;QACH,CAAC;QACD,MAAM,IAAI,KAAK,CAAC,QAAQ,CAAC,IAAI,CAAC,IAAI,CAAC,CAAC,CAAC;IACvC,CAAC;IACD,MAAM,KAAK,GAAG,MAAM,CAAC,IAAI,CAAC;IAE1B,IAAI,KAAK,GAAG,iBAAiB,CAC3B,aAAa,EACb,KAA2C,EAC3C,MAAM,CACP,CAAC;IACF,KAAK,GAAG,cAAc,CACpB,KAAK,EACL,mSAAmS,CACpS,CAAC;IAEF,MAAM,QAAQ,GAAG,UAAU,CAAC,KAAK,CAAC,CAAC;IACnC,MAAM,OAAO,GAAG,MAAM,CAAC,QAAQ,CAAC,gBAAgB,CAAC,CAAC;IAElD,KAAK,GAAG,aAAa,CACnB,KAAK,EACL,oBAAoB,QAAQ,CAAC,gBAAgB,iBAAiB,OAAO,CAAC,UAAU,GAAG,CACpF,CAAC;IACF,IAAI,QAAQ,CAAC,YAAY,CAAC,MAAM,GAAG,CAAC,EAAE,CAAC;QACrC,KAAK,GAAG,aAAa,CACnB,KAAK,EACL,2CAA2C,QAAQ,CAAC,YAAY,CAAC,IAAI,CAAC,IAAI,CAAC,GAAG,CAC/E,CAAC;IACJ,CAAC;IACD,IAAI,KAAK,CAAC,4BAA4B,EAAE,CAAC;QACvC,KAAK,GAAG,UAAU,CAChB,KAAK,EACL,yGAAyG,CAC1G,CAAC;IACJ,CAAC;IACD,kEAAkE;IAClE,uCAAuC;IACvC,KAAK,MAAM,CAAC,IAAI,QAAQ,CAAC,iBAAiB,IAAI,EAAE,EAAE,CAAC;QACjD,KAAK,GAAG,UAAU,CAAC,KAAK,EAAE,CAAC,CAAC,CAAC;IAC/B,CAAC;IAED,MAAM,cAAc,GAAqB;QACvC,gBAAgB,EAAE,QAAQ,CAAC,gBAAgB;QAC3C,YAAY,EAAE,QAAQ,CAAC,YAAY;QACnC,UAAU,EAAE,OAAO,CAAC,UAAU;QAC9B,YAAY,EAAE,YAAY;QAC1B,qBAAqB,EAAE,OAAO,CAAC,qBAAqB;QACpD,gBAAgB,EAAE,OAAO,CAAC,gBAAgB;QAC1C,YAAY,EAAE,OAAO,CAAC,YAAY;QAClC,sBAAsB,EAAE,OAAO,CAAC,sBAAsB;QACtD,SAAS,EAAE,QAAQ,CAAC,SAAS;KAC9B,CAAC;IAEF,MAAM,KAAK,GAAa,EAAE,CAAC;IAC3B,KAAK,CAAC,IAAI,CAAC,yBAAyB,KAAK,CAAC,IAAI,KAAK,KAAK,CAAC,UAAU,GAAG,CAAC,CAAC;IACxE,KAAK,CAAC,IAAI,CAAC,EAAE,CAAC,CAAC;IACf,KAAK,CAAC,IAAI,CAAC,2BAA2B,QAAQ,CAAC,gBAAgB,IAAI,CAAC,CAAC;IACrE,IAAI,QAAQ,CAAC,YAAY,CAAC,MAAM,GAAG,CAAC,EAAE,CAAC;QACrC,KAAK,CAAC,IAAI,CACR,qBAAqB,QAAQ,CAAC,YAAY,CAAC,GAAG,CAAC,CAAC,CAAC,EAAE,EAAE,CAAC,KAAK,CAAC,IAAI,CAAC,CAAC,IAAI,CAAC,IAAI,CAAC,EAAE,CAC/E,CAAC;IACJ,CAAC;IACD,KAAK,CAAC,IAAI,CAAC,EAAE,CAAC,CAAC;IAEf,KAAK,CAAC,IAAI,CAAC,eAAe,CAAC,CAAC;IAC5B,KAAK,CAAC,IAAI,CACR,UAAU,OAAO,CAAC,UAAU,aAAa,YAAY,CAAC,OAAO,CAAC,GAAG,EAAE,GAAG,CAAC,GAAG,CAC3E,CAAC;IACF,IAAI,OAAO,CAAC,qBAAqB,EAAE,CAAC;QAClC,KAAK,CAAC,IAAI,CAAC,0BAA0B,OAAO,CAAC,qBAAqB,EAAE,CAAC,CAAC;QACtE,KAAK,CAAC,IAAI,CACR,wQAAwQ,CACzQ,CAAC;IACJ,CAAC;IACD,KAAK,CAAC,IAAI,CAAC,EAAE,CAAC,CAAC;IAEf,KAAK,CAAC,IAAI,CAAC,cAAc,CAAC,CAAC;IAC3B,KAAK,CAAC,IAAI,CAAC,QAAQ,CAAC,SAAS,CAAC,CAAC;IAC/B,KAAK,CAAC,IAAI,CAAC,EAAE,CAAC,CAAC;IAEf,IAAI,QAAQ,CAAC,iBAAiB,IAAI,QAAQ,CAAC,iBAAiB,CAAC,MAAM,GAAG,CAAC,EAAE,CAAC;QACxE,KAAK,CAAC,IAAI,CAAC,yBAAyB,CAAC,CAAC;QACtC,KAAK,MAAM,CAAC,IAAI,QAAQ,CAAC,iBAAiB,EAAE,CAAC;YAC3C,KAAK,CAAC,IAAI,CAAC,KAAK,CAAC,EAAE,CAAC,CAAC;QACvB,CAAC;QACD,KAAK,CAAC,IAAI,CAAC,EAAE,CAAC,CAAC;IACjB,CAAC;IAED,KAAK,CAAC,IAAI,CAAC,2BAA2B,CAAC,CAAC;IACxC,KAAK,MAAM,CAAC,IAAI,OAAO,CAAC,sBAAsB,EAAE,CAAC;QAC/C,KAAK,CAAC,IAAI,CAAC,KAAK,CA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package/dist/tools/pvSignalWorkflow.d.ts

@@ -0,0 +1,82 @@
+import type { ToolResult } from "../providers/types.js";
+export declare function handlePvSignalWorkflow(rawInput: unknown): Promise<ToolResult>;
+export declare const pvSignalWorkflowToolSchema: {
+    readonly name: "pv.signal_workflow";
+    readonly description: "Compute disproportionality statistics (PRR, ROR, IC/BCPNN, MGPS/EBGM) on user-supplied drug-AE case counts and decide a signal verdict per EMA GVP Module IX rev 2. Returns the verdict (no/strengthening/confirmed/previously known/refuted), workflow recommendations, and canonical RMP signal-section text. To classify a finding as previously_known_signal, supply BOTH prior_known_signals AND reported_event so the tool can match the disproportionality to a specific known event. Optionally layers in GVP Considerations P.III pregnancy follow-up (birth/3mo/12mo) when both pregnancy_exposure and rmp_has_pregnancy_concern are true. Pairs with pv_classify. ⚠️ MGPS uses single-stratum gamma-Poisson shrinkage in v1 — when database counts are confounded by sex/age strata, EBGM/EB05 may be inflated; stratified MGPS is planned for v2. v1 takes user counts; v2 will also integrate EVDAS programmatic access per Reg. 2025/1466.";
+    readonly annotations: {
+        readonly title: "PV Signal Workflow";
+        readonly readOnlyHint: true;
+        readonly destructiveHint: false;
+        readonly idempotentHint: true;
+        readonly openWorldHint: false;
+    };
+    readonly inputSchema: {
+        readonly type: "object";
+        readonly properties: {
+            readonly drug: {
+                readonly type: "string";
+            };
+            readonly indication: {
+                readonly type: "string";
+            };
+            readonly reporting_period_months: {
+                readonly type: "number";
+                readonly minimum: 1;
+                readonly maximum: 120;
+                readonly default: 12;
+            };
+            readonly case_counts: {
+                readonly type: "object";
+                readonly properties: {
+                    readonly drug_event: {
+                        readonly type: "number";
+                        readonly minimum: 0;
+                        readonly description: "a — cases of THIS drug AND THIS event";
+                    };
+                    readonly drug_total: {
+                        readonly type: "number";
+                        readonly minimum: 0;
+                        readonly description: "a+b — all cases of the drug";
+                    };
+                    readonly event_total: {
+                        readonly type: "number";
+                        readonly minimum: 0;
+                        readonly description: "a+c — all cases of the event";
+                    };
+                    readonly grand_total: {
+                        readonly type: "number";
+                        readonly minimum: 0;
+                        readonly description: "a+b+c+d — all cases in DB";
+                    };
+                };
+                readonly required: readonly ["drug_event", "drug_total", "event_total", "grand_total"];
+            };
+            readonly data_source: {
+                readonly type: "string";
+                readonly enum: readonly ["eudravigilance", "faers", "vigibase_who", "national_db", "spontaneous_internal"];
+                readonly default: "eudravigilance";
+            };
+            readonly pregnancy_exposure: {
+                readonly type: "boolean";
+                readonly default: false;
+            };
+            readonly prior_known_signals: {
+                readonly type: "array";
+                readonly items: {
+                    readonly type: "string";
+                };
+                readonly default: readonly [];
+            };
+            readonly outcome_serious: {
+                readonly type: "boolean";
+                readonly default: false;
+            };
+            readonly rmp_has_pregnancy_concern: {
+                readonly type: "boolean";
+                readonly default: false;
+            };
+        };
+        readonly required: readonly ["drug", "indication", "case_counts"];
+    };
+};
+//# sourceMappingURL=pvSignalWorkflow.d.ts.map

package/dist/tools/pvSignalWorkflow.d.ts.map

@@ -0,0 +1 @@
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