heor-agent-mcp 1.1.1 → 1.2.0

package/README.md

@@ -5,6 +5,8 @@
 [![node](https://img.shields.io/node/v/heor-agent-mcp.svg)](https://nodejs.org)
 [![Try in ChatGPT](https://img.shields.io/badge/Try_in-ChatGPT-10A37F?logo=openai&logoColor=white)](https://chatgpt.com/g/g-69f651f588f48191b1d69d54409857ec-heoragent)
 [![Web UI](https://img.shields.io/badge/Web_UI-Vercel-000000?logo=vercel&logoColor=white)](https://web-michael-ns-projects.vercel.app)
+[![EU AI Pact](https://img.shields.io/badge/EU_AI_Pact-Signatory-003399?logo=europeanunion&logoColor=FFCC00)](https://web-michael-ns-projects.vercel.app/ai-transparency)
+[![AI Transparency](https://img.shields.io/badge/AI-Transparency_Note-blue)](https://web-michael-ns-projects.vercel.app/ai-transparency)
 
 **AI-powered Health Economics and Outcomes Research (HEOR) agent as a Model Context Protocol server.**
 
@@ -68,7 +70,7 @@ Add to your MCP configuration:
 
 ---
 
-## Tools (20)
+## Tools (21)
 
 | Tool | Purpose |
 |------|---------|
@@ -366,7 +368,7 @@ A companion chat interface is available at:
 
 **https://web-michael-ns-projects.vercel.app**
 
-- Chat with Claude Sonnet 4.6 + all 20 HEOR tools
+- Chat with Claude Sonnet 4.6 + all 21 HEOR tools
 - **BYOK (Bring Your Own Key)** — paste your Anthropic API key in the settings; it stays in your browser's localStorage and is never stored on our servers
 - Markdown rendering with styled tables, tool call cards with live progress timers, and theme-aware mermaid network diagrams
 - 12 example prompts covering literature search, CEA, BIA, NMA, ITC feasibility, RoB, EQ-5D 5L, EU JCA dossiers
@@ -528,6 +530,19 @@ MIT — see [LICENSE](./LICENSE).
 
 ---
 
+## Trust & Transparency
+
+HEORAgent is a **research and analysis tool** — not a clinical decision-support system. It is **not** classified as high-risk under the EU AI Act because it does not drive individual diagnosis, treatment, or monitoring; it falls under limited-risk transparency obligations only. Every output is intended for review by a qualified HEOR/HTA/PV professional before any action is taken.
+
+- **EU AI Pact signatory** — committed to AI governance, high-risk system mapping, and AI literacy promotion (voluntary commitments per the European Commission, ahead of the AI Act's August 2026 deadline).
+- **PRISMA-style audit trail** on every tool call (sources queried, succeeded, failed, assumptions applied).
+- **AI commentary explicitly labelled** — domain claims (ICERs, trial results, regulatory decisions) come exclusively from tool outputs, never from training-data recall.
+- **Methodology cited inline** — ISPOR, NICE DSU TSDs, NICE PMG36, Cochrane Handbook, GRADE, EMA GVP, Cope 2014, Phillippo 2016, Biz 2026.
+
+Full statement: **[/ai-transparency](https://web-michael-ns-projects.vercel.app/ai-transparency)** — risk classification, human oversight model, methodological references, and reporting channel.
+
+---
+
 ## Disclaimer
 
 **All outputs are preliminary and for research orientation only.** Results require validation by a qualified health economist before use in any HTA submission, payer negotiation, regulatory filing, or clinical decision. This tool does not replace professional HEOR expertise.

package/dist/jca/countryRegistry.d.ts

@@ -0,0 +1,21 @@
+/**
+ * Country profiles for the EU JCA PICO matrix analyzer (design log #13).
+ * Source of truth: latest available G-BA / HAS / AIFA / RedETS /
+ * Zorginstituut / NICE clinical-practice and HTA recommendations as of
+ * Q2 2026.
+ *
+ * Comparator lookups are coarse — molecule name + 1-line rationale only.
+ * Bumped via JCA_REVISION when EUnetHTA publishes new methodological
+ * guidance or country preferences change materially.
+ */
+import type { CountryProfile, IndicationCategory, Jurisdiction, OutcomePriority } from "./types.js";
+export declare const JCA_REVISION: "2026-05";
+export declare const COUNTRY_PROFILES: Record<Jurisdiction, CountryProfile>;
+/**
+ * Coarse classifier mapping a free-text indication to a category.
+ * Errs on "other" rather than guessing wrong.
+ */
+export declare function classifyIndication(indication: string): IndicationCategory;
+export declare function profileFor(jurisdiction: Jurisdiction): CountryProfile;
+export declare function outcomePriorityForCategory(category: IndicationCategory): OutcomePriority[];
+//# sourceMappingURL=countryRegistry.d.ts.map

package/dist/jca/countryRegistry.d.ts.map

@@ -0,0 +1 @@
+{"version":3,"file":"countryRegistry.d.ts","sourceRoot":"","sources":["../../src/jca/countryRegistry.ts"],"names":[],"mappings":"AAAA;;;;;;;;;GASG;AACH,OAAO,KAAK,EAEV,cAAc,EAEd,kBAAkB,EAClB,YAAY,EAEZ,eAAe,EAChB,MAAM,YAAY,CAAC;AAEpB,eAAO,MAAM,YAAY,EAAG,SAAkB,CAAC;AAuL/C,eAAO,MAAM,gBAAgB,EAAE,MAAM,CAAC,YAAY,EAAE,cAAc,CAsBjE,CAAC;AAEF;;;GAGG;AACH,wBAAgB,kBAAkB,CAAC,UAAU,EAAE,MAAM,GAAG,kBAAkB,CAoDzE;AAED,wBAAgB,UAAU,CAAC,YAAY,EAAE,YAAY,GAAG,cAAc,CAErE;AAED,wBAAgB,0BAA0B,CACxC,QAAQ,EAAE,kBAAkB,GAC3B,eAAe,EAAE,CAEnB"}

package/dist/jca/countryRegistry.js

@@ -0,0 +1,248 @@
+export const JCA_REVISION = "2026-05";
+function instrumentsFor(category) {
+    if (category === "oncology_nsclc" || category === "oncology_other") {
+        return ["EQ-5D-5L", "EORTC QLQ-C30"];
+    }
+    if (category === "ibd_uc" || category === "ibd_cd") {
+        return ["EQ-5D-5L", "IBDQ-32"];
+    }
+    if (category === "diabetes_t2" || category === "obesity") {
+        return ["EQ-5D-5L", "IWQOL-Lite"];
+    }
+    return ["EQ-5D-5L"];
+}
+function oncologyOutcomePriority() {
+    return ["OS", "PFS", "HRQoL", "AE"];
+}
+function ibdOutcomePriority() {
+    return ["remission", "HRQoL", "AE", "other"];
+}
+function chronicOutcomePriority() {
+    return ["HRQoL", "remission", "AE", "other"];
+}
+function outcomePriorityFor(category) {
+    if (category === "oncology_nsclc" || category === "oncology_other") {
+        return oncologyOutcomePriority();
+    }
+    if (category === "ibd_uc" || category === "ibd_cd") {
+        return ibdOutcomePriority();
+    }
+    return chronicOutcomePriority();
+}
+function nsclcSecondLineComparators(country) {
+    // NSCLC 2L EGFR-mutant: chemo doublet (carboplatin + pemetrexed) is
+    // standard everywhere; immunotherapy (pembrolizumab/nivolumab) is the
+    // alternative in DE/NL; ramucirumab + erlotinib is more common in IT/ES.
+    const instruments = instrumentsFor("oncology_nsclc");
+    const chemo = {
+        molecule: "carboplatin + pemetrexed",
+        rationale: `Chemotherapy doublet — standard 2L NSCLC backbone in ${country.toUpperCase()} per local clinical guidelines.`,
+        outcome_instrument_preferences: instruments,
+    };
+    const io = {
+        molecule: "pembrolizumab",
+        rationale: `Immunotherapy — frequently considered as comparator for 2L NSCLC where PD-L1 status supports it. Recognised in ${country.toUpperCase()} HTA submissions.`,
+        outcome_instrument_preferences: instruments,
+    };
+    const tki_alt = {
+        molecule: "afatinib",
+        rationale: `Alternative TKI option in EGFR-mutant 2L; relevant context comparator in ${country.toUpperCase()}.`,
+        outcome_instrument_preferences: instruments,
+    };
+    if (country === "de" || country === "nl")
+        return [chemo, io];
+    if (country === "fr")
+        return [chemo, tki_alt];
+    if (country === "it" || country === "es")
+        return [chemo, io, tki_alt];
+    if (country === "uk")
+        return [chemo, io];
+    return [chemo];
+}
+function ibdUcBiologicComparators(country) {
+    const instruments = instrumentsFor("ibd_uc");
+    // UC biologics universe (post-2024): vedolizumab, infliximab, ustekinumab,
+    // mirikizumab, ozanimod. National HTA preferences vary.
+    const ved = {
+        molecule: "vedolizumab",
+        rationale: `Gut-selective integrin inhibitor — established 1L biologic in ${country.toUpperCase()} for moderate-to-severe UC.`,
+        outcome_instrument_preferences: instruments,
+    };
+    const ifx = {
+        molecule: "infliximab",
+        rationale: `Anti-TNF — historical UC standard; biosimilar pricing keeps it as a comparator anchor in ${country.toUpperCase()}.`,
+        outcome_instrument_preferences: instruments,
+    };
+    const ust = {
+        molecule: "ustekinumab",
+        rationale: `IL-12/23 inhibitor — recognised UC biologic option.`,
+        outcome_instrument_preferences: instruments,
+    };
+    const oz = {
+        molecule: "ozanimod",
+        rationale: `S1P receptor modulator — oral option, increasingly considered in 1L moderate UC.`,
+        outcome_instrument_preferences: instruments,
+    };
+    if (country === "de")
+        return [ved, ifx, ust];
+    if (country === "fr")
+        return [ved, ifx, oz];
+    if (country === "it" || country === "es")
+        return [ved, ifx, ust, oz];
+    if (country === "nl")
+        return [ved, ust];
+    if (country === "uk")
+        return [ved, ifx, ust];
+    return [ved, ifx];
+}
+function genericComparators(country, category) {
+    const instruments = instrumentsFor(category);
+    return [
+        {
+            molecule: "standard of care (country-specific)",
+            rationale: `Coarse placeholder — confirm against latest ${country.toUpperCase()} HTA precedents and clinical guidelines.`,
+            outcome_instrument_preferences: instruments,
+        },
+    ];
+}
+function comparatorsFor(country, category, drug_class, line) {
+    if (category === "oncology_nsclc" && line === "second_line") {
+        return nsclcSecondLineComparators(country);
+    }
+    if (category === "ibd_uc") {
+        return ibdUcBiologicComparators(country);
+    }
+    // Drug-class-aware fallback for unknown indications
+    if (category === "oncology_other" || category === "oncology_nsclc") {
+        const instruments = instrumentsFor(category);
+        return [
+            {
+                molecule: "standard chemotherapy doublet",
+                rationale: `Default oncology comparator anchor for ${country.toUpperCase()}; refine against the indication's clinical trial protocol.`,
+                outcome_instrument_preferences: instruments,
+            },
+        ];
+    }
+    void drug_class;
+    return genericComparators(country, category);
+}
+function subgroupsFor(category) {
+    if (category === "oncology_nsclc") {
+        return [
+            "EGFR mutation status",
+            "PD-L1 TPS (≥50% / 1-49% / <1%)",
+            "ECOG performance status (0-1 vs 2)",
+            "brain metastases (yes/no)",
+        ];
+    }
+    if (category === "ibd_uc") {
+        return [
+            "Mayo total score (moderate vs severe)",
+            "prior biologic exposure (TNF-experienced vs naive)",
+            "extent of colitis (left-sided vs extensive)",
+        ];
+    }
+    if (category === "ibd_cd") {
+        return [
+            "CDAI (moderate vs severe)",
+            "prior biologic exposure",
+            "fistulizing vs luminal disease",
+        ];
+    }
+    if (category === "diabetes_t2") {
+        return ["baseline HbA1c", "BMI category", "CV risk status"];
+    }
+    if (category === "obesity") {
+        return ["BMI category", "comorbidities (T2D, CV, OSA)"];
+    }
+    return ["age strata", "comorbidity status"];
+}
+function profile(jurisdiction, hta_body) {
+    return {
+        jurisdiction,
+        hta_body,
+        outcome_instrument_preferences: ["EQ-5D-5L"],
+        outcome_priority: ["OS", "PFS", "HRQoL", "AE"],
+        comparators: (cat, dc, line) => comparatorsFor(jurisdiction, cat, dc, line),
+        population_subgroups: (cat) => subgroupsFor(cat),
+    };
+}
+export const COUNTRY_PROFILES = {
+    de: profile("de", "G-BA / IQWiG"),
+    fr: profile("fr", "HAS"),
+    it: profile("it", "AIFA"),
+    es: profile("es", "AEMPS / RedETS"),
+    nl: profile("nl", "Zorginstituut Nederland"),
+    uk: profile("uk", "NICE (post-Brexit, context only)"),
+    eu_other: {
+        jurisdiction: "eu_other",
+        hta_body: "Other EU member states — consult national HTA",
+        outcome_instrument_preferences: ["EQ-5D-5L"],
+        outcome_priority: ["OS", "PFS", "HRQoL", "AE"],
+        comparators: () => [
+            {
+                molecule: "consult national HTA body",
+                rationale: "v1 of jca_pico_scope covers DE/FR/IT/ES/NL + UK only. For other EU member states (BE, AT, SE, DK, FI, PL, CZ, HU, etc.), consult the national HTA body for jurisdiction-specific comparator preferences.",
+                outcome_instrument_preferences: ["EQ-5D-5L"],
+            },
+        ],
+        population_subgroups: () => [],
+    },
+};
+/**
+ * Coarse classifier mapping a free-text indication to a category.
+ * Errs on "other" rather than guessing wrong.
+ */
+export function classifyIndication(indication) {
+    const x = indication.toLowerCase();
+    if (x.includes("nsclc") ||
+        x.includes("non-small cell lung") ||
+        x.includes("lung cancer")) {
+        return "oncology_nsclc";
+    }
+    if (x.includes("cancer") ||
+        x.includes("oncolog") ||
+        x.includes("carcinoma") ||
+        x.includes("tumour") ||
+        x.includes("tumor") ||
+        x.includes("myeloma") ||
+        x.includes("leukemia") ||
+        x.includes("leukaemia") ||
+        x.includes("lymphoma")) {
+        return "oncology_other";
+    }
+    if (x.includes("ulcerative colitis") || x.includes("uc"))
+        return "ibd_uc";
+    if (x.includes("crohn"))
+        return "ibd_cd";
+    if (x.includes("type 2 diabetes") || x.includes("t2d") || x.includes("diabetes mellitus type 2")) {
+        return "diabetes_t2";
+    }
+    if (x.includes("obesity") || x.includes("overweight"))
+        return "obesity";
+    if (x.includes("cardiovascular") ||
+        x.includes("heart failure") ||
+        x.includes("hypertension")) {
+        return "cardiovascular";
+    }
+    if (x.includes("rheumatoid") ||
+        x.includes("psoriatic") ||
+        x.includes("ankylosing") ||
+        x.includes("lupus")) {
+        return "rheumatology";
+    }
+    if (x.includes("multiple sclerosis") ||
+        x.includes("alzheimer") ||
+        x.includes("parkinson") ||
+        x.includes("epilepsy")) {
+        return "neurology";
+    }
+    return "other";
+}
+export function profileFor(jurisdiction) {
+    return COUNTRY_PROFILES[jurisdiction];
+}
+export function outcomePriorityForCategory(category) {
+    return outcomePriorityFor(category);
+}
+//# sourceMappingURL=countryRegistry.js.map

package/dist/jca/countryRegistry.js.map

@@ -0,0 +1 @@
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package/dist/jca/scopeBuilder.d.ts

@@ -0,0 +1,15 @@
+import type { ComparatorEntry, DrugClass, Jurisdiction, LineOfTherapy, PicoMatrix } from "./types.js";
+export interface ScopeBuilderInput {
+    drug: string;
+    indication: string;
+    drug_class: DrugClass;
+    mechanism_of_action?: string;
+    line_of_therapy: LineOfTherapy;
+    biomarker_status?: string;
+    jurisdictions: Jurisdiction[];
+    regulatory_context: "pre_authorisation" | "post_authorisation" | "conditional_approval";
+}
+export declare function buildScope(input: ScopeBuilderInput): PicoMatrix;
+/** Lists every comparator molecule a country profile produced — used for the markdown report. */
+export declare function flattenComparators(country_specific: PicoMatrix["country_specific"]): ComparatorEntry[];
+//# sourceMappingURL=scopeBuilder.d.ts.map

package/dist/jca/scopeBuilder.d.ts.map

@@ -0,0 +1 @@
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package/dist/jca/scopeBuilder.js

@@ -0,0 +1,89 @@
+/**
+ * Pure scope-builder logic for jca_pico_scope. Given a normalised input,
+ * returns a fully-populated PicoMatrix without any I/O. See design log #13.
+ */
+import { classifyIndication, JCA_REVISION, outcomePriorityForCategory, profileFor, } from "./countryRegistry.js";
+export function buildScope(input) {
+    const category = classifyIndication(input.indication);
+    const country_specific = input.jurisdictions.map((j) => {
+        const p = profileFor(j);
+        const comparators = p.comparators(category, input.drug_class, input.line_of_therapy);
+        return {
+            jurisdiction: j,
+            hta_body: p.hta_body,
+            comparators,
+            population_subgroups: p.population_subgroups(category),
+            outcome_priorities: outcomePriorityForCategory(category),
+        };
+    });
+    const distinctMolecules = new Set();
+    for (const c of country_specific) {
+        for (const cmp of c.comparators)
+            distinctMolecules.add(cmp.molecule);
+    }
+    const distinct_comparator_count = distinctMolecules.size;
+    const heterogeneity_warning = input.jurisdictions.length > 1 && distinct_comparator_count >= 3;
+    const picos = buildPicos(input, country_specific);
+    const rationale = buildRationale(input, category, distinct_comparator_count);
+    return {
+        drug: input.drug,
+        indication: input.indication,
+        jca_revision: JCA_REVISION,
+        picos,
+        country_specific,
+        heterogeneity_warning,
+        distinct_comparator_count,
+        rationale,
+    };
+}
+function buildPicos(input, country_specific) {
+    const seen = new Set();
+    const picos = [];
+    let counter = 1;
+    const populationBase = input.biomarker_status
+        ? `${input.indication}; biomarker: ${input.biomarker_status}`
+        : input.indication;
+    for (const country of country_specific) {
+        for (const cmp of country.comparators) {
+            const key = `${cmp.molecule}::${country.outcome_priorities.join(",")}`;
+            if (seen.has(key))
+                continue;
+            seen.add(key);
+            picos.push({
+                id: `PICO-${counter}`,
+                population: populationBase,
+                comparator: cmp.molecule,
+                outcomes: country.outcome_priorities.map((o) => o.toString()),
+            });
+            counter += 1;
+        }
+    }
+    if (picos.length === 0) {
+        picos.push({
+            id: "PICO-1",
+            population: populationBase,
+            comparator: "standard of care",
+            outcomes: ["clinical effectiveness", "HRQoL", "AE"],
+        });
+    }
+    return picos;
+}
+function buildRationale(input, category, distinct) {
+    const parts = [];
+    parts.push(`JCA scope for ${input.drug} in ${input.indication} (${category} category) across ${input.jurisdictions.length} jurisdiction(s).`);
+    if (input.regulatory_context === "pre_authorisation") {
+        parts.push("Anticipatory scope — JCA scope is finalised at marketing authorisation; this output is for protocol-design and pre-MA market access strategy only.");
+    }
+    if (distinct >= 3) {
+        parts.push(`Heterogeneity warning: ${distinct} distinct comparator molecules across jurisdictions. Plan for evidence_network + itc_feasibility before estimation.`);
+    }
+    return parts.join(" ");
+}
+/** Lists every comparator molecule a country profile produced — used for the markdown report. */
+export function flattenComparators(country_specific) {
+    const out = [];
+    for (const c of country_specific)
+        out.push(...c.comparators);
+    return out;
+}
+//# sourceMappingURL=scopeBuilder.js.map

package/dist/jca/scopeBuilder.js.map

@@ -0,0 +1 @@
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package/dist/jca/types.d.ts

@@ -0,0 +1,41 @@
+export type Jurisdiction = "de" | "fr" | "it" | "es" | "nl" | "uk" | "eu_other";
+export type DrugClass = "monoclonal_antibody" | "small_molecule" | "atmp_cell" | "atmp_gene" | "atmp_tissue" | "biosimilar" | "vaccine" | "radiopharmaceutical" | "other";
+export type LineOfTherapy = "first_line" | "second_line" | "third_line_plus" | "any";
+export type OutcomePriority = "OS" | "PFS" | "HRQoL" | "AE" | "remission" | "other";
+export interface ComparatorEntry {
+    molecule: string;
+    rationale: string;
+    outcome_instrument_preferences: string[];
+}
+export interface CountryProfile {
+    jurisdiction: Jurisdiction;
+    hta_body: string;
+    outcome_instrument_preferences: string[];
+    outcome_priority: OutcomePriority[];
+    /** Pure function — given a drug-class and indication category, returns the comparator universe for this country. */
+    comparators: (indication_category: IndicationCategory, drug_class: DrugClass, line: LineOfTherapy) => ComparatorEntry[];
+    population_subgroups: (indication_category: IndicationCategory) => string[];
+}
+export type IndicationCategory = "oncology_nsclc" | "oncology_other" | "ibd_uc" | "ibd_cd" | "diabetes_t2" | "obesity" | "cardiovascular" | "rheumatology" | "neurology" | "rare_disease" | "infectious_disease" | "other";
+export interface PicoMatrix {
+    drug: string;
+    indication: string;
+    jca_revision: "2026-05";
+    picos: Array<{
+        id: string;
+        population: string;
+        comparator: string;
+        outcomes: string[];
+    }>;
+    country_specific: Array<{
+        jurisdiction: Jurisdiction;
+        hta_body: string;
+        comparators: ComparatorEntry[];
+        population_subgroups: string[];
+        outcome_priorities: OutcomePriority[];
+    }>;
+    heterogeneity_warning: boolean;
+    distinct_comparator_count: number;
+    rationale: string;
+}
+//# sourceMappingURL=types.d.ts.map

package/dist/jca/types.d.ts.map

@@ -0,0 +1 @@
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package/dist/jca/types.js

@@ -0,0 +1,2 @@
+export {};
+//# sourceMappingURL=types.js.map

package/dist/jca/types.js.map

@@ -0,0 +1 @@
+{"version":3,"file":"types.js","sourceRoot":"","sources":["../../src/jca/types.ts"],"names":[],"mappings":""}

package/dist/server.js

@@ -28,6 +28,7 @@ import { handleItcFeasibility, itcFeasibilityToolSchema, } from "./tools/itcFeas
 import { handleExamples, examplesToolSchema } from "./tools/examples.js";
 import { handleMaicWorkflow, maicWorkflowToolSchema, } from "./tools/maicWorkflow.js";
 import { handlePvClassify, pvClassifyToolSchema } from "./tools/pvClassify.js";
+import { handleJcaPicoScope, jcaPicoScopeToolSchema, } from "./tools/jcaPicoScope.js";
 import { randomUUID } from "node:crypto";
 import { trackToolCall, trackSession, shutdownAnalytics, inferSurface, } from "./analytics.js";
 import { createServer } from "node:http";
@@ -160,6 +161,7 @@ function createMcpServer(surfaceRef = { value: "direct_mcp" }, sessionIdRef = {
             examplesToolSchema,
             maicWorkflowToolSchema,
             pvClassifyToolSchema,
+            jcaPicoScopeToolSchema,
         ],
     }));
     server.setRequestHandler(CallToolRequestSchema, async (request) => {
@@ -228,6 +230,9 @@ function createMcpServer(surfaceRef = { value: "direct_mcp" }, sessionIdRef = {
                 case "pv.classify":
                     result = await handlePvClassify(args);
                     break;
+                case "jca.pico_scope":
+                    result = await handleJcaPicoScope(args);
+                    break;
                 default:
                     trackToolCall(name, Date.now() - callStart, "error", sessionIdRef.value || undefined, {
                         surface: surfaceRef.value,

package/dist/server.js.map

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

@@ -0,0 +1,57 @@
+import type { ToolResult } from "../providers/types.js";
+export declare function handleJcaPicoScope(rawInput: unknown): Promise<ToolResult>;
+export declare const jcaPicoScopeToolSchema: {
+    readonly name: "jca.pico_scope";
+    readonly description: "Produce the canonical EU Joint Clinical Assessment (JCA) PICO matrix for a drug-indication pair. Returns a consolidated PICO list (per JCA process under Reg. 2021/2282) plus country-specific comparator universes, outcome instrument preferences, population subgroup focus, and a heterogeneity warning when ≥3 distinct comparators emerge across jurisdictions. Pipe `pico_matrix.picos` directly into `hta_dossier({hta_body:\"jca\", picos: ...})`. v1 covers DE/FR/IT/ES/NL + UK (post-Brexit context).";
+    readonly annotations: {
+        readonly title: "JCA PICO Scope Analyzer";
+        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 description: "Drug name.";
+            };
+            readonly indication: {
+                readonly type: "string";
+                readonly description: "Disease/condition.";
+            };
+            readonly drug_class: {
+                readonly type: "string";
+                readonly enum: readonly ["monoclonal_antibody", "small_molecule", "atmp_cell", "atmp_gene", "atmp_tissue", "biosimilar", "vaccine", "radiopharmaceutical", "other"];
+            };
+            readonly mechanism_of_action: {
+                readonly type: "string";
+            };
+            readonly line_of_therapy: {
+                readonly type: "string";
+                readonly enum: readonly ["first_line", "second_line", "third_line_plus", "any"];
+                readonly default: "any";
+            };
+            readonly biomarker_status: {
+                readonly type: "string";
+                readonly description: "Optional biomarker status (e.g., 'EGFR T790M positive', 'PD-L1 TPS ≥50%').";
+            };
+            readonly jurisdictions: {
+                readonly type: "array";
+                readonly items: {
+                    readonly type: "string";
+                    readonly enum: readonly ["de", "fr", "it", "es", "nl", "uk", "eu_other"];
+                };
+                readonly default: readonly ["de", "fr", "it", "es", "nl"];
+            };
+            readonly regulatory_context: {
+                readonly type: "string";
+                readonly enum: readonly ["pre_authorisation", "post_authorisation", "conditional_approval"];
+                readonly default: "post_authorisation";
+            };
+        };
+        readonly required: readonly ["drug", "indication", "drug_class"];
+    };
+};
+//# sourceMappingURL=jcaPicoScope.d.ts.map

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

@@ -0,0 +1 @@
+{"version":3,"file":"jcaPicoScope.d.ts","sourceRoot":"","sources":["../../src/tools/jcaPicoScope.ts"],"names":[],"mappings":"AAoBA,OAAO,KAAK,EAAE,UAAU,EAAE,MAAM,uBAAuB,CAAC;AAgDxD,wBAAsB,kBAAkB,CACtC,QAAQ,EAAE,OAAO,GAChB,OAAO,CAAC,UAAU,CAAC,CA8LrB;AAED,eAAO,MAAM,sBAAsB;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;CAqCzB,CAAC"}

package/dist/tools/jcaPicoScope.js

@@ -0,0 +1,209 @@
+/**
+ * jca_pico_scope — EU Joint Clinical Assessment PICO matrix analyzer.
+ * Single-call tool that produces the canonical JCA consolidated-PICO list
+ * for a drug-indication pair across selected EU jurisdictions. Designed
+ * to feed directly into hta_dossier({hta_body:"jca", picos: ...}).
+ *
+ * See design log #13.
+ */
+import { z } from "zod";
+import { addAssumption, addWarning, createAuditRecord, setMethodology, } from "../audit/builder.js";
+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";
+const DRUG_CLASSES = [
+    "monoclonal_antibody",
+    "small_molecule",
+    "atmp_cell",
+    "atmp_gene",
+    "atmp_tissue",
+    "biosimilar",
+    "vaccine",
+    "radiopharmaceutical",
+    "other",
+];
+const LINES = ["first_line", "second_line", "third_line_plus", "any"];
+const JURISDICTIONS = [
+    "de",
+    "fr",
+    "it",
+    "es",
+    "nl",
+    "uk",
+    "eu_other",
+];
+const REG_CONTEXTS = [
+    "pre_authorisation",
+    "post_authorisation",
+    "conditional_approval",
+];
+const JcaPicoScopeSchema = z
+    .object({
+    drug: z.string().min(1, "drug is required"),
+    indication: z.string().min(1, "indication is required"),
+    drug_class: z.enum(DRUG_CLASSES),
+    mechanism_of_action: z.string().optional(),
+    line_of_therapy: z.enum(LINES).default("any"),
+    biomarker_status: z.string().optional(),
+    jurisdictions: z
+        .array(z.enum(JURISDICTIONS))
+        .min(1)
+        .default(["de", "fr", "it", "es", "nl"]),
+    regulatory_context: z.enum(REG_CONTEXTS).default("post_authorisation"),
+})
+    .strict();
+export async function handleJcaPicoScope(rawInput) {
+    const parsed = JcaPicoScopeSchema.safeParse(rawInput);
+    if (!parsed.success) {
+        const messages = [];
+        for (const issue of parsed.error.issues) {
+            if (issue.code === "invalid_enum_value" &&
+                typeof issue.received === "string") {
+                const suggestions = suggestForEnum(issue.received, issue.options);
+                messages.push(`Invalid ${issue.path.join(".")}: "${issue.received}". Allowed: ${issue.options.join(", ")}.${suggestions.length
+                    ? ` Did you mean ${suggestions.map((s) => `"${s}"`).join(", ")}?`
+                    : ""}`);
+            }
+            else {
+                messages.push(`${issue.path.join(".") || "input"}: ${issue.message}`);
+            }
+        }
+        throw new Error(messages.join("\n"));
+    }
+    const input = parsed.data;
+    let audit = createAuditRecord("jca.pico_scope", input, "text");
+    audit = setMethodology(audit, "EU Regulation 2021/2282 (HTA Regulation) — Joint Clinical Assessment; EUnetHTA Coordination Group methodological guidance; Annex II patient-relevant outcomes hierarchy. National HTA preferences sourced from G-BA/IQWiG, HAS, AIFA, AEMPS/RedETS, Zorginstituut, NICE.");
+    const matrix = buildScope({
+        drug: input.drug,
+        indication: input.indication,
+        drug_class: input.drug_class,
+        mechanism_of_action: input.mechanism_of_action,
+        line_of_therapy: input.line_of_therapy,
+        biomarker_status: input.biomarker_status,
+        jurisdictions: input.jurisdictions,
+        regulatory_context: input.regulatory_context,
+    });
+    audit = addAssumption(audit, `JCA scope produced for ${input.jurisdictions.join(", ")} (revision ${JCA_REVISION}). ${matrix.picos.length} consolidated PICO(s).`);
+    if (matrix.heterogeneity_warning) {
+        audit = addWarning(audit, `Comparator heterogeneity: ${matrix.distinct_comparator_count} distinct comparators across jurisdictions. NMA / Bucher feasibility may be compromised.`);
+    }
+    if (input.regulatory_context === "pre_authorisation") {
+        audit = addWarning(audit, "Pre-authorisation context — output is anticipatory only, not a JCA-finalised PICO list.");
+    }
+    const lines = [];
+    lines.push(`# JCA PICO Scope — ${input.drug} (${input.indication})`);
+    lines.push("");
+    lines.push(`**JCA revision:** ${JCA_REVISION} · **Jurisdictions:** ${input.jurisdictions.join(", ").toUpperCase()} · **Regulatory context:** ${input.regulatory_context}`);
+    lines.push("");
+    if (input.regulatory_context === "pre_authorisation") {
+        lines.push("> ⚠️ **Anticipatory scope only.** JCA scope is finalised at marketing authorisation. Use this output for protocol-design and pre-MA market-access strategy — not for actual JCA submission.");
+        lines.push("");
+    }
+    if (matrix.heterogeneity_warning) {
+        lines.push(`> ⚠️ **Comparator heterogeneity warning.** ${matrix.distinct_comparator_count} distinct comparator molecules across ${input.jurisdictions.length} jurisdictions. Run \`evidence_network\` + \`itc_feasibility\` before any quantitative estimation.`);
+        lines.push("");
+    }
+    lines.push("## Rationale");
+    lines.push(matrix.rationale);
+    lines.push("");
+    lines.push(`## Consolidated PICO list (${matrix.picos.length} PICOs)`);
+    lines.push("| ID | Population | Comparator | Outcomes |");
+    lines.push("|----|------------|------------|----------|");
+    for (const p of matrix.picos) {
+        lines.push(`| ${p.id} | ${p.population} | ${p.comparator} | ${p.outcomes.join(", ")} |`);
+    }
+    lines.push("");
+    lines.push("*Pipe `pico_matrix.picos` directly into `hta_dossier({hta_body:\"jca\", picos: ...})` to expand into a multi-PICO dossier.*");
+    lines.push("");
+    for (const c of matrix.country_specific) {
+        const flag = { de: "🇩🇪 Germany", fr: "🇫🇷 France", it: "🇮🇹 Italy", es: "🇪🇸 Spain", nl: "🇳🇱 Netherlands", uk: "🇬🇧 United Kingdom", eu_other: "🇪🇺 Other EU member states" }[c.jurisdiction] ?? c.jurisdiction;
+        lines.push(`## ${flag} — ${c.hta_body}`);
+        if (c.jurisdiction === "uk") {
+            lines.push("*Post-Brexit, NICE alignment context only — UK is outside the JCA process but most submissions still target NICE in parallel.*");
+        }
+        if (c.jurisdiction === "eu_other") {
+            lines.push("*v1 of `jca_pico_scope` covers DE/FR/IT/ES/NL + UK only — consult national HTA bodies for jurisdiction-specific comparator preferences.*");
+        }
+        lines.push("");
+        lines.push("**Comparators:**");
+        for (const cmp of c.comparators) {
+            lines.push(`- **${cmp.molecule}** — ${cmp.rationale}`);
+            lines.push(`  Outcome instruments: ${cmp.outcome_instrument_preferences.join(", ")}`);
+        }
+        if (c.population_subgroups.length > 0) {
+            lines.push("");
+            lines.push("**Population subgroups of HTA interest:**");
+            for (const s of c.population_subgroups)
+                lines.push(`- ${s}`);
+        }
+        lines.push("");
+        lines.push(`**Outcome priority order:** ${c.outcome_priorities.join(" → ")}`);
+        lines.push("");
+    }
+    // Surrogate-endpoint note for oncology indications
+    const isOncology = matrix.country_specific.some((c) => c.outcome_priorities[0] === "OS");
+    if (isOncology) {
+        lines.push("## Surrogate Endpoints");
+        lines.push("JCA prefers patient-relevant outcomes per Annex II of Implementing Regulation 2024/1381. **Surrogate endpoints (PFS, ORR, biomarker response) are accepted as secondary outcomes only and may face JCA scrutiny.** Plan an OS analysis even when PFS is the trial primary endpoint, and pre-specify any OS-from-PFS surrogacy assumptions in the dossier.");
+        lines.push("");
+    }
+    lines.push("## Suggested Next Steps");
+    lines.push(`1. Pipe \`pico_matrix.picos\` into \`hta_dossier({hta_body:"jca", submission_type:"initial", drug_name:"${input.drug}", indication:"${input.indication}", picos: ...})\`.`);
+    lines.push("2. Run `evidence_network` on the comparator universe to assess connectedness.");
+    lines.push("3. Run `itc_feasibility` to determine whether anchored/unanchored ITC, MAIC, or full NMA is appropriate.");
+    if (matrix.heterogeneity_warning) {
+        lines.push("4. Given the heterogeneity warning, expect multiple PICOs to require separate ITCs rather than a single network analysis.");
+    }
+    lines.push("");
+    lines.push("## References");
+    lines.push("- EU Regulation 2021/2282 — HTA Regulation");
+    lines.push("- EU Implementing Regulation 2024/1381 — JCA procedural rules");
+    lines.push("- EUnetHTA Coordination Group — Methodological Guidance Series");
+    lines.push("- Annex II — patient-relevant outcomes hierarchy (mortality, morbidity, HRQoL, AEs)");
+    lines.push("- National HTA bodies: G-BA / IQWiG, HAS, AIFA, AEMPS / RedETS, Zorginstituut Nederland, NICE");
+    lines.push("");
+    lines.push(auditToMarkdown(audit));
+    return {
+        content: lines.join("\n"),
+        audit,
+        pico_matrix: matrix,
+    };
+}
+export const jcaPicoScopeToolSchema = {
+    name: "jca.pico_scope",
+    description: "Produce the canonical EU Joint Clinical Assessment (JCA) PICO matrix for a drug-indication pair. Returns a consolidated PICO list (per JCA process under Reg. 2021/2282) plus country-specific comparator universes, outcome instrument preferences, population subgroup focus, and a heterogeneity warning when ≥3 distinct comparators emerge across jurisdictions. Pipe `pico_matrix.picos` directly into `hta_dossier({hta_body:\"jca\", picos: ...})`. v1 covers DE/FR/IT/ES/NL + UK (post-Brexit context).",
+    annotations: {
+        title: "JCA PICO Scope Analyzer",
+        readOnlyHint: true,
+        destructiveHint: false,
+        idempotentHint: true,
+        openWorldHint: false,
+    },
+    inputSchema: {
+        type: "object",
+        properties: {
+            drug: { type: "string", description: "Drug name." },
+            indication: { type: "string", description: "Disease/condition." },
+            drug_class: { type: "string", enum: DRUG_CLASSES },
+            mechanism_of_action: { type: "string" },
+            line_of_therapy: { type: "string", enum: LINES, default: "any" },
+            biomarker_status: {
+                type: "string",
+                description: "Optional biomarker status (e.g., 'EGFR T790M positive', 'PD-L1 TPS ≥50%').",
+            },
+            jurisdictions: {
+                type: "array",
+                items: { type: "string", enum: JURISDICTIONS },
+                default: ["de", "fr", "it", "es", "nl"],
+            },
+            regulatory_context: {
+                type: "string",
+                enum: REG_CONTEXTS,
+                default: "post_authorisation",
+            },
+        },
+        required: ["drug", "indication", "drug_class"],
+    },
+};
+//# sourceMappingURL=jcaPicoScope.js.map

package/dist/tools/jcaPicoScope.js.map

@@ -0,0 +1 @@
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package/package.json

@@ -1,13 +1,13 @@
 {
   "name": "heor-agent-mcp",
-  "version": "1.1.1",
+  "version": "1.2.0",
   "mcpName": "io.github.neptun2000/heor-agent",
   "license": "MIT",
   "author": "mnaumov",
   "engines": {
     "node": ">=20.0.0"
   },
-  "description": "AI-powered Health Economics and Outcomes Research (HEOR) MCP server — 20 tools across literature search (44 data sources incl. PubMed/ClinicalTrials.gov/Cochrane/NICE/CADTH/ICER), risk of bias (RoB 2/ROBINS-I/AMSTAR-2), cost-effectiveness modeling (Markov/PartSA/PSA/EVPPI), budget impact analysis, abstract screening, survival curve fitting (NICE DSU TSD 14), indirect comparisons (Bucher/NMA/MAIC/STC), pharmacovigilance study classification (EMA GVP rev 4), MAIC pipeline orchestration, and HTA dossier prep (NICE/EMA/FDA/IQWiG/HAS/EU JCA) with auto-GRADE + PV plan section",
+  "description": "AI-powered Health Economics and Outcomes Research (HEOR) MCP server — 21 tools across literature search (44 data sources incl. PubMed/ClinicalTrials.gov/Cochrane/NICE/CADTH/ICER), risk of bias (RoB 2/ROBINS-I/AMSTAR-2), cost-effectiveness modeling (Markov/PartSA/PSA/EVPPI), budget impact analysis, abstract screening, survival curve fitting (NICE DSU TSD 14), indirect comparisons (Bucher/NMA/MAIC/STC), pharmacovigilance study classification (EMA GVP rev 4), EU JCA PICO matrix analyzer, MAIC pipeline orchestration, and HTA dossier prep (NICE/EMA/FDA/IQWiG/HAS/EU JCA) with auto-GRADE + PV plan + NICE severity/inequalities sections",
   "type": "module",
   "main": "dist/server.js",
   "bin": {