heor-agent-mcp 1.3.1 → 1.3.2

package/dist/data/niceTaPrecedents.d.ts

@@ -0,0 +1,72 @@
+/**
+ * NICE Technology Appraisal precedent lookup.
+ *
+ * Maps drug-indication pairs to the relevant NICE TA number(s).
+ * Used by `hta_dossier` (NICE branch) to surface known precedents
+ * upfront and to catch user prompt errors of the form
+ * "cite TA902 for HFrEF" (TA902 is HFpEF/HFmrEF; TA679 is HFrEF).
+ *
+ * Verification policy:
+ * - Each entry is the canonical TA at time of writing (2026-05).
+ * - Indications use lowercase free-form keywords; matching is
+ *   substring-based to tolerate user phrasing variation.
+ * - When the user passes a different TA number in prose, the
+ *   tool surfaces both the user's number and the canonical one
+ *   without auto-overriding (we annotate the mismatch but
+ *   defer to user judgement).
+ *
+ * To add an entry: append to PRECEDENTS, keep keywords lowercase,
+ * keep `confidence: "high"` only for personally-verified entries.
+ *
+ * See design log #16.
+ */
+export interface NicePrecedent {
+    ta_number: string;
+    drug: string;
+    indication_keywords: string[];
+    title: string;
+    date: string;
+    url: string;
+    notes?: string;
+    confidence: "high" | "medium";
+}
+/**
+ * v1 list — top NICE TAs likely to be cited in HEOR submissions
+ * for the indications HEORAgent is most often used for. Expand
+ * over time. ~50 entries is enough to catch the common confusions
+ * (HFrEF vs HFpEF, indication-specific TAs, biosimilar splits).
+ */
+export declare const PRECEDENTS: ReadonlyArray<NicePrecedent>;
+/**
+ * Look up NICE TA precedents that match the given drug and indication
+ * substrings. Returns 0..n matches, ranked by drug match first then
+ * by number of indication keyword matches.
+ *
+ * Matching is intentionally loose: we want to catch "HFrEF",
+ * "heart failure with reduced ejection fraction", and "hf with
+ * reduced EF" all matching TA679. Both drug name and indication
+ * are lowercased before substring comparison.
+ */
+export declare function findPrecedents(drug: string, indication: string): NicePrecedent[];
+/**
+ * Detect when a user-supplied TA number is mismatched against the
+ * canonical TA for the indication. Returns a structured warning
+ * payload the caller can surface in the dossier output and audit.
+ *
+ * Example: user prompt "cite TA902 for dapagliflozin HFrEF"
+ *   → detects TA902 in prose, looks up canonical TA for
+ *     dapagliflozin+HFrEF (TA679), and returns a warning recommending
+ *     correction.
+ */
+export interface PrecedentMismatch {
+    user_supplied: string;
+    canonical: string;
+    user_supplied_url?: string;
+    canonical_url: string;
+    drug: string;
+    indication: string;
+    explanation: string;
+}
+export declare function detectMismatch(drug: string, indication: string, userSuppliedTaNumber: string | null | undefined): PrecedentMismatch | null;
+export declare function extractTaNumber(text: string): string | null;
+//# sourceMappingURL=niceTaPrecedents.d.ts.map

package/dist/data/niceTaPrecedents.d.ts.map

@@ -0,0 +1 @@
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package/dist/data/niceTaPrecedents.js

@@ -0,0 +1,152 @@
+/**
+ * v1 list — top NICE TAs likely to be cited in HEOR submissions
+ * for the indications HEORAgent is most often used for. Expand
+ * over time. ~50 entries is enough to catch the common confusions
+ * (HFrEF vs HFpEF, indication-specific TAs, biosimilar splits).
+ */
+export const PRECEDENTS = [
+    // SGLT2 inhibitors in heart failure — the TA679 / TA902 confusion
+    // that the management benchmark exposed.
+    {
+        ta_number: "TA679",
+        drug: "dapagliflozin",
+        indication_keywords: ["hfref", "heart failure with reduced ejection fraction", "reduced ejection fraction"],
+        title: "Dapagliflozin for treating chronic heart failure with reduced ejection fraction",
+        date: "2021-02",
+        url: "https://www.nice.org.uk/guidance/ta679",
+        notes: "DO NOT confuse with TA902 — TA902 covers HFpEF/HFmrEF, not HFrEF.",
+        confidence: "high",
+    },
+    {
+        ta_number: "TA902",
+        drug: "dapagliflozin",
+        indication_keywords: ["hfpef", "hfmref", "preserved ejection fraction", "mildly reduced ejection fraction"],
+        title: "Dapagliflozin for treating chronic heart failure with preserved or mildly reduced ejection fraction",
+        date: "2023-06",
+        url: "https://www.nice.org.uk/guidance/ta902",
+        notes: "DO NOT confuse with TA679 — TA679 covers HFrEF.",
+        confidence: "high",
+    },
+    {
+        ta_number: "TA773",
+        drug: "empagliflozin",
+        indication_keywords: ["hfref", "heart failure with reduced ejection fraction"],
+        title: "Empagliflozin for treating chronic heart failure with reduced ejection fraction",
+        date: "2022-03",
+        url: "https://www.nice.org.uk/guidance/ta773",
+        confidence: "high",
+    },
+    {
+        ta_number: "TA929",
+        drug: "empagliflozin",
+        indication_keywords: ["hfpef", "hfmref", "preserved ejection fraction", "mildly reduced ejection fraction"],
+        title: "Empagliflozin for treating chronic heart failure with preserved or mildly reduced ejection fraction",
+        date: "2023-09",
+        url: "https://www.nice.org.uk/guidance/ta929",
+        confidence: "high",
+    },
+    // SGLT2i in CKD
+    {
+        ta_number: "TA775",
+        drug: "dapagliflozin",
+        indication_keywords: ["chronic kidney disease", "ckd"],
+        title: "Dapagliflozin for treating chronic kidney disease",
+        date: "2022-03",
+        url: "https://www.nice.org.uk/guidance/ta775",
+        confidence: "high",
+    },
+    // SGLT2i in T2D
+    {
+        ta_number: "TA288",
+        drug: "dapagliflozin",
+        indication_keywords: ["type 2 diabetes", "t2dm", "type-2 diabetes"],
+        title: "Dapagliflozin in combination therapy for treating type 2 diabetes",
+        date: "2013-06",
+        url: "https://www.nice.org.uk/guidance/ta288",
+        confidence: "high",
+    },
+    // ARNI in HF
+    {
+        ta_number: "TA388",
+        drug: "sacubitril valsartan",
+        indication_keywords: ["heart failure", "hfref", "reduced ejection fraction"],
+        title: "Sacubitril valsartan for treating symptomatic chronic heart failure with reduced ejection fraction",
+        date: "2016-04",
+        url: "https://www.nice.org.uk/guidance/ta388",
+        confidence: "high",
+    },
+];
+/**
+ * Look up NICE TA precedents that match the given drug and indication
+ * substrings. Returns 0..n matches, ranked by drug match first then
+ * by number of indication keyword matches.
+ *
+ * Matching is intentionally loose: we want to catch "HFrEF",
+ * "heart failure with reduced ejection fraction", and "hf with
+ * reduced EF" all matching TA679. Both drug name and indication
+ * are lowercased before substring comparison.
+ */
+export function findPrecedents(drug, indication) {
+    const drugLower = drug.toLowerCase().trim();
+    const indicationLower = indication.toLowerCase().trim();
+    if (!drugLower || !indicationLower)
+        return [];
+    const scored = PRECEDENTS.map((p) => {
+        const drugMatch = drugLower.includes(p.drug) || p.drug.includes(drugLower);
+        if (!drugMatch)
+            return { p, score: 0 };
+        const matchedKeywords = p.indication_keywords.filter((kw) => indicationLower.includes(kw));
+        return { p, score: matchedKeywords.length };
+    });
+    return scored
+        .filter((s) => s.score > 0)
+        .sort((a, b) => b.score - a.score)
+        .map((s) => s.p);
+}
+export function detectMismatch(drug, indication, userSuppliedTaNumber) {
+    if (!userSuppliedTaNumber)
+        return null;
+    const userTa = userSuppliedTaNumber.trim().toUpperCase();
+    const canonical = findPrecedents(drug, indication);
+    if (canonical.length === 0)
+        return null;
+    const top = canonical[0];
+    if (top.ta_number.toUpperCase() === userTa)
+        return null;
+    // Check whether the user-supplied TA exists in our table for any
+    // OTHER indication of the same drug — if so, we can give a much
+    // more informative explanation.
+    const userTaEntry = PRECEDENTS.find((p) => p.ta_number.toUpperCase() === userTa);
+    let explanation;
+    if (userTaEntry) {
+        explanation =
+            `User cited ${userTa} (${userTaEntry.title}) but the canonical NICE TA for ` +
+                `"${drug} ${indication}" is ${top.ta_number} (${top.title}). ` +
+                `${userTaEntry.notes ?? ""} ${top.notes ?? ""}`.trim();
+    }
+    else {
+        explanation =
+            `User cited ${userTa} but the canonical NICE TA for ` +
+                `"${drug} ${indication}" is ${top.ta_number} (${top.title}).`;
+    }
+    return {
+        user_supplied: userTa,
+        canonical: top.ta_number,
+        user_supplied_url: userTaEntry?.url,
+        canonical_url: top.url,
+        drug,
+        indication,
+        explanation,
+    };
+}
+/**
+ * Extract a TA number (e.g. "TA902") from arbitrary prose. Returns
+ * the first match or null. Used to scan e.g. evidence_summary for
+ * a TA number the user may have referenced informally.
+ */
+const TA_NUMBER_REGEX = /\b(TA\d{2,4})\b/i;
+export function extractTaNumber(text) {
+    const m = text.match(TA_NUMBER_REGEX);
+    return m ? m[1].toUpperCase() : null;
+}
+//# sourceMappingURL=niceTaPrecedents.js.map

package/dist/data/niceTaPrecedents.js.map

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

@@ -0,0 +1,55 @@
+/**
+ * EU JCA scope eligibility checker.
+ *
+ * Per Regulation (EU) 2021/2282, JCA scope is phased:
+ *   • From 12 January 2025: oncology medicinal products + ATMPs with
+ *     new active substances.
+ *   • From 13 January 2028: orphan medicinal products added.
+ *   • From 13 January 2030: all new medicinal products.
+ *
+ * Therefore, a request to produce a JCA PICO matrix for, e.g.,
+ * dapagliflozin in HFrEF (cardiovascular, small molecule) is asking
+ * for something that does not exist today and won't until 2030.
+ *
+ * This module exposes a pure function the `jca_pico_scope` tool calls
+ * before producing any output, so the tool can:
+ *   (a) refuse to produce a fabricated JCA matrix when the indication
+ *       is not in scope, AND
+ *   (b) explain the scope rule, the canonical Regulation reference,
+ *       and the year the indication WILL be in scope.
+ *
+ * This closes the gap that Claude.ai surfaced during the management
+ * benchmark — Claude.ai dynamically discovered the JCA scope reality
+ * via web search; HEORAgent now has it baked in.
+ *
+ * See design log #16.
+ */
+import type { IndicationCategory } from "./types.js";
+export type DrugClassForScope = "monoclonal_antibody" | "small_molecule" | "atmp_cell" | "atmp_gene" | "atmp_tissue" | "biosimilar" | "vaccine" | "radiopharmaceutical" | "other";
+export interface ScopeEligibility {
+    /** True if the indication-drug-class combo is currently in JCA scope. */
+    in_scope: boolean;
+    /** Year (Jan 13) the combo enters JCA scope per Reg 2021/2282. */
+    in_scope_from_year: 2025 | 2028 | 2030;
+    /** Phase that gates scope entry. */
+    phase: "oncology_atmp" | "orphan" | "all_medicinal";
+    /** Human-readable explanation suitable for surfacing in tool output. */
+    explanation: string;
+    /** Canonical Regulation references. */
+    references: string[];
+}
+/**
+ * Determine whether a drug-indication combo is currently in JCA scope.
+ *
+ * Inputs are the same shape `jca_pico_scope` already collects, so the
+ * tool can call this with no schema change. The optional `is_orphan`
+ * flag tells us whether the product is orphan-designated; when omitted,
+ * we conservatively assume not orphan so the function never falsely
+ * places a combo in 2028 scope.
+ */
+export declare function checkScopeEligibility(args: {
+    indication_category: IndicationCategory;
+    drug_class: DrugClassForScope;
+    is_orphan?: boolean;
+}): ScopeEligibility;
+//# sourceMappingURL=scopeEligibility.d.ts.map

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

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package/dist/jca/scopeEligibility.js

@@ -0,0 +1,56 @@
+/**
+ * Determine whether a drug-indication combo is currently in JCA scope.
+ *
+ * Inputs are the same shape `jca_pico_scope` already collects, so the
+ * tool can call this with no schema change. The optional `is_orphan`
+ * flag tells us whether the product is orphan-designated; when omitted,
+ * we conservatively assume not orphan so the function never falsely
+ * places a combo in 2028 scope.
+ */
+export function checkScopeEligibility(args) {
+    const refs = [
+        "Regulation (EU) 2021/2282 (HTA Regulation), Article 7 — phased scope.",
+        "EU Implementing Regulation 2024/1381 — JCA procedural rules.",
+        "European Commission factsheet, JCA for Medicinal Products (Jan 2025): https://health.ec.europa.eu/document/download/ced91156-ffe1-472d-85eb-aa6a91dd707e_en?filename=hta_htar_factsheet-jca_en.pdf",
+    ];
+    // Phase 1 (in scope NOW, since 12 Jan 2025): oncology medicinal
+    // products + ATMP-class drugs (cell, gene, tissue) with new
+    // active substances.
+    const isOncology = args.indication_category === "oncology_nsclc" ||
+        args.indication_category === "oncology_other";
+    const isAtmp = args.drug_class === "atmp_cell" ||
+        args.drug_class === "atmp_gene" ||
+        args.drug_class === "atmp_tissue";
+    if (isOncology || isAtmp) {
+        return {
+            in_scope: true,
+            in_scope_from_year: 2025,
+            phase: "oncology_atmp",
+            explanation: "In JCA scope since 12 January 2025 (Phase 1: oncology medicinal products + ATMPs with new active substances).",
+            references: refs,
+        };
+    }
+    // Phase 2 (in scope from 13 Jan 2028): orphan-designated medicinal
+    // products. We treat this conservatively — only flag in-scope=true
+    // for orphan when the user explicitly sets is_orphan AND we're
+    // already past 2028. Since we can't predict the future, we always
+    // return out-of-scope today but with the right "in_scope_from_year".
+    if (args.is_orphan === true) {
+        return {
+            in_scope: false,
+            in_scope_from_year: 2028,
+            phase: "orphan",
+            explanation: "Orphan-designated medicinal products enter JCA scope from 13 January 2028 (Phase 2 of Reg 2021/2282). Until then, this indication is assessed at the national level only — produce a consolidated national-HTA PICO matrix instead.",
+            references: refs,
+        };
+    }
+    // Phase 3 (in scope from 13 Jan 2030): all new medicinal products.
+    return {
+        in_scope: false,
+        in_scope_from_year: 2030,
+        phase: "all_medicinal",
+        explanation: "Cardiovascular, metabolic, respiratory, neurology, infectious disease, rheumatology, IBD, and other non-oncology / non-ATMP indications enter JCA scope from 13 January 2030 (Phase 3 of Reg 2021/2282). Until then, this indication is assessed at the national level only — produce a consolidated national-HTA PICO matrix instead.",
+        references: refs,
+    };
+}
+//# sourceMappingURL=scopeEligibility.js.map

package/dist/jca/scopeEligibility.js.map

@@ -0,0 +1 @@
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package/dist/tools/htaDossierPrep.d.ts.map

@@ -1 +1 @@
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+{"version":3,"file":"htaDossierPrep.d.ts","sourceRoot":"","sources":["../../src/tools/htaDossierPrep.ts"],"names":[],"mappings":"AACA,OAAO,KAAK,EAEV,UAAU,EAGX,MAAM,uBAAuB,CAAC;AA64B/B,wBAAsB,oBAAoB,CACxC,SAAS,EAAE,OAAO,GACjB,OAAO,CAAC,UAAU,CAAC,CAuMrB;AAED,eAAO,MAAM,wBAAwB;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;CAyFpC,CAAC"}

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([
@@ -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);

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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/package.json

@@ -1,6 +1,6 @@
 {
   "name": "heor-agent-mcp",
-  "version": "1.3.1",
+  "version": "1.3.2",
   "mcpName": "io.github.neptun2000/heor-agent",
   "license": "MIT",
   "author": "mnaumov",