heor-agent-mcp 1.0.6 → 1.1.0

package/README.md

@@ -18,16 +18,18 @@ Built for pharmaceutical, biotech, CRO, and medical affairs teams who need rigor
 
 ---
 
-## What's new in v1.0.4
+## What's new in v1.1.0
 
-Senior HEOR methodology + ChatGPT support:
+Pharmacovigilance + workflow orchestration:
 
-- **GRADE inconsistency now uses I²** instead of study count. Single-study comparisons return `not_assessable` (per Cochrane 10.10) instead of being silently auto-downgraded as "Serious". Pass `heterogeneity_per_outcome` to `hta_dossier` and the Cochrane bands (50–74% Moderate, 75–89% Serious, ≥90% Very Serious) are applied directly.
-- **GRADE upgrading (Guyatt 2011)** — observational evidence with strong effects can now be upgraded from Low. Three criteria via `upgrading_per_outcome`: large effect (RR <0.5/>2.0 → +1; <0.2/>5.0 → +2), dose-response (+1), plausible confounding biasing toward null (+1). Capped at +2.
-- **Bucher consistency check** — when direct head-to-head A-vs-C evidence exists alongside the indirect A-vs-C estimate, `evidence_indirect` automatically tests Bucher's consistency assumption and flags violations (NICE DSU TSD 18). |z|≥1.96 = "substantial — consistency assumption appears violated."
-- **EQ-5D 5L impact is baseline-utility-aware.** Biz 2026 reports category-level medians, but the new 5L value set compresses utilities in the 0.6–0.9 range — a drug for mild plaque psoriasis (baseline ~0.85) sees a much bigger ICER increase than one for severe HS (baseline ~0.45), even though both are `non_cancer_qol_only`. Pass `baseline_utility` to `utility_value_set` for a calibrated estimate.
-- **ChatGPT Custom GPT support** — new OpenAPI 3.1 adapter at `/api/openapi` lets you build a Custom GPT in 5 minutes. See [ChatGPT Custom GPT](#chatgpt-custom-gpt) below.
-- **Surface-tagged analytics** — every `tool_call` PostHog event now carries a `surface` property (`claude_anthropic_web` / `chatgpt_adapter` / `claude_desktop` / `direct_mcp`) so you can break down usage by client.
+- **`pv_classify` tool** — classifies 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 (V/VI/VIII/VIII Addendum I), ENCePP protocol template ID, RMP implications, FDA analogue, and submission obligations. Pure decision-tree per EMA GVP rev 4 + EU Regulation 1235/2010 Article 107a. <200ms response.
+- **`hta_dossier` Pharmacovigilance Plan section** — pass `pv_classification` from `pv_classify` to `hta_dossier` and the dossier output now includes a PV Plan section between RoB and CEA. Without it, a one-line "PV plan not provided" note flags the gap so reviewers see what's missing.
+- **`maic_workflow` orchestrator** *(v1.0.6)* — runs the full MAIC discovery+screening pipeline (ITC feasibility + parallel literature_search + screening + RoB + network) in one MCP call. Built for ChatGPT-5.3 surfaces where chaining 5+ tool calls in parallel is unreliable; works equally well from Claude.
+- **`examples` tool** *(v1.0.5)* — pre-filled JSON inputs for heavy-schema tools (CEA, BIA, survival, MAIC, Bucher) plus a `maic_workflow_recipe` multi-step prompt template for ChatGPT users.
+- **CMS IRA awareness** — when `pv_classify` is called with US jurisdiction, output explicitly notes that CMS IRA Medicare price-negotiation calculations exclude PV cost data — track those obligations in the regulatory budget, not the HEOR cost-effectiveness model.
+- **GRADE I²-based inconsistency, GRADE upgrading (Guyatt 2011), Bucher consistency check, EQ-5D 5L baseline-utility-aware impact** *(v1.0.4)* — see [CHANGELOG.md](./CHANGELOG.md).
+- **ChatGPT Custom GPT support** *(v1.0.4)* — OpenAPI 3.1 adapter at `/api/openapi` lets you build a Custom GPT in 5 minutes. See [ChatGPT Custom GPT](#chatgpt-custom-gpt) below.
+- **Surface-tagged analytics** *(v1.0.4)* — every `tool_call` PostHog event carries a `surface` property (`claude_anthropic_web` / `chatgpt_adapter` / `claude_desktop` / `direct_mcp`).
 
 See [CHANGELOG.md](./CHANGELOG.md) for the full diff.
 
@@ -66,7 +68,7 @@ Add to your MCP configuration:
 
 ---
 
-## Tools (17)
+## Tools (20)
 
 | Tool | Purpose |
 |------|---------|
@@ -364,7 +366,7 @@ A companion chat interface is available at:
 
 **https://web-michael-ns-projects.vercel.app**
 
-- Chat with Claude Sonnet 4.6 + all 17 HEOR tools
+- Chat with Claude Sonnet 4.6 + all 20 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

package/dist/providers/types.d.ts

@@ -108,6 +108,8 @@ export interface DossierParams {
         dose_response?: boolean;
         plausible_confounding_toward_null?: boolean;
     }>;
+    /** Optional structured PV classification from pv_classify — when provided, populates the Pharmacovigilance Plan section. */
+    pv_classification?: any;
 }
 export interface ToolResult {
     content: string | object;

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package/dist/pv/decisionTree.d.ts

@@ -0,0 +1,23 @@
+/**
+ * Pure decision logic for pv_classify. Maps a study's metadata onto its
+ * EMA regulatory category. See design log #11 for the decision-tree
+ * diagram and rationale per branch.
+ *
+ * Order matters:
+ *   1. Pre-authorisation overrides everything → ICH E2E plan.
+ *   2. Spontaneous reports stand alone (not a study).
+ *   3. RMP commitment context → Annex 4 study.
+ *   4. Imposed by authority + post-MA → PASS imposed.
+ *   5. Otherwise classify by primary objective + study design.
+ *   6. Pregnancy population overrides the primary verdict (keeps it as
+ *      an alternative for transparency).
+ */
+import type { PvCategory, PvClassifyInput } from "./types.js";
+interface Decision {
+    primary_category: PvCategory;
+    alternatives: PvCategory[];
+    rationale: string;
+}
+export declare function classifyPv(input: PvClassifyInput): Decision;
+export {};
+//# sourceMappingURL=decisionTree.d.ts.map

package/dist/pv/decisionTree.d.ts.map

@@ -0,0 +1 @@
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package/dist/pv/decisionTree.js

@@ -0,0 +1,99 @@
+export function classifyPv(input) {
+    // 1. Pre-authorisation: never PASS — characterise via ICH E2E plan.
+    if (input.regulatory_context === "pre_authorisation") {
+        return withPregnancyOverride(input, {
+            primary_category: "ICH_E2E_pharmacovigilance_plan",
+            alternatives: [],
+            rationale: "Study is pre-authorisation. PASS designations require an existing marketing authorisation (Article 107a). Pharmacovigilance planning at this stage falls under ICH E2E and feeds the initial RMP at MAA submission.",
+        });
+    }
+    // 2. Spontaneous reports stand alone — Module VI baseline obligation.
+    if (input.study_design === "spontaneous_reports") {
+        return withPregnancyOverride(input, {
+            primary_category: "spontaneous_reporting_only",
+            alternatives: [],
+            rationale: "Spontaneous adverse-event reporting is the baseline PV obligation under GVP Module VI, not a designed study. Categorised as spontaneous_reporting_only.",
+        });
+    }
+    // 3. RMP commitment context → Annex 4 listed study.
+    if (input.regulatory_context === "rmp_commitment") {
+        const alts = input.imposed_by_authority
+            ? ["PASS_imposed"]
+            : ["PASS_voluntary"];
+        return withPregnancyOverride(input, {
+            primary_category: "RMP_Annex_4_study",
+            alternatives: alts,
+            rationale: "Study is an explicit RMP commitment, listed in RMP Annex 4 with milestone tracking. Per EMA GVP Module V.",
+        });
+    }
+    // 4. Imposed PASS — applies to conditional, accelerated, and standard
+    //    post-authorisation contexts when the authority has imposed the
+    //    obligation (Article 107n / 107a).
+    if (input.imposed_by_authority) {
+        return withPregnancyOverride(input, {
+            primary_category: "PASS_imposed",
+            alternatives: ["RMP_Annex_4_study"],
+            rationale: "Authority-imposed obligation in a post-authorisation context (Article 107n). Falls under GVP Module VIII as a Post-Authorisation Safety Study (imposed). PRAC pre-review of the protocol is required.",
+        });
+    }
+    // 5. Otherwise classify by primary objective + study design.
+    switch (input.primary_objective) {
+        case "safety":
+            return withPregnancyOverride(input, {
+                primary_category: "PASS_voluntary",
+                alternatives: ["active_surveillance_registry"],
+                rationale: "Safety-objective post-authorisation study without an imposed obligation → voluntary PASS under GVP Module VIII. ENCePP registration and a final report to EMA are encouraged but not mandatory.",
+            });
+        case "efficacy":
+        case "effectiveness":
+            return withPregnancyOverride(input, {
+                primary_category: "PAES",
+                alternatives: ["PASS_voluntary"],
+                rationale: "Effectiveness/efficacy-objective post-authorisation study → Post-Authorisation Efficacy Study (PAES). May trigger MA variation if results diverge from the MA effectiveness assumptions.",
+            });
+        case "drug_utilization":
+            return withPregnancyOverride(input, {
+                primary_category: "DUS",
+                alternatives: ["PASS_voluntary"],
+                rationale: "Drug utilisation objective → DUS under GVP Module VIII Addendum I. Used to characterise prescribing patterns and assess risk-minimisation measure effectiveness.",
+            });
+        case "natural_history":
+            return withPregnancyOverride(input, {
+                primary_category: "active_surveillance_registry",
+                alternatives: ["PASS_voluntary"],
+                rationale: "Natural history / disease epidemiology objective → active surveillance registry. Provides denominator data for PV signal detection.",
+            });
+        case "risk_minimisation_evaluation":
+            return withPregnancyOverride(input, {
+                primary_category: "PASS_voluntary",
+                alternatives: ["DUS"],
+                rationale: "Evaluation of risk-minimisation measure effectiveness → categorised as PASS (voluntary unless imposed). DUS is a valid alternative if the focus is utilisation rather than outcomes.",
+            });
+    }
+}
+function withPregnancyOverride(input, decision) {
+    if (!input.population_includes_pregnant)
+        return decision;
+    if (decision.primary_category === "ICH_E2E_pharmacovigilance_plan") {
+        // Pre-authorisation pregnancy planning still routes through ICH E2E
+        // but flag the pregnancy-registry follow-up as the post-MA step.
+        return {
+            primary_category: "ICH_E2E_pharmacovigilance_plan",
+            alternatives: ["pregnancy_registry"],
+            rationale: decision.rationale +
+                " Pregnancy population: a pregnancy registry will be required as a post-authorisation commitment per ICH E2E and EMA pregnancy-registry guidance.",
+        };
+    }
+    if (decision.primary_category === "pregnancy_registry")
+        return decision;
+    // Pregnancy override: keep the would-be primary as an alternative for
+    // transparency, promote pregnancy_registry to the primary verdict.
+    return {
+        primary_category: "pregnancy_registry",
+        alternatives: [decision.primary_category, ...decision.alternatives].filter((c, i, a) => a.indexOf(c) === i && c !== "pregnancy_registry"),
+        rationale: "Pregnancy population in scope → pregnancy registry takes priority over the primary classification. " +
+            decision.rationale +
+            " The original classification is retained as an alternative for protocol-design context.",
+    };
+}
+//# sourceMappingURL=decisionTree.js.map

package/dist/pv/decisionTree.js.map

@@ -0,0 +1 @@
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package/dist/pv/gvpModules.d.ts

@@ -0,0 +1,20 @@
+/**
+ * EMA Good Pharmacovigilance Practices (GVP) module + ENCePP template
+ * mapping per category. Source of truth: EMA GVP Rev 4.
+ *
+ * If EMA publishes Rev 5, bump GVP_REVISION + add a regression test that
+ * loads a known scenario and asserts the new module reference.
+ */
+import type { GvpModule, PvCategory } from "./types.js";
+export declare const GVP_REVISION: "rev_4";
+interface CategoryMapping {
+    gvp_module: GvpModule;
+    encepp_protocol_template?: string;
+    rmp_implications: string[];
+    fda_analogue?: string;
+    submission_obligations: string[];
+}
+export declare const CATEGORY_MAPPING: Record<PvCategory, CategoryMapping>;
+export declare function gvpFor(category: PvCategory): CategoryMapping;
+export {};
+//# sourceMappingURL=gvpModules.d.ts.map

package/dist/pv/gvpModules.d.ts.map

@@ -0,0 +1 @@
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package/dist/pv/gvpModules.js

@@ -0,0 +1,129 @@
+export const GVP_REVISION = "rev_4";
+export const CATEGORY_MAPPING = {
+    PASS_imposed: {
+        gvp_module: "VIII",
+        encepp_protocol_template: "ENCePP-PASS-001",
+        rmp_implications: [
+            "Update RMP Part III (PV Plan) to list this study as an imposed PASS.",
+            "Annex 4 of the RMP must reference the protocol and timelines.",
+        ],
+        fda_analogue: "FDA Postmarketing Required Studies (PMR)",
+        submission_obligations: [
+            "Protocol submission to PRAC for review prior to study start (Article 107n).",
+            "Annual safety update reports during conduct.",
+            "Final study report within 12 months of last data lock.",
+        ],
+    },
+    PASS_voluntary: {
+        gvp_module: "VIII",
+        encepp_protocol_template: "ENCePP-PASS-002",
+        rmp_implications: [
+            "Document study as a voluntary PASS in RMP Part III.",
+            "No PRAC pre-approval required; encouraged ENCePP registration.",
+        ],
+        fda_analogue: "FDA Postmarketing Commitment (PMC)",
+        submission_obligations: [
+            "Voluntary protocol notification to EMA EUPAS register.",
+            "Final study report when results available.",
+        ],
+    },
+    PAES: {
+        gvp_module: "VIII",
+        encepp_protocol_template: "ENCePP-PAES-001",
+        rmp_implications: [
+            "PAES results may trigger MA variation if effectiveness diverges from MA assumptions.",
+        ],
+        fda_analogue: "FDA Postmarketing Required Effectiveness Studies",
+        submission_obligations: [
+            "Protocol submission for PRAC review when imposed.",
+            "Periodic interim reports per MA condition.",
+        ],
+    },
+    RMP_Annex_4_study: {
+        gvp_module: "V",
+        encepp_protocol_template: "ENCePP-RMP-001",
+        rmp_implications: [
+            "Listed in RMP Annex 4 with study ID, status, milestone dates.",
+            "Study completion is a tracked RMP commitment.",
+        ],
+        fda_analogue: "FDA REMS Assessment Study",
+        submission_obligations: [
+            "Inclusion in every RMP update submitted to EMA.",
+            "Status reporting at PSUR cycles.",
+        ],
+    },
+    DUS: {
+        gvp_module: "VIII_Addendum_I",
+        encepp_protocol_template: "ENCePP-DUS-001",
+        rmp_implications: [
+            "DUS may be referenced in RMP Part III for risk minimisation effectiveness.",
+        ],
+        fda_analogue: "FDA Sentinel-eligible drug utilisation analysis",
+        submission_obligations: [
+            "ENCePP registration encouraged but not mandatory.",
+            "Final report submission per local jurisdiction requirements.",
+        ],
+    },
+    active_surveillance_registry: {
+        gvp_module: "VIII",
+        encepp_protocol_template: "ENCePP-REG-001",
+        rmp_implications: [
+            "Registry serves as data source for ongoing PV signal detection in RMP Part III.",
+        ],
+        fda_analogue: "FDA Sentinel / FAERS-linked registry",
+        submission_obligations: [
+            "Annual registry status report.",
+            "Periodic data linkages reported via PSUR.",
+        ],
+    },
+    pregnancy_registry: {
+        gvp_module: "VIII",
+        encepp_protocol_template: "ENCePP-PREG-001",
+        rmp_implications: [
+            "Pregnancy registry is a standard RMP commitment for teratogenic-risk drugs (Annex 4).",
+            "Outcomes feed into the Pregnancy section of every PSUR.",
+        ],
+        fda_analogue: "FDA Pregnancy Exposure Registry",
+        submission_obligations: [
+            "ENCePP and EUPAS registration.",
+            "Annual or biennial enrolment + outcomes reports to PRAC.",
+            "FDA pregnancy-registry standards apply when US is in scope.",
+        ],
+    },
+    spontaneous_reporting_only: {
+        gvp_module: "VI",
+        rmp_implications: [
+            "Spontaneous reporting is the baseline PV obligation under GVP Module VI; not a designed study.",
+        ],
+        fda_analogue: "FDA FAERS",
+        submission_obligations: [
+            "ICSR submission to EudraVigilance per Module VI timelines.",
+            "PSUR cycle compliance.",
+        ],
+    },
+    ICH_E2E_pharmacovigilance_plan: {
+        gvp_module: "V",
+        rmp_implications: [
+            "Pre-authorisation PV planning per ICH E2E feeds directly into the initial RMP submitted at MAA.",
+        ],
+        fda_analogue: "FDA premarket Pharmacovigilance Plan (per 21 CFR 314.81)",
+        submission_obligations: [
+            "PV plan included in module 1.8.2 of the MAA dossier.",
+            "Conversion to full RMP at MA grant.",
+        ],
+    },
+    not_pv_study: {
+        gvp_module: "VIII",
+        rmp_implications: [
+            "Study does not qualify as a pharmacovigilance study under EMA GVP definitions.",
+        ],
+        fda_analogue: "n/a",
+        submission_obligations: [
+            "No PV-specific submission obligations identified.",
+        ],
+    },
+};
+export function gvpFor(category) {
+    return CATEGORY_MAPPING[category];
+}
+//# sourceMappingURL=gvpModules.js.map

package/dist/pv/gvpModules.js.map

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

@@ -0,0 +1,27 @@
+export type PvCategory = "PASS_imposed" | "PASS_voluntary" | "PAES" | "RMP_Annex_4_study" | "DUS" | "active_surveillance_registry" | "pregnancy_registry" | "spontaneous_reporting_only" | "ICH_E2E_pharmacovigilance_plan" | "not_pv_study";
+export type GvpModule = "V" | "VI" | "VIII" | "VIII_Addendum_I";
+export type Jurisdiction = "eu" | "us" | "uk" | "japan" | "china";
+export interface PvClassification {
+    primary_category: PvCategory;
+    alternatives: PvCategory[];
+    gvp_module: GvpModule;
+    gvp_revision: "rev_4";
+    encepp_protocol_template?: string;
+    rmp_implications: string[];
+    fda_analogue?: string;
+    submission_obligations: string[];
+    rationale: string;
+}
+export interface PvClassifyInput {
+    drug: string;
+    indication: string;
+    study_design: "rct" | "single_arm" | "prospective_cohort" | "retrospective_cohort" | "case_control" | "registry" | "spontaneous_reports" | "drug_utilization" | "clinical_trial_extension" | "real_world_evidence";
+    primary_objective: "safety" | "efficacy" | "effectiveness" | "drug_utilization" | "natural_history" | "risk_minimisation_evaluation";
+    regulatory_context: "pre_authorisation" | "post_authorisation" | "conditional_approval" | "accelerated_approval" | "rmp_commitment";
+    imposed_by_authority: boolean;
+    population_includes_pregnant: boolean;
+    population_includes_paediatric: boolean;
+    multi_country: boolean;
+    jurisdictions: Jurisdiction[];
+}
+//# sourceMappingURL=types.d.ts.map

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

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

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

package/dist/pv/types.js.map

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

package/dist/server.js

@@ -27,6 +27,7 @@ import { handleUtilityValueSet, utilityValueSetToolSchema, } from "./tools/utili
 import { handleItcFeasibility, itcFeasibilityToolSchema, } from "./tools/itcFeasibility.js";
 import { handleExamples, examplesToolSchema } from "./tools/examples.js";
 import { handleMaicWorkflow, maicWorkflowToolSchema, } from "./tools/maicWorkflow.js";
+import { handlePvClassify, pvClassifyToolSchema } from "./tools/pvClassify.js";
 import { randomUUID } from "node:crypto";
 import { trackToolCall, trackSession, shutdownAnalytics, inferSurface, } from "./analytics.js";
 import { createServer } from "node:http";
@@ -158,6 +159,7 @@ function createMcpServer(surfaceRef = { value: "direct_mcp" }, sessionIdRef = {
             itcFeasibilityToolSchema,
             examplesToolSchema,
             maicWorkflowToolSchema,
+            pvClassifyToolSchema,
         ],
     }));
     server.setRequestHandler(CallToolRequestSchema, async (request) => {
@@ -223,6 +225,9 @@ function createMcpServer(surfaceRef = { value: "direct_mcp" }, sessionIdRef = {
                 case "workflow.maic":
                     result = await handleMaicWorkflow(args);
                     break;
+                case "pv.classify":
+                    result = await handlePvClassify(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/htaDossierPrep.d.ts.map

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

package/dist/tools/htaDossierPrep.js

@@ -42,6 +42,45 @@ const DossierSchema = z.object({
     }))
         .optional()
         .describe("Optional: GRADE upgrading flags per outcome for observational evidence (Guyatt 2011). 'large_effect' rates effect magnitude (large=RR<0.5 or >2.0; very_large=RR<0.2 or >5.0). 'dose_response' = documented gradient. 'plausible_confounding_toward_null' = bias would reduce effect. Capped at +2 steps. Ignored for RCT evidence (already High)."),
+    pv_classification: z
+        .object({
+        primary_category: z.enum([
+            "PASS_imposed",
+            "PASS_voluntary",
+            "PAES",
+            "RMP_Annex_4_study",
+            "DUS",
+            "active_surveillance_registry",
+            "pregnancy_registry",
+            "spontaneous_reporting_only",
+            "ICH_E2E_pharmacovigilance_plan",
+            "not_pv_study",
+        ]),
+        alternatives: z
+            .array(z.enum([
+            "PASS_imposed",
+            "PASS_voluntary",
+            "PAES",
+            "RMP_Annex_4_study",
+            "DUS",
+            "active_surveillance_registry",
+            "pregnancy_registry",
+            "spontaneous_reporting_only",
+            "ICH_E2E_pharmacovigilance_plan",
+            "not_pv_study",
+        ]))
+            .optional()
+            .default([]),
+        gvp_module: z.enum(["V", "VI", "VIII", "VIII_Addendum_I"]),
+        gvp_revision: z.literal("rev_4"),
+        encepp_protocol_template: z.string().optional(),
+        rmp_implications: z.array(z.string()).default([]),
+        fda_analogue: z.string().optional(),
+        submission_obligations: z.array(z.string()).default([]),
+        rationale: z.string().optional().default(""),
+    })
+        .optional()
+        .describe("Optional: structured PV classification from the pv_classify tool. When provided, the dossier output includes a Pharmacovigilance Plan section with the GVP module, ENCePP template, submission obligations, and RMP implications. When omitted, the section is replaced with a one-line note flagging the gap."),
 });
 import { createAuditRecord, addAssumption, addWarning, setMethodology, } from "../audit/builder.js";
 import { assessInconsistency } from "../grade/inconsistency.js";
@@ -119,6 +158,43 @@ const METHODOLOGY_BY_BODY = {
     jca: "EUHTA Regulation (EU) 2021/2282 — Joint Clinical Assessment",
     gvd: "Global Value Dossier — cross-market foundational evidence document (ISPOR GVD best practices)",
 };
+function appendPvPlanSection(lines, pv) {
+    if (!pv) {
+        lines.push("## Pharmacovigilance Plan");
+        lines.push("*PV plan not provided — call `pv_classify` first and pass the structured `pv_classification` to populate this section.*");
+        lines.push("");
+        return;
+    }
+    lines.push("## Pharmacovigilance Plan");
+    lines.push(`**Primary category:** \`${pv.primary_category}\``);
+    if (pv.alternatives && pv.alternatives.length > 0) {
+        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.fda_analogue) {
+        lines.push(`**FDA analogue:** ${pv.fda_analogue}`);
+    }
+    lines.push("");
+    if (pv.rationale) {
+        lines.push(`*${pv.rationale}*`);
+        lines.push("");
+    }
+    if (pv.submission_obligations && pv.submission_obligations.length > 0) {
+        lines.push("### Submission Obligations");
+        for (const o of pv.submission_obligations)
+            lines.push(`- ${o}`);
+        lines.push("");
+    }
+    if (pv.rmp_implications && pv.rmp_implications.length > 0) {
+        lines.push("### RMP Implications");
+        for (const r of pv.rmp_implications)
+            lines.push(`- ${r}`);
+        lines.push("");
+    }
+}
 function generateGradeTable(evidence, outcomes, robResults, heterogeneityPerOutcome, upgradingPerOutcome) {
     if (evidence.length === 0)
         return "";
@@ -547,6 +623,7 @@ export async function handleHtaDossierPrep(rawParams) {
         lines.push(``);
         audit = addAssumption(audit, "UK EQ-5D-5L value set transition flagged (NICE consultation 2026-04-15 to 2026-05-13)");
     }
+    appendPvPlanSection(lines, params.pv_classification);
     lines.push(auditToMarkdown(audit));
     const dossierTextContent = lines.join("\n");
     if (params.project) {

package/dist/tools/htaDossierPrep.js.map

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

@@ -0,0 +1,65 @@
+import type { ToolResult } from "../providers/types.js";
+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 annotations: {
+        readonly title: "PV Study Classification";
+        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 study_design: {
+                readonly type: "string";
+                readonly enum: readonly ["rct", "single_arm", "prospective_cohort", "retrospective_cohort", "case_control", "registry", "spontaneous_reports", "drug_utilization", "clinical_trial_extension", "real_world_evidence"];
+            };
+            readonly primary_objective: {
+                readonly type: "string";
+                readonly enum: readonly ["safety", "efficacy", "effectiveness", "drug_utilization", "natural_history", "risk_minimisation_evaluation"];
+            };
+            readonly regulatory_context: {
+                readonly type: "string";
+                readonly enum: readonly ["pre_authorisation", "post_authorisation", "conditional_approval", "accelerated_approval", "rmp_commitment"];
+            };
+            readonly imposed_by_authority: {
+                readonly type: "boolean";
+                readonly default: false;
+            };
+            readonly population_includes_pregnant: {
+                readonly type: "boolean";
+                readonly default: false;
+            };
+            readonly population_includes_paediatric: {
+                readonly type: "boolean";
+                readonly default: false;
+            };
+            readonly multi_country: {
+                readonly type: "boolean";
+                readonly default: false;
+            };
+            readonly jurisdictions: {
+                readonly type: "array";
+                readonly items: {
+                    readonly type: "string";
+                    readonly enum: readonly ["eu", "us", "uk", "japan", "china"];
+                };
+                readonly default: readonly ["eu"];
+            };
+        };
+        readonly required: readonly ["drug", "indication", "study_design", "primary_objective", "regulatory_context"];
+    };
+};
+//# sourceMappingURL=pvClassify.d.ts.map

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

@@ -0,0 +1 @@
+{"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,CACpC,QAAQ,EAAE,OAAO,GAChB,OAAO,CAAC,UAAU,CAAC,CAoJrB;AAED,eAAO,MAAM,oBAAoB;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;CAqCvB,CAAC"}

package/dist/tools/pvClassify.js

@@ -0,0 +1,198 @@
+/**
+ * pv_classify — pharmacovigilance study classification.
+ *
+ * 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,
+ * no I/O — modelled on itc_feasibility.
+ *
+ * See design log #11 for the decision tree and design rationale.
+ */
+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 { classifyPv } from "../pv/decisionTree.js";
+import { GVP_REVISION, gvpFor } from "../pv/gvpModules.js";
+const STUDY_DESIGNS = [
+    "rct",
+    "single_arm",
+    "prospective_cohort",
+    "retrospective_cohort",
+    "case_control",
+    "registry",
+    "spontaneous_reports",
+    "drug_utilization",
+    "clinical_trial_extension",
+    "real_world_evidence",
+];
+const PRIMARY_OBJECTIVES = [
+    "safety",
+    "efficacy",
+    "effectiveness",
+    "drug_utilization",
+    "natural_history",
+    "risk_minimisation_evaluation",
+];
+const REGULATORY_CONTEXTS = [
+    "pre_authorisation",
+    "post_authorisation",
+    "conditional_approval",
+    "accelerated_approval",
+    "rmp_commitment",
+];
+const JURISDICTIONS = ["eu", "us", "uk", "japan", "china"];
+const PvClassifySchema = z
+    .object({
+    drug: z.string().min(1, "drug is required"),
+    indication: z.string().min(1, "indication is required"),
+    study_design: z.enum(STUDY_DESIGNS),
+    primary_objective: z.enum(PRIMARY_OBJECTIVES),
+    regulatory_context: z.enum(REGULATORY_CONTEXTS),
+    imposed_by_authority: z.boolean().default(false),
+    population_includes_pregnant: z.boolean().default(false),
+    population_includes_paediatric: z.boolean().default(false),
+    multi_country: z.boolean().default(false),
+    jurisdictions: z.array(z.enum(JURISDICTIONS)).default(["eu"]),
+})
+    .strict();
+export async function handlePvClassify(rawInput) {
+    const parsed = PvClassifySchema.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("pv.classify", input, "text");
+    audit = setMethodology(audit, "EMA GVP Module VIII (Post-Authorisation Safety Studies, rev 4); GVP Module V (Risk Management Systems); GVP Module VIII Addendum I (DUS); GVP Module VI (Spontaneous Reporting); ICH E2E Pharmacovigilance Planning; EU Regulation 1235/2010 Article 107a (imposed PASS); ENCePP Code of Conduct.");
+    const decision = classifyPv(input);
+    const mapping = gvpFor(decision.primary_category);
+    audit = addAssumption(audit, `Primary verdict: ${decision.primary_category} → GVP Module ${mapping.gvp_module}.`);
+    if (decision.alternatives.length > 0) {
+        audit = addAssumption(audit, `Alternative classifications considered: ${decision.alternatives.join(", ")}.`);
+    }
+    if (input.population_includes_pregnant) {
+        audit = addWarning(audit, "Pregnant population in scope — pregnancy registry obligations apply on top of any other classification.");
+    }
+    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,
+        rmp_implications: mapping.rmp_implications,
+        fda_analogue: mapping.fda_analogue,
+        submission_obligations: mapping.submission_obligations,
+        rationale: decision.rationale,
+    };
+    const lines = [];
+    lines.push(`# PV Classification — ${input.drug} (${input.indication})`);
+    lines.push("");
+    lines.push(`**Primary category:** \`${decision.primary_category}\``);
+    if (decision.alternatives.length > 0) {
+        lines.push(`**Alternatives:** ${decision.alternatives.map((c) => `\`${c}\``).join(", ")}`);
+    }
+    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}\``);
+    }
+    lines.push("");
+    lines.push("## Rationale");
+    lines.push(decision.rationale);
+    lines.push("");
+    lines.push("## Submission Obligations");
+    for (const o of mapping.submission_obligations) {
+        lines.push(`- ${o}`);
+    }
+    lines.push("");
+    lines.push("## RMP Implications");
+    for (const r of mapping.rmp_implications) {
+        lines.push(`- ${r}`);
+    }
+    lines.push("");
+    if (input.jurisdictions.includes("us")) {
+        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("");
+    }
+    if (input.population_includes_pregnant) {
+        lines.push("## Pregnancy Population Override");
+        lines.push("A pregnancy registry is required regardless of the primary classification. This adds protocol obligations beyond the primary verdict — design the study to include both arms.");
+        lines.push("");
+    }
+    lines.push("## References");
+    lines.push("- EMA GVP Module VIII (Post-Authorisation Safety Studies, rev 4)");
+    lines.push("- EMA GVP Module V (Risk Management Systems)");
+    lines.push("- EMA GVP Module VIII Addendum I (Drug Utilisation Studies)");
+    lines.push("- EU Regulation 1235/2010, Article 107a (imposed PASS)");
+    lines.push("- ICH E2E — Pharmacovigilance Planning");
+    lines.push("- ENCePP Code of Conduct + protocol templates");
+    if (input.jurisdictions.includes("us")) {
+        lines.push("- FDA REMS Guidance for Industry (2019)");
+        lines.push("- FDA Sentinel Initiative documentation");
+        lines.push("- 21 CFR 314.81 (FDA premarket Pharmacovigilance Plan)");
+    }
+    lines.push("");
+    lines.push(auditToMarkdown(audit));
+    return {
+        content: lines.join("\n"),
+        audit,
+        pv_classification: classification,
+    };
+}
+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.",
+    annotations: {
+        title: "PV Study Classification",
+        readOnlyHint: true,
+        destructiveHint: false,
+        idempotentHint: true,
+        openWorldHint: false,
+    },
+    inputSchema: {
+        type: "object",
+        properties: {
+            drug: { type: "string", description: "Drug name." },
+            indication: { type: "string", description: "Disease/condition." },
+            study_design: { type: "string", enum: STUDY_DESIGNS },
+            primary_objective: { type: "string", enum: PRIMARY_OBJECTIVES },
+            regulatory_context: { type: "string", enum: REGULATORY_CONTEXTS },
+            imposed_by_authority: { type: "boolean", default: false },
+            population_includes_pregnant: { type: "boolean", default: false },
+            population_includes_paediatric: { type: "boolean", default: false },
+            multi_country: { type: "boolean", default: false },
+            jurisdictions: {
+                type: "array",
+                items: { type: "string", enum: JURISDICTIONS },
+                default: ["eu"],
+            },
+        },
+        required: [
+            "drug",
+            "indication",
+            "study_design",
+            "primary_objective",
+            "regulatory_context",
+        ],
+    },
+};
+//# sourceMappingURL=pvClassify.js.map

package/dist/tools/pvClassify.js.map

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

@@ -1,13 +1,13 @@
 {
   "name": "heor-agent-mcp",
-  "version": "1.0.6",
+  "version": "1.1.0",
   "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 — 15 tools across literature search (42 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), and HTA dossier prep (NICE/EMA/FDA/IQWiG/HAS/EU JCA) with auto-GRADE",
+  "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",
   "type": "module",
   "main": "dist/server.js",
   "bin": {