HEORAgent

Run maic_workflow for guselkumab vs risankizumab in ulcerative colitis with trials QUASAR and INSPIRE. Return the full 9-section pipeline report (ITC feasibility, parallel literature search, screening, RoB, evidence network, limitations, next steps).

Run jca_pico_scope for osimertinib in EGFR-mutant 2L non-small cell lung cancer across DE, FR, IT, ES, NL. Return the consolidated PICO list with country-specific comparators, outcome priorities, and heterogeneity warning. Then prepare an EU JCA dossier draft using the picos.

Classify a planned post-authorisation safety study for elranatamab in relapsed multiple myeloma — single-arm, conditional approval, imposed by EMA, EU + US jurisdictions. Then pass the pv_classification to hta_dossier as a NICE STA Pharmacovigilance Plan section.

Draft a NICE STA dossier for semaglutide in obesity. Apply the PMG36 severity modifier with absolute QALY shortfall 18 and proportional 0.92, and document health inequalities (lower socioeconomic status, mortality 1.6× higher in IMD quintile 1 vs 5, intervention narrows the disparity).

Run pv_signal_workflow for elranatamab in metastatic multiple myeloma. Case counts from EudraVigilance: drug_event=25, drug_total=1000, event_total=500, grand_total=100000. Outcome serious. Compute PRR, ROR, IC, MGPS — return the verdict, RMP signal-section text, and PRAC notification recommendation per GVP Module IX rev 2.

Run irb_review for a planned interventional Phase 2 trial of elranatamab in relapsed multiple myeloma — multi-site US + EU, pseudonymized data, industry-funded, greater-than-minimal risk. Return the review tier (US 45 CFR 46 + EU CTR 536/2014), GDPR Art. 9 + HIPAA §164.514 data-management plan, SAE-reporting framework (CTR Annex III + FDA IND Safety), ICF complexity tier, COI framework, and the ready-to-paste cover letter.

Run irb_review for a NIH-funded retrospective chart review of metformin outcomes in type 2 diabetes — academic single-site, anonymized via HIPAA Safe Harbor, US-only jurisdiction, minimal risk. I need the exempt determination, the de-identification framework, the COI obligations under PHS 42 CFR 50 Subpart F (NIH funding, not industry), and the cover letter. No interventional safety reporting needed.

First call pv_classify for tisagenlecleucel post-authorisation safety study in pediatric ALL — single-arm, conditional approval, imposed by EMA, EU + US. Then pass the resulting pv_classification into irb_review for the same study designed as a registry: pseudonymized data, industry-funded, multi-site US + EU, includes paediatric subjects. Return the irb_review output with Subpart D obligations (§46.406 generalizable-knowledge gate, EMA PIP), the CTR Annex III SAE framework (PASS_imposed override), and the cover letter.

I have MDS-UPDRS Part III scores for an early Parkinson's cohort: baseline mean 22, 12-month mean 28, 24-month mean 35 (n=120). Run evidence.clinical_scale to compute MCID-based responder rates per Horváth 2015 thresholds and compare the trajectory to the PPMI natural-history reference cohort. Then run jca_pico_scope for neurology_pd across DE/FR/IT/ES/NL to produce the JCA PICO matrix.

Search the literature for HFrEF disease burden and current treatment gaps (NHS perspective): mortality, hospitalization rates, KCCQ-12 / EQ-5D-5L deficits, healthcare costs. Then run evidence.unmet_need with the literature_evidence input to produce the structured 4-dimension unmet need framework. Pipe the output into hta_dossier({hta_body:"gvd"}) Section 4.

Run hta_workflow for sacubitril-valsartan in HFrEF as a NICE STA. Use NHS perspective, lifetime horizon, runs=2 on the literature search across PubMed/clinicaltrials/nice_ta/icer_reports. Cap CE iterations at 2500 PSA. Return the full 6-phase report (literature → screening → RoB → CE model → dossier draft → URL validation) with the v1.3.2 NICE TA precedent (TA388) auto-detected.

Semaglutide (Wegovy) has FDA and EMA approval for obesity. Check whether it is actually covered by NICE in the UK and by IQWiG / G-BA in Germany — then explain the key difference between what regulators (FDA/EMA) assess versus what HTA bodies (NICE, IQWiG, HAS) require. Why do drugs sometimes win regulatory approval but still fail to reach patients?

A new oncology drug just received EMA marketing authorisation. Build a step-by-step market access roadmap for the UK (NICE STA), Germany (IQWiG early benefit assessment / G-BA), and France (HAS SMR/ASMR rating). For each country: what evidence is needed, what are the key decision thresholds, and what does HEORAgent help prepare? Use existing NICE TAs and G-BA decisions on PD-1 inhibitors in NSCLC as benchmarks.

Search the literature for semaglutide cost-effectiveness in type 2 diabetes. Use PubMed, NICE TAs, and ICER reports.

Build a cost-effectiveness model comparing semaglutide 1mg vs sitagliptin 100mg for T2D from the NHS perspective. Use a lifetime horizon with PSA.

Search PubMed and NICE TAs for pembrolizumab in NSCLC, screen the results for adults with NSCLC comparing pembrolizumab to chemotherapy for overall survival, assess risk of bias on the screened studies, then draft a NICE STA dossier using the results.

Estimate the 5-year budget impact of adopting semaglutide for T2D in an NHS population of 50,000 eligible patients with 10-30% uptake.

Run a MAIC population-adjusted indirect comparison between SUSTAIN-7 and AWARD-11 for semaglutide vs dulaglutide, adjusting for age, BMI, and baseline HbA1c.

Create a new project for tirzepatide in obesity targeting NICE and ICER, then run an initial literature search.

Assess risk of bias on the SUSTAIN-6 cardiovascular outcomes trial (RCT) using Cochrane RoB 2, then generate a GRADE evidence summary table.

Compare the UK EQ-5D-3L and England EQ-5D-5L value sets for COPD, and estimate the QALY impact of transitioning to the new 2026 UK 5L value set under NICE's updated guidance.

Build a treatment comparison network for SGLT2 inhibitors in heart failure with reduced ejection fraction, assess NMA feasibility, and run a Bucher indirect comparison of empagliflozin vs dapagliflozin on cardiovascular death.

Fit parametric survival curves to KM data from MONARCH-3 for abemaciclib in HR+/HER2- breast cancer. Select the best distribution for a PartSA model per NICE DSU TSD 14 using AIC/BIC.

Draft an EU Joint Clinical Assessment (JCA) dossier for tislelizumab in gastric cancer. Include GRADE evidence quality table and gap analysis vs comparator.

Assess the feasibility of an indirect treatment comparison for JAK inhibitors in rheumatoid arthritis across 5 trials. Evaluate exchangeability, homogeneity, and consistency assumptions and recommend the appropriate method.