MASH Drug-Eligibility Dossier Builder

Concept

Both newly approved MASH therapies are restricted by fibrosis stage: resmetirom (a liver-directed thyroid hormone receptor β-selective agonist) and subcutaneous semaglutide (Wegovy) are FDA-approved only for adults with MASH and moderate-to-advanced fibrosis (F2–F3). Every prescription therefore needs documented staging — evidence usually scattered across a FibroScan in one system, FIB-4 labs in another, and a biopsy report in a third. The product pulls all staging artifacts into one place, maps them to each payer's eligibility criteria, generates the prior-authorization submission, and tracks adjudication. Where a patient does not qualify or coverage is denied, it surfaces the guideline-concordant alternatives the review specifies: structured behavioral modification (hypocaloric low-carbohydrate and low-fat diet, exercise, alcohol avoidance), cardiometabolic management, and bariatric surgery referral for BMI >35. The wedge: turn fibrosis documentation into fast, payer-ready access to the first approved MASH drugs.

Why now

The first conditional FDA approvals for MASH pharmacotherapy are in place: resmetirom, and semaglutide, which received accelerated approval in August 2025 for MASH with F2–F3 fibrosis on interim phase 3 ESSENCE results — 72 weeks of 2.4 mg/week subcutaneous semaglutide achieved both primary histologic endpoints: MASH resolution without worsening of fibrosis (62.9% vs. 34.3% placebo, p<0.001) and ≥1-stage fibrosis reduction without worsening of MASH (36.8% vs. 22.4% placebo, p<0.001). AASLD's November 2025 practice-guidance update on semaglutide gives the staging workflow a guideline anchor: candidates should have MASH with stage 2–3 fibrosis identified using non-invasive tests such as VCTE — exactly the artifact set (VCTE, FIB-4, biopsy where available) this tool assembles. The eligible funnel is enormous: MASLD affects ~60–70% of people with type 2 diabetes and ~70–80% of people with obesity, so even a small conversion to staged, treatment-eligible MASH creates substantial prescription volume that today stalls on paperwork.

What the new evidence strengthens — and where the idea stays bounded

• Guideline anchor for NIT staging: AASLD explicitly names non-invasive tests (e.g., VCTE) as the basis for identifying F2–F3 candidates, so each dossier and appeal can carry the guidance citation — converting 'we believe NITs suffice' into 'guideline-concordant staging.'
• Honest limit — guidance is not payer policy: Whether Optum, CVS/Caremark, and Express Scripts accept NIT-based staging alone for resmetirom/semaglutide prior authorization — or require histology — remains unverified. The tool therefore maintains a living, versioned payer-criteria map, flags accounts where a biopsy is demanded, and never assumes NIT sufficiency.
• Caveat — accelerated approval: Both drugs reached market via the accelerated pathway and final approval awaits long-term outcomes; labels and payer criteria could tighten. The product treats FDA labels and payer policies as versioned inputs that can change, not fixed assumptions.
• Adaptation — continuation packets: The AASLD update also specifies monitoring of treatment safety and efficacy, and payers are likely to require on-treatment documentation at reauthorization. The dossier builder extends to renewal packets (weight trajectory, labs, NIT re-assessment) so access does not lapse after first approval.

Open questions for the next iteration

• Variance in PA requirements across major payers (Optum, CVS/Caremark, Express Scripts) for resmetirom and semaglutide.
• Reliable extraction and normalization of fibrosis staging data from unstructured PDF reports across imaging vendors.
• Whether hepatology practices will pay, or manufacturers (Madrigal, Novo Nordisk) will offer free patient-access tools.
• Whether automated PA volume triggers heightened payer scrutiny or a 'denial loop.'
• Legal exposure from suggesting alternatives (e.g., bariatric surgery referral) on denial.