MARA R.A.T.I.N.G.™ METHODOLOGY

Method v2.0 — August 2026

1. Purpose & Scope

The MARA R.A.T.I.N.G.™ methodology produces an independent, standardized assessment of one question: how likely is it that a medicine — licensed or in late-stage development — will achieve broad reimbursement from leading Health Technology Assessment (HTA) bodies and payers?

A MARA Rating does not evaluate regulatory approval or clinical efficacy in isolation. It assesses post-authorisation market-access risk — the risk that a medicine wins approval and still fails to secure the price, coverage, or patient access its owners expect.

A MARA Rating is a standardized opinion of market-access risk, calibrated against historical outcomes. It is not a forecast of any individual outcome.

2. Rating Philosophy

The methodology adapts internationally recognized risk-rating principles to pharmaceutical market access. Four principles govern every rating:

Multi-factor discipline. Ten structured evidence domains capture clinical value, economic justification, and system integration. No single number or study decides a rating.

Historical calibration. Domain weights are informed by MARA’s longitudinal database of real HTA decisions. The framework reflects how payers have actually decided — not how we assume they will.

Independent committee governance. Every rating is determined by a multidisciplinary panel. No single analyst decides, and no client can direct an outcome.

Continuous surveillance. Evidence changes, and ratings follow it — under the published rules of our Rating Actions & Surveillance Policy, never silently.

3. Analytical Framework

3.1 The Ten Evaluation Domains

Each asset is assessed across ten standardized domains aligned with HTA logic:

1. Clinical effectiveness
2. Health-related quality of life
3. Cost-effectiveness
4. Safety & tolerability
5. Comparator appropriateness
6. Population representativeness
7. Care-pathway integration
8. Budget impact & resource use
9. Evidence quality & robustness
10. Residual uncertainty & equity considerations

Each domain contains four calibrated sub-domains, scored using structured qualitative anchors aligned with published HTA precedents. The domains define what must be demonstrated; they do not prescribe how sponsors must demonstrate it. As evidence practices evolve — real-world data, new trial formats — the framework absorbs them without changing what it measures.

3.2 The Rating Scale

Domain evidence is converted into a composite letter grade:

The proprietary weighting coefficients, non-linear aggregation logic, and break-points are the intellectual property of MARA Rating Company AG and are not disclosed. What we do keep in the open is the record itself: every published rating stays on the MARA Ratings List with its as-of date, whatever the subsequent decision. Band-level calibration is documented in dated Calibration Annexes, available to clients and diligence counterparties on request.

4. The R.A.T.I.N.G.™ Process

R — Robust Evidence Review. All publicly available material evidence is collected and validated. Only public, verifiable evidence enters a rating: confidential projections and forward-looking claims are excluded unless supported by published data.

A/T — Aligned Ten-Domain Assessment & Historical Weighting. Evidence is mapped to the structured scorecards. Domain scores are weighted using MARA’s historical database to reflect payer-aligned precedent.

I — Independent Expert Committee. A multidisciplinary panel — health-economics scientists, clinicians, access specialists, pricing strategists — challenges the assumptions and sensitivity analyses. Minutes are recorded.

N — Neutral Consensus Determination. The grade is set by structured deliberation. Issuers may correct factual inaccuracies; they cannot alter analytical opinions.

G — Grade Certification & Publication. The final rating is issued with documented rationale. Publication may be public or confidential at the client’s discretion — but once public, a rating stays on the record whatever the subsequent outcome.

5. Surveillance & Rating Actions

Ratings are monitored at least annually, and immediately upon material developments — new pivotal data, HTA decisions, pricing developments, safety findings, or changes in standard of care. Ratings may be affirmed, upgraded, downgraded, placed under review, or withdrawn.

The complete rules — what triggers an action, how the method itself is version-controlled, and how the record is kept in the open — are published in the Rating Actions & Surveillance Policy.

6. Calibration & Performance

Every MARA Rating cites the methodology version under which it was issued. The current methodology epoch is MARA 2.0, effective 11 August 2026: the calibration record was rebuilt so that calibration is measured outcome-blind and certified by independent reviewers, with every figure traceable to hash-manifested evidence archives. Ratings issued under earlier method versions remain on the record under their version and are not restated.

Band-level calibration results are recorded in dated Calibration Annexes. Each annex states its corpus definition, its as-of date, and its results in full; annexes are reissued as the evidence corpus grows, and superseded annexes stay on file — superseded, never edited. The current annex is available to clients and diligence counterparties on request.

The methodology is reviewed annually by the Expert Committee. Any change produces a new, dated methodology version, applied prospectively only; issued ratings stand. The method is never adjusted retroactively, and never at the request of a rated company. We keep the misses with the hits: every published rating remains on the record, dated, next to the decision that eventually followed it.

7. Independence & Governance

• Analysts are excluded from commercial pricing negotiations.
• Committee chairs rotate. High-value ratings require a majority of external experts.
• Evidence is restricted to public, verifiable sources.
• No company can commission a change to its own rating, and no rating is ever altered on client request.
• Methodology definitions and surveillance policies are publicly disclosed; proprietary coefficients remain confidential.
• An internal audit function benchmarks every rating against subsequent HTA outcomes.

MARA’s methodology is additionally undergoing independent academic validation in a project supported by Innosuisse, the Swiss federal innovation agency, in collaboration with ZHAW Zurich University of Applied Sciences.

Independence is structural, not symbolic.

8. Appeals & Corrections

Issuers may request a formal review upon presentation of new, material evidence. Appeals are heard by a committee independent of the original panel. Factual errors are corrected and documented; opinions are not negotiable.