Lorlatinib for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) previously not treated with an ALK inhibitor as of July 2023 – Market Access Risk Assessment

This page presents a standardized, committee-reviewed assessment of the reimbursement risk associated with Lorlatinib for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) previously not treated with an ALK inhibitor as of July 2023 – Market Access Risk Assessment, calibrated against historical HTA and payer outcomes across the US, EU4, UK, and Japan using a structured 10-domain evaluation framework.

Updates & Coverage Scope

MARA Ratings reflect the evidence and payer context available as of the stated date. Where material new evidence or payer decisions emerge, MARA may issue a rating action under the Rating Actions & Surveillance Policy.

For market-specific extensions or updated cut dates, request a revised assessment.

What the Complimentary MARA Rating Includes

The Full MARA Assessment provides full 10-domain scoring, weighted determinants, benchmarking against comparable assets, and historical context calibrated to observed HTA outcomes.

Reimbursement Risk Positioning

This assessment positions the asset relative to reimbursement thresholds observed across major HTA bodies. It distinguishes structural drivers of reimbursement risk from variables that are typically sensitive to evidence maturity or price expectations.

The Full MARA Assessment provides weighted scoring across all 10 domains and benchmarks this positioning against historical reimbursement outcomes for comparable evidence profiles.

Selected Risk Drivers

Below is a snapshot of domains that materially influence the MARA Rating. The Full MARA Assessment provides complete 10-domain scoring and the evidence-linked rationale for each domain outcome.

Clinical effectiveness

The evidence suggests that lorlatinib improves progression-free survival compared to crizotinib, but crizotinib is not typically used as a first-line treatment in the Healthcare. The indirect comparison with alectinib and brigatinib indicates potential benefits, but the ongoing nature of the clinical trial and uncertainties surrounding overall survival limit the strength of the evidence. This strengthens the market access risk assessment and overall reimbursement probability.

Cost effectiveness

The cost-effectiveness estimates for lorlatinib are substantially above the threshold considered acceptable by NICE. The committee concluded that, even with potential discounts, the ICERs remain unacceptably high, indicating that lorlatinib is unlikely to be cost-effective at its current price. This informs pricing and reimbursement risk and pharmaceutical reimbursement forecasting.

Quality of life

While there are indications that lorlatinib may improve quality of life for some patients, the evidence is mixed, and significant side effects have been reported that could negatively impact HRQoL. The committee noted that some patients experienced better quality of life on lorlatinib, but this was not universally applicable. These outcomes align with HTA decision predictors and support pricing and reimbursement assessment.

The Full MARA Reimbursement Risk Assessment expands this analysis with weighted scoring, benchmarking depth, and ranking versus hundreds of comparable assets.

Benchmarking & Historical Calibration

This asset is benchmarked against therapeutic-area comparators and a historical dataset of previously assessed products. MARA calibrates rating bands against observed reimbursement outcomes across major HTA bodies.

Scope of the Full MARA Assessment

Designed to support governance and diligence before major commitments in pricing, evidence generation, partnering, or launch planning.

What is the reimbursement risk of Lorlatinib for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) previously not treated with an ALK inhibitor as of July 2023 – Market Access Risk Assessment?

The MARA Rating provides a standardized, committee-reviewed assessment of the reimbursement risk associated with this drug–indication pair, calibrated against historical HTA and payer outcomes across the US, EU4, UK, and Japan.

The licensed report includes structured scoring across 10 payer-relevant domains, evidence-linked rationale, benchmarking against comparable assets, and identification of variables that may influence rating migration.

The complimentary summary provides the rating band, market access score, confidence level, and high-level context. Detailed domain scoring, benchmarking analysis, and full rationale are available in the licensed report.

Related Reimbursement Risk Assessments

Surveillance Status

This rating is subject to defined surveillance under the Rating Actions & Surveillance Policy. Where material new evidence, payer decisions, or policy changes occur, MARA may issue a rating action (affirmation, upgrade, downgrade, or under review) with an as-of date and rationale.

This aligns every report page with your governance system.

Professional Use Notice

MARA Rating is an independent analytical opinion intended for professional use in market access, HTA, and investment contexts. It does not constitute medical, legal, or investment advice.

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