About the Project
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Start date: 1 February 2027
A substantial body of research has demonstrated persistent divergence in health technology assessment (HTA) recommendations for identical medicines across countries, with roughly half of paired decisions disagreeing even among methodologically similar agencies. This literature has been written almost entirely from the perspective of the payer or HTA agency, asking why agencies reach different conclusions from the same evidence.
Far less is known about the other side. HTA outcomes are not simply received by manufacturers; they are anticipated, managed, and strategically shaped. Manufacturers decide whether to submit in a given market at all, when to submit for regulatory approval, and how to respond to rejection — through resubmission with revised evidence, price concessions, managed entry agreements, indication narrowing, or exit. These decisions, largely invisible in the existing divergence literature, are increasingly consequential determinants of patient access.
Two contemporaneous policy shocks make this the right moment to study manufacturer behaviour.
First, the EU HTA Regulation's Joint Clinical Assessment (JCA), applying to oncology medicines and ATMPs from January 2025, centralises clinical assessment while leaving pricing and reimbursement national — changing the calculus of where and how manufacturers engage.
Second, the US Most Favoured Nation (MFN) pricing initiative (Executive Order, May 2025, and subsequent manufacturer agreements) ties US prices to those in reference countries, creating powerful incentives to delay, avoid, or withdraw from low-price European markets to protect the US anchor price. Early market intelligence already indicates declining European launch activity and rising withdrawals. Meanwhile, the EU's revised pharmaceutical legislation proposes launch obligations that pull in the opposite direction. Manufacturers now face a strategic dilemma. Their responses will shape access across health systems for the next decade.
Aim
To update and extend the cross-country HTA divergence literature from the manufacturer's perspective, characterising how commercial strategy — non-submission, resubmission, and withdrawal — interacts with HTA processes and international pricing policy to determine patient access.
Research questions
Non-submission and withdrawal (the invisible access gap). For medicines centrally approved by the EMA (and comparators approved by FDA/MHRA), in which markets do manufacturers never file for reimbursement, or withdraw after filing? What product, market, and policy characteristics (therapeutic area, orphan status, expected price corridor, reference-pricing exposure, prior rejections elsewhere) predict non-submission?
Resubmission behaviour after rejection. When manufacturers return after a negative recommendation, what do they change — price, evidence package, target population, or risk-sharing arrangement — and which strategies convert rejections into acceptances across agencies (NICE, SMC, CDA-AMC, PBAC, HAS, G-BA, ZIN)?
The JCA natural experiment. Does the introduction of Joint Clinical Assessment alter submission timing, sequencing, and divergence in national reimbursement outcomes for in-scope medicines relative to pre-2025 cohorts and out-of-scope comparators?
The MFN layer. Is exposure to MFN reference-pricing baskets associated with changed manufacturer behaviour in European markets — later launches, non-submission, confidential-price-only arrangements, or withdrawal — and how does this interact with HTA stringency in each market?
Methods
Secondary research using publicly available data only. A retrospective cohort of new active substances approved by the EMA (with FDA/MHRA cross-reference) over approximately 2018–2027 will be constructed, linking: regulatory databases (EMA EPARs, FDA approvals, Project Orbis participation); public HTA appraisal documents and decision histories across 6–8 agencies; JCA outputs published from 2025; launch and availability data; and policy exposure variables (MFN reference-basket inclusion, external reference pricing rules). Analysis will combine descriptive comparative methods with regression and, where appropriate, difference-in-differences designs exploiting the JCA and MFN implementation dates as policy shocks. Qualitative document analysis of appraisal reports will support a taxonomy of resubmission strategies.
Significance
The project reframes HTA divergence as the product of a two-sided game rather than agency behaviour alone. It will produce the first systematic evidence on non-submission as an access barrier, a validated taxonomy of post-rejection strategies, and early empirical evaluation of two of the most significant pharmaceutical policy interventions of the decade. Findings will be directly relevant to HTA agencies, EU and national policymakers, industry market-access functions, and patient organisations concerned with equitable access.
Candidate profile
Suited to candidates with a background in health economics, health policy, pharmacy, or a quantitative social science, with interest in pharmaceutical policy and comparative health systems. No primary data collection or ethics approvals are required, making the project well defined and feasible within a standard PhD timeline.