Alternative access schemes for pharmaceuticals: bypassing scrutiny?

High prices of new medicines have led most European countries to set up health technology assessment (HTA): evidence-based processes that evaluate whether a drug’s benefits outweigh its costs, before it receives public funding. Yet, increasingly, expensive new medicines bypass this scrutiny.

Instead, they enter health systems through alternative access schemes: diverse provisions that provide patients with access to treatment that are not routinely funded – for example the English Cancer Drugs Fund or individual patient funding requests.

As a result, some drugs, including notably expensive cancer medicines, are prescribed even though they never demonstrated their “value for money” in HTA, reaching up to 5% of pharmaceutical budgets in some countries. Despite evidence of their growing significance, there is little systematic research on alternative access schemes.

This project seeks to understand why alternative access schemes emerged, how decisions in these schemes are made, and what the policy implications are for patients and public finances.

It systematises knowledge of this emerging phenomenon by providing an overview of alternative access schemes in Europe and a detailed analysis of their political economy in selected health systems. It will contribute to debates on affordability of new medicines.