OBJECTIVES: Patent expiry or the loss market exclusivity (LoE) are associated with a decrease of the list price of a drug, imposed or incentivised by healthcare authorities. This, together with the entry of generic copies of the drug, generates drug budget savings. This study assessed pricing and uptake dynamics of several oncology drugs and their generic copies after LoE and focused on three parameters: list price evolution, sales volume evolution and sales value evolution to identify the governing mechanisms that favour generic penetration and price erosion.

METHODS: A set of oncology drugs experiencing LoE was identified according to specific criteria (global peak sales >$250M, multiple registered indications, use in secondary care setting, LoE within past 6 years, several generics launched post-LoE). The study covered 28 primarily European countries and for each, 3-5 analogs were selected from the set based on local relevance. IQVIA MIDAS data was used to measure list price, volume and value evolution from t-6 months to t+24 months LoE.

RESULTS: Countries with policies that favour generic competition (e.g. incentives or procurement methods) but with no mandatory price decrease for originator drugs (e.g. Germany, Sweden or Denmark) experienced the most significant price decreases for generic drugs (60-80% versus originator prices pre-LoE) and had the best uptake for generics (up to 80% market share captured within 3 months in some Nordic countries). Countries with more restrictive rules for originator products (e.g. South Korea, Belgium and France) experienced lower generic uptake and list price convergence close to the mandatory requirements.

CONCLUSIONS: This study suggests that mandatory price rules cuts at LoE may lead to less efficient outcomes and to lower savings for healthcare systems. In developed countries, pro-generic policies other than price controls seem to encourage competition and may drive greater drug budget savings.