Impact of JCA and Project Orbis on the European Revenue Potential of an Oncology Product
Author(s)
Claudio Valenti, MA1, David Ringger, PhD2, Erika Wissinger, PhD3;
1Cencora, Milan, Italy, 2Cencora, Bern, Switzerland, 3Cencora, Conshohocken, PA, USA
1Cencora, Milan, Italy, 2Cencora, Bern, Switzerland, 3Cencora, Conshohocken, PA, USA
OBJECTIVES: To estimate the 5-year revenue impact that Joint Clinical Assessment (JCA) and Project Orbis may have on a new oncology product across the EU27 states (excluding Malta), Norway, Switzerland, and the United Kingdom (UK).
METHODS: Comparison of launch scenarios for a new oncology product to evaluate the potential impacts of JCA and Project Orbis against a base-case scenario. This base-case scenario is based on an analysis of the time-to-market and revenue potential of 48 oncology products launched between 2019 and 2022. Time to availability was determined by calculating the days between marketing authorization and product availability to patients in each market. Revenue potentials were estimated considering list prices, market size, pharmaceutical expenditure, and formal/informal international reference pricing (IRP) rules. The launch scenarios were developed considering the potential impact of JCA and Project Orbis on time-to-market availability. The corresponding revenue impacts were calculated for each launch scenario and compared against the base-case scenario.
RESULTS: In the best-case scenario, the time-to-market was accelerated by up to 40% due to the JCA. Conversely, in markets that typically submit immediately after receiving a positive Committee for Medicinal Products for Human Use (CHMP) opinion, the time-to-market was delayed by up to 3 months. Due to Project Orbis, the time-to-market was accelerated by up to 7 months for Switzerland and the UK. Although a faster erosion of list prices due to international reference pricing (IRP) was observed, the impact on total revenue appears minor over a 5-year period. A revenue sensitivity analysis across scenarios indicated a potential revenue increase of up to 14%.
CONCLUSIONS: Our analysis indicates that JCA and Project Orbis may present an opportunity for manufacturers to achieve higher revenues for new oncology products. Overall, the risk of faster price erosion is counterbalanced by the increased sales volume over a 5-year period.
METHODS: Comparison of launch scenarios for a new oncology product to evaluate the potential impacts of JCA and Project Orbis against a base-case scenario. This base-case scenario is based on an analysis of the time-to-market and revenue potential of 48 oncology products launched between 2019 and 2022. Time to availability was determined by calculating the days between marketing authorization and product availability to patients in each market. Revenue potentials were estimated considering list prices, market size, pharmaceutical expenditure, and formal/informal international reference pricing (IRP) rules. The launch scenarios were developed considering the potential impact of JCA and Project Orbis on time-to-market availability. The corresponding revenue impacts were calculated for each launch scenario and compared against the base-case scenario.
RESULTS: In the best-case scenario, the time-to-market was accelerated by up to 40% due to the JCA. Conversely, in markets that typically submit immediately after receiving a positive Committee for Medicinal Products for Human Use (CHMP) opinion, the time-to-market was delayed by up to 3 months. Due to Project Orbis, the time-to-market was accelerated by up to 7 months for Switzerland and the UK. Although a faster erosion of list prices due to international reference pricing (IRP) was observed, the impact on total revenue appears minor over a 5-year period. A revenue sensitivity analysis across scenarios indicated a potential revenue increase of up to 14%.
CONCLUSIONS: Our analysis indicates that JCA and Project Orbis may present an opportunity for manufacturers to achieve higher revenues for new oncology products. Overall, the risk of faster price erosion is counterbalanced by the increased sales volume over a 5-year period.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
P64
Topic
Health Policy & Regulatory
Topic Subcategory
Health Disparities & Equity, Pricing Policy & Schemes, Reimbursement & Access Policy
Disease
SDC: Oncology