427P - Oncology combination therapies in Asia-Pacific markets: What are the current access challenges?

Background

Combination therapies (CT) are increasingly being developed and used in oncology. They have clinical benefits over and above monotherapies but face challenges in their assessment and pricing, which can delay or prevent access for patients in Asia-Pacific (AP) markets, especially when CTs consist of multiple on-patent constituents with different manufacturers. OHE conducted a study to understand the access landscape for CTs in AP and current access challenges (if any).

Methods

We extracted information on the regulatory approval and reimbursement decisions from the website of regulatory and HTA agencies, and drug listings of 14 free-dose CTs that received EMA marketing authorisation between 2015 and June 2020. All CTs included a constituent therapy that is licensed in another indication or CT. Markets in scope were Hong Kong, New Zealand, Singapore, South Korea and Taiwan. We developed a discussion guide for a series of interviews held by IQVIA with regulatory and HTA experts in the AP markets and analysed the transcripts to identify access challenges specific to CTs in individual markets.

Results

Only 6 out of 14 CTs of interest achieved access in any of the five AP markets. These comprised on-patent molecules produced by a single manufacturer or one on-patent molecule in combination with off-patent molecules. Barriers to access include anti-trust law impeding pricing negotiations between multiple manufacturers, monotherapy-centric focus of regulatory and reimbursement processes, issues with tracking usage by indication to facilitate indication-based pricing, and payers’ focus on budget impact over value assessment.

Conclusions

A multi-faceted collaborative approach by payers and manufacturers is needed with steps to tackle each barrier and improve patient access to CTs in AP.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Office of Health Economics.

Funding

MSD International GmbH.

Disclosure

G. Kumar, M. Garau, L. Steuten: Financial Interests, Institutional, Funding, This research was funded by MSD: Office of Health Economics. S.C. Tan, Y-R. Chen: Financial Interests, Institutional, Full or part-time Employment: MSD.