Overcoming limited evidence to gain reimbursement for a blockbuster oncology drug
A major global drug manufacturer wished to achieve reimbursement in the UK and the return on investment for its promising drug against breast cancer. Our client faced a challenge, however: abundant evidence showed that their drug slowed cancer progression, but not enough data were available to determine whether the drug improved overall survival. This task was especially difficult because the client was proposing the drug as a first-line treatment, yet patients might use several downstream drugs as their disease progressed, confounding survival outcomes.
To prepare for the reimbursement submission, we completed a gap analysis of the existing evidence and compiled a list of its strengths and weaknesses. We explored multiple methods for linking the progression evidence to patient survival. In the end, we developed a model that drew on the difference in progression between the drug and control arms, as well as data on sequential oncology treatments. We successfully argued that despite the uncertainty due to confounding from the use of multiple medications during progression, the ability of the client’s drug to slow progression suggested a positive impact on patient survival.
We aligned the client’s global executive team and the local market access colleagues behind a submission that ultimately convinced three healthcare payers of the drug’s value (National Institute of Clinical Excellence, Scottish Medicines Consortium and the Irish National Centre for Pharmacoeconomics). As a result, the treatment was made available within the client’s desired pricing strategy – making the drug the first alternative to hormone therapy to become available in the last 10 years to women with breast cancer. Since regulatory agencies did not raise any concerns and no protracted negotiations over pricing were necessary, several thousand patients were able to benefit immediately from the treatment, substantially boosting the client’s market share.
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