What New Value-Based Contracting Models For Cell And Gene Therapies Will Be Needed To Promote Broad Patient Access?

THERE ARE THREE ESSENTIAL COMPONENTS TO A WORKING VALUE-BASED CONTRACT: it must: 1) focus on real and meaningful patient outcomes to which payers and manufacturers can agree; 2) provide the payer with meaningful value; and 3) be simple and easy to execute. In the past, value-based contracts developed by drugmakers were one-sided — focused on endpoints that were difficult to measure. Bluebird bio’s approach to Zynteglo demonstrates the shifting mindset of some industry players. With Zynteglo, a gene therapy that eliminates the need for blood transfusions, if patients need transfusions, bluebird will reimburse a payer up to 80% of the therapy’s cost, with some limitations. Treatment failure is easily tracked via claims — and the dollar values being reimbursed are meaningful to payers. Because the industry pipeline for cell and gene therapies is large and growing, with the potential for a sharp increase in the number of such products available, value-based contracts are becoming a necessity. In the past, manufacturers developing expensive therapies for rare conditions felt that payers couldn’t refuse coverage of their products. As the number of marketed therapies grows, payers will begin to manage rare disease drugs, including gene and cell therapies, the same way they manage traditional drugs in other categories. We are already seeing oncology drugs managed in the same ways cholesterol agents were once managed. Going forward, biotech and pharma companies need to be able to contract on the outcomes of their cell and gene products and, eventually, other products as well.

JEFFREY BERKOWITZ is CEO at Real Endpoints and a board member at H. Lundbeck A/S.