In the EU5, Highly Defined Target Populations as Well as Optimized and Subsidized Companion Diagnostic Tests Are Prime Market Access Levers for Molecularly Targeted Oncology Agents

In the EU5, Highly Defined Target Populations as Well as Optimized and Subsidized Companion Diagnostic Tests Are Prime Market Access Levers for Molecularly Targeted Oncology Agents

Decision Resources

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Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that, in the EU5 (France, Germany, Italy, Spain and the United Kingdom), interviewed payers and surveyed oncologists recognize that molecularly driven management is a valuable innovation in cancer care. However, payer insight and oncologist survey findings show that targeted populations must be highly defined, companion diagnostics optimized, and the cost of diagnostic testing subsidized in order to maximize a new brand’s market access potential. A validated biomarker predictive of response to a premium-priced targeted agent allows healthcare funds to be channeled towards the treatment of patients most likely to respond, which helps payers at national, regional, and local/hospital level keep control of their budgets. As more of these costly therapies are approved and prices continue to rise, however, it is vital that emerging agents have biomarkers demonstrating a very strong relationship with a clinically relevant end point. Additionally, the cost of diagnostic testing, which largely falls to the hospital or clinic, negatively impacts healthcare budgets, and interviewed payers stress that the overall costs of these agents must not outweigh the benefits as they strive to cut healthcare costs.

The new European Physician & Payer Forum report entitled also finds that well-designed cost-sharing schemes that are easily administered are one way of easing the cost burden of personalized medicine, and are increasingly a prescribing differentiator across the EU5. However, manufacturers must be mindful that payers in different countries prefer different cost-sharing models. Payment-by-results schemes, such as those in place for AstraZeneca’s Iressa for EGFR-positive non-small-cell lung cancer (NSCLC) and GSK’s Tyverb for HER2-positive breast cancer, are popular among Italian payers as they need only pay for patients who respond to a given drug. Payers in the U.K. feel the administrative burden of collecting payment from manufacturers with such schemes though, and prefer straightforward discounts on list price, such as that which is in place for Roche’s Tarceva for EGFR-positive NSCLC.

As near-term emerging agents in the breast cancer and NSCLC markets continue to exploit the opportunities presented by molecularly driven management strategies, the report also finds that Pfizer’s newly approved Xalkori for NSCLC tumors harboring the ALK-EML4 gene translocation is particularly well placed to significantly impact the NSCLC treatment algorithm for the small percentage of NSCLC patients whose tumors are ALK-EML4-positive (known as ALK-positive patients). In all countries except Germany, surveyed oncologists expect to test at least half of their NSCLC patients for this molecular characteristic by the end of 2015, with most respondents in all countries keen to prescribe the agent first line for ALK-positive NSCLC.

“Since our survey was fielded, Xalkori has been conditionally approved in Europe for previously treated advanced ALK-positive NSCLC,” said Decision Resources Analyst Amy Duval. “Xalkori’s label in the U.S., which does not stipulate pretreatment, and the ongoing PROFILE 1014 study of Xalkori in the first-line setting have likely influenced surveyed oncologists’ hopes of prescribing the drug for first-line patients. Payers note, however, that Xalkori is unlikely to be reimbursed outside of its initial label, so extensive first-line prescribing will likely require a label extension for the agent, as well as an additional health technology assessment in some EU5 countries.”

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