[BLOG]: Diagnostics as aids for specialty drug treatment

Fikry, MDFDA’s recent pre-market approvals of 2 new pharmaceutical drug therapies for non-small cell lung cancer (NCSLC) -- and simultaneous approval of 2 new tests used in connection with those therapies -- have cast a spotlight on the value of diagnostic laboratory tests as aids in realizing the potential of precision medicine. This PD-L1 class of NSCLC drugs belong to a new generation of pharmaceuticals for conditions ranging from high cholesterol levels to hepatitis C infection that harness insights into genetics and genomics to help address unmet health needs.

But the relatively high list prices of some “specialty pharmaceuticals” have prompted debate about how to appropriately value drug R&D and pricing. Within this heated environment, the significance of lab diagnostics not just in promoting accurate disease diagnosis but also to help facilitate treatment selection, monitoring and even drug development is often lost.

Related:Why new lung cancer drug approval is important

Consider the new direct acting antiviral therapies for hepatitis C viral infection. These treatments have cure rates of 95% or higher, but can run more than $80,000 for a 12-week course of treatment. Hepatitis C infection can run amok in the body for decades, promoting the development of liver fibrosis or cirrhosis and other adverse conditions before symptoms appear. As many as 3 of the 4 people with hepatitis C in the United States don’t know it, despite the wide availability of blood tests to screen for infection. Clearly, the value of these powerful new hepatitis C therapies on individual and public health is directly tied to the availability of relatively inexpensive lab tests. But when was the last time you read a news article about a new agent for hepatitis C that also highlighted the critical role of diagnostics in making its use possible?

 

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