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Personalized Medicine Growing, Though Challenges Remain

NEW YORK (GenomeWeb) – Since 2012, the number of drugs on the market developed through personalized medicine approaches has increased by 62 percent, according to a new report issued by the Personalized Medicine Coalition today.

However, while the PMC authors of The Personalized Medicine Report: Opportunity, Challenges, and the Future noted that personalized medicine can offer benefits such as making sure patients get the right drug at the right dose to increase effectiveness and reduce adverse events, they added that there are also still challenges with reimbursement and clinical adoption.

In its report, the PMC cites a number of successful examples, including HER2 testing. About 30 percent of breast cancer patients over express the HER2 gene and including a targeted drug in those patients' treatment regimen can reduce their recurrence risk by 52 percent, the authors wrote. Personalized medicine has also been helpful in identifying patients' risk for adverse drug effects. The US Food and Drug Administration now recommends pharmacogenomics testing for patients who are prescribed warfarin to determine the correct dosage.

But while the report's authors said such personalized approaches have the potential to reduce overall health care costs, such cost effectiveness claims have proven to be controversial.

The report cites Genomic Health's Onocotype DX test as an example of a genomic test guiding breast cancer treatment and saving money. Citing an economic analysis study performed by Genomic Health, the authors noted that therapy-guided testing could save $2,256 per patient tested due to reduced chemotherapy use.

But, others have found more mixed results. Researchers at Intermountain Healthcare for instance compared precision medicine-guided treatment for cancer patients versus standard of care and found that charges per progression-free survival week for patients in the precision medicine arm were slightly lower compared to the controls, at $4,665 versus $5,000. However, total costs were higher, at $91,790 versus $40,782 per patient, mainly due to the higher cost of targeted therapies as opposed to standard chemotherapy — though patients in the precision medicine arm did have longer average progression-free survival of 21.4 weeks versus 11 weeks for the control group.

The report acknowledges that while personalized medicine holds promise, there are still a number of challenges that need to be overcome. On the regulatory front, the FDA has not finalized its strategy for regulating laboratory-developed tests, although recently issued a white paper on the topic. So, for the time being, FDA-approved and LDT tests exist side by side, which some test developers have said creates an uneven playing field.

In addition, numerous test developers have discussed challenges in getting their tests reimbursed, while payors argue that test developers often do not demonstrate utility in randomized, statistically powered trials.

In order to overcome these challenges and realize the potential for personalized medicine, policy makers "must create an environment that encourages increased investment in diagnostics and targeted drugs, enables new advances in patient care that are safe, accurate and reliable, and establishes a viable pathway toward patient access," the PMC authors wrote.