By: Maureen Kingsley

PWC defines personalized medicine as “products and services that leverage the science of genomics and proteomics (directly or indirectly) and capitalize on the trends toward wellness and consumerism to enable tailored approaches to prevention and care.” Repeating the message delivered often by players and stakeholders in the personalized medicine world, the report’s authors state that the science of personalized medicine has the potential to eliminate unnecessary treatments, reduce the incidence of adverse reactions to drugs, increase the efficacy of treatments, and, ultimately, improve health outcomes. 

 

The report calls personalized medicine a “disruptive innovation” that will require the development of new business models that include collaboration as a key component. IVD companies in particular will likely collaborate with pharmaceutical companies, providers and provider systems, payers, and government, according to the report. “No player or sector with its current portfolio of capabilities can succeed in isolation,” the authors write. Specific collaborative efforts include identifying new pathways for approval of targeted diagnostics, therapeutics, and theranostics; designing regulatory, privacy, and intellectual-property frameworks to support new product development; and developing reimbursement strategies that encourage innovation and disseminate risk. 

 

Additional recommendations for diagnostics companies and other healthcare-related businesses include “articulating the benefits of products in the pipeline to payers and regulators as early as possible, to win their support and increase the odds of successful commercialization” and “engaging with academic medical centers and other research organizations with access to patient populations, to accelerate recruitment for clinical trials.” The report’s authors also point to the need to educate consumers about the importance and benefits of personalized medicine, as well as the need to “explore new developmental models that use patient subgroupings in order to enrich clinical trials, expedite conditional/interim approvals, and reduce postmarket label warnings or recalls.”

 

The report’s authors cite molecular diagnostics as a field that has shown some success and great promise. Molecular diagnostics is a fast-growing field and is expected to grow 14% annually between 2007 and 2012, from $2.6 to 5 billion, according to the report. Despite the expense (many times greater than standard lab tests’), payers are reimbursing for some molecular diagnostic tests, such as the Oncotype DX breast cancer test developed by Genomic Health. This particular test can help avoid even steeper chemotherapy costs when test results indicate such therapy is unwarranted.

Genetic testing accounted for roughly 21% of the molecular diagnostics market in 2007; the report’s authors predict greater competition from diagnostics that test for multiple conditions and produce faster results.

 

Additionally, as the molecular diagnostics segment heats up, some major pharmaceutical players are crossing over. The report cites Novartis as one example. (See “Novartis pursues molecular diagnostics in-house,” from the May 2009 issue of IVD Technology, for more information.)

 

Despite the success of and potential for molecular diagnostics, the report acknowledges the segment’s regulatory and other challenges. The future of the CLIA waiver for some diagnostic products is unknown, and last year CMS said it would discontinue paying for genetic testing to determine appropriate dosages of the blood-thinning drug Warfarin. There also exists the concern that the quickly expanding mine of information made available by molecular diagnostics tests outpaces clinician’s knowledge of how to interpret the results.

 

Overall, PWC’s report emphasizes collaboration of the various personalized medicine players; promotion of personalized medicine’s benefits to regulators, payers, and healthcare providers; and the importance of viewing the development of personalized medicine as “a marathon, not a sprint.” 

 

The report is available online at www.pwc.com/us/en/healthcare/publications/personalized-medicine.jhtml.