Personalized Medicine - Notable Concerns and Opportunities

Notable Concerns and Opportunities

• One of the significant barriers to genetic testing is thought to be the fear of discrimination, such as from an insurer or employer, as the data could be used in much the same way any other actuarial statistics are processed (the term "discrimination" has a connotation of illegitimacy, suggesting policy objections to treating genetic information the same way as other actuarial data). The Genetic Information Nondiscrimination Act, was signed by president George W. Bush in 2008, which despite certain exemptions may alleviate a barrier in the US to widespread use of genetic testing (and thus associated forms of personalized medicine).

• Some technologies underpinning personalized medicine could enable the pharmaceutical industry to develop a more efficient drug development process, based on the latest research on disease pathophysiology and genetic risk factors. Furthermore, a therapeutic agent could be marketed on the basis of a companion theranostic test result.

• The advent of new molecular diagnostic tests may open opportunities for using molecular blood fingerprint panels with health and disease states in patients.

• There is little evidence that diagnostics companies are embracing partnerships with pharma companies to develop theranostics. The development risk and time to market associated with drug candidates make the prospect of developing a companion diagnostic significantly less attractive to major diagnostics manufacturers than the revenues they generate from their traditional target market of clinical laboratories.

• Personalized medicine can raise new issues for those who pay for treatment. The cost of new diagnostic tests and individualized medications may be more expensive, but the predictive potential of personalized medicine could avert more costly treatments required after the onset of a disease. Insurance premiums today are based on actuarial statistics that apply to large, predictable populations. By contrast, personalized medicine targets small populations, which are far less stable and predictable from an actuarial standpoint. Payers would need to develop new actuarial assumptions on which to base their reimbursement models. Personalized medicine has the potential to reduce payers’ costs in the long term by providing the precise diagnostics required to avoid unnecessary or ineffective treatments, prevent adverse events, develop prevention strategies, and deliver more effective, targeted therapeutics. A trend towards pay for performance could accelerate the adoption of personalized medicine, if clinical data shows that targeted diagnostics and therapies reduce payers’ costs.

• For healthcare providers, personalized medicine offers the potential to improve the quality of care through more precise diagnostics, better therapies, and access to more accurate and up-to-date patient data. Primary care providers may have to build new service lines around prevention and wellness in order to replace revenues lost from traditional medical procedures. Physicians will also require a solid background in genomics and proteomics to make the best use of new data.

• The Genomics and Personalized Medicine Act was introduced in the U.S. Congress to address scientific barriers, adverse market pressures, and regulatory obstacles.

In addition, U.S. Secretary of Health and Human Services Mike Leavitt created a committee known as the Secretary's Advisory Committee on Genetics Health and Society (SACGHS) to study issues related to personalized medicine.