The Unintended Consequences of Personalized Medicine

Personalized-MedicineInnovative technological and scientific advancements in oncology have enabled scientists to unravel the biological complexity of more than 200 diseases commonly called cancer, and reexamine how these diseases should be classified, diagnosed, and treated.

Understanding how these diseases work and the applying of these insights to clinical practice have formed the foundation of personalized medicine, defined as the tailoring of drugs and other treatments to specific populations, based on their genetic profiles or other differentiating factors.

This concept provides a potential future in which prevention and treatment strategies will be individualized based on the molecular makeup of a patient and their disease, dramatically improving chances for better patient outcomes and reduced healthcare costs.

Those advancements may provide opportunities, but they also may pose potential unintended consequences to the healthcare system.

The aging American population, combined with an additional 32 million covered lives under the Affordable Care Act (ACA), and overall increased survivorship in patients have created new challenges surrounding affordability and accessibility to healthcare.

Increased pressure for greater clinical and economic advancements creates imbalance among innovation, quality, and cost. In addition, ACA requirements impose more disparity by requiring improved quality of care, greater transparency in reimbursement coverage, and performance-based payments.

Payers and providers who are responsible for the implementation and adoption of personalized medicine are challenged to navigate the new environment as they are the major stakeholders.

Full implementation of personalized medicine may create new challenges for stakeholders and their patients, such as:

  • More stringent regulatory framework requiring greater transparency and tighter reimbursement controls for costly diagnostic technologies
  • Loss of patients’ ability to make their own healthcare decisions
    • In an effort to optimize clinical outcomes and minimize costs, some current therapies are aligned with patients’ biomarkers in order to ensure therapies are targeted to a specific genotype mutation. A prime example of this can be seen in patients with advanced stage melanoma who have approximately a 3-month survival rate. There are two treatment options: one with a companion diagnostic test (personalized) and one without (non-personalized). Because the personalized therapy has a companion diagnostic test that specifically identifies appropriate patients, payers and providers may be influenced toward this therapy over the non-personalized in order to maximize therapeutic outcomes. However, this creates a potential unintended consequence involving the non-personalized treatment option, which demonstrates efficacy in approximately 20% of patients and can extend survivorship up to 3 years. Therefore, these patients may be denied potentially 33 months of extended life.

In an attempt to improve the overall healthcare system by managing costs through personalized, tailored treatments, new barriers are created that can directly impact patient outcomes and limit the personal choice of available healthcare options.

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