Although 2015 is just getting underway, Americans with devastating diseases already have a lot to celebrate.  During the State of the Union address, President Barack ObamaBarack Hussein ObamaFeehery: A whole new season of 'Game of Thrones' Mercury rollback is a direct threat to our children's health Lightfoot takes office as Chicago's first black woman mayor MORE announced his Precision Medicine Initiative, a new effort to accelerate biomedical discoveries.  Then came companion “discussion papers” from the House Energy and Commerce Committee and the Senate Committee on Health, Education, Labor and Pensions (HELP), setting the stage for passage of a 21st Century Cures Act in this session of Congress.

The excitement over these new government efforts, however, ignores an important question: will all Americans have “access to treatments that deliver the right treatment at the right time” as the President hopes?  What stands in the way is the raging debate over the costs of novel medicines and what medical innovation is really worth.


The latest evidence is a recent New York Times column in which Dr. Peter Bach at the Memorial Sloan Kettering Cancer Center calls the costs of innovative treatments “unsustainable” and advocates for “freeing” insurers from the “requirement to include all expensive drugs in their plans.” A major reason, according to Dr. Bach and others, is the claim that patients given a novel therapy for advanced disease may “only” live a few additional months – meaning these newer drugs are not economical.

This viewpoint flies in the face of advances in the field of genomics, which shows patients respond differently to therapies based on their genetic makeup and the genetic profile of their disease.   Moving away from what President Obama calls the “one-size-fits-all-approach” to treatment, precision medicines are tailored to specific characteristics of individuals, such as a person’s genetic makeup, resulting in treatments that improve chances of survival and reduce exposure to adverse effects. Already, successes with a number of molecularly-based cancer medicines show what is possible in improved outcomes when the right drug at the right dose is given to the right patient.

However, many patients may not benefit from these new treatments if their health plans limit access to precision medicines. Today, health plans and large pharmacy benefits management organizations routinely deny coverage of novel therapies by excluding them from formularies or by putting all treatments for a condition on the highest (“specialty”) tier where patients are asked to pay a percentage of the drug’s cost from 25% up to 71% (according to data from the Patient Advocate Foundation). Describing the impact on HIV patients, a new study in the New England Journal of Medicine found one in four of the 48 health plans on health exchanges in 12 states put all HIV drugs in a specialty tier where patients were required to pay at least 30% of the drug’s cost. This practice places the cost of needed treatment beyond the reach of most patients and may be illegal under federal discrimination laws.

Then there is the onerous “fail first” policy, also known as “step therapy,” in which health plans and managed care agents force patients to take the least expensive drug in a class first, followed by the next least expensive drug, even if physicians know these medications will not work. Not only is this a time-consuming process but it forces added costs on patients, delays access to needed medicines, and usurps health care practitioners’ rights to make medical decisions.

As an organization supporting greater access to innovative medicines, the Alliance for the Adoption of Innovations in Medicine (Aimed Alliance) believes attention must be given now to the insurance roadblocks that are designed to limit patient access to the novel therapies physicians prescribe. As the President’s Precision Medicine Initiative gets underway and hopefully, the Congress’s 21st Century Cures Act becomes law, federal and state policy changes are needed to ensure all patients have access to new treatments so the promise of precision medicine will be realized by all.

Worthy is policy director at the Alliance for the Adoption of Innovations in Medicine.