Annals of Long Term Care

Think of the world of accessing medications as a big bull’s eye. In Medicare’s perception, that is exactly the way that the market for pharmaceuticals should be viewed. Medicare believes it must play a very active role, as it believes that many key players will aim poorly, completely missing their desired target. And in the worst-case scenarios, prescribers’ aim will be so poor that they may actually wind up hitting patients who have adverse events because of access to an inappropriately prescribed medication. Rofecoxib is an example of “poor shooting” because of inadequate oversight, or so the typical congressional and regulatory argument would make it seem.

As a result of Medicare’s rise to the position of major payor for medications, Medicare believes that it needs to be very involved in medication management. Medicare is focusing on what the target looks like, and expects prescribers’ to hit a defined mark with perfect accuracy. The ideal is a world of “individualized medicine” where the exactly right medications are provided for each patient’s needs.

Medicare is utilizing many tools to assure that the right patient receives the right medication. These tools include defining access through specific diagnostic testing, RiskMaps, and narrowing of indications. It is also working to control external influence on patients and prescribers, as well as utilizing technology. But its tools go beyond these and include Medicare Part D guidance and regulations. In addition, the movement toward a pay-for-performance system is driven by the goal of encouraging providers to more appropriately manage medications.

How Medicare is doing this is of extreme interest to all stakeholders and will guide how medications will be managed. But in addition to acknowledging Medicare’s growing dominance in this process, clinicians and their patients can play a major role to influence the course that medication access takes.

Defined Access
To start, the federal government is defining who can have access to specific medications. This is done primarily in three ways: (1) requiring specific diagnostic testing, (2) utilizing FDA RiskMaps, and (3) narrowing the indications. Each of these tools is utilized to assure that specified medications are provided to the “right” patient. Obviously, we need to assure that the definition of “right” is clinically appropriate, being based on the best available evidence. In the case of the erythropoiesis-stimulating agents (ESAs), many have argued that the indications being applied are far too narrow, eliminating many patients who would benefit from having access to these medications.

Recently, the FDA considered strongly refusing to expand access of bevacizumab to women suffering from breast cancer. This consideration arose despite the fact that clinical trials demonstrated the longest reported “progression-free survival” for patients with advanced breast cancer through the use of bevacizumab.¹ An editorial in The Wall Street Journal noted that advanced therapies often prove more effective within targeted populations in some patients more than others. This is the problem when making decisions for large populations instead of for individual patients. While some individuals may in fact benefit from a given medication, others may be harmed by the same medication. Basing decisions as the FDA currently does on large general populations is contrary to individualized treatment plans. In this case, the narrow focus of the bull’s eye is restricting access for patients who would benefit from these medications. In the case of bevacizumab, the target was expanded because of the pressure applied by clinicians and patients.

A prime example of a pharmacodiagnostics test is the assessment of HER2 receptor expression in breast cancer tumors.