The Price Tag Continues to Increase

There hasn’t been a professional meeting that I have attended over the last 6 months where Solvaldi, Harvoni, and Viekiera were not mentioned—in fact, it became almost a game to note how quickly it would take for someone to bring up the cost and implications of these new hepatitis C virus (HCV) medications. Nevertheless, while the noise on this topic has begun to die down, the general aftermath and wake of this high pricing has not. There is a long list of new medications in the pipeline that make the $90,000 dollar price tag for the HCV drugs seem similar to the penny candy of my childhood.

A new entry for the treatment for cystic fibrosis (CF), Orkambi, was recently recommended for approved by the FDA’s advisory committee in May 2015, despite concerns regarding its modest level of effectiveness. The new medication, which is focused on the approximately 8500 patients in the United States with the genetic mutation found most often in people with CF, is a follow-up drug to the manufacturer’s other CF drug which targets those with a less common CF-causing genetic mutation. Orkambi is expected to have a wholesale price of $260,000 per year.

Recently, Congress has been debating the 21st Century Cures Act. This piece of legislation would revamp how the FDA reviews and approves medications, and it is intended to decrease the review period to allow new medications to make it to market in a more expedited time frame. That seems to make sense: who could argue about wanting to get life-saving or life-altering medications to the public in a timely manner? However, what does not seem to be addressed is the issue of what defines a life-saving or life-altering outcome. Is a medication that may keep a person alive for 6 more days, weeks, or months something that can be considered life-altering, or is it life-saving? Many would say that this question is not one for the FDA and rather, should be discussed in philosophy or theology classes. I would argue that it is a conversation needed not only at the FDA, but also in our physicians’ offices, our boardrooms, and around our dinner tables.

Over the last few years, discussions regarding value in healthcare have become more common. The Affordable Care Act has amplified the intensity of this conversation in addition to setting the US healthcare system down a path of paying for value versus activity. We need to have this same conversation about medications. I acknowledge that this is not an easy conversation to have, as each person may have a different perspective on what is meant by “value.” It is important to keep in mind that value transcends just the outcome—cost should also be included as a part of the value equation. Unfortunately though, as in other areas of healthcare, costs are neither transparent, nor consistent.

These questions and conversations are important. If we do not have this discussion at a national level, we will continue to have inconsistencies in coverage, ultimately leading to confusion and frustration. In addition to the potential problem of national perplexity, we also may put ourselves at risk for bankrupting the healthcare system on the back of increasing medication costs.