The 2014 debut of highly effective, yet very expensive drugs to treat hepatitis C launched a national conversation about the high cost of new prescription medications that could benefit millions. Much of the discussion focused on whether market forces or regulation should shape new drug pricing. While the debate continues, the list of new treatments approved by the U.S. Food and Drug Administration (FDA) continues to grow.
The first two therapies in the newest class of high-cost drugs – known as PCSK9 inhibitors – recently received FDA approval. These drugs are injected once or twice monthly and are highly effective in lowering cholesterol levels. But at a price tag upwards of $14,000 per patient each year and millions of potential patients, the costs could add up quickly. This is compounded by the fact that the drugs will need to be taken chronically for years, driving costs even higher and further straining our health care system.
In addition to price, it’s important to consider three factors when deciding how a drug is prescribed and paid for:
- How well does it work?
- Are there other types of drugs that accomplish the same clinical goal?
- Are there competing medications within the same drug class?
For example, the new hepatitis C drugs provided a cure in nearly 100 percent of patients treated, and no alternative drug classes were as effective. In addition, because the two new hepatitis C medications were released around the same time, competition helped drive down the cost.
But the situation we face with PCSK9 drugs is quite different. While we know the medications lower cholesterol, we are not sure that they prevent heart attacks and strokes as additional outcomes research is pending. And an inexpensive, alternative type of drug already exists – statins – a class that has historically done an excellent job of lowering cholesterol, reducing risk for cardiovascular events and thus saving millions of lives. Competition between the two new PCSK9s should help to drive down cost some, but likely not by enough to really lessen the financial impact.
Utilization Management is Key
Managing costs related to PCSK9 inhibitors must first focus on managing patient utilization. Based on the approved labels for the new medications, these drugs are indicated for treatment of high cholesterol caused by rare genetic conditions or for those with heart disease whose cholesterol can’t be controlled with statins alone. For everyone else, the first line of treatment will continue to be statins, and we’re working to ensure that those on statins take them as prescribed to achieve optimal health benefits. For all patients being treated for high cholesterol, the key message is that expensive drugs are not necessarily better.
A thoughtful, disciplined and clinically sound approach to PCSK9s and other high-cost medications will help ensure that patients have access to the drugs they need, while lessening the impact on the health care system.