The National Institute for health and Clinical Excellence (NICE) is a UK watchdog agency whose mission is to “provide guidance to help health and social care professionals to deliver the best possible care based on the best possible evidence”. It has the reputation of being a vigorous watchdog that ensures that the citizens of the UK receive good healthcare at a cost commensurate with the value of the treatment under consideration.
NICE made a pretty startling recommendation this week. Essentially, they have stated that the UK populations should be using more statins, drugs designed to lower LDL cholesterol, a major culprit in the progression of heart disease. NICE has decided that more National Health Service (NHS) - which provides healthcare for the vast majority of people in the UK – patients ought to be considered at risk of cardiovascular disease (CVD). The NHS, therefore, has advised that a greater number of people should be offered statins. The NICE draft guidance, now out for comment, recommends that people with a 10% risk of developing CVD over the next 10 years be offered statins. This is a significant change from the current NICE guideline which recommends statin use in patients with a 20% CVD risk. There are about 7 million CVD patients on statins now. If this recommendation is adopted, that number will add millions more statin users to the NHS rolls.
This is a pretty significant change. Surely, there must be some new data showing the benefits and importance of statins in preventing heart attacks and strokes and that this has prompted the new NICE guidance. Well, not exactly. The major driver for the proposed changes is the increased availability of generic statins making them more affordable. It turns out that the patents for most statins, with the exception of AstraZeneca’s Crestor, have expired. Thus, generic versions of Merck’s Zocor (simvastatin) and Pfizer’s Lipitor (atorvastatin) are available and cost pennies a day. It is estimated that statins prevent 7,000 deaths a year in the UK due to heart attacks. Plus, there are thousands of others saved from non-fatal heart attacks as well. Given these numbers, it is no surprise that NICE is recommending that these important drugs be made more broadly available.
Of course, statins could have just as easily been made more available a few years ago. Presumably, the same impact on helping those with CVD would also have happened then. However, the costs of statins were significantly higher then as Lipitor was still on patent and no generics were available. But now that cheap generic versions of statins are on the market, NICE feels that they are valuable enough for more people to be allowed to take them.
In the US, patients whom a physician felt would benefit from a statin have been able to get it for years and, for the most part, their prescriptions were covered by health insurance. In the US, there is no 10% or 20% risk cut-off as is imposed by NICE in the UK. Rather, patients who needed the medication got it. Certainly, health care costs are lower in the UK than in the US due to organizations like NICE. However, if you had CVD, where would you rather be treated?
