Sorry about the title couldn't resist. I have also been unable to resist the 63rd Annual Scientific Sessions of the American College of Cardiology (ACC.14), to which I am winging my way shortly. In a few days, healthcare professionals, academic experts and industry representatives will be descending on Washington D.C. to discuss and debate the latest research, treatment trends and technological breakthroughs in the field of cardiology. Two of the things I am looking forward to most are assessing the impact of the most recently released U.S. cholesterol guidelines and the seeing the latest data on the PCSK9 inhibitors.
Cholesterol criteria controversy
Towards the end of 2013, the American Heart Association and the ACC released four new sets of cardiovascular risk guidelines. In particular, their blood cholesterol guidelines (see here for an overview by DRG's Joseph Dwyer and Stefanie Matlok) have proved controversial. In a bold decision, the expert panel that developed the guidelines determined to use only the strongest evidence available to shape their recommendations. This meant that the advice was primarily limited to statin use in four distinct groups of patients (based on a revised CV risk assessment), and the abandonment of the long-held strategy of treating to lipid level targets. One of the major consequences is that there will be a considerable increase in the number of patients recommended to receive statins treatment, according to the new guidelines. A study recently published in the New England Journal of Medicine estimated that that almost 13 million people would be eligible for statin therapy in the United States.
The manufacturers of statins might be looking forward to a major boost in sales, and there will be an increase in statin use, but I suspect a dramatic increase in statin sales is less likely. For a start, the controversy surrounding the new guidelines (leading physicians have expressed concerns over the risk of overtreatment; some professional organizations have not endorsed the new guidelines; the new CV risk calculator has not been validated) is likely to arouse caution amongst prescribers. In addition, many physicians are very familiar with the ATP III guidelines and may take time to integrate the new guidelines into their practice, owing to the specific scope of the new guidelines. I expect the debate at ACC.14 to be lively and I am sure it will provide a gauge as to the impact that the new guidelines will have on the dyslipidemia market.
The evolution of evolocumab
Any increase in statins use could also provide a bonus for add-on therapies for dyslipidemia, as they can require a statin trial for reimbursement in some markets. One of the most exciting classes in development is the proprotein convertase subtilisin/kexin type 9 inhibitors the PCSK9 inhibitors. Phase II data for Amgen's evolocumab has demonstrated reductions in LDL-cholesterol approaching 70 percent on top of statin therapy. Amgen have announced that data from five Phase III trials will be presented at ACC.14, which hopefully will put some flesh on the bones of the topline results released earlier this year. Based on these new data, we may be able to see if the hype about the PCSK9 inhibitors is warranted, and whether or not they will convince the regulatory authorities. Look out for further blogs from the DRG team after ACC.14 as we dissect the results and discuss what they mean for the dyslipidemia market.
Tim Blackstock, M.B. Ch.B., is a business insights analyst in the Cardiovascular, Metabolic and Renal Disorders team at Decision Resources Group.
In-depth analysis of the dyslipidemia area, with accompanying epidemiology driven sales forecast models, is presented in Decision Resources Group's Dyslipidemia Pharmacor. The most recent edition was updated on January 2, 2014.