As physicians and researchers gather at the 65th Annual American College of Cardiology Scientific Sessions to discuss the latest approaches to cardiac care, we offer this summary of prescription trends and a look at the impact of future innovation on spending for these common conditions.
Cardiovascular Medications Review
Spending on medications to treat cardiovascular diseases decreased in 2015, according to the 2015 Express Scripts Drug Trend Report. However, both the high blood cholesterol and high blood pressure/heart disease categories remain among the top five costliest traditional therapy classes, with cholesterol-lowering medications still part of the trio of classes – along with diabetes and pain/inflammation – that accounted for more than 25% of total traditional drug spend in 2015.
- With annual spending decreasing 9.2%, cholesterol-lowering medications became the third costliest traditional therapy class in 2015, down from second costliest in 2014. The decrease in spending was heavily influenced by the availability of generic medications, which now account for 83.1% of the market share in the class.
- Statins represent four of the ten costliest drugs in this class. However, utilization of omega-3 acid ethyl esters – prescription strength formulations of fish oil – increased 78.2% in 2015, positioning fish oils as the fourth costliest product within this therapy class.
- A 14.9% decline in unit costs was the key factor in decreasing total spending within the high blood pressure/heart disease category in 2015.
The Emerging PCSK9 Inhibitors
Two PCSK9 inhibitors, Repatha™ (evolocumab) and Praluent® (alirocumab), entered the market in the second half of 2015. Based on the current FDA approvals, these new medications are indicated for patients with very specific and rare forms of high cholesterol that are unresponsive to traditional statin therapy. Given the high price tag and lack of long-term clinical data, utilization of these medications has been modest as the industry has worked together to ensure their appropriate use.
Express Scripts' Cholesterol Care Value ProgramSM (CCV) – which combines discounts on these PCSK9 therapies, rigorous utilization management for both drugs in the class, and a total cost cap for participating plans is helping hold down payers' spending on these medications.
For high blood cholesterol, development remains focused on protein-inhibiting therapies, such as PCSK9s and cholesterylester transfer protein (CETPs).
- Merck’s anacetrapib, an oral CETP inhibitor, could be approved in 2017. It would be used in combination with statins to provide additional LDL cholesterol lowering. The drug has also shown it can raise HDL cholesterol by 138%. Despite failures of all other CETP inhibitors previously in development, an independent Data Monitoring Committee recommended Merck’s REVEAL study to continue without changes.
- Bococizumab from Pfizer could be the next injectable PCSK-9 inhibitor, bringing additional competition for Repatha and Praluent, and greater opportunity for payers to control costs.
Spending on traditional high blood cholesterol therapies will likely decrease between 11-14% annually for the next several years. In May 2016, generic competition for the last popular brand statin, Crestor® (rosuvastatin) will be followed by generics for Zetia® (ezetimibe) in December 2016 and Vytorin® (ezetimibe/simvastatin) in April 2017.
With flat utilization and falling unit costs, annual spending on high blood pressure/heart disease medications will likely decrease 4-9%. Valsartan, the generic for Diovan, was first released in July of 2014, with several manufacturers following with their own generics in January of 2015. Generics to Benicar – the last large selling angiotensin receptor blocker (ARB) to lose patent protection – are expected to become available in October 2016. Benicar and Benicar HCT (combined with hydrochlorothiazide) had annual sales of approximately $1.845 billion in 2015.
Entresto™ (sacubitril/valsartan), a new heart failure medication approved in July 2015, has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure.
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