The August 17 article "Study: Amgen, Sanofi cholesterol drugs not cost effective, boost healthcare spending," highlights a flawed JAMA publication that exaggerates the costs of PCSK9 inhibitors and threatens to make it more difficult for patients to access them.
Cardiovascular disease (CVD) is the number one killer in the U.S, responsible for one death every 40 seconds and $600 billion in costs each year. Driving down the cost of CVD complications is imperative, and innovative therapeutics are our best hope.
Statins work extremely well for most patients with high cholesterol. These new therapies are intended for high risk patients who have already had a cardiovascular event and those genetically pre-disposed to extraordinarily high cholesterol who are already on optimal statin dose and cannot reach their desired goals.
The authors use a model with assumptions that over-estimate the size and underestimate the risk of the treated population resulting in exaggerated costs and low estimated value. In addition, using list price rather than the price payers actually pay after rebates and discounts inflates the cost estimates. As a result, the authors assert that these medications would add $120 billion in annual costs. In fact, these estimates are around 400 times higher than the 2016 analyst consensus estimates for PCSK9 inhibitors.
Proposing prices based on arbitrary cost-effectiveness thresholds is what some price controlled healthcare systems outside of the U.S. use to ration care. A balanced discussion about value is critical to inform complex decisions, but analyses should identify ranges and uncertainties, not assign arbitrary prices and ring "alarm bells" with exaggerated cost estimates. Health experts must focus on collaborating to both assess and unlock the value of innovation, while ensuring patients get access to the medicines they need.
Sincerely,
Raymond C. Jordan
Senior Vice President, Corporate Affairs
Amgen
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