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Amgen Letter Submitted to JAMA Editor

August 25, 2016

Letter to JAMA Editor

PCSK9 inhibitors (PCSK9is) represent the most innovative treatment for hyperlipidemia in two decades. The economic value of this novel class has generated headlines, but little in terms of balanced and informed debate.

In assessing value, the price of "healthcare" must be distinguished from the price of "improved health". Innovation has the potential to lower the price of achieving a healthier life. For example, novel HIV therapies drove the price of improved health from infinity, i.e. patients could not buy health at any price, to generic prices. Likewise, the PCSK9is offer such an opportunity.

The FDA is clear that PCSK9is should be used in patients with clinical atherosclerotic cardiovascular disease receiving maximally tolerated statins requiring additional LDL reduction.  Yet most analyses discussed by payers assume that all patients with elevated LDL will be treated. Analyses should focus on identifying the subpopulations where PCSK9is generate the greatest value. Claims that PCSK9is could cost the system $120 billion annually are intended to ring "alarm bells" and have led to inappropriate payer restrictions1.  The Kazi model employs arbitrary value thresholds imported from centralized healthcare systems to set prices and ration care, price controls in disguise.

Kazi incorrectly assumes that PCSK9is are dispensed indiscriminately, without clinical judgment to a large, lower risk population not optimized on prior therapy.  The estimated ASCVD annual event rate of 3% MACE events in the Kazi model is much lower than the 8% annual event rate from AHA or the observed 11% event rate from U.S. payer data2,3.  Instead of focusing on narrow MACE events, proper analyses should capture all events that patients and payers experience (e.g. revascularization).  Using ezetimibe as a comparator is problematic, since high risk patients with LDL-C>130 mg/dL are unlikely to achieve LDL targets given its modest LDL lowering effect. These are likely reasons that other value-based price estimates range from $15,000-$17,000 per year.3,4  Moreover, the Kazi model presents a non-credible annual budget impact of $120B, nearly 400 times the consensus analyst estimates.

Given the stakes for patients, a robust and balanced discussion about value is critical. Realistic value and budget impact estimates are needed to inform decisions, and reports like this with misestimating and discordance with clinical reality serve no interests. We should be focused on working collaboratively to develop high quality information that can help control health care costs while fueling innovation to lower the price of improving health.

Joshua J. Ofman, M.D., M.S.H.S.
Senior Vice President, Amgen
jofman@amgen.com

Tomas Philipson, Ph.D.
Co-Founder, Precision Health Economics
Daniel Levin Chair of Public Policy Studies at The University of Chicago

 


  1. Kazi et al." Cost-effectiveness of PCSK9 Inhibitor Therapy in Patients With Heterozygous Familial Hypercholesterolemia or Atherosclerotic Cardiovascular Disease." JAMA. 2016;316(7):743-753.
  2. Mozaffarian et al. "Heart Disease and Stroke Statistics-2015 Update: A Report From the American Heart Association." Circulation. 2015; 131(4): e29-322
  3. Jena et al. Value of Improved Lipid Control in Patients at High Risk for Adverse Cardiac Events. Am J Manag Care. 2016;22(6):e199-e207.
  4. Gandra S, et al. "Cost-Effectiveness of LDL-C Lowering with Evolocumab in Patients with High Cardiovascular Risk in the United States" Clinical Cardiology. 2016 Jun;39(6):313-20.