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Canakinumab not cost-effective to prevent recurrent CV events after MI
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The use of canakinumab to prevent recurrent CV events in patients with a prior MI was not cost-effective at current U.S. prices, according to a study published in JAMA Cardiology.
“Canakinumab has not been approved by the FDA for secondary prevention of cardiovascular disease, but if it were to be approved, the combination of small benefits and a high price makes canakinumab far from cost-effective for this indication,” Thomas S.G. Sehested, MD, and Jenny Bjerre MD, both from the department of cardiology at Copenhagen University Hospital in Denmark, told Cardiology Today. “To reach commonly accepted cost-effectiveness thresholds, future studies should either show a substantial mortality benefit or the company could make a very substantial price cut.”
Markov model
Researchers developed a Markov model to evaluate the outcomes and long-term costs associated with canakinumab (Ilaris, Novartis) in the U.S. health care sector. This model simulated outcomes of a hypothetical cohort that consisted of patients aged 61 years with a high-sensitivity C-reactive protein level greater than 2 mg/dL, previous MI and received standard of care after the MI either with or without canakinumab. The hypothetical patients who were treated with canakinumab were given 150 mg subcutaneously every 3 months.
During each month within the model, patients can either remain stable, undergo coronary revascularization, experience a recurrent MI, experience an infection, develop lung cancer or die of causes other than the ones listed. Once patients recovered from the infection or revascularization, they would return to their prior health status.
The model inputs were based on data from the CANTOS trial, a 3% annual discount rate, adjusted costs in 2018 U.S. dollars and half-cycle corrections to all outcomes. The current U.S. market price of canakinumab that was used in this study was $73,000 per year.
When canakinumab was added to standard of care, life expectancy increased from 11.31 years to 11.36 years. In addition, quality-adjusted life-years increased from 9.37 to 9.5 and costs increased from $242,000 to $1,074,000. The increase in cost yielded an incremental cost-effectiveness ratio of $6.4 million per QALY gained.
To meet the $100,000 per QALY willingness-to-pay threshold, the price would have to be decreased by more that 98%, or to $1,150 per year or less.
Robust results
The results were mostly robust for alternative assumptions such as lower infection rates while treated with canakinumab, lower health-related quality of life after recurrent CV events and reduced all-cause mortality while treated with canakinumab.
The incremental cost-effectiveness ratio of canakinumab improved to $3.5 million per QALY gained when the potential benefit of the treatment was included for lung cancer.
Patients with reduced high-sensitivity CRP levels less than 2 mg/dL and continued canakinumab treatment would have a cost-effectiveness ratio of $819,000 per QALY gained.
“The idea of only treating drug responders is intriguing and would also increase canakinumab’s cost-effectiveness,” Sehested and Bjerre said in an interview. “However, these results are based on post-randomization data, so it would be appropriate to investigate this approach in a proper randomized manner. Treating inflammation to prevent cardiovascular disease is an interesting new area in cardiovascular medicine. We hope to see more trials in the future with other drugs that decrease inflammation and hopefully improve cardiovascular outcomes.” – by Darlene Dobkowski
For more information:
Thomas S.G. Sehested, MD, can be reached at tsg.sehested@gmail.com. Jenny Bjerre, MD, can be reached at jennybjerre@gmail.com.
Disclosures: Sehested reports he received grants from the Lundbeck Foundation. Bjerre reports she received grants from the Danish Society of Cardiology and the Danish Heart Foundation. The other authors report no relevant financial disclosures.
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