FDA Approves Consensi™: A Novel Combination but a Conundrum for the Medicare Set-Aside

On May 31st, the FDA approved Kitov Pharma’s application for Consensi™. Consensi is a unique combination product containing amlodipine, a calcium channel blocker used for the treatment of hypertension, and celecoxib, a non-steroidal anti-inflammatory used for the treatment of osteoarthritis. The product’s labeling will include a single indication for patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate.

In a press release, Kitov Pharma’s CEO Isaac Israel touted Consensi as a product whose value proposition is to increase adherence in patients who suffer from both hypertension and osteoarthritis. Hypertension has been called the “silent killer” because it often does not produce noticeable signs and symptoms, and therefore tends to be undiagnosed and untreated. Even when hypertension is diagnosed and treated, nonadherence to antihypertensive medications is a significant problem and untreated hypertension is a significant driver of cardiovascular disease.  The results of a meta-analysis published in January 2017 revealed that 45.2% of patients with hypertension were nonadherent to prescribed medications.[1] Even more concerning was another finding in the same meta-analysis that 83.7% of patients with uncontrolled blood pressure were nonadherent to medications.[2]The results of this meta-analysis and other studies have demonstrated the need for additional adherence tools in the treatment of high blood pressure.

Consensi represents a unique challenge for the Medicare Set-Aside since celecoxib may very likely be related to a workers’ compensation injury but the amlodipine will not be related in the vast majority of cases.  The importance of adherence to an antihypertensive medication regimen cannot be denied, but in most cases the cost of amlodipine would be excluded from a Medicare Set-Aside allocation. With Consensi, the cost of both drugs will be incorporated into a single tablet formulation. Those striving for MSP compliance for claimants taking Consensi will need to figure out how best to address this new combination therapy.

Consensi will be available in 2.5mg/200mg, 5mg/200mg and 10mg/200mg tablet formulations.

[1] Abegaz T.M. et al. Nonadherence to antihypertensive drugs: A systematic review and meta-analysis. Medicine (Baltimore). v. 96(4):e5641, Jan. 2017.

[2] Ibid.

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