Three distinct drugs or drug classes are in late stage development for treatment of lipid abnormalities: PCSK9’s (AMGN, SNY, REGN), CETP’s (MRK, LLY), and ETC-1002 (ESPR). This raises the question of which drugs fit where if all or most are approved

Using population-based data (NHANES*) data which includes the lipid levels (LDL-C, HDL-C, triglycerides) and risk factors needed to establish appropriate therapy, we estimate the numbers of US patients eligible for each of the three drugs or drug classes

Assuming all 3 classes are approved, and that physicians target an aggressive LDL-C goal (40 mg/dl), we find that 12.9M patients are eligible for PCSK9’s, 10.8M are eligible for CETP’s, and 160k for ETC-1002. Notably 9.9M patients are eligible to simultaneously use both PCSK9 and CETP therapy. The point here is that PCSK9’s and CETP’s overlap far more often than they compete

As long as physicians treat LDL-C aggressively (pursue 40 mg/dl rather than 70 mg/dl), whether CETP’s are approved (yielding 12.9M PCSK9 eligible patients) or not (yielding 13.8M PCSK9 eligible patients) has little bearing on demand for PCSK9’s

Conversely, whether CETP’s are or are not approved has an enormous impact on the number of patients eligible for ETC-1002 – 160k if CETP’s are approved, v. 650k if CETP’s are not approved

Whether PCSK9’s or ETC-1002 are approved has little bearing on patient eligibility for CETP’s – all that matters is the level at which LDL-C and HDL-C goals are set

Given the relative sizes of the eligible patient populations and the relative amounts of remaining approval risks faced by PCSK9’s and CETP’s, all else equal (i.e. no CETP-specific risk discount) we would expect CETP consensus to be about one-half PCSK9 consensus. In reality, CETP consensus is about one-fifth PCSK9 consensus. We think PCSK9 consensus is far too low (please see last week’s note), and our preliminary reaction is that CETP consensus – even accounting for class risks – also is too low

*(National Health and Nutritional Examination Survey)


For our full research notes, please visit our published research site

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