Cost-Effectiveness of Inclisiran for Treating Hyperlipidemia

EP: 1.Pathophysiology of Hypercholesterolemia and Cardiovascular Disease

EP: 2.Risk Factors for Developing Hyperlipidemia

EP: 3.Identifying Patients at High Risk for CV Morbidity and Mortality

EP: 4.High Cholesterol Versus Familial Hypercholesterolemia

EP: 5.Aggressive LDL Lowering in High-Risk Patients

EP: 6.Mechanism of Action of Inclisiran in Lipid Lowering

EP: 7.Outcomes and Practical Implications of Newer Agents

EP: 8.EPA in the Prevention of CV Risk

EP: 9.Emerging Use of Inclisiran as Adjunct Therapy in Hyperlipidemia

EP: 10.Phase 3 ORION Trials for Inclisiran 

EP: 11.Inclisiran in the Current Treatment Landscape for Lipid Lowering

EP: 12.Challenging Guidelines in a Non-ACS Population 

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EP: 13.Cost-Effectiveness of Inclisiran for Treating Hyperlipidemia

EP: 14.Statins as the Standard of Care for Patients With Dyslipidemia

EP: 15.Dietary and Lifestyle Modifications in Lipid Management

EP: 16.Bempedoic Acid for Lipid Lowering

EP: 17.Shared Decision Making and Value-Based Care

EP: 18.Treatment Decisions and its Relation to Patient Accessibility

Keith C. Ferdinand, MD: I have a question that I’m going to ask after Linda’s comments on some of the things she mentioned on prior authorization. The question is, if we don’t get that prior authorization question answered for inclisiran, do you think we’re going to reproduce what we saw with the PCSK9 inhibitors, where doctors are going to just stop using it.

Linda, you were mentioning the difficulties with prior authorization. Do you want to tease that out a little more?

Linda Hemphill, MD: First, on the hopeful side, I have noticed that most payers are not demanding that Zetia be added to statin prior to PCSK9.

Keith C. Ferdinand, MD: They did at first, though.

Linda Hemphill, MD: At first, but I’m not seeing it much anymore. There are a few holdouts, and that’s a very hopeful sign. What was your other question?

Keith C. Ferdinand, MD: In terms of prior authorization and the potential barrier to the uptake of inclisiran if it reproduces what we saw early on with the PCSK9 inhibitors. My perception is a lot of my colleagues said this is too doggone hard and that these drugs are not cost-effective, after reading in the 2018 cholesterol guidelines that it is not cost-effective. We know that’s not true now with changes in pricing, etc. Do you think that’s going to happen with inclisiran? You don’t know; it’s investigational. We’re just talking.

Linda Hemphill, MD: We especially don’t know what the cost is going to be because this is not a monoclonal antibody, which are very expensive to produce. This is fairly cheap to produce, actually, and it’s only 2 doses a year. In fact, we may find a preference by the payers. We may not have that same resistance that we had to the monoclonal antibody inhibition of PCSK9.

Keith C. Ferdinand, MD: Anybody else have any other comments? We’re going to go back to the statins after this. Go ahead.

Dean Karalis, MD: We also don’t know with inclisiran exactly what the payment structure is going to be. People have talked about “buy and bill,” which most physicians and cardiologists have not had that much experience with. Maybe a little with imaging agents for nuclear imaging, but that adds a whole other layer of complexity with regard to not only affordability but also how available is it going to be for our patients.

Manesh Patel, MD: I don’t know, but I envision that what we’ve already heard from Linda, the molecule itself costs a lot less to produce than a monoclonal antibody. The model that I suspect they’re going to try to do has got to be learning from the past, which is if you allow a lot of barriers to be put in place to discourage physician behaviors. Let’s not take inclisiran for a second. I was part of the development of the novel oral anticoagulants. Ten years ago we presented that they were better than Warfarin. Ten years later, this is the first time we have more than 50% of patients getting some of the novel oral anticoagulants, which we know are better than Warfarin. We know that inclisiran will be a very effective therapy based on the data we’ve already seen. If the sponsors and the health systems are actually thoughtful, they’re going to go to large integrated delivery places and sell bulk product, potentially even do it at risk, and say you will get this much, treat all your patients who need it and meet the criteria, and let’s hope that we improve cardiovascular outcomes.

Now that’s optimistic. We will see if that’s actually what happens. But I suspect that unlike the Cadillac model, it may be more of the Honda model. But the Honda model is going to be a volume business, and hopefully they teach people to drive safely.

Keith C. Ferdinand, MD: If you enjoyed watching this HCPLive® Peer Exchange, please subscribe to our e-newsletters to receive upcoming Peer Exchanges and other great content right in your in-box. Thank you very much for listening to this program.

Transcript Edited for Clarity