Do Physicians Have High Hopes for LDL-Lowering Therapies in Cardiovascular Outcomes?

As one of the most prevalent diseases in the major pharmaceutical markets, dyslipidemia represents a compelling commercial opportunity for drug manufacturers. The excellent efficacy and safety profile of statins and their increasing availability as generics mean that this class will continue to dominate early lines of therapy. However, in statin-intolerant patients, or when these agents fail to sufficiently reduce the main target (blood plasma low-density lipoprotein cholesterol [LDL-C] levels), additional therapies are often required. Current statin add-on therapies suffer from a lack of outcomes data from large randomized, controlled trials and demonstrate only moderate success in terms of further reduction of LDL-C levels.

Given the close link between dyslipidemia and atherosclerotic diseases and cardiovascular death, physicians desire agents not only with greater LDL-C-reducing abilities but also with a proven impact in cardiovascular outcomes trials (CVOTs). Thought leaders are excited about the arrival of two novel antidyslipidemic drug classes, the cholesteryl ester transfer protein (CETP) inhibitors and the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, which have the potential to fulfill this unmet need. Another drug class being investigated in CVOTs is the prescription omega-3 acid ethyl esters. This report compares current and emerging therapies used alongside statins to treat dyslipidemia, identifies remaining areas of unmet need, and provides the opportunity to model different target product profile scenarios and forecast uptake of these profiles based on primary research.

Questions Answered in This Report:

  • A drug’s performance on at least eight efficacy end points, including effect on CV morbidity (e.g., nonfatal myocardial infarction [MI], nonfatal stroke), is important for drug approval and physician use. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European primary care physicians (PCPs) weight efficacy measures and other drug attributes in their prescribing decisions for dyslipidemia (in statin-treated patients)?

  • Reducing the rate of CV morbidity and mortality are key areas of unmet need for dyslipidemia (in statin-treated patients) according to the insights of surveyed U.S. and European PCPs. Which therapies in development for dyslipidemia (in statin-treated patients) are poised to fulfill these needs? What clinical and/or regulatory challenges must drug developers overcome to capitalize on these areas of unmet need? What degree of improvement over currently available therapies do surveyed U.S. MCO PDs seek from new therapies on key clinical attributes for which surveyed physicians indicate there is high unmet need?

  • Price and effect on mortality rate are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new dyslipidemia statin add-on therapies. What trade-offs across these and other clinical attributes are U.S. PCPs willing to make when considering the use of emerging therapies for dyslipidemia (in statin-treated patients)? Based on the trade-offs in price and performance across key drug attributes that U.S. PCPs are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for dyslipidemia (in statin-treated patients)?

  • Based on its clinical profile, ezetimibe (Merck & Co.’s Zetia/Ezetrol) is the current clinical gold standard in our Drug Comparator Model. What attributes do thought leaders believe differentiate this therapy from competing current therapies and emerging therapies? Will any therapies in development challenge ezetimibe as the future gold standard in 2017 or 2022?

Scope:

Attributes included in conjoint analysis based assessment of target product profiles for dyslipidemia (in statin-treated patients):

- Effect on mortality rate.

- Effect on major adverse cardiovascular event (MACE) rate.

- Effect on LDL-C levels.

- Effect on high-density lipoprotein cholesterol (HDL-C) levels.

- Effect on triglyceride (TG) levels.

- Dosage (route of administration and frequency).

- Price.

Attributes included in assessment of U.S. payers’ receptivity to new therapies for dyslipidemia (in statin-treated patients):

- Effect on CV morbidity.

- Effect on HDL-C levels.

- Effect on LDL-C levels.

- Effect on TG levels.

Physicians surveyed: 60 U.S. and 30 European PCP/GPs.

Payers surveyed: 20 U.S. MCO PDs.

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Ezetimibe (Merck & Co.’s Zetia/Ezetrol)

- Fenofibrate (Abbott’s Tricor/Lipanthyl, Kaken Seiyaku’s Lipanthyl, generics)

- ER niacin (AbbVie’s Niaspan, generics)

- Lovaza/Omacor (GlaxoSmithKline/AbbVie)

- Vascepa (AMR-101) (Amarin)

Emerging Therapies and Procedures

- Anacetrapib (Merck & Co.)

- Evacetrapib (Eli Lilly)

- Epanova (AstraZeneca)

- Evolocumab (AMG-145) (Amgen)

- Bococizumab (RN-316) (Pfizer)


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