New anti-cholesterol drugs could be biggest sellers ever…how do they measure up?

Westport, CT, July 7, 2015 –PRESS RELEASE– RxScorecard™ analysis of the new lipid-lowering therapies, the innovative PCSK9 inhibitors for patients with difficult-to-lower, high LDL-C (bad cholesterol) levels.

 

According to Real Endpoints’ (RE) just-released RxScorecard™ analysis of the new lipid-lowering therapies, the innovative PCSK9 inhibitors which could be highly valuable for patients with difficult-to-lower, high LDL-C (bad cholesterol) levels, are both comparable to each other and lack key data that would justify broader use.

The implications: payers will have an extraordinary opportunity to control costs in this class, which many analysts have predicted could far surpass hepatitis C treatment costs. Drug companies with PCSK9 inhibitors, to meet investors’ sales expectations from these drugs, will have to work hard to build evidence beyond their ability to lower LDL-C and to define areas of differentiation (both among each other and relative to existing and coming therapies in other classes).

“Because efficacy evidence for the PCSK9 inhibitors is based primarily on a single surrogate marker (LDL-C), and because they lack long-term outcomes data, payers will approach their adoption very conservatively,” says Beth Nash, MD, RE’s chief medical officer. “Nobody wants to repeat the Women’s Health Initiative clinical experience, where what we assumed about cardiovascular benefit and estrogen therapy turned out to be completely wrong — and nobody wants to be caught financially flatfooted like they were with HCV.”

Wall Street and PBMs have estimated that these drugs, which could provide dramatic benefits to people with uncontrolled LDL-C and at high risk of a cardiac event, could easily add north of $20 billion (and potentially up to $10 PMPM) in annual expense. Plans and employers will therefore need to be ready, at launch, with appropriate coverage policies and the tools to negotiate with manufacturers for a preferred product. Medicare plans will have to be particularly focused on choosing the right drug since CMS will likely add the PCSK9 inhibitor class to the list of drug categories it requires plans to monitor for adherence.

Based on RxScorecard’s analysis of dozens of trials, over 700 pages of FDA briefing documents, analyst reports, payer panel discussions, and clinical expert guidance, most plans/employers will create policies that significantly restrict the use of this class of drugs. Moreover, they will have the opportunity to restrict their formularies to a single PCSK9 inhibitor (at least for the vast majority of patients) – no matter which indications FDA ultimately approves.

Moreover, according to RxScorecard, with the relatively near-term arrival of new PCSK9 inhibitors and other drugs with different mechanisms of action, plans will be able to leverage the likelihood of competition into significantly better pricing.

Manufacturers, therefore, will need to demonstrate differentiable value in areas of importance to payers, such as their therapies’ ability to improve clinical outcomes, promote adherence, and deliver significant medical cost reductions.

“The most forward looking plans will be ready to choose a preferred candidate, and set coverage policies, virtually at the launch of these powerful new drugs,” says Roger Longman, Real Endpoints’ CEO, which could come as soon as July 24. “These plans recognize that, even if the FDA-approved indications are limited to the smallest populations, many physicians will look to use these drugs broadly, despite the lack of outcomes evidence – and where there are significantly less expensive options.” For example, RxScorecard shows key subpopulations where soon-to-be-generic Zetia (ezetimibe) plus a statin might be a smart and low-cost alternative to more expensive therapy.

For the first two drugs likely to be available, RxScorecard gives a slight advantage – at least until new data are available — to the Regeneron/Sanofi candidate alirocumab over Amgen’s evolocumab, in part because alirocumab’s lower-dose option permits a more conservative treatment approach, presumably at a lower initial cost than its own and Amgen’s higher-dose regimens.

An evidence-based, interactive, web-based tool, RxScorecard analyzes the relative performance of each new lipid-lowering drug on 26 elements defining efficacy, safety and ease-of-use, and economics — for three key subpopulations – patients with familial hypercholesterolemia, suboptimal response to statins and those who are statin intolerant. The analysis and assumptions behind it are completely transparent, regularly updated, and with all data inputs hyperlinked to the published evidence.

RxScorecard can help plans select a preferred drug in the category, justify selection to all key stakeholders, and create the basis for coverage policies. Drug companies can use it to reveal current areas of relative advantage and disadvantage from the payer’s point of view as well as to identify critical gaps in data that payers will require in selecting a preferred candidate.

In addition to PCSK9 inhibitors from Amgen (evolocumab), Regeneron/Sanofi (alirocumab) and Pfizer (bococizumab), the RxScorecard™ analysis includes scores on the two latest-stage CETP inhibitors (from Lilly and Merck) and on Esperion’s ETC-1002.

For more details of the RxScorecard analysis and free previews, contact Viviana Ramos at vramos@realendpoints.com or 203-517-4769 or visit realendpoints.com/our-businesses/rx-scorecard.

About Real Endpoints
Real Endpoints is a health care information and analytics company that prepares healthcare providers, payers and pharmaceutical companies for the value-based healthcare economy. RxScorecards are also available for COPD, HCV and adjuvant breast cancer.

Learn more at www.realendpoints.com