Payors’ Perspectives On Lipid Management

Payors are sure to be on guard about the introduction of new branded drugs, given that the stakes and costs are high.

A Zitter Group survey of payors in spring 2011 indicated that hyperlipidemia ranked fourth in terms of overall priorities for managing therapeutic areas, after cancer, type 2 diabetes, and asthma. That prioritization will give an advantage to generics over branded drugs. A later survey in the fall showed that 71% of payors planned to encourage the use of generic atorvastatin in both treatment-naïve and -experienced patients, through a variety of strategies.

The savings in the US for switching to generic atorvastatin could amount to $4.5 billion annually by 2014, based on Lipitor US sales, trends for other drugs following patent expiration and demographic changes associated with an aging population, noted Cynthia Jackevicius of Canadian Western University Health Sciences, in a New England Journal of Medicine Perspective column published January 19. However, this figure is based partly on a higher IMS Health estimate of US Lipitor sales in 2010 of $7.2 billion, prior to discounts and rebates.

There is also enormous competition in the cardioprevention space generally, with some 40 outcomes trials ongoing in cholesterol and diabetes that could have an impact on drugs in development. For example, Merck & Co. Inc.’s IMPROVE-IT study tests ezetimibe/simvastatin (Vytorin) against simvastatin alone in 18,000 with acute coronary syndrome against a low or high dose of simvastatin alone (patients treated to optimal targets). An interim analysis was completed in 2012 and data are expected in 2013.

A negative outcome would create further doubts about LDL-lowering, but a positive outcome would give payors another option and Vyotorin will become available as a generic before higher priced options.

In the post-Lipitor world, payors are particularly interested in approaches that work on a genetic pathway or on a different targeted mechanism for cholesterol synthesis and can be used for subpopulations that are inadequately treated with existing medications, said Robert Epstein, president of United BioSource Corp., a subsidiary of pharmacy benefits manager Medco Health Solutions Inc.

For the very small populations, outcomes studies are not essential, but having data that help translate study results in subpopulations into effects on resource utilization would kick a new drug “over the finish line” after launch, when it comes to reimbursement, he said.

Payors are less interested in broader high-risk populations, but if a drug shows “incredible efficacy” in an outcomes study that “no one’s going to deny access to therapy,” Epstein says.

With a modest reduction in events, payors would look more at the total cost of care question. Epstein declined to set a numeric threshold for reduction of events that would be needed. Value would be dependent on the relation between level of reduction of risk, cost of the new therapy, and effect on other resources, for example, reduction in hospitalization costs.

“A drug for all patients in secondary prevention would be a harder story to tell. The level of evidence has to be there to justify the cost,” Epstein said.

If new drugs are shown to decrease mortality dramatically, say by 30% to 50%, there should be a big market waiting for them, says pharma industry consultant Richard Pasternak, MD, who formerly led cardiovascular/atherosclerosis clinical research at Merck.

But what if much smaller reductions in benefit are shown, for example, 3% to 5%? “That’s a discussion we have to be more public about,” he said.

Plump responds that he personally believes that offsetting risk by 15% would be very significant. “Whether 15% from a payor perspective or societal perspective or individual clinician perspective is sufficient is something we have to understand better through pharmacoeconomic analyses and such,” the executive said.