Swallowing the CVS-Aetna Pill

First, a Canadian investigator uncovers a proprotein convertase gene on chromosome 1. Then, serendipitously, a laboratory in Paris, France, identifies a chromosome 1 mutation in families with familial hypercholesterolemia. If these 2 parties can find each other, they’ll make history.

Like any good love story, the research teams are paired up within a year—the same year that US investigators discover the proprotein in mice and identify a novel pathway that defines the role of proprotein convertase subtilisin/kexin type 9 (PCSK9) in low-density lipoprotein cholesterol regulation.

The story of how PCSK9 inhibitors came to be is a beautiful one wrought with relentless effort and good fortune. But the story that has followed is anything but pretty, according to Ann Marie Navar, MD, PhD. Rather, it’s a sad story about how access to a powerful biologic—one that holds the potential to change the world—was cordoned off from those who need it most.

That story is all too familiar to physicians like Navar, an assistant professor of cardiology at Duke Clinical Research Institute. Over the course of her long career, it’s become clear to her that the tension between pharmacy benefit managers (PBMs)—agents who set high costs for novel drugs like PCSK9 inhibitors—and payers who are often unwilling to meet those prices needs to be resolved.

“What’s not clear to me is how combining payers and PBMs will improve access for patients,” Navar said.

The Acquisition

After its latest blockbuster merger, CVS Health wants to show her how.Last December, the pharmacy company announced plans to acquire health and dental care company Aetna in a $69 billion venture. In a statement, CEO and President Larry J. Merlo said the merger would “remake the consumer health care experience” with its addition to PBM service CVS Caremark.

With 9700 retail sites, 1100 walk-in medical clinics, and 90 million plan members, CVS Health was already one of the most profitable US health care entities. Since its absorption of Aetna, it has gained products, services, and 45 million customers from the country’s third-largest health insurer.

A representative with CVS told MD Magazine® that the acquisition creates an opportunity to “redefine access to high-quality care in lower-cost, local settings—whether in the community, at home, or through digital tools.” At the time of purchase, officials discussed providing more telehealth services for patients with chronic diseases, remote physician intervention access, and follow-up counseling to improve patient prescription adherence.

It also provides an opportunity to cut high drug prices. From the company’s perspective, costs climb because of prescription confusion or lapses in regimen. That can be improved with more patient guidance. CVS plans to address that through its switch to real-time prescription information provider Surescripts, which claims to provide individualized alternatives to high-cost therapies both online and in the pharmacy.

The System’s Problem

Ann Marie Navar, MD, PhD

But physicians like Navar know the seeds of problematic drug costs are sowed long before they reach patients.In a study of 45,029 patients prescribed PCSK9 inhibitor therapies alirocumab or evolocumab between August 2015 and July 2016, Navar and colleagues found that just 47.2% (21,259) received insurance approval for the prescription. Of that population, about one-third (7366) abandoned their prescription at the pharmacy. The data suggest a strong correlation between abandonment and cost—just 7.5% of patients with no out-of-pocket costs abandoned their prescription, while more than 75% of patients with a co-pay of at least $350 abandoned theirs.

The rate of 52.8% of patients being rejected by payers is a byproduct of the tension between PBMs and buyers, Navar said. The entities’ uncompromising and conflicting policies could make important therapies elusive to their intended patients.

“In expanding development of these high-cost therapies, you have a corresponding massive increase in demand on providers,” Navar said.

She still holds hope for improvements under the CVS—Aetna conglomerate. The entity could use its new power to improve patient treatment access to both branded drugs and generics. There’s also opportunity to simplify the paperwork that physicians put into the prescription process under the unitary system. But there’s still a discord between PBMs and buyers, she said, and a need for policy fixes.

Following Trends

Jack Hoadley, PhD

“There’s so little transparency of drug pricing. Every payer and PBM negotiates its own discount price,” Navar said. “It’s just very opaque—who’s making money, and where?”For the past 5 to 7 years, Medicare Part D prescription drug plans (PDPs) have embraced the narrow pharmacy network—a benefit network for prescription consumers in which they are given either limited access to a certain amount of cost-efficient pharmacies or preferred access to select pharmacies through incentives.

The rate of PDPs offering preferred cost sharing in select network pharmacies grew from just 7% in 2011 to 87% in 2015. Results from a study that year showed that these programs could result in substantial co-payment savings on both branded drugs and generics.

In an essay accompanying the study, Jack Hoadley, PhD, research professor emeritus at the McCourt School of Public Policy at Georgetown University, noted that the effects of buyer—pharmacy networks are often 2-fold. “The higher volume for the pharmacy as a result of lower cost sharing for consumers means they offer deeper discounts; lower prices paid by consumers may also mean improved medication adherence,” Hoadley wrote.

But it’s hard to figure exactly whether CVS’ acquisition of Aetna will be better or worse for patient costs, Hoadley told MD Magazine®. He has noticed a stronger affiliation between patient and PBM since Medicare Part D’s venture into select networks. Though the average patient is free to consider differing co-pays at different pharmacies, Aetna customers are shouldered into buying from CVS.

“Plans really have always driven the decision on what brand drugs are available to patients, at least in terms of their coverage,” Hoadley said. “If you’ve got a PCSK9 inhibitor prescription for you in the plan, and Aetna doesn’t want to cover that now, you’re going to run into the same coverage limitation.”

Generic Roles

Hoadley said most who try to determine what will follow the acquisition are simply practicing “guess work.” He wondered whether retail giant Amazon would enter the realm of health care—just hours before the company announced it would be initiating a new health care network for its employees on January 30, alongside Berkshire Hathaway and JPMorgan Chase.Burgeoning all-purpose health care networks may be closely tied to the growth of generic drugs. Currently, generics make up 90% of the dispensed prescription drug market, with the FDA implementing new strategies to accelerate the field seemingly every day. It’s a boon for PBMs, who get a say in which generic therapies they offer, Hoadley said. But it’s good for patients too.

“That’s the biggest thing over past decade or two—the growth of generics,” Hoadley said. “As we move into all the biological drugs, we need the biosimilars to get into the market and be the generics for that market, to address the prices.”

As of now, the emergence of more generics and biosimilars is a more predictable outcome than whatever may come from PBM—buyer conglomerates.

How It Could Work

“We’re just getting more and more entangled in all the relationships, and I’m worried about how this will play out to the benefit of the consumers,” Hoadley said.Where Hoadley has concerns, Sanket Dhruva, MD, sees potential. Still, the Yale University cardiologist is cautious.

“I’m not saying, ‘Hey, we fixed things,’ but it’s an interesting arrangement with certainly some potential,” Dhruva told MD Magazine®. “I would make it clear that we’re going to have to be vigilant for unintended consequences.”

For one thing, CVS—Aetna follows a pattern that’s common in health care since passage of the Affordable Care Act—a pattern of consolidation.

“Whether this is what continues to happen, I’m not sure. But this is certainly where the trend is going, and this is an important experiment,” Dhruva said—an experiment that could bring welcome improvements in access to affordable prescription therapies, physician intervention, and proper care.

The onus for emphasizing proper care also falls on the FDA, Dhruva said. The agency must green-light necessary and proven generic and biologic therapies that are more readily accepted by prescribers.

Treading Forward but With Trepidation

PBMs like CVS are kick-starting that process. “They’re covering over 100 million lives in America. It’s a large number,” Dhruva said. “It makes sense that these are reliable prioritizations.”Navar noted the current system is not just failing patients; it’s also blunting the progress of doctors and investigators. That’s why physicians are all for addressing the issues of patient access to affordable medication in the United States—they just disagree about how to act.

“I hope that a merger like Aetna and CVS leads to better access, but I’ll remain a little cynical until I see improvements between the companies that sell the drugs and those who provide them,” Navar said.

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