CVS Scales Up New Clinical Trial Division, Spotlights Recruitment, Diversity, RWE

CVS Health, seeking to leverage its success in COVID-19 vaccine and therapeutics clinical trial recruitment, has opened the doors on a new clinical trial services division that it hopes will offer life sciences companies the opportunity to recruit more diverse study populations.

The new division, launched in May, initially will focus on scaling three core capabilities: precision patient recruitment, clinical trial delivery, and real-world evidence (RWE) generation and studies, according to CVS Health. Ultimately, the company foresees becoming a major player in clinical research services.

“As a Fortune 4 company, we are really looking to do this at a scale that just doesn’t exist currently, and we are well-suited to do that,” says Owen Garrick, M.D., vice president of clinical trial delivery at CVS Health Clinical Trial Services. Over the last year, CVS engaged 300,000 people in the U.S. as part of COVID-19 studies on vaccines and therapeutics, and “that hopefully will give you a sense of the magnitude at which we’re looking to operate,” Garrick tells AIS Health, a division of MMIT.

Potential clients include the largest life sciences companies, says Garrick. “If you look at the top 20 pharmaceutical companies, that’s the sort of group that we are currently working with and looking to work with more,” he says. “Our existing therapeutic areas are fairly broad, but clearly vaccines and other anti-infectives, endocrine and metabolic, such as diabetes, and cardiovascular. So a fairly broad initial set, and we’ll build out capabilities. We’ll eventually be more active in cancer studies.”

F. Randy Vogenberg, Ph.D., principal at the Institute for Integrated Healthcare in Greenville, S.C., tells AIS Health that this move into clinical research services isn’t at all a slam dunk for CVS Health. “Retailers have been dabbling in this for decades, to varying degrees of success,” he says. “It is a longer-term play vs. short-term and may not drive a lot of synergy in the retail hub for a sustainable period. It is a risk, no guarantee of sustainable revenues, and, if badly executed, could be very damaging to CVS’s reputation along with balance sheet.”
Other observers noted the possible risks involved, while also acknowledging potential benefits to CVS’s approach.

“Given CVS’s experience with COVID and the new focus by the FDA to insist on having some racial heterogeneity inside clinical trials, it does make sense to me that they’re going to get into that,” says Jeff Myers, senior vice president of market access and reimbursement strategies at Catalyst Health Care Consulting. In some cases, CVS’s role may make more sense as a subcontractor to another clinical research organization, leveraging CVS’s ability to recruit diverse trial participants but allowing a more experienced CRO to design and run the actual research, he says.

CVS Leverages COVID Trial Experience

The decision to invest in a new focus on clinical trials occurred during the COVID-19 pandemic, when CVS became involved with recruitment for several COVID vaccine studies, Garrick says. “That experience caused management to think through that this is something we’ve had success in during a public health emergency, and the success was really leveraging the already-existing footprint of CVS — we were already in diverse communities across the U.S., with strong relationships with our patients and partners. And that was really the sauce, if you will, for engaging around 300,000 people around COVID-19 studies.”

The studies for which CVS recruited patients involved both vaccines and treatments, Garrick says, although the company’s largest involvement was in the vaccine studies, which involved several different vaccine candidates, including “most if not all” of the vaccines that are currently authorized.

Clinical research isn’t entirely new to CVS: The company acquired some expertise in clinical trials research via its purchase of insurer Aetna Inc., which included Aetna’s Healthagen division, formed in 2013. For his part, Garrick joined CVS several months ago after serving as the president and CEO at Bridge Clinical Research, where he promoted diversity in clinical trials.

Healthagen performed retrospective and prospective studies that measured the impact of novel devices and therapeutics in a real-world setting, Garrick says. For example, he explains, Healthagen might identify a group of type 2 diabetic patients in their 30s who had to be converted to insulin treatment at an early age because oral hypoglycemic agents no longer were effective for them. Then, Healthagen might use analytics to retrospectively identify risk factors that could have led to that early onset of insulin requirements and use that data to design interventions to target individuals in their 20s, he says.

In addition, Garrick says, CVS Specialty Infusion Services has been conducting research for around 15 years, which could help the new clinical trials division gain a toehold in research on infused medications. “The ‘me-too’ oral drugs are a little bit of a thing of the past, but there’s more of a focus on personalized health care targeted therapeutics, and we are active and comfortable getting involved with all that.” Garrick points out that CVS has broad experience in infusions and adds, “for us, it’s really about converting and leveraging that knowledge and experience in the patient care setting to a research center.”

Now, the legacy Healthagen business has been folded into the new clinical trial division, he says. The specialty infusion research still is housed in CVS’s specialty infusion business, but the clinical trial services division engages with the specialty infusion business as part of its offerings.

CVS Clinical Trial Services has three departments, Garrick says. First, precision patient recruitment will leverage analytics and CVS’s national reach and local community connections “to engage individuals by first creating awareness and helping them learn about clinical trial opportunities that might be appropriate for them.” Recruiters then hand off patients either to CVS’s existing research sites if the company is involved in the research project or to another company’s research sites, he says.

The clinical trial delivery group, which Garrick oversees and calls “the most innovative and decentralized clinical trial network in the country,” will focus on Phase III and Phase IV clinical trials, both in CVS locations and in homes. CVS is “building and expanding our virtual capability,” he says. “The idea is to give patients a choice: They can come into a typical brick-and-mortar location — which is pretty standard in studies — [and] have the option to engage and participate in research at home, leveraging technology such as video visits, which we’ve all gotten more accustomed to during the pandemic.” The third department focuses on RWE generation, he says.

Trial Diversity Is Major Focus

CVS is spotlighting diversity and health equity as part of this initiative, explains Garrick. “As an example, looking at the locations as to where we build out these research sites, it’s part of our decision-making processes to make sure that the populations are diverse from an ethnic perspective, as well as from more of a social vulnerability index. When you think through the challenges of diversity in clinical trials, access is one of them, and location can help solve part of that access problem. The other way to help solve that is making sure that your workforce represents the community.”

The company’s Minute Clinics (intended to treat low-acuity ailments and provide services such as immunizations) and HealthHUBs (which focus on chronic disease management) already have a workforce that represents their communities, says Garrick. The clinical trials division will leverage those locations.

In addition, he says, “the other big component around a challenge with diversity in clinical trials is the trust factor. CVS is a trusted part of the community. We have individuals who are coming into our stores, getting prescriptions six or eight times a year and building that relationship with the local pharmacist, with the pharmacy tech, and as an extension as we’ve launched more research sites, continue that trusted relationship with our research professionals. So that is how we are looking at it, and we have the ability to scale that.”

CVS has opened research sites so far in California, Georgia, New Jersey and North Carolina, with plans to open additional sites this year and next, Garrick says, adding, “if you did a map of CVS and specifically our HealthHUB and Minute Clinic locations, [the research sites] will be in a combination of major metropolitan areas but also communities across the country where we currently do business.”

The CVS research arm also is looking to partner strategically with community organizations and academic medical centers, states Garrick. “In terms of being part of the health care delivery ecosystem, even though we’re a pretty large organization, this is not something we can do by ourselves.”

“At the end of the day, the aim and goal is really to improve health outcomes, and that is by assisting in bringing new medicines and new therapies to market for the customers — patients — and their providers,” Garrick says. “Our direct customers are the life science manufacturers.”

Friso van Reesema, senior account executive of health care analytics company Cotiviti and board director for the Health Equity Initiative, says the CVS initiative will help clinical trial diversity. “Representation for safety and effectiveness is lacking in clinical trials,” he tells AIS Health. “While the ‘n’ or sample size is representative for statistical significance for the most part, it’s lacking diversity for the real world. Participants in trials should reflect the population, paying special attention to those most affected by the disease in question.”

Lack of diversity in studies leads to interventions that don’t necessarily work well in diverse real-world populations, contends van Reesema. “This can be especially pronounced in the underserved, who are most at risk,” he says. “Besides the health equity issue, the current process to get new products to market is inefficient because it takes CROs longer to find the populations, explain the benefits of studying new treatments and enroll them with their stringent parameters. With its community focus, CVS Health’s new effort here should help improve efficiency but, more important, help improve clinical trial diversity, leading to better health outcomes and ultimately health equity.”

Recruitment Is Key Benefit, Experts Say

It’s unclear how CVS Health’s Clinical Trial Delivery division will fit into the overall CRO landscape, industry observers say. Among the various CROs, the major players include PPD Inc., IQVIA Inc., Labcorp Drug Development (formerly Covance), Parexel International Corp. and Syneos Health, says Mesfin Tegenu, CEO and chairman of RxParadigm, a pharmacy benefit cost management start-up focused on providing tools and transparency.

“There has been an 86% increase in total data endpoints per clinical research trial over the past 10 years,” he says. “Nearly 40% of trials begin under-enrolled, and 11% of sites fail to enroll a single patient. The average time it takes to bring a drug through clinical trials has decreased, [but] the rate of success has gone down.”

These factors have led to variable clinical trial performance, with increasing staff workloads, limited access to data analytics and difficulty finding patients, Tegenu states. “The result is a clinical site landscape change and growth of stand-alone clinical trial sites. This is part of a booming industry where the cost to develop a successful drug has grown from $802 million in 2003 to $2.6 billion today, with an average ROI [i.e., return on investment] of about 3%.”

“Most clinical trials fail to recruit enough patients, with issues ranging from delayed trials due to recruitment issues and dropout and ending trials early because of issues with recruitment and retention,” he notes. “Moreover, more than two-thirds of potential clinical trial patients live more than two hours from a study site. Therefore, it makes it challenging to recruit participants. Pharmacies are the most frequently visited health care setting and can potentially be a place to conduct such clinical trials, provided all other requirements are met.” CVS could potentially recruit patients for studies in any clinical area and could recruit and deliver clinical studies in particular areas of expertise, he explains.

Life sciences companies are most likely to outsource patient identification, data gathering, data analytics and reporting, says Tegenu, adding, “the conventional wisdom is outsourced specialized clinical trial service providers are cost effective for pharma companies. We see more and more manufacturers outsourcing this service.”

In offering clinical trial services, CVS is poised to win an additional revenue stream, realize synergy through its pharmacy channels and expand its customer base, he predicts, noting, “currently, CVS seems to be better structured to provide these services than its retail competitors. I wouldn’t say it will shake up the market, since this is not a volume- and unit cost-driven business.”

Myers also sees CVS’s enormous retail presence — and particularly its Minute Clinic arm — as a real benefit in trial recruitment. “They’ve got a lot of outreach that these other [CROs] don’t have,” he says.

Is CRO Purchase in CVS’s Future?

But, he adds, “What isn’t clear to me is the amount of intellectual capital they have to power and drive these types of studies.” In his experience, CROs are skilled at designing clinical trials powered to reach conclusions and can identify specific hospitals and providers to target for recruitment. “To the extent that CVS wants to do that, building it may be more expensive than buying it. And it wouldn’t surprise me if they tried to acquire some existing CRO for that knowledge. Maybe they already have it, but I wouldn’t think so,” he says.

“If you’re a drug company — especially a smaller one where you’re going to outsource all this stuff — the reason [you outsource] is because you can explain the mechanism of action and target, and the CRO can lay out for you a clinical program where you can outsource almost all of this,” he states. “Unless I had a product already approved where I’m seeking to expand the label, and I had a pretty high sophistication in knowing what the trial structure needed to be for approval, I’m not sure if I were a startup or a smaller biotech company that I would say, ‘Have CVS do it.’”

Still, if CVS Health decides to build or buy the CRO structure it would need for advanced expertise in clinical trial research, it could be a strong competitor in the CRO space, Myers asserts. “With retail presence, they can reach a lot of individuals quickly and relatively cheaply,” he says. “With a distribution site — Minute Clinics — they can actually ensure you’re taking the medication and do all of the clinical stuff, blood pressure and all those checks. And presumably, they can deliver clinical trial material cheaply, because they’re a giant PBM, so they’re dropping stuff off at stores four times a day. So it does make sense that for oral products or for subcutaneous products, that they could have a reasonable presence if they develop the infrastructure that the other guys have.”

However, it’s not clear to what extent CVS has relationships with physicians, he points out. “When you think about the way most CROs run clinical trials in the United States today, they don’t target individual patients,” he explains. “They target doctors who treat patients with a particular disease and use those doctors to introduce the concept of being in a clinical trial to their patients. And so it isn’t clear to me that CVS would have that kind of penetration in medical specialties. And because they’re a PBM and not a GPO [i.e., group purchasing organization], they most certainly don’t have it in hospitals, either.”

In fact, CVS’s trial recruitment strategy would be unusual, Myers says. “You’re recruiting patients basically out of a general population and then using nurse practitioners or others to sign them up and presumably send them to doctors so that you can start the clinical trial, because my guess is that you’re not going to be able to give unlicensed medication to patients via the nurse practitioner,” he says. “That’s not the way CROs are generally designed to recruit patients.”

Few new drugs target a giant population, Myers points out: “When was the last time you saw someone trying to create a new pain medication like Advil? So since most of this is going to be specialized, you are going to have to have some type of provider that manages both the provisioning of the product to patients and all of the data collection. I’m not sure how CVS is going to do that.”

Will There Be Focus on RWE Studies?

Vogenberg points out that there are three trends in clinical trial services: (1) less expensive and faster completion of studies in other countries, (2) smaller groups of patients for select conditions that are more rare in populations and (3) emergence of well-managed RWE studies that are becoming more acceptable to researchers and FDA scientists. Outsourcing reduces overhead for pharma without sacrificing quality or expertise, he says.

“It is the RWE studies that are of most interest to drug chains like CVS Health,” Vogenberg says. “They are comparatively much easier to do, and [CVS’s] volumes of patients in diverse geographic areas become attractive for outsourced services. Also remember that the scope of services are numerous and not likely all would be done by a ‘retail’ pharmacy entity like CVS Health.” He says other retail chains, such as Walgreens Boots Alliance, Inc. or other big box or supermarket pharmacies, might consider offering similar services, but those entities don’t have the same resources available for supporting RWE work.

CVS Health could be most successful in work on studies involving chronic care medications, since those represent the “great majority of patients seen and drugs dispensed in retail,” Vogenberg says. The company’s long-term care pharmacy group also would be particularly attractive to be more involved in RWE research, he adds.

“I think it is more about the desire to maximize the ability to use RWE studies to expand additional approvals faster through the FDA process, as time is money,” Vogenberg says. “Not every pharma or drug to study will need RWE, but the numbers do expand revenue sources for CVS and existing personnel in their organization as they hit a plateau for new growth in lives for PBM contracting.”

Vogenberg notes one last potential benefit for CVS, although it also contains some risk. “A key hidden agenda for CVS and other chains or health plans/PBMs would be advantageous contracting terms for drugs that may be offered at launch,” he says. “Some would argue that is a conflict of interest and could lead to litigation, given the verticalization of health care that has happened in recent years.”

Contact Garrick via spokesperson Tammy Arnold at arnoldtd@cvshealth.com, Vogenberg at randy@iih-online.com, Tegenu at mesfin.tegenu@rxparadigm.com and Myers and van Reesema via spokesperson Joe Reblando at joe@joereblando.com.

0

0

0 Comments

0

0

• Spotlight on Market Access