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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Walgreens Launches Clinical Trial Business with Goal of Leveraging Consumer Data, Technology, and Nationwide Reach to Increase Racial and Ethnic Diversity in Drug Research

By partnering with drug manufacturers to connect customers with clinical trials, the retail pharmacy chain believes this new venture will be the company’s “next growth engine.”

Walgreens is launching a business to connect customers with clinical drug trials, a venture that adds another offering to the retail pharmacy giants’ growing menu of healthcare services. This new venture might also mean additional test orders for clinical laboratories and pathology groups in areas that serve Walgreens customers.

In “By 2027, Walgreens Wants 1,000 Primary Care Clinics,” Dark Daily’s sister publication, The Dark Report, reported on Walgreens’ goal of building 1,000 primary care clinics at its retail pharmacies by 2027, a move which mimics the rollout of CVS Pharmacy MinuteClinic and Walmart Health primary care clinics in their retail locations.

Now, Walgreens is attempting to further redefine the patient experience by partnering with pharmaceutical companies to find participants for clinical trials, a business that could result in more Americans from underrepresented racial and ethnic populations enrolling in drug-development trials. With 9,021 retail pharmacies in all 50 states, it is well-positioned to know which of its customers would be candidates for different clinical trials.

“Walgreens’ trusted community presence across the nation, combined with our enterprise-wide data and health capabilities, enables us to pioneer a comprehensive solution that makes health options, including clinical trials, more accessible, convenient and equitable,” said Ramita Tandon, Walgreens’ Chief Clinical Trials Officer, in a press release.

Ramita Tandon, Walgreens’ Chief Clinical Trials Officer

Ramita Tandon, Walgreens’ Chief Clinical Trials Officer, believes Walgreens can play a role in solving the issues of diversity and declining enrollment in clinical trials. “Through the launch of our clinical trials services, we can provide another offering for patients with complex or chronic conditions in their care journey, while helping sponsors advance treatment options for the diverse communities we serve,” she said in a press release. (Photo copyright: Walgreens.)

Serving the Socially Vulnerable

In an interview with Fierce Healthcare, Tandon described the clinical trials business as Walgreens’ “next growth engine” of consumer-centric healthcare solutions.

According to the company press release, “Walgreens is addressing access barriers through a compliant, validated and secure decentralized clinical trial platform built on a rigorous compliance and regulatory framework to ensure patient privacy and security. This approach leverages owned and partner digital and physical assets, including select Health Corner and Village Medical at Walgreens locations, to directly engage patients at home, virtually or in-person.”

Walgreens notes that more than half of its roughly 9,000 U.S.-based stores are in “socially vulnerable areas.”

According to the Washington Examiner, a US Food and Drug Administration (FDA) study revealed that 75% of patients who participate in clinical trials are white, while just 11% are Hispanic and fewer than 10% are Asian or black. In addition, participation in clinical trials has been declining, with 80% of trials failing to attract enough participants on time.

Tandon maintains that making the process of participating in clinical trials easier is another key to increasing diversity and participation in clinical trials.

“During the clinical trial journey, we know it’s a burden for patients to visit sites. We also know that 78% of patient-consumers in the US live within five miles of a Walgreens,” she told PharmaVoice. “If a patient can complete much of the up-front clinical trial requirements at a local Walgreens, or conduct some of the visits digitally, it would make the whole clinical trial experience that much more positive and, maybe, encourage the patient to participate in new clinical trials going forward.”

Walgreens also plans to use its treasure-trove of customer data to find potential patients for its trials business.

“Understanding this detail of customer preference and segmentation can be quite useful particularly in clinical trials, for example, to create better protocols,” Tandon told PharmaVoice. “We are sitting on so much information, but we can, and need to, do a better job of using these insights in a real-world setting, which can be translated to pharma R/D or brand management organizations. We’re all about patient-centric drug development.”

FDA Seeks Diversity in Clinical Trails

Walgreens is in discussions with several drug manufacturers as it looks to launch this new venture.

“We are working very closely with them to understand their business needs and create the solution that’s going to be sort of bespoke to their specific trial needs,” Tandon told Fierce Healthcare. “Our goal is to move that needle and start to see a larger number of US patients participating and highly diverse participants that are coming into clinical trials.”

In April, an FDA press release announced new draft guidance aimed at “developing plans to enroll more participants from underrepresented racial and ethnic populations in the US into clinical trials.”

“Despite having a disproportionate burden for certain diseases, racial and ethnic minorities are frequently underrepresented in biomedical research,” the FDA stated. “Clinical trials provide a crucial base of evidence for evaluating whether a medical product is safe and effective; therefore, enrollment in clinical trials should reflect the diversity of the population that is ultimately going to use the treatment.”

Disintermediation of Retail Pharmacies

“Walgreens has a significant opportunity to create an interconnected healthcare ecosystem where we can use the physical assets of Walgreens and connect with patients and consumers at a local level to better support healthcare and healthcare equality,” Tandon said in PharmaVoice.

This is the latest example of a billion-dollar retail pharmacy chain diversifying away from simply filling prescriptions. Two types of competitors are driving the disintermediation of retail pharmacies because they end up directing patients away from the pharmacy:

  • Amazon.com acquired PillPack and now sends, via mail, prescriptions to patients’ homes.
  • Pharmacy benefit management (PBM) companies with a business model that encourage patients to get 90 days of prescriptions at once, mailed to their home.

In both cases, retail pharmacies lose access to patients. This is what is motivating several national pharmacy chains to offer primary care within their retail pharmacies (where following an office visit with a general practitioner, the patient simply crosses the store to the pharmacy to fill his/her prescription), as well as the clinical trial matching business.

As retail pharmacy chains become an increasingly disruptive force in healthcare, clinical laboratory managers and pathologists should be preparing new strategies to meet the testing needs of a changing primary care delivery model, which likely will include lab testing being offered in nontraditional medical locations.  

Andrea Downing Peck

Related Information:

Walgreens Launches Clinical Trial Business to Address Industrywide Access and Diversity Challenges and Redefine Patient Experience

Pharmacy Retail Giant Walgreens Looks to Disrupt Clinical Trials Business

By 2027, Walgreens Wants 1,000 Primary Care Clinics

FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials

Walgreens Opens First Clinical Trial Business to Achieve ‘Equitable’ Health Options

With Its Wealth of Patient Data, Walgreens Is Looking to Disrupt the Clinical Trial Space

Kroger Prescription Plans Partners with Myriad Genetics to Offer GeneSight Genetic Tests and Genetic Counseling in Kroger Pharmacies

Clinical laboratories may soon find opportunities to assist retail pharmacists who are doing genetic test counseling, as employers’ support of genetic testing advances

In another market example of acceptance of genetic tests by major employers, a new pilot program is underway by Kroger Prescription Plans that offers GeneSight by Myriad Genetics as a benefit. GeneSight is an LDT, a laboratory-developed pharmacogenomic test, used to treat psychiatric disorders, such as depression.

As part of the agreement with Myriad Genetics, Inc. (NASDAQ:MYGN), pharmacists at more than 2,300 Kroger stores will offer counseling about GeneSight to eligible employees and coordinate the testing with referring healthcare providers, according to a news release.

Clinical laboratory leaders and clinical pathologists will want to observe these early steps by Kroger to offer genetic tests and genetic test counseling in a retail pharmacy setting. If the GeneSight benefit option and in-store pharmacy interventions prove popular, Kroger Prescription Plans may soon offer other genetic tests, as well.

“Depression is a leading cause of disability and lost productivity in the United States, and only 40% of people reach remission after their first antidepressant medication,” Colleen Lindholz (above), President of Kroger Health, told the Cincinnati Business Courier. “We are committed to helping people combat this debilitating disease, and we’re proud to launch this pilot program. This test can help patients escape the frustrating process of trying multiple medications in the hopes of finding one that works.” (Photo copyright: EatingWell.)

Kroger Not the Only Pharmacy to Offer Genetic Tests and Counseling

Headquartered in Cincinnati, Ohio, Kroger (NYSE:KR) is the largest supermarket chain in the US and the country’s fourth-largest employer. Kroger Prescription Plans—a pharmacy benefit manager (PBM)—provides pharmacy management services and clinical programs to employers, including Kroger, in 32 states. But it’s not the only pharmacy company to offer genetic tests and genetic counseling.

Last year Albertsons Companies and Genomind, a personalized medicine platform, launched Genecept Assay (now known as Professional PGx)—a genetic test designed to help doctors make informed treatment decisions for their mental health patients—as well as pharmacy-based genetic counseling at select Albertsons and its subsidiaries, according to Supermarket News.

Participating locations include:

  • 21 Sav-On pharmacies at Albertsons in Boise, Idaho;
  • Five Jewel-Osco pharmacies in the Chicago area; and
  • Two Sav-On pharmacies at Acme supermarkets in the Philadelphia area.

The Albertsons-Genomind partnership is aimed at patients who may be struggling with a medication for depression, anxiety, obsessive-compulsive disorder, or other mental illnesses. Patients can receive counseling from “specially trained pharmacists” who work with referring clinicians to offer [Professional PGx], noted Supermarket News.

Pharmacists as Genetic Test Counselors?

Pathologists and medical laboratory leaders may be intrigued by the concept of putting pharmacists into the role of a genetic test counselor. However, pharmacists may need to increase their knowledge of pharmacogenomics, reported Drug Topics.

“The science advances in the field are just making it more critical that pharmacists have a really strong understanding of how to blend [pharmacogenomics] into their training,” Kathleen Jaeger, National Association of Chain Drug Stores (NACDS) Senior Vice President of Pharmacy Care and Patient Advocacy, told Drug Topics.

However, some see pharmacists as the natural experts in the space. “In my opinions, [pharmacists] should be the people who own pharmacogenetics. It’s a relatively new field, and who better than pharmacists to optimize drug therapy?” Daniel Dowd, PharmD, Vice President of Medical Affairs at Genomind, told Drug Topics.

Pharmacists will need to be proactive in working with companies that provide genetic testing, according to a Managed Health Care Connect Pharmacy Learning Network analysis, which also indicated billing for pharmacists’ informational services would need to be addressed.

“These opinions about this type of role for pharmacists will not be what pathologists want to hear,” stated Robert L. Michel, Editor-In-Chief of The Dark Report, Dark Daily’s sister publication. “Pathologists have had the role of the ‘doctor’s doctor’ for decades. Pathologists are trained in how to recognize disease, how to determine which medical laboratory tests are appropriate for the symptoms displayed by a patient, and how to interpret the results to select the best therapies.

“Additionally, pathologists are trained to understand the technical performance of clinical laboratory tests, such as whether the sample was of acceptable quality to produce a reliable result, whether the analyzer that produced a result was performing within specifications, and what factors should be considered in tandem with the lab test results when making a diagnosis,” he explained. “It is easy to see why the pathology profession would argue that pharmacists lack this depth of knowledge and experience when ordering and interpreting medical laboratory tests. How the pathology profession will respond to these developments involving pharmacists, interpretation of genetic test results, and counseling patients is not yet clear.”

Opportunities for Clinical Laboratories to Assist Pharmacies

This is not the first time Dark Daily has reported on genetic tests becoming popular as a corporate benefit. In “More Companies Pay for Employees to Have Genetic Tests in a Trend That Brings More Lab Test Volume to Medical Laboratories,” we predicted that genetic test coverage by companies would expand and possibly drive new sources of revenue through increased lab test volume.

Additionally, we suggested, clinical laboratory leaders and pathologists could find opportunities helping others understand the results of the genetic tests.

The recent partnerships between genetic test companies and corporate retail pharmacies suggest that clinical laboratories could benefit from reaching out to pharmacists who are now at a point-of-care and who may be looking to improve their knowledge of pharmacogenomics.

—Donna Marie Pocius

Related Information:

Myriad Announces Coverage Decision by Kroger Prescription Plans for GeneSight

GeneSight GUIDED Study Published in the Journal of Psychiatric Research

Myriad Pushing Ahead with Payers on GeneSight as Data from Large Randomized Study is Published

Impact of Pharmacogenomics on Clinical Outcomes in Major Depressive Disorder in the GUIDED Trial: A Large Patient-and-Rater-Blinded, Randomized, Controlled Study

Albertsons Cos Pharmacies Offer Genetic Testing

Pharmacogenomics and the Future of Pharmacy

Consumer Genetic Testing Pharmacogenomics, a Potential Opportunity for Pharmacists

More Companies Pay for Employees to Have Genetic Tests in a Trend that Brings More Test Volume to Medical Laboratories

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