April 19, 2021
BUSINES WIRE: My Vaccine Program (MVP) Combines Best-of-Breed Technologies to Address Consumer Engagement, Vaccine Hesitancy and Safety Surveillance Related to COVID-19
As COVID vaccine safety-related issues escalate, stakeholders implement digital strategies to communicate to leery consumers the risks/benefits of vaccination.
Thrifty White Takes the Lead in Re-Launching the Personalized-Medication Adherence and Persistence Program (P-MAPP) The P-MAPP, supported by MediMergent, FDA and multiple healthcare stakeholders, partner with pharmacists to improve outcomes for patients with Type 2 Diabetes
Plymouth, Minnesota –Robert Narveson, Chairman, President/CEO of Thrifty White Pharmacy addressed the P-MAPP Consortium Advisory Board regarding the role of his pharmacies in the P-MAPP.” Our business model aligns with the P-MAPP; listening to the Voice of the Patient and bringing the pharmacist out from behind the counter and engaging with patients. We are thrilled to be part of this program and demonstrate what pharmacists can do not only to impact improvement in health outcomes but to participate in broader research endeavors. As we reactivate patient enrollment, the realities of COVID-19 require that we conduct our Motivational Interviews remotely using video/audio conferencing. We are still engaging with patients and helping them to identify options for healthier outcomes.” Read More
The P-MAPP combines patient engagement, digital technologies and predictive analytics to define personalized strategies to improve medication adherence and persistence in patients with Type 2 diabetes. It is the first all pharmacy-based program supported by representatives from multiple stakeholder groups including regulators, prescribers, pharmacists, pharmaceutical companies, health insurers, professional organizations, medical device companies and academia. Thrifty White Pharmacy, the first pharmacy chain to launch the P-MAPP, kicks off reactivating patient enrollment following the COVID-19 lock-down.
Using the MediMergent digital platform, the P-MAPP collects data from real-world sources including patient-reported experience surveys, medical records, pharmacy fill/refill data, claims, and wearable devices. Based on a well-established behavioral model that identifies barriers to medication adherence, app-based surveys are completed by patients. Data are transferred, near-real time, to the enrolling pharmacists who schedule private counseling sessions with their patients to review the data and generate strategies to address drivers of non-adherence. Patients are followed for 12-months.
Norman Stockbridge, MD, PhD, Director, Division of Cardiology and Nephrology, FDA Center for Drug Evaluation and Research stated “reaching out to patients in multifaceted ways is even more critical today under the global COVID-19 pandemic than when the program launched in 2019. Patients are in critical need of outreach by healthcare providers, especially prescribers and pharmacists, to ensure that they are receiving appropriate medical attention and are following their medical regimens. The P-MAPP provides a structured pathway for such engagement.”
Greg Simon, President of MediMergent said “we talk about the patient being the most underutilized resource in healthcare yet we are organized to get information about the patient without focusing on getting information with the patient. The P-MAPP leverages the strengths of pharmacists to engage directly with patients, identify individual drivers of nonadherence behaviors and together generate personalized strategies to improve adherence and ultimately, health outcomes”.
About Thrifty White
Headquartered in Plymouth, MN, Thrifty White Pharmacy is a technology enabled healthcare services company focused on utilizing patient engagement to improve outcomes and reduce the cost of care. By leveraging the unique capabilities of pharmacists, combined with focused technology and clinical care plans, the company creates better patient experiences and improved patient outcomes. Thrifty White Pharmacy has been recognized by multiple organizations as a leading “Pharmacy Innovator” for its efforts to continually move the practice of pharmacy forward.
MediMergent LLC, The Real-World Evidence Company, utilizes digital technologies and patient engagement to collect and analyze Real-World Data. MediMergent’s digital platform provides an app-based, comprehensive remote monitoring system for data collection and analysis in support of large-scale clinical research programs. MediMergent is actively developing proprietary algorithms that enables adjudication of discrepancies that reside across multiple, siloed, often unreliable sources of Real-World Data.
Local Business Owner Sandra S. Garrett, Ph.D. of MediMergent, LLC Named to NSBA Leadership Council
Rockville, MD – Sandra S. Garrett, Ph.D. CEO of MediMergent, LLC, was recently named to the National Small Business Association (NSBA) Leadership Council. NSBA is the nation’s oldest small-business advocacy organization, and operates on a staunchly nonpartisan basis. Garrett, a recognized leader in the small-business community, joins the NSBA Leadership Council alongside other small-business advocates from across the country as they work to promote the interests of small business to policymakers in Washington, D.C. Read More
“As a small-business owner, I see daily the importance of being involved and active when it comes to laws and regulations,” stated Garrett. “Joining NSBA’s Leadership Council will enable me to take our collective small-business message to the people that need to hear it most: Congress.”
Garrett joined the NSBA Leadership Council as part of her efforts to tackle the many critical issues facing small business, including tax reform, regulatory restraint, health care costs and how the Affordable Care Act will impact small business. The NSBA Leadership Council is focused on providing valuable networking between small-business advocates from across the country while ensuring small business a seat at the table as Congress and regulators take up key small-business proposals.
“I am proud to have Dr. Sandra Garrett as part of our Leadership Council,” stated NSBA President and CEO Todd McCracken. “She came to us highly recommended and I look forward our coordinated efforts for years to come.”
Please click here to learn more about MediMergent, LLC (www.medimergent.com).
For more on the NSBA Leadership Council, please visit www.nsba.biz MediMergent, LLC is a data collection, integration and analytics company that utilizes its proprietary platform to implement customized, patient centric, real-world evidence projects for health care companies to support their commercial interests and regulators to better understand real-world patient safety and medication effectiveness.
MediMergent and FDA Launch New Stakeholder Initiative Against Medication Non-Adherence/Persistence Crisis
Rockville, MD – Healthcare data collection and analytics company MediMergent, LLC and the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) recently convened an Advisory Board to address strategies to combat the public health crisis related to medication non-adherence and persistence. Read More
· There are approximately 117 million Americans who have chronic diseases requiring lifelong medications; the non-adherence rate to their medicine by six months post initiation of therapy is approximately 50%. This results in approximately 125,000 deaths/year, nearly twice as high as the death rate due to opioid overdoses.
· Poor medication adherence/persistence results in up to $300 billion per year of added healthcare costs, a wastage of approximately 10% of the total annual healthcare budget.
Attendees to the Advisory Board meeting included healthcare stakeholders from FDA, biopharma companies, prescribers, pharmacies, insurers, health plans, data analytics companies and academia. The agenda focused on alignment of stakeholder incentives and implementation plans for sustainable strategies to improve medication non-adherence and persistence. The Advisory Board will provide oversight to program design, including delineation of outcome measures. Programs will enroll patients at pharmacies, infusion centers and physicians’ offices, including patients with Type II diabetes, cardiovascular disease, and cancer.
This new initiative to fight the medication non-adherence/persistence crisis represents the first effort for the FDA to engage with multiple stakeholders focused on a public health issue unrelated to regulatory approval or post-approval surveillance of a specific medication. It is developed through a five-year Research Collaboration Agreement (RCA) between MediMergent and CDER to deploy data collection and analytic tools for real-world evidence using MediMergent’s proprietary platform, the National Medication Safety Outcomes and Adherence Program (NMSOAP).
Norman Stockbridge, MD, PhD, Director, Division of Cardiovascular and Renal Products, CDER, FDA stated, “The lack of medication adherence and persistence is a public health crisis that should be remediable. It is a problem that affects drugs that are prescribed for major morbidity and mortality indications, like atrial fibrillation, with many patients discontinuing their anticoagulant therapy within
6 months from the initiation of dosing. The goal of this Advisory Board is to focus on methodologies that can impact patients’ behaviors to ensure positive outcomes.”
Fred Senatore MD, PhD, FACC, Medical Officer, Division of Cardiovascular and Renal Products, CDER, FDA, stated: “Issues leading to medication non-adherence are embedded in every hierarchical level of the ecological healthcare model. Making a difference must involve a collaboration of key stakeholders. Strategies to engage and incentivize patients have been shown to improve medication adherence and decrease the incidence of major adverse cardiovascular events. It is vital that we promote patient engagement and incentivize patients and other key stakeholders to effectively improve medication adherence.”
Robert Temple MD, Deputy Center Director for Clinical Science, CDER, FDA, noted that, “This Advisory Board represents a unique opportunity to explore methods of improving medication adherence and persistence with life-saving treatments of largely asymptomatic conditions, such as hypertension and/or hyperlipidemia, where a majority of patients across all ages and demographics stop therapy within a year or so. There is no more pressing medical problem facing the healthcare system.”
About the NMSOAP
The NMSOAP combines Patient Reported Outcome (PRO) instruments with medical records, prescription and claims data. These data determine longitudinal risk-related profiles on disease management and treatment, medication non-adherence/persistence, patient safety, clinical outcomes, drug effectiveness, REMs, and comparative effectiveness. The NMSOAP serves as an early warning surveillance tool for patients at risk of important adverse events.
About MediMergent LLC
MediMergent is a data collection and analytics company that utilizes its NMSOAP platform to implement customized, patient centric, real-world evidence projects for health care companies to support their commercial interests and regulators to better understand real world patient safety and medication effectiveness.
MediMergent and the FDA Sign Five Year Collaboration Agreement to Continue Collection of Patient-Centric Real World Evidence
Rockville, MD – Healthcare data integration and analytics company MediMergent LLC (The Company) and the Center for Drug evaluation Research (CDER) of the U.S. Food and Drug administration (FDA) have signed a five-year Research Collaboration Agreement (RCA) to continue the development of data collection and analytic tools for real-world evidence (RWE) using the Company’s proprietary platform, the National Medication Safety Outcomes and Adherence Program (NMSOAP). Read More
The NMSOAP, established under the Company’s initial RCA with CDER, completed a 10,000 patient proof-of-concept evaluation of patients treated with novel oral anticoagulants or standard of care for the prevention of atrial fibrillation (AF) related stroke, deep venous thromboembolism, or pulmonary embolism. The NMSOAP combines Patient Reported Outcomes (PRO) collected in the voice-of-the-patient with physicians’ medical records, medication prescription data from pharmacies, and health insurance claims data. The NMSOAP determines longitudinal risk-related profiles on disease management and treatment, medication adherence, patient safety, clinical outcomes, drug effectiveness, REMs, and comparative effectiveness.
Kenneth Borow, MD, President and Chief Medical Officer of MediMergent stated, “The renewal of our RCA continues our commitment to the FDA to bring cutting edge technology and analytics to the post-approval process. Our integrated patient centric approach analyzes data produced from all stakeholders who influence the patient’s health care journey and broadens the definition of RWE beyond a limited focus on claims data. New legislation (PDUFA VI and the 21st Century Cures Act) requires the use of RWE in the drug approval and commercialization process. MediMergent’s NMSOAP platform is well positioned to help biopharma and payers meet these requirements by creating an ecosystem that empowers patients to become more integrated members of their health care team. This includes efforts to enhance medication adherence/persistence, provide information that could identify early warning signs of potential adverse events, and open communication pathways among patients, caregivers, providers, pharmacists and health insurers.”
About the NMSOAP
The NMSOAP generates near real-time real-world evidence directly from patients who enroll through an efficient-point of-care approach that includes pharmacies, infusion centers or physician offices. The NMSOAP’s proprietary analytics uses cognitive intelligence to enable data sources to be adjudicated for discrepancies and to ascertain the “truth.” MediMergent prospectively enables biopharma and payer sponsored projects to efficiently translate real world data into patient centric real-world evidence.
MediMergent Presents Preliminary Results to FDA from its NMSOAP Evaluation of NOACs vs. Warfarin
Rockville, MD – Healthcare data integration and analytics company MediMergent LLC has developed a new data collection platform called the National Medication Safety Outcomes and Adherence Program (NMSOAP), that combines Patient Reported Outcomes (PRO) collected in the voice-of-the-patient with physician/provider medical records and prescription data from network pharmacies. Read More
The NMSOAP determines longitudinal risk-related profiles on disease management and treatment, medication adherence and persistence, patient safety, clinical outcomes, drug effectiveness, REMs, and comparative effectiveness. On August 5, 2016 the Company presented to senior members of the Center for Drug Evaluation Research (CDER) of the U.S. Food and Drug Administration (FDA), favorable preliminary results from its first real world evaluation using its NMSOAP technology. This NMSOAP evaluation collects data from patients treated with one of four FDA-approved novel oral anticoagulants [Xarelto® (rivaroxaban), Pradaxa® (dabigatran), Eliquis® (apixaban) or Savaysa (edoxaban)] or standard of care Coumadin® (warfarin and generics] for the prevention of atrial fibrillation (AF) related stroke, deep venous thromboembolism, pulmonary embolism, or other physician prescribed uses of oral anticoagulants.
According to Norman Stockbridge, M.D., Ph.D., Director, Division of Cardiovascular and Renal Products for CDER, “The FDA is hopeful that the NMSOAP approach to patient-directed healthcare data will build upon the information it already has from existing systems while helping to leverage near real-time real world evidence to inform FDA decision making”.
Preliminary NMSOAP data on the use of NOACs versus Warfarin has been acquired in the U.S. across 35 states from 6,174 patients who were taking oral anticoagulants for either on-label or off-label indications. Of these patients, 3,851 were being treated for stroke prevention associated with atrial fibrillation.
· For AF patients, NMSOAP baseline demographic and outcomes data were compared to data presented in a meta-analysis published by Ruff et. al.1that included 71,683 participants enrolled in one of four novel oral anticoagulant trials (RE-LY, ROCKET AF, ARISTOTLE, and ENGAGE AF-TIMI 48). The NMSOAP baseline data were similar to the meta-analysis data for age (including % age >75 yrs), gender, BMI, renal function, diagnosis of diabetes, and the use of aspirin.
· Vital status was confirmed in 94.2% of the 1,445 NMSOAP patients eligible for the 6-month PRO follow-up survey.
· Compared to the analysis of Ruff et. al., the NMSOAP novel oral anticoagulant-warfarin relative risk data reflected similar trends for all-cause mortality (RR = 1.0+0.1), ischemic cerebrovascular accidents (strokes) or systemic embolic events (RR <0.81 in favor of novel oral anticoagulants), and gastrointestinal bleeding (RR >1.25 in favor of warfarin).
“Novel oral anticoagulants have been quite well-characterized with regard to their safety and efficacy profile for the prevention of atrial fibrillation-related strokes,” Dr. Stockbridge continued. “Most of the data are the result of phase 3 clinical trials enriched for patients at high risk of atrial fibrillation related complications. The NMSOAP approach appears to be an important opportunity to explore whether data acquired in the real world, using a more patient-centric approach, that is integrated with medical records and pharmacy data can provide additional information to the already existing knowledge base relating to novel oral anticoagulants and other drugs of interest.”
The NMSOAP program improves post-marketing tracking of safety; evaluates evolving patterns of real-world medication adherence and persistence; pilots electronic health record-based study enrollment and data collection, and; assesses the effectiveness of post-approval risk mitigation strategies. The initial real world, post-marketing data collected in the NMSOAP novel oral anticoagulant-warfarin valuation demonstrates that:
· NMSOAP can recruit and retain patients and collect longitudinal data related to safety, outcomes, drug adherence and comparative effectiveness.
· The NMSOAP methodology can collect real world outcomes data consistent with published data from a meta-analysis of four large pivotal phase 3 clinical trials for stroke prevention in patients with atrial fibrillation.
· The three NMSOAP data sources [PROs, medical records and pharmacy data] are complementary and can serve as a foundation for cross-validation.
· The NMSOAP platform can create mutual incentives among providers, pharmacists and patients that support patient retention.”
Kenneth Borow, MD, President and Chief Medical Officer
of MediMergent stated, “It is imperative that the patient be brought more intimately into a partnership role in his/her own disease management. An important observation from the NMSOAP novel oral anticoagulant-warfarin evaluation was that the PRO data provided real-world, contemporaneous drug adherence and potential clinical outcomes information that is often unknown to the prescribing physician. Also observed was that the pharmacist and the pharmacy database served as important confirmatory data sources for resolution of discrepancies between the PROs and the patients’ medical records.”
About the NMSOAP
Established under a Research Collaboration Agreement with CDER, the NMSOAP is a partnership among patients, providers, pharmacists, payers, biopharma companies and regulators designed to collect near real-time real data directly from patients. NMSOAP enrolls patients primarily through pharmacies. As a part of the NMSOAP, the American Pharmacists Association (APhA) has developed
a national training program for pharmacists and their staff to aid in
collecting PRO data into the NMSOAP database. National retailer Kroger Co., the lead pharmacy chain for the NOAC-warfarin study, has leveraged its network of over 7,000 pharmacists in over 2,000 pharmacies nationwide to enroll patients into NMSOAP. Additional pharmacy partners include SuperValu, The Medicine Shoppe, and Cardinal Health.
1. Ruff CT, et. al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomized trials. Lancet 2014; 383: 955–962