The U.S. anticoagulant market is on the verge of a major shift in clinical practice. It is transitioning from a market dominated by a single injectable anticoagulant to a highly competitive one dominated by first-in-class novel oral anticoagulants.

Companies are vying with each other to introduce novel therapies that offer superior safety, efficacy and convenience to patients and physicians. This is a medical need that has been unmet for decades. New analysis from Frost and Sullivan’s Analysis of the Anticoagulant Market research finds that the market earned revenues of $4.7 billion in 2010 and expects it to reach $11.8 billion in 2016.

“Studies reveal that there are currently 2.7 million patients in the United States with atrial fibrillation (AF); however, this may be an underestimation as the actual figure could be as high as 4.0 million,” said Frost & Sullivan Senior Industry Analyst Deborah Toscano.

“Lifelong anticoagulant therapy is critical for stroke prevention in these patients, resulting in substantial commercial opportunities.”

Warfarin, the long-established gold standard therapy for stroke prevention in AF, carries many significant inherent risks such as bleeding, leaving a very narrow therapeutic window. The market experienced a robust growth period following the launch of Pradaxa (dabigatran), an oral direct thrombin inhibitor (DTI), in late 2010 and Xarelto (rivaroxaban), an oral factor Xa inhibitor, in 2011.

A second growth period is expected upon the anticipated launch of Eliquis (apixaban), an oral factor Xa inhibitor, in mid-2012. Edoxaban, an oral factor Xa inhibitor, is also in the pipeline. These agents are poised to dominate the market for stroke prevention in AF, a very large and partially untapped market.

They are also likely to grab substantial market share from the parenteral anticoagulants for prophylaxis of venous thromboembolism in orthopedic joint replacement surgery.

With the approval of Pradaxa and Xarelto and the imminent approval of their successors, the bar has been significantly raised for the anticoagulant market. Superiority to warfarin is paramount for new drug approval and market uptake. Patient and clinician acceptance will depend on strong data showing improvements in efficacy and lower risk of bleeding.

There is a fine line between the prevention of thrombosis and uncontrollable bleeding. Most often, bleeding issues or other safety concerns may not arise until late-stage clinical trials, or only in certain patient populations, after significant investments in drug development have been made.

In addition, bleeding issues or other safety concerns may surface in the future, particularly if the bleeding risk of the real-world population differs from that studied in clinical trials, leading to black-box warnings or market withdrawal. One of the shortcomings of oral anticoagulants is the lack of a strategy for reversal in case of emergency or uncontrolled bleeding.

“The oral anticoagulants are ideal for chronic therapy with their easy administration,” said Toscano. “However, the ability to quickly reverse the anticoagulant action in the event of an emergency is a critical, unmet need.”
Newcomers to the market that can address this issue will resolve the key shortfall of chronic anticoagulation therapy. Their drugs are likely to see rapid adoption into clinical practice.

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MinuteClinic, the retail health care division of CVS Caremark, and HCA’s TriStar Health, the largest and most comprehensive health system in Middle Tennessee, have entered into a clinical affiliation to enhance access to high quality, affordable health care services in the Nashville metropolitan area.

MinuteClinic has 14 walk-in medical clinics open seven days a week inside select CVS/pharmacy stores in Middle Tennessee. The agreement includes any current or future locations in Nashville and ten surrounding counties: Cheatham, Dickson, Hickman, Maury, Montgomery, Robertson, Rutherford, Sumner, Williamson and Wilson. The clinics are staffed by nurse practitioners who provide treatment for common family illnesses and administer wellness and prevention services, including health condition monitoring.

“MinuteClinic joins TriStar Health in its commitment to provide the highest quality medical care to the people of Middle Tennessee with a focus on reducing costs and increasing accessibility to health care services,” said Andrew Sussman, M.D., President, MinuteClinic and Senior Vice President/Associate Chief Medical Officer, CVS Caremark.

“In addition, TriStar has been at the forefront of electronic medical record technology. We look forward to working with them to integrate our systems and develop collaborative programs that improve patient outcomes and help people on their path to better health.” TriStar Health in Middle Tennessee includes 11 hospitals and two ambulatory surgery centers supported by about 2,800 physicians.

“We are excited about the opportunity to collaborate with MinuteClinic and enhance the overall continuity of care for patients in the communities we serve,” said Steve Corbeil, president of TriStar Health.

“This expanded clinical coordination is a natural partnership because their model to provide basic primary care at the time of day and at locations that are convenient for each patient goes hand in hand with TriStar’s mission to provide quality, cost effective healthcare services close to where our patients live and work.”

Under the agreement, TriStar Health physicians will serve as medical directors for MinuteClinic locations in Middle Tennessee.  In addition, MinuteClinic and TriStar Health will collaborate on patient education and disease management initiatives and will inform patients of the services each offers.

TriStar Health will accept patients who need a level of care that is not provided at MinuteClinic. Signage at MinuteClinic locations will inform patients that each site has a clinical affiliation with TriStar Health.

MinuteClinic and TriStar Health will begin to work toward fully integrating their electronic medical record systems to streamline communication around all aspects of each individual’s care.  With patient permission, MinuteClinic will electronically share medical histories and visit summaries with other TriStar Health locations in Middle Tennessee.

In the meantime, MinuteClinic will continue its standard practice of sending patient visit summaries to primary care providers via fax or mail, typically within 24 hours. MinuteClinic practitioners specialize in family health care and can diagnose, treat and write prescriptions for common family illnesses such as strep throat and ear, eye, sinus, bladder and bronchial infections.

Minor wounds, abrasions and joint sprains are treated, and common vaccinations such as influenza, tetanus, pneumonia, pertussis and Hepatitis A & B are available at most locations. Walk-in camp, sports and college physicals for adolescents are available daily. In addition, MinuteClinic administers a series of wellness services designed to help consumers identify lifestyle changes needed to improve their current and future health, including screenings and monitoring for diabetes, high blood pressure and high cholesterol.

No appointments are required at MinuteClinic and most health insurance is accepted. Most clinics in Middle Tennessee are open Monday – Friday, 8:00 a.m. to 7:00 p.m.; Saturday, 9 a.m. to 5:30 p.m. and Sunday, 10 a.m. to 5:30 p.m.

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Pointing to a study he delivered at a recent (Congressional Health Care Caucus), Phil Lebherz, Founder and Executive Director of the Foundation for Health Coverage Education (FHCE), has called upon Congress and the Obama administration to make 2012 a watershed year for adopting a “Point-of-Care” approach with Medicaid’s administrative program in an effort to save as much as $56 billion in administrative costs.

The costs being targeted are derived from complicated and duplicative steps that keep government administrative costs high and prevent qualified Medicaid recipients from seeking needed care.  Delayed treatment often results in higher overall costs, as patients are treated in hospital emergency rooms with higher incidence of requiring surgery and expensive intensive care services.

“If we continue to run government’s biggest program – Medicaid utilizing the program with 1980s technology, we will be out of money before we reach 2014,” said Lebherz.

In his testimony before the Congressional forum, Lebherz laid out the reasoning behind changing Medicaid from a complicated enrollment system to a “point-of-care” program by describing the current holes. The proposed (Point-of-Care Eligibility) system would target a large segment of the population who are eligible for Medicaid, yet are not enrolled, and access their care in hospitals’ Emergency Rooms. With these patients, the hospital is often left with unpaid bills that should be turned into Medicaid or another liable public entity.

The solution of moving to a Point-of-Care concept was created following (Onsite Study) conducted at four Emergency Rooms in San Diego, California in 2011. Over a period of a year, Sharp Healthcare asked 20,000 uninsured patients FHCE’s Eligibility Quiz, and 80.2% were found eligible for free or low-cost public health coverage.

A previous analysis of Medicaid numbers, detailed in this 2011 (Health Affairs article), demonstrates that a “point-of-care” system could solve the uninsured problem for an estimated 17 million Americans and trim billions of dollars from the government budget.

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One in three dollars spent on health care in Florida currently pays for unnecessary tests and treatments that physicians order to keep from being sued, according to a new Florida physician poll released by Patients for Fair Compensation. This spending equates to more than $40 billion dollars each year.

The poll, conducted by Oppenheim Research on behalf of Patients for Fair Compensation, showed that of physicians surveyed statewide, 88 percent said they practiced some form of “defensive medicine” in the past 12 months to protect themselves from frivolous lawsuits.

That means patients are paying more so doctors don’t get sued. ”Doctors order unnecessary medical care because they are in fear that one mistake could wipe out everything they’ve ever worked for,” said Richard L. Jackson, chairman of Patients for Fair Compensation, a new not-for-profit advocacy group.

Oppenheim Research, under the direction of Jay Rayburn, Ph.D., Florida State University School of Communications, conducted the statewide survey across a variety of physicians. Those doctors reported that 33 percent of overall healthcare costs can be attributed to the practice of defensive medicine.

According to 2009 data released by the Centers for Medicare and Medicaid Services, healthcare in Floridanow costs $132 billion annually. Based on its poll, Patients for Fair Compensation officials, estimate that more than $40 billion of Florida’s annual health care dollars are spent on unnecessary tests and treatments.

“That kind of money could certainly help pay for the healthcare of many uninsured Americans,” Jackson added. “If we eliminate defensive medicine, we can make healthcare more affordable for everyone.” In Florida’s current medical liability system, physicians risk personal financial exposure with every decision they make. They also abhor the litigation process. These factors force physicians to eliminate every potential threat of litigation, resulting in defensive medicine.

Patients for Fair Compensation was founded to educate and propose policy solutions that eliminate the incentives to practice defensive medicine by replacing the current medical liability system. For more information about Patients for Fair Compensation and the Patients’ Compensation System, visit www.patientsforfaircompensation.org.

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