ADHERENCE TO ANTI-COAGULATION THERAPY

THE IMPACT ON THE HEALTH CARE SYSTEM AND AN EFFECTIVE SOLUTION

Introduction
Medication adherence has been a significant issue for the healthcare system and pharmaceutical companies in particular. For several decades now, pharma has been trying to crack the code of getting patients to stay on their medications. You have likely seen a number of adherence programs come and go. They “go” because the either do not work or they do not work well enough to justify the investment. This is one of the “holy grails” of pharmaceutical marketing. You work so hard and invest so many resources in getting healthcare providers to write your products, only to lose a large portion of those scripts and that revenue to non-adherence.

There cannot be a one size fits all approach to adherence. This is where adherence programs have failed in the past. The approaches to improve adherence were the same regardless of the disease state. Patients are looking for individualized approaches to help them manage their disease.

“Medication non-adherence is a complicated problem that at its core is very individualized and requires a sophisticated segmentation solution.”
Paul Snyderman
Chief Research Officer, Health & Pharmaceuticals
Ipsos Healthcare

The National Consumers League (NCL) and their initiative “Scrip Your Future” recognizes that, at a minimum, the approaches to adherence need to be customized to the disease state. The NCL has developed adherence programs that focus on four disease states and the tools are different for each disease state. An area that is not included in “Scrip Your Future” is anti-coagulation therapy. However, given the number of patients on anti-coagulation therapy, the rate of non-adherence to anti- coagulation therapy, and the morbidity and mortality that can be associated with non-adherence to anti-coagulation, there needs to be a set of solutions to address non-adherence to anti-coagulation therapy.
ADHERENCE TO ANTI-COAGULANTS AND ANTI-PLATELETS IS AN ISSUE
For patients that have experienced an acute atherothrombotic event, anti-platelet therapy is the standard of care. This standard is evidence-based from the guidelines that have been published by the American Heart Association (AHA) and American College of Cardiology (ACC). However, in spite of these evidence-based guidelines, “the clinical implementation of the guidelines is suboptimal, in part because of physician and patient nonadherence.” (The Mayo Clinic) Current estimates by Mayo Foundation for Medical Education and Research put the compliance rate at less than 50% of atherothrombotic patients taking antiplatelet therapies as recommended by national guidelines. In addition, a recent study conducted by Medco Health Solutions, Inc. showed that 17% of the patients on Plavix discontinued Plavix by month 4. This non-adherence is an issue since there is a substantial body of evidence that demonstrates that poor adherence with antiplatelet therapy is associated with sub-optimal outcomes.
THE PATIENTS’ PERSPECTIVE: IMPACT ON LIFESTYLE AND OUTCOMES
A barrier to adherence with anti-platelet/anti-coagulation therapy is the patients’ concern about bleeding. Among the patients that discontinued warfarin during the first year of therapy, 81% of these patients cited concerns about bleeding.

There are many reasons for nonadherence, although adverse effects appear to be the main factors that affect patient adherence. With regard to antiplatelet therapy, perhaps the most important adverse event to address is the increased risk of bleeding.
The Mayo Clinic Proceedings

Many times, the bleeding is non-serious, that is nuisance bleeding, which may occur from small cuts or abrasions, but are difficult to stop. Among the patients on Plavix that have experienced bleeding (32.1% of total patients), the vast majority of these bleeding events, over 85%, were categorized as nuisance bleeding. In addition, nuisance bleeding caused 11.1% of patients to discontinue Plavix.

Nuisance bleeding can be difficult for patients to manage with many of them changing their lifestyle by avoiding activities that may result in accidental bleeding because they not have an effective way of stopping the bleeding from a minor cut. [something about gauze] The hassle of this minor or “nuisance” bleeding can trump the benefits of therapy and the risks associated with the discontinuation of the therapy.

“Recently, a case report was published of a patient who developed angina symptoms within 30 days of discharge after stent implantation and who ADMITTED TO STOPPING ANTIPLATELET THERAPY (prasugrel and aspirin) BECAUSE OF REPEATED BLEEDING FROM CUTS INCURRED WHILE SHAVING.”
The Mayo Clinic Proceedings
PHARMA’S PERSPECTIVE: LOSS OF REVENUE
Consider the impact of this non-compliance on both the manufacturer of Plavix and the healthcare system as a whole. Bristol-Myers Squibb reported $2B in sales of Plavix in 2010. With an 83% compliance rate within the first four months of therapy, there could be $400MM of lost revenue every four months. THIS TRANSLATES INTO $1.2B ANNUALLY IN LOST REVENUE DUE TO NON-ADHERENCE. Prior to the patent expiration of Plavix, there were an estimated 4MM patients on Plavix. In addition to these patients, there are an additional 3MM patients on Coumadin and other anti-platelets. If there is a similar non-adherence rate for Coumadin and other anti-platelets, the total annual revenue lost for the pharmaceutical industry is over $2B.

“We are seeing a sizable portion of patients drop off treatment in a fairly short time . . . points to a need and opportunity to provide dedicated and proactive patient support."

Eric Stanck
Vice-President, Research, Medco

The pharmaceutical industry needs to be able to connect with the patients on their medications. Patients are looking to the manufacturers of their medications for product and disease information and for help in managing their condition. Currently the ability for a dialogue to happen between the pharmaceutical industry and patients is limited. There is the ability for patients to connect among themselves, but industry is usually excluded from these conversations.
UNWANTED BLEEDING WHILE ON ANTI-COAGULATION THERAPY IS A CAUSE OF NON-ADHERENCE
A complaint expressed by patients on anti-coagulation therapy is the concern about bleeding. Many times the minor, non-life-threatening bleeding can get in the way of compliance with anti-coagulation therapy. The Mayo Clinic Proceedings stated that “although not life-threatening, this type of bleeding is important because it may lead to non-adherence. A rebound platelet activation effect has been documented after cessation of anti-platelet therapy in a non-adherent patient, putting the patient at increased risk of recurrent ischemic events.”

“There is increasing awareness that even nuisance bleeding complications are enough for some patients to stop therapy, especially since the benefits of antiplatelet therapy may not be readily apparent.”
The Mayo Clinic Proceedings

What if there was a better way to manage this nuisance bleeding? How many more patients would be compliant with their anti-coagulation therapy?

NUISANCE BLEEDING IS MORE THAN A NUISANCE – IT IS A PROBLEM, BUT IT IS A PROBLEM THAT CAN BE MANAGED.

WHAT IF WE COULD IMPACT THE PROBLEM OF NUISANCE BLEEDING
Patient adherence to anti-coagulation therapy is hindered by two factors: 1) the lack of disease and therapy specific information and tools for adherence and 2) the limited ability for the pharmaceutical industry to have interactions with patients on anti-coagulation therapy.

Inspiration Medical Technology, Inc. is developing tools specifically focused at improving adherence to anti-coagulation therapy by focusing on the better management of nuisance bleeding. Inspiration has developed a two-pronged approach to help patients on anti-coagulation therapy stay on their medication and take it as directed by their health care providers. These patients need better tools to manage the nuisance bleeding when it occurs and they need a way to get and share more information on their medication and their condition.

Inspiration Medical Technology has recently received approval for the OTC use of AllaQuix™, a novel topical hemostat wound dressing that is indicated for use in the management of minor topical bleeding wounds such as minor abrasions and minor skin lacerations. AllaQuix™ is a chitosan-based topical wound dressing. Chitosan-based wound dressings have proven to be effective in helping stimulate the body’s own clotting mechanism, even in people on anti-coagulation therapy or with comprised clotting mechanisms. Common gauze and adhesive bandages, such as Band-Aids, often fail patients on anti-coagulation therapy. There are few effective options for these patients to be able to quickly and effectively stop bleeding from minor cuts. AllaQuix™ can be the answer for these patients. Giving these patients on anti-coagulation therapy AllaQuix™ to manage their nuisance bleeding will eliminate one cause of non-adherence to therapy.

In addition to having a physical tool available to manage nuisance bleeding, patients are looking for additional information on their medication and condition. The internet and social media can help foster this dialogue and create an authentic community that is dedicated to helping people live better while on anti-coagulation therapy. Many patients leave the hospital or clinic on anti-coagulation therapy without having all that they need to know about their therapy. Pharmaceutical manufacturers, who have helpful information and tools for these patients, are hampered in their ability to directly reach and interact with these patients. Inspiration Medical Technology has started www.nuisancebleeding.com and @nuisancebleeding on Twitter to help foster the communication with these patients and among the patients. These tools can be used to facilitate communication among the patients, providers, and manufacturers.
THERE ARE ACTIONS YOU CAN TAKE NOW TO CHANGE THE IMPACT ON NUISANCE BLEEDING ON ANTI-COAGULATION THERAPY ADHERENCE
Non-adherence to anti-coagulation therapy is having a negative effect on your bottom-line. There are low-cost, high-return actions that you can take right now to reverse that situation.

PROVIDE ALLAQUIX™ TO THE PATIENTS ON [BLOOD THINNER].
A low-cost investment from you can get AllaQuix™ into the hands of the patients on [BLOOD THINNER] for a one-time free trial for the patients. Giving your patients on [BLOOD THINNER] a sample of AllaQuix™ and information on ordering additional quantities, will give them an effective way to manage their nuisance bleeding which may lead to better adherence to [BLOOD THINNER].

BECOME A SUPPORTER OF WWW.NUISANCEBLEEDING.COM.
Through becoming a supporter of nuisancebleeding.com, you have the opportunity to provide content to be featured on the website, as well as access to the Twitter account to disseminate information or ask questions. These channels will allow you to help patients manage their anti-coagulation therapy and give you further insights into the patients that are taking [BLOOD THINNER].
MEDICATION ADHERENCE TO ANTI-COAGULATION THERAPY IS A SIGNIFICANT ISSUE.
It is having substantial impact on patient outcomes and satisfaction, while causing excess costs within the health care system. In addition, there is likely a negative effect on the revenues of [BLOOD THINNER]. So many resources, money and time, are invested in gaining that initial prescription for [BLOOD THINNER]. Do not let those patients and prescriptions slip away due to non-adherence.

CONTACT:
Stephen Miller
Inspiration Medical Technology, Inc.
sm@inspirationmedtech.com
(651) 262-9937
ABOUT INSPIRATION MEDICAL TECHNOLOGY, INC.
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