Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

For patients following Total Joint Arthroplasty (TJA), what are the comparative risks and benefits, of postoperative Xarelto versus Lovenox?

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

Lovenox versus Xarelto for the prevention of postoperative venous thromboembolism (VTE)

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

The patient population for this proposal includes all postoperative TJA patients, all age ranges, both female and male, and any coexisting diagnoses / co-morbidities.

One exception to this proposal is the possible exclusion of patients who are currently on a medication regimen, including but not limited to, Plavix, Pradaxa and Coumadin, as they may pose a higher risk for postoperative bleeding.

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

No

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

The research we are proposing would develop and review the health-related benefits of Xarelto versus Lovenox, specifically matching, or superseding, the efficacy and safety of the drugs, as well as proving the extra convenience of no interactions and reduced need for monitoring.

In addition to the clinical efficacy, we will also be investigating and analyzing the cost-benefit of Xarelto versus Lovenox.

And a final benefit will be the patient satisfaction, and improved compliance, with Xarelto as an oral medication versus Lovenox as an injectable (sub-q) medication.

Describe any health-related risks, side effects, or harms that you are concerned about.

With regard to the Xarelto drug, there is concern about the possibility of postoperative infection, excessive wound drainage, hemarthrosis, return

to surgery and readmission of the postoperative TJA patient.

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Arthritis and nontraumatic joint disorders

AHRQ Priority Populations

• Low income groups
• Minority groups
• Women
• Elderly
• Individuals with special health care needs, including individuals with disabilities or who need chronic care or end-of-life health care

Federal Health Care Program

• Medicaid
• Medicare
• Other

Importance

Describe why this topic is important.

The comparative research between Xarelto and Lovenox is extremely important in order to improve the delivery and cost-effectiveness of medicine with the upcoming bundled payment model and healthcare reform.

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

At both the Banner CORE Center for Orthopedics, a co-management model between The CORE Institute and Banner Health, we are always looking for increased quality improvement, more cost efficient and safe medicationdelivery for our patients.

Due to our annual volume of TJA patients, if Xarelto proves to be a superior drug over Lovenox, then the savings from not only a cost perspective, but from a quality improvement perspective (decreased infection, bleeding, re-operation and readmission rates) will prove the comparative benefit.

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

The comparative question posed regarding Xarelto and Lovenox may cause uncertainly amongst some of the surgeons due to a potential variation in clinical care and evidence-based practice with the administration of Xarelto. However, evidence-based literature, as well as education to the medical

center and surgeons, will be completed in order to alleviate any concern or uncertainty.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

The findings from the research question will answer if Xarelto is safer, superior and more cost effective, thus providing comparative benefit over

Lovenox. If the findings are indeed positive, than work may initiate to convert from current DVT prescribing of Lovenox to Xarelto.

Describe the timeframe in which an answer to your question is needed.

3 months

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

Not applicable.

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

The findings from the research question will answer if Xarelto is safer, superior and more cost effective, thus providing comparative benefit over

Lovenox. If the findings are indeed positive, than work may initiate to convert from current DVT prescribing of Lovenox to Xarelto.

Are you making a suggestion as an individual or on behalf of an organization?

Organization

Please tell us how you heard about the Effective Health Care Program

We were apprised of the Effective Health Care Program, Comparative Effectiveness Grant, through work we prepared as part of a CMS Innovation Grant.