Optimizing Oral Anticoagulation in Managed Care

After their presentations at the 2004 World Stroke Congress in Vancouver, BC,

J. Jaime Caro, MDCM, FRCPC, FACP, and Gregory W. Albers, MD, joined a

discussion arranged by

and moderated

by Kenneth Schaecher, MD, Medical Director of Utilization Management at Intermountain

Healthcare in West Valley City, Utah.

The American Journal of Managed Care

The Role of Ximelagatran

Dr Schaecher:

We've now discussed theeconomics of stroke prevention and theeffectiveness of ximelagatran versus warfarinseparately. Let's see if we can combinethese 2 topics by looking into the future topredict how ximelagatran will fit into thecost structures for atrial fibrillation [AF]-related stroke. Dr Caro, how do you thinkthe availability of a drug like ximelagatranwould impact your Medicare cost model?

Dr Caro:

It clearly would depend on theprice of the drug and on how much monitoringfor liver function needs to be done.Depending on those 2 things, this drug couldmake the substantial cost savings projectedin the model's "what if"optimization analysesa reality.

Dr Albers:

I agree. Obviously, drug cost isa key component to figuring out how muchyou are going to actually save.

Dr Schaecher:

If ximelagatran is eventuallyapproved for use in AF patients forstroke prevention, do you think the overallpercentage of AF patients receiving optimalanticoagulation will go up?

Dr Albers:

That was the hope from thebeginning, because our current effectivetreatment is so significantly underutilized.With an easier-to-use medication, a largenumber of patients currently receivingaspirin, and even some not receiving therapyfor stroke prevention, would be able toswitch over to ximelagatran. And then manyother patients who have been taking warfarinfor years are very excited about the factof not having to have a blood test everymonth and are looking forward to the opportunityto have a noncoagulation-monitoreddrug on the market.

Dr Schaecher:

Who would get ximelagatran?

Dr Albers:

We've been studying the drugat Stanford for several years in the SPORTIFV trial and we have many patients who havehad a stroke or have AF. And, as I just mentioned,they are excited about the opportunityof switching to a drug which is not goingto send them to the laboratory every monthand make them worry every time they get anew prescription, take an antibiotic, or goon a trip where their diet changes. Some ofour patients don't mind warfarin and don'tmind getting those monthly blood tests, butfrom my experience, that's a minority. Sofrom my perspective, depending on the cost,I think there will be a substantial number ofpatients who are currently taking warfarinwho are going to choose it, and then I thinkthat most new high-risk patients with AFwould probably also choose to go on to thenew agent rather than warfarin.

Dr Schaecher:

So it sounds like a combinationof switchovers from warfarin as wellas new-to-anticoagulation patients.

Dr Albers:

Yes. In particular, those whohave had a very difficult time remaining inthe therapeutic range taking warfarin willlikely switch. Some physicians and patientsare wary of all new drugs, and some of thesephysicians typically advise when a newdrug comes out to wait 1 year or more tosee what happens. Some people will haveconcerns about the liver function testingand they'll want to see more data from thephase 4 experience. But in addition tothese wait-and-see physicians, there will bea number of physicians who are quite anxiousto be able to do away with the INR[international normalized ratio] monitoring.

Dr Caro:

The tiers and copays will alsoaffect which patients use ximelagatran first.If the copays are high, doctors and patientswill adjust and you'll see more use amongpeople who are really having problems andless uptake in new patients. If tiers andcopays are lower, you'll see a more rapidswitch over to the new drug plus fasteruptake into new patients.

Dr Schaecher:

How does the pace ofthese switchovers and new patients affectthe economic model that was created to predictthe cost effectiveness of anticoagulationoptimization?

Dr Caro:

The rate of uptake does make adifference in the model's results. We'velooked at different rates at which peoplewould convert to more optimized care inboth the treated and untreated populationsover time, and obviously you capture differentamounts of the benefit depending onhow quickly people uptake.

Dr Schaecher:

Would the reduction inbleeding side effects associated with ximelagatran,as seen in SPORTIF, have any majorimpact on total stroke management cost?

Dr Caro:

Probably not, because most ofthe minor bleeds don't generate muchresources. Cost becomes significant whenyou're talking about major gastrointestinal[GI] bleeding, retroperitoneal bleeding,intracranial hemorrhage, that sort of thing.The indirect consequences of minor bleedingmay actually have some impact, however,because it's so bothersome and scary forpatients and doctors, and often leads tochanges in management.

Dr Schaecher:

How might the necessityfor the measurement of liver ALT [alanineaminotransferase] for 6 months and renalfunction at least once with ximelagatrantherapy affect the total cost estimates?

Dr Caro:

It will have an impact. Even ifunit costs are low, if everybody needs to doit, the total cost becomes significant.However, in the "what if"analysis using a $4per day price for ximelagatran discussed earlier,these monitoring tests had already beenincorporated. So, the projected half billionin savings with a switch of 50% of warfarin-treatedpatients to ximelagatran is based onthe assumption of monthly liver functionsdone on every patient taking ximelagatranfor 1 year.

Ischemic vs Hemorrhagic Stroke

Dr Schaecher:

Dr Albers, what is yoursense of the average per-patient costs forischemic stroke versus anticoagulant-relatedintracranial hemorrhage versus anticoagulant-related GI bleed?

Dr Albers:

The costs vary from institutionto institution, but there's no questionthat the brain hemorrhage costs are higher,with patients having longer lengths of stay,more complications, and higher morbidityand mortality rates from their strokes. Socertainly an institution would rather takecare of ischemic strokes than hemorrhagicstrokes if they're getting a fixed cost reimbursementper patient.

Dr Caro:

Yes, it's cheaper by about halfto take care of an ischemic stroke thanan intracranial hemorrhage at the acutelevel. Over the long term, curiously, theyeven out, but that's because intracranialhemorrhage has a higher mortality and sofewer people end up accruing long-termcosts.

Dr Schaecher:

Do either of you thinkthat the practicing clinicians have a sense ofthese stroke costs?

Dr Albers:

Most practicing physicians aredealing with the medical issues. But they doknow it's more frightening to have a brainhemorrhage. That's why treatments with asignificant risk of brain hemorrhage definitelycatch physicians'attention. They oftenthink a stroke is caused by God whereas abrain hemorrhage is caused by the physician.They're very sensitive about treatmentsthat lead to brain hemorrhages, allthe way from tPA [tissue plasminogen activator]treatment for acute stroke to anticoagulationfor stroke prevention.

Dr Caro:

I agree.

The Future of Anticoagulation

Dr Schaecher:

What effect will a directthrombin inhibitor, such as ximelagatran,have on the anticoagulation clinics that havespread around the country during the pastdecade?

Dr Albers:

They are not going to goaway. There are many indications for anticoagulation,and right now we're only lookingat 3 that are being proposed to the USFood and Drug Administration for ximelagatran,and, as Dr Caro said, we don't knowwhat the uptake is going to be in terms ofcost of this drug, copays, and uptake bymanaged care. So certainly, these clinicsare not going to disappear. There's going tobe a need for them, but they may eventuallyhave much less business. Maybe some ofthem will help take care of the liver monitoringfor ximelagatran.

Dr Caro:

I agree. Initially there will notbe any impact. After a few years, hopefully,the clinics will then be used for the patientswho need them most to get optimal care.

Dr Schaecher:

Given the usual lagbetween a major study publication and theissuance of a consensus evidence-basedguideline, what do you think insurers'responsewill be to ximelagatran if it is eventuallyapproved? Do you believe that they'llsee the advantages of the drug and allow it tobe used appropriately by any clinician, or doyou think they'll put some restrictions on it?

Dr Albers:

I think most major insurancecarriers are going to be happy to pay for thedrug, again, depending on the cost. In managedcare or VA [Veterans Affairs]-type systemswith restrictions, forms, or specialprescribing criteria, I don't know. I thinkthose local restrictions will be fairly independentof national guidelines. The guidelineswill certainly come out in favor of thisonce it reaches the market, and I don't thinkinsurance companies are going to be waitingfor guidelines to say that this is a good ideabefore they'll approve use of the drug.

Dr Schaecher:

What role do you thinkcurrent or future CMS [Centers forMedicare and Medicaid Services] reimbursementpolicies might play in shapingthe economics of stroke prevention, anddetermine the uptake of an oral anticoagulantlike ximelagatran?

Dr Caro:

Medicare coverage can have amajor impact on uptake. The cost to individualpatients, depending on how the drugis paid for, could be substantial and couldtherefore lead to reluctance to prescribe it,or patient noncompliance. If Medicare takesthe lead and covers the drug under whateverprogram finally gets implemented, thenthat will also have a spillover effect andinfluence how managed care and drug planscover it.

Dr Schaecher:

Dr Albers, what are thenext steps for researchers in studying thesafety and efficacy of ximelagatran?

Dr Albers:

The key areas involve otherindications. We now have high-quality datafrom the 7300 patients involved in SPORTIFIII and V. So, we have a very good feel forsafety and efficacy in the AF setting. Whatwe don't have are data from mechanicalheart valves. Do we need different dosing forthose types of patients? There are still otherissues in acute stroke management andother places where warfarin is used, such ascongestive heart failure. Also, we need tofind out if this is a good drug to give beforeyou cardiovert a patient.

Dr Schaecher:

What should managedcare decision makers be asking themselvesnow about this new drug?

Dr Albers:

I think they should talk totheir physicians about where they see use ofthe drug, because if the drug gets on themarket, you're not restricted to just whatthe label says. And there may be somephysicians who feel comfortable enoughwith this that they want to extrapolate it toother patient groups (for example, patientswith hypercoagulable states or patients withantiphospholipid antibodies). So the managedcare groups may want to decidewhether they think that's a good idea fortheir group and how interested their doctorsare in extrapolating the indications beyondthe label.

Dr Schaecher:

Even in those settings, thecosts of delivering optimal care remains afactor.

Dr Albers:

True. But those cost questionsare going to be harder to answer because wewon't have data about efficacy in some ofthese other indications.

Dr Schaecher:

What other cost considerationsshould managed care be consideringas they evaluate this drug?

Dr Caro:

We need to continue collectingdata about how this drug is used in actualpractice. Who uses it? What is the compliance?Are there liver problems?

Dr Albers:

Yes. We certainly need to getthe phase 4 liver experience. Will liver problemsemerge when this drug hits the market?That's a big question on many people'sminds.

Dr Schaecher:

What should cliniciansand stroke specialists within managed caresettings be doing today to get ready to evaluateximelagatran and the other potentialnew oral anticoagulants that are comingdown the pike?

Dr Albers:

Capturing data makes a lot ofsense. If you're in a big managed care group,you want systems in place to capture data onthe issues we've talked about: the types ofpatients that are being switched, the costsassociated with switching, the compliancewith therapy, and how close the efficacy andbleeding rates in practice are to the efficacyand bleeding rates in the trials. There's a lotto think about with the major potentialchange in anticoagulation that is on thehorizon.

Dr Caro:

The other message for managedcare is to ensure that adequate education isavailable for clinicians. Ximelagatran wouldmean a change of paradigm, and clinicianswill need to think about AF and other conditionsin a different way. Managed care needsto drive that paradigm change.

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