Managing and Monitoring NOAC Therapy in NVAF

SEPTEMBER 13, 2018
 

Gary M. Besinque, PharmD, FCSHP; Jaime E. Murillo, MD; Juvairiya Pulicharam, MD; Ralph J. Riello III, PharmD, BCPS; and Peter Salgo, MD, review considerations for selecting and using a novel oral anticoagulant therapy in patients with nonvalvular atrial fibrillation (NVAF).

Transcript: 

Peter Salgo, MD: What are the strategies for dosing and managing the adverse effects of the NOACs [novel oral anticoagulants] as opposed to warfarin? How do we even start this?

Ralph J. Riello III, PharmD, BCPS: To an extent, all of these medications are renally cleared. I was joking before about the serum creatinine check, but that becomes very important. You have to assess the patient’s renal function and dose reduce if their creatinine clearance is below a certain threshold. With apixaban, for instance, it’s the ABCs—the age, body weight, and the creatinine, as well.

Peter Salgo, MD: How do you monitor patients who are being treated with these novel agents?

Gary M. Besinque, PharmD, FCSHP: Basically, you watch what their creatinine is doing and make sure that nothing has been added to their medication list that may interfere with the action of the non-warfarin oral agent.

Peter Salgo, MD: So you’re not measuring the effect of the drug, you’re measuring the mechanism of clearance by measuring the creatinine to be sure that the drug is going to be cleared? And if the creatinine goes up, you have to assume that the drug is not being cleared?

Gary M. Besinque, PharmD, FCSHP: Yes, correct.

Peter Salgo, MD: What do you do if the creatinine doubles?

Jaime E. Murillo, MD: There are clear guidelines that provide direction as to when to reduce the dose, depending on the clearance.

Peter Salgo, MD: Do you know the impact on the cost of therapy, regarding the side effect profiles of these newer agents versus Coumadin? Which is cheaper when you put the whole package together? 

Juvairiya Pulicharam, MD: When you look at the total health care cost, this could be cheaper. We still need to do more studies, and we’ll discuss this later.

Peter Salgo, MD: What do you think?

Juvairiya Pulicharam, MD: I think it will be cheaper.

Peter Salgo, MD: Because you avoid the clinic. You avoid the frequent blood draws. 

Juvairiya Pulicharam, MD: If you take both the direct and indirect costs…

Jaime E. Murillo, MD: You avoid the risk associated with increased bleeding, hospitalizations, and so on. At some point, we’re going to get to that conclusion because that’s the same story we saw when we only had warfarin and patients were in the hospital. The insurance company would not pay for them to go home on Lovenox because Lovenox was too expensive. And yet, they were willing to pay for 3 or 4 more days of hospitalization. That doesn’t make sense.

Peter Salgo, MD: Sanity has never been an issue when dealing with reimbursement. As a pharmacist, do you have input into which of these new agents to use? How do you work with everybody?

Ralph J. Riello III, PharmD, BCPS: It’s actually scary how much input I sometimes have on a patient’s therapy. Again, I’m a big proponent of shared decision-making. I’m not going to recommend a medication for a patient if they can’t go home and afford it, or if they don’t know about it and don’t feel that they want to take it. But, in terms of the team and rounding, I’m in the cardiac intensive care unit on a daily basis. We use a lot of DOACs [direct-acting oral anticoagulants] at Yale. With Connecticut’s Medicaid program, HUSKY D, this is free. There is no copay, and there are no prior authorizations for the direct oral anticoagulants, as a class. So, we’re pretty lucky. We deal with a high proportion of dual eligible patients, so we’re pretty confident that we can prescribe them something affordable. We actually created this kind of DOAC algorithm, based on a lot of the comorbidities that we feel may lend a bit more benefit with one agent over another. At the end of the day, it’s important to remember that these drugs are way more similar than they are different.

Peter Salgo, MD: Some of them are bid [2 times a day]. Some of them are qd [every day]. Does that make a difference to practitioners? Does it make a difference to patients?

Ralph J. Riello III, PharmD, BCPS: I think it primarily makes a difference to patients. A lot of them, if they’re already on a twice-daily drug routine, are fine with taking the apixaban or dabigatran, which are administered twice a day. But, if they’re not, and if AFIB [atrial fibrillation] may be the only issue that they have, beside other comorbidities like hypertension, they might object to taking something twice a day. You’ve got to offer them the options and help them to decide.

Jaime E. Murillo, MD: It is important to consider the type of patient. For the younger patient who has a lower risk of bleed, in whom you can give the medication once a day, you can probably ensure more compliance than for the elderly patient who is used to taking medication several times a day, and so on. It’s important to keep that in mind. One dose of a bid a day is definitely not enough. Some patients think, “Well, if I’m taking it every day I should be fine.”

Peter Salgo, MD: To interpret what you just said, if it’s a lower risk of bleeding, you can use the longer half-life agent. That is the bid drug. If you stop it because somebody is bleeding, it’s going to go away more quickly and you can control the bleeding more easily. Is that right?

Gary M. Besinque, PharmD, FCSHP: You have to be careful because the once-a-day drug has a shorter half-life than the twice-a-day drug.

Peter Salgo, MD: How can you take it once a day, but it has a shorter half-life?

Gary M. Besinque, PharmD, FCSHP: You just referred to some of the illogic that we sometimes have to deal with.
 
 

Gary M. Besinque, PharmD, FCSHP; Jaime E. Murillo, MD; Juvairiya Pulicharam, MD; Ralph J. Riello III, PharmD, BCPS; and Peter Salgo, MD, review considerations for selecting and using a novel oral anticoagulant therapy in patients with nonvalvular atrial fibrillation (NVAF).

Transcript: 

Peter Salgo, MD: What are the strategies for dosing and managing the adverse effects of the NOACs [novel oral anticoagulants] as opposed to warfarin? How do we even start this?

Ralph J. Riello III, PharmD, BCPS: To an extent, all of these medications are renally cleared. I was joking before about the serum creatinine check, but that becomes very important. You have to assess the patient’s renal function and dose reduce if their creatinine clearance is below a certain threshold. With apixaban, for instance, it’s the ABCs—the age, body weight, and the creatinine, as well.

Peter Salgo, MD: How do you monitor patients who are being treated with these novel agents?

Gary M. Besinque, PharmD, FCSHP: Basically, you watch what their creatinine is doing and make sure that nothing has been added to their medication list that may interfere with the action of the non-warfarin oral agent.

Peter Salgo, MD: So you’re not measuring the effect of the drug, you’re measuring the mechanism of clearance by measuring the creatinine to be sure that the drug is going to be cleared? And if the creatinine goes up, you have to assume that the drug is not being cleared?

Gary M. Besinque, PharmD, FCSHP: Yes, correct.

Peter Salgo, MD: What do you do if the creatinine doubles?

Jaime E. Murillo, MD: There are clear guidelines that provide direction as to when to reduce the dose, depending on the clearance.

Peter Salgo, MD: Do you know the impact on the cost of therapy, regarding the side effect profiles of these newer agents versus Coumadin? Which is cheaper when you put the whole package together? 

Juvairiya Pulicharam, MD: When you look at the total health care cost, this could be cheaper. We still need to do more studies, and we’ll discuss this later.

Peter Salgo, MD: What do you think?

Juvairiya Pulicharam, MD: I think it will be cheaper.

Peter Salgo, MD: Because you avoid the clinic. You avoid the frequent blood draws. 

Juvairiya Pulicharam, MD: If you take both the direct and indirect costs…

Jaime E. Murillo, MD: You avoid the risk associated with increased bleeding, hospitalizations, and so on. At some point, we’re going to get to that conclusion because that’s the same story we saw when we only had warfarin and patients were in the hospital. The insurance company would not pay for them to go home on Lovenox because Lovenox was too expensive. And yet, they were willing to pay for 3 or 4 more days of hospitalization. That doesn’t make sense.

Peter Salgo, MD: Sanity has never been an issue when dealing with reimbursement. As a pharmacist, do you have input into which of these new agents to use? How do you work with everybody?

Ralph J. Riello III, PharmD, BCPS: It’s actually scary how much input I sometimes have on a patient’s therapy. Again, I’m a big proponent of shared decision-making. I’m not going to recommend a medication for a patient if they can’t go home and afford it, or if they don’t know about it and don’t feel that they want to take it. But, in terms of the team and rounding, I’m in the cardiac intensive care unit on a daily basis. We use a lot of DOACs [direct-acting oral anticoagulants] at Yale. With Connecticut’s Medicaid program, HUSKY D, this is free. There is no copay, and there are no prior authorizations for the direct oral anticoagulants, as a class. So, we’re pretty lucky. We deal with a high proportion of dual eligible patients, so we’re pretty confident that we can prescribe them something affordable. We actually created this kind of DOAC algorithm, based on a lot of the comorbidities that we feel may lend a bit more benefit with one agent over another. At the end of the day, it’s important to remember that these drugs are way more similar than they are different.

Peter Salgo, MD: Some of them are bid [2 times a day]. Some of them are qd [every day]. Does that make a difference to practitioners? Does it make a difference to patients?

Ralph J. Riello III, PharmD, BCPS: I think it primarily makes a difference to patients. A lot of them, if they’re already on a twice-daily drug routine, are fine with taking the apixaban or dabigatran, which are administered twice a day. But, if they’re not, and if AFIB [atrial fibrillation] may be the only issue that they have, beside other comorbidities like hypertension, they might object to taking something twice a day. You’ve got to offer them the options and help them to decide.

Jaime E. Murillo, MD: It is important to consider the type of patient. For the younger patient who has a lower risk of bleed, in whom you can give the medication once a day, you can probably ensure more compliance than for the elderly patient who is used to taking medication several times a day, and so on. It’s important to keep that in mind. One dose of a bid a day is definitely not enough. Some patients think, “Well, if I’m taking it every day I should be fine.”

Peter Salgo, MD: To interpret what you just said, if it’s a lower risk of bleeding, you can use the longer half-life agent. That is the bid drug. If you stop it because somebody is bleeding, it’s going to go away more quickly and you can control the bleeding more easily. Is that right?

Gary M. Besinque, PharmD, FCSHP: You have to be careful because the once-a-day drug has a shorter half-life than the twice-a-day drug.

Peter Salgo, MD: How can you take it once a day, but it has a shorter half-life?

Gary M. Besinque, PharmD, FCSHP: You just referred to some of the illogic that we sometimes have to deal with.
 
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