Newer anticoagulants drug class
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Newer Anticoagulants Drug Class. Nicole N. Nguyen, PharmD Senior Clinical Pharmacist Health Care Services October 16, 2013. Newer Anticoagulants. Apixaban Dabigatran etexilate R ivaroxaban. February 2013 P & T Motion.

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Newer anticoagulants drug class

Newer Anticoagulants Drug Class

Nicole N. Nguyen, PharmD

Senior Clinical Pharmacist

Health Care Services

October 16, 2013


Newer anticoagulants

NewerAnticoagulants

  • Apixaban

  • Dabigatran etexilate

  • Rivaroxaban


February 2013 p t motion

February 2013 P & T Motion

  • After considering the evidence of safety, efficacy and special populations for newer anticoagulant drugs for the prevention of stroke or systemic embolism in patients who are medically ill, undergoing surgery or with nonvalvular atrial fibrillation, I move that apixaban, dabigatran, and rivaroxaban are safe and efficacious for their approved indications. Apixaban, dabigatran, and rivaroxaban cannot be subject to therapeutic interchange in the Washington preferred drug list.


Criteria

Criteria

  • FDA approved indications and dosing

  • Initial criteria includes trial of warfarin or reason given why unable to use warfarin (includes patient or provider refusal).

    • This was added due to new products on market without long term safety, and ability to reverse anticoagulant effect if needed.


Eliquis apixaban

Eliquis (apixaban)

  • Indication: Non-valvular atrial fibrillation, to reduce the risk of stroke and systemic embolism

  • Dosing: 5 mg BID

    • 2.5mg BID if at least 2 of the following:

      • age ≥ 80 years,

      • body weight ≤ 60kg, or

      • serum creatinine ≥ 1.5 mg/dL


Pradaxa dabigatran etexilate

Pradaxa (dabigatran etexilate)

  • Indication: Non-valvular atrial fibrillation, to reduce the risk of stroke and systemic embolism

  • Dosing:

    • 150mg BID if creatinine clearance (CrCl) >30 mL/min

    • 75mg BID if CrCl 15 -30 mL/min


Xarelto rivaroxaban

Xarelto (rivaroxaban)

  • Indications:

    • Non-valvular atrial fibrillation, to reduce the risk of stroke and systemic embolism

    • Treatment of deep vein thrombosis (DVT)

    • Treatment of pulmonary embolism (PE)

    • Reduction in the risk of recurrence of DVT and PE after initial 6 months treatment for DVT and/or PE

    • prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery


Xarelto rivaroxaban continued

Xarelto (rivaroxaban) continued

  • Dosing:

    • A-fib: CrCl >50 mL/min: 20mg QD CrCl 15 to 50 mL/min: 15mg QD

    • Treatment DVT and PE: 15mg BID x 21 days, then 20mg QD

    • Reduction in risk of recurrence of DVT/PE: 20mg QD

    • Hip replacement: 10mg QD x 35 days

    • Knee replacement: 10mg QD x 12 days


Medicaid experience with pa

Medicaid experience with PA

  • For all newer anticoagulants there are requests for off-label use, including valvular a-fib.

  • For all newer anticoagulants there are requests for incorrect dosing.

  • Pradaxa approved first & have limited to non-valvular a-fib. Have received requests for valvular a-fib.


Continued

continued

  • Pradaxa FDA warning issued not to use in patients with mechanical prosthetic heart valves due to increased risk of strokes, heart attacks, and blood clots forming on the mechanical heart valves than users of the anticoagulant warfarin. The use of Pradaxa valve replacement made of natural biological tissue, known as a bioprosthetic valves, has not been evaluated and cannot be recommended.


Questions

Questions?

Clinical questions specific to Newer Anticoagulants?


Source of criteria

Source of Criteria

  • Current criteria in these drug classes was established through HCA’s internal Drug Evaluation Matrix Committee, prior to selection as PDL classes

  • Not previously brought to the DUR Board under Authorization program because criteria are specific to FDA labeling and use of less costly alternatives


Dur board review

DUR Board review

As per previous presentation:

  • Use of generic(s) as first line agents for PDL classes explicitly requires review under RCW (unlike authorization program)

  • Limiting product selection / endorser DAW according to FDA labeled indications requires review under RCW


Agency recommendations

Agency Recommendations

  • Newer Anticoagulants

    • Approve requirement to use warfarin first line, with lenient exceptions including preference, convenience, or compliance factors

    • Approve requirement for use within FDA labeling and dosing

    • Eliminate DAW, requiring clinical justification by prescriber for selection of non-preferred product


Stakeholder input

Stakeholder Input

  • Newer Anticoagulants


Motion newer anticoagulants

Motion: Newer Anticoagulants

  • Require warfarin first line?

  • Limit use to FDA labeling, including dosing requirements?

  • Remove DAW privelige?

  • Modifications to criteria by DUR Board?


Questions1

Questions?

More Information:

http://www.hca.wa.gov/medicaid/billing/pages/prescription_drug_program.aspx

or

http://www.hca.wa.gov/medicaid/pharmacy/Pages/index.aspx

Nicole N. Nguyen PharmD, Senior Clinical Pharmacist

Health Care Services

[email protected]

Tel: 360-725-1757


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