Dabigatran (Pradaxa) Coverage Criteria
Customize your policy alerts
Sign up for Ambetter Georgia Policy CP.PMN.53 alerts
Get alerted when Policy CP.PMN.53 changes without checking for updates manually.
Monitor payer policy activity
Criteria and prior authorization rules for coverage of dabigatran (Pradaxa) for Ambetter Georgia Medicaid members, including indications, initial and continued therapy requirements, dosing limits, contraindications, and documentation requirements.
No material clinical or coverage changes in this revision.
Coverage Criteria for Dabigatran (Pradaxa)
Continued Therapy Criteria - NVAF, DVT/PE, Prophylaxis
Covered when ALL of the following are met
Approval duration: 12 months
Other Diagnoses/Indications
Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider submits sufficient documentation demonstrating efficacy and safety per the off‑label use policy. Specifically, requests for non‑FDA indications require evidence consistent with Ambetter Georgia’s off‑label use policy (CP.PMN.53) or other applicable evidence of coverage documents before authorization will be considered.
Initial Therapy Authorization
Criteria for Continued Therapy
Continued Therapy
Continued therapy is authorized when the member currently receives drug via benefit or met initial criteria and is responding positively; dose increases must remain ≤300 mg/day.
Approval duration: 12 months
Provider Actions and Documentation Requirements
Prior authorization required for Pradaxa
Prior authorization is required for Pradaxa (dabigatran). Approval is granted only when the member meets all initial approval criteria, including an FDA‑listed indication, required prior trial of Eliquis (apixaban) unless contraindicated, and that the total daily dose does not exceed 300 mg.
Step therapy: trial of Eliquis (apixaban) required
A trial and failure (or documented contraindication/intolerance) to apixaban (Eliquis) is required prior to approval; the member must have used Eliquis for ≥ 30 days at up to maximally indicated doses.
- Failure of Eliquis used for ≥ 30 days at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced.
Submit clinical documentation with prior‑auth request
Provider must submit supporting clinical documentation (e.g., office chart notes, lab results, or other clinical information) demonstrating that the member meets all approval criteria.
- Include documentation of indication, prior anticoagulant use (dates/doses of Eliquis), and dosing/renal function as applicable.
Denial risk for missing documentation or non‑FDA indications
Requests lacking documentation that the member meets approval criteria, or requests for non‑FDA indications without sufficient supporting evidence, may be denied.
- Non‑FDA approved indications require sufficient documentation of efficacy and safety per off‑label use policy CP.PMN.53 or evidence of coverage documents.
Clinical and Coding Parameters
Step Therapy Requirements
| Step | Requirement | Duration / Notes |
|---|---|---|
| 1 | Trial and failure of apixaban (Eliquis) used for ≥ 30 days at up to maximally indicated doses, unless apixaban is contraindicated or clinically intolerable | Duration: apixaban trial ≥ 30 days; refer to Appendix B for therapeutic alternative dosing (Eliquis dose limit 20 mg/day). |
Quantity Limits and Dosing
Definitions
Background
Dabigatran (Pradaxa) is a direct thrombin inhibitor approved for multiple anticoagulant indications including reduction in risk of stroke and systemic embolism in non‑valvular atrial fibrillation (NVAF), treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) following initial parenteral anticoagulation, reduction in risk of recurrent DVT/PE, and prophylaxis of DVT/PE after hip replacement surgery. Dosing is indication‑ and renal function–dependent (see CrCl categories: >30 mL/min and 15–30 mL/min), and capsules are available in 75 mg, 110 mg, and 150 mg strengths.
Policy Revision History
Policy became effective for Ambetter Georgia coverage of dabigatran (Pradaxa) with specified initial and continued therapy criteria, step therapy requiring prior apixaban trial, and a 300 mg/day dose limit.
Scheduled next policy review date set for 2021-05-21 per document metadata.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.