CurrentCignaPolicy N/A

Anticoagulants - Dabigatran Prior Authorization Policy

Policy Summary

PayerCigna

PolicyAnticoagulants - Dabigatran Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAdded oral pellets; revised alternative trial medication note

Effective Date

Next Review DateMay 21, 2025

Key ActionObtain prior authorization for dabigatran capsules and Pradaxa oral pellets and document prior therapy or acute start and use the specified approval durations when authorizing.

POLICY UPDATE CHANGES

Pradaxa oral pellets were added to the policy.

Note about alternative trial medications expanded to include Eliquis oral suspension/sprinkle, Xarelto oral suspension, and others for the 'other thromboembolic-related conditions' criterion.

Annual revisions included review dates and summary statements; some revisions noted 'No criteria changes'.

4FDA-approved covered adult/pediatric indications (capsules)

2FDA-approved covered pediatric indications (oral pellets)

1Not-covered indications listed

Coverage Summary

Cigna prior authorization policy for dabigatran etexilate mesylate capsules (Pradaxa) and Pradaxa oral pellets detailing coverage criteria for FDA‑approved indications and other thromboembolic-related uses, approval durations, pediatric age limits, and not-covered conditions. Coverage stance: covered_with_criteria. Note: capsule and oral pellet products are distinct dosage forms and, due to bioavailability differences, are not substitutable mg-per-mg.

Pradaxa (dabigatran capsules) - Covered Indications

Covered as medically necessary when criteria for FDA-approved indications or other uses with supportive evidence are met.

ANY of the following

ALL of the following
- Atrial Fibrillation (or Atrial Flutter)
  Approve for 1 year if the patient is ≥ 18 years of age.
- Deep Vein Thrombosis or Pulmonary Embolism, Treatment
  Approve for 1 year if the patient is ≥ 8 years of age.
- Deep Vein Thrombosis or Pulmonary Embolism, To Reduce the Risk of Recurrence
  Approve for 1 year if the patient is ≥ 8 years of age.
- Deep Vein Thrombosis or Pulmonary Embolism in a Patient Undergoing Hip Replacement Surgery, Prophylaxis
  Approve for 60 days if the patient is ≥ 18 years of age.
- Deep Vein Thrombosis in a Patient Undergoing Knee Replacement Surgery, Prophylaxis (Other Uses with Supportive Evidence)
  Approve for 60 days if the patient is ≥ 18 years of age.
- ALL of the following
  - Patient is ≥ 8 years of age
  - ONE of
    Patient has tried warfarin, fondaparinux, or a low molecular weight heparin product (e.g., enoxaparin, dalteparin)
    Patient has been started on dabigatran capsules for the treatment of an acute thromboembolic condition

Pradaxa Oral Pellets (dabigatran oral pellets) - Covered Indications

Covered as medically necessary when criteria for FDA-approved indications or other uses with supportive evidence are met.

ANY of the following

ALL of the following
- Venous Thromboembolic Events, Treatment
  Approve for 1 year if the patient is ≥ 3 months to < 12 years of age. Examples: DVT, cerebral venous thrombosis/sinus thrombosis, PE, central-venous thrombosis.
- Venous Thromboembolic Events, To Reduce the Risk of Recurrence
  Approve for 1 year if the patient is ≥ 3 months to < 12 years of age. Examples: DVT, cerebral venous thrombosis/sinus thrombosis, PE, central-venous thrombosis.
- ALL of the following
  - Patient is ≥ 3 months to < 12 years of age

Not Medically Necessary / Exclusions

Uses considered not medically necessary

ALL of the following

Pradaxa (capsules) or Pradaxa Oral Pellets for ANY other use(s) not listed as covered
This list may not be all inclusive; criteria updated as new data available.
Venous Thromboembolism in an Acutely Ill Medical Patient, Prophylaxis
Specifically listed as not covered; Xarelto is labeled for this use and guideline-supported.

Applicable Products / Codes

Drugs in scopeNDCCovered

Pradaxa (dabigatran etexilate mesylate) capsules	Boehringer Ingelheim, generic - policy covers capsules
Pradaxa Oral Pellets (dabigatran etexilate oral pellets)	Boehringer Ingelheim - oral pellets for pediatric patients

Provider Actions & Authorization Rules

Prior Authorization

Prior authorization required

Prior authorization is recommended/required for dabigatran capsules and Pradaxa oral pellets for prescription benefit coverage; approvals are provided for specified durations per indication.

Approvals are provided for the duration noted per indication.

Documentation Required

Document prior therapy or acute start for other thromboembolic conditions

For 'other thromboembolic-related conditions' requests, document patient age and either trial of warfarin/fondaparinux/low molecular weight heparin (LMWH) or documentation that dabigatran (capsules) or Pradaxa oral pellets were started for an acute thromboembolic condition.

Acceptable alternative DOAC formulations per the policy note: apixaban (Eliquis) tablets for oral suspension, apixaban Sprinkle (Eliquis) capsules for oral suspension, rivaroxaban (Xarelto) oral suspension, and edoxaban (Savaysa) tablets (policy notes differ slightly between capsules and oral pellets as reflected in history).

Clinical Evidence & References

Evidence sources include the Prescribing information: Pradaxa capsules and oral pellets prescribing information (Boehringer Ingelheim), November 2023, and guideline sources such as CHEST, ASCO, NCCN, ASH, ACC/AHA, and the NIH COVID-19 antithrombotic guidance. References and cited 2024 guideline documents are included in the policy.

Background

Dabigatran (Pradaxa) is a direct thrombin inhibitor with FDA-approved indications including non-valvular atrial fibrillation, prophylaxis of DVT/PE after hip replacement, treatment of DVT/PE and reduction in risk of recurrence in adults and select pediatric populations. Oral pellets are FDA-approved for certain pediatric VTE indications (treatment and recurrence reduction in patients 3 months to < 12 years). The capsule and oral pellet products are approved for different indications/age groups and, due to differences in bioavailability, the products are not substitutable on a mg-per-mg basis.

Other thromboembolic-related conditions: examples include superficial vein thrombosis, splanchnic vein thrombosis, hepatic vein thrombosis, or prophylaxis of venous thromboembolism in a high-risk patient.

Revision History

05/21/2025material_additionLatest

Pradaxa oral pellets were added to the policy; conditions for approval for oral pellets were added (pediatric indications and other-use criteria).

05/21/2025material_revisionLatest

Note about alternative trial medications expanded to include Eliquis oral suspension/sprinkle and Xarelto oral suspension for the 'other thromboembolic-related conditions' criterion.

04/05/2023