Varithena™

(polidocanol injectable foam) 1%

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Varithena Mechanism of Action
Varithena Canister with Varithena Transfer Unit
Varithena Administration Kit Contents
Varithena Mechanism of Action
Varithena Canister with Varithena Transfer Unit
Varithena Administration Kit Contents

Varithena (polidocanol) injectable foam is for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Varithena improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.

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Product Description

Features and Benefits Overview

Varithena is a non-thermal, non-tumescent treatment for the great saphenous vein system (GSV) and associated veins of the GSV system, and is the only FDA approved foam indicated for treating venous insufficiency. Varithena’s patented Microfoam UDSS™ technology produces cohesive, low-nitrogen microfoam1 with O2:CO2 (65:35) gas mixture with <0.8% nitrogen. The cohesive microfoam fills the lumen for circumferential contact1 where it’s designed to displace blood and destroy the endothelial lining efficiently. Varithena uses no tumescent anesthesia and takes about 10 minutes to administer.

Clinical Trials

VANISH-1 and VANISH-2 Clinical Trials

Varithena was evaluated in two randomized, blinded, multi-center clinical trials to asses the efficacy and safety for Varithena with the primary endpoint as improvement in varicose vein symptoms.* Clinical trial efficacy measures also included improvement in varicose vein appearance and physiological response to treatment.

  • Data demonstrates efficacy and durability of Varithena treatment in the GSV
  • To measure symptom relief, the VVSymQ® instrument was developed and thoroughly tested for reliability, sensitivity, and content validity, in accordance with FDA guidelines for the development of patient-reported outcomes (PRO) tools.2 It is the first and only varicose vein symptom PRO tool to meet these requirements.
  • Using the VVSymQ® electronic daily diary, study patients rated the severity of the 5 most relevant varicose vein symptoms (HASTI™ Symptoms):
    • Heaviness
    • Achiness
    • Swelling
    • Throbbing
    • Itching

*Primary endpoint: Improvement in symptoms as measured by change in VVSymQ® Score from baseline to Week 8.

Conclusion

Varithena provided clinically meaningful improvement* in symptoms and appearance in patients with incompetent great saphenous veins (GSV), accessory saphenous veins, and visible varicosities of the GSV system. Improvement was measured by a patient global impression of change (PGIC) questionnaire at Week 8.

*Percent of patients who reported their symptoms (or appearance of varicose veins) had “moderately improved” or “much improved” compared with baseline.

Ordering Information

Varithena can be ordered directly through Boston Scientific or another approved specialty distributor. A new Varithena administration pack is needed to each patient. It is recommended you have an additional Varithena bi-cannister and administration pack on hand at all times.  

Direct Order Contact Information

Distributor Customer Telephone Web Orders
BSC Direct Physician Offices, Hospitals 855-971-8346 (VEIN) VarithenaCustomerCare@bsci.com

Reimbursement Information

Varithena can be ordered directly through Boston Scientific or another approved specialty distributor. A new Varithena administration pack is needed to each patient. It is recommended you have an additional Varithena bi-cannister and administration pack on hand at all times.

Varithena is described by one of two active Category I CPT® codes, 36465 and 36466, when used in truncal veins and is now included in a majority of regional and national payers polices and local coverage decisions.3

As of January 1st, 2020, Varithena may be billed with one of the following CPT codes listed below, for the physician office setting. Per CPT instructions, the code selected should accurately describe the service performed.

CPT Code Description Total RVUs Payment
36465 Injection non-compounded foam sclerosant, single vein 42.95 $1,550.05
36466 Injection non-compounded foam sclerosant, multiple veins 47.65 $1,719.67
36470* Injection sclerosing solution, single vein 3.10 $111.88
36471* Injection sclerosing solution, multiple veins, same leg 5.59 $201.74
*If the targeted vein is an extremity truncal vein and injection of non-compounded foam sclerosant with ultrasound guided compression maneuvers to guide dispersion of the injectate is performed, see 36465,36466. Reference: Current Procedural Terminology (CPT®) Professional Edition 2019. CPT Copyright 2019 American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association.

Disclaimer

Health economic and reimbursement information provided by Boston Scientific Corporation is gathered from third-party sources and is subject to change without notice as a result of complex and frequently changing laws, regulations, rules and policies. This information is presented for illustrative purposes only and does not constitute reimbursement or legal advice. Boston Scientific encourages providers to submit accurate and appropriate claims for services. It is always the provider's responsibility to determine medical necessity, the proper site for delivery of any services and to submit appropriate codes, charges, and modifiers for services that are rendered. Boston Scientific recommends that you consult with your payers, reimbursement specialists and/or legal counsel regarding coding, coverage and reimbursement matters. It is always the provider's responsibility to understand and comply with national coverage determinations (NCD), local coverage determinations (LCD) and any other coverage requirements established by relevant payers which can be updated frequently.
CPT® Copyright 2019 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Restrictions Apply to Government Use. Fee schedules, relative value units, conversion factors, and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

References

1 Eckmann DM. Polidocanol for endovenous microfoam sclerosant therapy. Expert Opin Investig Drugs. 2009;18(12):1919-1927.
2 Todd KL III, Wright DI, and the VANISH-2 Investigator Group. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of saphenofemoral junction incompetence. Phlebology. 2014;29(9):608-618. doi:10.1177/0268355513497709.
3 Data on file. Provensis Ltd, 2013.
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