By: Nick Morrison, MD, FACS, FACPh, RPhS Visit VeinGlobal at http://www.veinglobal.com/ for more presentations and videos on this topic, or for more information on venous disease news, education and research.

1. Polidocanol Endovenous Microfoam:
Where Are We?
Varithena™
[Previously referred to as Varisolve®
or polidocanol
endovenous microfoam (PEM)]
Thursday, April 24

2. Research GrantResearch Grant
Consultant, Research Grant - SapheonConsultant, Research Grant - Sapheon
Educational Grant, MediUSAEducational Grant, MediUSA
Consultant, MerzConsultant, Merz
Scientific Advisory Board, VenXScientific Advisory Board, VenX
Medical Director, Morrison Vein/Training InstituteMedical Director, Morrison Vein/Training Institute
Monument Valley, Arizona

3. Varithena™
PEM (polidocanol endovenous microfoam) patent-
protected drug/device combination
Highly uniform sclerosant/gas foam (CO2/O2)

4. Some previous treatment modality clinical trials used
duplex ultrasound response or GSV closure as the
primary endpoint
Ultrasound response a surrogate endpoint with no
clear relationship with patient benefit
FDA requested BTG establish clinical benefit
through use of patient-reported outcomes (PROs)
as 1° end-points
BTG developed VVSymQ instruments to measure
patient benefit in terms of…
Symptoms:
Heaviness Throbbing
Aching Itching
Swelling
Clinical Trials - Efficacy

5. 2 ° Other PRO measurement tools
Patient Self-Assessment of Appearance of Visible Varicose Veins (PA-V3
)
Noticeability Scale (0 to 4)
0 = Not at all noticeable to 4 = Extremely noticeable
Independent Panel Review of Visible Varicose Veins (IPR-V3
)
IPR-V3
score—median of 3 independent clinician reviewers
blinded to treatment and time point
3° End-points
a)Duplex ultrasound response:
Elimination of reflux at SFJ
and/or
Complete occlusion of treated truncal vein at 8 wks
b)VCSS – physician-reported outcome measurement instrument
c)VEINES-QOL – disease-specific QoL instrument
Clinical Trials - Efficacy

6. Clinical Trials - Efficacy
Phase II (pts)
UK Safety Profile 24
First US Study 40
US MRI Study 83
Compression Method 20
UK Echocardiography Study 35
Pilot Phase III 39
38 control pts
Pilot Low Conc. Microfoam 16
Phase III Pts Controls
European Phase III 437 219
VANISH-1 223 56
VANISH-2 175 57
Adjunct 79 38
All trials total pts randomized
Pts Controls
1192 408

7. Baseline Disease Characteristics
Vanish-1 Vanish-2
Mean GSV diameter, mm (range)
7.6mm(1.5 - 25.9) 8.7mm (3.1 - 19.4)
CEAP clinical class, n (%)
C2 137 (49.1) 74 (31.9)
C3 79 (28.3) 93 (40.1)
C4 57 (20.4) 53 (22.8)
C5/C6 6 (2.2) 12 (5.2)
Clinical Trials - Efficacy
(Vanish-1, Vanish-2)

8. 1° End-point
VVSymQ
Varithena™
superior compared to placebo (p<0.0001) at 8 weeks
*regardless of GSV diameter
2° End-points
PA-V3
Score
Varithena™
superior compared to placebo (p<0.0001) at 8 weeks
IPR-V3
Score
Varitherna™
superior compared to placebo (p<0.0001) at 8 weeks
3° Endpoints
Duplex Response
Varithena™
superior compared to placebo (p<0.0001-0.0009) at 8 weeks
VCSS
Varithena™
superior compared to placebo (p<0.0001) at 8 weeks
VEINES-QoL
Varithena™
superior compared to placebo (p<0.0001) at 8 weeks
Clinical Trials - Efficacy
(Vanish-1, Vanish-2)

9. Clinical Trials - Safety1333 patients in 12 clinical trials
437 patients in placebo-controlled clinical trials
Most common AE’s (>3%)
a) extremity pain/discomfort
b) retained coagulum
c) injection site hematoma/pain
d) SVT
e) extravasation
No anaphylaxis or life-threatening hypersensitivity
No clinically evident PE
DVT:
PASTE – 2.9%
Proximal – 1.7%
Distal – 1.1%
Muscular – 1.4% } 4.2%

10. Clinical Trials - Safety
Neurosensory events:
Incidence of neurological or visual adverse events within 1
day of treatment was 2.7% in all Varithena™
patients
and 4.0% in the placebo groups
Visual impairment
Burning sensation
Dizziness
Dysgeusia
Headache
Hypoesthesia
Migraine
Paresthesia
Presyncope
Restless legs syndrome

11. Varithena™
(polidocanol injectable foam) is
indicated 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.
Clinical Indications

12. Two major hurdles…..
Cost and Reimbursement
Physician Acceptance

13. Reimbursement/Costs
Wife: I have some good news and some bad
news.
Husband: What's the good news?
Wife: The good news is I found a picture
that's worth $500,000.
Husband: Wow! That's wonderful! What's
the bad news?
Wife: The bad news is that the picture is of
you and your secretary!

14. Costs
$3195 or $71 per mL
PLUS
Administration pack – transfer unit, syringes, manometer
tubing, compression pads
Cost per Treatment:
5mL - $395 10mL - $750 15mL (max allowed) -
$1,105
Average Study Treatment Volume:
11-12mL per patient
45mL multi-treatment canister:

15. What impact will cost have?
Angiodynamics/Merz
(STS, Asclera)
Market penetration
significantly less than predicted

16. Reimbursement
Comprehensive reimbursement support services
• Provider training support
• Product information
• Benefit verification support
• Prior authorization and documentation support
• Determination of patient drug and procedure
out of pocket (OOP)
• Order and distribution support
• Insurer-specific coverage policy matching,
coding, and billing support
• Underpaid or denied claim appeals
assistance
• Claims tracking support

17. Reimbursement
Procedure:
In light of the lack of a Category I CPT code, it is recommended that
the best interim coding strategy for the FDA approved percutaneous
endovenous ablation procedure using an injectable foam
drug/device combination approach is 37799 (unlisted procedure,
vascular surgery); and that CPT codes 36475 (RF) – 36478 (EVLA) and
or 37765 (AP) may be suitable as potential crosswalks for insurers to
establish appropriate RVU levels for the Varithena™ procedure.
Varithena™
Foam (HCPCS coding)
J3490 – Unclassified drug
Medicare reimbursement - typically cost + 6%

18. Conclusions
1) The stuff seems to work pretty well
2) The stuff seems to be pretty safe in
experienced hands
Impediments to adoption
1) Cost high – over 10 x cost of homemade
2) My homemade foam works pretty
damn well
3) No reimbursement codes yet, but BTG
spending a sh**load to help

19. Thank you for your kind attention
nickmorrison2002@yahoo.com