Polidocanol Endovenous Microfoam: Where Are We?

Polidocanol Endovenous Microfoam: Where Are We?

Varithena ™

[Previously referred to as Varisolve® or polidocanol endovenous microfoam (PEM)]

Thursday, April 24

Research GrantResearch GrantConsultant, Research Grant - SapheonConsultant, Research Grant - SapheonEducational Grant, MediUSAEducational Grant, MediUSAConsultant, MerzConsultant, MerzScientific Advisory Board, VenXScientific Advisory Board, VenXMedical Director, Morrison Vein/Training InstituteMedical Director, Morrison Vein/Training Institute

Monument Valley, Arizona

Varithena ™

PEM (polidocanol endovenous microfoam) patent-protected drug/device combination

Highly uniform sclerosant/gas foam (CO2/O2)

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-pointsBTG developed VVSymQ instruments to measure patient benefit in terms of…

Symptoms:Heaviness ThrobbingAching ItchingSwelling

Clinical Trials - Efficacy

2 ° Other PRO measurement toolsPatient 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-pointsa)Duplex ultrasound response:

Elimination of reflux at SFJand/or

Complete occlusion of treated truncal vein at 8 wksb)VCSS – physician-reported outcome measurement instrumentc)VEINES-QOL – disease-specific QoL instrument

Clinical Trials - Efficacy

Clinical Trials - Efficacy

Phase II (pts)UK Safety Profile 24First US Study 40US MRI Study 83Compression Method 20UK Echocardiography Study 35Pilot Phase III 39

38 control ptsPilot Low Conc. Microfoam 16

Phase III Pts ControlsEuropean Phase III 437 219VANISH-1 223 56VANISH-2 175 57Adjunct 79 38

All trials total pts randomizedPts Controls

1192 408

Baseline Disease CharacteristicsVanish-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)

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 weeks3° Endpoints

Duplex Response Varithena ™ superior compared to placebo (p<0.0001-0.0009) at 8 weeks

VCSSVarithena ™ superior compared to placebo (p<0.0001) at 8 weeks

VEINES-QoLVarithena ™ superior compared to placebo (p<0.0001) at 8 weeks

Clinical Trials - Efficacy(Vanish-1, Vanish-2)

Clinical Trials - Safety1333 patients in 12 clinical trials

437 patients in placebo-controlled clinical trialsMost common AE’s (>3%)

a) extremity pain/discomfort b) retained coagulumc) injection site hematoma/paind) SVTe) extravasation

No anaphylaxis or life-threatening hypersensitivityNo clinically evident PEDVT:

PASTE – 2.9%Proximal – 1.7%Distal – 1.1% Muscular – 1.4% } 4.2%

Clinical Trials - SafetyNeurosensory 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 groupsVisual impairmentBurning sensation

Dizziness Dysgeusia Headache Hypoesthesia Migraine Paresthesia Presyncope Restless legs syndrome

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

Two major hurdles…..

Cost and Reimbursement

Physician Acceptance

Reimbursement/Costs

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Costs

$3195 or $71 per mL

PLUSAdministration 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:

What impact will cost have?Angiodynamics/Merz

(STS, Asclera)Market penetration

significantly less than predicted

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

ReimbursementProcedure: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 drugMedicare reimbursement - typically cost + 6%

Conclusions1) The stuff seems to work pretty well2) The stuff seems to be pretty safe in

experienced handsImpediments to adoption

1) Cost high – over 10 x cost of homemade2) My homemade foam works pretty

damn well3) No reimbursement codes yet, but BTG

spending a sh**load to help

Thank you for your kind attention

[email protected]