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Measuring the true pathway of innovation into the NHS
UroLift® – A Case Study
Justin Hall, Vice President & General Manager EMEA, NeoTract Inc.
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Mission:Identify Clinical NeedsDevelop Paradigm Shifts
Invent or License
Prove FeasibilityLaunch Medtech Companies
Innovation driven by clinical need
Improve Quality of Care
NeoTract, Inc. initiated within ExploraMed, a Medical Device Incubator
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ExploraMed – results
• 1995 Founded• 1996 EndoMatrix,Inc.
• Tissue bulking device for incontinence.• Acquired by C.R. Bard in 1997
• 1996 TransVascular,Inc.• Percutaneous bypass, stem cell therapy• Acquired by Medtronic in 2003
• 2004 Acclarent,Inc.• ENT “Balloon Sinuplasty”• Acquired by J&J in 2010
• 2005 NeoTract,Inc.• UroLift BPH implant
• 2006 Vibrynt,Inc.• Implant for morbid obesity
• 2007 Moximed,Inc.• KineSpring for knee osteoarthritis
• 2014 Nuelle launched• Female sexual health
• 2015 NC7 launched
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NeoTract at a Glance
• Developer of the UroLift® system, a minimally invasive treatment for Benign Prostatic Hyperplasia (BPH)
• Founded in 2004
• All Manufacturing in Pleasanton: Certified Class 8/100,000 CER
• UroLift approved in USA, Canada, Europe, S Korea, Singapore, Mexico and Australia
• 15000+ patients treated with UroLift worldwide to date
150 Employees, Headquartered in Pleasanton, CA
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Anatomy of BPH secondary to LUTS?
Normal BPH
Hypertrophied detrusor muscle
Obstructed urinary flow
PROSTATE
BLADDER
URETHRA
Roehrborn CG, McConnell JD. In: Walsh PC et al, eds. Campbell’s Urology. 8th ed. Philadelphia, Pa: Saunders; 2002:1297-1336.
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Recognizing the Symptoms of BPH- A couples disease!
• Frequent urination• Multiple trips to the bathroom at night• Sudden urge to urinate• Difficult or painful urination• Weak or slow urine flow• Incomplete elimination of urine• Stopping and starting of flow
Abrams, et al., Neurourology and Urodynamics 2002; Maximilian, et al., BJU Intl 2012
SO WHAT?
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The burden of BPH In Europe
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BPH: It’s not about the prostate…
• It’s about bladder health.– Continued obstruction makes bladder
work harder– Eventually bladder decompensates– Well documented– BPH medications affect symptoms but
do not reduce obstruction – bladder health inevitably worsens
• Men undergo surgery much later in the disease process
• Bladder remains obstructed, less opportunity for recovery
1 Flanigan, Reda, Bruskewitz et al. J Urol 1998.WW: watchful waitingTURP: transurethral resection of the prostate
Dise
ase
Prog
ress
ion
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Delayed Disobstruction Also Increases COST
Disease Progression
Cost
of C
are
Prevention
Surgery
Palliative Rx
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Recently we set out to map this cost for NICE and Lord Carter’s review…....
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BPH – Annual burden for Primary Care
NeoTract Confidential
£9,047,638.54
£16,421,465.42
£14,480,338.04
£1,687,089
.52£7,166,325
.84
£57,667,708.81
£1,770.28
Finasteride
Dutasteride
Alfuzosin Hydrochloride
Indoramin
Tamsulosin & Dutasteride Hydrochloride
Tamsulosin Hydrochloride
Terazosin Hydrochloride
Annual Spend on BPH drugs1
£107 Million
Primary Care Consultations2
1.6 Million
Cost of Primary Care Consultations (2003)3
£44 Million
1. Health and Social Care Information Centre 2014. 2. Kirby R et al. ProState of the Nation report. A call to action: delivering more effective care for BPH patients in the UK. 2009. 3. Speakman M et al. BJU Int 2015; 115:508-519
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Burden of BPH – Hospital admissions
NeoTract Confidential
Annual burden of BPH (2014/15)
Unique patients: 130,584Admissions: 184,449Procedures: 237,341
Cost per year £321 Million50% non-electiveAverage LOS = 9.5 days
5-year burden of BPH (2009 -2014)
Total admissions: 1 Million (trending up)Cost £1.7 Billion
£2,457
Health Episode Statistics. Patients entering hospital who are diagnosed with BPH (N40X any diagnosis position). Cost based on national Tariff
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BPH surgery – Annual cost
NeoTract Confidential
Health Episode Statistics – OPCS M65, 2014/15. Cost based on National Schedule of References Costs LB25E 2013/14
Procedures: 18,699
Cost per patient £2,718Cost per year £51 MillionInpatient bed days 51,000Elective theatre hours 19,000-29,000
94% Elective vs 6% day case
Average LOS = 2.74 days60% patients have major or intermediate complications and co-morbidities
£51 Million
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5 year pathway burden of post-operative complications following BPH surgery
NeoTract Confidential
Source: Health Economic Statistics. For every patient who had BPH surgery (OPCS M65) in 2009, an analysis of complications (listed by ICD10) for each of the 5 years following the procedure. Numbers of spells and costs (based on tariff) for this activity
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Cumulative and annual cost burden of complications from BPH surgery
NeoTract Confidential
2009 2010 2011 2012 2013 2014£0
£20,000,000
£40,000,000
£60,000,000
£80,000,000
£100,000,000
£120,000,000 Total annual cost of complications
£109 Million70,000
hospital spells
Cumulative cost of complications from single cohort of patients treated in 2009
Source: Health Economic Statistics. For every patient who had BPH surgery (OPCS M65) in 2009, an analysis of complications (listed by ICD10) for each of the 5 years following the procedure. Numbers of spells and costs (based on tariff) for this activity
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> 1 in 5 patients return to BPH drug treatment after surgery
NeoTract Confidential
Strope S et al. Urology 2015; 86: 1115-1122
BPH Medication after TURP or Laser
21%25%
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Even 1 in 10 de-novo patients require BPH medication after surgery
NeoTract Confidential
11% 8%
BPH Medication after TURP or Laser
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The LUTS / BPH Cycle – Burden of Care
NeoTract Confidential
Primary Care(Medication / GP
Consultations)
Emergency Admission
Surgery
Post-operative
Complications
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SOLUTION?: Can we Shift Paradigm of BPH care to Increase Impact & Lower Cost
Disease Progression
Cost
of C
are
Prevention
Surgery
Palliative Rx
Prostatic Urethral Lift
• Earlier disobstruction reverses bladder decay
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Only 3 procedures tried for BPH:
1. Remove prostate tissue• Enucleation: Simple, HoLEP, Robotic, […Water jet?]• Resection: TURP, TUIP, Bipolar• Vaporization: PVP laser, HoLAP, Button
2. Injure/scar/ablate prostate tissue• Microwave (7), TUNA(3)• Ethanol, Toxins (4), […Steam?]
3. Open the prostate• Stents(6)
• Excellent disobstruction
• Serious adverse events• Lengthy recovery
• Modest disobstruction
• Poor consistency, durability• Lengthy recovery
• Immediate disobstruction
• Irritation• Complications requiring removal
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NEED: Nothing Fills the Ideal Space
Tolerability
Effec
tiven
ess
•Decreased libido•Ineffective first 2-3 mo. 1,5
•Difficult recovery period• Catheter 1-2 wks3
• 4-6 wks before improvement4
• 30-70% irritative symptoms1
•Inconsistent response
1 AUA Guidelines 20032 Varkarakis et al, The Prostate 58: 248-251 (2004)3 Rubenstin J, Transurethral Microwave Thermotherapy of the Prostate (TUMT), eMedicine article, July 20044 Muruve, N, Transuretheral Needle Ablation of the Prostate (TUNA), eMedicine article, June 20055 AUA: Urologyhealth.org
5ari
TUMTTUNA
•Fatigue, dizziness, anejaculation, impotence1,5
•Surgical Standard• 5% Re-op at 10 yrs1,2
• 3-5 hospital days• 4-6 weeks recovery• 65% ejac dysfunction1
• 10% impotence1
•TURP-like with reduced bleeding
AlphaBlocker
Laser
TURP
+Steam
+Button+Bipolar
+tadalafil
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The Solution that Urologists & Healthcare Systems Seek• Straightforward Procedure
– Rapidly and easily deployable (no capital outlay, infrastructure or staff changes
– Reliable, reproducible– Ambulatory - Local anesthesia
• Rapid Relief– Reduce patient complications, recovery time and healthcare burden
• Preserve Function– Bladder function– Sexual function
• Durable– Years of relief
• Cost Effective– Less expensive for system
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A NEW View: What is BPH really?• BPH is a mechanical problem.
• Benign Prostate Hyperplasia is, by definition, benign tissue.
• Removing or destroying this benign tissue can cause complications.
• Why not just move it out of the way?
Pressure
Hyperplastic tissue takes more
work to open
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Fast Forward The Award Winning UroLift® Implant
Permanent Transprostatic Implant2015 BRONZE
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UroLift Becoming a Standard of Care11 years of Diligent Development
July Jan Aug Sept Dec Jan Feb April Feb2011 2012 2013 2013 2013 2014 2014 2014 2016
PUBLISHED
Randomized Crossover Study
Positive Guidance
N.I.C.E.PUBLISHED
2 Year Durability
De Novo Approval
HCPCS Coding
CoverageAETNA
PUBLISHEDRandomized
Blinded Study
PUBLISHEDSexual
FunctionOver 8,000
treated
PUBLISHED
3 Year Randomized
Durability
PUBLISHED
BPH6 Study: Randomized
to TURP
Coverage
Medicare 49 states Kaiser, AetnaSeveral Blue CrossSeveral privates
PUBLISHED
‘Real-World’European Registry
PUBLISHED
Safety & Feasibility
Category 1 CPT Codes
[Effective Jan’15]
PUBLISHED
LOCAL Study
MAC00226-01 Rev A Positive MTEPN.I.C.E.
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Clinical evidence – unrivaled in BPH technologiesPublished:Can J Urol USA Randomized (n=206, 3 yr)EU J Urol BPH6 Randomized (n=80, 1 yr)Blad Dys Rep Meta-AnalysisUrology Practice USA Randomized (n=206, 2 yr)J Urology USA Randomized (n=206, 1 yr)J Sex Med USA Sexual Function Analysis (n=140, 1 yr)BJUI USA Crossover Study (n=53, 1 yr)Can J Urol USA LOCAL Study (n=51, 1 mo)EU J Urol EU Multi-National Study (n=102, 1 yr)Urology J. 2 Year Multi-Center Study (n=64, 2 yrs)J. Sex Med Sexual Function Analysis (n=64)BJUI First-in-Man Experience (n=19, 1 yr)Pop Health Health Economics of UroLiftCan J Urol TechniqueProg Urologie French experienceUrol Neur Uro Spanish experience
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Rapid, reproducible and durable results
0 6 12 18 24 30 36 42 480
5
10
15
20
25
Months
Mea
n IP
SS
Roehrborn et al.
Sonksen et al.
McNicholas et al.
Chin et al.
Roehrborn et al. Can J Urol 2015; Sonksen et al. Eur Urol 2015; McNicholas et al. Eur Urol 2013; Chin et al. Urology 2012
MAC00226-01 Rev A
Retreatment remains low: 12.6% at 4 years
4-year data presented at EAU Congress March 2016 recentlypublished
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Minimally Invasive Safety Profile
Most common AE were mild to moderate, typically resolve by 2-4 weeks:
No incidence (0%) of de novo sustained ejaculatory or erectile dysfunction.
PULSubjects
ControlSubjects
Dysuria 34% 17%
Hematuria 26% 5%
Pelvic pain 18% 5%
Urgency 7% 0%
Urge Incontinence 4% 2%
UTI 3% 2%
Roehrborn et al. Can J Urol 2015
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Improved Quality of Care
• UroLift patients recover more quickly– TURP catches up only between 6 to 12 months
• UroLift patients satisfied sooner and to greater extent
0 1 2 3 4 5 6 7 8 9 10 11 1220%
30%
40%
50%
60%
70%
80%
90%
100%
PUL
TURP
Months
Reco
vere
d (Q
oR V
AS)
p<0.05
p<0.05
Sonksen et al. Eur Urol 2015; 68; 643-652.
1 2 3 4 5 6 7 8 9 10 11 1255%
60%
65%
70%
75%
80%
85%
90%
95%
PULTURP
Months
Satis
fied
Patie
nts*
*would recommend procedure
PUL randomized to TURP [gold standard surgery]
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UK N.I.C.E. Approves UroLift as Cost Effective Alternative to TURP
• Only BPH procedure to be shown to be cost effective when compared to TURP and HoLEP (e.g. Greenlight laser is not recommended).
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The Solution that Urologists & Healthcare Systems Seek
• Straightforward Procedure– Reliable, reproducible– Local anesthesia
• Rapid Relief– Reduce patient “earn out” and practice burden
• Preserve Function– Bladder function– Sexual function
• Durable– Years of relief
• Cost Effective– Less expensive for system
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Perceived cost
True cost
• Consumables• Procedure cost• Diathermy• Morcellation• Histology• Maintenance• Repair• Upgrades• Servicing• Amortisation
The “Current Gold standards” Myth
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UroLift® and The
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Mapping our Journey into the NHS … and we are just getting going
CE Mark
NICE IPG Urolift given
incorrect OPCS code)
NICE Medical
Technology Guidance
New combination
code in HRG4+
announced
Introduction of HRG4+
delayed for 1 year
Urolift included in Accelerated
Access Review
Urolift awarded
Innovation Technology
Tariff* (effective 1 April 2017)
*Subject to consultation
Oct 2014First NHS patients treated
with UroLift as part of pilot at Frimley Park
Other hospitals adopt Urolift – at risk due to insufficient funding through
tariff
Start programme of engagement with
AHSNs
Innovation EXPO –
showcased by Wessex
AHSN
Jan 20142010 Aug 2015 Sept 2015 Apr 2016 Oct 2016 Nov 2016
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Mapping our Journey into the NHS … and we are just getting going
CE Mark
NICE IPG Urolift given
incorrect OPCS code)
NICE Medical
Technology Guidance
New combination
code in HRG4+
announced
Introduction of HRG4+
delayed for 1 year
Urolift included in Accelerated
Access Review
Urolift awarded
Innovation Technology
Tariff* (effective 1 April 2017)
*Subject to consultation
Oct 2014First NHS patients treated
with UroLift as part of pilot at Frimley Park
Start programme of engagement with
AHSNs
Innovation EXPO –
showcased by Wessex
AHSN
Jan 20142010 Aug 2015 Sept 2015 Apr 2016 Oct 2016 Nov 2016
The UroLift system should be considered for use in men with lower urinary tract symptoms of benign prostatic hyperplasia who are aged 50 years and older and who have a prostate of
less than 100 cm3.
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Mapping our Journey into the NHS … and we are just getting going
CE Mark
NICE IPG Urolift given
incorrect OPCS code)
NICE Medical
Technology Guidance
New combination
code in HRG4+
announced
Introduction of HRG4+
delayed for 1 year
Urolift included in Accelerated
Access Review
Urolift awarded
Innovation Technology
Tariff* (effective 1 April 2017)
*Subject to consultation
Oct 2014First NHS patients treated
with UroLift as part of pilot at Frimley Park
Start programme of engagement with
AHSNs
Innovation EXPO –
showcased by Wessex
AHSN
Jan 20142010 Aug 2015 Sept 2015 Apr 2016 Oct 2016 Nov 2016
Innovative medical technologies with cost saving potential
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Mapping our Journey into the NHS … and we are just getting going
CE Mark
NICE IPG Urolift given
incorrect OPCS code)
NICE Medical
Technology Guidance
New combination
code in HRG4+
announced
Introduction of HRG4+
delayed for 1 year
Urolift included in Accelerated
Access Review
Urolift awarded
Innovation Technology
Tariff* (effective 1 April 2017)
*Subject to consultation
Oct 2014First NHS patients treated
with UroLift as part of pilot at Frimley Park
Start programme of engagement with
AHSNs
Innovation EXPO –
showcased by Wessex
AHSN
Jan 20142010 Aug 2015 Sept 2015 Apr 2016 Oct 2016 Nov 2016
Innovation and Technology tariff will:• help cut the hassle experienced by clinicians and innovators in getting uptake and
spread across the NHS• guarantee automatic reimbursement of approved technologies
NHS England, November 2016
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Mapping our Journey into the NHS … and we are just getting going
CE Mark
NICE IPG Urolift given
incorrect OPCS code)
NICE Medical
Technology Guidance
New combination
code in HRG4+
announced
Introduction of HRG4+
delayed for 1 year
Urolift included in Accelerated
Access Review
Urolift awarded
Innovation Technology
Tariff* (effective 1 April 2017)
*Subject to consultation
Oct 2014First NHS patients treated
with UroLift as part of pilot at Frimley Park
Other hospitals adopt Urolift – at risk due to insufficient funding through
tariff
Start programme of engagement with
AHSNs
Innovation EXPO –
showcased by Wessex
AHSN
Jan 20142010 Aug 2015 Sept 2015 Apr 2016 Oct 2016 Nov 2016
Innovation and Technology tariff will:• help cut the hassle experienced by clinicians and innovators in getting uptake and
spread across the NHS• guarantee automatic reimbursement of approved technologies
NHS England, November 2016
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Scope of the productivity and efficiency savings from Urolift
40% Adoption
Clinical practice tells us that >40% of men undergoing surgery for LUTS would be clinically eligible for a prostatic urethral lift procedure as alternative to current surgical practice
NeoTract Confidential
Men requiring surgery for BPH
Urolift >40%
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LUTS due to BPH: Impact of UroLift on Pathway**Estimate based on 8,000 UroLift/yr (40% of TURP pts)
COSTS BURDEN TO THE NHS
Reduces Primary Care consultations£ Saving to be determined
PRIMARY CARE
ACUTE CARE
BPH-related hospital episodes
SurgeryACUTE CARE
Reduces procedure costs
>£4 Million/yr savingSaves 21,000 bed days and 8,000-12,000 main theatre hours
BPH drug treatment
£107 Million/yrPrimary Care Consultations
1.6 million consultations
£44 Million/yr
BPH-related hospital episodes
£321 Million/yrAverage length of stay: 9 days
50% of acute care is non-elective
Elective BPH surgery
£54 Million/yr20,000 TURP procedures/yr
60,000 inpatient bed days/yr20-40,000 theatre hours/yr
Surgery-related complications
£109 Million/yr 70,000 hospital spells
Reduces complication costs and hospital spells
>£22 Million/yrSaves 14,000 hospital spells
New drug use within
3 yrs of TURP: 22%
Reduces BPH drug treatment£ Saving to be determined
ESTIMATED COST SAVING
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Thank you and questions