ECO10 - Measuring the true pathway of innovation in the NHS

Measuring the true pathway of innovation into the NHS

UroLift® – A Case Study

Justin Hall, Vice President & General Manager EMEA, NeoTract Inc.

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

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

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

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.

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?

The burden of BPH In Europe

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

Delayed Disobstruction Also Increases COST

Disease Progression

Cost

of C

are

Prevention

Surgery

Palliative Rx

Recently we set out to map this cost for NICE and Lord Carter’s review…....

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

Burden of BPH – Hospital admissions


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

BPH surgery – Annual cost


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

5 year pathway burden of post-operative complications following BPH surgery


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

Cumulative and annual cost burden of complications from BPH surgery


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

> 1 in 5 patients return to BPH drug treatment after surgery


Strope S et al. Urology 2015; 86: 1115-1122

BPH Medication after TURP or Laser

21%25%

Even 1 in 10 de-novo patients require BPH medication after surgery


11% 8%

BPH Medication after TURP or Laser

The LUTS / BPH Cycle – Burden of Care


Primary Care(Medication / GP

Consultations)

Emergency Admission

Surgery

Post-operative

Complications

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

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

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

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

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

Fast Forward The Award Winning UroLift® Implant

Permanent Transprostatic Implant2015 BRONZE

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.

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

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

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

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]

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).

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

Perceived cost

True cost

• Consumables• Procedure cost• Diathermy• Morcellation• Histology• Maintenance• Repair• Upgrades• Servicing• Amortisation

The “Current Gold standards” Myth

UroLift® and The

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


CE Mark



NICE Medical

Technology Guidance

New combination

code in HRG4+

announced


delayed for 1 year


Access Review

Urolift awarded







AHSNs

Innovation EXPO –

showcased by Wessex

AHSN


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.


CE Mark



NICE Medical

Technology Guidance

New combination

code in HRG4+

announced


delayed for 1 year


Access Review

Urolift awarded







AHSNs

Innovation EXPO –

showcased by Wessex

AHSN


Innovative medical technologies with cost saving potential


CE Mark



NICE Medical

Technology Guidance

New combination

code in HRG4+

announced


delayed for 1 year


Access Review

Urolift awarded







AHSNs

Innovation EXPO –

showcased by Wessex

AHSN


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


CE Mark



NICE Medical

Technology Guidance

New combination

code in HRG4+

announced


delayed for 1 year


Access Review

Urolift awarded






Other hospitals adopt Urolift – at risk due to insufficient funding through

tariff


AHSNs

Innovation EXPO –

showcased by Wessex

AHSN


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

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


Men requiring surgery for BPH

Urolift >40%

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

Thank you and questions

ECO10 - Measuring the true pathway of innovation in the NHS

Healthcare

Transcript of ECO10 - Measuring the true pathway of innovation in the NHS