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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
1. Injure/scar/ablate prostate tissue
• Microwave (7), TUNA(3)
• Ethanol, Toxins (4), […Steam?]
1. 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](https://image.slidesharecdn.com/9-161208141015/75/ECO10-Measuring-the-true-pathway-of-innovation-in-the-NHS-20-2048.jpg)
![UroLift Becoming a Standard of Care
11 years of Diligent Development
PUBLISHED
Randomized
Crossover Study
Positive
Guidance
N.I.C.E.PUBLISHED
2 Year
Durability
De Novo
Approval
HCPCS Coding
Coverage
AETNA
PUBLISHED
Randomized
Blinded Study
PUBLISHED
Sexual
Function
Over 8,000
treated
PUBLISHED
3 Year
Randomized
Durability
PUBLISHED
BPH6 Study:
Randomized
to TURP
Coverage
Medicare 49 states
Kaiser, Aetna
Several Blue Cross
Several privates
PUBLISHED
‘Real-World’
European
Registry
PUBLISHED
Safety &
Feasibility
Category 1
CPT Codes
[Effective Jan’15]
PUBLISHED
LOCAL Study
MAC00226-01 Rev A Positive MTEP
N.I.C.E.](https://image.slidesharecdn.com/9-161208141015/75/ECO10-Measuring-the-true-pathway-of-innovation-in-the-NHS-26-2048.jpg)
![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
20%
30%
40%
50%
60%
70%
80%
90%
100%
0 3 6 9 12
Recovered(QoRVAS)
Months
PUL
TURP
p<0.05
p<0.05
Sonksen et al. Eur Urol 2015; 68; 643-652.
55%
60%
65%
70%
75%
80%
85%
90%
95%
1 2 3 4 5 6 7 8 9 10 11 12
SatisfiedPatients*
Months
PUL
TURP
*would recommend procedure
PUL randomized to TURP [gold standard surgery]](https://image.slidesharecdn.com/9-161208141015/75/ECO10-Measuring-the-true-pathway-of-innovation-in-the-NHS-30-2048.jpg)
Uploaded byInnovation Agency
ECO10 - Measuring the true pathway of innovation in the NHS
The document discusses the introduction and clinical evidence for the UroLift system, a minimally invasive treatment for benign prostatic hyperplasia (BPH). It summarizes the clinical trials demonstrating UroLift's rapid and durable relief of BPH symptoms with minimal side effects. It also outlines UroLift's journey to approval and reimbursement in the UK, including a positive NICE recommendation and being granted an Innovation Technology Tariff to facilitate adoption in the NHS. UroLift is positioned as a cost-effective alternative to traditional BPH surgeries that allows for quicker recovery and preservation of sexual function.
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ECO10 - Measuring the true pathway of innovation in the NHS
- 1. Measuring the truepathway of innovation into the NHS UroLift® – A Case Study Justin Hall, Vice President & General Manager EMEA, NeoTract Inc.
- 2. Mission: Identify Clinical Needs DevelopParadigm Shifts Invent or License Prove Feasibility Launch Medtech Companies Innovation driven by clinical need Improve Quality of Care NeoTract, Inc. initiated within ExploraMed, a Medical Device Incubator
- 3. 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
- 4. NeoTract at aGlance • 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
- 5. Anatomy of BPHsecondary 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.
- 6. Recognizing the Symptomsof 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?
- 7. The burden ofBPH In Europe
- 8. BPH: It’s notabout 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 waiting TURP: transurethral resection of the prostate DiseaseProgression
- 9. Delayed Disobstruction AlsoIncreases COST Disease Progression CostofCare Prevention Surgery
- 10. Recently we setout to map this cost for NICE and Lord Carter’s review…....
- 11. BPH – Annualburden 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
- 12. Burden of BPH– Hospital admissions NeoTract Confidential Annual burden of BPH (2014/15) Unique patients: 130,584 Admissions: 184,449 Procedures: 237,341 Cost per year £321 Million 50% non-elective Average 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
- 13. 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 £2,718 Cost per year £51 Million Inpatient bed days 51,000 Elective theatre hours 19,000-29,000 94% Elective vs 6% day case Average LOS = 2.74 days 60% patients have major or intermediate complications and co-morbidities £51 Million
- 14. 5 year pathwayburden 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
- 15. Cumulative and annualcost burden of complications from BPH surgery NeoTract Confidential £0 £20,000,000 £40,000,000 £60,000,000 £80,000,000 £100,000,000 £120,000,000 2009 2010 2011 2012 2013 2014 Total annual cost of complications £109 Million 70,000 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
- 16. > 1 in5 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%
- 17. Even 1 in10 de-novo patients require BPH medication after surgery NeoTract Confidential 11% 8% BPH Medication after TURP or Laser
- 18. The LUTS /BPH Cycle – Burden of Care NeoTract Confidential Primary Care (Medication / GP Consultations) Emergency Admission Surgery Post-operative Complications
- 19. SOLUTION?: Can weShift Paradigm of BPH care to Increase Impact & Lower Cost Disease Progression CostofCare Prevention Surgery Prostatic Urethral Lift • Earlier disobstruction reverses bladder decay
- 20. Only 3 procedurestried for BPH: 1. Remove prostate tissue • Enucleation: Simple, HoLEP, Robotic, […Water jet?] • Resection: TURP, TUIP, Bipolar • Vaporization: PVP laser, HoLAP, Button 1. Injure/scar/ablate prostate tissue • Microwave (7), TUNA(3) • Ethanol, Toxins (4), […Steam?] 1. 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
- 21. NEED: Nothing Fillsthe Ideal Space Tolerability Effectiveness •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 2003 2 Varkarakis et al, The Prostate 58: 248-251(2004) 3 Rubenstin J, Transurethral Microwave Thermotherapy of the Prostate (TUMT), eMedicine article, July 2004 4 Muruve, N, Transuretheral Needle Ablation of the Prostate (TUNA), eMedicine article, June 2005 5 AUA: Urologyhealth.org 5ari TUMT TUNA •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 Alpha Blocker Laser TURP
- 22. The Solution thatUrologists & 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
- 23. 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
- 25. Fast Forward TheAward Winning UroLift® Implant Permanent Transprostatic Implant 2015 BRONZE
- 26. UroLift Becoming aStandard of Care 11 years of Diligent Development PUBLISHED Randomized Crossover Study Positive Guidance N.I.C.E.PUBLISHED 2 Year Durability De Novo Approval HCPCS Coding Coverage AETNA PUBLISHED Randomized Blinded Study PUBLISHED Sexual Function Over 8,000 treated PUBLISHED 3 Year Randomized Durability PUBLISHED BPH6 Study: Randomized to TURP Coverage Medicare 49 states Kaiser, Aetna Several Blue Cross Several privates PUBLISHED ‘Real-World’ European Registry PUBLISHED Safety & Feasibility Category 1 CPT Codes [Effective Jan’15] PUBLISHED LOCAL Study MAC00226-01 Rev A Positive MTEP N.I.C.E.
- 27. Clinical evidence –unrivaled in BPH technologies Published: Can J Urol USA Randomized (n=206, 3 yr) EU J Urol BPH6 Randomized (n=80, 1 yr) Blad Dys Rep Meta-Analysis Urology 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 UroLift Can J Urol Technique Prog Urologie French experience Urol Neur Uro Spanish experience
- 28. Rapid, reproducible anddurable results 0 5 10 15 20 25 0 6 12 18 24 30 36 42 48 MeanIPSS Months 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 recently published
- 29. Minimally Invasive SafetyProfile Most common AE were mild to moderate, typically resolve by 2-4 weeks: No incidence (0%) of de novo sustained ejaculatory or erectile dysfunction. PUL Subjects Control Subjects 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
- 30. Improved Quality ofCare • UroLift patients recover more quickly – TURP catches up only between 6 to 12 months • UroLift patients satisfied sooner and to greater extent 20% 30% 40% 50% 60% 70% 80% 90% 100% 0 3 6 9 12 Recovered(QoRVAS) Months PUL TURP p<0.05 p<0.05 Sonksen et al. Eur Urol 2015; 68; 643-652. 55% 60% 65% 70% 75% 80% 85% 90% 95% 1 2 3 4 5 6 7 8 9 10 11 12 SatisfiedPatients* Months PUL TURP *would recommend procedure PUL randomized to TURP [gold standard surgery]
- 31. UK N.I.C.E. ApprovesUroLift 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).
- 32. The Solution thatUrologists & 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
- 33. Perceived cost True cost •Consumables • Procedure cost • Diathermy • Morcellation • Histology • Maintenance • Repair • Upgrades • Servicing • Amortisation The “Current Gold standards” Myth
- 34.
- 35. Mapping our Journeyinto 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 2014 First 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
- 36. Mapping our Journeyinto 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 2014 First 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.
- 37. Mapping our Journeyinto 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 2014 First 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
- 38. Mapping our Journeyinto 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 2014 First 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
- 39. Mapping our Journeyinto 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 2014 First 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
- 40. Scope of theproductivity 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%
- 41. LUTS due toBPH: 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 Surgery ACUTE CARE Reduces procedure costs >£4 Million/yr saving Saves 21,000 bed days and 8,000-12,000 main theatre hours BPH drug treatment £107 Million/yr Primary Care Consultations 1.6 million consultations £44 Million/yr BPH-related hospital episodes £321 Million/yr Average length of stay: 9 days 50% of acute care is non-elective Elective BPH surgery £54 Million/yr 20,000 TURP procedures/yr 60,000 inpatient bed days/yr 20-40,000 theatre hours/yr Surgery-related complications £109 Million/yr 70,000 hospital spells Reduces complication costs and hospital spells >£22 Million/yr Saves 14,000 hospital spells New drug use within 3 yrs of TURP: 22% Reduces BPH drug treatment £ Saving to be determined ESTIMATED COST SAVING
- 42. Thank you andquestions