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A Healthcare Actuary’s Survey of 100 Focal Laser Ablation (FLA) Patients John Fortin Atlanta, Georgia September, 2015

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Summary of Key Findings

1) Patients want a treatment option that preserves future options and has minimal side effects. This alternative to doing “all or nothing” is a transformational paradigm shift.

2) Patients are well educated, higher socio-economic group, and have low-to-intermediate risk3) 95% of patients are in retail setting and 5% are in investigational clinical trials4) Only 15% initially learned about mp MRIs from a physician5) 99% report MRI and Guided Biopsy are effective with no or minimal side effects6) Only 6% initially learned about Focal Laser Ablations from a physician7) 99% would recommend FLA to a friend8) 87% report FLA was effective and no recurrence9) 81% report no significant ED and an additional 13% say it is too early to tell10) 86% report no significant Urinary Dysfunction and another 6% say it is too early to tell11) 94+% report they were able to resume their normal daily activities within a week12) What would they have done differently? Nothing or very little … except skip the TRUS (aka

Random or Blind) Biopsy

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Survey BackgroundØFLA Patients’ Survey, not a Clinical Study, conducted over last 14 months

• IncludesProstateCancer(PCa) FLAtreatmentdoneinUSprimarilyinthelast30months– earliesttreatmentin2009

• 100patientsresponding havemedianage61attimeofFLA;fromage43to89• Patientsareapproximately:28%GS6,50%GS(3+4),15%GS(4+3),and7%GS8+• About2/3ofFLAtreatmentswerehemi-gland and1/3werebilateral• Hypothesis:Whole glandsolutions (primarily prostatectomyandradiation)oftenovertreat andActive

Surveillancemayundertreatmanymen, particularlyinlow-to-intermediateriskclassification. So,SurveyexploresFLAasapossible middle-ground approach,ormalelumpectomy.

ØScope includes mp MRI (“mp” stands for “multiparametric” using new MRI technology to analyze anatomical and functional prostate images), MRI Guided Biopsy, and FLA

ØUsed www.surveymonkey.com/s/JQLJ3MW to collect responsesØLead author is John Fortin, FLA patient and Healthcare ActuaryØMuch thanks for design/review from FLA patients Wayne Williams and Henry Oat

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Q2: In which region of the United States do you live?Answered: 100 Skipped: 0

1.NewEngland(Maine,NH,VT,MA,RI,CT)

Goodgeographicrepresentation

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Q3: What is the highest level of school you have completed or the highest degree you have received?Answered: 100 Skipped: 0

Highlyeducatedwith>80%BachelorsorHigherDegrees

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Q4: What was your annual income at the time of the FLA? Or if not employed, what was it when you were actively employed?Answered: 92 Skipped: 8

Medianincome>$100,000

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Q5: Are you White, Black or African-American, American Indian or Alaskan Native, Asian, Native Hawaiian or other Pacific islander, or some other race?Answered: 99 Skipped: 1

95%Caucasian,yetAfrican-Americanshave250%ofnormal riskindying fromPCa

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Q6: What was your type of occupation at the time of your FLA?Answered: 100 Skipped: 0

9%

58%

33%

Whitecollarand/ornotdemandingphysically

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Q7: From whom did you first learn about mp MRI?Answered: 100 Skipped: 0

Only15%fromPhysicians

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Q8: From whom did you first learn about Focal Laser Ablation?Answered: 100 Skipped: 0

Only6%fromPhysicians

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Q9: Before the FLA, how many core samples (needles) from blind biopsies, including saturation biopsies, had already been taken in total?Answered: 100 Skipped: 0

Median:12CoreTRUS(akaRandomorBlind)biopsiesbeforeFLA

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Q10: How do you view the results of any mp MRI and MRI Guided Biopsy that you have had (please select one)?Answered: 100 Skipped: 0

99%Effectivewithnoorminimalsideeffects

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Q11: Who performed your Focal Laser Ablation (please select one)?Answered: 100 Skipped: 0

InthisSurvey,vastmajoritywithDr.Walser andDr.Sperling;only5%investigationalclinicaltrialsNationalInstituteof

Health

UniversityofChicago Other

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Q12: How do you view the role of Focal Laser Ablation treatment (please select one)?Answered: 100 Skipped: 0

87%said“treats…sincethereisstillaprostate”.However,manypatientsviewFLAasadefinitivetreatment forthecurrentlesions…amalelumpectomy.Alsonotethatmanypatientsrejectthepremisethatsurgery/radiation/other shouldbecalleda“cure”sincethereissignificantchanceofrecurrence nomatterwhattreatmentisused.

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Q13: Why did you choose FLA (please select as many as needed)?Answered: 100 Skipped: 0

Itissafe.

Ifthereisafuture re-treatment,itallowsmetochoose fromanumber ofoptions includingFLA.

ItminimizestheamountoftimethatIwillbedisabled.

Ithasnoorminimalsideeffects.

Itiseffective.

#1Preserveretreatmentoptionsand#2MinimizeSideEffects;re-treatcouldbetouch-up…this isdramaticallybetterthancomplex,riskysalvageoptionsaftersurgery/radiation.

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Q14: After the FLA, did or will you use Active Surveillance with mp MRI and other tests, as needed, to monitor your situation on a regular basis?Answered: 100 Skipped: 0

98%arecommittedtoActiveSurveillanceprotocolincludingMRIs

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Q15: As far as you know, after the FLA, are there any new lesions that need treatment?Answered: 100 Skipped: 0

“New”includespreviouslytreatedlesionswith inadequatemargins.The%needingmoretreatmentwillriseovertimewith longerfollow-up.However,outcomeswillimproveinthefuturewithmorephysicianexperience,widermarginsandbettertechnology(improvedimaging,broaderlaser,bettersoftware).Ø 87%No

Ø 13%Yes

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Q16: If it should return, would you consider using FLA to treat it?Answered: 100 Skipped: 0

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Q17: With regard to decision to have FLA as your treatment, what would you have done differently?Answered: 100 Skipped: 0

88%- Verylittleifanything;#2response– Other:“SkiptheTRUS/RandomBiopsy”

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Q18: Thus far, the insurance carrier or Medicare has paid what portion of your bill?Answered: 100 Skipped: 0

Manyclaimsarestillincourseofsettlement.

Medicare,TRICARE(DOD),Cigna,Aetna,GoldenRule(UnitedHealthcare),BCBSofTX,BCBSofGA,BCBSofTN,BCBSofIL,andHealthNet haveallpaidsubstantialamountsonatleastonepatient.

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Q19: Evaluate the following statements.Answered: 100 Skipped: 0 Agree Strongly

Agree

99%

7%

81%

86%

80%

94%

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Patient Comments

Ø “MDs and insurance companies need to understand the difference between ‘experimental and investigational’ vs. ‘new and FDA approved’”

Ø “Blind biopsy is worthless … first biopsy should have been MRI guided”

Ø “None of the three urologists I saw mentioned FLA … one of them did not even know about mp MRI”

Ø “Only side effects were due to catheter”Ø “I am 6 years post FLA, no signs of cancer and no side

effects”

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Conclusion: Low-to-Intermediate Risk FLA Patient Perspective of Options

Option1ActiveSurveillance

Ø GS+familyhistory+PNI+ otherrisksreveallesionsmaynotbeindolent

Ø Clinicianswarnthatprogression isconcern,soneedprocedure now

UNDERTREATMENT

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Conclusion: Low-to-Intermediate Risk FLA Patient Perspective of Options

Option1ActiveSurveillance

Ø GS+familyhistory+PNI+ otherrisksreveallesionsmaynotbeindolent

Ø Clinicianswarnthatprogression isconcern,soneedprocedure now

UNDERTREATMENT

Option2SurgeryorRadiation

Ø Oddsofhaltingdiseaseprogression 50%to90%

Ø Noorminimal impactonlongevity

Ø EDandurinaryrisksarehighandQualityofLifewon’tbethesame

OVERTREATMENT

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Conclusion: Low-to-Intermediate Risk FLA Patient Perspective of Options

Option1ActiveSurveillance

Ø GS+familyhistory+PNI+ otherrisksreveallesionsmaynotbeindolent

Ø Clinicianswarnthatprogression isconcern,soneedprocedure now

UNDERTREATMENT

Option2SurgeryorRadiation

Ø Oddsofhaltingdiseaseprogression 50%to90%

Ø Noorminimal impactonlongevity

Ø EDandurinaryrisksarehighandQualityofLifewon’tbethesame

OVERTREATMENT

Option3FocalLaserAblation

ü Excellentchanceoffullyablatinglesions

ü Noorminimal sideeffects

ü Ifre-treatmentisneeded, zapagainorothertreatment

ü Analogy tobreastcancerlumpectomy

ATTRACTIVEOPTION