1
Fostering Active Surveillance in Low-Risk Prostate Cancer Andre T. C. Chen 1 , MD PhD; Rafael Ielpo, MD 2 ; Thiago Castellar, BEng 3 , Luis F. R. Sampaio, MD, MPH 2 1 Instituto do Cancer do Estado de São Paulo, Hospital das Clinicas da Faculdade de Medicina da USP, São Paulo, Brazil; 2 Seguros Unimed, São Paulo, Brazil; 3 ADVISIA, São Paulo, Brazil CONTEXT - This work was developed at Seguros Unimed, a Health Insurance Provider in Brazil with nationwide coverage of approximately 520,000 lives. - Brazilian private health care sector covers 47 million people or 24% of the country´s population 1 (Fig.1). Fee-for- service is the predominant payment modality. A clinical outcome mentality takes time to be implemented and needs to be fostered through clear, honest communication between stakeholders, including payers, providers and patients. - Prostate cancer (PCa) is among men the second most incident cancer worldwide 3 and the most incident cancer in Brazil 4 , representing respectively, 13.9% and 31.7% of all cancer cases in men. - Low-risk PCa ranges from 40 to 77% of cases 5-7 - Active surveillance (AS) is an adequate option in the management of low-risk PCa 8 - Randomized data comparing AS vs active treatments have consistently shown non-inferior survival and lower incidence of impotence and incontinence 5,6,9,10 - In Brazil, AS is rarely adopted in the management of Pca. - To address the low adoption of AS, we created a Prostate Cancer Management Program to reformulate the delivery of care for prostate cancer patients. The program involves three pillars: reformulation of payment model, development of evidence-based treatment guidelines and implementation of health outcome measurement. - We developed an economical model from the perspective of the Health Insurance Provider to compare direct costs of AS vs Active treatment (open/laparoscopic prostatectomy, 3D or IMRT radiotherapy). We estimated an average net saving of USD 539.11 per patient included in AS program [10y-time span; annual inflation 2.95%; WACC 10%; 3.70 BRL = 1 USD (Jan 14, 2019)]. Following the initial cost analysis, we developed a shared saving algorithm to reward physicians for patients that fulfilled criteria and were kept in AS (Table 2). - We have also developed evidence-based treatment guidelines, as well thresholds to trigger action. In the end of 2018, we started a pilot, implementing the new payment model as well as the treatment guidelines with a local health care provider. - We are currently developing and validating the tools to collect ICHOM localized prostate cancer standard set, as well as the appropriate informed consents to comply with national laws and regulations. Andre T C Chen, MD, PhD; andre [email protected] Rafael Ielpo, MD; rafael [email protected] LESSON POINT 1 WHAT DID YOU DO? REFERENCES Contact information: SITUATION/ BACKGROUND IMPACT OF CHANGES ON OUTCOMES - We are at the beginning of a new institutional culture, bringing clinical endpoints to a spotlight dominated by costs. - Our Prostate Cancer Management Program is perceived by Health Care Providers as a positive initiative that shifts the payer focus from reducing costs to providing quality health care in a financially sustainable fashion. 24,4% Public 47 million people Total Population 2 : 207.660.929 Private Urinary Incontinence Erectile Dysfunction Active Surveillance 10 4% 53% Radical Prostatectomy 5,10 17-21% 81% Radical Radiotherapy 10 4% 66% † Within the given range of medical bonuses, all scenarios are cost-saving * Procedures performed within the scope of proposed evidence-based guideline The successful implementation of active surveillance for low-risk prostate cancer requires a reformulation of the current fee-for-service model. 1. Agencia Nacional de Saúde Suplementar, http://www.ans.gov.br/perfil-do- setor/dados-e-indicadores-do-setor, acessed in Jan, 30, 2019. 2. FUNDAÇÃO INSTITUTO BRASILEIRO DE GEOGRAFIA E ESTATÍSTICA, RESOLUÇÃO No- 4, Anexo, Diário Oficial da União, Aug 30, 2017. 3. Bray F, Ferlay J, Soerjomataram I, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2018;68:394-424. 4. INCA. Estimativa 2018 - Incidência de câncer No Brasil, 2017. http://www.inca.gov.br/estimativa/2018/estimativa-2018.pdf. 5. Wilt TJ, Brawer MK, Jones KM, et al. Radical Prostatectomy versus Observation for Localized Prostate Cancer. N Engl J Med 2012;367:203-213. 6. Hamdy FC, Donovan JL, Lane JA, et al. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer. N Engl J Med 2016;375:1415-1424. 7. Martin RM, Donovan JL, Turner EL, et al. Effect of a low-intensity PSA-based screening intervention on prostate cancer mortality: The CAP randomized clinical trial. JAMA - J Am Med Assoc 2018;319:883-895. 8. Klotz L, Vesprini D, Sethukavalan P, et al. Long-term follow-up of a large active surveillance cohort of patients with prostate cancer. J Clin Oncol 2015;33:272-277. 9. Wilt TJ, Jones KM, Barry MJ, et al. Follow-up of Prostatectomy versus Observation for Early Prostate Cancer. N Engl J Med 2017;377:132-142. 10. Donovan JL, Hamdy FC, Lane JA, et al. Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med 2016;375:1425-1437. LESSON POINT 2 US$ 0 54 108 162 216 270 324 0 495.440 464.179 432.919 401.658 370.398 339.137 307.877 135 483.231 451.970 420.710 389.449 358.189 326.928 295.668 216 475.905 444.645 413.384 382.124 350.863 319.603 288.342 405 458.812 427.552 396.291 365.031 333.770 302.510 271.249 541 446.603 415.342 384.082 352.821 321.561 290.300 259.040 676 434.394 403.133 371.873 340.612 309.352 278.091 246.831 811 422.184 390.924 359.663 328.403 297.142 265.882 234.621 Yearly Medical Bonus for Individual Low-risk PCa Patient in Active Surveillance Additional Medical Bonus per prostatectomy* Figure 2. Private Health Care Coverage by State 1 Figure 1. Brazil´s Health Care Coverage by funding source 1 Table 1. Patient -Reported Urinary and Erectile Dysfunction at 2 Years, According to Treatment Strategy 5 to 10% 10 to 20% 20 to 30% More than 30% Table 2. Sensitivity Analysis of Shared Savings Program† per 100 patients with Low- Risk Prostate Cancer (PCa) included in Active Surveillance Program

Fostering Active Surveillance in Low-Risk Prostate Cancer · - Prostate cancer (PCa) is among men the second most incident cancer worldwide3 and the most incident cancer in Brazil4,

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Page 1: Fostering Active Surveillance in Low-Risk Prostate Cancer · - Prostate cancer (PCa) is among men the second most incident cancer worldwide3 and the most incident cancer in Brazil4,

Fostering Active Surveillance in Low-Risk Prostate Cancer

Andre T. C. Chen 1, MD PhD; Rafael Ielpo, MD 2; Thiago Castellar, BEng 3, Luis F. R. Sampaio, MD, MPH 2

1 Instituto do Cancer do Estado de São Paulo, Hospital das Clinicas da Faculdade de Medicina da USP, São Paulo, Brazil; 2 Seguros Unimed, São Paulo, Brazil; 3 ADVISIA, São Paulo, Brazil

CONTEXT- This work was developed at Seguros

Unimed, a Health Insurance Provider in Brazil with nationwide coverage of approximately 520,000 lives. - Brazilian private health care sector covers 47 million people or 24% of the country´s population1 (Fig.1). Fee-for-service is the predominant payment modality.

A clinical outcome mentality takes time to be implemented and needs to be

fostered through clear, honest communication between stakeholders,

including payers, providers and patients.

- Prostate cancer (PCa) is among men the second most incident cancer worldwide3 and the most incident cancer in Brazil4, representing respectively, 13.9% and 31.7% of all cancer cases in men.- Low-risk PCa ranges from 40 to 77% of cases5-7

- Active surveillance (AS) is an adequate option in the management of low-risk PCa8

- Randomized data comparing AS vs active treatments have consistently shown non-inferior survival and lower incidence of impotence and incontinence5,6,9,10

- In Brazil, AS is rarely adopted in the management of Pca.

- To address the low adoption of AS, we created a Prostate Cancer Management Program to reformulate the delivery of care for prostate cancer patients. The program involves three pillars: reformulation of payment model, development of evidence-based treatment guidelines and implementation of health outcome measurement. - We developed an economical model from the perspective of the Health Insurance Provider to compare direct costs of AS vs Active treatment (open/laparoscopic prostatectomy, 3D or IMRT radiotherapy). We estimated an average net saving of USD 539.11 per patient included in AS program [10y-time span; annual inflation 2.95%; WACC 10%; 3.70 BRL = 1 USD (Jan 14, 2019)]. Following the initial cost analysis, we developed a shared saving algorithm to reward physicians for patients that fulfilled criteria and were kept in AS (Table 2). - We have also developed evidence-based treatment guidelines, as well thresholds to trigger action. In the end of 2018, we started a pilot, implementing the new payment model as well as the treatment guidelines with a local health care provider. - We are currently developing and validating the tools to collect ICHOM localized prostate cancer standard set, as well as the appropriate informed consents to comply with national laws and regulations.

Andre T C Chen, MD, PhD; [email protected]

Rafael Ielpo, MD; [email protected]

LESSON POINT 1

WHAT DID YOU DO?REFERENCES

Contact information:

SITUATION/ BACKGROUND

IMPACT OF CHANGES ON OUTCOMES- We are at the beginning of a new institutional culture, bringing clinical endpoints to a spotlight dominated by costs. - Our Prostate Cancer Management Program is perceived by Health Care Providers as a positive initiative that shifts the payer focus from reducing costs to providing quality health care in a financially sustainable fashion.

24,4%

Public

47 million people

Total Population2: 207.660.929

Private

Urinary Incontinence Erectile Dysfunction

Active Surveillance10

4% 53%

Radical Prostatectomy5,10 17-21% 81%

Radical Radiotherapy10

4% 66%

† Within the given range of medical bonuses, all scenarios are cost-saving* Procedures performed within the scope of proposed evidence-based guideline

The successful implementation of

active surveillance for low-risk prostate cancer requires a

reformulation of the current fee-for-service

model.

1. Agencia Nacional de Saúde Suplementar, http://www.ans.gov.br/perfil-do-

setor/dados-e-indicadores-do-setor, acessed in Jan, 30, 2019.

2. FUNDAÇÃO INSTITUTO BRASILEIRO DE GEOGRAFIA E ESTATÍSTICA, RESOLUÇÃO No-

4, Anexo, Diário Oficial da União, Aug 30, 2017.

3. Bray F, Ferlay J, Soerjomataram I, et al. Global cancer statistics 2018: GLOBOCAN

estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA

Cancer J Clin 2018;68:394-424.

4. INCA. Estimativa 2018 - Incidência de câncer No Brasil, 2017.

http://www.inca.gov.br/estimativa/2018/estimativa-2018.pdf.

5. Wilt TJ, Brawer MK, Jones KM, et al. Radical Prostatectomy versus Observation for

Localized Prostate Cancer. N Engl J Med 2012;367:203-213.

6. Hamdy FC, Donovan JL, Lane JA, et al. 10-Year Outcomes after Monitoring, Surgery,

or Radiotherapy for Localized Prostate Cancer. N Engl J Med 2016;375:1415-1424.

7. Martin RM, Donovan JL, Turner EL, et al. Effect of a low-intensity PSA-based

screening intervention on prostate cancer mortality: The CAP randomized clinical trial.

JAMA - J Am Med Assoc 2018;319:883-895.

8. Klotz L, Vesprini D, Sethukavalan P, et al. Long-term follow-up of a large active

surveillance cohort of patients with prostate cancer. J Clin Oncol 2015;33:272-277.

9. Wilt TJ, Jones KM, Barry MJ, et al. Follow-up of Prostatectomy versus Observation

for Early Prostate Cancer. N Engl J Med 2017;377:132-142.

10. Donovan JL, Hamdy FC, Lane JA, et al. Patient-Reported Outcomes after

Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med

2016;375:1425-1437.

LESSON POINT 2

US$ 0 54 108 162 216 270 324

0 495.440 464.179 432.919 401.658 370.398 339.137 307.877

135 483.231 451.970 420.710 389.449 358.189 326.928 295.668

216 475.905 444.645 413.384 382.124 350.863 319.603 288.342

405 458.812 427.552 396.291 365.031 333.770 302.510 271.249

541 446.603 415.342 384.082 352.821 321.561 290.300 259.040

676 434.394 403.133 371.873 340.612 309.352 278.091 246.831

811 422.184 390.924 359.663 328.403 297.142 265.882 234.621

Yearly Medical Bonus for Individual Low-risk PCa Patient in Active Surveillance

Ad

dit

ion

al M

edic

al

Bo

nu

s p

er

pro

sta

tect

om

y*

Figure 2. Private Health Care Coverage by State1

Figure 1. Brazil´s Health Care Coverage by funding source1

Table 1. Patient -Reported Urinary and Erectile Dysfunction at 2 Years, According to Treatment Strategy

5 to 10%

10 to 20%

20 to 30%

More than 30%

Table 2. Sensitivity Analysis of Shared Savings Program† per 100 patients with Low-Risk Prostate Cancer (PCa) included in Active Surveillance Program