Jonas&de&Souza,&MD,&MBA Assistant&Professor&&& · 2018-09-24 · Costs to the payer...

Jonas de Souza, MD, MBA Assistant Professor

The University of Chicago

•  I have no conflicts of interests

Disclosures

•  I have no conflicts of interests today – Moving to Humana in July 2017 –  I will have conflicts of interests

Disclosures

•  Describe how we developed and validated the COmprehensive Score for financial Toxicity PRO

•  Illustrate applicaIons of the COST-‐PRO in pracIce

•  Discuss potenIal future direcIons

Financial Toxicity

Costs to the payer

•  I have no conflicts of interest to disclose

Presented by: Jonas de Souza, MD

MEDICARE 2004 PPPY: $37799

MEDICARE 2014 PPPY: $51566

COMMERCIAL 2004 PPPY: $55789

COMMERCIAL 2014 PPPY: $90656

Costs to the payer

•  I have no conflicts of interest to disclose


MEDICARE 2004

MEDICARE 2014

COMMERCIAL 2004

COMMERCIAL 2014

62%

36%

Cost-sharing is increasing


VISIBLE TO THE PATIENTS

Patients only see the tip of the iceberg


•  COST-‐SHARING, PREMIUMS •  INDIRECT COSTS (LOSS OF INCOME) •  DIRECT NON-‐MEDICAL (CHILDCARE, ETC)

The tip of the iceberg sinks the ship

VISIBLE TO THE PATIENTS •  COST-‐SHARING, PREMIUMS •  INDIRECT COSTS (LOSS OF INCOME) •  DIRECT NON-‐MEDICAL (CHILDCARE, ETC)

BANKRUPTCY IN CANCER PATIENTS LINKED TO EARLY

MORTALITY (RAMSEY ET AL)

FINANCIAL BURDEN LINKED TO HRQOL

(ZAFAR ET AL) (FENN ET AL)

COST-SHARING RELATED TO ADHERENCE

(DUSETZINA ET AL)


“A cancer patient killed himself after he was told he had been “A cancer patient killed himself after he was told he had been refused a wonder drug by his local trust.” a wonder drug by his local trust.”

Ratain MJ: Biomarkers and Clinical Care. AAAS/FDLI Colloquium, Personalized Medicine in an Era of Health Care Reform, 2009

Financial Toxicity Grade 5?

Ratain MJ: Biomarkers and Clinical Care. AAAS/FDLI Colloquium, Personalized Medicine in an Era of Health Care Reform, 2009

A PaIent-‐Centered View

A lot, some, a liYle, not at all

From qualitaFve to quanFtaFve

COST = COmprehensive Score for financial Toxicity

de Souza JA, Yap B, Hlubocky FJ, et al. The Development of a Financial Toxicity Patient Reported Outcome in Cancer: The COST Measure. Cancer. 2014. http://onlinelibrary.wiley.com/doi/10.1002/cncr.28814/abstract

A PaIent-‐Centered View Development of the COST-PROM

de Souza JA, Yap B, Hlubocky FJ, Cella D, Ratain MJ, Daugherty CK. The Development of a Financial Toxicity Patient Reported Outcome in Cancer: The COST Measure. Cancer. 2014. http://onlinelibrary.wiley.com/doi/10.1002/cncr.28814/abstract

20 patients

35 patients

46 patients

100 patients 46 from step 3 plus 54 only for factor analysis

•  PaIents with advanced cancers

•  Who received chemotherapy for at least 3 months

•  Last treatment not longer than 6 months prior to the assessment

A PaIent-‐Centered View Development of the COST-PROM – 1/4 steps

20 patients

35 patients

46 patients


•  The qualitaIve interviews with 20 paIents, literature review and expert opinion resulted in 147 items

•  A_er reducIon due to overlapping content, a total of 58 items were retained: 31 items from paIents, 25 items from the literature, 2 from experts • 58 items were classified into 8 financial items, 13 resource items, 17 affect items, 10 coping items, and 10 family items

58 items retained



20 patients

35 patients

46 patients


•  Importance score = frequency x importance •  Retain all items unIl at least 3 items per domain had been retained – 28 items excluded

•  30 items going to step 3

58 items retained

30 items retained


20 patients

35 patients

46 patients


58 items retained

30 items retained

Inter-item correlation Item-total correlation

Preliminary factor analysis

35 patients

46 patients


•  Following FACT formadng

•  CollecIng sociodemographics


•  Pairs of items with an IIC >0.7 were identified and, within each correlated pair, the item with the highest importance score in step 2 was retained


•  Pairs of items with an IIC >0.7 were identified and, within each correlated pair, the item with the highest importance score in step 2 was retained

•  Items with nonsignificant item-total correlations (ITCs) (ie, not significantly related to the instrument total score; P  >  .05) were excluded

35 patients

46 patients


• Interim factor analysis revealed 2 factors, an items/factor raIo of 6 and wide communaliIes

16 items retained

13 items retained


20 patients

35 patients

46 patients


16 items retained

13 items retained

58 items retained

30 items retained

•  Based on preliminary analysis, simulaIon work1 esImated a minimum of 95 paIents would be considered appropriate to factor analysis 1 - Mundfrom DJ, Shaw DG, Tian Lu K. Minimum sample size recommendations for conducting factor analyses. Int J Testing. 2005;5: 159-168.


20 patients

35 patients

46 patients +

54 patients

Factor Analysis

16 items retained

13 items retained

58 items retained

30 items retained


20 patients

35 patients

46 patients


•  Items with loadings less than 0.5 to be removed

•  Two items removed: “My insurance does not provide adequate treatment coverage for my illness and care-‐related expenses” (0.44) “I rely on friends or family to help with the costs of health care” (0.43)

Final: 11 items

COST = COmprehensive Score for financial Toxicity

•  11 items •  1-‐ factor soluIon explained 93% of variance in the data •  Cronbach-‐alpha 0.9 •  Mean IIC: 0.47 •  Mean ITC: 0.71 •  1 financial item, 2 resources and 8 affect items


A PaIent-‐Centered View Development of the COST-PROM




Clinical Relevance?


A PaIent-‐Centered View COST-PROM - HRQOL

•  Financial Toxicity (Hypotheses) •  Correlates with HRQOL •  Independent of mood states •  Independent of personal adtudes or traits •  Independent of willingness to discuss costs •  Controlled for clinical trial parIcipaIon

Approached: 375 paIents who have been on chemotherapy for at least 3 months

Agreed to ParFcipate: 236 paIents (62.9%)

Analyzed: 233 paIents (62.1%)

Withdrew: 3 paIents due to the financial nature of the study

(0.8%) Declined to ParFcipate: 139 paIents (37.1%)

233 patients with advanced stage cancers were recruited at UCM-affiliated centers

de Souza, J. A., Yap, B. J., Wroblewski, K., Blinder, V., Araújo, F. S., Hlubocky, F. J., Nicholas, L. H., O'Connor, J. M., Brockstein, B., Ratain, M. J., Daugherty, C. K. and Cella, D. (2017), Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer, 123: 476–484.

Characteristics of respondents and non-respondents in the study

Respondents n = 233

Non-respondents n = 142

p-value Age (mean±SD) 58.4±11.5 63.6±12.8 <0.001 Gender

Female 136 (58.4%) 69 (48.9%) 0.08 Male 97 (41.6%) 72 (51.1%)

Marital Status Married 170 (73.3%) 87 (61.3%) 0.02 Divorced/separated/widowed 38 (16.4%) 26 (18.3%) Never married 24 (10.3%) 29 (20.4%)

Race/ethnicity Caucasian, non-Hispanic 154 (66.4%) 80 (56.3%) 0.07 Non-Caucasian 78 (33.6%) 62 (44.6%)

Insurance type Private or employer-based 144 (61.8%) 72 (50.7%) 0.07 Medicare (+ or - supplement) 73 (31.3%) 59 (41.6%) Medicaid 13 (5.6%) 11 (7.8%) COBRA continuation coverage 3 (1.3%) 0 (0.0%)

Household income (mean±SD)1 $68,107±28,232 $62,936±25,718 0.07 P-values are from t-tests or chi-square tests between participants and non-participants in the study.1 Income was based on Census Data related to a patient’s zipcode. !



COST-PROM

HRQOL

Mood States

Social Desirability

OOP

Admissions

Compliance

Willingness to Discuss Costs



COST-PROM

HRQOL

Mood States

Social Desirability

OOP

Admissions

Compliance


•  Brief POMS: r = -‐0.26, p <0.01

•  Marlowe-‐Crowne Social Desirability: r= 0.16, p = 0.28

•  FACT-‐G: r = 0.42, p < 0.001 •  PWB: r = 0.35, p < 0.05 •  SWB: r = 0.33, p < 0.05 •  EWB: r= 0.32, p < 0.05 •  FWB: r = 0.41, p < 0.01



OOP

Admissions

Compliance


•  ParIal correlaIons •  Age, ECOG PS •  variables found to be significantly associated with COST on mulIvariate analyses:

• Income, employment, ethnicity, inpaIent admission, psychological distress

•  FACT-‐G: 0.31, p<0.01

•  EORTC: 0.20, p<0.001


COST-PROM Income (FPL)

OOP

Admissions

Compliance •  r=0.28, p<0.01

ER visits

Admissions

A PaIent-‐Centered View COST-PROM - Predictors

No statistically significant interactions were found, including the interaction between income and employment.

•  PaIent-‐centered •  ScienIfically-‐derived •  Correlated with a meaningful outcome (HRQoL)

A PaIent-‐Centered View COST-PROM

•  PaIent-‐centered •  ScienIfically-‐derived •  Correlated with a meaningful outcome (HRQoL)

Useful in clinic or research?

A PaIent-‐Centered View COST-PROM

ApplicaIon Cross-‐secIonal Studies in Single Diseases

ApplicaIon Understanding Cost Discussion Preferences

ApplicaIon Understanding Cost Discussion Preferences

Preferred Cost Communicator: Who do you want to talk to about costs?

Note: 3% of patients selected “other” as their preferred cost communicator. “Other” responses included: “expert in the hospital”, “hospital administrator”, “I don’t know”, “Medicare/Medicaid”, “whoever can negotiate with insurance” and 2 responses of “insurance company employee”.


•  Physician: –  PaIents with less financial toxicity are more likely to want to discuss

costs with their physician (OR= 1.02, p=0.05) –  Those on oral drugs are 3.4 Fmes more likely than those on IV therapy to

want to talk to their physicians about costs (p=0.005)

•  Social Worker: –  PaIents with increased financial toxicity are more likely to want to speak

to a social worker (OR= 0.97, p=0.04) –  Non-‐Caucasians are 2.26 Fmes more likely to want to speak to a Social

Worker (p=0.01)

•  Financial Counselor: –  A trend is seen; paIents who want to speak to a financial counselor have

increased financial toxicity (OR=0.60, p=0.16)







Worker (p=0.01)









Worker (p=0.01)



•  CollaboraIon with the North American Thyroid Cancer Survivorship Study

•  591 paIents with thyroid cancer within the past 6 years were surveyed in 2 countries:

–  553 (93.6%) in the U.S., and 38 (6.4%) in Canada

•  In mulIvariate analyses, the independent predictors of worse Financial Toxicity were lower income (p < 0.001), female gender (p = 0.01), lower educaIonal level (p=0.002), treatment in the U.S., (p=0.002), and worse HRQoL (p<0.001)

ApplicaIon Comparison of Distress Between Countries

www.costofcancercare.org

www.costofcancercare.org (as of Feb 2017)

�  Agreement with Patient Access Network Foundation �  All patients received co-pay assistance �  Patients assessed at baseline, 1-month, 3-month and

6-month �  308 patients with baseline, 1-month and 3-month

data


�  COST changes over time!

�  COST (FT) improved over 3 months

�  HRQoL did not improve

Validation sample: mean COST  ±  SD, 22.23  ±  11.89)


�  Score changes over time! �  Can find out why their

financial toxicity improved? �  Self-report use of

navigators, financial counselors, transportation vouchers, support groups

�  Or only the copay assistance?

Validation sample: mean COST  ±  SD, 22.23  ±  11.89)


�  179 pts (42%) had a navigator, 106 (34%), a social worker, 107 (35%), a financial counselor, 94 (31%) a support group, and 50 (16%), received a transportation voucher

� None of these “interventions” were associated with improved financial toxicity


�  179 pts (42%) had a navigator, 106 (34%), a social worker, 107 (35%), a financial counselor, 94 (31%) a support group, and 50 (16%), received a transportation voucher

� None of these “interventions” were associated with improved financial toxicity

� Annals of obvious research: in a selected population of patients seeking help to pay for their drugs, nothing much helps but paying for their drugs!

COST

FACT-G

Grade 0 Financial Toxicity

Grade 1

Grade 2

Grade 3

Hig

her b

ette

r qua

lity

of li

fe

Sig

nific

ant a

nd M

eani

ngfu

l

CTCAE (Common Terminology Criteria for Adverse Events) •  Grade 0, none •  Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic

observations only; intervention not indicated. •  Grade 2 Moderate; minimal, local or noninvasive intervention indicated •  Grade 3 Severe or medically significant but not immediately life-threatening

ApplicaIon Grading Financial Toxicity

Currently about 865 paIents

Future direcIons

�  ICD10 code for financial toxicity

�  Post-marketing measurement �  A PRO to be required in the post-approval drug

process?

Future direcIons My Dream Approach to Financial Toxicity

(aka “my interrupted project”)

�  We are making progress in survival and outcomes

�  We do expensive things to our patients �  Let’s not ever forget how we also impact

their finances �  Let’s use science and evidence to develop

solutions

In Summary

Table 1: Demographics, Part 1 Survey Participants (n=233)

Age Mean, median [Range]

58.4, 59 [27-88]

Sex Female Male

58.4% (136) 41.6% (97)

Race Caucasian, Non-Hispanic Non-Caucasian

66.4% (154) 33.6% (78)

Employment Status Working (Full or Part-Time) Unemployed Retired Disability Other

33.6% (78) 9.1% (21) 32.8% (76) 19.4% (45) 5.1% (12)

Education Level Less than college Some college Completed college or higher

22.3% (52) 30.5% (71) 47.2% (110)

Marital Status Married/Cohabitating Divorced/Widowed/Separated Single, Never Married

73.3% (170) 16.4% (38) 10.3% (24)

Insurance Type Private/Employer Insurance Medicare Medicaid COBRA

61.8% (144) 31.3% (73) 5.6% (13) 1.3% (3)

Clinical Trial Status Yes No

27.9% (65) 72.1% (168)

Table 1: Demographics, Part 2 Survey Participants (n=233)

Length of Disease < 1 year > 1 year

38.6% (90) 61.4% (143)

Line of Therapy Adjuvant/Neoadjuvant 1st Line Metastatic 2nd Line Metastatic 3rd Line Metastatic 4th Line Metastatic or Later

20.2% (47) 35.6% (83) 18.9% (44) 13.7% (32) 11.6% (27)

COST Score Mean, median [Range]

22.2, 23 [0-44]

Financial Well Being Score Mean, median [Range]

5.8, 5.5 [1-10]

FACT-G Quality of Life Score Mean, median [Range]

77.0, 79 [23.8-108]

EORTC Quality of Life Score Mean, median [Range]

61.5, 66.7 [0-100]

Income- Median Zip Mean, median [Range]

$68,048.9, $60,325 [$21,155-$201,354]

Income- Final Mean, median [Range]

$90,003.9, $67,282 [$0-$1,600,000]

Federal Poverty Level Mean 25th Percentile 50th Percentile 75th Percentile

514.6% 276.3% 376.7% 555.5%

Treatment Center University of Chicago Hospitals* NorthShore University Health System

85.4% (199) 14.6% (34)

Treatment Mode of Administration Oral Drug Only IV Drug (IV Drug Only or in Combination with Oral)

12.0% (28) 88.0% (205)

CommunicaFon Preferences: My doctor should consider my out-‐of-‐pocket costs as

he/she makes medical decisions

Knowledge/Experience: My doctor knows how much I am spending on

out-of-pocket medical costs.

Scores Survey Participants (n=233)

COST Score Median [Range]

23 [0-44]

POMS Median [Range]

14 [1-50]

FACT-G Quality of Life Score Median [Range]

79 [23.8-108]

EORTC Quality of Life Score Median [Range]

66.7 [0-100]

Median Scores

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Jonas&de&Souza,&MD,&MBA Assistant&Professor&&& · 2018-09-24 · Costs to the payer...

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