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NOPR
National Oncologic PET Registry
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(5/5/06)
PET Reimbursement
• Complex, slowly evolving process
• Dependent on FDA approval of PET drugs
– Facilitated by FDAMA (1997)
• Reimbursable clinical indications
– Determined by technology assessment panels of
third-party payers
– Process dominated by Centers for Medicare and
Medicaid Services (CMS)
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(5/5/06)
Medicare Coverage of PET
• CMS elected not to consider oncologic
indications for PET broadly
• Rather evaluated the evidence on a cancerspecific and indication-specific basis
• Problematic because the specific evidence
typically has not been very robust
• “Catch 22”
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(5/5/06)
Medicare Reimbursement for Oncologic PET (2005)
• Diagnosis, staging, and restaging of:
Non-small cell lung cancer
Esophageal cancer
Colorectal cancer
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(5/5/06)
Lymphoma
Malignant melanoma
Head and neck cancer
Staging, restaging, and Rx monitoring of breast cancer
Detection of TG+/RAI– thyroid cancer
Staging of cervical cancer (– CT/MRI outside pelvis)
All other cancers/indications
– National registry
What is the NOPR?
• In 2000, the Centers for Medicare and Medicaid Services
(CMS) expanded its coverage of positron emission
tomography (PET) with F-18 fluorodeoxyglucose (FDG) to
a wide variety of indications for several common cancers but not all cancers.
• In November 2004, CMS proposed expanding PET
coverage to most other cancers, if providers collect
relevant data in a CMS-approved clinical registry.
• CMS Initiative
– Coverage with Evidence Development (CED)
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(5/5/06)
The National Oncologic PET Registry (NOPR):
• CMS has determined that, as data accumulate, additional
cancers may be covered for PET
• “Coverage with Evidence Development” provides clinically
appropriate care during data collection, via a registry
• NOPR’s program covers those cancers neither
specifically covered, nor non-covered, by CMS as of 2004
• For low-prevalence cancers, there likely would never be
adequate quality evidence to support a coverage decision
• All Medicare-eligible PET facilities can participate
o Program entirely funded by user fees
• CMS reimbursement depends on timely data submission
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(5/5/06)
NOPR:
A Nationwide Collaborative Program
Sponsored by
Advisor
Managed by
Endorsed by
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(5/5/06)
Chair, Bruce Hillner, MD, Virginia Commonwealth University
Co-chair, Barry A. Siegel, MD, Washington University
R. Edward Coleman, MD, Duke University
Anthony Shields, MD, PhD Wayne State University
Statistician: Dawei Liu, PhD, Brown University
Epidemiologist: Ilana Gareen, PhD, Brown University
NOPR Objectives
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Primary: To assess the effect of FDG-PET on
referring physicians’ plans of intended patient
management across the spectrum of the expanded
cancer indications for FDG-PET
Secondary: To assess the effect of FDG-PET on
referring physicians’ plans of intended patient
management in relation to:
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o
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(5/5/06)
Specific type of cancer
Specific indication for FDG-PET
Patient performance status
Physician’s role as provider of cancer treatment
Type of FDG-PET study (PET/CT vs. conventional PET)
Summary: NOPR Workflow
Referring MD
requests PET
Ask patient
for consent
Pre-PET
Form
PET
done
PET
interpreted
& reported
Post-PET
Form sent,
including question for
referring MD consent
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(5/5/06)
Ongoing
patient
management
Post-PET Form
completed.
Claim submitted
Pre-PET Form – 5 Questions
1. Reason for the PET Scan
–
(Diagnosis, Initial Staging, Restaging, Suspected Recurrence, Treatment
Monitoring)
2. Cancer Site/Type
3. Disease Stage Summary
NED, Localized, Regional, Metastatic, Unknown
4. Performance Status (ECOG classification)
5. Intended Patient Management Plan
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(5/5/06)
Post-PET Form
• Questions customized by clinical Indication for PET
(Diagnosis, staging, etc.)
– 3 - 6 questions per indication
– Most require a Yes or No answer
• 2 Questions are asked on both the Pre-PET and PostPET Forms
– Intended Patient Management Plan
– Planned Cancer Care Provider
• Referring Physician Consent
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(5/5/06)
NOPR Status: May 8, 2006 through August 31, 2008
• 1,731 PET facilities nationwide participating
(nearly 90% of all PET facilities)
• 116,484 patients registered
• 94,076 patients - data entry completed
• Approximately 92% of patients and 96% of
referring physicians consent to research use of
data
NOPR Accrual (Cases Completed/Business Day)
Location of Participants (as of April 15, 2008)
Top Ten Cancers in NOPR registry
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Ovary / Uterine Adenexa
Prostate
Pancreas
Kidney / Other Urinary Tract
Bladder
Small Cell Lung
Stomach
Non-small Cell Lung
Myeloma
Uterus, body
Top Ten NOPR Cancer Types & Indications
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Ovary / Uterine Adnexa – Recurrence
Prostate – Initial Staging
Ovary / Uterine Adnexa – Treatment Monitoring
Ovary / Uterine Adnexa – Restaging
Prostate – Recurrence
Pancreas – Initial Staging
Stomach – Initial Staging
Prostate – Restaging
Bladder – Initial Staging
Pancreas – Suspected Primary
Major NOPR Cancer Types vs. Incidence
(Patients Over Age 65)
Cancer Type
Total NOPR
Scans (2007)*
(5/5/06)
Scans per
Incidence
(2007)
Prostate
3,769
116,659
3.2%
Ovary and Adnexa
3,706
9,625
38.5%
Pancreas
3,561
21,962
16.2%
Bladder
2,665
44,570
6.0%
Kidney/Other Urinary Tract
2,623
20,886
12.6%
Small Cell Lung
2,390
19,657
12.2%
Stomach
2,349
13,048
18.0%
Myeloma
1,336
10,194
13.1%
*Excluded Scans done for treatment monitoring
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Incidence
(CDC 2004)
Results of NOPR
Overall Change in Management:
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Diagnosis, Staging, Restaging, Recurrence.
Data on 22,975 scans from May 8, 2006 – May 7, 2007.
J Clinical Oncology 2008
Treatment Monitoring
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Data on 10,447 scans from May 8, 2006 – Dec 31, 2007.
In press in Cancer
Individual Cancer Management
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(5/5/06)
Staging, Restaging, Recurrence.
Data on 40,863 scans from May 8, 2006 – May 7, 2008.
In press in J Nuclear Medicine
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(5/5/06)
Cohort Profile
• First year of NOPR (5/8/06
to 5/7/07)
• 22,975 “consented” cases
from 1,519 facilities
• Technology profile
– 84% PET/CT
– 71% non-hospital
– 76% fixed sites
• NOPR continues;
> 90,000 PET studies to date
Hillner
et al., J Clin Oncol 2008
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(5/5/06)
PET Changed Intended Management in 36.5% of Cases
Clinical Indication for PET Study (Percent)
Pre-Pet
Plan
Post-PET
Plan
Treat
Dx
Staging
Restaging
Recurrence
All
n=5,616
n=6,464
n=5,607
n=5,388
n=22,975
Same
16.0
46.5
15.8
20.4
25.5
Non-Treat
Same
52.9
14.0
48.0
40.7
37.9
Non-Treat
Treat
23.2
31.6
28.6
29.2
28.3
Treat
Non-Treat
7.9
7.9
7.5
9.7
8.2
31.1
39.5
36.1
39.0
36.5
Patients with change
post-PET (%)
Hillner et al., J Clin Oncol 2008
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(5/5/06)
Changes in Intended Management (%)
Stratified by Pre-PET Plan
Pre-PET Plan
Image
n=9,518
Biopsy
n=3,552
Watch
n=2,199
Treatment
n=7,706
Image
5.8
6.0
4.6
3.0
Biopsy
9.5
24.0
9.0
6.8
Watch
37.2
33.6
62.3
15.6
Same Rx
NA
NA
NA
42.4
New or Major
Change in Rx
47.6
36.3
24.1
8.7
Minor change Rx
NA
NA
NA
23.5
Post-PET Plan
Hillner et al., J Clin Oncol 2008
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(5/5/06)
Cancer Specific Change in Management (1 of 2)
Bladder
Brain
Cervix
Kidney
Diagnosis
Staging
Restaging
44.3
(174)
31.6
(158)
---
39.9
(1,461)
--
36.4
(1,239)
--
36.1
(341)
41.1
(895)
26.9
(353)
34.4
(979)
25.4
(710)
% (patients)
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(5/5/06)
Suspected
Recurrence
36.7
(878)
40.5
(222)
35.9
(290)
32.4
(1,059)
Cancer Specific Change in Management (2 of 2)
Diagnosis Staging
Ovary
Pancreas
Prostate
Small Cell
Lung
Myeloma
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(5/5/06)
35.3
(306)
30.2
(1,190)
28.0
(321)
21.7
(281)
--
43.2
(378)
39.2
(1,491)
32.0
(2042)
43.3
(1,082)
52.2
(402)
Restaging
Suspected
Recurrence
37.7
(1,971)
38.3
(1,021)
34.0
(1,477)
40.8
(1,357)
46.4
(1009)
44.5
(2,160)
39.3
(802)
39.4
(1,790)
38.1
(544)
50.9
(373)
Imaging-adjusted Change in Management
• Inclusion of cases where the pre-PET plan was
alternative imaging (CT or MRI) may overestimate the
impact of PET
• As a lower boundary of the impact of PET on intended
management, we re-analyzed the data assuming no
benefit from the information provided by PET in cases
with a pre-PET imaging plan (all such cases were
included in the denominator)
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(5/5/06)
Cancer Specific Change in Management
• The overall change averaged 38.0%, ranged from
48.7% in myeloma to 31.4% in non-melanoma skin
cancer.
• Across indications (staging, restaging, recurrence)
PET only had a greater impact in myeloma.
• The imaging adjusted impact averaged 14.7%,
ranged from 16.2% in ovarian cancer to 9.6% in nonmelanoma skin cancer.
• Imaging adjusted change for myeloma was 11.5%.
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(5/5/06)
Treatment Monitoring (1 of 2)
Bladder
(768)
Brain
(89)
Cervix
(145)
Kidney
(760)
Adjust Dose
Or Duration
of Therapy
Switch To
Another
Therapy
From Therapy
To Supportive
Care
Total
Change
30.2
14.9
8.3
53.5
30.3
14.6
15.7
60.6
32.4
13.1
8.9
54.4
24.1
15.6
5.2
45.0
% (patients)
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(5/5/06)
Treatment Monitoring (2 of 2)
Ovary
(1,995)
Pancreas
(1,269)
Prostate
(884)
Small Cell
Lung (975)
Testis
(32)
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(5/5/06)
Adjust Dose
Or Duration
of Therapy
Switch To
Another
Therapy
From Therapy
To Supportive
Care
Total
Change
30.2
15.0
8.3
53.5
28.6
15.4
4.3
48.4
22.5
13.9
6.7
43.2
28.2
17.4
7.4
--
--
--
53.1
Combined
28.1
Strengths
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“Real world” data
Timely data
Very large patient cohorts
Current technology (85% PET/CT)
Good observational studies usually match controlled
studies in magnitude and direction of effect
(Concato NEJM 2000; Benson NEJM 2000; Ionnanidis JAMA 2001)
• Results similar to a more tightly managed singleinstitution study (Hillner 2004)
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(5/5/06)
Limitations
• Collected change in “intended” management, not
actual management
• Unknown if management changes were in the correct
direction or improve long-term outcomes
• NOPR does not address:
– Whether PET should be used in lieu of or as a complement to other imaging
techniques
– The optimal sequencing of CT, MRI and PET.
– How much ‘better’ is PET than next best legacy method
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(5/5/06)
Summary
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Change in intended management associated with PET in previously noncovered cancers was similar to that reported in single-institution studies of
covered cancers.
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~1/3 of older patients undergoing PET for cancer types covered under
Medicare’s CED policy had a major change in intended management, including
type of treatment.
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Examination of individual cancers did not find a significant difference in
treatment changes between cancer.
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NOPR has not yet examined if PET actually changed patient management or if
PET improved outcome (can be examined in future studies).
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CMS is considering our application to expand the use of PET to other cancers.
(5/5/06)
MedCAC Meeting
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(5/5/06)
Held August 20, 2008
Technology assessment presentation
NOPR results – Dr. Hillner
SNM/ARC/AMI presentation – Dr. Mankoff
Ovarian Cancer National Alliance
International Myeloma Foundation
Open comments
Comment Letter
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(5/5/06)
Require clear record of clinical question
Provide additional guidance on usage
Require accreditation or experience requirements
Limit new coverage for body FDG-PET to PET/CT
Continue NOPR for therapy monitoring