NOPR

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NOPRNOPRNational Oncologic PET RegistryNational Oncologic PET Registry

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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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Medicare Coverage of PET

• CMS elected not to consider oncologic indications for PET broadly

• Rather evaluated the evidence on a cancer-specific and indication-specific basis

• Problematic because the specific evidence typically has not been very robust

• “Catch 22”

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Medicare Reimbursement for Oncologic PET (2005)• Diagnosis, staging, and restaging of:

Non-small cell lung cancer LymphomaEsophageal cancer Malignant melanomaColorectal cancer 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/indicationsAll other cancers/indications

– National registryNational registry

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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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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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NOPR: NOPR: A Nationwide Collaborative ProgramA Nationwide Collaborative Program

Sponsored by

Managed by

Advisor

Endorsed by

• 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

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NOPR Objectives• 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: o Specific type of cancer o Specific indication for FDG-PET o Patient performance status o Physician’s role as provider of cancer treatment o Type of FDG-PET study (PET/CT vs. conventional PET)

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Referring MD requests PET

Pre-PET Form

PETdone

PET interpreted& reported

Post-PETForm sent,

including question for referring MD consent

Post-PET Form completed.

Claim submitted

Ongoingpatient

management

Summary: NOPR Workflow

Ask patient for consent

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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 SummaryNED, Localized, Regional, Metastatic, Unknown

4. Performance Status (ECOG classification)

5. Intended Patient Management Plan

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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 Post-PET Forms

– Intended Patient Management Plan– Planned Cancer Care Provider

• Referring Physician Consent

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• 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

• 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

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Major NOPR Cancer Types vs. Incidence(Patients Over Age 65)

Cancer TypeTotal NOPR

Scans (2007)*Incidence

(CDC 2004)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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Results of NOPR

Overall Change in Management:– Diagnosis, Staging, Restaging, Recurrence.– Data on 22,975 scans from May 8, 2006 – May 7, 2007.– J Clinical Oncology 2008

Treatment Monitoring– Data on 10,447 scans from May 8, 2006 – Dec 31, 2007.– In press in Cancer

Individual Cancer Management– 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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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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PET Changed Intended Management in 36.5% of Cases

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

Patients with change post-PET (%) 31.1 39.5 36.1 39.0 36.5


Clinical Indication for PET Study (Percent)

Pre-Pet Plan

Post-PET Plan

Dxn=5,616

Staging n=6,464

Restaging n=5,607

Recurrence n=5,388

Alln=22,975

Treat Same 16.0 46.5 15.8 20.4 25.5

Non-Treat Same 52.9 14.0 48.0 40.7 37.9

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Changes in Intended Management (%) Stratified by Pre-PET Plan

Image n=9,518

Biopsy n=3,552

Watch n=2,199

Treatment n=7,706

Post-PET Plan

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

Pre-PET Plan


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Cancer Specific Change in Management (1 of 2)

Diagnosis Staging Restaging Suspected Recurrence

Bladder 44.3(174)

39.9(1,461)

36.4(1,239)

36.7(878)

Brain 31.6 (158)

-- -- 40.5(222)

Cervix --- 36.1 (341)

26.9 (353)

35.9(290)

Kidney 25.4(710)

41.1 (895)

34.4 (979)

32.4(1,059)

% (patients)

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Cancer Specific Change in Management (2 of 2)

Diagnosis Staging Restaging Suspected Recurrence

Ovary 35.3(306)

43.2 (378)

37.7 (1,971)

44.5(2,160)

Pancreas 30.2 (1,190)

39.2 (1,491)

38.3 (1,021)

39.3(802)

Prostate 28.0(321)

32.0 (2042)

34.0 (1,477)

39.4(1,790)

Small Cell Lung

21.7(281)

43.3 (1,082)

40.8 (1,357)

38.1 (544)

Myeloma -- 52.2(402)

46.4(1009)

50.9 (373)

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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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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 non-melanoma skin cancer.

• Imaging adjusted change for myeloma was 11.5%.

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Treatment Monitoring (1 of 2)

Adjust DoseOr Durationof Therapy

Switch To AnotherTherapy

From TherapyTo Supportive

Care

Total Change

Bladder (768) 30.2 14.9 8.3 53.5Brain (89) 30.3 14.6 15.7 60.6Cervix (145) 32.4 13.1 8.9 54.4Kidney (760) 24.1 15.6 5.2 45.0

% (patients)

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Treatment Monitoring (2 of 2)

Adjust DoseOr Durationof Therapy

Switch To AnotherTherapy

From TherapyTo Supportive

Care

Total Change

Ovary (1,995) 30.2 15.0 8.3 53.5Pancreas (1,269) 28.6 15.4 4.3 48.4Prostate (884) 22.5 13.9 6.7 43.2Small Cell Lung (975) 28.2 17.4 7.4 53.1Testis (32) -- -- --

Combined28.1

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Strengths• “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 single-institution study (Hillner 2004)

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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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Summary • Change in intended management associated with PET in previously non-

covered cancers was similar to that reported in single-institution studies of covered cancers.

• ~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.

• Examination of individual cancers did not find a significant difference in treatment changes between cancer.

• NOPR has not yet examined if PET actually changed patient management or if PET improved outcome (can be examined in future studies).

• CMS is considering our application to expand the use of PET to other cancers.

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MedCAC Meeting• 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

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Comment Letter• 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

NOPR

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