HCNMC Hillner NOPR 2014 overview · NOPR Development and Startup • Took nearly 18 months to: –...

Bruce E Hillner Barry A. Siegel and NOPR team

What We Have Learned From the National Oncologic PET Registry?

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Medicare Coverage of PET

•  Standard for reimbursement is “reasonable and necessary”

•  In 1990s, CMS adopted a new evidence-‐based approach for making coverage determinations – Requires peer-‐reviewed scientiGic evidence to document that new technology leads to changes in patient management and to improved health outcomes for Medicare beneGiciaries

• Poor quality of evidence used in support of MRI coverage

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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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Does PET Improve Health Outcomes in Patients with Cancer?

•  Evidence accruing in the last few years • Randomized controlled trials

– All done in countries with highly restricted PET coverage

– Most show superiority (patient-centered outcomes)

•  Practice-based evidence (e.g., registries) • Change in management largely used as a

“surrogate” for improved outcome

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Medicare Reimbursement for Oncologic PET (2005)

•  Diagnosis, staging, and restaging of: Non-small cell lung cancer Lymphoma Esophageal cancer Malignant melanoma Colorectal 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) •  Mechanism announced in November 2004 to cover all

other cancers and indications–National Registry

National Oncologic PET Registry: A 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, Fenghai Duan, PhD, Brown University •  Epidemiologist: Ilana Gareen, PhD, Brown University

Objective •  Assess the effect of PET on referring physicians’

plans of intended patient management –  across a wide spectrum of cancer indications

for PET not currently covered by Medicare

Hypothesis •  PET will lead to change of patient management

as often for non-covered as reported for covered cancers

NOPR Life Cycle

•  2006 FDG-PET •  2009 FDG-PET •  Linkage/Validation with Medicare Claims •  2011 NaF-PET Bone

Goals

•  Provide access to the service (PET) •  Minimize the burden to patients, PET facilities,

and referring physicians •  Generate evidence of reasonable quality to help

CMS decide whether to expand coverage of PET •  Registry to be financially self-supporting

Referring MD requests PET

Pre-PET Form

PET done

PET interpreted & reported

Post-PET Form sent,

including question for referring MD consent

Post-PET Form completed.

Claim submitted

Ongoing patient

management

NOPR Workflow

Ask patient for consent

Pre-PET Form: Intended Patient Management

q  Observation (with close follow-up) q  Additional imaging (CT, MRI) or other non-invasive diagnostic tests q  Tissue biopsy (surgical, percutaneous, or endoscopic). q  Treatment (if treatment is selected, then also complete the following)

Treatment Goal: (check one) q Curative q Palliative Type(s): (check all that apply)

–  q Surgical q Chemotherapy (including biologic modifiers) –  q Radiation q Other q Supportive care

If PET were not available, your current management strategy would be (select one)?

Intended management, given PET findings, asked on post-PET form

NOPR Development and Startup •  Took nearly 18 months to:

–  Finalize protocol –  Develop web-based data entry –  Address various regulatory requirements

•  Monitoring after startup disclosed several problems that needed fixing or education ü One can be certain that even the best designed questions

will be answered illogically by some participants

Key NOPR Results (Before 2009 NCD) Overall Impact on Patient Management

–  Diagnosis, Staging, Restaging, Recurrence –  Data on 22,975 scans from May 8, 2006 – May 7, 2007 –  J Clin Oncol 2008; 26:2155-61

Impact on Patient Management by Cancer Type –  Confirmed Cancers –  Staging, Restaging, Recurrence –  Data on 40,863 scans from May 8, 2006 – May 7, 2008 –  J Nucl Med 2008; 49:1928-35

Treatment Monitoring –  Data on 10,447 scans from May 8, 2006 – Dec 31, 2007 –  Cancer 2009:115:410-18

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

Hillner et al., J Clin Oncol 2008

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

Hillner et al., J Clin Oncol 2008

Clinical Indication for PET Study (Percent)

Pre-Pet Plan

Post-PET Plan

Dx n=5,616

Staging n=6,464

Restaging n=5,607

Recurrence n=5,388

All n=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

Essentially uniform across different cancer types

Impact of PET Used for Treatment Monitoring •  Ovarian, pancreas, NSCLC, SCLC most frequent •  Metastatic disease in 54% •  PET findings led to:

–  Switch to another therapy in 26% –  Adjust dose or duration of therapy in 17% –  Switch from therapy to observation/supportive care in 6%

•  Management change more often if post-PET prognosis worse rather than improved/unchanged (70% vs. 40%)

Hillner et al., Cancer 2009

Expanded Coverage by CMS

Final NCD: April 3, 2009 •  PET covered for initial treatment strategy for essentially all

cancers (except prostate cancer, breast cancer diagnosis and axillary nodal staging, and melanoma regional nodal staging)

–  One scan per patient per cancer •  For subsequent treatment strategy, expanded coverage for

PET in legacy conditions to include treatment monitoring and new coverage for cervical and ovarian cancer and myeloma

•  Coverage with evidence development (NOPR) continued for remaining non-covered PET studies (~10% of Medicare total)

NOPR Limitations •  Data “quality” •  Potential that physicians may have been inGluenced by the knowledge that future Medicare reimbursement might be inGluenced by their responses

•  No control group –  A fundamental problem with observational studies, and de6ining proper control group is problematic

•  Collected change in intended management, not actual management –  Tried to address by studies linking NOPR plans to claims data

NOPR Limitations •  Unknown if management changes were in the correct direction or improve long-‐term outcomes –  Using management change as surrogate requires prior data on test accuracy and value of therapies

•  DeGining the relevant long-‐term outcomes for a diagnostic (instead of therapeutic) procedure is controversial

•  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’ PET is than next best method

NOPR-2009

•  Data collection continued for subsequent treatment strategy of remaining cancers (with minor CRF modiGications)

•  155,540 scans with complete data submission •  Primary analysis: comparison of NOPR-‐2006 and NOPR-‐2009 cohorts (J Nucl Med 2012; 53:831) –  Restaging, recurrence or treatment monitoring known cancers

–  Data on 41,145 scans (2006) and 70,358 scans (2009)

–  “Results strongly suggest it is unlikely that new useful information will be obtained by extending the coverage of certain cancer types and indications only under CED.”

NOPR-2009 Reconsideration Request

•  6/20/2012 Submission requesting that oncologic FDG-‐

PET be covered without CED

•  3/13/2013 Draft decision memorandum ü End NOPR for FDG-‐PET ü One-‐scan limit for subsequent treatment strategy PET ü Non-‐coverage for prostate cancer

•  Comment Period: Vigorous public response (> 200) •  6/11/2013 Final decision memorandum

Oncologic FDG-PET: Final Decision Summary

•  NOPR ended for FDG-‐PET for all cancers •  Three-‐scan limit for subsequent treatment strategy PET, with additional scans permitted at Medicare contractor discretion –  3 better than 1, but still not rational –  Not clear how this will be operationalized

•  Prostate cancer is covered for subsequent treatment strategy PET

•  PET = PET, PET/CT, or PET/MRI

Oncologic FDG-PET: Final Decision Summary

•  Three-‐scan limit motivated by CMS concern that PET is widely used for surveillance (statutorily non-‐covered)

•  Virtually no evidence that surveillance PET (or other advanced imaging) leads to improved patient outcomes

•  1st occurrence of CMS putting quantitative limit on advanced imaging

•  To date, no effective technical plan for a center to be aware of a patient’s lifetime ‘count’

•  Need evidence to refute this restriction or change referring physician and patient expectations

NOPR Life Cycle •  2006 FDG-PET •  2009 FDG-PET •  Linkage/Validation with Medicare Claims •  2011 NaF-PET Bone with ~18,000 scans

ProBiles of NaF-‐PET Registry 1/27/2012 – 12/31/2013

Prostate Breast Lung Others % by

indication Initial staging 2,301 181 166 223 26% Suspected 1st osseous metastases

4,686 781 380 653 59%

Progression of known osseous metastases

1,297 199 -‐-‐ 236 15%

% by type 75% 10% 5% 5% Hillner JNM in press

ProBile of FOM -‐-‐ suspected 1st osseous metastases scans

Prostate Breast Lung Others Reason for imaging Pain only 15 57 56 49 Elevated or rising tumor marker 49 7 2 4 Evidence from other imaging 6 10 10 10 Pre-‐scan summary stage Known metastases 33 30 43 41 Unknown stage 38 39 30 34

Hillner JNM in press

Dominance of Pre-‐PET plans of other Imaging in FOM

Prostate Breast Lung Others Image 57 73 78 71

Body CT 23 17 18 16 Body MRI 17 14 15 12 FDG-‐PET 13 26 29 30

Treatment 26 11 11 16 Biopsy 3 4 4 5 Watch 14 11 8 9


Distribution of NaF-‐PET Findings from Suspected Pre-‐PET Plans in Prostate Ca

N Benign Probable Unifocal Multi Diffuse P-‐

value Any treatment

517 61 11 3 19 5 -‐-‐

Body CT 443 66 8 4 16 6 0.40 Body MRI 320 55 13 4 20 7 0.13 FDG-‐PET 240 48 12 1 25 13 <.0001


NaF-PET findings and actions 1st osseous metastases Prostate Breast Lung Others

Normal, benign, or equivocal (69%) (62%) (54%) (57%)

Watch 52 71 59 63

Treat 38 15 30 25

DeBinitive (28%) (24%) (27%) (26%) Watch 12 15 20 16 Biopsy 2 4 7 8 Image 7 23 19 12

Treatment 79 58 55 65 with hormones 50 28 0 6

with chemotherapy 25 28 34 25 with radiotherapy 20 20 34 29

with bisphosphonates 29 27 11 21

Change in intended management of suspected 1st osseous metastases

Prostate Breast Lung Other P-‐value

Patients 4,686 781 380 653 Change in intended management, %

43.6 24.3 36.0 31.1 <0.0001

95% CI 42.2 -‐ 45.0 21.3 -‐ 27.3 31.2 -‐ 40.9 27.5 -‐ 34.6

Imaging adjusted frequency of change, %

15.0 7.7 8.7 8.0 <0.0001

95% CI 13.9 – 16.0 5.8 -‐ 9.5 5.8 -‐ 11.5 5.9 -‐ 10.0


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Conclusions

•  NOPR has successfully used one pathway to help achieve coverage for PET in cancer

•  But pathway quite slow and burdensome •  Clinical trials of new molecular imaging

tracers and methods must focus, from the outset, on obtaining evidence of improved patient outcomes

Thank you

[email protected]

HCNMC Hillner NOPR 2014 overview · NOPR Development and Startup • Took nearly 18 months to: –...

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