Positron Emission Tomography (PET) Scans in Ovarian Cancer

1. Ovarian Cancer National Alliance www.ovariancancer.org Positron Emission Tomography (PET) Scans in Ovarian Cancer Effectiveness of PET Scans and Recommendations for CMS August 20, 2008

2. Ovarian Cancer National Alliance www.ovariancancer.org Contents • Ovarian Cancer Background • Ovarian Cancer National Alliance (OCNA) • Coverage with Evidence Decision • PET Scans in Ovarian Cancer: Initial Diagnosis • PET Scans in Ovarian Cancer: Recurrence • PET Scans in Ovarian Cancer: Monitoring Treatment • Recommendations

3. Ovarian Cancer National Alliance www.ovariancancer.org Ovarian Cancer Background • This year, 21,650 American women will be diagnosed with ovarian cancer, and 15,520will die from the disease (American Cancer Society, 2008) • Deadliest gynecologic cancer and the 5th leading cause of cancer death among women • Less than half of the women diagnosed will die within five years

4. Ovarian Cancer National Alliance www.ovariancancer.org Ovarian Cancer Background (con’t) • Initial Detection • < 20% women diagnosed in early (most treatable) cancer stages • No reliable early detection test • Combination of pelvic/rectal exam, transvaginal ultrasound and CA-125 serum blood test used for detection • Recurrence • > 70% ovarian cancer patients • CA-125 may be early route to detect recurrence • CA-125 inaccurate picture of extent of disease or falsely elevated • Radiologic devices (i.e. PET scans) • Cancer extent and location

5. Ovarian Cancer National Alliance www.ovariancancer.org Ovarian Cancer National Alliance (OCNA) • National umbrella organization with state and local groups • Represents grassroots activists, women’s health advocates and health care professionals • Patient advocacy group dedicated to conquering ovarian cancer

6. Ovarian Cancer National Alliance www.ovariancancer.org Coverage with Evidence Decision • Centers for Medicare and Medicaid Services’ (CMS’) Coverage with Evidence Decision (CED) • PET or PET/CT scans • Covers Medicare patients • Part of a clinical trial • Clinical Trial Results (administered by National Oncologic PET Registry (NOPR) • providers changed treatment decisions for 1/3 of cases • > 9% patients enrolled had ovarian cancer • High enrollment for rare cancer • CMS’ mission is to ensure effective, up-to-date health care coverage and to promote quality care for beneficiaries

7. Ovarian Cancer National Alliance www.ovariancancer.org PET Scans in Ovarian Cancer: Initial Diagnosis • Pre-operative PET or PET/CT scans • Detect tumors otherwise unnoticed • Appropriate “debulking” • High sensitivity and specificity • Illuminate full extent of tumor proliferation • Determine original course of treatment

8. Ovarian Cancer National Alliance www.ovariancancer.org PET Scans in Ovarian Cancer: Recurrence • Sensitive to small volumes of disease • Assist in determining CA-125 accuracy for individual patient • Some patients do not emit CA-125 antigen, PET scans monitor patients for recurrence

9. Ovarian Cancer National Alliance www.ovariancancer.org PET Scans in Ovarian Cancer: Monitoring Treatment • Monitoring chemotherapy response • Resistance to platinum-based chemotherapies (after multiple recurrences) • Patients may respond better to other treatments • Stop ineffective toxic therapy from being administered • Reduce costs of care • Currently unable to predict treatment response before chemotherapy

10. Ovarian Cancer National Alliance www.ovariancancer.org Recommendations • OCNA urges CMS: • To provide coverage for PET and PET/CT scans for women with ovarian cancer for: • Diagnosis and staging • Post-surgery evaluations • Monitoring treatment results and recurrence • Proper evaluation and treatments to provide appropriate care at appropriate time – consistent with CMS’s mission • Provide most cost-effective and humane treatment of patients • OCNA thanks CMS in advance for providing access under the Coverage with Evidence Decision while CMS makes its National Coverage Analysis