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Interpreting the Latest National Comprehensive Cancer Network (NCCN) Guidelines Devon Webster, MD Board Certified in Internal Medicine and Medical Oncology gy Associate Medical Director Ann Correa, RN, OCN Training & Special Projects Lead AllMed Healthcare Management © AllMed Healthcare Management, Inc. Overview • About the NCCN • Updates to the Guidelines – – – – Breast Cancer Colon Cancer Lung Cancer Th id C Thyroid Cancer • New Guidelines for Survivorship • Determining D t i i medical di l necessity it ffor cancer care The NCCN: A Not-for-Profit Alliance of th World’s the W ld’ 23 L Leading di C Cancer C Centers t New Members in 2013: • UC San Diego Moores Cancer Center • University of Colorado Cancer Center “Our mission, “O i i as an alliance lli off lleading di cancer centers t d devoted t d to patient care, research, and education, is to improve the quality, effectiveness, and efficiency of cancer care so that patients can lead better lives. lives ” The NCCN Clinical Practice Guidelines i O in Oncology l • 58 guidelines with 149 algorithms – – – Sequential management decisions and interventions for 97% of malignant cancers C Consensus recommendations d ti b based d on th the b bestt evidence id available at the time they are derived Continuously updated and revised to reflect new data and new clinical information • Used as the standard for clinical policy in oncology by many clinicians and payers • Sign-in: www.nccn.org Classification of Recommendations in th NCCN Guidelines the G id li • Category 1 – Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate • Category g y 2A* – Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate • Category 2B – Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate • Category C 3 – Based upon any level of evidence, there is major NCCN disagreement that the intervention is appropriate * All recommendations are category 2A unless otherwise noted. 2013 Updates: Breast Cancer Workup Breastt MRI optional; B ti l consider id ffor mammographically occult tumors Metastatic Disease • Ado-trasutuzumab emtansine (Herceptin DM1) is preferred for treatment of HER2+ HER2 disease with prior exposure to Herceptin Adjuvant Chemotherapy • TAC is i no longer l preferred f d • Dose dense AC followed by weekly Taxol now preferred • NCCN Guidelines. Breast Cancer. Version 2.2013. 2013 Updates: Colon Cancer Lynch syndrome testing • MMR protein t i ttesting ti iis now recommended for any patient under age 50 with colon cancer or with stage II colon l cancer Metastatic disease • • • Bevacizumab is now recommended in the second-line setting Ziv-aflibercept in combination with FOLFIRI or irinotecan as second-line second line therapy for irinotecan naïve patients Regorafenib as late-line therapy for patients refractory to all options NCCN Guidelines. Colon Cancer. Version 2.2013. 2013 Updates: Non Non-small small cell Lung Cancer Screening • Screening with low-dose CT is recommended in high-risk smokers and former smokers (See NCCN Guidelines for lung cancer screening) Workup • Mediastinoscopy and/or EBUS replaced by “Pathologic mediastinal lymph node evaluation” which can include CTCT biopsy Adjuvant chemotherapy • Patients likely to receive chemotherapy may receive induction chemotherapy (preoperative) as an alternative NCCN Guidelines. Non small cell . Version 2.2013. Updates for Thyroid Carcinoma: N d l Evaluation Nodule E l i • Follicular or Hürthle cell neoplasm – Consider molecular diagnostics • Follicular lesion of undetermined d t i d significance i ifi – Consider molecular diagnostics g NCCN Guidelines. Thyroid Carcinoma. Version 2.2013. Updates for Thyroid Carcinoma: M d ll Medullary Th Thyroid id Carcinoma C i • Recurrent or p persistent disease – – Cabozantinib (category 1) added as an option to consider Vandetanib changed from category 2A to category 1 recommendation • New to algorithm – Increasing tumor markers, in the absence of structural disease progression, are not an indication for treatment with vandetanib or cabozantinib • Revised – While not FDA approved for treatment of thyroid cancer, other commerciallyy available small molecular kinase inhibitors ((such as sorafenib or sunitinib) can be considered if clinical trials, vandetanib, or cabozantinib are not available or appropriate, or if the patient progresses on vandetanib or cabozantinib NCCN Guidelines. Thyroid Carcinoma. Version 2.2013. Updates for Thyroid Carcinoma: A Anaplastic l i Thyroid Th id Carcinoma C i New section provides systemic therapy options – Concurrent chemoradiation regimens: paclitaxel/carboplatin, paclitaxel, cisplatin, doxorubicin – Chemotherapy regimens: paclitaxel/carboplatin, paclitaxel, doxorubicin NCCN Guidelines. Thyroid Carcinoma. Version 2.2013. Need for Guidelines for Survivorship Estimated Number of Cancer Survivors in the United States From 1975 to 2012 • According to National Cancer Institute (NCI), (NCI) there are >13 million American cancer survivors as of January 2012 • Individual is considered a cancer survivor from the g moment of diagnosis • Recognizing and managing the healthcare needs of cancer survivors i h has b become a significant responsibility of oncologists and primary care providers NCI. Survivorship-related statistics and graphs. Available at: http://dccps.nci.nih.gov/ocs/prevalence/. First-Ever NCCN Guidelines for S Survivorship i hi • 8 distinct areas of care – – – – – – – – Anxiety and depression Cognitive function Exercise Fatigue Immunizations and infections Pain Sexual function Sleep disorders • Sample assessment tool with 2-3 questions on each of the 8 key criteria NCCN Guidelines. Survivorship. Version 1.2013. Determining Medical Necessity for Cancer Care: H How H Health lth Plans Pl Use U the th NCCN G Guidelines id li • When making reimbursement decisions about different cancer treatments • Coverage C off off-label ff l b l use off d drugs and biologics for cancer treatment – – If indicated in the guidelines in place at the time of treatment with category 1, 2A, or 2B level of evidence Unless plan language explicitly prohibits off-label use of drugs Independent Medical Review: F ilit t D Facilitates Determination t i ti off M Medical di l N Necessity it • Medical necessity must be supported by thorough clinical d documentation t ti • Independent medical review looks at whether a specific procedure/treatment was medically necessary • Provides specialty match to allow healthcare plans to ensure that the requested treatment falls under the medical necessity requirements before approving a course of treatment • Reviewers stay on top of treatments as they are studied more extensively and potentially accepted into clinical guidelines • Avoids conflicts of interest, which can relate to economics, lack of specialists to review cases, or having the same doctor who denied a case review an appeal Conclusions • NCCN promotes continuous quality improvement in cancer care – Creates/updates clinical practice guidelines used by patients, clinicians, and other healthcare decision-makers • Many health plans have adopted NCCN guidelines for making coverage decisions for patients with cancer, who often require complex therapies • Diagnostic Di i testing i and d therapies h i ffor cancer continue i to evolve rapidly – Clinicians and health p plans face the challenge g of ensuring g that all patients receive preventive, diagnostic, treatment, and supportive services that are most likely to lead to optimal outcomes Questions & Answers All participants will receive a free copy of our latest publication via email:“Interpreting the Latest NCCN Guidelines” Keep an eye out for our next webinar invitation for the May webinar “Bariatric Surgery: When is it Medically Necessary?” which we are please to announce, has been approved for CEU credits by the CCMC! For more information, contact us: AllMed Healthcare Management, g , Inc.. (800) 400-9916 [email protected] www.allmedmd.com Follow us on Twitter: @allmedmd Join our LinkedIn Group: Clinical Decision Makers