8/21/2015. Trends. Organ Transplant Goals and objectives. Goal. Objectives

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1 Organ Transplant 2015 Dennis Irwin, MD National Medical Director, Transplantation and VAD, Complex Medical Conditions Goals and objectives Goal Review trends in transplant in the United States in 2015, principals of patient selection, how to match the right patient to the right program and highlight some of the important drivers in financial and clinical outcomes. Objectives Describe important trends in transplantation At a high level be able to recognize appropriate patient selection, i.e., who to evaluate? Identify certain important drivers of variation in clinical and financial outcomes Identify resources available to the case managers that will help direct patients to the program that meets the patient s need 2 Trends 1

2 Solid organ transplant For the past decade, the trend has been flat. Accessed June 7, Organ transplants per million, age < 65 (United States) Milliman US Organ and Tissue Transplant Cost Estimates 2005, 2008, 2011 and Available at: Accessed July 26, Patients on the waiting list on December 31 of the year (active only) OPTN/SRTR 2012 Annual Data Report: Introduction. American Journal of Transplantation, Vol. 14, No. Suppl 1, January 2014, pp

3 Organ discard rates among organs recovered for transplantation OPTN/SRTR 2012 Annual Data Report: Deceased Organ Donation. American Journal of Transplantation, Vol. 14, No. Suppl 1, January 2014, pp Trends in stem cell transplantation Pasquini MC, Zhu X. Current uses and outcomes of hematopoietic stem cell transplantation: 2014 CIBMTR Summary Slides. Available at: 8 Trends in stem cell transplantation Pasquini MC, Zhu X. Current uses and outcomes of hematopoietic stem cell transplantation: 2014 CIBMTR Summary Slides. Available at: 9 3

4 Thousands 8/21/2015 Transplant trend: billed charges (all phases) Milliman Average Billed by Transplant Type (Phases I IV) $1,750 $1,500 $1,250 $1,000 $750 $500 $250 $ BMT ALLO BMT AUTO HEART* KIDNEY LIVER LUNG Milliman US Organ and Tissue Transplant Cost Estimates 2005, 2008, 2011 and Available at: Accessed July 26, Cost Drivers Kidney transplant cost drivers Pre-transplant Dialysis pre-transplantation Time on the wait list Previous kidney transplant COPD, CAD and CHF Time to completion of evaluation Post-transplant One-year graft failure Acute humoral rejection in the first 30 days Pneumonia Previous kidney transplant Optum adult transplant cases evaluated and transplanted 1/1/2010-4/30/2013 with UHC commercial insurance coverage. Cost adjusted to 2013 with Consumer Price Index for medical care services. 12 4

5 Living donor advantage in medical expense Total Medical Cost per Patient by Phase $250,000 $210,650 $200,000 $150,000 $151,431 $23,206 $34,373 $53,437 $100,000 $50,000 $- $50,153 $53,274 $24,798 LD (N=666) $86,776 $36,064 DD (N=336) Evaluation (P=0.0163) Transplant Admission (P=0.0473) Waitlisting (P<0.0001) 1-Year Post Transplant (P=0.0044) Optum adult transplant cases evaluated and transplanted 1/1/2010-4/30/2013 with UHC commercial insurance coverage. Cost adjusted to 2013 with Consumer Price Index for medical care services. 13 Preemptive transplant advantage in medical expense $300,000 Total Medical Cost per Patient by Phase $250,000 $200,000 $201,857 $25,122 $256,556 $37,310 $54,554 $150,000 $49,329 $100,000 $50,000 $- $83,188 $87,406 $20,613 $51,269 $40,000 $7,081 $4,225 LD Preemptive LD Nonpreemptive (N=283) (N=383) $88,901 $116,819 $26,585 $50,475 $47,873 $7,096 $4,745 DD Preemptive DD Nonpreemptive (N=92) (N=244) Evaluation Waitlist Transplant Admission 1-Year Post-Transplant Optum adult transplant cases evaluated and transplanted 1/1/2010-4/30/2013 with UHC commercial insurance coverage. Cost adjusted to 2013 with Consumer Price Index for medical care services. 14 Liver transplant cost drivers Pre-transplant CHF, cancer and diabetes Time on the wait list Time to completion of evaluation Transplant from the hospital Post-transplant Dialysis in the first 30 days One-year graft failure UTI in the first 30 days Wound infection in the first 30 days Transplant from the hospital COPD Liver dysfunction in the first 30 days Cholangiocarcinoma Optum adult transplant cases evaluated and transplanted 1/1/2010-4/30/2013 with UHC commercial insurance coverage. Cost adjusted to 2013 with Consumer Price Index for medical care services. 15 5

6 Heart transplant cost drivers Pre-transplant VAD during wait list VAD during evaluation COPD Renal insufficiency Time on waitlist Post-transplant Dialysis in the first 30 days Transplant from the hospital One-year graft failure Optum adult transplant cases evaluated and transplanted 1/1/2010-4/30/2013 with UHC commercial insurance coverage. Cost adjusted to 2013 with Consumer Price Index for medical care services. 16 The Appropriate Candidate Indications: kidney transplant End-stage Renal Disease (ESRD) Combined liver/kidney transplant Combined heart/kidney transplant 18 6

7 Indications: kidney transplant End-stage Renal Disease (ESRD) Chronic renal failure with a Glomerular Filtration Rate (GFR) < 20 ml/min Chronic renal failure on dialysis Symptomatic uremia Anticipated ESRD as defined above within next 12 months (preemptive transplantation) Combined liver/kidney transplant Combined heart/kidney transplant 19 Indications: kidney transplant End-stage Renal Disease (ESRD) Combined liver/kidney transplant when one of the following is present: Candidates with persistent Acute Kidney Injury (AKI) for 4 weeks with one of the following: - Stage 3 AKI as defined by modified RIFLE criteria, i.e. a threefold increase in serum creatinine (Scr) from baseline, Scr 4.0 mg/dl with an acute increase of 0.5 mg/dl or on renal replacement therapy - egfr 35 ml/min (MDRD-6 equation) or GFR 25 ml/min (iothalamate clearance). Candidates with Chronic Kidney Disease (CKD), as defined by the National Kidney Foundation, for 3 months with one of the following: - egfr 40 ml/min (MDRD-6 equation) or GFR 30 ml/min (iothalamate clearance) - Proteinuria 2 g a day - Kidney biopsy showing > 30% global glomerulosclerosis or > 30% interstitial fibrosis - Metabolic disease Combined heart/kidney transplant Nadim MK, Sung RS, et al. Simultaneous liver kidney transplantation summit: current state and future directions. American Journal of Transplantation. 2012; 12: Indications: kidney transplant End-stage Renal Disease (ESRD) Combined liver/kidney transplant Combined heart/kidney transplant Low-risk patients with ESRD or CKD with egfr < 33 ml/min 21 7

8 Indications: kidney transplant End-stage Renal Disease (ESRD) Combined liver/kidney transplant Combined heart/kidney transplant Usually due to primary non-function, rejection, recurrent disease and/or immunosuppression toxicity. 22 Indications: liver transplant Transplantation is indicated for patients with End-Stage Liver Disease (ESLD) with a life expectancy < months and who have developed life-threatening complications. MELD score 15, either calculated or with additional MELD points awarded by Regional Review Board (RRB) following review Hepatocellular carcinoma within Milan criteria determined by the OPTN dynamic Imaging criteria 23 Indications: liver transplant Transplantation is indicated for patients with End-Stage Liver Disease (ESLD) with a life expectancy < months and who have developed life-threatening complications. MELD score 15, either calculated or with additional MELD points awarded by Regional Review Board (RRB) following review Consider Living Donor Liver Transplant for patients with MELD Hepatocellular carcinoma within Milan criteria determined by the OPTN dynamic Imaging criteria 24 8

9 Too well to transplant? Correlation with 1 year OLT survival American Journal of Transplantation 2005; 5: Risk of death with/out LDLT: A2ALL experience Hepatology 54: Indications: liver transplant Transplantation is indicated for patients with End-Stage Liver Disease (ESLD) with a life expectancy < months and who have developed life-threatening complications. MELD score 15, either calculated or with additional MELD points awarded by Regional Review Board (RRB) following review. Hepatocellular carcinoma within Milan criteria determined by the OPTN dynamic Imaging criteria Not a candidate for subtotal resection The HCC meets the definition of a Stage T2 lesion(s) that include any of the following: - One lesion greater than or equal to 2 cm and less than or equal to 5 cm in size - Two or three lesions greater than or equal to 1 cm and less than or equal to 3 cm in size No macrovascular involvement No identifiable extrahepatic spread of tumor to surrounding lymph nodes, lungs, abdominal organs or bone 27 9

10 Indications: liver transplant Transplantation is indicated for patients with End-Stage Liver Disease (ESLD) with a life expectancy < months and who have developed life-threatening complications. MELD score 15, either calculated or with additional MELD points awarded by Regional Review Board (RRB) following review. Hepatocellular carcinoma within Milan criteria determined by the OPTN dynamic Imaging criteria Usually due to primary non-function, hepatic artery thrombosis, portal vein thrombosis, rejection, chronic cholestasis without chronic rejection and recurrent disease 28 Indications: heart transplant Heart failure with severe cardiac disability despite optimal medical therapy, New York Heart Association (NYHA) Class III or IV or American Heart Association Stage D AND objective evidence of impaired functional capacity (peak oxygen consumption, VO2max <14 ml/kg/min) Valvular heart disease (uncorrectable) with left ventricular dysfunction Recurrent life-threatening arrhythmias not otherwise correctable Intractable angina with uncorrectable coronary artery disease Primary cardiac tumors confined to the myocardium Refractory heart failure requiring continuous inotropic support Severe hypertrophic or restrictive cardiomyopathy (NYHA Class IV) Congenital Heart Disease (CHD) 29 Indications: lung transplant Any ambulatory patient with end-stage pulmonary disease: Clinically and physiologically severe disease Medical therapy ineffective or unavailable Limited life expectancy, usually less than two to three years Ambulatory, with rehabilitation potential Acceptable nutritional status, usually 80 to 120 percent of ideal body weight Satisfactory psychosocial profile and support system Adequate coverage for the procedure and for post-transplantation care Age <65 or in well selected patients with end-stage pulmonary disease who are >65 years old Usually due to non-function of the grafted organ, rejection refractory to immunosuppressive therapy, bronchiolitis obliterans (chronic rejection) and airway complications not correctable by other measures 30 10

11 Indications: pancreas transplant Simultaneous Pancreas/Kidney transplant (SPK) Pancreas After Kidney (PAK) Pancreas Transplant Alone (PTA) 31 Indications: pancreas transplant Simultaneous Pancreas/Kidney transplant (SPK) Pancreas After Kidney (PAK) Pancreas Transplant Alone (PTA) Labile diabetes mellitus with documented life-threatening hypoglycemic unawareness and/or frequent hypoglycemic episodes despite optimal medical management, Clarke Hypoglycemic Score 4 OR Inability to tolerate exogenous insulin Severe physical or psychological impairment that make it impossible to administer exogenous insulin safely 32 Indications: intestine and multivisceral transplant Intestine Liver/small bowel/pancreas with or without addition of stomach or colon Retransplant 33 11

12 Indications: intestine and multivisceral transplant Intestine Patients with irreversible intestinal failure with associated life-threatening complications (Fishbein) Dependent on TPN with cholestatic liver disease If cholestasis is advanced, or cirrhosis is present, a combined liver/intestine transplant is performed Isolated intestinal transplants are performed in the presence of cholestasis only when the liver disease is felt to be reversible Inability to maintain fluid and electrolyte balance Recurrent sepsis as a result of either line sepsis or intestinal stasis Dependent on TPN with loss of or impending loss of (using last major vessel) vascular access Non-reconstructible gastrointestinal (GI) tract Liver/small bowel/pancreas with or without addition of stomach or colon Retransplant 34 Indications: intestine and multivisceral transplant Intestine Liver/small bowel/pancreas with or without addition of stomach or colon Liver/intestine: - One of the above under intestine AND - Biopsy proven fibrotic changes within the liver indicating that the TPN associated liver dysfunction is irreversible OR - Clinical assessment of significant portal hypertension (such as hypersplenism) where biopsy may not be available or warranted or considered safe to perform Multivisceral: - All of the above under Intestine AND - Technical considerations that make the anastamoses of one or more of the separate organs problematic when compared to an en bloc dissection and transplantation that requires fewer vascular and intestinal anastamoses OR - Desmoid tumors Retransplant 35 Indications for stem cell transplant Malignant conditions (~ 95%) Acute myelogenous leukemia Acute lymphoblastic leukemia Myelodysplastic syndrome Chronic myelogenous leukemia Chronic lymphocytic leukemia Non-Hodgkin lymphoma Hodgkin lymphoma Multiple myeloma Germ cell tumor Neuroblastoma Other conditions (~ 5%) Myeloproliferative disorder Severe aplastic anemias and other marrow failure syndromes Immune deficiencies Inherited metabolic disorders Hemoglobinopathies 36 12

13 ASBMT and CIBMTR ASBMT = American Society for Blood and Marrow Transplantation 37 Choosing the Right Program Utilization data for solid organ transplants National, regional, state and center level Data for multiple organs (liver/heart, for example) transplants are available Sort by organ, age, donor type (living or deceased), for example Sort by causes of death, gender, ethnicity, blood type, for example Updated monthly with three month lag

14 Program performance for solid organ transplants Reports for all transplant programs and Organ Procurement Organizations (OPO) Risk-adjusted Program Specific Reports (PSR) for all single organ transplants and kidney/pancreas and heart/lung Published every six months Data is stale: months old when published Analytic methodology changed in 2015 Bayesian statistics presented now p-value no longer presented but is used by CMS and MPSC for center flagging 40 Outcomes and volume for stem cell transplant programs Additional information for stem cell transplant programs NMDP/CIBMTR*: Transplants by disease and center Leukemias and Lymphomas Inherited Immune System Disorders Inherited Metabolic Disorders Myelodysplastic & Myeloproliferative Disorders Histiocytic, Plasma and Stem Cell Disorders Other Malignancies Transplant cost Preparing for transplant More information: Transplant outcomes and data: FACT accreditation**: * NMDP/CIBMTR = National Marrow Donor Program and Center for International Blood and Marrow Transplant ** FACT = Foundation for the Accreditation of Cellular Therapy

15 Important Trends to Watch Potential game changers New Kidney Allocation System (KAS) Priority given for time on dialysis before listing Increased priority for highly sensitized recipients Possible change to Liver Allocations System Decrease points for HCC in certain circumstances Increased regional and national sharing Treatment of HCV pre- and post-transplant Will HCV positive livers be put into HCV negative recipients followed by treatment of the recipient with Harvoni or similar? Stay tuned. Thiotepa $5,767/unit with up to 20 units per treatment in certain stem cell transplants Kidney Paired Donation If we can get this moving, there could be 1,000 3,000 more kidney transplants yearly Organ Transport Systems (lung, liver, kidney and heart) 44 Thank you 15