1. ASBMT RETREAT INSURANCE FOR CLINICAL TRIALS Keith Sullivan October 3, 2011

2. Do Insurer Denials Restrict Clinical Trials? Peters NEJM 1994: 23% of requests for coverage for ABMT for breast cancer were denied by insurers. Light NEJM 1994 (accompanying editorial): More fairness, rationality and public accountability to insurance reimbursement for clinical trials is needed. GAO report 1999: No evidence of widespread limitations on patient access to NIH clinical trials by insurers. AHRQ Technology Assessment 2009: Although published data are near non-existent to quantify the magnitude of the effect of third party denials on recruitment into clinical trials, insurance policies do restrict recruitment onto NIH supported clinical studies.

3. Insurance Denial and Access to Cancer Trials (Kimmel Cancer Center, Johns Hopkins, 2003-2008) 628 of 4617 (14%) requests for insurance coverage for a cancer trial were denied 22% of those denied coverage lacked clinical trial benefit in their policies while 78% had insurance that allowed trials. Residents of PA (which has no state statute for cancer trials) were twice as likely to be denied as those of MD (which does) Denials spanned all racial, gender and ethnic groups Klamerus, Clin Cancer Res, 16:5997-6003,2010

4. Does Insurance Status Affect Outcome? (Review of 23 published studies in lung cancer) Patients with lung cancer and no insurance or Medicaid were compared to those with private insurance or Medicare The no insurance/Medicaid group had: – More advanced stages of cancer at diagnosis – Higher lung cancer incidence rates – Higher stage – specific and overall mortality – Less likelihood of undergoing curative procedures Slatore, Am J Respir Crit Care Med 182:1195-1205, 2010

5. States That Require Health Plans to Cover Patient Care Costs in Clinical Trials (n=36, Dec 2010) Blue Highlight indicates: states have passed legislation or instituted special agreements requiring health plans to pay the cost of routine medical care you receive as a participant in a clinical trial. AlaskaFloridaMaineNevadaOregon Virginia ArizonaGeorgiaMarylandNew HampshireRhode Island Washington, DC CaliforniaIndianaMassachusettsNew JerseySouth Carolina West Virginia ColoradoIowaMichiganNew MexicoTennessee Wisconsin ConnecticutKentuckyMissouriNorth CarolinaTexas Wyoming DelawareLouisianaNebraskaOhioVermont

6. State Statutes for Clinical Trials Coverage (36 states) Require NIH, FDA, DOD or VA support/approval Most are for Phase II-III Trials Disease Restrictions Apply: 26 are for Cancer only 3 are for Life-Threatening Disease (CT, TX, WV) 7 are for All Diseases (IN, MA, NB, NM, NC, OH, OR) (most took effect 2009/2010) Federal Health Care Reform Act (effective Jan. 1, 2014) Applies to all clinical trials that treat cancer or life-threatening diseases

7. SCOT Treatment Approved by Insurer (initial + appeal): 69/104 submissions Duration of Insurance Reviews: 1-8 months. Approved pts then randomized on study: 53/97 SCOT Eligible Patients Must Have Insurance Approval Before Randomization & Treatment SCOT Insurance Review and Appeals Revised 2/10

8. Reasons For Insurer Denials 26 Experimental or Investigational* 5No clinical trial benefits 4Diagnosis not covered 24 Unknown/unstated * Reprints of published promising results of treatment of SSc with Cy (NEJM 2006) and SCT (Blood 2007) were submitted with all insurance applications

9. Scleroderma (SCOT) Trial Insurance Denial Variation Center Pts EnrolledRandomized% Randomized U. Michigan 15 10 66% Duke 28 18 64% Mass General 16 10 62% FHCRC 18 8 44% MD Anderson 20 7 35% City of Hope 17 4 23% Med. College Wisconsin 26 2 8%

10. CONCLUSIONS Health insurer payment decisions can be arbitrary and inconsistent Data show some insurers delay and deny patient access on an NIH sponsored randomized clinical trial These restrictions do impede clinical research and the evidence needed to advance health care in America

11. You Can’t Make This Up……

12. Audience Participation: Clinical Trials and Insurance For Patients <65 yo with Private Health Insurance: 1.What percent of patients are denied for transplant A.<25% B.25-50% C.>50% D.Don’t know 2.What percent of those denied go on to transplant? A.<25% B.25-50% C.>50% D.Don’t know

13. Audience Participation (2) 3.At what point do you request approval for a clinical trial? A.Same time as the transplant approval request B.When transplant approved C.Do not request if no charges go to the insurer D.Never 4.What percent of insured patients have no clinical trials benefit? A.<25% B.25-50% C.>50% D.Don’t know

14. Audience Participation (3) 5. Of those denied a clinical trial, how many are appealed? A.<25% B.25-50% C.>50% D.Never E.Don’t know 6. Of those denied a clinical trial, how many go onto the trial? A.<25% B.25-50% C.>50% D.Never or rarely E.Don’t know

15. Open Mic Questions (1) 1.What are the issues of clinical trials coverage at your center? 2.Which are the most difficult transplants to get approved? 3.Which are the most difficult clinical trials to get approved?

16. Open Mic Questions (2) 4.How have you adapted? 5.How has industry helped? 6.What could industry and ASBMT do to increase clinical trials coverage?

17. It Had to Happen…