1. Endpoints for Stimulant Treatments: Persuading the Payor Eric C. Strain, M.D. Johns Hopkins University School of Medicine MOST Meeting March 25-26, 2015

2. 1. An area I think about, but not my usual focus A couple of caveats

3. 1. An area I think about, but not my usual focus (but an expert is someone from out of town…) A couple of caveats

4. 1. An area I think about, but not my usual focus 2. This is the realm of cost-benefit analyses, and my read of addictions cost-benefit analyses is that there is some controversy in this field (measures, etc.) – it is especially difficult to assess benefits A couple of caveats

5. 1. An area I think about, but not my usual focus 2. This is the realm of cost-benefit analyses, and my read of addictions cost-benefit analyses is that there is some controversy in this field (measures, etc.) – it is especially difficult to assess benefits Will start by talking about costs, and then benefits… A couple of caveats

6. 1. New pharmacological treatment (new cost) 2. Replace (cost offset) an existing pharmacological treatment 3. Replace (cost offset) a non-pharmacological treatment New medications

7. 1. New pharmacological treatment Examples: imipramine for depression (1958) buprenorphine for opioid addiction (2003) New medications

8. 1. New pharmacological treatment Examples: imipramine for depression (1958) buprenorphine for opioid addiction (2003) Note can be a medication for the indication, but new treatment is markedly different in how used (e.g., buprenorphine) Result in potential for new (substantial) costs to health care system New medications

9. 1. New pharmacological treatment A medication for stimulant use disorder will be a new medication (new costs to health care system) New medications

10. 2. Replace (cost offset) an existing pharmacological treatment Example: sertraline (zoloft) for depression (1991) Can be incremental costs (e.g., new drug [sertraline] vs. a generic [fluoxetine]), but new cost is likely less than if a completely new medication type Seeing this with buprenorphine now? New medications

11. 3. Replace (cost offset) a non-pharmacological treatment Example: lithium (1949) vs. institutionalization for bipolar disorder A new medication that may have costs to health care system, but it offsets some other health care cost that is even more expensive New medications

12. What about benefits then? New medications

13. Benefits in addictions treatment can be hard to quantify There are health care related ones, and social benefits New medications

14. Health care benefits Important! Intuitively we (clinicians) think they occur Lag between treatment and benefit may make it hard to demonstrate May be easier to shift the health care cost to somewhere else, if health care benefit is not quickly demonstrated New medications

15. Social benefits Important! For addictions, a variety of impacts (e.g., work, legal problems, family stabilization) Tend to not have a direct payor benefit (social good is good, but it doesn’t directly impact payor’s bottom line) New medications

16. Should a measure for stimulant use disorders show health care benefit, or social benefit? New medications

17. Having a measure that shows health care benefit would seem to be particularly persuasive to payors (e.g., a treatment that decreases other health care costs in a relatively quick manner) Demonstrating social benefits is good, but will likely impact the payor primarily if the payor is the state Final thoughts

18. Acknowledgements Support of NIDA Patients and staff at the Behavioral Pharmacology Research Unit at Johns Hopkins University School of Medicine

19. Thank you.