Models for Effective Medication Use in Health Care Systems

1. Models for Effective Medication Use in Health Care Systems Susan J. Curry, Ph.D. University of Illinois at Chicago

2. Models for effective medication use in health care systems for treatment of tobacco use and dependence should be consistent with models for treatment of other chronic conditions

3. Health System Health Care Organization Community Resources and Policies Self-Management Support DeliverySystem Design ClinicalInformationSystems Decision Support Informed, Activated Patient Prepared, Proactive Practice Team Productive Interactions Functional and Clinical Outcomes Chronic Care Model

4. Medication can be used effectively if it is: • Available • Affordable • Appealing • Appropriately used

5. Making Medications Available: Formulary Decisions • Prescription drug costs up 19% in 2000 • 36% of increase due to new, >$ drugs • higher drug costs not offset by lower medical costs • Insurers & MCOs control costs and outcomes by making evidence-based decisions on whether to place new drugs on formulary

6. Formulary decisions • Focus on clinical outcomes as well as economics • Made by committee • Use standardized guidelines

7. Regence BlueShield Formulary Guidelines • Regence clinical pharmacists complete detailed review of each drug based on clinical literature. • Medical literature on efficacy, effectiveness and relative safety is foundation for formulary review • FDA “AB” rated generics will generally be preferred Mather et al, A J Man Care, 1999;5(3):277-285

8. Regence BlueShield Formulary Guidelines • Brand names only included when offer value (e.g., significantly more clinically effective than generics or other brands in the same therapeutic class) • When clinical studies show that several drugs are clinically equivalent, only the products with the lowest net cost will be included in the formulary Mather et al, A J Man Care, 1999;5(3):277-285

9. Regence BlueShield Formulary Guidelines • Improved dosage forms only considered when their cost effectiveness can be documented • For each drug, manufacturers are required to submit dossiers that include detailed clinical and economic information, including data from published and unpublished studies, and outcomes modeling Mather et al, A J Man Care, 1999;5(3):277-285

10. Regence BlueShield Formulary Guidelines • Economic modeling will be used to evaluate the impact of each drug on patients’ clinical outcomes, medical claims, and costs of care. Mather et al, A J Man Care, 1999;5(3):277-285

11. Formulary decisions bottom line • ‘Burden of proof’ is on the medication (and, by extension the manufacturer) • As number and types of pharmacotherapies for tobacco use cessation increases there will be increasing demand from health systems for data on their relative clinical and cost effectiveness

12. Making medications affordable: Insurance coverage • Use goes up with full coverage • 25% vs. 14% used NRT over 12 months (Schauffler et al, Tob Cont, 2001) • But not always… • 19% vs. 24% used Zyban • 28% vs. 26% used NRT over 12 months (Boyle et al, Health Affairs, 2002)

13. Making medications affordable: Insurance coverage • The more it costs, the less it’s used • 50% co-payment on NRT associated with 31% drop in use (Curry et al, NEJM, 1998) • Many with coverage don’t know they have it • 30% in Boyle study knew of coverage • Use of medications higher if aware of coverage (42% Zyban; 31% NRT)

14. Making medications affordable: Insurance coverage • How benefit is structured can impact availability and use of new medications • Bundled with behavioral program • Coverage for specific medications or all FDA-approved • Amount dispensed per prescription

15. Making pharmacotherapy appealing • Does prior failure with pharmacotherapy reduce demand for new treatment? • National data not available, but RTC data suggest not • Over 60% of volunteers for Zyban effectiveness trial had prior use of NRT • Pharmacotherapy may have inherent appeal to smokers looking for the ‘magic bullet’

16. Making pharmacotherapy appealing • Pharmaceuticals’ investments • Direct-to-consumer marketing • Academic detailing for clinicians • Health care system investments • vital sign stamps, chart stickers for easy identification of smokers • medical record prompts for advice, assistance • clinical information systems and registries for follow-up

17. Facilitating appropriate use • Medication approval in efficacy trials • face-to-face prescribing • regular monitoring & behavioral support • Medication use in effectiveness conditions • over-the-phone prescriptions • under-dosing (amount &/or duration) • concurrent smoking • no behavioral support

18. Facilitating appropriate use: Behavioral support • Bundled coverage ensures behavioral support • Seamless protocols for obtaining pharmacotherapy as part of behavioral program ensures medication use

19. Facilitating appropriate use: Behavioral support • Integrated Model* • Telephone-based enrollment & screening for medication eligibility • case review for questionable, ineligible by program physicians • notification of potential medication use to patient’s primary care provider • Medications and written behavioral program materials sent by mail *From Swan, McAfee, Curry et al, Arch Int Med (in press)

20. Facilitating appropriate use: Behavioral support • Integrated model, cont’d • Patient enrolled in state of the art telephone counseling program(4 outreach calls over 6 months; access to toll-free quitline for 1 year) • Treatment progress reports sent to primary care physicians

21. Facilitating appropriate use: Behavioral support Dose OR = 1.05 [0.94,1.17] Program OR = 1.21 [1.08,1.35]

22. Moderate intensity behavioral programs do improve long-term outcomes • Can be provided ‘in-house’ or through linkages with community-based programs (e.g., state quit-lines)

23. Re-cap • Medications must be available • May be a higher bar for new medications • Affordability is important • Particularly for lower income smokers where prevalence is increasingly concentrated • Chronic disease care models in health care systems are appropriate • Behavioral (self-management) support is a key component