1. Joanne Armstrong, MD, MPH A Health Plan’s Approach to Translating Research Findings into Practice 17 Alpha-Hydroxyprogesterone Caproate

2. Aetna Health benefits company –Range of plan designs: HMO, Point-of-Service, PPO, and Indemnity 13 million covered lives, 3.5 million women age 15-49¹ Network of physicians and hospitals –23,000 Ob Gyns; 100,000 PCPs; 3,000 hospitals 148,600 deliveries in 2003 –10,700 prior preterm births (indicated and spontaneous) estimated Average inpatient admission costs for infants <2500 grams range from $23,000 – $64,000 2 –Infants <1500gm week average inpatient admission costs $99,000 1. September 2004 2. CY 2003, Aetna Managed Care Monitor, 9/2004, DRG 386, 387, 388

3. Aetna Moms-To-Babies™ Maternity Management Program Provides nurse case management to selected members with impactable, high risk conditions –Preterm birth “prevention” services targeted to high risk women, including African Americans Provides general educational information to all members and physicians on a range of obstetrical issues Coordinates health care services within Aetna, with health care providers, and with external vendors

4. Member Identification for Moms-To-Babies Program Member self-identification Physician registration Pregnancy risk survey

5. View of 17 Progesterone: Meis, et al. N Engl J Med. 2003;348(24):2379-June 2003 Clinical Policy Bulletin coverage position-July 2003 ACOG Committee Opinion-November 2003 Monitoring of prescription use-August 2003-January 2004 –Approximately 1-2 prescriptions per month

6. Exploration of barriers-March 2004 Unaware of literature, potential benefit, and whether it is “recommended by ACOG” Uncertain about insurance coverage Uncertain source of medication and unreliable supply Perceived patient unwillingness to self-administer Difficulty identifying patients early enough for therapy Concern over teratogenic potential “No financial reward”  Hassle for physicians

7. Goals Increase member and physician awareness of literature, potential value Create reliable supply of medication for Aetna members Remove access barriers Assist in coordination of services Provide case management/compliance management support

8. Overcoming Barriers: Covered Benefit Clinical policy bulletin adoption-July 2003 –Medical benefit for HMO members –Pharmacy benefit for PPO members Injection of medication by physician also covered Home nurse teaching visit covered once.  No coverage barrier for members

9. Overcoming Barriers: Medication Availability Compounding pharmacy requirements –Identify a pharmacy licensed and inspected in all 50 states. –Assurance of quality. Compliance with or plan for compliance with United States Pharmacopoeia guidelines (USP-797) to regulate the practice of sterile compounding (became effective January 1, 2004) Recommendation from network physicians –Real time reporting capability Freedom Pharmacy: 888-660-4283 –Ramped up production –Established mechanism to report members on medication to Moms-To- Babies

10. Overcoming Barriers: Self-Administration Members encouraged to learn self-administration Single home nurse teaching visit covered Physician administration also covered

11. Overcoming Barriers: Early Identification of Eligible Members 88% of women delivering live birth in 2003 received care within 42 days of enrolling in plan. 1 If information delivered in setting of perinatal consultation, window of opportunity is shortened. Need to not rely on perinatal consultation Proactive identification of eligible members and delivery of information directly to them about potential value of medication. –Claims reviewsMember self-identification –Pharmacy reportsPhysician identification 1. HEDIS 2003

12. Overcoming Barriers: Member Education Multiple vehicles to deliver member information –Telephonic by Aetna nurses –Letters to members identified as eligible –Created preterm birth video –Home nurse education visits –Employer/work place information Key member messages: –Availability of new literature –Covered benefit –Availability of medication –Aetna will assist with coordination of services

13. Overcoming Barriers: Physician Education Physician News articles-August 2004 Mailing to 25,000 contracted OBGYNs, Perinatologists, Neonatologists, Midwives-September 2004

14. Summary of Initiative Member identified as eligible for 17 progesterone Member contacted by Aetna nurse case manager –Provide information on preterm birth, literature, medication –Coordination of consultation with perinatal services, if desired –Assistance with getting medication –Coordination of home nurse teaching visit Letter sent to physician about members eligibility Weekly compliance support by Aetna nurse case manager q week for first month, then q month Outcome information collected after delivery

15. Physician Feedback Questions are about inclusion/exclusion criteria of prior preterm birth: –Clarification of indications –How late is too late to begin? –Does gestational age of prior preterm birth influence action? Non-evidence based practice questions –Use as tocolytic –Use for recurrent pregnancy loss Some concerns about cost-effectiveness, esp. for prior delivery at 35-37 weeks. What do we know about Medicaid patient’s ability to self-administer medication Some malpractice issues: –Does offering increase liability if adverse outcome? –Does failure to offer increase liability if adverse outcome? –Most wish ACOG’s statement were more definitive

16. Aetna Next Steps CME for high volume ObGYN and perinatal groups –Collaborate with SMFM on content Collaborate with AAFP to educate Family Physicians Monitor outcomes –Challenged by lack of good control group

17. Questions