1. Uptake of a New Cervical Cancer Prevention Technology in a Medicaid Population Rebecca Anhang Price AcademyHealth Annual Research Meeting June 10, 2008 Funding: Foundation for Informed Medical Decision Making; Novartis Fellowship

2. Background: Cervical Cancer and Human Papillomavirus (HPV) Virtually all cervical cancers are caused by carcinogenic or high risk strains of human papillomavirus (HPV). In 2000, the FDA approved a DNA test that detects carcinogenic types of HPV. –Two main uses: Reflex testing for equivocal Pap results (ASC-US or atypical squamous cells of uncertain significance) Primary screening for women age 30+

3. Background: Timeline of Clinical Guideline Releases Initial FDA approval of HPV testing for triage of Pap test results deemed ASC-US Consensus Guidelines by the American Society for Colposcopy and Cervical Pathology (ASCCP) released American Cancer Society (ACS) guidelines released U.S. Preventive Services Task Force guidelines released American College of Obstetricians and Gynecologists guidelines released Digenes DTC campaign for HPV DNA testing launched March 2000 April 2002 November 2002 January 2003 March 2003 August 2003 March 2005 FDA approves expanded indication for HPV DNA testing: Primary screening of women over age 30, in conjunction with the Pap test April 2006 June 2006 Merck & Co.s DTC campaign for HPV awareness launched FDA approves Merck & Co.s HPV vaccine Feb 2004 Co- sponsored Interim Guidance from National Cancer Institute, ASCCP, ACS published

4. Research Objectives To evaluate the impact of clinical guidelines on the uptake of HPV DNA tests. To identify patient and provider characteristics associated with overall and clinically appropriate HPV DNA test use.

5. Methods: Data Florida Medicaid claims database, July 2001 – June 2006. Inclusion criteria: –Age 21 to 64 –Eligible through TANF/AFDC, family planning or pregnancy –Continuously enrolled for at least 12 months –No hysterectomy during study period Resulting dataset included 310,427 cervical screening test claims and 13,550 HPV DNA test claims for 415,239 Medicaid enrollees.

6. Methods: Analysis Dependent Variables: –HPV DNA test (given receipt of cervical cancer screening test) –Appropriate test (given receipt of HPV DNA test) Independent Variables of Interest: –Time variables (time trend, dummy dates for clinical guideline releases) –Patient race/ethnicity –Provider specialty Other Covariates: –Patient age, ASC-US diagnosis, district of residence, total months enrolled –Pathology lab volume Estimation approach: –Generalized estimating equations with logit link. –Robust standard error estimates to account for patient clustering within providers.

7. Results: Sample Characteristics * Turn 30 at some point during the study period. ASC-US diagnosis can only be determined among those for whom a cervical screening test claim is filed. Characteristic Beneficiaries (n = 415,239) Age, years (%) 21 – 29 30 – 64 * 46.71 53.29 Race/ethnicity (%) White Black Hispanic Other 40.37 34.13 22.90 2.60 Diagnosis (%) Atypical squamous cells of uncertain significance (ASC-US) 1.15 Screening Behavior (%) Received any cervical screening test Received an HPV DNA test 40.02 2.87

8. Results: HPV Test Use, July 2001 – June 2006

9. Results: Appropriate HPV Test Use, July 2001 – June 2006

10. Results: Effects of Guidelines on HPV Test Use GEE Parameter Estimates (n = 310,427, 13,550 HPV DNA tests) Time trend (by month) 0.007 *** Clinical guidelines Release of American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines (4/02) 0.882 *** Release of American Cancer Society (ACS) guidelines (11/02) 0.160 ** FDA approval for 30+ (3/03)0.193 ** Release of American College of Obstetricians and Gynecologists (ACOG) guidelines (8/03) 0.250 *** Release of co-sponsored interim guidance (2/04)-0.038 *p<0.05; **p<0.01; ***p<0.0001 Models also control for patient, provider and lab characteristics, as well as the fixed effects of residence in each of 11 Medicaid districts in Florida, and total number of months enrolled in Medicaid.

11. Results: Differential Diffusion of HPV Test Use by Race/Ethnicity and Provider Specialty Note: Predicted probabilities from multivariate models including time trend, important dates, patient age, race/ethnicity, and ASC-US diagnosis, provider specialty, pathology lab volume, fixed effects of residence in each of 11 Medicaid districts in Florida, and total number of months enrolled in Medicaid. Models also include interaction effects for monthly time trend * patient race/ethnicity and provider specialty * patient race/ethnicity.

12. Results: Predictors of Appropriate HPV Test Use Clinical guidelines were not consistently associated with appropriate HPV test use. Obstetricians/gynecologists were more likely than primary care providers to administer the test appropriately.

13. Conclusions Uptake of the HPV DNA test was sustained by introduction of multiple sets of clinical guidelines. –Guidelines did not consistently promote appropriate use. Racial/ethnic disparities in HPV DNA test use resolved within three years of the tests introduction. –Early adoption of testing by obstetricians/gynecologists helped to close the gap.

14. Implications Release of clinical guidelines is associated with increases in use of a new technology. –However, guidelines may not be associated with increases in appropriate use. Adoption of new technologies may initially occur more slowly in minority groups. –However, these groups can catch up, assisted by early guideline adherence by specialists.