Inappropriate Testosterone Billings
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1 Inappropriate Testosterone Billings Carla Patrick-Fagan March 30, 2015 Truven Health Analytics Inc. All Rights Reserved. 1
2 Agenda Proposed in the 2015 analytic plan Steroid prescriptions Code of Federal Regulations on prescribing Schedule III drug diversion Newsworthy stories of inappropriate therapy Appropriateness of Low T therapy PI baseline or follow up tests Methodology Company experience Next steps/recommendations Truven Health Analytics Inc. All Rights Reserved. 2
3 2015 Analytic Plan Truven Health Analytics Inc. All Rights Reserved. 3
4 Steroids reasons to prescribe Licensed physicians prescribe for testosterone deficiency, delayed puberty, low red blood cell count, breast cancer, and tissue wasting resulting from AIDS. (Retrieved March 27, 2015 from ) Endogenous androgen; normal growth and development of male sex characteristics Testosterone replacement therapy: [usually] indicated in adult males for conditions associated with a deficiency or absence Primary hypogonadism (congential or acquired) Hypogonadic hypogonadism (congenital or acquired) (Retrieved March 24, 2015, from Sometimes prescribed for women to treat premature ovarian failure (Retrieved March 27, 2015 from Replacement therapy performance enhancing steroid abuse (Retrieved March 27, 2015 from Truven Health Analytics Inc. All Rights Reserved. 4
5 21 CFR Part 1300 Schedule III/IIIN Controlled Substances (3/3N) Substances in this schedule have a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. Stimulants Depressants Nalorphine 9400 Narcotic drugs Anabolic steroids Hallucinogenic substances (Retrieved March 27, 2015 from Anabolic steroid means any drug or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone) (Retrieved March 27, 2015 from Truven Health Analytics Inc. All Rights Reserved. 5
6 21 CFR Part Retrieved March 27, 2015 from Truven Health Analytics Inc. All Rights Reserved. 6
7 Schedule III prescription drugs subject to diversion Common types of diversion: Illicit prescribing Providing unnecessary prescriptions Selling prescription drugs obtained legally Patients buying from/diverters selling to potentially illegal internet pharmacies Enter buy androgel in search engine (Adapted from retrieved March 27, 2015) Image retrieved March 27, 2015 from Truven Health Analytics Inc. All Rights Reserved. 7
8 Inappropriate testosterone therapy in the news Image source: Truven Health Analytics Inc. All Rights Reserved. 8
9 Inappropriate testosterone therapy in the news Tavernise, New York Times retrieved from /09/18/health/testosteronedrugs-fda.html?_r=0 Truven Health Analytics Inc. All Rights Reserved. 9
10 PI baseline or follow up tests done? 20-25% prescribed therapy had no baseline testosterone test (Retrieved March 24, 2015 from Prescription Drug Dosing and Administration To ensure proper dosing, serum testosterone concentrations should be measured at intervals Revised November, 2014 To ensure proper dosing, approximately 2 weeks after starting therapy, the early morning serum testosterone concentration should be measured following system application the previous evening Revised: 11/2013 Truven Health Analytics Inc. All Rights Reserved. 10
11 PI baseline or follow up tests done? Prescription Drug Testim (gel) Axiron (topical solution) Dosing and Administration Morning, pre-dose serum testosterone concentrations should be measured approximately 14 days after initiation of therapy to ensure proper serum testosterone concentrations are achieved Revised 01/2015 Your healthcare provider will test your blood before you start and while you are taking AXIRON. Revised 06/2014 Hemoglobin and hematocrit levels (to detect polycythemia) should be checked periodically in patients receiving long-term androgen administration Revised 07/2014 Truven Health Analytics Inc. All Rights Reserved. 11
12 Methodology 48 months of paid professional, facility and drug claims 02m15 database Amounts paid greater than $0 Final claims Subset of lab CPT and prostate cancer screening HCPCS codes Lab CPT codes G0102 (Prostate CA Screening, DRE) G0103 (PSA Screening) Testosterone prescription drug claims without a professional or facility claim One year prior to prescription Ninety days after prescription Days supply more than five days Truven Health Analytics Inc. All Rights Reserved. 12
13 Androgel is 84% of Rx amounts paid INJECTABLES 7% TESTIM 5% ANDROGEL 84% ANDRODERM 2% AXIRON 1% Truven Health Analytics Inc. All Rights Reserved. 13
14 Company experience: amounts paid prior 4 years 353 NCPDP IDs 354 patients 500 prescriptions (RxScript Nums) Approximately $181,862* paid for testosterone drugs prescribed with no visits: One year prior to date prescribed 90 days after date prescribed Prescribed Drug Amt Net Paid ANDROGEL $152,761 INJECTABLES $12,370 TESTIM $9,631 ANDRODERM $4,436 AXIRON $2,664 Total $181,862 * Excludes known drug claim issues Truven Health Analytics Inc. All Rights Reserved. 14
15 Testosterone therapy by PBM four years experience New PBM 48% Old PBM 47% Truven Health Analytics Inc. All Rights Reserved. 15
16 Testosterone therapy claim counts no visit 2014 spike Truven Health Analytics Inc. All Rights Reserved. 16
17 Next Steps/Recommendations Refresh this in 4Q2015 Implement as an operational recovery Identify patients for further review Continue monitoring; utilization expected to increase over time Truven Health Analytics Inc. All Rights Reserved. 17
18 References Depo-Testosterone - FDA prescribing information, side effects and uses. (n.d.). Retrieved March 24, 2015, from Gary. (n.d.). Retrieved March 30, 2015, from HIGHLIGHTS OF PRESCRIBING INFORMATION. (n.d.). Retrieved March 24, 2015, from (n.d.). Retrieved March 24, 2015, from (n.d.). Retrieved March 24, 2015, from (n.d.). Retrieved March 24, 2015, from (n.d.). Retrieved March 27, 2015, from Truven Health Analytics Inc. All Rights Reserved. 18
19 References (n.d.). Retrieved March 27, 2015, from (n.d.). Retrieved March 27, 2015, from Controlled Substance Schedules. (n.d.). Retrieved March 27, 2015, from Title 21 Code of Federal Regulations. (n.d.). Retrieved March 27, 2015, from Tavernise, S. (2014, September 18). F.D.A. Panel Backs Limits on Testosterone Drugs. New York Times, p. A18(L). Retrieved March 24, 2015, from Testim - FDA prescribing information, side effects and uses. (n.d.). Retrieved March 24, 2015, from Testosterone Replacement Clinic Agrees to Pay the Government $1.6 Million for Alleged Medicaid Fraud The National Law Review. (n.d.). Retrieved March 30, 2015, from Truven Health Analytics Inc. All Rights Reserved. 19
20 Appendix Supporting Material Truven Health Analytics Inc. All Rights Reserved. 20
21 Retail pharmacies with questionable Part D billing OEI Truven Health Analytics Inc. All Rights Reserved. 21
22 Testosterone Therapy NDC List Truven Health Analytics Inc. All Rights Reserved. 22
23 Truven Health Analytics Inc. All Rights Reserved. 23
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