# Presentation: 772846

## System for       Thalidomide              Education and                     Prescribing                            SafetyTM            Selected Topics of Interest        Thalomid® (thalidomide) NDA 20-785                          Celgene, Corp.

## S.T.E.P.S. Program Objectives

**To prevent fetal exposures to thalidomide**
**To educate regarding risks of thalidomide **
**To provide procedures to reduce risk of fetal exposure to thalidomide**
**To identify at-risk behaviors by surveying patients and prescribers**
**To provide a mechanism for intervention & remediation when at-risk behaviors identified via *****S.T.E.P.S.***
**	****Serves as the mechanism for restricted distribution**

## Slide 3

## “Old” STEPS - Areas for Improvement

**At-risk behaviors from BU survey identified only after drug dispensed**
**Time delay to identification of at-risk behavior and intervention is suboptimal**
**BUSEC’s primary focus is not real-time patient interventions**
**Program design could do more to assure compliance with program procedures (e.g. HCG tests)**
**Program has limited risk groups categories (M/F) doesn’t allow for targeted risk management strategies (e.g. AFCBP vs. AFNCBP)**
**Program doesn’t utilize current technologies**
**Target specific risk groups**
**Record availability/storage/management/archiving**
**Efficiency/quality of accounting/auditing/reporting on STEPS activities**

## “New” S.T.E.P.S.TM    -  1

**Launched July 30, 2001**
**Address areas for improvement identified in “Old” *****STEPS***
**Many of the elements the same**
**Registration of Prescriber, Pharmacist, and Patient**
**Educational materials**
**brochure & video tape**
**Patient counseling / education**
**Limit to 28-day supply of Thalomid (blister packs)**
**Call healthcare provider for any suspected fetal exposure (M or F) - 800 number for Celgene provided**
**No blood donation**
**Contraception (FCBP) & latex condoms (males)**
**Pregnancy tests unchanged**

## “New” S.T.E.P.S.TM    -  2

**Six Risk Groups**
- Adult females of childbearing potential
- Adult females not of childbearing potential
- Female children of childbearing potential
- Female children not of childbearing potential
- Adult males
- Male children
**Consent forms computer generated for specific risk group based upon responses entered into program - includes (DOB, address, diagnosis for Thalomid treatment)**
**Must participate in Registry and telephonic interactive voice response system (IVR) survey (Celgene administers and performs interventions)**
**BUSEC Follow-up Survey now optional - utilizes risk groups (n=6)**
- Quality assurance / program evaluation

## IVR

**IVR = Interactive Voice Response System**** **
**a brief, automated, telephone-based survey (Celgene administers)**
**survey questions are tailored to patient’s specific risk group**
**a tool designed to **
**identify at-risk behavior and trigger real-time interventions (Celgene intervenes)**
**foster compliance with *****STEPS***** program procedures**
**The IVR system is used to “activate” prescriptions**

##  NEW S.T.E.P.S.

- Physician Visit

- Consent Signed

- Celgene Voice Response System

- Drug Dispensed to patient

- 1

- 2

- 3

***Blinded*** Patient List Sent to BU (**ALL** patients) not implemented yet, etc

***A***

***B***

**BU**

- Prescription Provided, Pharmacist to dispense

*Physician calls IVR*

*Patient calls IVR*

*Pharmacist calls IVR*

*Envelope supplied to mail back to BU should the patient agree to participate*

*Celgene mails initial survey with unique identifier **not implemented yet*

## S.T.E.P.S. Overview

**Approximately 65,000 patients registered since July, 2001**
**3****rd**** Quarter, 2003:**
**Approximately 50,000 surveys completed (mandatory compliance survey conducted by Celgene)**
**Approximately 5% were “flagged” and required an intervention prior to prescription activation**
**The largest proportion of “flagged surveys” was in the FCBP risk group, mostly related to outdated pregnancy tests**

## Percentage of women experiencing unintended pregnancy during 1st year (perfect use)

**Periodic abstinence****	****	****1-9**
**Male condom****	****	****	****3**
**Diaphragm****	****	****	****	****6****	**
**Oral contraceptives****	****	****0.1 **
**Injectable methods****	****	****0.3**
**IUD****	****	****	****	****	****0.1-1.5**
**Surgical**
**Vasectomy****	****	****	****0.1**
**Tubal ligation****	****	****	****0.5**

- Source:  Contraceptive Technology, 1998

## Contraception Failure(rates per 1,000)

**Periodic abstinence****	****198**
**Male condom****	****	****	****90**
**Diaphragm****	****	****	****81 ****	**
**Oral contraceptives****	****70 **
**Injectable methods****	****	****32 **
**IUD****	****	****	****	****5-14***
**Surgical**
**Vasectomy****	****	****	****<10**
**Tubal ligation****	****	****7.5-36**
- * Cumulative 5-year failure rates

- Source:  ACOG Bulletin No. 46, Sept 2003