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`[KADCYLA FAQ SCRIPT FOR INBOUND CALLS]
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`Required content
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`General introduction
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`Transfer information
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` Page 6
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` Page 7
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`Transfer to KADCYLA Access Solutions Page 8
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`Transfer to Medical Communications Page 10
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`Transfer to Product Support
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`Transfer to Genentech Patient Resource Center
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`Adverse events Page 14
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`Transactional opt-in
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`Commercial opt-in
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`Opt-out Page 19
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`Off-label questions and/or questions with no approved response Page 20
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`KADCYLA information
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`1. What is KADCYLA?
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`2. What is the generic name of KADCYLA?
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`3.
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`Is KADCYLA right for me?
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`4. Who should NOT take KADCYLA?
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`5. What are the approved uses of KADCYLA?
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`6. What is HER2-positive breast cancer?
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`7. What is metastatic breast cancer?
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`8. How does KADCYLA work?
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`9. How might KADCYLA help me?
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`Important safety considerations with KADCYLA
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` Page 28
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`10. What are the most common side effects of KADCYLA?
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`11. What are the most serious side effects of KADCYLA?
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`12. What are additional possible serious side effects of KADCYLA?
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`13. What can I expect with my first dose or future doses of KADCYLA?
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`14. Can KADCYLA be used in pregnant women?
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`15. Are there any infusion-related reactions associated with KADCYLA?
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`16. What should I know about KADCYLA before starting treatment?
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`HCP Important Safety Information and Closing Page 38
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`Patient/Caregiver Important Safety Information and Closing Page 40
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`IMMUNOGEN 2238, pg. 2
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`IPR2014-00676
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`Page 3 of 43
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`[REQUIRED CONTENT]
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`Notes:
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`1. This is an FAQ script for inbound calls.
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`2. Copy in gray highlights reflects instructions for the Nurse and will not be read aloud to caller
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`3 . Start with the greeting in the General Introduction section, and then proceed to the
`appropriate FAQ to address each caller’s needs.
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`4. Read disclaimer below and remind caller that the information provided is for
`educational purposes only and is not meant to replace the advice of his or her
`healthcare provider.
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`Inform each caller that the call will be recorded for quality and training purposes.
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`5.
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`6. Read the appropriate Indication Statement and Boxed Warning to each caller at the start of the
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`call, as part of the General Introduction/greeting.
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`7. Read the generic name ado-trastuzumab emtansine (a-DO tras-TOO-zoo-mab em-TAN-seen) to
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`the caller at the first mention of KADCYLA.
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`8. Read the Important Safety Information at the end of each call. Direct caller to a
`specific section of the PI for additional information. Do not try to interpret or explain
`information in the PI. Direct caller to the Internet for the full PI or, if he/she does not
`have Internet access, send him/her a copy of the PI in the mail. See Transactional opt-in
`script.
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`9 . The questions at the end of each FAQ are meant to guide you in assessing the caller’s
`understanding of the information and the answer. Use them as you feel necessary.
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`If a person calls to opt out of the program, or if at any time during the call the person
`1 0 .
`wishes to opt out, he or she may opt out of the program. See Opt-Out script. The call center
`will record the reason for the opt-out and remove the caller from the program.
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`11. All questions and responses are intended for use with patients, caregivers, and
`healthcare providers unless otherwise noted.
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`[Disclaimer should be read to all callers.]
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`The information provided is not intended to be a substitute for the advice of your healthcare team.
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`Always discuss with your healthcare team any questions you may have about your cancer therapy and
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`treatment with KADCYLA™ (ado-trastuzumab emtansine).
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`IMMUNOGEN 2238, pg. 3
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`[Indication statement should be read to the caller at the start of each call. Read professional indication
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`for HCPs and patient indication for all other callers. Read the boxed warning after the indication
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`statement.]
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`[HCP indication]
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`KADCYLA, or ado-trastuzumab emtansine, injection for intravenous use, as a single agent, is indicated
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`for the treatment of patients with HER2-positive, metastatic breast cancer, or MBC, who previously
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`received trastuzumab and a taxane, separately or in combination. Patients should have either:
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` Received prior therapy for metastatic disease, or
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` Developed disease recurrence during or within six months of completing adjuvant therapy
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`[Patient indication]
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`KADCYLA is approved to treat HER2-positive breast cancer that has spread to other parts of the body
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`(metastatic breast cancer) after prior treatment with trastuzumab (Herceptin) and a taxane. Prior
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`treatment could have been for the initial treatment of breast cancer or for the treatment of cancer that
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`had spread to other parts of the body.
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`[Boxed warning should be read to the caller after the indication statement, at the start of each call. Read
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`professional boxed warning to HCPs and patient boxed warning for all other callers.]
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`[HCP boxed warning]
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`Boxed WARNINGS: HEPATOTOXICITY, CARDIAC TOXICITY, EMBRYO(cid:173)FETAL TOXICITY
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` Do not substitute KADCYLA for or with trastuzumab
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` Hepatotoxicity: Serious hepatotoxicity has been reported, including liver failure and death in
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`patients treated with KADCYLA. Monitor serum transaminases and bilirubin prior to initiation
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`of KADCYLA treatment and prior to each KADCYLA dose. Reduce dose or discontinue KADCYLA
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`as appropriate in cases of increased serum transaminases or total bilirubin
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` Cardiac toxicity: KADCYLA administration may lead to reductions in left ventricular ejection
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`fraction (LVEF). Evaluate left ventricular function in all patients prior to and during treatment
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`with KADCYLA. Withhold treatment for clinically significant decrease in left ventricular
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`function
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` Embryo-fetal toxicity: Exposure to KADCYLA can result in embryo-fetal death or birth defects.
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`Advise patients of these risks and the need for effective contraception
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`IMMUNOGEN 2238, pg. 4
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`IPR2014-00676
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`Page 5 of 43
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`[Patient boxed warning]
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`What is the most important safety information I should know about KADCYLA?
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`KADCYLA is not the same medicine as trastuzumab, known as Herceptin.
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`There are possible serious side effects of KADCYLA. Contact your doctor right away if you experience any
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`of these symptoms. Your doctor may do tests before starting KADCYLA and before each dose to monitor
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`for these side effects. KADCYLA treatment may be stopped or the dose may be lowered if you
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`experience any of these side effects.
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`Liver problems
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` KADCYLA may cause severe liver problems that can be life-threatening. Symptoms of liver
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`problems may include vomiting, nausea, eating disorder (anorexia), yellowing of the skin
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`(jaundice), stomach pain, dark urine, or itching
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`Heart problems
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` KADCYLA may cause heart problems, including those without symptoms (such as reduced heart
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`function) and those with symptoms (such as congestive heart failure). Symptoms may include
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`swelling of the ankles or legs, shortness of breath, cough, rapid weight gain of greater than 5 lbs
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`in less than 24 hours, dizziness or loss of consciousness, or irregular heartbeat
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`Pregnancy
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` Receiving KADCYLA during pregnancy can result in the death of an unborn baby and birth
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`defects. Birth control should be used while you receive KADCYLA and for 6 months after your
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`last dose of KADCYLA
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`If you are exposed to KADCYLA during pregnancy, contact your healthcare provider right away;
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`you are also encouraged to enroll in the MotHER Pregnancy Registry by calling 1-800-690-6720
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`
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`If you are a mother who is breastfeeding, you should talk with your doctor about either stopping
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`breastfeeding or stopping KADCYLA
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`Contact your doctor right away if you experience symptoms associated with these side effects.
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`IMMUNOGEN 2238, pg. 5
`Phigenix v. Immunogen
`IPR2014-00676
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`Page 6 of 43
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`[GENERAL INTRODUCTION]
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`[AUTO ATTENDANT GREETING]
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`Purpose: Used by general call center operators when a call center nurse is not available.
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`Welcome to the KADCYLA Support Line, a service of Genentech.
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`If your call is a medical emergency, please hang up the phone and dial 911 or your local emergency
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`response unit. In order to insure the highest quality of service to you, your call may be monitored or
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`recorded. If you are calling from a rotary telephone, please remain on the line and a representative will
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`be with you shortly.
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`[REACTIVE SCRIPT]
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`Purpose: Used to respond to any inbound call.
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`Hello, thank you for calling the KADCYLA Support Line. This is <Name, Role and Credentialing>. How
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`may I help you?”
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`
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`[Address caller’s needs using approved content and Indication and Safety Information]
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`IMMUNOGEN 2238, pg. 6
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`Page 7 of 43
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`[TRANSFER INFORMATION]
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`[All transfers will be warm transferred during business operating hours as applicable for each group.]
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`[For information regarding Reimbursement, Access, SMN Forms, Co-Pay Assistance or Free Drug, Private
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`Insurance, HMO, PPO, Medicare, Payment, Access, transfer to KADCYLA Access Solutions Script]
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`[For HCPs with clinical questions about KADCYLA, transfer to Medical Communications (See KADCYLA
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`MedCom script)]
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`[For HCPs with product inquiries about KADCYLA, transfer to Product Support (See Product Support
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`Script)]
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`[For patients and caregivers with product inquiries about KADCYLA, transfer to Genentech Patient
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`Resource Center (See Genentech Patient Resource Center Script)]
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`[For information regarding adverse event reporting, see Adverse Events script]
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`IMMUNOGEN 2238, pg. 7
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`IPR2014-00676
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`Page 8 of 43
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`[TRANSFER TO KADCYLA ACCESS SOLUTIONS]
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`Purpose: To be used by call center RNs to describe the features and benefits of KADCYLA Access
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`Solutions for callers with financial questions, such as insurance coverage, co-pay assistance, general
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`billing/coding, etc.
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`[If during Access Solutions business hours:]
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`For patients and their healthcare providers, KADCYLA Access Solutions provides coverage and
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`reimbursement support, patient assistance, and informational resources. Callers to KADCYLA Access
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`Solutions will be connected promptly to a dedicated specialist.
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`[Offer warm transfer only during KADCYLA Access Solutions Business hours 9 AM to 8 PM Eastern time
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`Monday through Friday]
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`If you are interested, I can transfer you to KADCYLA Access Solutions right now. May I transfer you?
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`If yes
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`If no
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`Great! I’ll transfer you right now, but in case
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`Okay, no problem. Can I give you the number
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`we get disconnected, please call back to 1-888-
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`to call later if you change your mind?
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`249-4918. KADCYLA Access Solutions is
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`
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`[If yes] Do you have a pen and paper
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`available Monday through Friday from 6 AM to
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`ready? [When caller is ready] It is 1-888-
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`5 PM Pacific time. You can also learn more
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`249-4918. KADCYLA Access Solutions is
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`about KADCYLA Access Solutions by visiting
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`available Monday through Friday from 6
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`www.genentech-access.com/kadcyla. Thank
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`AM to 5 PM Pacific time. You can also learn
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`you and have a great day.
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`more about KADCYLA Access Solutions by
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`visiting www.genentech-
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`[Transfer call to KADCYLA Access Solutions]
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`access.com/kadcyla. Thank you and have a
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`Hello, this is <Caller Name> with the KADCYLA
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`great day.
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`Support Line. I have <Caller Name> on the line.
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`
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`[If no] No problem. If you change your
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`He/she has a question about <topic>. Here
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`mind, don’t hesitate to call us back. We
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`he/she is…
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`may be reached at 1-888-249-4918. Thank
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`you for calling the KADCYLA Support Line.
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`Have a great day.
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`IMMUNOGEN 2238, pg. 8
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`Page 9 of 43
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`[End call]
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`[If outside of Access Solutions business hours:]
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`Unfortunately, the KADCYLA Access Solutions operators are not available at this time. I can give you the
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`direct number for KADCYLA Access Solutions and their operating hours so you can contact them directly.
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`Do you have a pen? Here is the direct number for KADCYLA Access Solutions. It is 1-888-249-4918, and
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`they are available Monday through Friday from 6 AM to 5 PM Pacific Time. You can also learn more about
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`KADCYLA Access Solutions by visiting www.genentech-access.com/kadcyla.
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`IMMUNOGEN 2238, pg. 9
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`IPR2014-00676
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`Page 10 of 43
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`[TRANSFER TO MEDICAL COMMUNICATIONS]
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`[Purpose: Used when warm-transferring an HCP to the Medical Communications Department.]
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`[If a patient or caregiver calls with a question or request that cannot be addressed]
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`<Mr./Mrs./Ms. Last Name>, the KADCYLA Support Line is not set up to answer the specific
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`question/concern that you have. Please discuss your questions and concerns with your healthcare
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`provider. He or she is your primary source of information and care.
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`Do you have any other questions that I can help answer today?
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`[If YES, go to approved FAQs]
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`[If NO, go to Patient/Caregiver Important Safety Information and Closing]
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`
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`
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`[For HCPS: If during MedCom business hours:]
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`<Dr./Mr./Ms. Last Name>, the KADCYLA Support Line is not set up to answer the specific
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`question/concern that you have. The Medical Communications Department may be able to assist you.
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`Would you like me to transfer you right now?
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`[If yes]
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`[If no]
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`Great! I’ll transfer you right now. But let me
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`I will give you the Medical Communications
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`give you the number in case we get
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`Department's direct number in case you want
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`disconnected. Do you have a pen? The direct
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`to contact them. Do you have a pen and paper
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`number for the Medical
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`ready? [When caller is ready]
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`Communications Department is 1-800-821-
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`The direct number is 1-800-821-8590 and they
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`8590 and they are available between 6 AM
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`are available between 6 AM and 5 PM Pacific
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`and 5 PM Pacific Time. Just one moment
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`Time.”
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`please…
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`“Is there anything else I can help you with
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`[Transfer call to MedCom]
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`today?”
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`Hello, this is <Caller Name> with the KADCYLA
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`
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`Support Line. I have <Caller Name> on the line.
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`[Address additional matters]
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`IMMUNOGEN 2238, pg. 10
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`IPR2014-00676
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`Page 11 of 43
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`He/she has a question about <topic>.
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`[End call]
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`Here he/she is…
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`[Transfer caller]
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`IMMUNOGEN 2238, pg. 11
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`IPR2014-00676
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`Page 12 of 43
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`[TRANSFER TO PRODUCT SUPPORT]
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`[Purpose: Used when warm transferring a healthcare team member to Product Support.]
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`[If during product support business hours:]
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`<Dr./Mr. last name>, unfortunately this educational support program is not set up to help answer the
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`specific question/concern that you have, but the Product Support Department may be able to assist you.
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`Would you like me to transfer you right now?
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`[If yes]
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`[If no]
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`Great! I’ll transfer you right now, but in case we get
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`I will give you the direct number for the
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`disconnected the number to the Product Support
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`Product Support Department so you can
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`Department is 1-800-821-8590. They are available
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`contact them. Do you have a pen and paper
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`Monday through Friday from 6:30 am to 3:30 pm
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`handy?
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`Pacific time. Just one moment, please…
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`[When caller is ready]
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`
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`Here is the number. It is 1-800-821-8590. They
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`[Warm transfer to product support]
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`are available Monday through Friday from 6:30
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`Hello, this is <caller name> with the KADCYLA Patient
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`am to 3:30 pm Pacific time.
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`Support Line. I have <caller name> on the line.
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`
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`He/she has a question about <topic>. Here he/she
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`Do you have any other questions about
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`KADCYLA or HER2-positive breast cancer that I
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`can help answer today?
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`
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`is…
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`[Transfer caller.]
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`[Address additional concerns. Then proceed to
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`Important Safety Information.]
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`[CLOSING—read after Important Safety
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`Information]
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`Thank you for calling and have a nice day.
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`[End call]
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`IMMUNOGEN 2238, pg. 12
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`IPR2014-00676
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`Page 13 of 43
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`[TRANSFER TO GENENTECH PATIENT RESOURCE CENTER]
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`[Purpose: Used when warm transferring a patient or a caregiver to the Genentech Patient Resource
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`Center]
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`[If during Genentech Patient Resource Center business hours:]
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`<Mr./Ms. last name>, unfortunately the KADCYLA Patient Support Line is not set up to help answer the
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`specific question/concern that you have, but the Genentech Patient Resource Center may be able to
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`assist you. Would you like me to transfer you right now?
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`
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`[If yes]
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`[If no]
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`Great! I’ll transfer you right now, but in case
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`Okay, no problem. I will give you the Genentech Patient
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`we get disconnected, the direct number for
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`Resource Center’s direct number so you can contact
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`the Genentech Patient Resource Center is 1-
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`them on your own time. Do you have a pen and paper
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`877-436-3683 and they are available
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`handy?
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`between 6 am and 5 pm Pacific time. Just one
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`[When caller is ready]
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`moment please…
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` Great, here is the direct number for the Patient
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`
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`Resource Center. It is 1-877-436-3683, and they are
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`[Transfer call to Genentech Patient Resource
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`available between 6 am and 5 pm Pacific time.
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`Center]
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`Do you have any other questions about KADCYLA or
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`Hello, this is <caller name> with the KADCYLA
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`HER2-positive breast cancer that I can help answer
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`Patient Support Line. I have <caller name> on
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`today?
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`the line. He/she has a question about
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`[Address additional concerns. Then proceed to
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`<topic>. Here he/she is…
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`Important Safety Information]
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`
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`[Transfer caller.]
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`[CLOSING—read after Important Safety Information]
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`Thank you for calling and have a nice day.
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`[End call]
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`IMMUNOGEN 2238, pg. 13
`Phigenix v. Immunogen
`IPR2014-00676
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`Page 14 of 43
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`[ADVERSE EVENTS]
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`[Purpose: To record an adverse event as reported by a patient or someone calling on the patient’s
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`behalf.]
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`
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`[If caller mentions an adverse event or special situation event:]
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`Please remember to talk with your doctor about any side effects you’re experiencing. Since you called
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`today to report this, I would like to collect more information from you for a report I will be filing. Did you
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`know that the Food and Drug Administration, or FDA, requires this information as part of the review of
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`all drug manufacturers? What you say will, of course, be treated in confidence, but we will need to
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`report this information to Genentech so that they can learn more about the safety of their medicines. I
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`appreciate your cooperation.
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`
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`The Drug Safety Department at Genentech may contact you within the next few days by phone or by
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`registered mail, such as FedEx or UPS, if they require additional information.
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`
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`Is it okay if they contact you for more information?
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`
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`
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`[If yes or no, document on RO-GNE: Adverse Event Form.]
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`[If no] Okay, no problem. I will notify Genentech’s Drug Safety Department that you do not want
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`to be contacted about this report after today. Would you like to have your doctor follow up with
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`Genentech Drug Safety?
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`o
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`[If yes] Great. What is the name of your doctor and the telephone number at which
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`he/she can be reached?
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`o
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`[If no] Okay, no problem. [Proceed]
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`
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`[If yes] Thank you. Would you also be willing to provide your doctor’s contact information so
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`that they may contact your doctor for more information?
`
`o
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`[If yes] Thank you. What is the name of your doctor and the telephone number at which
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`he/she can be reached?
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` Thank you.
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`
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`In order to properly record this issue so it can be followed up in the right way, I will need to collect some
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`information from you. This will take a few minutes, so I want to thank you again for your time.
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`IMMUNOGEN 2238, pg. 14
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`Page 15 of 43
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`Are you calling for yourself, or on behalf of someone else?
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`
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`[If caller is an enrolled patient or caller is calling with regard to an enrolled patient, locate record
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`in the tracking system by asking for first name/last name, DOB, etc. Use information in the
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`tracking system to fill out RO-GNE: Adverse Event Form]
`
`
`
`[If caller is not an enrolled patient or not calling about an enrolled patient, ask all questions to
`
`fill out the RO-GNE: Adverse Event Form]
`
`
`
`[Start RO-GNE: Adverse Event Form.]
`
`
`
`[If patient information already exists in the tracking system (DOB, sex, etc.) do not ask questions
`
`again. If patient is in the tracking system, confirm age and current weight.]
`
`
`
`You may not have all of the information we are asking you about, but we certainly appreciate your
`
`providing us with the information you have.
`
`
`
`[Complete RO-GNE: Adverse Event Form]
`
`Thank you for taking the time to report this information because Genentech takes these types of events
`
`very seriously. Please talk with your healthcare provider (HCP) about this event. Share with him or her
`
`any questions or concerns you might have. If you would like to review the full KADCYLA Prescribing
`
`Information, visit www.kadcyla.com or talk with your HCP. We can also mail a copy to you. Remember,
`
`your healthcare team is your primary source of care and information, and should always be contacted
`
`for medical advice and treatment.
`
`
`
`[Complete RO-GNE: Adverse Event Form]
`
`Thank you. That is all of the information I was looking for. I will send this information to the people who
`
`need it at Genentech Drug Safety.
`
`
`
`[If patient asks questions about AE:]
`
`[If patient asks any questions about the adverse event, you may use the approved FAQs as appropriate
`
`and refer him or her to his or her healthcare team. When done, proceed]
`
` Do you have any other questions about the side effect(s) you just reported?
`
`
`
`[Advance to Patient/Caregiver Important Safety Information and Closing.]
`
`
`
`
`
`
`
`IMMUNOGEN 2238, pg. 15
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`IPR2014-00676
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`Page 16 of 43
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`
`
`
`
`[TRANSACTIONAL OPT-IN]
`
`
`
`[To be used with patients and caregivers who have not or who do not want to opt into receiving
`
`information about KADCYLA and other Genentech products and programs related to HER2+ breast
`
`cancer, and who are requesting fulfillment of an item such as the PI.]
`
` I
`
` would be happy to mail you the materials you requested. I want to let you know that by providing your
`
`information, you agree to allow Genentech and/or its agents to collect the information provided and to
`
`use it to fulfill your request.
`
`Now, could I please have your First and Last Name?
`
`[Caller replies]
`
`Great, thank you. How about a mailing address? [Fill in all information below]
`
`Address 1
`
`Address 2
`
`City
`
`State
`
`Zip Code
`
`[Caller replies]
`
`Thank you. [Pause] Okay, you’re all set, Mr./Mrs. <caller name>. We have fulfilled your request for
`
`<requested item>.
`
`
`
`[After completion of data intake]
`
`Mr./Mrs. <name>, Do you have any other questions about KADCYLA or HER2-positive breast cancer that
`
`I can help answer today?
`
`[Address patient’s questions using approved FAQs. When done, continue to Patient/Caregiver Important
`
`Safety Information and Closing.]
`
`
`
`
`
`
`
`
`
`IMMUNOGEN 2238, pg. 16
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`IPR2014-00676
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`Page 17 of 43
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`
`
`[COMMERCIAL OPT-IN]
`
`
`
`[Purpose: To be used with patients and caregivers who wish to receive communication about KADCYLA
`
`and other Genentech products and programs related to HER2+ breast cancer.]
`
`
`
`As you know, you can always call the KADCYLA Support Line to get information, support, and resources
`
`during treatment with KADCYLA. You can also sign up to receive information about KADCYLA and other
`
`Genentech products and programs related to HER2+ breast cancer. Would you like to sign up to receive
`
`this information?
`
`
`
`[If no] No problem. If you change your mind and wish to sign up in the future, please call us back
`
`at 1-855-KADCYLA, or 1-855-523-2952. How else can I help you today? [Once caller’s needs have
`
`been addressed, advance to Patient/Caregiver Important Safety Information and Closing]
`
`
`
`[If yes] Great. Before we get started, I want to let you know that by providing your information,
`
`you confirm that you are 18 years of age or older and you agree to allow Genentech and its
`
`agents to collect the information provided and to be contacted by Genentech and its agents
`
`about HER2-positive breast cancer and related Genentech products and disease education using
`
`this information in the future. Are you with me so far?
`
`o
`
`[Caller replies] Great. [Proceed]
`
`
`
`Furthermore, you are agreeing that Genentech and its agents may contact you by phone, e-mail,
`
`or mail per the information you provided during enrollment and that such electronic or other
`
`written communications may include information regarding your health within them. Genentech
`
`will not sell, rent, or otherwise distribute your name and any personally identifiable information
`
`outside of Genentech and its agents. Genentech will only use your information in accordance
`
`with the Genentech Privacy Policy that can be found at www.gene.com. And finally, you may
`
`change your communication preferences or cancel your enrollment in this program at any time
`
`by calling the KADCYLA Support Line at 1-855-KADCYLA, or 1-855-523-2952. Do you have any
`
`questions?
`
`
`
`[Caller replies]
`
`o <If yes, repeat or clarify anything the caller did not understand>
`
`o <If no, proceed>
`
`
`
`
`
`
`
`
`
`IMMUNOGEN 2238, pg. 17
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`Page 18 of 43
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`Great. Now we can start. This won’t take much longer. [Record information below]
`
` May I please have your First and Last Name (required)?
`
`[Caller replies]
`
` Thank you. May I have your E-mail address, Mr./Mrs. <name> (required)?
`
`[Caller replies]
`
`Can you please verify your e-mail (required)?
`
`[Caller replies]
`
` What is your mailing address?
`
`Address 1
`
`Address 2
`
`City
`
`State
`
`Zip Code
`
`[Caller replies]
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` And what is your phone number?
`
`[Caller replies]
`
`
`
` And are you presently undergoing treatment with KADCYLA?
`
`[Caller replies]
`
`[] Yes
`
`[] No
`
`[] Unsure
`
`
`
`
`
`Great, thank you for taking the time to answer these questions. That’s all the information I need. How
`
`else can I help you today? [Once caller’s needs have been addressed, advance to Patient/Caregiver
`
`Important Safety Information and Closing]
`
`
`
`
`
`
`
`
`
`IMMUNOGEN 2238, pg. 18
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`IPR2014-00676
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`Page 19 of 43
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`
`
`[OPT-OUT]
`
`
`
`[Purpose: Read if patient requests opt-out]
`
`
`
`[If caller requests to opt out, use Objection Handling script within the Inbound script to first try to
`
`address caller’s concerns. If after doing so the caller still wishes to opt out of the KADCYLA Patient
`
`Support Line and/or future communications, use the script below.]
`
`
`
`We respect your privacy and will promptly process your request to be removed from communications
`
`about KADCYLA and other Genentech products and programs related to HER2+ breast cancer.
`
`
`
`[Record opt-out in system]
`
` I
`
` just want to remind you that if you change your mind and wish to receive this information in the
`
`future, you can do so by calling 1-855-KADCYLA or 1-855-523-2952. Is there anything else related to
`
`KADCYLA or breast cancer that I can help you with today?
`
`
`
`[Respond using approved FAQ or proceed to Patient/Caregiver Important Safety Information
`
`and Closing]
`
`
`
`
`
`
`
`
`
`IMMUNOGEN 2238, pg. 19
`Phigenix v. Immunogen
`IPR2014-00676
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`

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`Page 20 of 43
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`
`
`[OFF-LABEL QUESTIONS AND/OR QUESTIONS WITH NO APPROVED RESPONSE]
`
`
`
`I’m sorry, but the KADCYLA Support Line is not set up to answer the specific question/concern that you
`
`have.
`
`
`
`When the FDA approves treatments, it approves them for use in a certain way and in people with
`
`certain types of diseases. KADCYLA is approved to treat HER2-positive breast cancer that has spread to
`
`other parts of the body (metastatic breast cancer) after prior treatment with trastuzumab (Herceptin)
`
`and a taxane. Prior treatment could have been for the initial treatment of breast cancer or for the
`
`treatment of cancer that had spread to other parts of the body.
`
` I
`
` can’t address your question or concern because it relates to the use of KADCYLA for something other
`
`than for what I just described. Please discuss your questions and concerns with your healthcare provider.
`
`You can also find useful information, resources, and patient support by visiting
`
`InformationAboutCancer.com. Please remember that your healthcare provider is always your best
`
`source of information.
`
`[For patients]
`
`I can, however, transfer you to our Patient Resource Center, which may better be able to address your
`
`question. Please remember that your healthcare provider is always your best source of information.
`
`
`
`Would you like me to transfer you now?
`
`
`
`
`
`[] Yes [Use Patient Resource Center transfer script]
`
`[] No. What other questions about KADCYLA can I help answer for you today? [Use FAQs to
`
`answer patient’s question]
`
`
`
`[For HCPs]
`
`I can, however, transfer you to our Medical Communications Department, which may better be able to
`
`address your question. Would you like me to transfer you now?
`
`
`
`
`
`[] Yes [Use Medical Communications transfer script]
`
`[] No. What other questions about KADCYLA can I help answer for you today? [Use FAQs to
`
`answer patient’s question]
`
`
`
`
`
`
`
`IMMUNOGEN 2238, pg. 20
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`IPR2014-00676
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`Page 21 of 43
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`
`
`[KADCYLA INFORMATION]
`
`
`
`QUESTION 1: What is KADCYLA?
`
` KADCYLA is approved to treat HER2-positive breast cancer that has spread to other parts of the
`
`body (metastatic breast cancer) after prior treatment with trastuzumab (Herceptin) and a
`
`taxane. Prior treatment could have been for the initial treatment of breast cancer or for the
`
`treatment of cancer that had spread to other parts of the body.
`
`
`
`Like many cancer medicines, KADCYLA is given by intravenous infusion
`
`o KADCYLA is given in your doctor’s office or at a hospital or infusion center
`
` KADCYLA is the first HER2-targeted treatment of its kind for metastatic breast cancer
`
`o
`
`It is a made up of 2 cancer-fighting drugs in one
`
`
`
`It is important to remember that KADCYLA is not the same medicine as trastuzumab, known as
`
`Herceptin
`
`
`
`Has this information clarified your understanding of KADCYLA?
`
`
`
`[If yes]
`
`o Great. Are there any other questions you have about KADCYLA that I can try to answer
`
`today?
`
`o
`
`[Refer to FAQs to answer any questions]
`
`
`
`[If no]
`
`o What, in particular, did you find confusing?
`
`o
`
`[Review answer, refer to FAQs, or direct patient to healthcare provider for further
`
`information]
`
`
`
`QUESTION 2: What is the generic name of KADCYLA?
`
` The generic name of KADCYLA is ado-trastuzumab emtansine
`
`
`
`Does this answer your question?
`
`
`
`[If yes]
`
`o Excellent. Do you have any other questions about KADCYLA today?
`
`o
`
`[Refer to FAQs to answer any questions]
`
`
`
`[If no]
`
`
`
`
`
`
`
`IMMUNOGEN 2238, pg. 21
`Phigenix v. Immunogen
`IPR2014-00676
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`

`
`Page 22 of 43
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`o What else were