Kiniksa/Rilonacept In-Service

March 5th, 2021

● Patients with recurrent pericarditis experience pain & fatigue, fear, anxiety, depression,
frustration, complexity of condition as it relates to treatment
● Kiniksa One Connect:
○ Primary point of contact for HCPs and pts, provide prior authorization support,
financial assistance support, injection training support, benefits verification
○ Provides consistent support throughout treatment journey
○ Triaging → dispensing commercial product
○ Spanish & English form
■ Online availability for download
○ Prior authorization letters (PALs) guide HCP and patients through PA and
appeals
■ Payers may require PA for ARCALYST
■ PALs can also assist in identifying sources of financial support for
patients
● Assistance programs
○ Quick start: supports pts with delay in coverage for treatment initiation
○ Bridge: supports pts with gap in coverage for treatment
○ Patient assistance program: supports pts with no coverage for treatment
○ Commercial co-pay program: supports pt with commercial co-pay program ($10)
● Injection training & disease education with trained ARCALYST nurse educators
○ In-person and/or virtual training is based on the pts needs
■ Watch patient self-inject with virtual nurse
■ If patient needs another training, can happen on the spot or schedule for
subsequent day
○ First ARCALYST administration is important because it sets the tone and
patient’s comfort level with their treatment moving forward
■ Patient is educated on how to reconstitute medication
● Ongoing follow-up maximizes patient experience
○ PAL and specialty pharmacy will coordinate with patient to ensure every aspect
of ARCALYST treatment is running smoothly
● ARCALYST will be distributed in limited distribution model

● Serious Adverse Events:

○ Any untoward medical occurrence that at any dose: results in death, is life
threatening, requires inpatient hospitalization
● Sources of AEs
○ Fax, phone, general conversation with patient/provider, social media, email, at
conference/meeting
● Pregnancies should always be reported to Kiniksa as important safety information.
○ Any drug exposure (maternal and/or paternal) at conception and/or during
pregnancy and/or during lactation
● Reporting an AE/PC → AE/ PC Form available
○ FIll out as many fields as possible on the adverse event/product complaint form
and send to the fax or email listed on the form
○ At minimum fill out: pt name/contact info, suspect medicinal product (include lot
number if known), reporting source or reporter, event or outcome
○ Report within 1 business day
■ productcomplaints@kiniksa.com (product complaints)
■ drugsafety@kiniksa.com (adverse events/safety information)
● Kiniksa stresses that all product complaints should be reported to them to comply with all
regulatory requirements
○ Product complaints sometimes associated with either adverse events or
associated with safety information
● Any questions concerning PC reporting or AE/safety information contact:
○ productcomplaints@kiniksa.com
○ drugsafety@kiniksa.com
● Medical Information Request Processing
○ Medical info call center (Eversana)→ all pharmacists
■ Responsible for addressing live calls/inquires from HCPs, consumers and
caregivers
■ Documents AE and PC
■ Escalates inquires to Kiniksa MI if additional research is required
○ Contact: 1-833-KINIKSA (546-4572) option 3
○ Online request via “contact us” on website or via email
■ www.kiniksa.com
■ www.heartofinflammation.com
■ www.whatispericarditis.com
■ Email: medinfo@kiniksa.com
○ Submit inquiry via a field representative (Veeva CRM or medical information
request form)