SKYRIZI Dosing & Access The Specialty Pharmacy will inform the HCP on the patient's coverage and provide Prior Authorization requirements.
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SKYRIZI Dosing & Access The Specialty Pharmacy will inform t INDICATIONS1 • Plaque Psoriasis: HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. • Psoriatic Arthritis: HUMIRA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. • Hidradenitis Suppurativa: HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. SAFETY CONSIDERATIONS1 Serious Infections Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. These infections include active tuberculosis (TB), reactivation of latent TB, invasive fungal infections, and bacterial, viral, and other infections due to opportunistic pathogens. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Malignancies Lymphoma, including a rare type of T-cell lymphoma, and other malignancies, some fatal, have been reported in patients treated with TNF blockers, including HUMIRA. Other Serious Adverse Reactions Patients treated with HUMIRA also may be at risk for other serious adverse reactions, including anaphylaxis, hepatitis B virus reactivation, demyelinating disease, cytopenias, pancytopenia, heart failure, and a lupus-like syndrome. Indication2 SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Safety Considerations2 SKYRIZI may increase the risk of infection. Instruct patients to report signs or symptoms of clinically important infection during treatment. Should such an infection occur, discontinue SKYRIZI until infection resolves. Evaluate patients for tuberculosis infection prior to initiating treatment with SKYRIZI. Avoid use of live vaccines in SKYRIZI patients. Please see additional Important Safety Information, including BOXED WARNING on Serious Infections and Malignancy for HUMIRA on page 11, and additional Important Safety Information for SKYRIZI on page 12. Please see Full Prescribing Information for HUMIRA. Please see Full Prescribing Information for SKYRIZI. References: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc. 2. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc. 1
Access Guide — Resources How an Access Specialist Can Help 3 Access Specialists have expertise in payer-specific policies and can educate you on payer-specific prior authorization processes. SKYRIZI® (risankizumab-rzaa) Dosing and Access Information 4 Get dosing details for new and existing patients, as well as a step-by-step guide to the access process. Skyrizi Complete Enrollment and Prescription Form 6 For all new SKYRIZI patients, fill this out with your patient and fax it to Skyrizi Complete and the Specialty Pharmacy. Contact Details for Specialty Pharmacies 7 View a list of specialty pharmacies that AbbVie has contracted with to provide product specific support for SKYRIZI. HUMIRA Dosing and Access Information 8 Get dosing details for new and existing patients, as well as a step-by-step guide to the access process. HUMIRA Complete Enrollment and Prescription Form 10 For all new HUMIRA patients, fill this out with your patient and fax it to HUMIRA Complete and the Specialty Pharmacy. Indications and Important Safety Information for HUMIRA (adalimumab) 11 Indication and Important Safety Information for SKYRIZI® (risankizumab-rzaa) 12 Please see Important Safety Information, including BOXED WARNING on Serious Infections and Malignancy for HUMIRA on page 11, and Important Safety Information for SKYRIZI on page 12. Please see Full Prescribing Information for HUMIRA. Please see Full Prescribing Information for SKYRIZI. ©2021 AbbVie Inc. North Chicago, IL 60064 US-MULT-210343 May 2021 2
Skyrizi Complete and HUMIRA Complete Access Specialists Access Specialists Help Patients Get Timely Access to Therapy Access Specialists are experts in payer-specific policies and processes • Educate the office on available options based on each patient’s unique financial situation • Educate on payer prior authorization and appeal processes so you can determine the best access solution for each patient’s unique situation • Partner with you and your patient’s Insurance Specialist to help avoid any treatment delays or disruptions caused by access situations For support over the phone, call your Access Specialist or reach out to your sales representative to have them put you in touch. Or, call 1.877.COMPLETE (1.877.266.7538). Please see Indications and Important Safety Information, including BOXED WARNING on Serious Infections and Malignancy for HUMIRA on page 11, and Indication and Important Safety Information for SKYRIZI on page 12. Please see Full Prescribing Information for HUMIRA. Please see Full Prescribing Information for SKYRIZI. ©2021 AbbVie Inc. North Chicago, IL 60064 US-MULT-210343 May 2021 3
SKYRIZI® (risankizumab-rzaa) Dosing Information Dosing 1st Dose 2nd Dose Subsequent Doses Week 0 Week 4 Every 12 Weeks For patients who were previously injected in-office and now self-inject at home: • The Specialty Pharmacy can arrange for shipping the medication to the patient’s home. Skyrizi Complete and some Specialty Pharmacies can reinforce training on how to properly inject: • When the patient’s Specialty Pharmacy reaches out to confirm the next dose and collect the co-pay, they will confirm where the patient is taking the medication. They should also confirm dose location with the office but, if they cannot reach the HCP, the pharmacy will evaluate and assess each patient’s need on a case-by-case basis For new patients who will be self-injecting their first dose: • Check the box next to “Patient” in Section 7 of the Skyrizi Complete Enrollment and Rx form (entitled “SKYRIZI Shipping Preferences”) Nurse Ambassadors,* as well as some Specialty Pharmacies, have virtual supplemental injection training capabilities to help the patient become more familiar with self-injection. *Nurse Ambassadors are provided by AbbVie and do not provide medical advice or work under the direction of the prescribing health care professional (HCP). They are trained to direct patients to speak with their HCP about any treatment-related questions, including further referrals. Safety Considerations1 SKYRIZI may increase the risk of infection. Instruct patients to report signs or symptoms of clinically important infection during treatment. Should such an infection occur, discontinue SKYRIZI until infection resolves. Evaluate patients for tuberculosis infection prior to initiating treatment with SKYRIZI. Avoid use of live vaccines in SKYRIZI patients. Please see Indication and additional Important Safety Information for SKYRIZI on page 12. Please see Full Prescribing Information for SKYRIZI. Reference: 1. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc. ©2021 AbbVie Inc. North Chicago, IL 60064 US-MULT-210343 May 2021 4
SKYRIZI® (risankizumab-rzaa) Access Information >95% of national commercial patients have access to SKYRIZI as preferred on formulary, as of January 2021.1*† Access Process For first dose and subsequent doses (for both HCP and self-admin) What the HCP should do Communications the patient and HCP should expect For the FIRST DOSE — Week 0 Skyrizi Complete Enrollment 1 and Rx Form Complete the enrollment and Rx form with your patient • A Skyrizi Complete Nurse Ambassador‡ will reach out and submit to Skyrizi Complete and your patient's to the patient by phone, educate them on obtaining preferred Specialty Pharmacy. their medication, answer questions, and discuss next Ensure your patient expects to receive a phone call from steps. The Nurse Ambassador will discuss potential the Nurse Ambassador and the Specialty Pharmacy. cost-saving resources for qualifying patients. If you would like to receive a copy of the Benefits • The Specialty Pharmacy will inform the HCP on the Verification or Prior Authorization forms and requirements patient’s coverage and provide Prior Authorization from Skyrizi Complete, check the box in section 5. requirements. SEE PAGE 6 FOR ENROLLMENT AND Rx FORM. SEE PAGE 7 FOR A LIST OF SPECIALTY PHARMACIES. Prior Authorization 2 Fill out the Prior Authorization required by the patient’s • A Nurse Ambassador will reach out to the patient to confirm that insurance and send back to the Specialty Pharmacy. they understand their insurance and any next steps. • The Specialty Pharmacy will inform the HCP of the patient's SEE PAGE 3 FOR ACCESS SPECIALIST INFORMATION payer-specific Prior Authorization process and next steps. INCLUDING WHEN TO CONTACT THEM IF YOU HAVE QUESTIONS ABOUT THE PRIOR AUTHORIZATION PROCESS. Shipment 3 Drug will be shipped to the patient upon Prior Authorization • The Specialty Pharmacy will reach out to the patient to collect co-payment and will confirm when and where to send approval, which typically takes between 5 and 10 business the medication. days from Prior Authorization receipt by the Specialty Pharmacy. • A Nurse Ambassador will contact the patient to confirm they have spoken with the Specialty Pharmacy. The Ambassador Take this timing into consideration when completing the can also reinforce training on proper injection technique and need-by date on the enrollment and Rx form on page 6 in provide remote injection training. section 7. NOTE: If the patient does not speak with the Specialty Pharmacy, the Specialty Pharmacy will not ship their medication. For SUBSEQUENT DOSES — Week 4 and every 12 weeks thereafter Additional Prior Authorizations • The Specialty Pharmacy will reach out to 4 the patient to collect co-payment for each Insurance companies have variable Prior Authorization subsequent dose and confirm shipping address. requirements, but most require at least 1 per year. • The Specialty Pharmacy will reach out to the HCP with any additional Prior Authorization required. • A Nurse Ambassador will reach out to the patient prior to and after each dose. *Formulary definitions: Preferred/Step 1 means the product is placed on the plan’s preferred formulary. Non-preferred products require a higher out-of-pocket cost or step edit, or are placed on a higher tier. Coverage means placed on formulary without a step edit through other biologics. For SKYRIZI, this could include coverage on a non-preferred tier, which may result in higher out-of-pocket cost. Based on formulary under the pharmacy benefit. National commercial health plan formulary status under the pharmacy benefit, updated as of January 2021. †Available only to patients with commercial insurance who meet eligibility criteria. See enrollment forms for full Terms and Conditions. ‡Ambassadors do not provide medical advice and are trained to direct patients to speak with their healthcare professional about any treatment-related questions, including further referrals. Please see Indication and Important Safety Information for SKYRIZI on page 12. Please see Full Prescribing Information for SKYRIZI. Reference: 1. Data on file, AbbVie Inc. Payer-reported lives. January 2021. ©2021 AbbVie Inc. North Chicago, IL 60064 US-MULT-210343 May 2021 5
FAXING INSTRUCTIONS: 1. Fax to Skyrizi Complete (1.678.727.0690) 2. Fax to the patient’s preferred Specialty Pharmacy Enrollment and Prescription Form Questions? Call 1.866.759.7494 Sections in BLUE (1, 2, 3, 4) are necessary for enrollment into Skyrizi Complete. Required fields are marked with an asterisk (*). The health care professional (HCP) and the patient or legally authorized person should fill out this form completely before leaving the office. 1 PATIENT’S INFORMATION - To be completed by patient or legally authorized person. Please print clearly. First Name*: Last Name*: Date of Birth: / / Gender: (check one) M F Address*: City*: State*: ZIP*: Home Phone*: Mobile Phone: Email Address*: Spanish interpreter needed Best Time to Call (Monday-Friday): Anytime Morning Afternoon Evening When did you start on treatment?* Not Yet Started 0-3 Months Ago 4-6 Months Ago 7-12 Months Ago Over 12 Months Ago By enrolling, you may receive your own Nurse Ambassador provided by AbbVie. Ambassadors do not work under the direction of your health care professional (HCP) or give medical advice. They are trained to direct patients to their HCP for treatment-related advice, including further referrals. To learn about AbbVie’s privacy practices and your privacy choices, visit www.abbvie.com/privacy.html. I would like to receive news and updates about AbbVie’s products, clinical trials, research opportunities, programs, and other information that may be of interest to me. 2 INSURANCE INFORMATION Check box if your doctor’s office will copy and attach insurance cards. Beneficiary/Cardholder Name: Prescription Insurance: Medical Insurance: Rx Group #: Medical Insurance ID #: Rx ID #: Group #: Rx Bin #: Rx PCN #: FOR HEALTH CARE PROVIDER USE ONLY 3 DIAGNOSIS* Plaque Psoriasis (Ps) (ICD-10 Code: L40.0) Date of Diagnosis: _______/______/_______ 4 PRESCRIBER INFORMATION I would like to receive a copy: Benefits Verification summary Prior Authorization form Prescriber’s Name (First, Last)*: Office Phone*: Address*: Office Contact Name: City*: State*: ZIP*: NPI #*: Office Fax*: Email: 5 CLINICAL INFORMATION Prior Therapies: Concomitant Medications: TB Test (Date): / / Pos Neg Weight: Height: Drug Allergies: Fax any necessary clinical/office notes to the preferred Specialty Pharmacy only. Plaque Psoriasis: BSA % 6 INJECTION TRAINING I request supplemental injection training and/or administration, if needed, for this patient. Order valid for up to one year. Fill out and sign pharmacy prescription below. 7 PHARMACY PRESCRIPTION - OPTIONAL - Fill out and sign corresponding prescription below. Patient’s preferred Specialty Pharmacy: Check if faxed to Specialty Pharmacy Choose One SKYRIZI Presentation: PRESCRIBER CERTIFICATION: I certify that the above therapy is medically necessary and that the PEN 150mg information provided is accurate to the best of my knowledge. I certify that I am the prescriber who has prescribed SKYRIZI to the previously identified patient and that I provided the patient with a description SYRINGE 150mg of the Skyrizi Complete patient support program. I authorize Skyrizi Complete to act on my behalf for the Check appropriate boxes to indicate quantity to dispense purposes of transmitting this prescription to the appropriate pharmacy designated by the patient utilizing their benefit plan (if applicable). (one dose each) and directions: Initiation at Week 0: Inject 150mg SC Initiation at Week 4: Inject 150mg SC x______________________ Inject 150mg SC every 12 weeks thereafter Refills: Prescriber’s Signature: (REQUIRED) Date: ____/____/____ 8 SKYRIZI SHIPPING PREFERENCES Date needed: ____/____/_____ First Dose Address: Prescriber Patient Follow-Up Doses Address: Prescriber Patient 9 SKYRIZI COMPLETE PRESCRIPTION - required in the event a commercially insured patient with a valid RX for SKYRIZI experiences an insurance access challenge. See Program Terms and Conditions on reverse side. Please complete the full form as well as this section and sign below. Prescription to be filled through an AbbVie-authorized pharmacy. I understand that faxing this form to Skyrizi Complete will result in an original copy being simultaneously transmitted to the AbbVie-authorized pharmacy under this section. Choose One SKYRIZI Presentation: PRESCRIBER CERTIFICATION: I certify that the above therapy is medically necessary and that the information provided is accurate PEN 150mg to the best of my knowledge. I certify that I am the prescriber who has prescribed SKYRIZI to the previously identified patient and that I provided the patient with a description of the Skyrizi Complete patient support program. I authorize Skyrizi Complete to act on my behalf SYRINGE 150mg for the purposes of transmitting this prescription to the appropriate pharmacy. I understand that the no charge resource through Skyrizi Complete may support patients who are experiencing a delay in insurance coverage for SKYRIZI until coverage is obtained, and I confirm Inject 150mg SC at Week 0, Week 4, and that I will support the above-identified patient in seeking to secure such coverage as I deem appropriate. I certify that I will not seek every 12 weeks thereafter reimbursement from any third party payor for any no charge product dispensed by an AbbVie authorized pharmacy. Quantity: 1 dose of 150mg Refills: Prescriber’s Signature: (REQUIRED) x___________________________________________ Date: ___/____/____ IMPORTANT INFORMATION: By submitting this form you are referring the above patient to AbbVie’s patient support program to determine eligibility and receive support related to an AbbVie product. AbbVie, its affiliates, collaborators and agents will use the information collected about you and your patient to provide the patient support and perform research and analytics, on a de-identified basis, for management of the program. For more information about the categories of personal information collected by AbbVie and the purposes for which AbbVie uses personal information, visit www.abbvie.com/privacy.html. Please share this information with your patient. Please see Please seeImportant Safety Indication and Information ImportantandSafety full Indication on pagefor Information 4. Please SKYRIZIseeon fullpage Prescribing 12. Information. 3 US-SKZ-210091 6 Please see Full Prescribing Information for SKYRIZI.
Contact Details for Specialty Pharmacies Contact Details Contact Details for for Specialty SpecialtyPharmacies Pharmacies SKYRIZI is broadly available via open distribution and prescriptions may be sent to the Specialty Pharmacy of the patient’s choosing. SKYRIZI is broadly available via open distribution and prescriptions may be sent to the Specialty Pharmacy of the patient’s choosing. AbbVie has contracted with the specialty pharmacies listed below to provide product specific support. Specialty Pharmacy contact details AbbVie has contracted with the specialty pharmacies listed below to provide product specific support. Specialty Pharmacy contact details AcariaHealth T: 800.511.5144 F: 877.541.1503 acariahealth.com Accredo T: 800.803.2523 F: 888.302.1028 accredo.com AcariaHealth T: 800.511.5144 F: 877.541.1503 acariahealth.com AllianceRx Walgreens Prime T: 888.347.3416 F: 877.231.8302 alliancerxwp.com Accredo T: 800.803.2523 F: 888.302.1028 accredo.com Amber Specialty Pharmacy T: 888.370.1724 F: 402.896.3774 amberpharmacy.com AllianceRx Walgreens Prime T: 888.347.3416 F: 877.231.8302 alliancerxwp.com Ardon Health T: 855.425.4085 F: 855.425.4096 ardonhealth.com Amber Specialty Pharmacy T: 888.370.1724 F: 402.896.3774 amberpharmacy.com BioMatrix Specialty Pharmacy T: 855.359.9679 F: 610.545.6030 biomatrixsprx.com Ardon Health T: 855.425.4085 F: 855.425.4096 ardonhealth.com BioPlus T: 888.292.0744 F: 800.269.5493 bioplusrx.com BioMatrix Specialty Pharmacy T: 855.359.9679 F: 610.545.6030 biomatrixsprx.com Optum Specialty Pharmacy T: 855.427.4682 F: 877.342.4596 briovarx.com BioPlus T: 888.292.0744 F: 800.269.5493 bioplusrx.com CVS Specialty T: 800.237.2767 F: 800.323.2445 cvsspecialty.com Optum Specialty Pharmacy T: 855.427.4682 F: 877.342.4596 briovarx.com Humana Pharmacy T: 800.486.2668 F: 877.405.7940 humanapharmacy.com CVS Specialty T: 800.237.2767 F: 800.323.2445 cvsspecialty.com Kroger Specialty Pharmacy T: 888.355.4191 F: 888.355.4192 krogerspecialtypharmacy.com Humana Pharmacy T: 800.486.2668 F: 877.405.7940 humanapharmacy.com Magellan Rx T: 866.554.2673 F: 866.364.2673 magellanhealth.com Kroger Specialty Pharmacy T: 888.355.4191 F: 888.355.4192 krogerspecialtypharmacy.com Meijer Specialty Pharmacy T: 855.263.4537 F: 734.391.2365 meijerspecialtypharmacy.com Magellan Rx T: 866.554.2673 F: 866.364.2673 magellanhealth.com Premier Pharmacy Services T: 800.540.4700 F: 800.540.3400 premierpharmacyservices.com Meijer Specialty Pharmacy T: 855.263.4537 F: 734.391.2365 meijerspecialtypharmacy.com Senderra Specialty Pharmacy T: 888.777.5547 F: 888.777.5645 senderrarx.com Premier Pharmacy Services T: 800.540.4700 F: 800.540.3400 premierpharmacyservices.com ReCept Pharmacy T: 866.326.1425 F: 866.326.9731 receptrx.com/contact/our-locations/ Senderra Specialty Pharmacy T: 888.777.5547 F: 888.777.5645 senderrarx.com US Bioservices T: 888.518.7246 F: 888.418.7246 usbioservices.com ReCept Pharmacy T: 866.326.1425 F: 866.326.9731 receptrx.com/contact/our-locations/ US Bioservices T: 888.518.7246 F: 888.418.7246 usbioservices.com For support in person or over the phone, call your Access Specialist at 1.877.COMPLETE (1.877.266.7538). For support in person or over the phone, call your Access Specialist at 1.877.COMPLETE (1.877.266.7538). Please see Indication and Important Safety Information for SKYRIZI on page 12. Please©2020 see AbbVie Full Prescribing Information Inc. North Chicago, for SKYRIZI.April 2020 IL 60064 US-MULT-200134 ©2020 AbbVie Inc. North Chicago, IL 60064 US-MULT-200134 April 2020 ©2021 AbbVie Inc. North Chicago, IL 60064 US-MULT-210343 May 2021 7
HUMIRA (adalimumab) Dosing Information Dosing For new patients who have received injection training and will be self- INITIAL DOSE & injecting their first dose: CORRESPONDING NDC MAINTENANCE DOSE & NDC • The Specialty Pharmacy can arrange Psoriatic Arthritis* for shipping the medication to the patient’s home. HUMIRA Complete and some Specialty Pharmacies can Day 1 reinforce training on how to properly Continue with one 40 mg injection every other week inject: • When the patient’s Specialty Pharmacy reaches out to confirm 40 mg Pen the next dose and collect the co- pay, they will confirm where the NDC: 0074-0554-02 NDC: 0074-0554-02 patient is taking the medication. HUMIRA Pen Carton 40 mg/0.4 mL HUMIRA Pen Carton 40 mg/0.4 mL ADMINISTRATION CONSIDERATIONS1 Plaque Psoriasis • In clinical trials, the most common Starter Pack adverse reaction was injection site reactions. 20% of patients treated with HUMIRA developed Day 1 Day 8 Day 22 injection site reactions (erythema Continue with one 40 mg and/or itching, hemorrhage, pain injection every other week or swelling), compared to 14% of patients receiving placebo. Most were mild and did not necessitate 80 mg Pen 40 mg Pen 40 mg Pen discontinuation. NDC: 0074-1539-03 NDC: 0074-0554-02 HUMIRA Pen 80 mg/0.8 mL and 40 mg/0.4 mL HUMIRA Pen Carton 40 mg/0.4 mL • Anaphylaxis or serious allergic Psoriasis Starter Package (3 count) reactions may occur. Hidradenitis Suppurativa – Adults and Adolescents ≥ 60 kg [Patients aged 12-17 years and older weighing ≥ 60 kg (132 lbs)] SAFETY CONSIDERATIONS1 Starter Pack Choose a Maintenance Option Serious Infections Patients treated with HUMIRA are OPTION 1 OPTION 2 at increased risk for developing Day 1 Day 15 Starting on Day 29, Starting on Day 29, serious infections that may lead continue with one continue with one OR to hospitalization or death. These 80 mg injection 40 mg injection every other week weekly infections include active tuberculosis (TB), reactivation of latent TB, invasive fungal infections, and bacterial, (2) 80 mg Pens 80 mg Pen viral, and other infections due to NDC: 0074-0124-03 NDC: 0074-0124-02 NDC: 0074-0554-02 opportunistic pathogens. Most HUMIRA Pen 80 mg/0.8 mL HUMIRA Pen Carton 80 mg/0.8 mL HUMIRA Pen Carton 40 mg/0.4 mL Hidradenitis Suppurativa Starter Package (3 count) patients who developed these Hidradenitis Suppurativa – Adolescents 30 kg to < 60 kg infections were taking concomitant [Patients aged 12-17 years old weighing 30 kg to < 60 kg (66 lbs to < 132 lbs)] immunosuppressants such as Starter Pack methotrexate or corticosteroids. Malignancies Day 1 Day 8 Day 22 Lymphoma, including a rare type Continue with one 40 mg of T-cell lymphoma, and other injection every other week malignancies, some fatal, have been reported in patients treated with TNF blockers, including HUMIRA. 80 mg Pen 40 mg Pen 40 mg Pen Other Serious Adverse Reactions NDC: 0074-1539-03 NDC: 0074-0554-02 Patients treated with HUMIRA also may HUMIRA Pen Carton 40 mg/0.4 mL HUMIRA Pen 80 mg/0.8 mL and 40 mg/0.4 mL Hidradenitis Suppurativa Adolescent Starter be at risk for other serious adverse Package (3 count) reactions, including anaphylaxis, *No special initial dosing required. hepatitis B virus reactivation, Please see Indications and additional Important Safety Information, including demyelinating disease, cytopenias, pancytopenia, heart failure, and a BOXED WARNING on Serious Infections and Malignancy, on page 11. lupus-like syndrome. Please see Full Prescribing Information for HUMIRA. Reference: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc. ©2021 AbbVie Inc. North Chicago, IL 60064 US-MULT-210343 May 2021 8
HUMIRA (adalimumab) Access Information 99% of national commercial patients have access to HUMIRA as preferred on formulary, as of January 2021.1*† Access Process For first dose and subsequent doses (for both HCP and self-admin) Communications the patient and HCP What the HCP should do should expect For the FIRST DOSE — Week 0 HUMIRA Complete Enrollment and Rx Form 1 • A HUMIRA Complete Nurse Ambassador‡ will reach out to the Complete the enrollment and Rx form with your patient and patient by phone, educate them on obtaining their medication, send to HUMIRA Complete and the Specialty Pharmacy. answer questions and discuss next steps. The Nurse Ambassador will discuss potential cost-saving resources for qualifying patients. Ensure your patient expects to receive a phone call from the Nurse Ambassador and the Specialty Pharmacy. • The Specialty Pharmacy will inform the HCP on the patient’s coverage and provide Prior Authorization requirements. If you would like to receive the Prior Authorization requirements from HUMIRA Complete, please check the box in section 5. SEE PAGE 10 FOR ENROLLMENT AND Rx FORM. Prior Authorization • A Nurse Ambassador will reach out to the patient to confirm that 2 Fill out the Prior Authorization required by the patient’s they understand their insurance and any next steps. insurance and send back to the Specialty Pharmacy. If you would like to receive a copy of the Benefits Verification • The Specialty Pharmacy will inform the HCP of the patient's or Prior Authorization forms and requirements from HUMIRA payer-specific Prior Authorization process and next steps. Complete, check the box in section 5. SEE PAGE 3 FOR ACCESS SPECIALIST INFORMATION INCLUDING WHEN TO CONTACT THEM IF YOU HAVE QUESTIONS ABOUT THE PRIOR AUTHORIZATION PROCESS. Shipment • The Specialty Pharmacy will reach out to the patient to collect 3 co-payment and will confirm when and where to send the Drug will be shipped to the patient from their medication. Specialty Pharmacy. • A Nurse Ambassador will contact the patient to confirm they have spoken with the Specialty Pharmacy. The Ambassador can also reinforce training on proper injection technique and provide remote injection training. NOTE: If the patient does not speak with the Specialty Pharmacy, the Specialty Pharmacy will NOT ship their medication. For SUBSEQUENT DOSES Additional Prior Authorizations • The Specialty Pharmacy will reach out to the patient to collect 4 Insurance companies have variable Prior Authorization co-payment for each subsequent dose and confirm shipping requirements, but most require at least 1 per year. address. • The Specialty Pharmacy will reach out to the HCP with any additional Prior Authorization required. • A Nurse Ambassador will reach out to the patient prior to each dose during the first few months. *Formulary Definitions: Access means the product is covered and not NDC blocked. Restrictions may apply. Preferred/Step 1 means the product is placed on the plan’s preferred formulary. Non-preferred products require a higher out-of-pocket cost or step edit, or are placed on a higher tier. First line refers to a preferred or parity formulary status. Based on formulary status under the pharmacy benefit. †Available only to patients with commercial insurance who meet eligibility criteria. See enrollment forms for full Terms and Conditions. ‡Ambassadors do not provide medical advice and are trained to direct patients to speak with their healthcare professional about any treatment-related questions, including further referrals. Please see Indications and Important Safety Information, including BOXED WARNING on Serious Infections and Malignancy, on page 11. Please see Full Prescribing Information for HUMIRA. Reference: 1. Data on file, AbbVie Inc. Payer-reported lives. January 2021. ©2021 AbbVie Inc. North Chicago, IL 60064 US-MULT-210343 May 2021 9
Faxing Instructions: 1. Fax to HUMIRA Complete (1.678.727.0690) 2. Fax to the patient’s preferred Specialty Pharmacy Enrollment and Prescription Form Questions? Call 1.800.448.6472 Sections in PLUM (1, 2, 3, 4) are necessary for enrollment into HUMIRA Complete. Required fields are marked with an asterisk (*). The health care professional (HCP) and the patient or legally authorized person should fill out this form completely before leaving the office. 1 Patient’s Information - To be completed by patient or legally authorized person. Please print clearly. First Name*: Last Name*: Date of Birth: / / Gender: (check one) M F Address*: City*: State*: ZIP*: Home Phone*: Mobile Phone: Email Address*: Spanish interpreter needed I consent to receive recurring text messages from AbbVie, including service updates, medication reminders and marketing messages, to the above mobile number. Message and data rates may apply. My consent is not a condition of receiving goods or services. I can reply HELP for help. I can text STOP to unsubscribe any time. Best Time to Call: Monday-Friday Anytime Morning Afternoon Evening When did you start on treatment?* Not Yet Started 0-3 Months Ago 4-6 Months Ago 7-12 Months Ago Over 12 Months Ago By enrolling, you may receive your own Nurse Ambassador provided by AbbVie. Ambassadors do not work under the direction of your HCP or give medical advice. They are trained to direct patients to their HCP for treatment-related advice, including further referrals. To learn about AbbVie’s privacy practices and your privacy choices, visit www.abbvie.com/privacy.html. I would like to receive news and updates about AbbVie’s products, clinical trials, research opportunities, programs, and other information that may be of interest to me. 2 Insurance Information Check box if your doctor’s office will copy and attach insurance cards. Beneficiary/Cardholder Name: ____________________________________________ Prescription Insurance: Medical Insurance: ________________________________________________________ Rx Group #: Medical Insurance ID #: ____________________________________________________ Rx ID #: Group #: __________________________________________________________________ Rx Bin #: _____________________________________ Rx PCN #: FOR HEALTH CARE PROVIDER USE ONLY 3 Diagnosis* Plaque Psoriasis (Ps) Psoriatic Arthritis (PsA) Hidradenitis Suppurativa (HS) ICD-10: 4 Prescriber Information I would like to receive a copy: Benefits Verification summary Prior Authorization form Prescriber’s Name (First, Last)*: ________________ Office Phone: _________________________________________ Address: ______________________________________________ Office Contact Name: ________________________________ City: ________________ State: ______ ZIP*: NPI #*: _______________________________________ Office Fax*: __________________________________________ Email: 5 Clinical Information Date of Diagnosis: _________/________/__________ Concomitant Medications: ___________________________ TB Test (Date): ______/______/_______ Pos Neg Prior Therapies: _______________________________ Weight: __________________ Height: ___________________ ______________________________________________ Drug Allergies: _______________________________________ Fax any necessary clinical/office notes to the preferred Specialty Pharmacy only. ______________________________________________ Plaque Psoriasis Only: BSA % __________________________ 6 Injection Training I request supplemental injection training and/or administration, if needed, for this patient. Order valid for up to one year. Fill out and sign pharmacy prescription below. 7 Pharmacy Prescription - Select medication, fill out and sign corresponding prescription below. Patient’s preferred Specialty Pharmacy: ________________________________________ Check if faxed to Specialty Pharmacy Key: HUMIRA Citrate-free (CF) HUMIRA with citrate-buffers Starting therapy: Ongoing therapy: Plaque Psoriasis PEN HUMIRA (CF) 40mg/0.4ml PEN HUMIRA Starter Pack (CF) 80mg/0.8ml, 40mg/0.4ml Choose 1 SYRINGE HUMIRA (CF) 40mg/0.4ml Choose 1 SYRINGE HUMIRA (CF) 40mg/0.4ml Presentation PEN HUMIRA 40mg/0.8ml Presentation PEN HUMIRA Starter Pack 40mg/0.8ml SYRINGE HUMIRA 40mg/0.8ml SYRINGE HUMIRA 40mg/0.8ml PEN HUMIRA (CF) 80 mg/0.8ml (For HS only) 80mg subcutaneous inj. on Day 1, 40mg subcutaneous inj. on Day 8 and Day 22 Plaque Psoriasis and Psoriatic Arthritis #QS No Refills SIG: One 40mg SC inj. every other week Hidradenitis Suppurativa (HS) (Choose 1 from both sections) QTY: #2 (1 month) #6 (3 months) Refills: __________ PEN HUMIRA Starter Pack (CF) 80mg/0.8ml Hidradenitis Suppurativa (HS) Choose 1 SYRINGE HUMIRA (CF) 40mg/0.4ml One 40mg SC inj. on Day 29 and every week thereafter Presentation PEN HUMIRA Starter Pack 40mg/0.8ml Choose 1SIG One 80mg SC inj. on Day 29 and every other week thereafter SYRINGE HUMIRA 40mg/0.8ml QTY: 1 month supply 3 month supply Refills: __________ 160mg SC inj. on Day 1, Choose 1SIG 80mg SC inj. on Day 15 80mg SC inj. on Day 1, on Day 2, and on Day 15 #QS No Refills PRESCRIBER CERTIFICATION: I certify that the above therapy is medically necessary and that the information provided is accurate to the best of my knowledge. I certify that I am the prescriber who has prescribed HUMIRA to the previously identified patient and that I provided the patient with a description of the HUMIRA Complete patient support program. I authorize HUMIRA Complete to act on my behalf for the purposes of transmitting this prescription to the appropriate pharmacy designated by the patient utilizing their benefit plan (if applicable). Prescriber’s Signature: (REQUIRED)* _________________________________________________________________________________ Date*: _______/_______/__________ IMPORTANT INFORMATION: By submitting this form you are referring the above patient to AbbVie’s patient support program to determine eligibility and receive support related to an AbbVie product. AbbVie, its affiliates, collaborators and agents will use the information collected about you and your patient to provide the patient support and perform research and analytics, on a de-identified basis, for management of the program. For more information about the categories of personal information collected by AbbVie and the purposes for which AbbVie uses personal information, visit www.abbvie.com/privacy.html. Please share this information with your patient. Pleasesee Please see Indications Important and Important Safety Information, Safety INCLUDING Information, including BOXED BOXED WARNING WARNING on on Serious Serious Infections Infections and Malignancy, and Malignancy, on page 4. on page 11. Please see full Prescribing Information. Please see Full Prescribing Information for HUMIRA. 3 US-HUM-200591 10
Indications and Important Safety Information for HUMIRA (adalimumab) 1 HUMIRA INDICATIONS • Non-melanoma skin cancer (NMSC) was reported during clinical trials for HUMIRA-treated patients. Examine all patients, particularly those with a • Plaque Psoriasis: HUMIRA is indicated for the treatment of adult patients history of prolonged immunosuppressant or PUVA therapy, for the presence with moderate to severe chronic plaque psoriasis who are candidates for of NMSC prior to and during treatment with HUMIRA. systemic therapy or phototherapy, and when other systemic therapies are • In HUMIRA clinical trials, there was an approximate 3-fold higher rate of medically less appropriate. HUMIRA should only be administered to patients lymphoma than expected in the general U.S. population. Patients with who will be closely monitored and have regular follow-up visits with a chronic inflammatory diseases, particularly those with highly active disease physician. and/or chronic exposure to immunosuppressant therapies, may be at • Psoriatic Arthritis: HUMIRA is indicated, alone or in combination with higher risk of lymphoma than the general population, even in the absence non-biologic DMARDs, for reducing signs and symptoms, inhibiting the of TNF blockers. progression of structural damage, and improving physical function in adult • Postmarketing cases of acute and chronic leukemia were reported with TNF patients with active psoriatic arthritis. blocker use. Approximately half of the postmarketing cases of malignancies • Hidradenitis Suppurativa: HUMIRA is indicated for the treatment of moderate in children, adolescents, and young adults receiving TNF blockers were to severe hidradenitis suppurativa in patients 12 years of age and older. lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents. IMPORTANT SAFETY INFORMATION HYPERSENSITIVITY SERIOUS INFECTIONS • Anaphylaxis and angioneurotic edema have been reported following Patients treated with HUMIRA are at increased risk for developing serious HUMIRA administration. If a serious allergic reaction occurs, stop HUMIRA infections that may lead to hospitalization or death. Most patients who and institute appropriate therapy. developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. HEPATITIS B VIRUS REACTIVATION • Use of TNF blockers, including HUMIRA, may increase the risk of reactivation Discontinue HUMIRA if a patient develops a serious infection or sepsis. of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases Reported infections include: have been fatal. • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB • Evaluate patients at risk for HBV infection for prior evidence of HBV infection have frequently presented with disseminated or extrapulmonary disease. before initiating TNF blocker therapy. Test patients for latent TB before HUMIRA use and during therapy. Initiate • Exercise caution in patients who are carriers of HBV and monitor them treatment for latent TB prior to HUMIRA use. during and after HUMIRA treatment. • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, • Discontinue HUMIRA and begin antiviral therapy in patients who candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients develop HBV reactivation. Exercise caution when resuming HUMIRA after with histoplasmosis or other invasive fungal infections may present with HBV treatment. disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. NEUROLOGIC REACTIONS Consider empiric anti-fungal therapy in patients at risk for invasive fungal • TNF blockers, including HUMIRA, have been associated with rare cases infections who develop severe systemic illness. of new onset or exacerbation of central nervous system and peripheral • Bacterial, viral, and other infections due to opportunistic pathogens, demyelinating diseases, including multiple sclerosis, optic neuritis, and including Legionella and Listeria. Guillain-Barré syndrome. Carefully consider the risks and benefits of treatment with HUMIRA prior to • Exercise caution when considering HUMIRA for patients with these initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have disorders; discontinuation of HUMIRA should be considered if any of these been exposed to TB, 3. with a history of opportunistic infection, 4. who resided disorders develop. in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely • There is a known association between intermediate uveitis and central for the development of signs and symptoms of infection during and after demyelinating disorders. treatment with HUMIRA, including the possible development of TB in patients HEMATOLOGIC REACTIONS who tested negative for latent TB infection prior to initiating therapy. • Rare reports of pancytopenia, including aplastic anemia, have been • Do not start HUMIRA during an active infection, including localized reported with TNF blockers. Medically significant cytopenia has been infections. infrequently reported with HUMIRA. • Patients older than 65 years, patients with co-morbid conditions, and/or • Consider stopping HUMIRA if significant hematologic abnormalities occur. patients taking concomitant immunosuppressants may be at greater risk of infection. CONGESTIVE HEART FAILURE • If an infection develops, monitor carefully and initiate appropriate therapy. • Worsening and new onset congestive heart failure (CHF) has been reported • Drug interactions with biologic products: A higher rate of serious infections with TNF blockers. Cases of worsening CHF have been observed with has been observed in RA patients treated with rituximab who received HUMIRA; exercise caution and monitor carefully. subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with AUTOIMMUNITY anakinra or abatacept, with no demonstrated added benefit in patients • Treatment with HUMIRA may result in the formation of autoantibodies and, with RA. Concomitant administration of HUMIRA with other biologic rarely, in development of a lupus-like syndrome. Discontinue treatment if DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not symptoms of a lupus-like syndrome develop. recommended based on the possible increased risk for infections and other potential pharmacological interactions. IMMUNIZATIONS • Patients on HUMIRA should not receive live vaccines. MALIGNANCY • Pediatric patients, if possible, should be brought up to date with all Lymphoma and other malignancies, some fatal, have been reported in immunizations before initiating HUMIRA therapy. children and adolescent patients treated with TNF blockers, including HUMIRA. • Adalimumab is actively transferred across the placenta during the third Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare trimester of pregnancy and may affect immune response in the in utero type of T-cell lymphoma, have been reported in patients treated with TNF exposed infant. The safety of administering live or live-attenuated blockers, including HUMIRA. These cases have had a very aggressive disease vaccines in infants exposed to HUMIRA in utero is unknown. Risks and course and have been fatal. The majority of reported TNF blocker cases have benefits should be considered prior to vaccinating (live or live-attenuated) occurred in patients with Crohn’s disease or ulcerative colitis and the majority exposed infants. were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with ADVERSE REACTIONS a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence • The most common adverse reactions in HUMIRA clinical trials (>10%) of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with were: infections (e.g., upper respiratory, sinusitis), injection site reactions, these other immunosuppressants. headache, and rash. • Consider the risks and benefits of HUMIRA treatment prior to initiating or continuing therapy in a patient with known malignancy. • In clinical trials, more cases of malignancies were observed among HUMIRA-treated patients compared to control patients. Please see Full Prescribing Information for HUMIRA. Reference: Please1. see HUMIRA Injection [package accompanying insert]. North Chicago, full Prescribing IL: AbbVie Inc. Information. ©2021©2020 AbbVie AbbVie Inc.Inc. North NorthChicago, Chicago, IL 60064 US-MULT-200134 IL 60064 April 2020 May 2021 US-MULT-210343 11
Indication and Important Safety Information for SKYRIZI® (risankizumab-rzaa)1 Indication SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Important Safety Information Infection SKYRIZI® (risankizumab-rzaa) may increase the risk of infection. Do not initiate treatment with SKYRIZI in patients with a clinically important active infection until it resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, closely monitor and discontinue SKYRIZI until the infection resolves. Tuberculosis (TB) Prior to initiating treatment with SKYRIZI, evaluate for TB infection and consider treatment in patients with latent or active TB for whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients with active TB. Administration of Vaccines Avoid use of live vaccines in patients treated with SKYRIZI. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating SKYRIZI, complete all age appropriate vaccinations according to current immunization guidelines. Adverse Reactions Most common (≥1%) adverse reactions associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. SKYRIZI is available in a 150 mg/mL prefilled syringe and pen. Terms and Conditions apply. This benefit covers SKYRIZI® (risankizumab-rzaa). Eligibility: Available to patients with commercial prescription insurance coverage for SKYRIZI who meet eligibility criteria. Co-pay assistance program is not available to patients receiving prescription reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law or by the patient’s health insurance provider. If at any time a patient begins receiving prescription drug coverage under any such federal, state, or government-funded healthcare program, patient will no longer be able to use the Skyrizi Complete Savings Card and patient must call Skyrizi Complete at 1.866.SKYRIZI to stop participation. Patients residing in or receiving treatment in certain states may not be eligible. Patients may not seek reimbursement for value received from the Skyrizi Complete program from any third-party payers. Offer subject to change or discontinuance without notice. Restrictions, including monthly maximums, may apply. Patients who are members of insurance plans that claim to reduce or eliminate their patients' out of pocket co-pay, co-insurance, or deductible obligations for certain prescription drugs based upon the availability of, or patient's enrollment in, manufacturer sponsored co-pay assistance for such drugs (often termed "maximizer" programs) will have an annual maximum program benefit of $6,000.00 per calendar year. This assistance offer is not health insurance. To learn about AbbVie’s privacy practices and your privacy choices, visit www.abbvie.com/privacy.html For support in person or over the phone, call your Access Specialist at 1.877.COMPLETE (1.877.266.7538). Please see Full Prescribing Information for SKYRIZI. Reference: 1. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc. ©2 020 AbbVie Inc. North Chicago, IL 60064 US-MULT-200134 April 20 20 ©2021 AbbVie Inc. North Chicago, IL 60064 US-MULT-210343 May 2021 12
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