2019 national commercial, Medicare Part D, and Medicaid as of January, 20192
NOW APPROVED For moderate to severe rheumatoid arthritis (RA) in adult MTX-IR patients1
Get started with the
Enrollment & Prescription Form
Building toward HUMIRA-Level Coverage
97%
Preferred2*
66%
Coverage3*
2019 national commercial coverage updated as of November, 20193
*Formulary definitions: Coverage means placed on formulary without a single step edit through other biologics. For RINVOQ, this could include coverage on a non‑preferred tier which may result in a higher out‑of‑pocket cost. 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.
If your eligible RINVOQ patient’s commercial insurance experiences an initial delay or denial, they may still be able to access their prescribed therapy at no charge while coverage is established, up to 24 months.*
Complete and send the single Enrollment and Prescription form to RINVOQ Complete. Your Access Specialist will call your office with next steps.†
Get started with the enrollment & prescription form
*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 eligible to participate in program. Available to patients between the ages of 18-63 with commercial prescription insurance coverage who meet eligibility criteria. Eligibility: Patients must be diagnosed with moderate to severe rheumatoid arthritis, have a valid prescription for RINVOQ™ and participate in a commercial insurance plan that has denied or not yet made a formulary decision for RINVOQ. Once the patient’s insurance plan has made a formulary decision and established a process for reviewing coverage requests for RINVOQ, continued eligibility for the program requires the submission of a Prior Authorization prior to the next scheduled dose and appeal of the coverage denial within 180 days. Program provides RINVOQ at no charge to patients for up to 2 years or until they receive insurance coverage approval, whichever occurs earlier. Offer subject to change or discontinuance without notice. This is not health insurance and program does not guarantee insurance coverage.
†Available only to patients with commercial insurance who meet eligibility criteria. See enrollment form for full Terms and Conditions.
One EXCEPTIONAL patient experience
NURSE
AMBASSADORS*
Empower patients
Our Nurse Ambassadors are the heart of RINVOQ Complete
Nurse Ambassadors provide 1:1 support to help meet the unique needs of each individual patient, including:
- Committed to answering questions throughout the experience to help avoid disruptions.
- Answer patients’ insurance questions, help them identify ways to save on prescription costs, and connect them with additional insurance expertise.
To have your patients connect with a
Nurse Ambassador, call
1‑800-2-RINVOQ (1‑800‑274‑6867)
NEW ACCESS
SPECIALISTS
Insurance support when needed
- Resource with expertise on Medicare and commercial plans at a national, local, and program level so that they can educate on potential options to consider based on each patient’s unique financial situation.
- Can educate on payer prior authorization and appeal processes so you can determine the best access solution for each patient’s unique situation.
For support in person or over the phone, call
1‑877‑COMPLETE (1‑877‑266‑7538)
ACCESS & SUPPORT
Help with access &
treatment affordability
RINVOQ Complete can help your commercial patients save:
- With the RINVOQ Complete Savings Card, your eligible commercially insured patients may pay as little as $5 per monthly dose.†
- RINVOQ Complete may help eligible commercially insured patients experiencing initial coverage delays or denials access their prescribed therapy at no charge while coverage is established.‡
For more information about Eligibility Criteria, call
1-800-2-RINVOQ (1-800-274-6867)
*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.
†Terms and Conditions apply. This benefit covers RINVOQ™ (upadacitinib) alone or for RINVOQ plus one of the following medications: methotrexate, leflunomide (Arava®), or hydroxychloroquine (Plaquenil®). Eligibility: Available to patients with commercial prescription insurance coverage for RINVOQ 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 RINVOQ Complete Savings Card and patient must call RINVOQ Complete at 1.800.2RINVOQ 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 RINVOQ Complete program from any third-party payers. Offer subject to change or discontinuance without notice. Restrictions, including monthly maximums, may apply. This is not health insurance.
Arava and Plaquenil are registered trademarks of their respective owners.
‡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 eligible to participate in program. Available to patients between the ages of 18-63 with commercial prescription insurance coverage who meet eligibility criteria. Eligibility: Patients must be diagnosed with moderate to severe rheumatoid arthritis, have a valid prescription for RINVOQ™ and participate in a commercial insurance plan that has denied or not yet made a formulary decision for RINVOQ. Once the patient’s insurance plan has made a formulary decision and established a process for reviewing coverage requests for RINVOQ, continued eligibility for the program requires the submission of a Prior Authorization prior to the next scheduled dose and appeal of the coverage denial within 180 days. Program provides RINVOQ at no charge to patients for up to 2 years or until they receive insurance coverage approval, whichever occurs earlier. Offer subject to change or discontinuance without notice. This is not health insurance and program does not guarantee insurance coverage.
RINVOQ COMPLETE APP
Track treatment
The Complete App helps patients start and stay on track with their prescribed treatment:
- For eligible patients, provide access to savings resources
- Fit RINVOQ into their personal routines along with customized reminders
- Log symptoms
- Identify and track progress towards personal goals
Coming soon, RINVOQ patients will be able to use the RINVOQ Complete App.
COMPLETEPRO.COM
Streamline the Rx process
CompletePro.com enables seamless enrollment into RINVOQ Complete, and helps streamline the prescription process for your patients.
With CompletePro.com, you can:
- Request benefits verifications
- Complete and submit prior authorizations
- Send prescriptions to the patient’s specialty pharmacy of choice, with the option to include a savings card
- Track and monitor where patients are in the prescription process
Download forms to help patients get the support they need
to start and stay on track with RINVOQ
PRACTICE FORMS AND RESOURCES
To enroll a patient in RINVOQ Complete:
Fill out the form with your patient
This form enrolls your patient and can be used to initiate a prescription with your patient’s preferred speciality pharmacy.
Fill out the patient support prescription in Section 6
This may help your commercially insured patients get access to RINVOQ if they experience a delay or denial in their insurance coverage.*
Fax the form to 1-678-727-0690
You will receive a call from an Access Specialist to discuss next steps. In addition, fax the form to your patient’s specialty pharmacy if using the Pharmacy Prescription in Section 9.
Inform your patient that they have been enrolled
Let your patient know that they will be receiving a call from their Nurse Ambassador.
*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 eligible to participate in program. Available to patients between the ages of 18-63 with commercial prescription insurance coverage who meet eligibility criteria. Eligibility: Patients must be diagnosed with moderate to severe rheumatoid arthritis, have a valid prescription for RINVOQ™ and participate in a commercial insurance plan that has denied or not yet made a formulary decision for RINVOQ. Once the patient’s insurance plan has made a formulary decision and established a process for reviewing coverage requests for RINVOQ, continued eligibility for the program requires the submission of a Prior Authorization prior to the next scheduled dose and appeal of the coverage denial within 180 days. Program provides RINVOQ at no charge to patients for up to 2 years or until they receive insurance coverage approval, whichever occurs earlier. Offer subject to change or discontinuance without notice. This is not health insurance and program does not guarantee insurance coverage.
ACCESS AND REIMBURSEMENT FORMS
RINVOQ Complete is here to help your patients get timely access to RINVOQ. Along with requesting information from a RINVOQ Complete Access Specialist, you can download the forms you need to get started.
Templates
Instructions
Here you can download helpful guidelines and tips for completing these templates.
This information is for informational purposes only and is not intended to provide reimbursement or legal advice. The information presented here does not guarantee payment or coverage.
PATIENT FORMS AND RESOURCES
RINVOQ COMPLETE ENROLLMENT
Once you and your patient complete the RINVOQ Complete Enrollment and Prescription Form, simply fax it to RINVOQ Complete and inform your patient that they will be receiving a call from their Nurse Ambassador. If you complete the Pharmacy Prescription, also fax it to your patient’s chosen specialty pharmacy.
ADDITIONAL RESOURCES
See how COMPLETE PRO can help streamline your prescription process
Seamlessly enroll patients into RINVOQ Complete, request benefit verifications, send prior authorizations, and more.
See RINVOQ dosing information
View dosing recommendations for RINVOQ, the first once-daily JAK1-selective inhibitor in RA.
ACR Response Criteria1
ACR response criteria incorporate physician and patient assessments, as well as acute inflammatory, pain, and physical function measures.
ACR response criteria incorporate physician and patient assessments, as well as acute inflammatory, pain, and physical function measures.
ACR=American College of Rheumatology; CRP=C-reactive protein; HAQ‑Dl=Health Assessment Questionnaire Disability Index
Reference:
1. Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology. Preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. Arthritis and Rheumatism.1993;36(6):729-740.
Study Design & Baseline Characteristics
SELECT-COMPARE
Adults with moderately to severely active RA who had an inadequate response to MTX1
aX-ray imaging was performed at these time points; Week 14 for non-responder patients, who were rescued.2
bRescue criteria: At Weeks 14,18 and 22 if <20% improvement in TJC and SJC vs baseline; at Week 26 all remaining PBO patients were switched to RINVOQ, and patients receiving RINVOQ or ADA were switched to ADA or RINVOQ, respectively, if CDAI>104
cStarting at Week 26, initiation or change in background RA medication(s) including corticosteroids, NSAIDs, or acetaminophen was permitted.5
Primary Endpoint1
- ACR20 response: RINVOQ 15 mg + MTX vs Placebo + MTX at Week 12
SELECT RANKED SECONDARY ENDPOINTS2
At Week 12 vs Placebo + MTX
- Change from baseline in DAS28-CRP
- Change from baseline in HAQ-DI
- Change from baseline in SF-36 (PCS)
- DAS28-CRP ≤ 3.2 (LDA)
- DAS28-CRP < 2.6 (CR)
At Week 12 vs Adalimumab + MTX
- ACR50 response (superiority)
- Change from baseline in Patient's assessment of pain (superiority)
- Change from baseline in HAQ-DI (superiority)
At Week 26 vs Placebo + MTX
- ∆ mTSS
SELECT PRESPECIFIED NONRANKED ENDPOINTS5-7
- ACR20/50/70 response rates at all visits (except those that were ranked timepoints)
- Proportion of patients achieving CR based on DAS28-CRP, DAS28-ESR, SDAI, CDAI, and Boolean criteria at all visits (except those that were ranked timepoints).
- Proportion of patients with no radiographic progression (mTSS ≤ 0) at Week 26
- Change from baseline in mTSS at Week 48
- Change from baseline in joint space narrowing score and joint erosion score at Week 26 and Week 48
Data Limitations
Prespecified nonranked endpoints were not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.
SELECT-COMPARE was not designed to evaluate the efficacy of HUMIRA + MTX vs placebo + MTX. No conclusions regarding this comparison can be made.
Baseline Characteristics6,8
†Based on prednisone equivalent
ADA=adalimumab; ACPA=anti citrullinated protein antibody; ACR=American College of Rheumatology; ACR20=improvement of at least 20% in tender joint count, swollen joint count, and at least 3 other core criteria; ACR50=improvement of at least 50% in tender joint count, swollen joint count, and at least 3 other core criteria; ACR70=improvement of at least 70% in tender joint count, swollen joint count, and at least 3 other core criteria; bDMARD=biological disease-modifying antirheumatic drugs; CDAI=clinical disease activity index; CR=clinical remission; CRP=C reactive protein; DAS28=Disease Activity Score; HAQ-DI=health assessment questionnaire disability index; hsCRP=high sensitivity C-reactive protein; LDA=low disease activity; mTSS=modified total Sharp score; MTX=methotrexate; PhGA=physician’s global assessment of disease activity; PtGA=patient’s global assessment of disease activity; QD=once per day; RA=rheumatoid arthritis; RF=rheumatoid factor; SD=standard deviation; SDAI=simplified disease activity index; SF-36 PCS=Short-form 36 Physical Component Score; SJC66=swollen joint count of 66 joints; TJC68=tender joint count of 68 joints; VAS=visual analog scale
REFERENCES
1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
2. Fleischmann R, Pangan AL, Song I-H, et al. Supplement - Upadacitinib versus Placebo or Adalimumab in Patients with Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase 3, Double-Blind, Randomized Controlled Trial. Arthritis Rheumatol. July 2019. doi:10.1002/art.41032
3. Data on File. ABVRRTI68439.
4. Upadacitinib Meets All Primary and Ranked Secondary Endpoints Including Superiority Versus Adalimumab in Phase 3 Study in Rheumatoid Arthritis. AbbVie Inc. https://news.abbvie.com/news/upadacitinib-meets-all-primary-and-ranked-secondary-endpoints-including-superiority-versus-adalimumab-in-phase-3-study-in-rheumatoid-arthritis.htm. April 9, 2018. August 15, 2019.
5. Fleischmann RM, Genovese MC, Enejosa JV, et al. Safety and effectiveness of upadacitinib or adalimumab plus methotrexate in patients with rheumatoid arthritis over 48 weeks with switch to alternate therapy in patients with insufficient response. Ann Rheum Dis. July 2019. doi:10.1136/annrheumdis-2019-215764
6. Fleischmann R, Pangan AL, Song I-H, et al. Upadacitinib versus Placebo or Adalimumab in Patients with Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase 3, Double-Blind, Randomized Controlled Trial. Arthritis Rheumatol. July 2019. doi:10.1002/art.41032
7. Data On File. ABVRRTI68440.
8. Fleischmann R, Pangan AL, Mysler E, et al. A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib to Placebo and to Adalimumab, in Patients with Active Rheumatoid Arthritis with Inadequate Response to Methotrexate. Oral Presentation at: The ACR Annual Meeting 2018, 19–24 October 2018, Chicago, USA.
Study Design & Baseline Characteristics
SELECT-EARLY
Adults with moderately to severely active RA who were MTX naïve1
RINVOQ is not indicated for MTX-naïve patients
aInitially 947 patients were randomized in the study, but two patients were never dosed.
bX-ray images of hands and feet obtained at these time points.4
cPrior to Week 26, patients not achieving response criteria (≥20% improvement in SJC and TJC) at two consecutive visits starting at Week 12 continued on their blinded therapy and the investigator optimized background RA medications (NSAIDs, corticosteroids, and/or low-potency analgesics).2
dAt Week 26 patients with CDAI≤2.8 continued their original study drug; background medications were optimized in patients with CDAI>2.8 but ≥20% improvement in TJC and SJC; among patients with CDAI >2.8 and <20% improvement in TJC and SJC, RINVOQ 15 mg or Upadacitinib 30 mg were added by re‑randomization according to 1:1 ratio for those initially randomized to MTX, and MTX was added for those initially randomized to RINVOQ 15 mg or Upadacitinib 30 mg.3 Rescue protocol from Week 26 was as follows:
1. CDAI ≤ 2.8
2. ≥ 20% ∆BL in TJC, SJC but CDAI >2.8
3. ≥ 20% ∆BL in TJC, SJC and CDAI >2.8
Primary Endpoint1
- ACR50 response at Week 12
Ranked Secondary Endpoints2,5
At Week 12
- Change from baseline in DAS28-CRP
- Change from baseline in HAQ-DI
- DAS28-CRP ≤ 3.2 (LDA)
- Change from baseline in SF-36 (PCS)
At Week 24
- Change from baseline in mTSS
- DAS28-CRP < 2.6 (CR)
Select prespecified
nonranked endpoints4,5
- ACR 20/50/70 at all visits (except those that were ranked timepoints)
- Change from baseline in mTSS at Week 48
- Proportion of patients with no radiographic progression (mTSS ≤ 0) at Week 24
- Change from baseline in JE and JSN score at Week 24 and Week 48
Data Limitations
Prespecified nonranked endpoints were not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.
Baseline Characteristics6
*Prednisone equivalent dose in patients receiving oral glucocorticoids at baseline.
Anti-CCP=Anti-cyclic citrullinated peptide; ACR=American College of Rheumatology; ACR20=improvement of at least 20% in tender joint count, swollen joint count, and at least 3 other core criteria; ACR50=improvement of at least 50% in tender joint count, swollen joint count, and at least 3 other core criteria; ACR70=improvement of at least 70% in tender joint count, swollen joint count, and at least 3 other core criteria; CDAI=clinical disease activity index; CR=clinical remission; CRP=C reactive protein; csDMARD=conventional synthetic disease-modifying antirheumatic drugs; DAS28=Disease Activity Score; HAQ-DI=health assessment questionnaire disability index; hsCRP=high sensitivity C-reactive protein; JE=joint erosion score; JSN=joint space narrowing; LDA=low disease activity; mTSS=modified total Sharp score 28 joints; MTX=methotrexate; NSAIDs=Non-steroidal anti-inflammatory drugs; PhGA=physician’s global assessment of disease activity; PtGA=patient’s global assessment of disease activity; QD=once per day; RA=rheumatoid arthritis; RF=rheumatoid factor; SD=standard deviation; SDAI=simplified disease activity index; SF-36 PCS=Short-form 36 Physical Component Score; SJC66=swollen joint count of 66 joints; TJC68=tender joint count of 68 joints; VAS=visual analog scale
REFERENCES
1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
2. Van Vollenhoven R, Takeuchi T, Pangan AL, et al. Monotherapy with Upadacitinib in MTX-Naïve Patients with Rheumatoid Arthritis: Results at 48 Weeks from the SELECT-EARLY Study. Poster presented at: The European Congress of Rheumatology, 12–15 June 2019, Madrid, Spain.
3. Data on File. ABVRRTI68563.
4. Peterfy CG, Genovese MC, Song I-H, et al. Inhibition of Structural Joint Damage With Upadacitinib as Monotherapy or in Combination with Methotrexate in Patients with Rheumatoid Arthritis: 1 Year Outcomes from the SELECT Phase 3 Program. Poster presented at: The European Congress of Rheumatology, 12-15 June 2019, Madrid, Spain.
5. Data on File. ABVRRTI68564.
6. Van Vollenhoven R, Takeuchi T, Pangan AL, et al. A Phase 3, Randomized Controlled Trial Comparing Upadacitinib Monotherapy to MTX Monotherapy in MTX-Naïve Patients with Active Rheumatoid Arthritis. Oral Presentation at: The ACR Annual Meeting 2018, 19-24 October 2018, Chicago USA.
Study Design & Baseline Characteristics
SELECT-NEXT
Adults with moderately to severely active RA who had an inadequate response to csDMARD(s)1
aFrom Week 24, initiation of or change in corticosteroids, NSAIDs, acetaminophen and or initiation of csDMARDs (up to 2) was permitted in patients not achieving CDAI≤10.Starting at Week 24, study drug was discontinued in patients who failed to show >/=20% improvement in TJC and SJC compared to baseline at 2 consecutive visits.3
Primary Endpoint1
- ACR20 response at Week 12
Select Ranked Secondary Endpoints2,6
At Week 12:
Percentage of patients achieving
- DAS28-CRP < 2.6 (CR)
- DAS28-CRP ≤ 3.2 (LDA)
- CDAl ≤ 10 (LDA)
Select Prespecified nonranked secondary endpoints2,6
- ACR50 and ACR70 response at Week 12
- ACR20 response at Week 1
Data Limitations
Prespecified nonranked endpoints were not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.
Baseline Characteristics4
*Based on prednisone equivalent
ACPA=anti-citrullinated protein antibody; ACR=American College of Rheumatology; ACR20=improvement of at least 20% in tender joint count, swollen joint count, and at least 3 other core criteria; ACR50=improvement of at least 50% in tender joint count, swollen joint count, and at least 3 other core criteria; ACR70=improvement of at least 70% in tender joint count, swollen joint count, and at least 3 other core criteria; bDMARD= biological disease-modifying anti-rheumatic drug; CDAI=clinical disease activity index; CR=clinical remission; CRP=C reactive protein; csDMARD=conventional synthetic disease-modifying anti-rheumatic drug; DAS28=Disease Activity Score; FACIT-F=Functional Assessment of Chronic Illness Therapy–Fatigue; HAQ-DI=health assessment questionnaire disability index; hsCRP=high-sensitivity C-reactive protein; LDA=low disease activity; MTX=methotrexate; PBO=placebo; mTSS=modified total Sharp score; PhGA=physician’s global assessment of disease activity; PtGA=patient’s global assessment of disease activity; QD=once per day; RA=rheumatoid arthritis; RF=rheumatoid factor; SD=standard deviation; SDAI=simplified disease activity index; SF-36 PCS=Short-form 36 Physical Component Score; SJC66=swollen joint count of 66 joints; TJC68=tender joint count of 68 joints; TNFi=tumor necrosis factor inhibitor; VAS=visual analog scale.
REFERENCES
1. RINVOQ [package insert]. North Chicago, IL: AbbVie Inc.
2. Burmester GR, Kremer JM, Van den Bosch F, et al. Supplement - Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018;391(10139):2503-2512.
3. Data on File. ABVRRTI68981.
4. Burmester GR, Kremer JM, Van den Bosch F, et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease‑modifying anti‑rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018;391(10139):2503-2512.
5. Burmester GR, Van den Bosch F, Bessette L, et al. Long-Term Safety and Efficacy of Upadacitinib in Patients with Rheumatoid Arthritis and an Inadequate Response to csDMARDs: Results at 60 Weeks From the SELECT-NEXT Study. Poster presented at: The European Congress of Rheumatology, 12-15 June 2019, Madrid, Spain.
6. Data On File. ABVRRTI68843.