In the management of Rheumatoid Arthritis…

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IMPORTANT NOTICES
DURING COVID-19

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IMPORTANT NOTICES
DURING COVID-19

Look deeper into KEVZARA:
Revealing Clinical, Economic,
and Practical Value FOR YOUR PLAN

Targeted MOA that inhibits the effects of chronically elevated IL-6

Robust clinical program spanning MTX-IR and TNF-IR patients

Head-to-head superiority study as a monotherapy vs adalimumab

Long- and short-term efficacy and safety data

Competitive pricing

Consistent Q2W dosing

Predictable budget impact

Cost-effectiveness data

Open distribution network

Button-free pen and prefilled syringe with 14-day storage

Coverage, access, and education support

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clinical value

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ILLUMINATING THE EVIDENCE

Targeted MOA that inhibits the effects
of chronically elevated IL-6

IL-6 is a pro-inflammatory cytokine produced by a variety of cell types, including local production by
synovial and endothelial cells in joints affected by inflammatory processes such as RA¹
KEVZARA, an IL-6Ri, specifically targets and binds with a high affinity to both soluble and membrane-
bound IL-6 receptors, thereby inhibiting IL-6 signaling^1,2

Observed Effects
of Sarilumab based on
PHARMACODYNAMIC studies¹

The clinical significance of these findings is unknown.
*Following single-dose SC administration of sarilumab in patients with RA, absolute neutrophil
counts decreased to the nadir between 3 and 4 days and thereafter recovered toward baseline.¹

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A ROBUST CLINICAL PROGRAM SPANNING MTX-IR
and TNF-IR POPULATIONS

Adult patients with moderately to severely active RA, diagnosed based on ACR criteria

MTX-IR and TNF-IR
PATIENT POPULATIONS

Two Pivotal, Randomized,
Double-Blind, Placebo-
controlled Studies

HEAD-TO-HEAD
SUPERIORITY STUDY AS A
MONOTHERAPY
VS ADALIMUMAB

Two Pivotal, Randomized,
Monotherapy Study
(not included in KEVZARA USPI)

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Long-term SAFETY AND EFFICACY data

Open-label extension (OLE) study limitations and additional study context

These data are not included in the US Prescribing Information.

LONG-TERM SAFETY ANALYSIS

This was a comprehensive safety analysis from pooled studies of patients who received at least 1 dose of sarilumab in combination with DMARD(s) as of last data analysis on January 15, 2018.⁴

LONG-TERM EFFICACY ANALYSIS

Efficacy assessments in this analysis did not include all of the primary endpoints from the placebo-controlled period of the pivotal trials analyzed.

For analysis of no radiographic progression, linear extrapolation was used to impute missing data. Patients with missing data after the imputation were considered progressors.⁴

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AND EFFICACY DATA BY CONTACTING YOUR
SANOFI GENZYME ACCOUNT DIRECTOR

Given the limitations and context described above, caution should be used in interpreting these data. Look Deeper

economic value

Look deeper into economic value:
Exposing the bottom line

COMPETITIVELY PRICED amongst RA products

Comparison Of Annual Wac For
Self-Administered Ra Therapies^5*

These products are not therapeutically equivalent and not interchangeable. This only reflects the acquisition price and not overall cost.
These products vary in their efficacy and safety, and they have different active ingredients. There are no data from clinical trials that
provide differences in efficacy and safety and dosing as they relate to overall product costs. In addition, the quantities of a drug product
a patient will require during treatment will vary.
Trademarks are the property of their respective owners.
*Annual WAC prices as of February 2021; subject to change.⁵

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A History of Significant Price Increases over the last 7 years

WAC PRICE INCREASES FOR SELF-ADMINISTERED RA THERAPIES⁵*

These products are not therapeutically equivalent and not interchangeable. This only reflects the acquisition price and not overall cost.
These products vary in their efficacy and safety, and they have different active ingredients. There are no data from clinical trials that provide differences in efficacy and safety and dosing as they relate to overall product costs. In addition, the quantities of a drug product a patient will require during treatment will vary.
Trademarks are the property of their respective owners.
*Annual WAC prices as of February 2021; subject to change.⁵

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REDUCTIONS IN CRP LEVELS at Consistent q2W Dosing

The recommended dose of KEVZARA is 200 mg Q2W as an SC injection¹
KEVZARA can be used with or without MTX or other conventional DMARD(s). Dosing of MTX and other conventional DMARDs may vary¹
Reduce the dose to 150 mg Q2W for the management of neutropenia, thrombocytopenia, and elevated liver enzymes¹
KEVZARA initiation is not recommended in patients with an ANC <2000 per mm³, platelet count <150,000 per mm³, or ALT or AST >1.5x ULN¹

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Predictable budget impact

IN A CLAIMS ANALYSIS OF PATIENTS PRESCRIBED SC ACTEMRA CONSISTING OF DATA
FROM TRUVEN MARKETSCAN AND OPTUM CLINFORMATICS DATABASES…^6*

62%
EITHER INITIATED
OR ESCALATED
TO THE HIGHER
WEEKLY DOSE

37%
ESCALATED
FROM Q2W
TO QW
DOSING

These dose
escalations can
almost double
projected
annual cost

62%EITHER INITIATED
OR ESCALATED
TO THE HIGHER
WEEKLY DOSE

37%
ESCALATED
FROM Q2W
TO QW
DOSING

These dose
escalations can
almost double
projected
annual cost

KEVZARA is the only IL-6
inhibitor that does not
require dose escalation^1,7

These products are not therapeutically equivalent and not interchangeable. This only reflects the acquisition price and not overall cost.
These products vary in their efficacy and safety, and they have different active ingredients. There are no data from clinical trials that
provide differences in efficacy and safety and dosing as they relate to overall product costs. In addition, the quantities of a drug product
a patient will require during treatment will vary.
Trademarks are the property of their respective owners.
*Based on a retrospective cohort study from administrative medical and pharmacy claims data obtained from the Truven MarketScan database and the Optum Clinformatics database between October 1, 2012 and June 30, 2017.⁶

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STUDIED IN COST-EFFECTIVENESS ANALYSIS VS MARKET LEADER

KEVZARA has been studied in a cost-effectiveness analysis as a monotherapy vs adalimumab monotherapy^8*
KEVZARA as a monotherapy has been studied vs adalimumab monotherapy in an analysis of the incremental cost per effectively treated patient^9†

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DATA BY CONTACTING YOUR SANOFI
GENZYME ACCOUNT DIRECTOR

*Funding for this research was contributed to by the Institute for Clinical and Economic Review.⁸
^†Funding for this study was provided by Sanofi Genzyme and Regeneron Pharmaceuticals.⁹
Intended for use with payers, formulary committees, or other similar entities for purposes of population-based
drug selection, coverage, and/or reimbursement decision-making, pursuant to FD&C Act Section 502(a).

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practical value

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SURPASSING THE EXPECTED

Open distribution networks. Patient support programs. Button-free pen
and pre-filled syringe must be refrigerated at 36-46°F but that can be kept
at room temperature (<77°F) for up to 14 days, if needed¹

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dosing and administration

Look deeper into our in-network
specialty pharmacies^*

Open distribution networks, button-free pen and prefilled syringe
with 14-day storage, and patient support programs¹

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into our in-network
specialty pharmacies^*

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into KEVZARA dosing
and administration

*Sanofi and Regeneron Pharmaceuticals, Inc. do not recommend any particular specialty pharmacy.
However, health plans may recommend or mandate a particular pharmacy.

Coverage Support
Patient Access Support
Nurse Support

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into our
patient
support
programs

For more information, call KevzaraConnect at 1-844-KEVZARA (1-844-538-9272) Option 1,
Monday–Friday, 8 AM–9 PM Eastern time.

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CLICK HERE TO CONTACT
YOUR SANOFI
GENZYME
ACCOUNT DIRECTOR
FOR MORE
INFORMATION.
YOU’LL BE GLAD YOU DID.

References:

KEVZARA [prescribing information]. Bridgewater, NJ: Sanofi/Regeneron Pharmaceuticals, Inc.
Genovese MC, et al. Arthritis Rheumatol. 2015;67(6):1424-1437.
Burmester GR, et al. Ann Rheum Dis. 2017;76(5):840–847.
Data on file, Sanofi/Regeneron. EULAR poster SAT0172. June 2018.
Data on file. Analysource. Prices updated February 2021.
Punekar R, et al. AM Health Drug Benefits. 2019;12(8):400-409.
Actemra [prescribing information]. South San Francisco, CA: Genentech, Inc.; 2019.
Whittington MD, et al. J Manag Care Spec Pharm. 2019;25(1):80-87.
Fournier M, et al. Clinicoecon Outcomes Res. 2019;11:117-128.

INDICATION

KEVZARA is indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS INFECTIONS

Patients treated with KEVZARA are at increased risk for developing serious infections that may lead to hospitalization or death. Opportunistic infections have also been reported in patients receiving KEVZARA. Most patients who developed infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Avoid use of KEVZARA in patients with an active infection.

Reported infections include:

Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before KEVZARA use and during therapy. Treatment for latent infection should be initiated prior to KEVZARA use.
Invasive fungal infections, such as candidiasis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
Bacterial, viral and other infections due to opportunistic pathogens.

Closely monitor patients for signs and symptoms of infection during treatment with KEVZARA. If a serious infection develops, interrupt KEVZARA until the infection is controlled.

Consider the risks and benefits of treatment with KEVZARA prior to initiating therapy in patients with chronic or recurrent infection.

CONTRAINDICATION

Do not use KEVZARA in patients with known hypersensitivity to sarilumab or any of the inactive ingredients.

WARNINGS AND PRECAUTIONS

Infections. Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving immunosuppressive agents for rheumatoid arthritis (RA). The most frequently observed serious infections with KEVZARA included pneumonia and cellulitis. Among opportunistic infections, TB, candidiasis, and pneumocystis were reported with KEVZARA.
- Hold treatment with KEVZARA if a patient develops a serious infection or an opportunistic infection.
- Patients with latent TB should be treated with standard antimycobacterial therapy before initiating KEVZARA. Consider anti-TB therapy prior to initiation of KEVZARA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but having risk factors for TB infection.
- Consider the risks and benefits of treatment prior to initiating KEVZARA in patients who have: chronic or recurrent infection, a history of serious or opportunistic infections, underlying conditions in addition to RA that may predispose them to infection, been exposed to TB, or lived in or traveled to areas of endemic TB or endemic mycoses.
- Viral reactivation has been reported with immunosuppressive biologic therapies. Cases of herpes zoster were observed in clinical studies with KEVZARA.
Laboratory Abnormalities. Treatment with KEVZARA was associated with decreases in absolute neutrophil counts (including neutropenia), and platelet counts; and increases in transaminase levels and lipid parameters (LDL, HDL cholesterol, and/or triglycerides). Increased frequency and magnitude of these elevations were observed when potentially hepatotoxic drugs (e.g., MTX) were used in combination with KEVZARA. Assess neutrophil count, platelet count, and ALT/AST levels prior to initiation with KEVZARA. Monitor these parameters 4 to 8 weeks after start of therapy and every 3 months thereafter. Assess lipid parameters 4 to 8 weeks after start of therapy, then at 6 month intervals.
Gastrointestinal Perforation. GI perforation risk may be increased with concurrent diverticulitis or concomitant use of NSAIDs or corticosteroids. Gastrointestinal perforations have been reported in clinical studies, primarily as complications of diverticulitis. Promptly evaluate patients presenting with new onset abdominal symptoms.
Immunosuppression. Treatment with immunosuppressants may result in an increased risk of malignancies. The impact of treatment with KEVZARA on the development of malignancies is not known but malignancies have been reported in clinical studies.
Hypersensitivity Reactions. Hypersensitivity reactions have been reported in association with KEVZARA. Hypersensitivity reactions that required treatment discontinuation were reported in 0.3% of patients in controlled RA trials. Injection site rash, rash, and urticaria were the most frequent hypersensitivity reactions. Advise patients to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction. If anaphylaxis or other hypersensitivity reaction occurs, stop administration of KEVZARA immediately. Do not administer KEVZARA to patients with known hypersensitivity to sarilumab.
Active Hepatic Disease and Hepatic Impairment. Treatment with KEVZARA is not recommended in patients with active hepatic disease or hepatic impairment, as treatment with KEVZARA was associated with transaminase elevations.
Live Vaccines. Avoid concurrent use of live vaccines during treatment with KEVZARA due to potentially increased risk of infections. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving KEVZARA.

ADVERSE REACTIONS

The most common serious adverse reactions were infections. The most frequently observed serious infections included pneumonia and cellulitis. The most common adverse reactions (occurred in at least 3% of patients treated with KEVZARA + DMARDs) are neutropenia, increased ALT, injection site erythema, upper respiratory infections, and urinary tract infections.

DRUG INTERACTIONS

Exercise caution when KEVZARA is co-administered with CYP substrates with a narrow therapeutic index (e.g. warfarin or theophylline), or with CYP3A4 substrates (e.g. oral contraceptives or statins) as there may be a reduction in exposure which may reduce the activity of the CYP3A4 substrate.
Elevated interleukin-6 (IL-6) concentration may down-regulate CYP activity such as in patients with RA and hence increase drug levels compared to subjects without RA. Blockade of IL-6 signaling by IL-6Rα antagonists such as KEVZARA might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to altered drug concentrations.

USE IN SPECIFIC POPULATIONS

KEVZARA should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Because monoclonal antibodies could be excreted in small amounts in human milk, the benefits of breastfeeding and the potential adverse effects on the breastfed child should be considered along with the mother’s clinical need for KEVZARA.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to KEVZARA during pregnancy. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-311-8972.
Use caution when treating the elderly.

Advise patients to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Please click here to see full Prescribing Information, including Boxed WARNING.
ACR, American College of Rheumatology; ALT, alanine transaminase; AST, aspartate transaminase; BID, twice a day; CRP, C-reactive protein; DMARD, disease-modifying antirheumatic drug; IL, interleukin; IL-6Ri, interleukin-6 receptor inhibitor; MOA, mechanism of action; MTX, methotrexate; MTX-IR, methotrexate inadequate response; Q2W, every other week; QD; once a day; QW, once a week; RA, rheumatoid arthritis; SC, subcutaneous; TNFi, tumor necrosis factor inhibitor; TNF-IR, tumor necrosis factor inadequate response; USPI, US Prescribing Information; WAC, wholesale acquisition cost.

Indication

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