Getting started
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Enroll your patients in BI SOLUTIONS PLUS
Have a GPP plan
Whether your patients have been previously diagnosed or newly diagnosed, it is important they have a patient-centric program that provides support with access to treatment.
BI SOLUTIONS PLUS provides patients with education, support, and access to information about SPEVIGO
Patient benefits
- Financial support options, such as the Copay Program and information on access to additional financial support options.*† Terms and Conditions apply
- Understanding their coverage for SPEVIGO
- Patient and Community Clinical Educators available to provide education sessions about SPEVIGO
- Additional resources may be provided to help patients start and stay on therapy, as prescribed
Additional resources
- Benefit investigation and prior authorization support
- Assistance with identifying distributors, specialty pharmacies, and alternate sites of care
- Reimbursement and Access Associate Directors (RAADs) are also available to answer questions about SPEVIGO-related reimbursement and coverage information
- The SPEVIGO SC Bridge Program* provides medication if there are delays in coverage. Terms and Conditions apply
*For eligible patients.
GPP=generalized pustular psoriasis.
Help your eligible patients save
†Commercially insured patients who enroll in BI SOLUTIONS PLUS could pay as little as $0. See Terms and Conditions.
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Enrolling your patients:
Step 1
Download and complete the BI SOLUTIONS PLUS enrollment and prescription forms
To facilitate enrollment:
- Ensure all forms are completed, signed by the patient and healthcare provider, and submitted together
- Include the front and the back of the patient’s insurance card
- If the healthcare professional is unable to capture the patient's signature in-office, then a representative will
reach out to obtain the signature - Inform your patients to expect a call from their Patient Navigator within 1 day. This call may come from an
unknown number
Step 2
Fax the signed and completed forms to 855-237-0134
Step 3
BI SOLUTIONS PLUS will notify you to confirm that your forms have been received
Upon completion of enrollment, BI SOLUTIONS PLUS will conduct a Benefits Investigation and a Patient Navigator will coordinate with your patient. You will receive updates along the way.
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Boehringer Ingelheim also offers additional resources to support your patients’ SPEVIGO journeys
Through BI SOLUTIONS PLUS, there is also access to a Patient and Community Clinical Educator and a Reimbursement and Access Associate Director (RAAD)
Patient and Community Clinical Educators‡
Clinical Educators offer one-on-one sessions with patients in person, by phone, or online. Caregivers are encouraged to attend.
Topics covered by Clinical Educators include:
- A patient’s diagnosis and how it can impact them
- Starting SPEVIGO, including Important Safety Information
- Preparing for treatment and what to expect during treatment
- Who will provide SPEVIGO and how it will be received
‡Patient and Community Clinical Educators are not your doctor and cannot give medical advice; they can provide information and resources on your condition and what to expect with SPEVIGO and can provide supplemental injection education.
Access and reimbursement support
Contact a Boehringer Ingelheim Reimbursement Access Associate Director (RAAD) if you or your office staff have questions as you help patients throughout the fulfillment process.
RAADs can:
- Answer questions about process challenges or payor requirements, including questions related to navigating the prior authorization (PA) appeals processes
- Help navigate through questions that may occur during the prescription/referral process
For more information about getting started on SPEVIGO,
call 1-833-SPEVIGO (773-8446) or contact a sales consultant.
SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.
CONTRAINDICATIONS
SPEVIGO is contraindicated in patients with severe or life-threatening hypersensitivity to spesolimab-sbzo or to any of the excipients in SPEVIGO. Reported hypersensitivity reactions have included drug reaction with eosinophilia and systemic symptoms (DRESS).
WARNINGS AND PRECAUTIONS
Infections: SPEVIGO may increase the risk of infections. In patients with a chronic infection or a history of recurrent infection, consider the potential risks and expected clinical benefits of treatment prior to prescribing SPEVIGO. Treatment with SPEVIGO is not recommended in patients with any clinically important active infection until the infection resolves or is adequately treated. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur during or after treatment with SPEVIGO. If a patient develops a clinically important active infection, discontinue SPEVIGO therapy until the infection resolves or is adequately treated.
Risk of Tuberculosis: Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SPEVIGO. Avoid use of SPEVIGO in patients with active TB infection. Consider initiating anti-TB therapy prior to initiating SPEVIGO in patients with latent TB or a history of TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SPEVIGO treatment.
Hypersensitivity and Infusion-Related Reactions:
- SPEVIGO-associated hypersensitivity reactions may include immediate reactions, such as anaphylaxis, and delayed reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS).
- Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported in clinical trials with spesolimab-sbzo in subjects with GPP.
- If a patient develops signs of anaphylaxis or other serious hypersensitivity, discontinue SPEVIGO immediately and initiate appropriate treatment.
- If a patient develops mild or moderate hypersensitivity during an intravenous infusion or other infusion-related reactions, stop SPEVIGO infusion and consider appropriate medical therapy (eg, systemic antihistamines and/or corticosteroids). Upon resolution of the reaction, the infusion may be restarted at a slower infusion rate with gradual increase to complete the infusion.
Vaccinations: Prior to initiating SPEVIGO for treatment of GPP, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid use of live vaccines in patients during and for at least 16 weeks after treatment with SPEVIGO. No specific studies have been conducted in SPEVIGO-treated patients who have recently received live viral or live bacterial vaccines.
ADVERSE REACTIONS
Intravenous SPEVIGO for Treatment of GPP Flare (Study Effisayil-1): Most common adverse reactions reported in ≥5% of patients treated with SPEVIGO in the clinical trial were asthenia and fatigue, nausea and vomiting, headache, pruritus and prurigo, infusion site hematoma and bruising, and urinary tract infection (UTI).
Specific Adverse Reactions
Infections: The most frequent adverse reactions that occurred in subjects treated with intravenous SPEVIGO were infections. During the 1-week placebo-controlled period in Study Effisayil-1, infections were reported in 14% of subjects treated with SPEVIGO compared with 6% of subjects treated with placebo. Serious infection (UTI) was reported in 1 subject (3%) in the SPEVIGO group and no subjects in the placebo group. Infections observed through Week 1 in Study Effisayil-1 in subjects treated with SPEVIGO were mild (29%) to moderate (71%).
Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS): Two cases of DRESS were reported in Study Effisayil-1 in subjects with GPP who were treated with intravenous SPEVIGO. RegiSCAR DRESS validation scoring (with the following categories: “no,” “possible,” “probable,” or “definite” DRESS) was applied to the reported cases. Reported cases were assessed as “no DRESS” and “possible DRESS.”
Subcutaneous SPEVIGO for Treatment of GPP When Not Experiencing a Flare (Study Effisayil-2): Regarding the exposure-adjusted incidence rates for subjects on randomized treatment prior to receiving rescue treatment for flare or completing trial without a flare, the rate per 100-patient years for injection site reaction (including erythema, pain, swelling, induration, urticaria, and warmth at the injection site) was 31.6 for the subcutaneous SPEVIGO cohort (600 mg loading dose followed by 300 mg every 4 weeks) vs 12.7 for the placebo cohort. The rate per 100-patient years for UTI was 18 for SPEVIGO vs 0 for placebo. The rate per 100-patient years for pruritus was 8.8 for SPEVIGO vs 0 for placebo. The rate per 100-patient years for arthralgia was 13.3 for SPEVIGO vs 6 for the placebo cohort. There were 3 subjects who discontinued subcutaneous SPEVIGO due to treatment-emergent adverse events of psoriasis compared to no subjects in the placebo cohort who discontinued placebo for any treatment-emergent adverse event.
Safety in Study Effisayil-2 After Flare: In Effisayil-2, subjects who experienced a GPP flare and received at least one dose of an open-label single intravenous 900 mg dose of SPEVIGO were treated with open-label subcutaneous SPEVIGO 300 mg. These subjects (n=19) received subcutaneous dosing at every 12 weeks, which could have been increased to every 4 weeks based on GPPPGA total score or pustulation subscore increased by ≥1 from any previous open-label maintenance visit. The reported safety profile of open-label subcutaneous SPEVIGO use after treatment of GPP flare with open-label intravenous SPEVIGO use was consistent with the safety profiles of use of SPEVIGO from Trial Effisayil-1 and randomized controlled data from Trial Effisayil-2.
Clinical Development of Spesolimab-sbzo
Guillain-Barre Syndrome (GBS): Among approximately 835 subjects exposed to spesolimab-sbzo during clinical development, GBS was reported in 3 subjects who received various doses of spesolimab-sbzo via various methods of administration in clinical trials for unapproved indications.
SPECIFIC POPULATIONS
Pediatric Use: The safety and effectiveness of SPEVIGO for the treatment of GPP have been established in pediatric patients 12 years of age and older and weighing at least 40 kg. Use of SPEVIGO for this indication is supported by data from a randomized, placebo-controlled study, which included 6 pediatric subjects 14 to 17 years of age with a history of GPP treated with subcutaneous SPEVIGO (Study Effisayil-2), and evidence from an adequate and well-controlled study of intravenous SPEVIGO in adults with GPP (Study Effisayil-1), with additional pharmacokinetic analyses showing similar drug exposure levels in adults and pediatric subjects 12 years of age and older and weighing 40 kg or more. The safety and effectiveness of SPEVIGO in pediatric patients younger than 12 years of age or in pediatric patients weighing less than 40 kg have not been established.
CL-SPG-100005 03.19.2024
Please see SPEVIGO Prescribing Information, including Medication Guide.