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The Factor Forum is an engaging podcast series for healthcare professionals that provides peer insights and experiences that have helped them enhance treatment for their patients with hemophilia B. The series dives deep into topics, including treatment approaches, comorbidity management, patient cases, and the benefits of a multidisciplinary care team.

Graphic for Episode 1 of 'The Factor Forum' podcast, showing blood cells in the background

FACTORING IN SHLs AND EHLs FOR HEMOPHILIA B PATIENTS

Looks at the evolution of factor treatment and how EHLs have changed the hemophilia treatment landscape by optimizing care

  • ALPROLIX [package insert]. Waltham, MA: Bioverativ Therapeutics Inc.
  • Björkman S. Population pharmacokinetics of recombinant factor IX: implications for dose tailoring. Haemophilia. 2013;19(5):753-757.
  • Data on file. Waltham, MA; Bioverativ Therapeutics Inc.
  • Diao L, Li S, Ludden T, Gobburu J, Nestorov I, Jiang H. Population pharmacokinetic modelling of recombinant factor IX Fc fusion protein (rFIXFc) in patients with haemophilia B. Clin Pharmacokinet. 2014;53(5):467-477.
  • Geraghty S, Dunkley T, Harrington C, Lindvall K, Maahs J, Sek J. Practice patterns in haemophilia A therapy–global progress towards optimal care. Haemophilia. 2006;12(1):75-81.
  • Gui T, Lin HF, Jin DY, et al. Circulating and binding characteristics of wild-type factor IX and certain Gla domain mutants in vivo. Blood. 2002;100(1):153-158.
  • Hacker M, Messer WS, Bachmann KA. Pharmacology: Principles and Practice. 1st ed. Academic Press; 2009.
  • Iorio A, Fischer K, Blanchette V, Rangarajan S, Young G, Morfini M; Pharmacokinetic (PK) Expert Working Group of the International Prophylaxis Study Group (the IPSG). Tailoring treatment of haemophilia B: accounting for the distribution and clearance of standard and extended half-life FIX concentrates. Thromb Haemost. 2017;117(6):1023-1030.
  • Kachalsky E, Geary M, Pennick L, et al. The role of the hemophilia treatment center social worker in the United States. Poster presented at: WFH 2016 World Congress; July 24-28, 2016; Orlando, Florida.
  • Lenting PJ, Schooten CJM van, Denis CV. Clearance mechanisms of von Willebrand factor and factor VIII. J Thromb Haemost. 2007;5(7):1353-1360.
  • Lock J, de Bekker-Grob EW, Urhan G, et al; 'OPTI-CLOT' study group. Facilitating the implementation of pharmacokinetic-guided dosing of prophylaxis in haemophilia care by discrete choice experiment. Haemophilia. 2016;22(1):e1-e10.
  • Morfini M. The history of clotting factor concentrates pharmacokinetics. J Clin Med. 2017;6(3):35.
  • Pasi KJ, Fischer K, Ragni M, et al. Long-term safety and efficacy of extended-interval prophylaxis with recombinant factor IX Fc fusion protein (rFIXFc) in subjects with haemophilia B. Thromb Haemost. 2017;117(3):508-518.
  • Pasi KJ, Fischer K, Ragni M, et al. Long-term safety and sustained efficacy for up to 5 years of treatment with recombinant factor IX Fc fusion protein in subjects with haemophilia B: results from the B-YOND extension study. Haemophilia. 2020;26(6):e262-e271.
  • Powell JS, Pasi KJ, Ragni MV, et al; B-LONG Investigators. Phase 3 study of recombinant factor IX Fc fusion protein in hemophilia B. N Engl J Med. 2013;369(24):2313-2323.
  • Srivastava A, Santagostino E, Dougall A, et al; WFH Guidelines for the Management of Hemophilia panelists and co-authors. WFH guidelines for the management of hemophilia, 3rd edition. Haemophilia. 2020;26(suppl 6):1-158.
  • Swiech K, Picanço-Castro V, Covas DT. Production of recombinant coagulation factors: are humans the best host cells? Bioengineered. 2017;8(5):462-470.
  • Torres-Ortuño A, Cuesta-Barriuso R, Nieto-Munuera J. Parents of children with haemophilia at an early age: assessment of perceived stress and family functioning. Haemophilia. 2014;20(6):756-762.
  • van Os S, Ryder N, Hart DP, Troop N. Adherence to prophylaxis in adolescents and young adults with severe haemophilia: a qualitative study with healthcare professionals. Health Psychol Behav Med. 2020;8(1):55-72.
Graphic for Episode 2 of 'The Factor Forum' podcast, showing blood cells in the background

AN APPROACH TO COMPLEX CASES IN HEMOPHILIA B

Explores common comorbidities and how choosing the right treatment regimen can impact patient outcomes and adherence

  • ALPROLIX [package insert]. Waltham, MA: Bioverativ Therapeutics Inc.
  • Astermark J, Hermans C, Ezzalfani M, et al. rFIXFc prophylaxis improves pain and levels of physical activity in haemophilia B: post hoc analysis of B-LONG using haemophilia-specific quality of life questionnaires. Haemophilia. 2022;28(1):18-26.
  • Data on file. Waltham, MA; Bioverativ Therapeutics Inc.
  • Kachalsky E, Geary M, Pennick L, et al. The role of the hemophilia treatment center social worker in the United States. Poster presented at: WFH 2016 World Congress; July 24-28, 2016; Orlando, Florida.
  • Lewandowska M, Nasr S, Shapiro AD. Therapeutic and technological advancements in haemophilia care: quantum leaps forward. Haemophilia. 2022;28(suppl 4):77-92.
  • Nolan B, Klukowska A, Shapiro A, et al. Final results of the PUPs B-LONG study: evaluating safety and efficacy of rFIXFc in previously untreated patients with hemophilia B. Blood Adv. 2021;5(13):2732-2739.
  • Pasi KJ, Fischer K, Ragni M, et al. Long-term safety and sustained efficacy for up to 5 years of treatment with recombinant factor IX Fc fusion protein in subjects with haemophilia B: results from the B-YOND extension study. Haemophilia. 2020;26(6):e262-e271.
  • Powell JS, Pasi KJ, Ragni MV, et al; B-LONG Investigators. Phase 3 study of recombinant factor IX Fc fusion protein in hemophilia B. N Engl J Med. 2013;369(24):2313-2323.
  • Shapiro AD, Kulkarni RD, Ragni MV, et al. Post hoc longitudinal assessment of efficacy and safety of recombinant factor IX Fc fusion protein in hemophilia B. Blood Adv. Published online February 27, 2023. doi:10.1182/bloodadvances.2022009230
  • Srivastava A, Santagostino E, Dougall A, et al; WFH Guidelines for the Management of Hemophilia panelists and co-authors. WFH guidelines for the management of hemophilia, 3rd edition. Haemophilia. 2020;26(suppl 6):1-158.
  • Stoffman J, Andersson NG, Branchford B, et al. Common themes and challenges in hemophilia care: a multinational perspective. Hematology. 2019;24(1):39-48.

ALPROLIX in clinical and real-world settings

ALPROLIX Clinical Experience: 
A conversation with Dr Amy Shapiro, MD, and Dr Lynn Malec, MD

Protection,* Experience, and Dosing:
A Discussion With Dr De Angulo

*ALPROLIX has been proven to help patients prevent bleeding episodes using a prophylaxis regimen.1

Dr Guillermo De Angulo shares his clinical experience with ALPROLIX.
Hear about how he integrates ALPROLIX into his practice and how he evaluates his patients’ ongoing treatment.

Access and reimbursement

Billing and coding information

The codes listed below are provided for informational purposes only and are not intended to substitute for or influence the independent medical judgment of the prescriber. The codes may not apply to all patients or to all health plans, and additional codes not listed may apply to some patients. The treating physician is solely responsible for diagnosis, coding and determination of the appropriate ICD-10-CM codes that describe the patient’s condition and are supported by the medical record.

The ICD-10-CM and HCPCS codes provided are based on AMA or CMS guidelines. Use of the information below does not guarantee that the payor will provide coverage for ALPROLIX. Because government and other third-party payor coding requirements change periodically, please verify current coding requirements directly with the payor being billed.

Chart displaying ICD-10-CM diagnosis code D67, which is associated with hereditary Factor IX deficiency
Chart listing ALPROLIX NDCs and nominal potency values
Chart showing HCPCS code J7201, which corresponds to ALPROLIX injection, Factor Ix, Fc Fusion protein
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ALPROLIX instructions for use

This document contains information on how to use ALPROLIX, including reconstitution, pooling, administration, and storage.

ALPROLIX offers a range of financial assistance programs for your patients

Kids B-LONG was a phase 3 open-label study that investigated the safety and efficacy of ALPROLIX in 30 previously treated pediatric patients with severe hemophilia B. All 30 patients were treated with ALPROLIX on an individualized prophylactic regimen. Fifteen patients were 1 to 5 years of age; 15 patients were 6 to 11 years of age.1

Free Trial Plus Program

Patients can receive their first 30-day supply of ALPROLIX generally within 24-48 hours with a valid prescription from their healthcare provider. Sanofi Patient Services will review your patient’s health insurance information for their coverage of ALPROLIX while you and your patient decide if this is the right medication for them to continue taking.

Copay Program

Whether your patient is new to ALPROLIX or already on therapy, ALPROLIX offers a Copay Program to eligible patients that can cover up to $20,000 of copayment, or co-insurance, and out-of-pocket costs associated with their prescription. Best of all, there are no income requirements or caps, so your patient can get started with their treatment right away.
Learn more about Copay Savings for ALPROLIX.

Factor Access Program

Helps your patient access ALPROLIX, even if their insurance coverage is interrupted—for example, they are between jobs or changing insurers.

Sanofi Support Programs Enrollment Form
Sanofi Support Programs Enrollment Form in Spanish (en Español)
Sanofi Support Programs Bilingual Enrollment Form

The Copay Program does not cover prescriptions eligible to be reimbursed, in whole or in part, by a state or federal health care program, including but not limited to Medicare, Medicare Advantage Plans (Example: FreedomBlue offered through BlueCross Blue Shield), Medicare Part D, Medicaid, Medigap, Veterans Affairs, Department of Defense, or TRICARE. In accordance with State law, the Program does not reimburse infusion-related charges for commercially insured patients residing in Massachusetts, Michigan, or Rhode Island. (Charitable Access Program patients residing in these states are eligible to receive assistance for infusion-related charges while they are receiving charitable drug.) No claim for reimbursement of any out-of-pocket expenses covered by the Copay Program may be submitted to any third-party payer, whether public or private. The Copay Program is available only in the United States and cannot be combined with any other rebate/coupon, free trial, or similar offer. Copay benefits are not transferrable. Sanofi reserves the right to rescind, revoke, modify, or amend this program without notice. Program details provided upon registration.

Patients can manage their hemophilia with the help of MicroHealth tracking

Sanofi has joined with MicroHealth in supporting patients and healthcare providers to better manage hemophilia.

Learn more

Download for IOS                       Download for Android

Google Play and the Google Play logo are trademarks of Google LLC.
Apple and the Apple logo are trademarks of Apple Inc. App Store is a service mark of Apple Inc.

Interface of a hemophilia management app, MicroHealth, featuring user details and menu options like treatment and messages.

Hemophilia B Advocacy Groups

This listing is provided as a resource only and does not constitute an endorsement by Sanofi of any particular organization or its programming. Additional resources on this topic may be available and should be investigated. Sanofi does not review or control the content of non-Sanofi websites. These listings do not constitute an endorsement by Sanofi of information provided by any other organizations.

The Coalition for Hemophilia BNational Hemophilia FoundationHemophilia Federation of AmericaWorld Federation of Hemophilia
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Request more information or a meeting with an ALPROLIX representative

Indication

ALPROLIX is a recombinant DNA derived, coagulation Factor IX concentrate indicated in adults and children with hemophilia B for:

  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding
  • Routine prophylaxis to reduce the frequency of bleeding episodes

Limitation of Use

ALPROLIX is not indicated for induction of immune tolerance in patients with hemophilia B.

Important Safety Information

Contraindication

ALPROLIX is contraindicated in patients who have a known history of hypersensitivity reactions, including anaphylaxis, to the product or its excipients.

Warnings and Precautions

  • Allergic-type hypersensitivity reactions, including anaphylaxis, are possible with factor replacement therapies, and have been reported with ALPROLIX. Discontinue use of ALPROLIX if hypersensitivity symptoms occur, and initiate appropriate treatment.
  • Formation of neutralizing antibodies (inhibitors) to Factor IX has been reported following administration of ALPROLIX. Patients using ALPROLIX should be monitored for the development of Factor IX inhibitors. Clotting assays (e.g., one-stage) may be used to confirm that adequate Factor IX levels have been achieved and maintained.
  • The use of Factor IX products has been associated with the development of thromboembolic complications.
  • Nephrotic syndrome has been reported following attempted immune tolerance induction in hemophilia B patients with Factor IX inhibitors and a history of allergic reactions to Factor IX. The safety and efficacy of using ALPROLIX for immune tolerance induction have not been established.

Adverse reactions

The most common adverse reactions (incidence ≥1%) in previously untreated patients were injection site erythema, hypersensitivity, and Factor IX inhibition. The most common adverse reactions (incidence ≥1%) in previously treated patients were headache, oral paresthesia, and obstructive uropathy.

Indication

Important Safety Information

References: 1. ALPROLIX [package insert]. Waltham, MA: Bioverativ Therapeutics Inc.

©2024 Sanofi. All rights reserved. ALPROLIX and Sanofi are registered trademarks of Sanofi or an affiliate. All other trademarks are the property of their respective owners. MAT-US-2021406-v10.0-09/2024 Last updated: September 2024