Variation in access to hemophilia A treatments in the United States

Figures & data

Figure 1. Coverage variation across health plans (n = 296 coverage policies across 16 health plans). Numbers in parentheses refer to the number of policies issued by each health plan. One plan did not issue policies for the included products.

Figure 2. Coverage variation across treatment classes (n = 296 coverage policies across 16 health plans). Number in parentheses refers to the number of policies issued for all treatments in the class. EHL, Extended half-life; FVIII, Factor VIII; SHL, Short half-life.

Table

Hemophilia A Treatments
Short half-life FVIII Concentrates		Hemophilia A Indication
Advate^1	Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method	Prophylaxis and on-demand
Alphanate^2	Antihemophilic Factor/von Willebrand Factor Complex (Human)	Prophylaxis and on-demand
Helixate FS^3	Antihemophilic Factor (Recombinant), Formulated with Sucrose	Prophylaxis and on-demand
Hemofil M^4	Antihemophilic Factor (Human), Method M, Monoclonal Purified	Prophylaxis and on-demand
Humate-P^5	Antihemophilic Factor/von Willebrand Factor Complex (Human)	Prophylaxis and on-demand
Koate-DVI^6	Antihemophilic Factor (Human)	Prophylaxis and on-demand
Kogenate FS^7	Antihemophilic Factor [Recombinant], Formulated with Sucrose	Prophylaxis and on-demand
Kovaltry^8	Antihemophilic Factor (Recombinant)	Prophylaxis and on-demand
Monoclate-P^9	Antihemophilic Factor (Human), FVIII:C Pasteurized, mAb Purified	Prophylaxis and on-demand
NovoEight^10	Antihemophilic Factor (Recombinant)	Prophylaxis and on-demand
Nuwiq^11	Antihemophilic Factor (Recombinant)	Prophylaxis and on-demand
Recombinate^12	Antihemophilic Factor (Recombinant)	Prophylaxis and on-demand
ReFacto^13	Antihemophilic Factor, (Recombinant)	Prophylaxis and on-demand
Xyntha^14	Antihemophilic Factor (Recombinant)	Prophylaxis and on-demand
Xyntha Solofuse^15	Antihemophilic Factor (Recombinant)	Prophylaxis and on-demand
Extended Half-Life FVIII Concentrates
Adynovate^16	Antihemophilic Factor (Recombinant), PEGylated	Prophylaxis and on-demand
Afstyla^17	Antihemophilic Factor (Recombinant), Single Chain	Prophylaxis and on-demand
Eloctate^18	Antihemophilic Factor (Recombinant), Fc Fusion Protein	Prophylaxis and on-demand
Esperoct^19	Antihemophilic factor (Recombinant), glycopegylated-exei	Prophylaxis and on-demand
Jivi^20	Antihemophilic Factor (Recombinant), PEGylated-aucl	Prophylaxis and on-demand
Bypassing Agents
FEIBA^21	Anti-Inhibitor Coagulant Complex	Prophylaxis and on-demand
NovoSeven^22	Coagulation Factor VIIa (Recombinant)	On-demand
Obizur^23	Antihemophilic Factor (Recombinant), Porcine Sequence	On-demand
Desmopressin
DDAVP Injection^24	Desmopressin acetate	Prophylaxis
Stimate^25	Desmopressin acetate	Prophylaxis and on-demand
Non-Factor Product
Hemlibra^26	Emicizumab-kxwh	Prophylaxis

¹Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (Advate) [package insert]. Baxter Healthcare Corp. Food and Drug Administration; 2011. [cited 2019, Aug 27]. Available from: https://www.fda.gov/media/70008/download.

² Antihemophilic Factor/von Willebrand Factor Complex (Human), Plasma/Albumin-Free Method (Alphanate) [package insert]. Grifols Biologicals Inc. Food and Drug Administration; 2018. [cited 2019, Aug 27]. Available from: https://www.fda.gov/media/71753/download.

³ Antihemophilic Factor (Recombinant) (Helixate FS) [package insert]. CSL Behring; 2016. [cited 2019, Aug 27]. Available from: https://labeling.cslbehring.com/PI/US/HelixateFS/EN/HelixateFS-Prescribing-Information.pdf.

⁴ Antihemophilic Factor (Human), Method M, Monoclonal Purified (Hemofil M) [package insert]. Baxalta US Inc.; 2018. [cited 2019, Aug 27]. Available from: https://www.shirecontent.com/PI/PDFs/HEMOFILM_USA_ENG.pdf.

⁵ Antihemophilic Factor/von Willebrand Factor Complex (Human), Plasma/Albumin-Free Method (Humate-P) [package insert]. CSL Behring GmbH. Food and Drug Administration; 2007. [cited 2019, Aug 27]. Available from: https://www.fda.gov/media/73587/download.

⁶ Antihemophilic Factor (Human) (Koate-DVI) [package insert]. Kedrion Biopharma; 2012. [cited 2019, Aug 27]. Available from: https://www.koate-dvi.com/documents/385822/0/Koate_DVI.pdf/fb455459-5ac0-43d3-bb48-363389a7c5c3?t=1414164745000.

⁷ Antihemophilic Factor (Recombinant) (Kogenate FS) [package insert]. Bayer Corp. Food and Drug Administration; 2014. [cited 2019, Aug 27]. Available from: https://www.fda.gov/media/70484/download.

⁸ Antihemophilic Factor (Recombinant) (Kovaltry) [package insert]. Bayer HealthCare. Food and Drug Administration; 2016. [cited 2019, Aug 27]. Available from: https://www.fda.gov/media/96221/download.

⁹ Antihemophilic Factor (Human) (Monoclate-P) [package insert]. CSL Behring; 2014. [cited 2019, Aug 27]. Available from: https://labeling.cslbehring.com/PI/US/Monoclate-P/EN/Monoclate-P-Prescribing-Information.pdf.

¹⁰ Antihemophilic Factor (Recombinant) (NovoEight) [package insert]. Novo Nordisk. Food and Drug Administration; 2018. [cited 2019, Aug 27]. Available from: https://www.fda.gov/media/119099/download.

¹¹ Antihemophilic Factor (Recombinant) (Nuwiq) [package insert]. Octapharma USA, Inc. Food and Drug Administration; 2015. [cited 2019, Aug 27]. Available from: https://www.fda.gov/media/93485/download.

¹² Antihemophilic Factor (Recombinant) (Recombinate) [package insert]. Baxter Healthcare Corp. Food and Drug Administration; 2010. [cited 2019, Aug 27]. Available from: https://www.fda.gov/media/78275/download.

¹³ Antihemophilic Factor (Recombinant) (ReFacto) [package insert]. Genetics Institute, Inc. Food and Drug Administration; No date available. [cited 2019, Aug 27]. Available from: https://www.fda.gov/media/69972/download.

¹⁴ Antihemophilic Factor (Recombinant) (Xyntha) [package insert]. Wyeth Pharmaceuticals. Food and Drug Administration; 2014. [cited 2019, Aug 27]. Available from: https://www.fda.gov/media/70399/download.

¹⁵ Antihemophilic Factor (Recombinant) (Xyntha Solofuse) [package insert]. Wyeth Pharmaceuticals. Food and Drug Administration; 2014. [cited 2019, Aug 27]. Available from: https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/xyntha.

¹⁶ Antihemophilic Factor (Recombinant), PEGylated (Adynovate) [package insert]. Baxalta US Inc. Food and Drug Administration; 2015. [cited 2019, Aug 27]. Available from: https://www.fda.gov/media/94470/download.

¹⁷ Antihemophilic Factor (Recombinant) Single Chain (Afstyla) [package insert]. CSL Behring Lengnau AG. Food and Drug Administration; 2016. [cited 2019, Aug 27]. Available from: https://www.fda.gov/media/98080/download.

¹⁸ Antihemophilic Factor (Recombinant), Fc Fusion Protein (Eloctate) [package insert]. Biogen. Food and Drug Administration; 2014. [cited 2019, Aug 27]. Available from: https://www.fda.gov/media/88746/download.

¹⁹ Antihemophilic Factor (Recombinant), glycopegylated-exei (Esperoct) [package insert]. Novo Nordisk, Inc. Food and Drug Administration; 2019. [cited 2019, Aug 27]. Available from: https://www.fda.gov/media/120351/download.

²⁰ Antihemophilic Factor (Recombinant), PEGylated-aucl (JIVI) [package insert]. Bayer Healthcare, Inc. Food and Drug Administration; 2018. [cited 2019, Aug 27]. Available from: https://www.fda.gov/media/115934/download.

²¹ Anti-Inhibitor Coagulant Complex (FEIBA NF) [package insert]. Baxter Healthcare Corp. Food and Drug Administration; 2013. [cited 2019, Aug 27]. Available from: https://www.fda.gov/media/78852/download.

²² Coagulation Factor VIIa (Recombinant) (NovoSeven) [package insert]. Novo Nordisk. Food and Drug Administration; 2006. [cited 2019, Aug 27]. Available from: https://www.fda.gov/media/70435/download.

²³ Antihemophilic Factor (Recombinant), Porcine Sequence (Obizur) [package insert]. Baxter Healthcare Corp. Food and Drug Administration; 2014. [cited 2019, Aug 27]. Available from: https://www.fda.gov/media/89987/download.

²⁴ Desmopressin acetate (DDAVP Injection) [package insert]. Ferring Pharmaceuticals US. Food and Drug Administration; 2018. [cited 2019, Aug 27]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018938s035lbl.pdf.

²⁵ Desmopressin acetate (Stimate) [package insert]. CSL Behring. Food and Drug Administration; 2013. [cited 2019, Aug 27]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020355s020lbl.pdf.

²⁶Emicizumab-kxwh (Hemlibra) [package insert]. Genentech, Inc. Food and Drug Administration; 2018. [cited 2019, Aug 27]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761083s002s004lbl.pdf.