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Hemophilia: Long-Acting Factor Products VIII

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Hemophilia: Long-Acting Factor Products VIII UTAH MEDICAID DUR REPORT FEBRUARY 2017 HEMOPHILIA A: NEWLY APPROVED RECOMBINANT FACTOR VIII CONCENTRATES (LONG-ACTING ANTIHEMOPHILIC FACTORS) AFSTYLA ADYNOVATE ELOCTATE KOVALTRY Drug Regimen Review Center Joanita Lake B.Pharm, MSc EBHC (Oxon), Clinical Pharmacist Valerie Gonzales, Pharm.D., Clinical Pharmacist Joanne LaFleur, Pharm.D., MSPH, Associate Professor Acknowledgement We thank the following professionals for their input on this review: The University of Utah Home Infusion Pharmacy, Pharmacy Manager: Jamie Doi Slade, PharmD, Hemophilia Case Mangers: Jennifer Green, RN & Norma Sonntag, RN University of Utah College of Pharmacy Copyright © 2017 by University of Utah College of Pharmacy Salt Lake City, Utah. All rights reserved Contents Introduction ................................................................................................................................................................... 3 Methodology .................................................................................................................................................................. 6 Long-acting Recombinant Factor VIII Products ............................................................................................................ 6 Clinical Guidelines ........................................................................................................................................................ 7 Clinical Efficacy .......................................................................................................................................................... 10 Cochrane Systematic Review(s) ............................................................................................................................. 10 Other Systematic Review(s) ................................................................................................................................... 10 Additional Safety Evidence ......................................................................................................................................... 11 Treatment Management in Utah & Clinical Case Manager Input ............................................................................... 13 Misuse, Abuse, and Inappropriate Use of Factor Replacement Products .................................................................... 15 Place in Therapy and Potential Criteria for Review .................................................................................................... 15 Utah Medicaid Utilization Data ................................................................................................................................... 18 Conclusions ................................................................................................................................................................. 22 Appendix 1 – Drug Information .................................................................................................................................. 23 Appendix 2 – Inhibitors ............................................................................................................................................... 26 Appendix 3 – Systematic Reviews .............................................................................................................................. 27 Appendix 4 – University of Utah Home Infusion Case Management ......................................................................... 32 References ................................................................................................................................................................... 35 2 Introduction Congenital hemophilia is a rare, inherited, lifelong bleeding disorder which “in about one-third of the time, the baby with hemophilia is the first one in the family to be affected with a mutation in the gene for the clotting factor.”1 Patients with hemophilia have low levels of clotting factors VIII or IX, and this could result in spontaneous bleeding or life-threatening prolonged bleeding following injuries or surgery.1 “The level of factor VIII or factor IX in the blood usually stays the same throughout the person’s life.”2 A genetic mutation on the X chromosome can cause the clotting protein to be absent or dysfunctional. Hemophilia occurs in all racial and ethnic groups, however, is primarily seen in men (with only one copy of certain genes on the X chromosome), occurring in about 1 out of every 5,000 male births.1 Although rare, females may also have hemophilia in which case both X chromosomes are affected or one is affected and the other is missing or inactive. Females are most often asymptomatic carriers of hemophilia, passing the defected clotting-factor gene onto the child. 1 Although there are several different types of hemophilia, hemophilia A (a deficiency of factor VIII) and hemophilia B (a deficiency of factor IX) are the most common.1 Hemophilia A occurs in about 80% of patients with hemophilia, while about 20% have hemophilia B.1 A deficiency in factor VIII prolongs the activated partial thromboplastin time (aPTT) and is confirmed using assays that assess the activity level of the specific factor in the patient’s blood sample.3 It is worth noting that endogenous factor VIII (FVIII) originates in endothelial cells (not in hepatocytes like other factors) and has a half-life between 8 and 12 hours.3-6 Hemophilia severity is classified according to the following:7 • Mild: Clotting-factor activity level 6-30% of the normal expected level (about 25% of cases) • Moderate: Clotting-factor activity level 1-5% of normal (about 15% of cases) • Severe: <1% of the normal expected clotting-factor activity level (about 60% of cases) The number of affected individuals with hemophilia A in the U.S. is estimated by the Centers for Disease Control and Prevention (CDC) to be approximately 20,000 individuals.1 The CDC has set up a monitoring system, known as the Universal Data Collection System (UDCS), made possible through collaboration with the U.S. Hemophilia Treatment Center Network (USHTCN). A newer program, Community Counts, will continue to improve and expand upon the collected UDCS datasets.8 Data reports under development will summarize information including, but not limited to, demographics, product use, bleeding rates, inhibitor development, treatment patterns, infection rates, use of healthcare services, and mortality.8 Currently, available reports include patient characteristics such as age, sex, ethnicity, race, insurance status, and concomitant infections for different factor deficiencies.9 Hemophilia can lead to chronic joint disease and pain (due to spontaneous bleeding into joints), seizures and paralysis (from bleeding into the brain), or death (due to unstoppable bleeding or bleeding into a vital organ). Bleeding often re-occurs in the same joint causing degradation, decreased range of motion, and reduced quality of life.1,7 “Eventually, the patient may need a radiosynovectomy, joint fusion, or joint replacement.”10 Early initiation of prophylactic treatment with blood factors reduces bleeding episodes and therefore prevents joint disease and other complications.11-13 “Without adequate treatment, many people with hemophilia die before they reach adulthood. However, with proper treatment, life expectancy for people with hemophilia is about 10 years less than that of males without hemophilia, and children can look forward to a normal life expectancy.”2 Another form of FVIII hemophilia is acquired hemophilia (AH), however, is much rarer.2 It is an autoimmune disorder caused by the development of autoantibodies that inactivate FVIII. It mostly 3 occurs in the elderly or in young women during late stages of pregnancy or postpartum.2 This form affects both men and women equally and is often precipitated by a pre-existing medical condition (such as malignancy, autoimmune disorder, or pregnancy) or by an allergic reaction to a medication (as reported with penicillin, ciprofloxacin, sulphonamides, clopidogrel, phenytoin, and fludarabine). AH manifests with extensive cutaneous purpura and internal bleeding, however, not so much joint bleeding, as is the case with congenital hemophilia. This condition is treated and often resolves upon the employment of hemostatic agents and immunosuppressants. 14 This review focuses on the newly approved long-acting recombinant factor VIII products for use in congenital hemophilia A. Hemophilia A is treated by intravenously administering factor VIII using either a plasma-derived factor or a recombinant, genetically engineered factor to reduce bleeding and improve joint health. In the 1970’s and 1980’s, blood-borne infections such as hepatitis and HIV were a problem with the use of the plasma-derived products since it was not possible to test for these infections. Subsequently, many patients with hemophilia became infected. Risk of HIV transmission is now much lower with the current use of blood donor screening, heat treatments, and nanofiltration. Nonetheless, the risk of viral transmission remains a possibility with plasma-derived factors. Recombinant products have been available since 1992. The first generation products were stabilized with human albumin; newer generation products do not require this technique and thus do not pose risks of blood-borne disease transmission since they have never been in contact with human blood products.7,15 Treatment with recombinant factor VIII products is the standard of care for symptomatic hemophilia
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