VONVENDI was approved several weeks ago for an expanded use in the United States for perioperative bleeding management. The FDA (US Food and Drug Administration) approved the use of the recombinant drug to include the treatment and control of bleeding and the perioperative management of bleeding in adults that suffer from von Willebrand disease.
VONVENDI, also known as recombinant von Willebrand factor (rVWF) is the only approved purified recombinant von Willebrand factor available in the United States for the treatment of von Willebrand disease (VWD). As the most common inherited blood disorder, the disease is seen in roughly one-percent (1%) of the population and is characterized by the inability of a patient’s blood to clot properly. Primarily seen at birth, the bleeding disorder may in rare instances manifest later in a patient’s life. Basically, the disorder is caused by a defect in a person’s genetic chromosomes that leads to problems manufacturing an important protein involved in the blood clotting process. Symptoms such as constant gum bleeding, excessive nosebleeds, and skin cuts not healing quickly or properly are commonly seen. In woman, unrestrained menstrual flow often times occurs.
By expanding its approval of VONVENDI, the FDA now allows its use in the perioperative management of bleeding in patients with VWD, as well as the on-demand treatment that it was initially approved for in 2015. Approved only for use in adults (eighteen years of age or older), the rVWF allows for the control of the excessive bleeding seen in patients using an individualized and on demand approach. Since not every bleeding episode requires its use, physicians can customize dosages to meet the needs of their patients based on the bleeding site, severity of the bleeding episode and the person’s previous medical history.
Specialty Pharmacy Selected as Authorized Provider
Manufactured and distributed by Shire, a global leader in the treatment of rare diseases, it is interesting to note that BioMatrix Specialty Pharmacy announced in a press release that they have been selected as an authorized provider of the medication. Started up in 2015, BioMatrix has quickly become a national player in the specialty pharmacy market and digital health technology solutions. BioMatrix is composed of a “family” of companies that include:
– Decillion Healthcare
– Elwyn Pharmacy Group
– Factor Support Network
– Matrix Health
– Medex Biocare
Hemlibra – Another Specialty Drug Example
Another example of a specialty pharmacy recently selected to be an authorized provider for a new drug release occurred in January of 2018, as HPC Specialty Pharmacy announced being chosen as an authorized provider by Genentech for Hemlibra. The newest medication approved by the FDA for patients having hemophilia type A with inhibitors, Hemlibra (known as Emicizumab ) is a humanized monoclonal antibody used in hemophilia patients who’d developed resistance to other treatments. In April of 2018, it was additionally approved by the FDA for use in patients who have not developed resistance to other treatments, as a routine prophylaxis in preventing and reducing the frequency of bleeding episodes in both adults and children with hemophilia A (with factor VIII inhibitors).
HPC Specialty Pharmacy was established in 2002 in Saraland, Alabama and stands for “Hemophilia Preferred Care”. Now located in Mobile, the pharmacy has expanded their services to include pharmaceuticals used for treating such diseases as multiple sclerosis, Crohn’s disease, rheumatoid arthritis, and IVIg.
Questions About Becoming an Authorized Provider?
Becoming a preferred provider as a specialty pharmacy can be a complex process. Because specialty pharmacies deal with both extremely costly and complex medications, becoming approved as an authorized provider takes time and involves having a proven process. Healthcare Consultants Pharmacy Staffing has helped more specialty pharmacies startup and successfully operate a business than any other pharmacy consulting firm in the nation. We have in-house experts that have been through the process and know the specialty pharmacy industry “inside and out”.
From major hospitals and healthcare systems to individual community retail pharmacies, HCC has been the nationally renowned pharmacy consulting firm of choice for over 28 years now. HCC can assist with expert advice in any area of your pharmacy business or practice. We urge you to contact us today to see how our Pharmacy Consulting services can help you improve your business now and be ready for the future. With a full-time staff of in-house Pharmacy Consultant specialists, HCC can answer any questions that you may have in all Pharmacy settings. Contact us online or call us today at 800-642-1652 for a free consultation.