All haemophilia A patients in Republic of Ireland get continued access to Sobi’s extended half-life factor replacement therapy
Sobi United Kingdom (UK) and Republic of Ireland (RoI) and the RoI’s Haemophilia Product Selection and Monitoring Advisory Board (HPSMAB) have extended the contract for the supply of Sobi’s Elocta® (efmoroctocog alfa) until 31 December 2020. This means that all people with haemophilia A (PwHA) requiring factor VIII (FVIII) replacement therapy in the RoI will continue to have access to Sobi’s extended half-life (EHL) therapy for another 12 months under the terms of the current agreement.
This contract extension is a result of positive patient feedback to the HPSMAB regarding Elocta (rFVIIIfc). Alongside the contract extension for Sobi’s Alprolix® (eftrenonacog alfa) for people with haemophilia B (PwHB) requiring factor IX (FIX) replacement therapy last year, this maintains the RoI as one of the only countries in the world to routinely offer only EHL therapies as factor replacement treatment to all haemophilia patients.
rFVIIIfc was first introduced in the RoI in 2016 and became the only factor replacement therapy for PwHA used in 2018, when Sobi UK-RoI won a tender to supply the whole of the RoI. The new extension to the agreement continues Sobi’s exclusive arrangement with the RoI and secures patient access to Elocta for all patients requiring factor replacement therapy.
Brian O’Mahony, Chief Executive of the Irish Haemophilia Society, said: “The Irish Haemophilia Society are pleased with the continued access to the EHL FVIII (Elocta) and EHL FIX (Alprolix) which we have been using since 2017. The availability of EHL factor concentrates has led to a measurable improvement in quality of life for people with haemophilia in Ireland which we reported on during the International Society of Thrombosis and Haemostasis conference earlier this year.”
Neil Dugdale, Vice-President and General Manager of Sobi UK and RoI, added: “Ireland has emerged in recent years as one of the leading countries for the treatment and management of haemophilia. As part of our ongoing commitment to people living with haemophilia, we are proud to be able to continue to provide sustainable access to our EHL treatments.”
Ireland’s progressive approach combines expert medical care co-ordinated across the country by the National Haemophilia Service, a very active patient community via the Irish Haemophilia Society and an inclusive approach to efficient purchasing of necessary therapies via competitive tendering and assessment.
St James’s Hospital in Dublin, in conjunction with the Haemophilia Product Selection and Monitoring Advisory Board (HPSMAB), awarded Sobi a contract to supply rFVIIIfc for the treatment of haemophilia A in January 2018 for a minimum of two years. The St James’s Hospital tender process is run according to EU procurement rules and leads the way in its multi-stakeholder approach, including formal representation of patients within the decision-making process.
About haemophilia A and B
Haemophilia is a rare, genetic disorder in which the ability of a person's blood to clot is impaired. Haemophilia A occurs in about one in 5,000 male births annually, and more rarely in females. Haemophilia B occurs in about one in 25,000 male births annually, and more rarely in females. The World Federation of Hemophilia estimates that approximately 210,000 people are currently diagnosed with haemophilia A and B worldwide.1
People with haemophilia A and B experience bleeding episodes that can cause pain, irreversible joint damage and life-threatening haemorrhages. Prophylactic injections of factor VIII and factor IX can temporarily replace the clotting factors that are needed to control bleeding and prevent new bleeding episodes.2 The World Federation of Hemophilia (WFH) recommends prophylaxis as the optimal therapy as it can prevent bleedings and joint destruction.3
The Haemophilia Product Selection and Monitoring Advisory Board (HPSMAB) consists of patient, clinician and payer representatives who advise on the selection and monitoring of treatments for haemophilia and related bleeding disorders in Ireland.
Elocta® (efmoroctocog alfa) is a recombinant clotting factor therapy developed for Haemophilia A using Fc fusion technology to prolong circulation in the body. It is engineered by fusing factor VIII to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body), enabling Elocta (rFVIIIfc) to use a naturally occurring pathway to extend the time the therapy remains in the body (half-life). rFVIIIfc is manufactured using a human cell line in an environment free of animal and human additives.
rFVIIIfc is approved and marketed by Sobi for the treatment of Haemophilia A in the EU, Iceland, Norway, Liechtenstein, Switzerland, Kuwait and Saudi Arabia. It is approved and marketed as ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein] by Sanofi in the United States, Japan and Canada. It is also approved in Australia, New Zealand, Brazil and other countries, where Sanofi has the marketing rights. rFVIIIfc has been licenced and marketed in the UK and Ireland since 2015.
As with any factor replacement therapy, allergic-type hypersensitivity reactions and development of inhibitors may occur in the treatment of Haemophilia A. Inhibitor development has been observed with rFVIIIfc, including in previously untreated patients. Note that the indication for previously untreated patients is not included in the EU Product Information for rFVIIIfc. The Summary of Product Characteristics for rFVIIIfc is available here: https://www.medicines.org.uk/emc/product/5100/smpc
Alprolix® (eftrenonacog alfa) [Coagulation Factor IX (Recombinant), Fc Fusion Protein], is a recombinant clotting factor therapy developed for Haemophilia B using Fc fusion technology to prolong circulation in the body. It is engineered by fusing factor IX to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body), enabling Alprolix (rFIXfc) to use a naturally occurring pathway to extend the time the therapy remains in the body (half-life). While Fc fusion technology has been used for more than 15 years, Sanofi and Sobi have optimised the technology and are the first companies to utilise it in the treatment of Haemophilia. rFIXfc is manufactured using a human cell line in an environment free of animal and human additives.
rFIXfc is approved for the treatment of Haemophilia B the European Union, Iceland, Liechtenstein, Norway and Switzerland, and marketed by Sobi. It is also approved in the United States, Canada, Japan, Australia, New Zealand, Brazil and other countries, and Sanofi has marketing rights in these regions.
Allergic-type hypersensitivity reactions and development of inhibitors have been observed with rFIXfc in the treatment of Haemophilia B, including in previously untreated patients.
About Sobi in the United Kingdom and Republic of Ireland
As the affiliate in the UK and RoI of the international biopharmaceutical company SobiTM, our team is committed to Sobi’s vision of providing sustainable access to innovative therapies and transforming the lives of people affected by rare diseases. We bring something rare to rare diseases – a belief in the strength of focus, the power of agility and the potential of the people we are dedicated to serving. The hard work and dedication of approximately 1300 employees around the globe has been instrumental in the success across Europe, North America, the Middle East, Russia and North Africa. You can find more information about Sobi at www.sobi.com.