Three biosimilars used for blood clot prevention secure public reimbursement status in British Columbia, one of several Canadian provinces that has a biosimilar switching program.
Patients in British Columbia, Canada, now have access to 3 new biosimilars for the prevention of blood clot disorders, all of which reference Lovenox (enoxaparin).
Redesca, Noromby, and Inclunox have been added to the list of reimburseable biosimilars covered by PharmaCare, the province’s public health plan. Noromby was developed by Juno Pharmaceuticals, Inclunox is a Sandoz product, and Redesca was developed by Valero Pharmaceuticals. Both the original and high-potency versions of the drugs are available for public reimbursement.
“We are very pleased to have secured public coverage for Redesca in British Columbia while its originator enoxaparin has been simultaneously delisted. Our biosimilar is now covered in every province, and it is already our best-selling drug. We anticipate further upside going forward now that it is publicly fully covered and that hospitals across the country are making the step to move to biosimilars LMWH [low molecular weight heparin]," said Frederic Fasano, president and chief operating officer at Valero, in a company statement.
Enoxaparin is a LMWH that acts as an anticoagulant medication for the treatment and prevention of venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism both during pregnancy and following certain types of surgery. It is also used in patients with acute coronary syndrome and history of heart attacks and can serve as a replacement to oral blood thinners when other treatments for noncancer-related VTE have failed.
British Columbia is 1 of the 5 provinces and 6 jurisdictions that have a biosimilars switching policy that enables reference products to be automatically substituted with a biosimilar version. British Columbia adopted its policy in November 2019, and in August 2020, it moved into the third phase of the program, which included the addition of 3 rituximab biosimilars to its list of options for patients to switch to from Rituxan.
The province began another phase on November 30, 2021, which involves switching patients with type 1 or type 2 diabetes who are on or are scheduled to start therapy with the originator insulin lispro (Humalog) and insulin aspart (NovoRapid). By May 29, 2022, all patients will either have to switch or start therapy with biosimilars Admelog (insulin lispro) or Trurapi (insulin aspart) or risk losing coverage.
“Our government’s biosimilars program continues to help people in British Columbia save money by accessing more treatment options that are less expensive than the originator drug and are just as effective….The new biosimilars we are announcing will be of great assistance to those who develop blood clots, which can be deadly,” said Adrian Dix, Minister of Health, in a statement for the province.
British Columbia officials specified that because enoxaparin is used in patients for less than 6 months, patients who are currently administered the reference product will not have to switch to a biosimilar and will be able to continue with their Lovenox prescription until their treatment course is complete.
Therefore, only patients who need to start a new enoxaparin treatment course will be administered a biosimilar. Exceptions may be granted for patients whose providers conclude that they are medically unable to take the biosimilars and whose exceptional coverage requests are approved by PharmaCare’s Special Authority branch.
Additionally, PharmaCare is updating how it provides coverage for treatments associated with cancer-related thrombosis, allowing patients with cancer to access dalteparin, enoxaparin, and tinzaparin without needing to try blood thinner warfarin first.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf
October 25th 2024At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.