The dental and medicinal benefits board, TLV, has decided on 19 October that ORGOVYX® (relugolix), tablets for the treatment of advanced hormone-sensitive prostate cancer in Sweden, should be included in the pharmaceutical benefit scheme from 2023-10-20

• TLV assesses the severity of advanced hormone-sensitive prostate cancer as high¹.
• The condition is progressive and carries a risk of developing metastatic castration-resistant prostate cancer (mCRPC), which is associated with a greatly shortened lifespan and reduced quality of life¹.
• Orgovyx is the first castration treatment in the form of a tablet, which means that patients avoid injection-related side effects that are the case with today's treatments and that it frees up time for the health care^2,1.

SOLNA, Sweden, Oct. 24, 2023 /PRNewswire/ -- Accord Healthcare (Accord), is pleased to announce that patients with advanced prostate cancer now have access to a new treatment option when TLV has decided that the first and only oral castration treatment, androgen deprivation therapy (ADT), for advanced hormone-sensitive prostate cancer will be subsidized.

Orgovyx® which was approved by the European Medicines Agency (EMA) on 29 April 2022 is a gonadotropin-releasing hormone (GnRH) antagonist³. By binding to and blocking the GnRH receptor, GnRH antagonists rapidly reduce testicular testosterone production. Stopping the release of testosterone from the testicles in prostate cancer is called medical castration and is a cornerstone of the medical treatment of prostate cancer. Medical castration treatment has previously only been available as a depot injection or depot implant, which can give patients injection-related side effects and ties up time for healthcare. It takes longer time to achieve the intended effect with the most commonly used castration treatments (so-called GnRH agonists) than for GnRH antagonists⁴.

"At Accord, we work to develop new treatment options that meet the needs of patients and healthcare, where Orgovyx is a good example that benefits both parties, with reduced side effects and a more comfortable administration for patients and it releases resources for the healthcare system when no injections are needed ." says Jan Stenfors, medical & scientific advisor for the Nordics and Baltics.

Anders Bjartell, professor and chief physician in urology at Skåne University Hospital in Malmö, comments on the subsidy approval in this way: "It is gratifying to be able to offer our patients with advanced prostate cancer a castration treatment in tablet form with a very fast-acting effect. After treating patients in the HERO study, we are now looking forward to evaluate this new exciting medicine on a larger scale."

• "TLV assesses that the effect of relugolix on lowering serum levels of testosterone is significantly better than with leuprorelin." ¹
• "TLV assesses that the cost of using Orgovyx does not exceed the cost that TLV assesses as reasonable for treating conditions with a high degree of severity." ¹
• "Overall, TLV assesses that the cost of using Orgovyx is reasonable and that the criteria in Section 15 of the Benefits Act are also otherwise met. The application must therefore be approved." ¹

Prostate cancer is the most common form of cancer in men Sweden and is also the most common cause of cancer-related death among men. There are approximately 10,000 new cases per year, with the median age at diagnosis being 70.5 years. Most patients who cannot be cured by surgery or radiation receive castration treatment, often with the addition of other medical treatment.⁴

About Accord Healthcare

Accord Healthcare is one of the fastest growing pharmaceutical companies in Europe. Our global organization enables us to deliver essential and affordable healthcare medicines that benefit patients worldwide.

Accords is always looking for ways to improve products and increase patient access to them.

We provide over 40 oncology drugs, and have a large number of additional substances are in our pipeline, with several new market approvals expected in the next five years. We particularly focus on the major tumor diseases such as breast and prostate cancer, in addition to hematological and cancer supportive care.

In May 2022, Accord was selected by Myovant Sciences as its commercial partner for the European commercialization of relugolix for the treatment of advanced hormone-sensitive prostate cancer.

Referenser:

1. Orgovyx ingår i högkostnadsskyddet - Tandvårds- och läkemedelsförmånsverket TLV
2. Shore ND, Saad F, Cookson MS, et al. N Engl J Med. 2020;382(4):2187–2196) Available at: https://pubmed.ncbi.nlm.nih.gov/32469183/
3. European Medicines Agency, Orgovyx Summary of Product Characteristics (SPC). Available at: https://www.ema.europa.eu/en/documents/product-information/orgovyx-epar-product-information_en.pdf (last accessed August 2022)
4. Prostate cancer. National care programme. 2023-09-19 Nationellt vårdprogram prostatacancer - RCC Kunskapsbanken (cancercentrum.se)

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