Growth of Commercial Operations– SCENESSE® for EPP

The commercial operations based on the distribution of SCENESSE® for adult patients with erythropoietic protoporphyria (EPP) continued to progress in the 2021 financial year. The key developments and achievements in key jurisdictions are outlined here.

In Europe

  • Demand for SCENESSE® near normalised during the 2021 financial year after an initial adverse impact of the coronavirus pandemic in the 2020 financial year
  • Patient continuation on treatment remains above 94% in the European Economic Area
  • Progress has been made in extending distribution of SCENESSE® to patients in more European countries
  • Expert physicians have published data on the use of SCENESSE® to treat EPP patients

In the USA

  • April 2021 marked the first anniversary of the commencement of treatment in the USA
  • Over 40 Specialty Centers have been trained and accredited to provide treatment to patients across the USA
  • The number of private and national insurers agreeing to reimburse the cost of treatment exceeds 60
  • Considerable effort has been exerted to obtain a set of codes for the drug and the treatment to smooth the administrative process of reimbursement

Global Treatment Progress


  • The Therapeutic Goods Administration (TGA) granted approval to prescribe SCENESSE® to adult patients with EPP in October 2020
  • We are working with the Pharmaceutical Benefits Advisory Committee to make the drug available on the Pharmaceutical Benefits Scheme to enable access to the treatment for patients


  • The Ministry of Health granted access to distribute SCENESSE® to adult patients with EPP in February 2021


  • Collaboration with our partner in China continues to focus on treating a small number of EPP patients to establish a database of Chinese patients to enable discussions on the path of regulatory approval to distribute SCENESSE® with Chinese authorities
  • Assessment of the regulatory process in Japan is ongoing
  • CLINUVEL is committed to extend the distribution of SCENESSE® for EPP to other jurisdictions