Review of Commercial Operations USA

From Regulatory Approval to First Treatment

In October 2019, the US Food and Drug Administration (FDA) granted CLINUVEL approval to distribute SCENESSE® as the first ever treatment for adult erythropoietic protoporphyria (EPP) patients. This was a significant milestone for the Company and its stakeholders, as it culminated many years of focus and effort to develop the drug, complete clinical studies, and liaise with the FDA to gain approval. CLINUVEL’s US team and supporting personnel proceeded swiftly to put the distribution arrangements in place to enable the treatment of the first EPP patient in April 2020. Upon release of this Annual Report, CLINUVEL will have been distributing SCENESSE® in the USA for just under two and a half years and it is timely to outline the initial plans and achievements in the USA in the critical past implementation period.

Key Features of the Plan

The plan to commence commercial operations in the US was extensive and set aggressive targets for the team. Some of the key objectives were to:

  • establish a patient registry, build a network of Specialty Centers across the United States to treat EPP patients;
  • work with insurers on arrangements to reimburse the cost of treatment;
  • establish a savings program to assist EPP patients in need of financial assistance;
  • establish new and unique drug and treatment codes to smooth the reimbursement process; and
  • establish a distribution facility for efficient distribution of the drug in the US.
CLINUVEL’s Commercial Operations in the USA
Item Planned Achieved Comment
Patient Registry

Establish an EPP patient registry

The Company promptly established and continues to rapidly expand the registry

This information is confidential for insurance purposes

Specialty Centers

30 Specialty Centers by end of 2021

30 Centers were trained and accredited by mid-2021

40 Centers were trained by the end of 2021

We are maintaining over 40 Centers across the USA, with the goal of enabling patients to get access close to home


Build a network of private and public insurers making SCENESSE® available, initially through Prior Authorization (PA) then on formulary

Over 100 national and state insurers are reimbursing the cost of treatment

Government health insurers are also providing treatment coverage

The reception of insurers has been positive and new insurance providers continue to include SCENESSE® into their drug policy/formulary

Savings Program

Establish a savings program to assist patients with out-of-pocket costs of treatment

Established and operational

This supports patients in need of financial assistance to ensure equitable access to healthcare


Initiate unique codes for the drug and treatment

Drug J-Code (HCPCS II) for SCENESSE® J7352 x 16 units “Afamelanotide implant, 1 mg”, became effective January 2021

Procedural CPT Code (HCPCS I) for administration of the drug since CPT11981, became effective January 2022

The unique codes have enabled smoother reimbursement of costs of treatment

Distribution Facility

Establish a drug distribution facility with a partner in the US by the end of 2021

The US distribution facility was established in Q2 2021

The domestic distribution facility has increased efficiency and shortened the time from order to delivery of the medication

Patient registry

The patient registry was the first objective met. Data collected is protocolised, stored, and only used with patients’ consent, exclusively for insurance purposes, ensuring compliance with the requirements of the Health Insurance Portability and Accountability Act (HIPAA). After an initial foundation period, the registry grew rapidly in 2021 and continues to expand.

An extensive network of Specialty Centers

The initial plan of 30 Specialty Centers across the United States was to provide a manageable travel time for patients to receive treatment (no greater than five hours’ travel). A more extensive network of over 40 Specialty Centers has now been established, well in advance of our planned roll out. This means the average travel time for patients to receive treatment has further decreased, while patients have greater choice of Specialty Center for their treatment.

Each Specialty Center has been trained and accredited by CLINUVEL. The CLINUVEL team maintains close communication with the Centers to solve any problems or issues in the management and administration of patient treatment, particularly to ensure that insurance qualification and approval of coverage are obtained, and treatment is provided efficiently.

As CLINUVEL registers new EPP patients on the registry, the US team continues to identify and train physicians nationwide that are within the proximity of the EPP patients’ residences. Several Centers have included more healthcare professionals and support staff to administer SCENESSE® and care for EPP patients, further expanding their Center’s EPP program and the value they add to their patients.

The range and number of insurers reimbursing the cost of treatment

The CLINUVEL team was very active early-on in the implementation period to engage a large number of insurers and educate them on EPP and its treatment with SCENESSE®, in order to facilitate treatment coverage for their EPP patients. It was pleasing that the insurers progressively approved coverage under Prior Authorization, where each patient needs to be approved for treatment by their insurer based on their medical history. As insurers have become more familiar with the treatment and patients’ individual needs, the process has become faster and smoother, particularly to reduce the burden on new patients seeking treatment.

Today there are over 100 private/commercial health plan insurance companies across the US providing coverage for the cost of SCENESSE® treatment. Government health insurance plans (e.g., Medicare and Medicaid) are also providing coverage to a small number of EPP patients in the US.

Savings Program

The CLINUVEL team works closely with each EPP patient to assist them in navigating the complexities of their health care plan coverage, billings, and reimbursements. The Company established the SCENESSE® Savings Program to provide support to EPP patients in need of financial assistance, in order to facilitate equitable access to healthcare. The Program is designed to cover out-of-pocket expenses for treatment, based on proven individual patient need. Eligible EPP patients have received assistance through the SCENESSE® Savings Program since 2020.

Drug and treatment codes

The healthcare reimbursement landscape in the US is complex and requires administrative procedures to be established for both insurers and healthcare providers. Unique drug and treatment codes enable much smoother patient treatment and reimbursement processes, essentially expediting the overall access for patient access to treatment. As part of establishing the commercial infrastructure for SCENESSE® the US team worked to facilitate the approval and listing of these codes.

The recommended Healthcare Common Procedure Coding System (HCPCS) codes for SCENESSE® treatment include:

  • Code: E80.0 “Erythropoietic protoporphyria”, assigned under the World Health Organization’s International Statistical Classification of Diseases and Related Health Problems (ICD-10);
  • National Drug Code (NDC) Code: 73372-0116-1 or 73372-0116-01;
  • (HCPCS I) CPT 11981: “Insertion, drug delivery implant (i.e., bioresorbable, biodegradable, non-biodegradable)”; and
  • J-Code (HCPCS II): J7352 Afamelanotide implant, 1 mg; 1 billable unit = 1 mg.

The Level II HCPCS unique J-code (J7352) for SCENESSE® was approved and listed, effective from January 2021 while the Category I CPT Code® (CPT11981) for the administration of SCENESSE® was approved and listed, effective from January 2022. These codes have significantly expedited the approval of administration of treatment for patients and simplified the medical billing and reimbursement for the Speciality Centers.

Establishment of a distribution facility

The Company had planned to establish a US distribution centre to support the network of Specialty Centers across the country by the end of 2021. The rapid development of the Specialty Center network necessitated this being brought forward, and a distribution facility was established with a partner in Florida in Q2 2021. This immediately improved the logistical management associated with distribution and reduced the time from order to delivery.

Patient Feedback

CLINUVEL has worked closely to build relationships with the US EPP community since the commencement of our EPP program in 2006. Many patients and their families have followed our program closely (including volunteering to participate in clinical trials and joining the first ever FDA public workshop on EPP in October 2017) and have welcomed the approval of the first ever treatment for EPP. Our long-standing relationship with the community has allowed the Company to keep patients informed and, ultimately, facilitate their treatment, with many enthusiastically referring their physicians to the CLINUVEL team to consider adding their clinics as Speciality Centers.

Consistent with the experience in Europe, patient retention in the US is high, which we take as a measure of overall effectiveness of, and satisfaction with, the treatment. The team regularly receives constructive feedback from EPP patients regarding their treatment experience. The positive feedback provided expressing appreciation and gratitude is encouraging to the entire CLINUVEL team and EPP Specialty Centers. Excerpts from the feedback of two patients, representative of many we receive, are highlighted.

EPP Patient 1

The doctors in my Center have been absolutely wonderful to work with. They seem truly invested and so caring in the process. I have done a lot on the phone with their team and their response time has been great.

EPP Patient 2

This is truly a life changing experience for me and my family. The doctor has a tremendous amount of knowledge about the medicine and the process, and under his care, I have seen an outstanding improvement in my quality of life outdoors.


CLINUVEL’s commercial distribution in the US has been established ahead of plan and in an effective and timely manner. The US team’s dedication and perseverance have been instrumental in assisting both Specialty Centers and patients with PA submissions, liaising with the Centers and insurers in confirming contractual rates and reimbursement claims, and providing general support. The speed and thoroughness of the establishment of commercial operations in the USA is now part of CLINUVEL history and serves as internal model to duplicate and indeed, surpass in other jurisdictions. The CLINUVEL team has established positive rapport with Specialty Centers, patients, and insurers. They will extend its support to new Centers and patients of the EPP community to continue to build commercial distribution in the years ahead to meet growing demand from patients for treatment with SCENESSE®.