This FAQ is intended for US residents only.
SCENESSE® is not right for everyone, and individual results may vary. Talk with your doctor to decide if SCENESSE® may be right for you.
General questions
SCENESSE® implant is a prescription medication indicated to increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).
Please register through Patient Registration to receive additional information about SCENESSE ®.
Once registered, the CLINUVEL team will be available to assist you with any questions and guide you through the treatment process.
The approved label is one implant every two months. SCENESSE® is not right for everyone, and individual results may vary. Talk with your doctor to decide if SCENESSE® may be right for you.
CLINUVEL is unable to facilitate compassionate access to SCENESSE® at this time.
Programs are being established to increase EPP patient treatment access.
The Patient Assistance Program (previously the Savings Program) can support you throughout your treatment with SCENESSE®. The program can assist you in 3 key topics: understanding insurance coverage, referrals to EPP Specialty Centers, and eligibility for financial assistance.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects occurred in more than 2% of patients who received SCENESSE® during clinical trials:
Implant site reaction, nausea, oropharyngeal pain, cough, fatigue, skin hyperpigmentation, dizziness, melanocytic nevus, respiratory tract infection, somnolence, non-acute porphyria, skin irritation.
A unique identifier (ID) number is assigned to you to receive SCENESSE® treatment. The unique identifier (ID) number is implemented to ensure quality control, to allow medication tracking, and to provide assistance to eligible patients for SCENESSE® treatment.
You will need to provide your unique ID to the treating physician to receive the SCENESSE® medication.
You can obtain the unique patient identifier (ID) number by registering under the Patient Registration tab.
You can also use your assigned ID number to log in and access information about new Specialty Centers as they become activated in the coming months.
If you are already in contact with the EPP Specialty Center, please provide the assigned unique patient identifier ID to the center.
If you are not in contact with an EPP Specialty Center, please log in to the www.scenesse.com with your assigned ID and password to go to the EPP centers tab to view center details.
After you have identified your preferred EPP center and had your first visit with the treating physician, please notify us which center you selected at [email protected] and our team will assist the EPP center to obtain Prior Authorization approval from your insurance company.
SCENESSE® is only being made available to patients by trained and accredited EPP Specialty Centers in line with the approved Prescribing Information. Only medical specialists are eligible.
CLINUVEL is working to train and accredit up to 40 Specialty Centers. Trained and accredited Specialty Centers will be available on www.scenesse.com as the centers become available. Details cannot be made available prior to training or accreditation, nor will CLINUVEL provide timelines for individual Centers becoming accredited.
CLINUVEL welcomes inquiries from doctors interested in learning more about SCENESSE®. To request contact, please go to the Contact Us section and complete the Inquiry form. A member of the CLINUVEL team will reach out to you.
What will a Specialty Center request from me when I contact them? When will they be able to see me?
The Specialty Centers may ask for your health plan information and EPP diagnosis documentation.
As each centers vary, please contact the preferred center for more details.
The COVID-19 situation is evolving. At this time, you will be advised by Specialty Center what measures are in place to mitigate risks and whether treatment is available to them.
Yes, although there may be a change-over period and additional requirements imposed by individual centers.
You are encouraged to have:
- Twice-yearly full body skin examination in line with the approved Prescribing Information.
- Annual check-ups of their liver and gallbladder function with their porphyria specialist or primary care physician (PCP).
- Annual physical examination with their primary care physician (PCP).
Your doctor may also discuss light and sun protection measures with you, as well as observing the site of implantation.
You should speak to your healthcare professional if you have specific concerns or questions. The full Prescribing Information is available at here.
CLINUVEL is unable to provide any guidance to non-US patients. You are encouraged to speak to your healthcare professional.
SCENESSE® is not approved for EPP patients under the age of 18.
Please go to the Contact Us section and complete the inquiry form. A member of the CLINUVEL team will reach out to you.
Insurance and payment questions
| ICD-10-CM Diagnosis Codes | Definition |
| E80.0 | Erythropoietic protoporphyria Please refer to the ICD-10-CM Manual for a complete description of the diagnosis code. |
| J-Code | Definition |
| J7352 | Afamelanotide Implant, 1mg |
| CPT Code | Definition |
| 11981 | Insertion, non-biodegradable drug delivery implant |
| NDC Code | Definition |
| 73372-0116-1 or 73372-0116-01 | 16 mg of afamelanotide, bioresorbable implant. |
Yes, you will need to contact your insurance company to confirm coverage of treatment with SCENESSE® under your current health plan. The coverage could be listed under either a medical benefit guideline, medical specialty drugs guideline, and/or the prior authorization list.
SCENESSE® is the only FDA-approved treatment for EPP. There is no alternative treatment on the market.
If your health plan does not cover SCENESSE® at this time or if you are unsure if your insurer covers SCENESSE®, the CLINUVEL team and the EPP Center will work with you to request a formulary exception from your Insurer and obtain Prior Authorization approval on your behalf. Please get in contact with CLINUVEL using this form and our team will contact you directly.
Please go to the Contact Us section and complete the Inquiry form. A member of the CLINUVEL team will reach out to you.
The Patient Assistance Program (previously the Savings Program) can support you throughout your treatment with SCENESSE®. The program can assist you in 3 key topics: understanding insurance coverage, referrals to EPP Specialty Centers, and eligibility for financial assistance.
To receive assistance through the Patient Assistance Program, please register through Patient Registration [link to patient registration tab]. Once you have completed the registration process, you will receive additional information from the CLINUVEL team on the Patient Assistance Program.
Please note that the Patient Assistance Program is only available to residents of the 50 US states, District of Columbia, Guam, Puerto Rico or the Virgin Islands. Further terms and conditions apply.
Many insurance questions may be specific to an individual’s circumstances.
Please register through Patient Registration or go to Contact Us section and a member of the CLINUVEL team will contact you.