FAQs

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).

The first step to receiving treatment is to be issued with a unique identifier (ID) number, which is initiated by submitting your details through the SCENESSE® website. A unique identifier (ID) number must be issued to you prior to treatment.

If you do not have commercial or private health insurance coverage, please go to the Treatment Access page to submit your details and obtain a unique identifier (ID) number. If you have private insurance, please go to the Savings Program page to check your eligibility and submit your details.

Once you have submitted details through the Treatment Access or Savings Program pages, you will receive further information from the CLINUVEL team within 2 working days.

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.

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 in order for you to receive SCENESSE® treatment. The unique identifier (ID) number is implemented to ensure quality control, to allow medication tracking, and to provide savings to eligible patients through the SCENESSE® Savings Program.

You will need to provide your unique ID to the treating physician in order to receive the SCENESSE® medication.

You can obtain the unique patient identifier (ID) number by signing up with either the Treatment Access or the Savings Program.

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.

The Savings Program may be available to you to help cover out-of-pocket costs of your treatment if you have commercial or private health insurance.

Once you have completed the Savings Program form, you will receive further information from the CLINUVEL team on the Savings Program and be eligible to be issued a unique identifier (ID) number. An ID must be issued to you prior to treatment.

After the treatment, you can submit requested documentation to be eligible for the Savings Program.

Not all EPP patients may be eligible for the Savings Program. The Savings 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.

The Treatment Access page allows patients who do not have commercial or private health insurance coverage to obtain a unique identifier (ID) number.

Once you have completed the Treatment Access form, you will receive further information from the CLINUVEL team to be issued an ID.

An ID must be issued to you prior to treatment.

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 US_EPP@clinuvel.com and our team will assist the EPP center to obtain Prior Authorization approval from your insurance company.

CLINUVEL is unable to facilitate compassionate access to SCENESSE®. Programs are being established to increase EPP patient treatment access.

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

The suggested billing codes for SCENESSE® are:

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

17999

Unlisted procedure, skin, mucous membrane and subcutaneous tissue

 

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.