About SCENESSE®

What is SCENESSE®?

SCENESSE® is a prescription medication that contains the active substance afamelanotide. Afamelanotide is used to increase tolerance to the sun and light in adults with a confirmed diagnosis of erythropoietic protoporphyria (EPP). EPP is a condition in which patients have an increased sensitivity to sunlight and artificial light sources.

How does SCENESSE® work?

SCENESSE® (pronounced “sen-esse”) acts by increasing the levels of eumelanin in the skin, shielding against UV radiation (UVR) and visible light, including sunlight.

Afamelanotide is a synthetic form of a hormone called alpha-melanocyte stimulating hormone (α-MSH). Afamelanotide works in a way similar to the natural hormone, by making skin cells produce eumelanin which is a brown-black type of melanin pigment in the skin. By increasing the amount of eumelanin and acting as an antioxidant, SCENESSE® can help to reduce the sensitivity of the skin to sunlight and artificial UV light sources.

What are the ingredients in SCENESSE®?

Active ingredient: afamelanotide (16mg)

Inactive ingredient: Poly (DL-lactide-co-glycolide), a bioresorbable polymer

How is SCENESSE® administered?

SCENESSE® implant is given subcutaneously by a trained health care professional.

The implant is injected under your skin using a cannula and stylet (obturator).

Before inserting the implant, your doctor may decide to give you a local anesthetic to numb the area where the implant is to be inserted. The implant is inserted directly into the fatty area above your hip, known as the supra-iliac crest.

At the end of the insertion procedure, you may be able to feel the implant under your skin. Over time the implant will dissolve and be absorbed by the body, this will happen within 50 to 60 days after implantation.

A single SCENESSE® implant is administered every 2 months.

Possible billing codes for SCENESSE® ​

Correct coding is the responsibility of the provider submitting a claim for the item or service. Here we provide general billing and coding information for SCENESSE® and related services. Please check with the payor to verify coding or special billing requirements.

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

J3490

Drugs unclassified injection

CPT ®* Code

Definition

17999

Unlisted procedure, skin, mucous membrane and subcutaneous tissue

NDC Code

Definition

73372-0116-1

16 mg of afamelanotide, bioresorbable implant.
Some payors require physicians to report 11-digit NDCs when reporting a drug on a claim form. Converting the 10-digit NDC for SCENESSE® to an 11-digit NDC requires the use of a leading zero in the package size section of the NDC (i.e., the last section)

Please note: Other codes may also be appropriate for SCENESSE®. The codes provided are not exhaustive and additional codes may apply.

*The CPT codes is supplied for informational purposes only and represent no statement, promise, or guarantee, expressed or implied, by CLINUVEL, INC. or its third-party service providers that these codes will be appropriate or that reimbursement will be made.

Prior Authorization Forms

The information provided is not a guarantee of coverage or payment (partial or full). Actual benefits are determined by each plan administrator in accordance with its respective policy and procedures.

Th
e forms are presented for informational purposes only and is not intended to provide reimbursement or legal advice, nor does it promise or guarantee coverage, levels of reimbursement, payment, or charge. It is not intended to increase or maximize reimbursement by any Insurer. Laws, regulations, and policies concerning reimbursement are complex and are updated frequently. While CLINUVEL has made an effort to be current as of the issue date of this document, the information may not be as current or comprehensive when you view it. Please refer to the applicable plan’s website, or contact the plan for more information about coverage or any restrictions or prerequisites that may apply. We strongly recommend you consult the Insurer for its reimbursement policies. 

CLINUVEL, INC. does not endorse and is not responsible for the content on any of the websites listed below, or the services provided by these organizations. Clicking on any of the links below will take you to a website to which our Privacy Policy does not apply. We encourage you to read the privacy policy of every website you visit. Click on the link to be taken to the Insurer’s website. 

Insurers

Prior Authorization Information

Aetna

Formularies & Pharmacy Clinical Policy Bulletins
Provider Precertification Lists

Prior Authorization Form

Anthem Blue Cross Blue Shield

Prescription Drug Prior Authorization Information
California Prescription Drug Prior Authorization Information
California Prescription Drug Prior Authorization Request Form
Georgia Prescription Drug Prior Authorization Information

AmeriHealth

FutureScripts Provider Prior Authorization Form (select form)

Aspirus Arise Health Plan of Wisconsin

Provider Prior Authorization Form 

BlueCross BlueShield Excellus

General Exception Request Form (Self Administered Drugs)

BlueCross BlueShield Northeastern New York

Prior Authorization Form (select)

BlueCross BlueShield Western New York

Prior Authorization Form (select)

Blue Cross and Blue Shield of Alabama

Pharmacy: Drug Coverage Guidelines 
Provider-Administered Drug Policies and Forms 
General Prescription Drug Coverage Authorization Request Form

Blue Cross and Blue Shield of Florida/Florida Blue

Prior Authorization Program Information
Medical Pharmacy Prior Authorization Lists and Utilization Management
Member Prescription Drug Prior Authorization Forms

CVS PA Form

Blue Cross Blue Shield of Massachusetts

Medication Prior Authorization Requests

Blue Cross Blue Shield of Michigan

Provider Prior Authorization for Medical Drugs

Medication Prior Authorization Request

Blue Cross and Blue Shield of Minnesota

Prescription Drugs 
Tools & Resources For Health Care Providers: Electronic Prior-Authorization

Prior Authorization/Precertification Request

Blue Cross and Blue Shield of North Carolina

Prior Review and Limitations
Prior Authorization Facsimile Form
Online Prior Authorization Requests

Blue Cross BlueShield Carefirst

Prior Authorization Inquiries and Appeals
Online Prior Authorization Form

Precertification Request for Authorization of Services

Health Net

Prior Authorization Form

Independence Blue Cross

Specialty Medical Benefit Drugs (search for product)
Prior Authorization Forms

General Prior Authorization Form

Premera Blue Cross

Drugs Requiring Approval
Prior Authorization Request Form (select one)

1199SEIU Benefit and Pension Funds

Provider Prior Authorization Form Search

CareContinuum Provider Prior Authorization Form

360 Prevea

Outpatient Prior Authorization Form

Coordinated Health Ambetter – Centene

Prior Authorization Online Form

Outpatient Prior Authorization Form

Dean Health Plan

Outpatient Prior Authorization Form

HealthWell Foundation

SCENESSE® Copay Assistance

Online Application

LifeWise Health Plans

Provider Prior Authorization Form

Medical Mutual

Provider Prior Authorization Form

Network Health

Commercial Medical Authorization Request Form

New Hampshire Healthy Families

Medication Prior Authorization Request Form

Regence BlueCross BlueShield of Oregon

Pre-Authorization Request

Pre-authorization form

Tufts Health Plan

Medication Prior Authorization Requests Form

UHA Health Insurance

Prior Authorization Request and Notification Form

WellFirst Health

Prescribers Prior Authorization Form

WPS Health

Prior Authorization and Referral Request Form

Definitions

ICD-10 = International Statistical Classification of Diseases and Related Health Problems 10th Revision, a medical classification list by the World Health Organization (WHO). It contains codes for diseases, signs and symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or diseases. Available at:
https://www.cdc.gov/nchs/icd/icd10cm.htm.

J-code = J-codes are part of the Healthcare Common Procedure Coding System (HCPCS) codes that are assigned to drugs by the Centers for Medicare and Medicaid Services (CMS). Available at: 
https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS-Items/2018-Alpha-Numeric-HCPCS-File-.html

CPT = Current Procedural Terminology. CPT Copyright 2017 American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association. CPT 2018 Professional Edition. Chicago, Ill: American Medical Association, 2017

NDC Code = National Drug Code is a unique 10-digit, 3-segment numeric identifier assigned to each medication listed under Section 510 of the US Federal Food, Drug, and Cosmetic Act. The NDC number identifies the labeler, product, and trade package size.

Insurance Cost and Coverage Glossary

Co-insurance
Patient’s share of the costs of a covered healthcare service, calculated as a percentage (for example, 20%) of the allowed amount for the service. The patient will pay co-insurance once the patient’s deductible has been met.

Co-payment
A fixed amount (for example, $25) the patient pays for a covered healthcare service, usually when the patient receives the service. The amount can vary by the type of covered healthcare service.

Deductible
The amount the patient owes for healthcare services before his/her health insurance or plan begins to pay. For example, if the patient’s deductible is $1500, the patient’s plan won’t pay anything until the patient has met the $1500 deductible for covered healthcare services subject to the deductible. The deductible may not apply to all services.

Out-of-pocket cost
The net amount that it costs the patient, after insurance payments and other forms of support are subtracted from the total cost.

Prior Authorization
Also known as: preauthorization, prior approval, or precertification. This is a decision by the patient’s health insurance or plan that a healthcare service, a treatment plan, a prescription drug, or durable medical equipment is medically necessary. The patient’s health insurance or plan may require preauthorization for certain services before the patient receives them, except in an emergency.

Prior Authorization isn’t a promise that the patient’s health insurance or plan will cover the cost. Actual benefits are determined by each plan administrator in accordance with its respective policy and procedures.