Chapter: Drugs - Medical Benefit
© Blue Cross and Blue Shield of Montana
Current Effective Date: 03/01/2010
Original Effective Date: 09/01/2007
Revised Dates: March 1, 2010
The U.S. Food and Drug Administration (FDA) approved Elaprase (idursulfase) as an orphan drug on July 24, 2006. Orphan products are generally developed to treat rare diseases or conditions that affect fewer than 200,000 people in the U.S. Elaprase is used to treat Hunter syndrome, also known as Mucopolysaccharidosis II or MPS II, an X-linked recessive inherited disorder diagnosed in approximately one in 65,000 to 132,000 births (mostly males). It is given intravenously every week over one to three hours.
Prior authorization is recommended. To authorize, call Blue Cross and Blue Shield of Montana (BCBSMT) Customer Service at 1-800-447-7828 or fax your request to the Medical Review Department at 406-437-7863. A retrospective review is performed if services are not prior authorized.
BCBSMT considers Elaprase medically necessary for patients who meet all of the following criteria:
• Diagnosed with Hunter syndrome
• Age 5 to 65 years
• Given intravenously at the recommended dosage of 0.5 mg/kg weekly.
Not Medically Necessary
BCBSMT considers the use of Elaprase not medically necessary for any use not indicated above.
Advanced Member Notice of Financial Liability for Denied Services
When the criteria for coverage is not met, BCBSMT encourages all participating providers to have a member complete and sign an Advanced Member Notification (AMN) form stating that BCBSMT will not cover this service, supply, device, or drug. If an AMN is signed prior to delivery of the service, participating providers can balance bill the patient. If an AMN is not signed, participating providers are financially liable and cannot balance bill the BCBSMT member for denied services. Services provided by an out-of-state provider that are denied as not medically necessary are the financial responsibility of the patient even if an AMN is signed.
Refer to the Advanced Member Notification medical policy for more information. The AMN form is available at www.bcbsmt.com (Click on Providers and then Forms).
Rationale for Benefit Administration
This medical policy was developed through consideration of peer reviewed medical literature, FDA approval status, accepted standards of medical practice in Montana, Technology Evaluation Center evaluations, and the concept of medical necessity. BCBSMT reserves the right to make exceptions to policy that benefit the member when advances in technology or new medical information become available.
The purpose of medical policy is to guide coverage decisions and is not intended to influence treatment decisions. Providers are expected to make treatment decisions based on their medical judgment. Blue Cross and Blue Shield of Montana recognizes the rapidly changing nature of technological development and welcomes provider feedback on all medical policies.
When using this policy to determine whether a drug will be covered, please note that member contract language will take precedence over medical policy when there is a conflict.
J3490 UNCLASSIFIED DRUGS
1.FDA Approves First Treatment for Hunter Syndrome. http://www.fda.gov/bbs/topics/NEWS/2006/NEW01418.html
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History of Development