New to Market Specialty Drugs PPA Requirements

Restricted Product(s):

• Newly FDA approved drugs or newly approved FDA labeled indications for drugs with existing specific policies, for administration by a healthcare professional

Rationale:

• This policy addresses new-to-market specialty drugs that do not have a specific policy and new FDA labeled indications for specialty drugs addressed in existing policies, covered under the medical benefit 
• Specialty drugs paid through the medical benefit are high-cost prescription medications used to treat complex or chronic conditions like cancer, autoimmune conditions or genetic disorders. Specialty drugs frequently require special handling (like refrigeration during shipping) and administration (such as injection or infusion). Patients prescribed specialty drugs must be monitored by medically trained staff to determine if the therapy is working. Patients must also be monitored for adverse emergent reactions with appropriate interventions 
• Specialty drugs may be covered through either medical or prescription drug insurance. Specialty drugs that are available on the medical benefit typically require close provider supervision and are limited to certain provider settings (such as office, outpatient, ambulatory surgical center, or home health agency
• Specialty drugs are very expensive – $1,000 or more per month – and spending on them is growing 15 to 20 percent a year. And every year, the U.S Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approves many new drugs. Starting in 2014, in order to expedite the development and review of these products, the FDA’s CDER implemented a number of regulatory programs, including Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval to speed up availability and bring new drugs to market in the US
• New to market specialty drugs are defined as drugs that have only been available for purchase on the US market for 90 days or less from the FDA approval date. New to market specialty drugs are required to have prior plan approval (PPA) but may not have a specific medical policy available for which criteria have been developed. Many new to market specialty drugs have limited published data and are often identified using an unlisted HCPCS code on claims submissions.

Criteria for Medical Necessity:

The restricted product(s) may be considered medically necessary when the following criteria are met:

1. The requested specialty product is a new to market drug; OR 
2. The specialty product is being requested for a new FDA labeled indication for a specialty product addressed within an existing specific corporate medical policy but the new indication is not; AND
3. The requested product is paid under the member’s medical benefit; AND 
4. No specific corporate medical policy exists addressing the new to market restricted specialty drug or new labeled indication; AND
5. The requested use of the requested specialty product meets the FDA labeled indications for the applicable diagnosis or treatment; OR
6. The requested use of the requested specialty product is an accepted indication for the treatment of cancer in one of the following standard reference compendia, for drugs approved by the FDA for treatment of cancer: 
   1. The National Comprehensive Cancer Network Drugs & Biologics Compendium; OR
   2. The Thomson Micromedex® DRUGDEX® ; OR
   3. The Elsevier Gold Standard’s Clinical Pharmacology; OR
   4. Any other authoritative compendia as recognized periodically by the United States; OR
   5. Secretary of Health and Human Services; AND
7.  Based on the standard benefit language for Blue Cross NC members, FDA approved specialty drug guidelines will be used as the criteria for coverage when a specific corporate medical policy is not available; AND
8. Drugs prescribed for treatment of cancer in accordance with FDA label may be considered medically necessary when clinical benefit has been established, and should not be determined to be investigational as defined in Corporate Medical Policy (CMP), “Investigational (Experimental) Services” [please refer to CMP “Investigational (Experimental) Services” for a summary of evidence standards from nationally recognized compendia]; AND
9. The requested new to market specialty drug will NOT be used for non-oncologic (cancer treatment) indications outside of FDA labeling; AND
10. The requested new to market specialty drug will NOT be used for oncologic (cancer treatment) indications outside nationally recognized compendia recommendations with the highest level of evidence (i.e., Level 1, 2A, 2B); AND 
11. The requested specialty product will be used within FDA labeled or compendia accepted dosing requirements.

Duration of Approval: Limited to 90 days from date of FDA approval. Reauthorization will be required after 90 days.

Applicable service codes: C9399, J3490, J3590 

** To review the Blue Cross NC prior plan approval (PPA) list for an updated list of specialty drugs covered under the medical benefit, please use the following link: http://www.bcbsnc.com/assets/providers/public/pdfs/PPA-Service-Code-List.pdf 

References:

all information referenced is from FDA package insert unless otherwise noted below. 

Policy Implementation/Update Information

June 2021: Criteria change: Medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021. *Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy.

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