Prior authorization for new-to-market medical drugs

CarePartners of Connecticut now requires prior authorization for coverage of the following medications:

• Stimufend (HCPCS Q5127) (a biosimilar of Neulasta) and Rolvedon (HCPCS J1449) were both approved by the FDA in September 2022 to treat patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
• Spevigo (HCPCS J1747) is a novel selective monoclonal antibody approved by the FDA in September 2022 for the treatment of generalized pustular psoriasis.
• Tecvayli (HCPCS C9148) was approved by the FDA in October 2022 for relapsed or refractory multiple myeloma.
• Lunsumio (HCPCS J9999) was approved by the FDA in December 2022 to treat adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
• Tzeild (HCPCS C9149) was approved by the FDA in November 2022 to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients 8 years of age and older with Stage 2 type 1 diabetes.
• Skyrizi (HCPCS J2327) was approved by the FDA in January 2023 to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, active psoriatic arthritis, and moderately to severely active Crohn's disease.
• Hemgenix (J1411) is an adeno-associated virus vector-based gene therapy approved by the FDA in November 2022 for the treatment of adults with Hemophilia B.

For more information, please refer to the following medical necessity guidelines, which outline the clinical coverage criteria that must be met for prior authorization of these drugs, approved indications, coverage limitations, and more.

• Neutropenia Colony Stimulating Agents – Long Acting Medical Necessity Guidelines
• Medicare Part B Step Therapy Medical Necessity Guidelines
• Spevigo Medical Necessity Guidelines
• Tecvayli Medical Necessity Guidelines
• Lunsumio Medical Necessity Guidelines
• Tzeild Medical Necessity Guidelines
• Skyrizi Medical Necessity Guidelines
• Hemgenix Medical Necessity Guidelines

In addition, we’ve updated the criteria on the Continuous Glucose Monitoring Systems: Freestyle Libre 2 and Dexcom G6 Medical Necessity Guidelines to align with CMS’s Glucose Monitors Local Coverage Determination (L33822). This LCD previously required three or more daily administrations of insulin and that the member be treated with a continuous subcutaneous insulin pump, but now requires that the member be insulin treated and have a history of problematic hypoglycemia in order to be covered.

We’ve also updated our Xolair Medical Necessity Guidelines to:

• Distinguish medical benefit dosage from pharmacy benefit dosage
• Clarify that Xolair 75mg and 150mg prefilled syringes are covered under the member’s prescription drug benefit if Xolair is being self-administered