This section highlights some of the pipeline drugs expected to be approved by the U.S. Food and Drug Administration (FDA) in late 2019 or early 2020 that may significantly impact clinical practice and/or pharmaceutical costs.
|
Drug name/ manufacturer |
Proposed use |
How it works |
What’s important |
|
bb2121 / bluebird bio |
Treatment of advanced multiple myeloma that has failed or not responded to other therapies |
bb2121 is a chimeric antigen receptor T-cell therapy (CAR-T) immune-oncology agent. CAR-T therapy is a new type of immuno-oncology that harnesses patient’s own immune system to eliminate cancer cells. |
Route of administration: IV injection Benefit coverage: Medical Anticipated FDA decision: 4Q2019 or early 2020 US sales forecast in 2024: $399M |
|
luspatercept / Acceleron Pharma, Inc. |
Treatment of Beta-Thalassemia, an ultra-rare genetic blood disorder that causes severe anemia |
Luspatercept is the first treatment designed to repair the red blood cell (RBC) production defect that causes Beta-Thalassemia and restore RBC production. It works by targeting specific proteins involved in late-stage red blood cell production and significantly reducing or eliminating the need for frequent and lifelong blood transfusions. |
Route of administration: Subcutaneous (SC) self-administered injection Benefit coverage: Pharmacy Anticipated FDA decision: 4Q2019 US sales forecast in 2024: $483M |
|
valoctogene roxaparvovec / BioMarin Pharmaceutical, Inc. |
Treatment of hemophilia A |
Valoctogene is a one-time gene therapy treatment designed to replace the missing gene that causes hemophilia A, thereby restoring normal blood clotting function and eliminating the need for lifelong factor replacement therapy. |
Route of administration: IV injection Benefit coverage: Medical Anticipated FDA decision: 4Q2019 or early 2020 US sales forecast in 2024: $657M |
Notes:
U.S. sales forecast provided by EvaluatePharma. www.evaluatepharma.com Accessed February 4, 2019
Benefit coverage is based on currently available information and could change pending final FDA-approved prescribing information.
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Health benefit plans vary, but in general to be eligible for coverage a drug must be approved by the Food and Drug Administration (FDA), prescribed by a health care professional, purchased from a licensed pharmacy and medically necessary. Some plans require use an in-network pharmacy for prescriptions to be covered. Coverage is subject to any plan deductible, copayment and/or coinsurance requirements. Product availability may vary by location and plan type and is subject to change. All group health insurance policies and health benefit plans contain exclusions and limitations. For costs and complete details of prescription drug coverage, contact a Cigna representative.
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