Pipeline review

DRUG NAME/ MANUFACTURER PROPOSED USE HOW IT WORKS WHAT’S IMPORTANT
clascoterone / Cassiopea Topical treatment of acne Topically applied androgen receptor inhibitor Route of administration: Topical
Benefit coverage: Pharmacy
Anticipated FDA decision: 8/2020
Global sales forecast in 2024: $286M
exenatide implantable / Intarcia Type 2 diabetes Subcutaneous implant continuously delivers exenatide for 3 months (introductory dose) or 6 months (maintenance).  Exenatide is also available as a subcutaneous injection: Byetta (administered twice daily) or Bydureon (administered weekly). Route of administration: Subcutaneous (SC) implant
Benefit coverage: Medical
Anticipated FDA decision: 3/2020
abrocitinib / Pfizer Moderate-to-severe atopic dermatitis An oral janus kinase (JAK) 1 inhibitor for adults and adolescents 12 years and older.  Atopic dermatitis (AD) is a chronic skin disease characterized by inflammation of the skin and skin
barrier defects.
Route of administration: Oral
Benefit coverage: Pharmacy, Specialty
Anticipated FDA decision: 1Q2020
Estimated cost per year: $36,000
idecabtagene / Bluebird Bio Treatment of advanced multiple myeloma that has failed or not responded to other therapies Chimeric antigen receptor T-cell therapy (CAR-T) immuno-oncology agent.  CAR-T therapy is a new type of immuno-oncology that harnesses patient’s own immune system to eliminate cancer cells. If approved, it will be the first CAR-T therapy for use in multiple myeloma. Route of administration: IV injection
Benefit coverage: Medical, Specialty
Anticipated FDA decision: 2020
Estimated cost: $475,000
valoctocogene roxaparvovec / BioMarin Pharmaceutical, Inc. Treatment of hemophilia 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.  Hemophila A affects about 16,000 Americans with 400 male births per year. Route of administration: IV injection
Benefit coverage: Medical, Specialty
Anticipated FDA decision: 8/2020
Estimated cost: $2-3M
beta beglogene daralentivec / Bluebird Bio Treatment of transfusion-dependent beta thalassemia One-time gene therapy treatment that genetically modifies a patient's own hematopoietic stem cells to deliver the beta-globin gene.  Current treatment may include regular blood transfusions, chelation therapy to remove excess iron due to transfusions, surgery to remove spleen and/or gallbladder (if needed), and possible bone marrow transplant.  In the United States, thalassemia’s prevalence is approximately 1 in 272,000 or about 1,000 people. Route of administration: IV infusion
Benefit coverage: Medical, Specialty
Anticipated FDA decision: 2020
Estimated cost: $2M+ 
lisocabtagene maraleucel / Bristol-Myers-Squibb Treatment of relapsed/refractory aggressive large B-cell non-Hodgkin lymphoma Chimeric antigen receptor T-cell therapy (CAR-T) immuno-oncology agent.  CAR-T therapy is a new type of immuno-oncology that harnesses patient’s own immune system to eliminate cancer cells. Yescarta and Kymriah (both CAR-T therapies) are also indicated for DLBCL when failing 2 prior therapies. Route of administration: IV injection
Benefit coverage: Medical, Specialty
Anticipated FDA decision: 8/2020
Estimated cost: $373,000
ozanimod / Celgene Treatment of relapsing multiple sclerosis S1P receptor modulator that is similar but more selective than Gilenya (fingolimod).  Also in development for ulcerative colitis and Crohn's disease. Route of administration: Oral capsules
Benefit coverage: Pharmacy, Specialty
Anticipated FDA decision: 3/2020
Estimated cost per year: $60,000-80,000

Notes:
Benefit coverage is based on currently available information and could change pending final FDA-approved prescribing information.

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