Pipeline review

DRUG NAME/ MANUFACTURER PROPOSED USE HOW IT WORKS WHAT’S IMPORTANT
vericiguat /
Bayer/Merck
Chronic heart failure Soluble guanylate cyclase stimulator for oral use in combination with other heart failure therapies to reduce the risk of cardiovascular death and heart failure hospitalization. Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 1/20/2021
Cost Estimate: Unknown
casimersen /
Sarepta
Duchenne muscular dystrophy (DMD) In DMD, a mutation in the gene for dystrophin, a muscle protein, causes progressive muscle wasting. Exons are bits of DNA or RNA that contain the information needed to produce specific proteins. Bypassing (skipping) the defective exon, allows a partly-working form of dystrophin to assemble. Casimersen would be indicated for those with genetic mutations amenable to skipping exon 45 of the Duchenne gene. Route of administration: Intravenous infusion
Benefit coverage: Medical, Specialty
Anticipated FDA decision: 2/25/2021
Cost Estimate: $300,000+ per patient per year
aducanumab / Biogen/Eisai Alzheimer's disease Monoclonal antibody for the treatment of Alzheimer's disease that targets beta amyloid.  One of the pathological hallmarks of Alzheimer's disease are beta amyloid plaques which cause atrophy of the brain and surrounding blood vessels. Route of administration: Intravenous infusion
Benefit coverage: Medical, Specialty
Anticipated FDA decision: 3/7/2021
Cost Estimate: $50,000-$100,000 per patient per year
idecabtagene vicleucel (Ide-cel) /
Bluebird Bio/Bristol Myers Squibb
Multiple myeloma CAR-T therapy for treatment of patients with relapsed or refractory aggressive large B-cell non-Hodgkin lymphoma.  One time IV infusion of the patient's own genetically modified T-cells. Route of administration: Intravenous infusion
Benefit coverage: Medical, Specialty
Anticipated FDA decision: 3/29/2021
Cost Estimate: $475,000 per patient
abrocitinib /
Pfizer
Atopic dermatitis Janus kinase 1 (JAK1) inhibitor for the treatment of patients
with moderate-to-severe atopic dermatitis
Route of administration: Oral
Benefit coverage: Pharmacy, Specialty
Anticipated FDA decision: 4/25/2021
Cost Estimate: $55,000 per patient per year
tralokinumab /
LEO Pharma
Atopic dermatitis Anti-interleukin-13 for the treatment of moderate to severe atopic dermatitis.  Atopic dermatitis (AD) is a chronic skin disease characterized by inflammation of the skin and skin
barrier defects.
Route of administration: Subuctaneous injection
Benefit coverage: Pharmacy, Specialty
Anticipated FDA decision: 4/27/2021
Cost Estimate: $40,000 per patient per year
pegunigalsidase alfa /
Protalix BioTherapeutics
Fabry disease Enzyme replacement therapy designed to be a more stable enzyme than currently marketed enzyme replacement therapies Route of administration: Intravenous infusion
Benefit coverage: Medical, Specialty
Anticipated FDA decision: 4/27/2021
Cost Estimate: $300,000 per patient per year

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

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