December 2018

Pipeline review

Drug name/ manufacturer

Proposed use

How it works

What’s important

AVXS-101/AveXis

Treatment of type I spinal muscular atrophy (SMA); type I SMA is a rare genetic neuromuscular disease that may occur in approximately 200–250 US births annually

One-time gene therapy that delivers a functioning copy of the missing gene that causes SMA

Route of administration: IV injection

Benefit coverage: Medical

Anticipated FDA decision: Late 2018 or early 2019

U.S. sales forecast in 2024: $781M; analysts speculate that AVXS-101 could be priced in the range of $4M–$5M per patient

esketamine/ Johnson & Johnson

Treatment of major depressive disorder (MDD) that does not respond to standard treatments

Esketamine provides a potent and rapid onset antidepressant effect but has significant side effects and potential for misuse. It will likely be used in severely depressed or suicidal individuals who do not respond to other therapies, and administered in a medically supervised setting

Route of administration: Intranasal

Benefit coverage: Medical

Anticipated FDA decision: 1Q2019

U.S. sales forecast in 2024: $437M

siponimod/Novartis

Treatment of secondary progressive and relapsing forms of multiple sclerosis (MS)

Same mechanism as Gilenya® but does not

appear to have cardiovascular side effects. Limited treatment options for secondary progressive MS

Route of administration: Oral

Benefit coverage: Pharmacy

Anticipated FDA decision: 1Q2019

U.S. sales forecast in 2024: $699M

NKTR-181/Nektar

Treatment of chronic low back pain

New type of opioid for pain that exhibits a very low incidence of side effects (e.g., euphoria, respiratory depression) and very low misuse potential

Route of administration: Oral

Benefit coverage: Pharmacy

Anticipated FDA decision: 2Q2019

U.S. sales forecast in 2024: $149M

AR101/Aimmune Therapeutics

Desensitization for individuals with peanut allergies

AR101 is an oral formulation of peanut protein. Gradually increasing doses of AR101 are given daily to desensitize individuals over a six-month period. Oral administration may be preferred over current injectable treatment options

Route of administration: Oral

Benefit coverage: Pharmacy

Anticipated FDA decision: 1H2019

U.S. sales forecast in 2024: $1,747M

Viaskin Peanut/DBV Technologies

Desensitization for individuals with peanut allergies

Viaskin Peanut uses a similar desensitization approach to AR101, except the peanut protein is delivered via a topical transdermal patch. Transdermal patch administration may be preferred over current injectable treatment options

Route of administration: Topical transdermal patch

Benefit coverage: Pharmacy

Anticipated FDA decision: 1H2019

U.S. sales forecast in 2024: $687M

lisocabtagene maraleucel/Celgene

Treatment of relapsed or refractory DLBCL (diffuse large B-cell lymphoma)

Lisocabtagene will be the third CAR-T (chimeric antigen receptor T-cell) cellular gene therapy on the market, following Kymriah and Yescarta

Route of administration: Intravenous

Benefit coverage: Medical

Anticipated FDA decision: 2H2019

U.S. sales forecast in 2024: $782M

brolucizumab/ Novartis

Treatment of wet age-related macular degeneration (wet AMD)

Brolucizumab works similar to other wet AMD agents by stopping the growth and leakage of blood vessels inthe eye. It may offer the advantage of less frequent dosing (every 12 weeks) over currently available treatments for wet AMD

Route of administration: Intraocular

Benefit coverage: Medical

Anticipated FDA decision: 2H2019

U.S. sales forecast in 2024: $877M

VX-659 + ivacaftor + tezacaftor/Vertex

Treatment of cystic fibrosis (CF)

Targets specific gene mutations that cause CF. Current CF treatments (Kalydeco, Orkambi, Symdeko) are only effective in approximately 30% of the CF population. In addition to potentially being more effective in improving lung function, up to 90% of individuals with CF may respond to the VX-659 triple combination

Route of administration: Oral

Benefit coverage: Pharmacy

Anticipated FDA decision: 4Q2019

U.S. sales forecast in 2024: $2,066M

1. EvaluatePharma, Evaluate Ltd., London, United Kingdom. www.evaluatepharma.com Accessed November 8, 2018
2. Biomedtracker, Informa Business Intelligence, Inc., New York, NY. www.biomedtracker.com Accessed November 8, 2018
Note: Benefit coverage is based on currently available information and could change pending final FDA-approved prescribing information

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