Specialty Pipeline

<< Drug Pipeline Review

Last updated: 05.26.21

DRUG NAME/ MANUFACTURER PROPOSED USE COST ESTIMATE PER PATIENT HOW IT WORKS WHAT’S IMPORTANT
abrocitinib (Pfizer) Atopic dermatitis (AD) $55,000/yr Janus kinase 1 (JAK1) inhibitor for the treatment of patients with moderate-to-severe AD. Inhibiting JAK 1 is thought to modulate pro-inflammatory cytokines, which are key drivers in the pathophysiology of atopic dermatitis. Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: April 2021
Impact: The American Academy of Dermatology estimates that between 10% and 20% of children and about 1% to 3% of adults are affected by AD.
aducanumab (Aduhelm -
Biogen/Eisai)
Alzheimer's disease (AD) $50,000 - $100,000/yr Monoclonal antibody targeting beta amyloid for the treatment of early Alzheimer's disease. The cause of AD is not completely understood, but the two pathological hallmarks are beta-amyloid plaques which cause atrophy of the brain and surrounding blood vessels and tau proteins that cause tangles within brain neurons. Route of administration: Intraveneous
Benefit coverage: Medical
Anticipated FDA decision: June 2021
Impact: Biogen estimates that 1.4M Americans with early AD may be candidates for treatment with aducanumab. In the U.S.  AD is the sixth leading cause of death.
arimoclomol (Miplyffa - Orphazyme) Niemann-
Pick Disease Type C (NPC)
$300,000+/yr Molecular chaperone activator that stimulates the normal cellular protein repair pathway for the treatment of Niemann- Pick Disease Type C (NPC). Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: June 2021
Impact: At an estimated one case of NPC in 120,000 live births, fewer than 50 new cases are discovered in the U.S each year. The total U.S. patient population is believed to be about 200.
beta beglogene darolentivec
(Zynteglo - Bluebird Bio)
β thalassemia $2 million+ for one-time infusion Gene therapy for the treatment of transfusion-dependent β thalassemia. Upon extraction of the patients own CD34+ hematopoietic stem
cells, the cells are genetically modified using a lentiviral gene vector to deliver the ß A-T87Q beta-globin gene to these cells. Once modified, they are returned to the patient.
Route of administration: Intraveneous
Benefit coverage: Medical
Anticipated FDA decision: 2022
Impact: β-thalassemia is estimated to affect approximately 1 in 100,000 individuals in the general population.  In the U.S., thalassemia’s prevalence is approximately 1 in 272,000 or about 1,000 people.
bimekizumab (UCB) Plaque psoriasis $65,000/yr Monoclonal antibody that blocks the effects of IL-17A and IL-17F for the treatment of moderate-to-severe plaque psoriasis. Route of administration: Subcutaneous
Benefit coverage: Pharmacy
Anticipated FDA decision: July 2021
Impact: Plaque psoriasis affects approximately eight million patients in the U.S.; moderate-to-severe plaque psoriasis accounts for nearly 35% of psoriasis cases.
ciltacabtagene autoleucel (JNJ-
4528 – Janssen)
Multiple myeloma $475,000 B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy in previously treated patients with multiple myeloma - an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. Route of administration: Intraveneous
Benefit coverage: Medical
Anticipated FDA decision: 2021
Impact: It is estimated that, in 2020, 32,270 people were diagnosed and 12,830 died from the disease in the U.S.
deucravacitinib (Bristol Myers
Squibb)
Plaque psoriasis $45,000/yr Tyrosine kinase 2 (TYK2) inhibitor for use in patients with moderate to severe plaque psoriasis. It inhibits the interleukin (IL)-12, IL-23 and Type 1 interferon pathways, which are implicated in the pathogenesis of psoriasis and other immune-mediated diseases. Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 2021
Impact: Plaque psoriasis affects approximately eight million patients in the U.S.; moderate-to-severe plaque psoriasis accounts for nearly 35% of psoriasis cases.
efgartigimod (Argenx) Myasthenia gravis (MG) $450,000/yr FcRn-targeting antibody fragment designed to deplete pathogenic IgGs for the treatment of MG; MG is an autoimmune disease that is caused by poor nerve signaling resulting in the weakness of
the voluntary muscles.
Route of administration: Intraveneous
Benefit coverage: Medical
Anticipated FDA decision: December 2021
Impact: MG is thought to affect approximately 65,000 Americans, but prevalence is probably higher since it is often underdiagnosed.
eladocagene exuparvovec (PTC
Therapeutics)
Aromatic-L-amino-acid decarboxylase (AADC)
deficiency
$4M for one-time infusion Recombinant, adeno-associated virus, containing the human DNA to replace an enzyme, AADC, the  deficiency of which is a rare neurologic disease which may be fatal. Route of administration: Intracerebral infusion
Benefit coverage: Medical
Anticipated FDA decision: 2021
Impact: AACD deficiency is extremely rare; about 100 patients with this disease have been identified in the U.S.
inclisiran (Leqvio - Novartis) High LDL cholesterol $5,500/yr Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor that uses RNA interference to treat elevated levels of low-density cholesterol; treatment of adults with atherosclerotic cardiovascular disease (ASCVD) or heterozygous
familial hypercholesterolemia who have elevated LDL-C while being on a maximum tolerated dose of a lipidlowering therapies. 
Route of administration: Subcutaneous
Benefit coverage: Medical
Anticipated FDA decision: May 2021
Impact: It’s estimated that there are more than 11 million patients in the U.S. with familial hypercholesterolemia and/or clinical ASCVD.
obeticholic acid (Intercept
Pharmaceuticals)
Nonalcoholic steatohepatitis (NASH) $15K-$20K/yr Farnesoid X receptor (FXR) agonist for the treatment of NASH; Nonalcoholic fatty liver disease, a common form of chronic liver disease, is characterized by fat buildup in the liver.  Its more severe progressive form, NASH, damages liver cells and causes inflammation, potentially resulting in fibrosis, cirrhosis, end-stage liver disease, liver transplant, liver cancer and liver-related death. Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 2022
Impact: It’s estimated that there are around 3M NASH patients with advanced fibrosis (F3 or F3-like, without cirrhosis) in the U.S., of which around 500,000 patients are thought to be under the care of a hepatologist or gastroenterologist. These 500,000 patients are Intercept’s target patient population for obeticholic acid.
pegcetacoplan (Apellis) Paroxysmal nocturnal hemoglobinuria (PNH) $500,000/yr A synthetic cyclic peptide conjugated to a polyethylene glycol (PEG) polymer that binds specifically to C3 and C3b, effectively blocking all three pathways of complement activation (classical, lectin, and alternative) for the treatment of PNH. PNH is a rare disease caused by the destruction of red blood cells with 50% of patients observing hemoglobin in their urine.  As a result, patients often suffer from hemolytic anemia, infections and blood clots. Route of administration: Subcutaneous
Benefit coverage: Pharmacy
Anticipated FDA decision: May 2021
Impact: The prevalence for PNH is around 8,000 to 10,000 cases in North America and Europe. The incidence for PNH is 1-2 cases per one million people and will typically affect young adults 35-40 years of age.
pegunigalsidase alfa (Protalix
BioTherapeutics)
Fabry disease (FD) $300,000/yr Plant cell-expressed, recombinant alpha-galactosidase-A enzyme for the treatment of FD - a rare genetic disease
caused by mutations in galactosidase alpha gene (GLA), resulting in little to no α-galactosidase-A (α-Gal-A), a lysosomal enzyme.
Route of administration: Intraveneous
Benefit coverage: Medical
Anticipated FDA decision: April 2021
Impact: FD affects an estimated 1 in 40,000 to 60,000 males, while female prevalence remains unknown. There are about 7,000 patients in the U.S. with FD.
ponesimod (Janssen) Multiple sclerosis (MS) $60,000-$80,000/yr Selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, a class of drugs that is believed to functionally inhibit S1P activity and reduce the number of circulating lymphocytes by trapping them in the  lymph nodes. Therefore, there are less inflammatory cells available to cross into the central nervous system (CNS) where they could damage myelin. Myelin is a protective sheath that insulates nerve cells and is damaged in patients  with multiple sclerosis. Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 2021
Impact: Approximately 1,000,000 Americans have MS
sotorasib (Amgen) Non-small cell lung cancer (NSCLC) $200,000/yr KRAS G12C inhibitor for the treatment of patients with locally advanced or metastatic NSCLC with
KRAS G12C mutation, as determined by an FDA-approved test, following at least one prior systemic therapy; around 13% of NSCLC patients carry KRAS G12C mutations, and the cancer-linked gene is implicated in up to a third of all human cancers.
Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: August 2021
Impact: Each year in the US, approximately 25,000 patients with NSCLC with G12C mutations may be candidates for treatment with sotorasib.
sutimlimab (Sanofi) Primary cold agglutinin
disease (CAD)
$300,000+/yr C1s inhibitor, sutimlimab, works by inhibiting C1s, a complement-cascade protease, to block
signals for inflammation and cell destruction; CAD is a type of nonhereditary autoimmune hemolytic anemia.
Route of administration: Intraveneous
Benefit coverage: Medical
Anticipated FDA decision: 2021
Impact: At a prevalence of around 16 per 1 million people, an estimated 5,200 Individuals in the U.S. may be affected, but one-half or more of patients have mild forms of the condition.
tralokinumab (LEO Pharma) Atopic
dermatitis (AD)
$40,000/yr Anti-IL-13 for the treatment of moderate to severe ADA; atopic dermatitis (AD) is a chronic skin disease characterized by inflammation of the skin and skin barrier defects. Route of administration: Subcutaneous
Benefit coverage: Pharmacy
Anticipated FDA decision: April 2021
Impact: The American Academy of Dermatology (AAD) estimates that between 10% and 20% of children and about 1% to 3% of adults are affected by AD.
valoctocogene roxaparvovec
(Roctavian – BioMarin
Pharmaceuticals)
Hemophilia A $2-3 million as one-time infusion Valoctocogene is an adeno-associated virus (AAV) vector gene therapy that can penetrate cells without harming them, it replaces the missing gene needed to produce factor VIII. Route of administration: Intraveneous
Benefit coverage: Medical
Anticipated FDA decision: 2022
Impact: According to BioMarin, about 2,400 patients in the US will be candidates for treatment with valoctocogene.
vosoritide (BioMarin) Achondroplasia $350,000/yr Analog of C-type Natriuretic Peptide (CNP) for the treatment of children with achondroplasia; the most common form of disproportionate short stature in humans, achondroplasia results from
mutations of FGFR3 genes.
Route of administration: Subcutaneous
Benefit coverage: Pharmacy
Anticipated FDA decision: August 2021
Impact: Achondroplasia affects about one birth in 10,000 to 30,000; or around 100 to 400 babies per year in the U.S. Among the estimated 30,000 Americans living with the condition, roughly one-quarter of individuals are under the age of 18 – the years when growth plates in bones typically remain open, allowing for increases in height.

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