Traditional Pipeline

<< Drug Pipeline Review

Last updated: 05.26.21

DRUG NAME/ MANUFACTURER PROPOSED USE HOW IT WORKS WHAT’S IMPORTANT
amphetamine (AR19 - Arbor
Pharmaceuticals)
Attention-deficit/hyperactivity disorder (ADHD) in children 3-17 years of age and in adults 18 and older Immediate-release, tamper-resistant amphetamine capsule
for the treatment of ADHD; amphetamine is a stimulant drug
Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 2021
Impact: According to the Centers for Disease Control and Prevention, ADHD is one of the most common childhood disorders and can continue through adolescence and adulthood. It is estimated to affect 5 percent of children and 2.5 percent of adults in the U.S.
ansofaxine (Luye Pharma) Major depressive disorder A pro-drug of desvenlafaxine formulated as a sustained-release tablet; ansofaxine is a serotonin-norepinephrine-dopamine triple reuptake inhibitor (SNDRI), with one of the active metabolites being a serotonin-norepinephrine reuptake inhibitor (SNRI) Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 2021
Impact: An estimated 17.3 million adults in the United States had at least one major depressive episode, representing about 7% of all U.S. adults. An additional 3.2 million adolescents, aged 12 to 17, in the U.S. had at least one major depressive episode. This number represented 13.3% of the U.S. population aged 12 to 17.
budesonide oral suspension (Eohilia - Takeda) Localized esophageal inflammation caused by eosinophilic esophagitis (EoE) Topically active, oral viscous formulation of budesonide (topical corticosteroid) for improving esophageal eosinophil counts and endoscopic findings in adults with a new diagnosis of EoE Route of administration: Topical/Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 2022
Impact: Shire estimates 150,000 patients in the U.S. are impacted by EoE annually.
daridorexant (Idorsia) Insomnia Dual orexin receptor antagonist (DORA) for the treatment of
insomnia
Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 2022
Impact: Approximately 30% of adults report one or more symptoms of insomnia, including difficulty initiating and/or maintaining sleep.
dasiglucagon (HypoPal Rescue Pen - Zealand Pharma) Severe hypoglycemia in diabetes Novel dasiglucagon (glucagon analog); glucagon is the standard of care for treating severe hypoglycemia Route of administration: Subcutaneous
Benefit coverage: Pharmacy
Anticipated FDA decision: 2021
Impact: According to the American Diabetes Association, glucagon should be prescribed for all individuals at increased risk of clinically significant hypoglycemia, defined as blood glucose less than or equal to 54 mg/dL.
dihydroergotamine mesylate
(Trudhesa - Impel NeuroPharma)
Migraine  Dihydroergotamine mesylate for the acute treatment of migraine headaches with or without aura in adult patients; dihydroergotamine mesylate (DHE) acts centrally, decreasing vascular tone and slowing the heart rate, as well as peripherally, to block alpha-receptors for the treatment of migranes Route of administration: Intranasal
Benefit coverage: Pharmacy
Anticipated FDA decision: 2021
Impact: Migraine affects approximately 12% of U.S. adults, or about 39 million Americans.
donepezil transdermal system
(Adlarity - Corium)
Dementia Once-weekly patch formulation of donepezil (a cholinesterase inhibitor) for treatment of dementia of the Alzheimer's type Route of administration: Transdermal
Benefit coverage: Pharmacy
Anticipated FDA decision: 2021
Impact: Alzheimer’s disease is the most common form of dementia, affecting 5.8 million Americans over the age of 65, as well as hundreds of thousands under the age of 65 who have early-onset Alzheimer’s.
drospirenone / estetrol (Estelle -
Mithra)
Contraception Estetrol (E4, 15mg) and drospirenone (DRSP, 3mg), a combined oral contraceptive for the prevention of pregnancy Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 2021
Impact: There are 61 million U.S. women of reproductive age (15–44); about 43 million of them (70%) are at risk of unintended pregnancy.
eflornithine/sulindac (Cancer
Prevention Pharmaceuticals)
Familial adenomatous polyposis
(FAP)
Combination of the ornithine decarboxylase inhibitor and the non-steroidal anti-inflammatory drug for pharmaco-preventive treatment of adults with FAP; eflornithine, an ornithine decarboxylase inhibitor, may help prevent colorectal cancer by disrupting the polyamine synthesis pathway, a molecular pathway that is thought to be important in the development of colorectal and other cancers Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 2021
Impact: Familial adenomatous polyposis (FAP) occurs in approximately one in 5,000 to 10,000 individuals in the United States and accounts for about 0.5% of all cases of colorectal cancer.
gefapixant (MK-7264 - Merck) Refractory chronic cough (RCC) or unexplained chronic cough
(UCC)
Selective P2X3 receptor antagonist for the treatment RCC or UCC in adults; It is believed that excessive activation of P2X3 receptors is associated with hyper-sensitization of sensory neurons; neuronal hyper-sensitization in the airways and lungs, triggered by injury or infection, can cause an exaggerated, persistent and frequent urge to cough Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 2021
Impact: The prevalence of chronic cough (a cough lasting more than 8 weeks) is estimated at 10% of the general adult population globally, and in up to 46% of these cases, no treatable cause can be identified.
insulin glargine (Semglee -
Mylan/Biocon)
Diabetes To allow interchangeability with Proposed Indication(s): Sanofi's long-acting insulin, Lantus; the primary activity of insulin is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake Route of administration: Subcutaneous
Benefit coverage: Pharmacy
Anticipated FDA decision: 2021
Impact: An estimated 22.5 million adults will be diagnosed with type 2 diabetes. In the U.S., the basal insulin market is estimated at more than $6 billion.
olanzapine / samidorphan (Lybalvi  - Alkermes) Olanzapine-induced weight gain Combination of olanzapine and samidorphan, a novel potent mu-opioid antagonist, to mitigate some of the adverse effects
from olanzapine (e.g. weight gain) for the treatment of schizophrenia and Bipolar 1 disorder
Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 2021
Impact: An estimated 2.4 million American adults have schizophrenia, with men and women affected equally.
pneumococcal vaccine, 15-valent
(V114 - Merck)
Pneumococcal conjugate vaccine A 15-valent pneumococcal conjugate vaccine for the prevention of pneumococcal disease in adults aged 18 years of age and older Route of administration: Intramuscular
Benefit coverage: Pharmacy
Anticipated FDA decision: 2021
Impact: Globally, pneumococcal pneumonia is estimated to cause about 500,000 deaths and 30 million episodes in adults 70 years and older annually.
pneumococcal vaccine, 20-valent
(20vPnC vaccine - Pfizer)
Pneumococcal conjugate vaccine 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older Route of administration: Intramuscular
Benefit coverage: Pharmacy
Anticipated FDA decision: 2021
Impact: Globally, pneumococcal pneumonia is estimated to cause about 500,000 deaths and 30 million episodes in adults 70 years and older annually.
relugolix/estradiol/norethindrone
(Myovant/Takeda)
Uterine fibroids Gonadotropin-releasing hormone (GnRH) receptor antagonist combined with the estrogen and progestin for oral treatment
of women with heavy menstrual bleeding associated with uterine fibroids
Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 2021
Impact: Uterine fibroids can affect up to 70% of Caucasian women and up to 80% of African American women by age 50.
risperidone e.r. (Rykindo - Luye
Pharma)
Schizophrenia and bipolar disorder Risperidone extended-release microsphere formulation; Injectable (depot) formulation of risperidone for the treatment of schizophrenia Route of administration: Intramuscular
Benefit coverage: Pharmacy
Anticipated FDA decision: 2021
Impact: Approximately 3.5 million people in the United States are diagnosed with schizophrenia and it is one of the leading causes of disability.
semaglutide (Ozempic - Novo Nordisk) Weight management GLP-1 analog for chronic weight management; New indication for use as a once-weekly subcutaneous injection (2.4mg) for weight management in adults with obesity (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) with at least one weight related comorbidity, as an adjunct to reduced-calorie diet and increased physical activity Route of administration: Subcutaneous
Benefit coverage: Pharmacy
Anticipated FDA decision: 2021
Impact: According to the U.S. Centers for Disease Control and Prevention (CDC), 42.5% of adults aged 20 and older are considered obese. In addition, as many at 73.6% of adults 20 years of age and older are considered overweight or obese.
testosterone undecanoate (Kyzatrex -
Marius Pharmaceuticals)
Hypogonadism Soft gelatin capsule formulation of the testosterone replacement therapy for treatment of primary and secondary
hypogonadism in adult men
Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 2021
Impact: It's estimated that 15 million men in the United States suffer from hypogonadism, but only approximately 10% are currently treated.
topiramate oral solution (ET-101 -
Eton Pharmaceuticals)
Seizure disorders Liquid formulation of topiramate as monotherapy for the treatment of partial-onset or primary general tonic-clonic
seizures in pediatric patients aged 2 years and older; for adjunctive therapy for partial-onset seizures, including Lennox-Gastaut syndrome, in patients aged 2 yrs and up; and for preventative treatment of migraine in patients 12 yrs and older
Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 2021
Impact: In 2018, topiramate products had annual sales of approximately $800 million.
viloxazine (SPN-812 - Supernus) Attention-deficit/hyperactivity disorder (ADHD) in children 3-17 years of age and in adults 18 and older A serotonin norepinephrine modulating agent (non-stimulant) to treat attention-deficit hyperactive disorder (ADHD) Route of administration: Oral
Benefit coverage: Pharmacy
Anticipated FDA decision: 2021
Impact: According to the U.S. Centers for Disease Control and Prevention (CDC), ADHD is one of the most common childhood disorders and can continue through adolescence and adulthood. It is estimated to affect 5 percent of children and 2.5 percent of adults in the U.S.

Legal Disclaimer | Privacy | Product Disclosures | Cigna Company Names

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 details of coverage, review your plan documents or contact a Cigna representative.

All Cigna products and service are provided exclusively by or through operating subsidiaries of Cigna Corporation, including Cigna Health and Life Insurance Company, (CHLIC), Cigna Behavioral Health, Inc., Cigna Health Management, Inc., Evernorth, Accredo Health Group, Inc., Express Scripts, Inc., ESI Mail Pharmacy Service, Inc., Express Scripts Pharmacy, Inc., Tel-Drug, Inc., Tel-Drug of Pennsylvania, L.L.C., Lynnfield Drug, Inc., and HMO or service company subsidiaries of Cigna Health Corporation. Policy forms: OK - HP-APP-1 et al., OR - HP-POL38 02-13, TN - HP-POL43/HC-CER1V1 et al. (CHLIC). The Cigna name, logo, and other Cigna marks are trademarks of Cigna Intellectual Property, Inc. "Express Scripts" is a trademark of Express Scripts Strategic Development, Inc. This newsletter is not intended for residents of New Mexico.

© 2021 Cigna. All rights reserved