Press Releases

Eisai and Oklahoma Health Care Authority Enter Value-Based Agreement for FYCOMPA

Oct 24, 2018

WOODCLIFF LAKE, N.J., Oct. 24, 2018 /PRNewswire/ -- Eisai Inc. the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., announced today that they have signed a value-based contract for FYCOMPA® (perampanel) CIII with Oklahoma Health Care Authority (OHCA) premised on reduction of hospitalizations of OHCA patients with epilepsy. The OHCA is the first state Medicaid agency in the country with Centers for Medicare & Medicaid Services (CMS) approval for negotiating value-based or outcomes-based contracts with pharmaceutical companies.

Eisai logo. (PRNewsFoto/Eisai Inc.)

Uncontrolled epilepsy is associated with significant incremental healthcare utilization and costs, including costs related to hospitalizations. Only 42 percent of all U.S. adults living with epilepsy reported complete seizure freedom.

"People living with epilepsy are significantly more likely to be insured under Medicaid and less likely to have private health insurance. We feel it is critical to do as much as possible for these patients," said Ivan Cheung, Chairman and CEO of Eisai Inc. "This value-based partnership with the Oklahoma Health Care Authority underscores our confidence in the value FYCOMPA can deliver as patients and their entire healthcare team strive together toward the ultimate goal of seizure freedom."

"We look forward to collaborating with Eisai to engage in this epilepsy-focused, value-based agreement to help improve patient outcomes and save resources in particular as they relate to hospitalizations," said Nancy Nesser, Pharmacy Director for the Oklahoma Health Care Authority. "This agreement is yet another step toward building a responsive health care system for Oklahoma and delivering much-needed epilepsy treatment options to patients that benefit from our SoonerCare insurance programs."

About Epilepsy
Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. Epilepsy is one of the most common neurological disorders, which affects about 3.4 million people in the United States, including 470,000 children. Children with uncontrolled seizures are at greater risk for sudden unexpected death in epilepsy (SUDEP), which is relatively uncommon in childhood, but the risk increases if epilepsy persists into adulthood.

Partial-onset seizures are the most common type of seizure seen in people with epilepsy, accounting for 60 percent of all seizures. Convulsive seizures account for up to 25 percent of all epilepsy, with primary generalized tonic-clonic seizures being one of the most common and severe forms of seizures.

Missed medication doses are the number one cause of breakthrough seizures, which can cause significant injury to patients. People who experience breakthrough seizures have an increased risk of fractures or head injuries, emergency room (ER) visits, and hospitalization, as well as an associated increase in healthcare costs.

About FYCOMPA
FYCOMPA is a prescription medicine used in people with epilepsy aged 4 and older alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures, and with other medicines to treat primary generalized tonic-clonic seizures for people with epilepsy aged 12 and older.

FYCOMPA, a unique oral medication, is a selective, non-competitive AMPA (alpha-amino-3-hydroxy-5- methyl-4-isoxazolepropionic acid) receptor antagonist. The precise mechanism by which FYCOMPA exerts its antiepileptic effects in humans is unknown. It is not known if FYCOMPA is safe and effective for partial-onset seizures in children under 4 years of age or for primary generalized tonic-clonic seizures in patients under 12 years of age. In a pharmacokinetic study, it has been demonstrated that because of its long  half-life, a missed dose of FYCOMPA does not significantly impact plasma levels.

FYCOMPA is supplied as 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg film-coated tablets, and as a 0.5 mg/mL oral suspension formulation. FYCOMPA has been designated by the U.S. Drug Enforcement Administration as a federally-controlled substance (CIII).

Please visit www.FYCOMPA.com to learn more about the treatment.

What is FYCOMPA® (perampanel)?
FYCOMPA is a prescription medicine used:

  • alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures in people with epilepsy aged 4 and older
  • with other medicines to treat primary generalized tonic-clonic seizures in people with epilepsy aged 12 and older

It is not known if FYCOMPA is safe and effective for partial-onset seizures in children under 4 years of age or for primary generalized tonic-clonic seizures in patients under 12 years of age.

Important Safety Information

What is the most important information I should know about FYCOMPA?

1.   FYCOMPA may cause mental (psychiatric) problems, including:

  • new or worse aggressive behavior (including homicidal behavior), hostility, anger, anxiety, or irritability
  • being suspicious or distrustful (believing things that are not true)
  • seeing objects or hearing things that are not there
  • confusion
  • difficulty with memory
  • other unusual or extreme changes in behavior or mood

Tell your healthcare provider right away if you have any new or worsening mental problems while taking FYCOMPA.

2.   Like other antiepileptic drugs, FYCOMPA may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.  Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

- thoughts about suicide or dying

- attempt to commit suicide

- new or worse depression

- new or worse anxiety

- feeling agitated or restless

- panic attacks

- trouble sleeping (insomnia)

- new or worse irritability

- acting aggressive, being angry, or violent

- acting on dangerous impulses

- an extreme increase in activity and talking (mania)

- other unusual changes in behavior or mood

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

How can I watch for early symptoms of suicidal thoughts and actions?

  • Pay attention to any changes especially sudden changes in mood, behaviors, thoughts, or feelings
  • Keep all follow-up visits with your healthcare provider as scheduled

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop FYCOMPA without first talking with your healthcare provider. Stopping suddenly can cause serious problems and can cause you to have seizures more often.

Before taking FYCOMPA, tell your healthcare provider about all of your medical conditions, including if you:

  • have or have had depression, mood problems, aggressive or hostile behavior (for example, homicidal behavior), suicidal thoughts or behavior, or other psychiatric problems
  • have liver or kidney problems
  • drink alcohol
  • have abused prescription medicines, street drugs, or alcohol in the past
  • are pregnant or plan to become pregnant. It is not known if FYCOMPA will harm your unborn baby. If you become pregnant while taking FYCOMPA, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry (1-888-233-2334)
  • are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby if you take FYCOMPA and to decide if you will take FYCOMPA or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking FYCOMPA with certain other medicines can cause side effects or reduce either drug's benefit. These medicines include: birth control, carbamazepine, phenytoin, oxcarbazepine, rifampin, and St. John's Wort.

What should I avoid while taking FYCOMPA?
Do not drive, operate heavy machinery, or do other dangerous activities until you know how FYCOMPA affects you. FYCOMPA may make you dizzy, sleepy, or tired. Do not drink alcohol or take other medicines that make you sleepy or dizzy until you talk to your healthcare provider. FYCOMPA taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse. FYCOMPA when taken with alcohol may also make your mood worse, increase anger, confusion, and depression.

What are the possible side effects of FYCOMPA?

FYCOMPA may cause other serious side effects, including:

  • Dizziness, vertigo (sense of spinning), and problems walking normally. You may have problems walking normally if you are unsteady because you feel dizzy. These symptoms can increase when your dose of FYCOMPA is increased. Your risk of feeling dizzy and having problems walking normally may be higher if you are elderly.
  • Sleepiness and tiredness
  • Increased risk of falls. Taking FYCOMPA can increase your chance of falling. These falls can cause serious injuries. Your risk of falling may be higher if you are elderly.
  • A serious allergic reaction that may affect your skin or other parts of your body such as your liver, kidneys, heart, or blood cells. This allergic reaction can be life-threatening and can cause death. Call your healthcare provider right away if you have:
  • a skin rash, hives
  • fever or swollen glands that do not go away
  • swelling of your face
  • shortness of breath, swelling of the legs, yellowing of the skin or whites of the eyes, or dark urine

The most common side effects of FYCOMPA include:

- dizziness

- nausea and vomiting

- headache

- sleepiness

- weight gain

- bruising

- tiredness

- vertigo (sense of spinning)

- abdominal pain

- irritability

- problems walking normally

- anxiety

- falls

- problems with muscle coordination


FYCOMPA is a controlled substance (CIII) because it can be abused or lead to drug dependence. Keep FYCOMPA in a safe place to protect it from theft and never give it to anyone else because it may harm them. Selling or giving away FYCOMPA is against the law.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see accompanying Full Prescribing Information for FYCOMPA (perampanel), including Boxed WARNING.

About Eisai Inc.
At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.

Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, and marketing capabilities. Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US and follow us on Twitter and LinkedIn.

About the Oklahoma Health Care Authority
The Oklahoma Health Care Authority (OHCA) administers two health programs for the state. The first is SoonerCare, Oklahoma's Medicaid program. SoonerCare works to improve the health of qualified Oklahomans by ensuring that medically necessary benefits and services are available. Qualifying Oklahomans include certain low-income children, seniors, the disabled, those being treated for breast or cervical cancer and those seeking family planning services. The second program OHCA operates is Insure Oklahoma, which assists qualifying adults and small business employees in obtaining health care coverage for themselves and their families. Currently, there are 821,781 Oklahomans enrolled in OHCA's programs.   The agency contracts with a network of 48,486 providers. For more information, visit www.okhca.org or www.insureoklahoma.org.

Contact:



Media Inquiries

Investor Inquiries

Michele Randazzo

Alex Scott

Eisai Inc.

Eisai Inc.

201-746-2979

201-746-2177

 

SOURCE Eisai Inc.


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