+ Technology/Innovation
Press release submission | May 10, 2019

EISAI INC.: Lower Hospitalization Rates In Epilepsy Patients Treated With Adjunctive FYCOMPA® (perampanel) CIII

Eisai Inc. issued the following announcement on May 9.

-- Eisai presents key data from three retrospective real-world analyses at the 2019 American Academy of Neurology (AAN) Annual Meeting

-- Significantly greater reduction in all-cause and epilepsy-related hospitalizations in patients treated with FYCOMPA vs lacosamide

-- Risk of all-cause and epilepsy-related hospitalizations dropped in Medicaid patients who started FYCOMPA when compared to hospitalizations one year before starting treatment

-- Patients treated with a short half-life antiepileptic drug (AED) were significantly more likely to be hospitalized and had more hospitalizations than those treated with a long half-life AED

Eisai Inc. presented the latest clinical results on FYCOMPA®(perampanel) CIII, at the 2019 American Academy of Neurology Annual Meeting in Philadelphia, including analyses highlighting the health and economic benefits of FYCOMPA. Twenty-one scientific abstracts were presented by both Eisai and independent investigators, underscoring a collective commitment to advancing research in epilepsy care across the age spectrum.

"At Eisai, we are working to develop solutions, including medications and technology, with the ultimate goal of helping epilepsy patients achieve seizure freedom," said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai Inc. "The FYCOMPA data we've presented at AAN provides insights that we hope will help improve patient care and shows Eisai's commitment to continuing research that supports the epilepsy community in this mission."

Key findings show that:

  • Patients treated with perampanel had a significantly greater reduction in all-cause hospitalizations compared to those treated with lacosamide, (25.3% vs 30.3%; p=0.0010; respectively). A similar result was seen for epilepsy-related hospitalizations (a reduction of 19.6% vs. 22.6%; p=0.0376, perampanel and lacosamide, respectively).
  • The risk of all-cause inpatient hospitalizations decreased in Medicaid patients with epilepsy who were treated with perampanel for one year (38% pre-perampanel vs 30% post-perampanel; risk ratio of 0.79 [0.69-0.90]). A similar result was seen for epilepsy-related hospitalizations (32% pre-perampanel vs 25% post-perampanel; risk ratio of 0.78 [0.67-0.91]).
  • In patients with uncontrolled epilepsy, treatment with a long half-life AED was associated with a significantly lower risk of hospitalization than those treated with a short half-life AED (in both unadjusted [0.81, 95% CI: 0.73, 0.89; p<0.001] and adjusted relative risk of hospitalization [0.84, 95% CI: 0.76, 0.93; p=0.0007]).
"Uncontrolled epilepsy has been associated with higher hospitalization rates, longer hospital stays and more frequent emergency room visits, resulting in greater morbidity and higher health care costs for patients," said Manoj Malhotra, MD, Vice President, Head of Medical Affairs at Eisai. "This hospitalization data suggests that starting FYCOMPA can be a benefit for patients who are looking for a treatment regimen that requires less frequent dosing."

In September 2018, FYCOMPA was approved for monotherapy and adjunctive use in pediatric patients 4 years and older for the treatment of POS with or without secondarily generalized seizures. FYCOMPA was first approved in 2012 for adjunctive use in partial-onset seizures (POS) in patients 12 years and older. In 2015, it was approved as adjunctive therapy for PGTC seizures in patients with epilepsy 12 years and older.

To date, FYCOMPA is approved in 55 countries and has been used to treat more than 200,000 patients worldwide across all indications.

Key data presented include:

Some of these data include post-hoc exploratory or retrospective analyses. Please see limitations below.

Poster presentation number: 5-022

Tuesday, May 7, 2019, 5:30-6:30 p.m.

Inpatient Hospitalization Risk in Patients with Epilepsy Before and After Perampanel Treatment

Edward Faught, MD, Xuan Li, MS, Jiyoon Choi, PharmD, Manoj Malhotra, MD, Russell L. Knoth, PhD

Summary: In a retrospective study, a nationally representative medical and pharmacy claims database was used to identify 1,771 patients who had filled a perampanel prescription between July 2014 and June 2016. Patients were selected if they were 4-11 years old with any partial-onset (focal) seizures (POS), or ≥12 years with any POS or any primary generalized tonic–clonic seizures (GTCS), had continuous observations for the one-year period prior to and following this date. Clinical outcome variables were the one-year all-cause and epilepsy-related relative risk of inpatient hospitalization following perampanel initiation. Compared to the pre-index period, the post-perampanel period was associated with a significantly lower risk of inpatient hospitalization. The one-year all-cause inpatient hospitalization risk ratio was 0.76 (0.71-0.82), with a 36.2% hospitalization risk during the pre-period compared to 29.5% risk in the one-year follow-up period. Similarly, the one-year epilepsy-related inpatient hospitalization risk ratio was 0.72 (0.66-0.79), with 30.8% during the pre-index period, compared to 23.9% during the follow-up period. The Symphony Health database is an administrative claims database and may contain errors or omissions in codes for procedures, diagnoses, or dispensing. Impact of perampanel use on emergency room visits could not be examined, as these were not identified separately in the database and may be included under outpatient or inpatient visits.

Pre-perampanel period

Post-perampanel period

All-cause Inpatient hospitalization rate

(Risk ratio=0.76, 0.71-0.82)

36.2%

29.5%

Epilepsy related hospitalization rate

(Risk Ratio=0.72, 0.66-0.79)

30.8%

23.9%

Poster presentation number: 5-014

Thursday, May 9, 2019, 5:30-6:30 p.m.

Inpatient Hospitalization Risk in Medicaid Patients with Epilepsy Before and After Perampanel Treatment

Debanjana Chatterjee, PhD, Xuan Li, MS, Manoj Malhotra, MD, Jiyoon Choi, PharmD

Summary: For this analysis, a nationally representative medical and pharmacy claims database was used to identify 614 Medicaid patients who filled a perampanel prescription between July 2014 to June 2016. Patients were selected if they were 4-11 years old with any partial-onset (focal) seizures (POS), or ≥12 years with any POS or any primary generalized tonic–clonic seizures (GTCS), had continuous observations for the one-year period prior to and following this date. Outcome variables were the one-year all-cause and epilepsy-related relative risk of inpatient hospitalization following perampanel initiation. Compared to the pre-index period, the post-perampanel period was associated with a significantly lower risk of inpatient hospitalization. The one-year all-cause inpatient hospitalization risk ratio was 0.79 (0.69-0.90), with 38.3% during the pre-period compared to 30.3% in the one-year follow-up period. Similarly, the one-year epilepsy-related inpatient hospitalization risk ratio was 0.78 (0.67-0.91), with 32.2% hospitalization risk during the pre-index period, compared to 25.2% risk during the follow-up period. The Symphony Health database is an administrative claims database and may contain errors or omissions in codes for procedures, diagnoses, or dispensing. Impact of perampanel use on emergency room visits could not be examined, as these were not identified separately in the database and may be included under outpatient or inpatient visits.

Pre-perampanel period

Post-perampanel period

All-cause Inpatient hospitalization rate

(Risk ratio=0.79, 0.69-0.90)

38.3%

30.3%

Epilepsy related hospitalization rate

(Risk ratio=0.78, 0.67-0.91)

32.2%

25.2%

Poster presentation number: 5-018

Tuesday, May 7, 2019, 5:30-6:30 p.m.

Inpatient Hospitalizations Rates in Patients Diagnosed with Epilepsy and Treated with Perampanel or Lacosamide

Edward Faught, MD, Xuan Li, MS, Jiyoon Choi, PharmD, MBA, Manoj Malhotra, MD, Russell L. Knoth, PhD

Summary: The retrospective analysis of claims data included 1,717 patients (at least 12 years or older) in each cohort who were treated with perampanel or lacosamide, another antiepileptic drug (AED), (for a total of 3,434 patients) and if they had at least two diagnoses of epilepsy or non-febrile convulsions. All-cause and epilepsy-related hospitalization rates were observed for one year following the start of treatment. Patients treated with perampanel had a significantly greater reduction in all-cause hospitalizations compared to those treated with lacosamide, (25.3% vs 30.3%; p=0.0010; respectively). A similar result was seen for epilepsy-related hospitalizations, a reduction of 19.6% vs 22.6%; p=0.0376, perampanel and lacosamide, respectively. Among those who had any hospitalization in the baseline period, patients treated with perampanel had a 59.9% reduction in all-cause hospitalizations vs. a 48.6% reduction for those treated with lacosamide (p<0.05). A similar result was seen for epilepsy-related hospitalizations, a reduction of 65% vs 58.9% (p<0.05), respectively. The Symphony Health database is an administrative claims database and may contain errors or omissions in codes for procedures, diagnoses, or dispensing. Because of the limitations of claims data, it was not known if patients were taking the approved dosage of perampanel, if all patients had partial-onset seizures or were receiving perampanel as adjunctive therapy for primary generalized tonic-clonic seizures.

Poster presentation number: 5-002

Tuesday, May 7, 2019, 5:30-6:30 p.m.

Risk of Hospitalization in Patients with Uncontrolled Epilepsy Treated with a Long Versus Short Half-Life Adjunctive Antiepileptic Medication

Joyce Cramer, BS, Eunice Chang, PhD, Jessie Yan, PhD, Russell L Knoth, PhD, Contessa Fincher, PhD, Manoj Malhotra, MD, Jiyoon Choi, PharmD

Summary:  A retrospective, longitudinal cohort study using the Symphony Health Solution (SHS) Patient Integrated Dataverse to identify 4,984 patients aged ≥12 years and diagnosed with epilepsy between 8/1/2012 to 7/31/2017.  Once identified, patients were stratified into one of two groups based on the index AED half-life. Following stratification, 2,279 were treated with a long half-life (LHL) AED (>20 hours) and 2,705 with a short half-life (SHL) AED (<20 hours). In the one-year follow-up, unadjusted relative risk of hospitalization was lower in the long half-life group vs the short half-life group (0.81, 95% CI: 0.73, 0.89; p<0.001).  After adjusting for group differences, the relative risk of hospitalization for the long half-life group was significantly lower than that of the short half-life group (0.84, 95% CI: 0.76, 0.93]; p=0.0007). The SHS data set only includes inpatient data from 30% of hospitals in the U.S. Patients who were serviced by the hospitals included in the SHS data set could not be differentiated from those with missing data from hospitals outside of the SHS data set to perform the analysis. In conclusion, in patients with uncontrolled epilepsy who were initiated on an adjunctive AED, the choice of an LHL vs SHL AED was associated with a significantly lower risk of hospitalization and the benefits of selecting an LHL AED as adjunctive therapy should be considered for appropriate patients with uncontrolled epilepsy. The observed reduction in utilization would likely reduce cost and improve the economic burden associated with this chronic disease.

Limitations

These results should be interpreted cautiously. Potential confounders, including changes in background AEDs and the potential association between treatment duration and different tolerability, could have influenced study results. Because of the limitations of claims data, it was not known if patients were taking the approved dosage of perampanel, if all patients had partial-onset seizures or were receiving perampanel as adjunctive therapy for primary generalized tonic-clonic seizures to be consistent with perampanel's approved use.

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. 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.

Original source can be found here.

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