I'VE HAD MY FULFIL
24 WEEK STUDY (WITH A 26 WEEK EXTENSION)
THE STUDY INCLUDED 1,810 PATIENTS
WHAT WAS THE LENGTH AND AMOUNT OF PATIENTS INCLUDED IN IMPACT?
LENGTH: 52 WEEKS
PATIENTS: 10,335
WHAT WAS THE LENGTH, AMOUNT OF PATIENTS, AND MEAN AGE IN THE ETHOS STUDY?
LENGTH: 52 WEEKS
PATIENTS: 8,588
MEAN AGE: 64.6
WHAT WAS THE LENGTH, MEAN AGE, AND NUMBER OF PATIENTS IN KRONOS?
LENGTH: 24 WEEKS
MEAN AGE: 64.9
NUMBER OF PATIENTS: 1,902
PATIENTS WHO USE A CASH-PAY OPTION RECEIVE THE SAME FINANCIAL BENEFIT WHETHER THEY RECEIVE TRELEGY OR BREZTRI.
TRUE
BOTH MANUFACTURERS OFFER TO PAY UP TO $100 FOR EACH MONTHLY PRESCRIPTION, WHILE THE PATIENT IS RESPONSIBLE TO PAY THE REMAINING BALANCE.
WHAT WERE THE TREATMENT ARMS IN FULFIL?
TRELEGY DPI
SYMBICORT DPI
WHAT WERE THE TREATMENT ARMS IN IMPACT?
TRELEGY ELLIPTA
BREO ELLIPTA
ANORO ELLIPTA
WHAT WERE THE TREATMENT ARMS IN THE ETHOS STUDY?
BREZTRI (320BUDESONIDE)
BREZTRI (160 BUDESONIDE)
BEVESPI
PT009
WHAT WAS THE REQUIRED FEV1 RANGE FOR INCLUSION IN THE KRONOS STUDY?
25%-80%
(50.8% OF PATIENTS HAD SEVERE/VERY SEVERE AIRFLOW LIMITATION VS 71.4% IN ETHOS)
ACCORDING TO OUR MOST RECENT MARKET ACCESS COVERAGE UPDATE, WHAT PERCENTAGE OF COVERAGE DOES BREZTRI CARRY FOR BOTH COMMERCIAL AND MEDICARE PART D PLANS NATIONALLY?
COMMERCIAL = 74.2%
MEDICARE PART D = 68.9%
DURING THE RUN-IN PERIOD, WHAT MEDICATION DID PATIENTS TAKE?
PATIENTS CONTINUED THEIR CURRENT MEDICATION.
WHAT WAS THE PRIMARY ENDPOINT AND RESULT IN IMPACT
PRIMARY ENDPOINT: ANNUAL RATE OF MODERATE OR SEVERE EXACERBATIONS
RESULT: 34% DIFFERENCE IN RATE OF MODERATE OR SEVERE EXACERBATIONS IN TRELEGY VS. ANORO
DURING THE RUN-IN PERIOD, WHAT MEDICATION WERE PATIENTS IN ETHOS GIVEN?
IPATROPIUM BROMIDE (SABA) 4 TIMES DAILY
ALBERTEROL FOR RESCUE
PATIENTS COULD CONTINUE AN ICS IF DESIRED
WHAT PERCENTAGE OF PATIENTS IN KRONOS HAD NO EXACERBATION HISTORY IN THE PREVIOUS YEAR?
74%
(18.5% HAD JUST ONE EXACERBATION)
WHAT IS THE AVERE OUT OF POCKET COST OF BREZTRI FOR A MEDICARE PATIENT?
$51.38
(FOR COMMERCIAL INSURANCE PATIENTS...WITHOUT USING THE ZERO CARD...THE AVERAGE OUT OF POCKET COST IS $39.46.)
WHAT WAS THE INLCUSION CRITERIA FOR PATIENTS IN FULFIL WITH REGARD TO FEV1?
LESS THAN 50% AND A CAT SCORE GREATER OR EQUAL TO 10
OR
BETWEEN 50-80% AND CAT SCORE GREATER TO OR EQUAL TO 10 AND 2 MODERATE EXACERBATIONS OR 1 SEVERE EXACERBATION IN LAST YEAR
WHAT WAS THE REDUCTION IN ALL-CAUSE MORTALITY IN PATIENTS ON TRELEGY VS ANORO IN THE IMPACT TRIAL?
28% (FOR PATIENTS ON AND OFF TREATMENT)
BASED ON FEV1 AND HISTORY OF EXACERBATIONS, WHICH QUADRANT WOULD THE PATIENTS IN ETHOS CONSIDERED TO BE IN BASED ON GOLD CRITERIA?
WHAT WAS THE POST-DOSE FEV1 IMPROVEMENT AND AGAINST WHAT PRODUCT IN THE KRONOS STUDY?
116ML IMPROVEMENT VS. SYMBICORT
A patient, with a confirmed diagnosis of COPD, was given a script for Breztri (woohoo!!). The patient is commercially-insured and has a high deductible plan with a $2000 out of pocket spend. The nurse gave the patient a Breztri Zero Pay card along with a sample (double woohoo!!). How much will the patient pay for their Breztri?
$0 IF THEIR PLAN COVERS BREZTRI
$40 IF THEIR PLAN DOES NOT COVER BREZTRI OR THEIR IS A PA REQUIRED.
WHAT IS THE KEY SECONDARY ENDPOINT AND RESULT IN FULFIL?
SECONDARY ENDPOINT: EXACERBATION REDUCTION
RESULT: THERE WAS A STATISTICALLY SIGNIFICANT REDUCTION IN MODERATE/SEVERE EXACERBATION RATE WITH TRELEGY COMPARED WITH SYMBICORT TURBUHLAER (35%)
BASED ON THE 2015 GOLD GUIDELINES, WHICH QUADRANT DID THE PATIENT POPULATION IN IMPACT MIRROR?
GROUP D
HOWEVER, DUE TO UPDATES IN GOLD, ROUGHLY 30% OF THE PATIENTS ARE NOW CONSIDERED TO HAVE LOWER EXACERBATION RISK AND WOULD BE CLASSIFIED AS GOLD CLASS B
THE SECONDARY ENDPOINT IN ETHOS WAS: ANNUAL RATE OF SEVERE EXACERBATIONS RESULTING IN HOSPITALIZATION OR DEATH. HOWEVER, WHAT WAS THE PRIMARY ENDPOINT IN THE STUDY AND THE RESULT?
ENDPOINT: ANNUAL RATE OF MODERATE/SEVERE COPD EXACERBATIONS
RESULT: 24% REDUCTION VS BEVESPI
13% REDUCTION VS. PT009
THERE WAS A 52% REDUCTION IIN MODERATE/SEVERE EXACERBATIONS. THIS WAS A SECONDARY ENDPOINT IN KRONOS. THERE WERE TWO PRIMARY ENDPOINTS: POST DOSE FEV1 AND WHAT WAS THE OTHER? AND, WHAT WAS THE RESULT?
ENDPOINT: MORNING PRE-DOSE TROUGH FEV1 AT 24 WEEKS
RESULT: THIS HAD NON-SIGNIFICANT IMPROVEMENT AT 24 WEEKS (13ML) VS. BEVESPI
WHEN USING THE ZERO PAY CARD, WHAT IS THE MAXIMUM SAVINGS LIMIT AMOUNT PER 30-DAY SUPPLY OF BREZTRI?
$594.68
(THE LIST PRICE FOR BREZTRI IS $590.40. THE LIST PRICE FOR TRELEGY IS $601.86. TRELEGY INSTITUTES A MAXIMUM SAVINGS OF $2400 PER YEAR)