VIEWPOINTS
Why We Can Have Both Innovative Drugs and Lower Drug Prices
“ I ’ m an oncologist who has seen his patients reap huge benefits from the kind of high-priced innovation drug companies love to talk about . I ’ m also a health-policy specialist who has looked carefully at the long-term impact of drug company prices and profits . I ’ m convinced that we don ’ t have to choose between reasonable prices and innovation .
This isn ’ t just my personal opinion . In August , the nonpartisan Congressional Budget Office ( CBO ) looked at the past investments of drug companies and estimated that if their returns on the top 20 % of drugs dropped 15-25 %, drug companies would not develop two out of 200 drugs that are likely to get FDA approval over the next 10 years . That means drug price regulation like that being considered in the reconciliation bill would prevent only 1 % of all new drugs from coming to market . ... This hardly constitutes the “ end of innovation ” that drug companies and others ominously warn is inevitable with any price regulation . Nor does drug price regulation mean that millions of Americans will have to suffer for lack of a cure or transformative treatment for their cancer or serious illnesses .
What it does mean is that tens of millions of Americans might finally be able to afford to take the medications that could save their lives .”
— Ezekiel Emanuel , MD , PhD , oncologist and chair of the department of medical ethics and health policy at the University of Pennsylvania , in Politico
Start with IMBRUVICA ® in 1L CLL 1
LIVING LONGER WITHOUT PROGRESSION
Superior PFS : IMBRUVICA ® + rituximab vs FCR in E1912 1
89 % ( 95 % CI : 85 , 92 ) estimated PFS rate with IMBRUVICA ® + rituximab at 3 years vs 70 % ( 95 % CI : 61 , 78 ) with FCR in patients ≤70 years old 1 , 2
HR = 0.34 ( 95 % CI : 0.22 , 0.52 ; P < 0.0001 ) ( primary endpoint ) 1 , 3
CLL / SLL
IMBRUVICA ® ( ibrutinib ) is a kinase inhibitor indicated for the treatment of adult patients with :
• Chronic lymphocytic leukemia ( CLL )/ Small lymphocytic lymphoma ( SLL ).
1L = frontline , CI = confidence interval , FCR = fludarabine , cyclophosphamide , and rituximab , HR = hazard ratio , PFS = progression-free survival .
Visit IMBRUVICAHCP . com to learn more
Second Primary Malignancies : Other malignancies ( 10 %), including non-skin carcinomas ( 4 %), occurred among the 1,476 patients who received IMBRUVICA ® in clinical trials . The most frequent second primary malignancy was non-melanoma skin cancer ( 6 %).
Tumor Lysis Syndrome : Tumor lysis syndrome has been infrequently reported with IMBRUVICA ® . Assess the baseline risk ( e . g ., high tumor burden ) and take appropriate precautions .
Monitor patients closely and treat as appropriate .
Embryo-Fetal Toxicity : Based on fi ndings in animals , IMBRUVICA ® can cause fetal harm when administered to a pregnant woman . Advise pregnant women of the potential risk to a fetus . Advise females of reproductive potential to use effective contraception during treatment with IMBRUVICA ® and for 1 month after the last dose . Advise males with female partners of reproductive potential to use effective contraception during the same time period .
ADVERSE REACTIONS
The most common adverse reactions ( ≥30 %) in patients with B-cell malignancies ( MCL , CLL / SLL , WM and MZL ) were thrombocytopenia ( 54.5 %)*, diarrhea ( 43.8 %), fatigue ( 39.1 %), musculoskeletal pain ( 38.8 %), neutropenia ( 38.6 %)*, rash ( 35.8 %), anemia ( 35.0 %)*, and bruising ( 32.0 %).
The most common Grade ≥ 3 adverse reactions ( ≥5 %) in patients with B-cell malignancies ( MCL , CLL / SLL , WM and MZL ) were neutropenia ( 20.7 %)*, thrombocytopenia ( 13.6 %)*, pneumonia ( 8.2 %), and hypertension ( 8.0 %).
Approximately 9 % ( CLL / SLL ), 14 % ( MCL ), 14 % ( WM ) and 10 % ( MZL ) of patients had a dose reduction due to adverse reactions .
Approximately 4-10 % ( CLL / SLL ), 9 % ( MCL ), and 7 % ( WM [ 5 %] and MZL [ 13 %]) of patients discontinued due to adverse reactions .
* Treatment-emergent decreases ( all grades ) were based on laboratory measurements .
DRUG INTERACTIONS
CYP3A Inhibitors : Co-administration of IMBRUVICA ® with strong or moderate CYP3A inhibitors may increase ibrutinib plasma concentrations . Dose modifi cations of IMBRUVICA ® may be recommended when used concomitantly with posaconazole , voriconazole , and moderate CYP3A inhibitors . Avoid concomitant use of other strong CYP3A inhibitors . Interrupt IMBRUVICA ® if strong inhibitors are used short-term ( e . g ., for ≤ 7 days ). See dose modifi cation guidelines in USPI sections 2.3 and 7.1 .
CYP3A Inducers : Avoid coadministration with strong CYP3A inducers .
SPECIFIC POPULATIONS
Hepatic Impairment ( based on Child-Pugh criteria ): Avoid use of IMBRUVICA ® in patients with severe hepatic impairment . In patients with mild or moderate impairment , reduce recommended IMBRUVICA ® dose and monitor more frequently for adverse reactions of IMBRUVICA ® .
Please see Brief Summary on the following pages .
References : 1 . IMBRUVICA ® ( ibrutinib ) Prescribing Information . Pharmacyclics LLC . 2 . Data on fi le . Pharmacyclics LLC . 3 . Shanafelt TD , Wang XV , Kay NE , et al . Ibrutinib-rituximab or chemoimmunotherapy for chronic lymphocytic leukemia . N Engl J Med . 2019 ; 381 ( 5 ): 432-443 .
© Pharmacyclics LLC 2021 © Janssen Biotech , Inc . 2021 02 / 21 PRC-07705a