The non-small-cell lung cancer (NSCLC) and
prostate cancer drug markets are already crowded with generics and novel branded
agents jockeying for position in the sequence of treatment, but developers
continue to pursue new products that could meet unmet needs in these two
common, life-threatening cancers. In both indications, generic versions are
available for traditional mainstay therapies: platinum-based chemotherapy
agents such as carboplatin and cytotoxics such as paclitaxel in NSCLC, and
hormonal drugs such as leuprolide and cytotoxics such as docetaxel in prostate
cancer. However, an array of new drugs have been approved since 2010, and
oncologists have quickly adopted several of them, including the alternative
cytotoxic Eli Lilly’s Alimta (pemetrexed) in NSCLC and the novel hormonal drug
Johnson & Johnson’s Zytiga (abiraterone) in prostate cancer. New compounds
that target specific molecular pathways also hold promise for the treatment of
niche populations with particular genetic traits in lung cancer. That said, the
use of novel, premium-priced therapies is under growing pressure from payers
and provider groups whose compensation is increasingly tied to compliance with
cost-control measures. At the same time, drug development costs may rise with
the need for multiple clinical trials to demonstrate competitive value in each
patient subgroup. Meanwhile, patent expirations are triggering sudden revenue
drops as payer cost-control programs push generic prescribing.
Key products in the oncology market
include the following:
- Eli Lilly’s Alimta (pemetrexed), an alternative
cytotoxic drug that was approved in 2008 for the treatment of non-squamous-cell
NSCLC in combination with a platinum agent and in 2009 was approved as a
maintenance monotherapy in second-line treatment.
- Pfizer’s Xalkori (crizotinib), which targets an
ALK gene translocation and was approved in 2011 as a monotherapy in all
treatment lines for patients with non-squamous-cell NSCLC who test positive for
the ALK variation.
- Johnson & Johnson’s novel hormonal agent
Zytiga (abiraterone), an orally administered, irreversible CYP17
inhibitor approved in 2011, in combination with prednisone, for
docetaxel-pretreated metastatic castrate-resistant prostate cancer.
- Astellas’s novel hormonal agent Xtandi
(enzalutamide), an androgen receptor signaling inhibitor approved in 2012 for
the treatment of docetaxel-pretreated metastatic castrate-resistant prostate
In this report, we explore the use,
reception, and pathway status of these key current and recently approved cancer
therapies across multiple cancer populations in a survey of 101 oncologists and
41 managed care organization (MCO) pharmacy and medical directors. We also gauge
payer and physician outlook toward two late-stage emerging therapies: Boehringer
Ingelheim’s Giltotrif (afatinib)
and Algeta/Bayer HealthCare’s Xofigo (radium-223). By exploring the attitudes and expectations of
prescribers and payers toward current, recently approved, and emerging cancer
therapies, stakeholders can gain an understanding of the treatment paradigm and
the changing reimbursement climate for oncology.
Questions Answered in This Report:
How does the use of select NSCLC and prostate
cancer drugs vary as physicians and MCOs create and implement clinical pathway
programs (CPPs)? What metrics determine whether novel and emerging therapies
are included in pathways for specific patient populations and in successive
lines of treatment?
How does the adoption of clinical pathways
change the mechanisms of reimbursement for prescribers, and what incentives are
offered to oncologists to induce compliance with pathway designs? How
influential are the incentives offered through CPPs, accountable care organizations
(ACOs), and bundled payment arrangements?
How have physicians incorporated or how will
they incorporate Alimta, Xalkori, Zytiga, and Xtandi into clinical practice?
How will CPPs designed by oncologists and by MCOs impact uptake? Will ACOs and
bundled payment arrangements reinforce or temper that impact for specific
How do physicians expect to incorporate two emerging
agents, Boehringer Ingelheim’s Giltotrif (afatinib) and Algeta/Bayer HealthCare’s Xofigo
(radium-223), into their prescribing practices? What
restrictions will MCOs impose as they create clinical pathways, contract with
ACOs, and reimburse through bundled payments? What does physician and payer
receptivity to these emerging therapies imply for drug developers hoping to
enter the oncology space?
Each of these strategies – clinical
pathways, ACO contracting, and the use of bundled payments – stand to benefit
or hamper specific oncology brands. A previous report studying the role of
clinical pathways and ACOs in breast and colorectal cancer pointed to sharp
changes in market access parameters for many therapies, and similar issues are
likely to emerge from this focus on NSCLC and prostate cancer.
Markets covered: United States.
Primary research: 101 oncologists, 41 MCO pharmacy/medical directors.
small-cell lung cancer, squamous small cell lung cancer, biochemical recurrent
(hormone sensitive) prostate cancer, non-metastatic castrate-resistant prostate
cancer, and metastatic castrate-resistant prostate cancer.
Population segments: Our data and analyses are segmented by
the following cancer populations: populations within NSCLC (NSQ stage IV and SQ
Stage IV) biochemical recurrent (hormone sensitive) prostate cancer,
non-metastatic castrate-resistant prostate cancer, and metastatic
castrate-resistant prostate cancer.