There are currently no
FDA-approved targeted therapies for ovarian and endometrial cancer.
Roche/Genentech/Chugai’s Avastin (bevacizumab) was approved for first-line
advanced ovarian cancer (CaO) in Europe in December 2011 and received a
subsequent European approval in October 2012 for recurrent platinum-sensitive
ovarian cancer. In the United States, where Avastin has not yet received formal
approval, interviewed oncologists report off-label use in all settings;
however, they state that gaining reimbursement for the drug’s use in CaO can be
challenging despite recommended use by the NCCN guidelines. In both ovarian and
endometrial cancer (EMC) current treatment is dominated by chemotherapy.
Treatment guidelines for endometrial cancer also recommend the use of hormone
therapy and Avastin is mentioned in the NCCN treatment guidelines for
covered in this report:
Avastin (bevacizumab) is a monoclonal antibody that targets VEGF and is used
off-label in advanced CaO.
- Janssen Biotech’s
Doxil, a pegylated liposomal doxorubicin (PLD) that is indicated for treatment
of CaO after failure of platinum-based chemotherapy. This agent is also often
used as a monotherapy for treatment of advanced/recurrent EMC.
taxanes—paclitaxel (Bristol-Myers Squibb’s Taxol, generics) and docetaxel
(Sanofi’s Taxotere, generics) are commonly used to treat CaO and EMC in
particular in the front-line and most commonly in combination therapy,
typically with platinum agents.
- The platinum
agents—carboplatin (generics) and cisplatin (generics) play an important role
in treatment of CaO and EMC. Most commonly these agents are prescribed in the
first-line setting; frequently in combination with taxanes. Patients typically
receive platinum-based therapy for as long as their disease is perceived to be
responsive to platinum-based treatment (i.e., may receive multiple lines of
therapy with platinum agents).
- Merck &
Co/Endocyte’s vintafolide, a folate molecule conjugated to the vinca alkaloid
microtubule destabilizing agent, is an emerging therapy aiming to gain approval for
platinum-resistant advanced CaO.
Votrient (pazopanib), a small-molecule multi-tyrosine kinase inhibitor, is being
examined in a Phase III trial for treatment of advanced CaO as maintenance
therapy following treatment in the first-line setting with platinum-containing
Ingelheim’s nintedanib, a kinase inhibitor of VEGFR, PDGFR, and FGFR, is an
emerging therapy which is being examined in a Phase III trial in first-line
Bio’s trebananib, a Tie-2 receptor and angiopoietin-1 (Ang-1)- and
angiopoietin-2 (Ang-2)-inhibiting peptibody, is being examined in three Phase
III trials in CaO spanning three patient populations—first-line advanced CaO,
recurrent platinum sensitive CaO, and recurrent platinum-resistant CaO.
Zentaris’s AEZS-108, a conjugate of doxorubicin and LHRH, is
being examined in second-line advanced EMC in a Phase III trial.
this report, we explore the use and formulary status of key current therapies
for CaO and EMC and the likely reception of key emerging therapies in a survey
of 103 oncologists, and 30 managed care organization directors. By
understanding the attitudes and expectations of prescribers and payers toward
current and emerging CaO and EMC therapies, stakeholders can gain an
understanding of the treatment paradigm and changing reimbursement climate for CaO
Questions Answered in This Report:
How extensive is
the off-label use of Avastin in CaO and EMC? In which patient populations is
Avastin most frequently prescribed? What are the drivers for prescribing of
Avastin? What are the obstacles and barriers that oncologists encounter when
prescribing Avastin for CaO? Do surveyed oncologists think it is likely that
Avastin will gain regulatory approval in CaO? How will Avastin gaining
regulatory approval in CaO and EMC affect prescribing habits of this agent?
What is the current
state of reimbursement for key CaO and EMC therapies? What restrictions, if at
all, are in place on prescribing of Avastin in CaO and EMC?
attributes would secure routine high use of an emerging therapy in first-line
advanced CaO? What is surveyed physicians opinion on emerging therapies for CaO
and how will they likely incorporate these agents into the treatment paradigm,
if approved? What do surveyed oncologists believe will constrain their
prescribing of novel agents for CaO?
What access and
reimbursement hurdles and MCOs likely to implement on novel agents for in CaO
and EMC? What factors are important to payers for formulary inclusion and
favorable tier status in CaO?
- Primary research: 103
medical oncologists, 30 MCO pharmacy/medical directors.
- Epidemiology: 2013
and 2021 U.S. CaO drug treatable patient populations— early-stage advanced CaO,
first-line advanced CaO, second-line platinum-sensitive CaO, second-line
platinum-resistant CaO, third-line advanced CaO, fourth-and subsequent-line
segments: Where appropriate, our data and analyses are segmented in CaO by line
of therapy (early-stage CaO to fourth- and subsequent-lines advanced CaO). For
EMC we segment patient where appropriate based on stage of the disease (early
and advanced EMC, as well as recurrent EMC).