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In late 2022, the FDA approved
the first gene therapy for bladder cancer, Ferring Pharmaceuticals’ Adstiladrin
(nadofaragene firadenovec-vncg). Almost three-quarters of oncologists surveyed by
Zitter Insights expressed at least
moderate interest in the agent, and payers said they expect to manage the
drug to label. While the drug gives another treatment alternative to a
much-needed area, it likely will continue to put financial pressure on
payers, industry experts tell AIS Health. (Both AIS Health and Zitter
Insights are divisions of MMIT.)
Oncologists, payers report
interest
- On Dec. 16, the
FDA approved Adstiladrin for the treatment of adults with high-risk,
Bacillus Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder
cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary
tumors. The company said it expects the therapy to be available in the
second half of 2023.
- Zitter polled
36 commercial payers covering 117.3 million lives and 101 oncologists
about their management of bladder cancer. Payers covering almost half of
commercial lives expressed some awareness of Adstiladrin, while more
than half of oncologists said the same. However, 72% of the oncologist
respondents said they were at least moderately interested in the gene
therapy.
- Commercial
payers with 79% of beneficiaries said that they expected to manage
Adstiladrin to label within six months of its launch. One respondent
noted the agent’s “potential to be better than standard of care” and the
patient population’s “high unmet need.” Payers also said that they
likely would put step therapy requirements in place for the product,
while one respondent said their health plan may put quantity limits on
it.
Drug will face off against
Keytruda
- “Bladder cancer
is one of the most common forms of cancer. New cases of bladder cancer
are classified as…NMIBC,” explains Mesfin Tegenu, CEO and chairman of
RxParadigm, Inc. “Historically, there have been limited treatment
options for patients with NMIBC that are not responsive to BCG besides
bladder removal surgery. Given that BCG is the standard of care,
patients who receive BCG will generally experience disease recurrence
and progression.”
- “There are not
many treatment options for the high-risk, BCG-unresponsive NMIBC
patient,” observes Winston Wong, Pharm.D., president of W-Squared Group.
He notes that valrubicin is “the only chemotherapy agent approved for
this indication. Mitomycin, gemcitabine, docetaxel, paclitaxel and
epirubicin are also utilized.”
- Pembrolizumab —
currently available as Keytruda from Merck & Co., Inc. — will be
Adstiladrin’s main competitor, Tegenu tells AIS Health, although “it is
too early to tell whether Adstiladrin will pull market share given the
unknown clinical advantages of one agent over the other. Additional data
is warranted, such as event-free survival or overall survival, side
effect profile and long-term effects for Adstiladrin to determine
whether one agent will be preferred.”
- “The potential
advantage that Adstiladrin has over pembrolizumab is the intravesical
administration,” Wong maintains. “Basically, pembrolizumab and
Adstiladrin have the same indication, although the ‘who are ineligible
for or have elected not to undergo cystectomy’ is not included in the
Adstiladrin indication. Looking at the pivotal efficacy studies, the
percentage of complete responders and the duration of response is in
favor of Adstiladrin; however, the ability of Adstiladrin to pull market
share away from pembrolizumab will depend upon real-world evidence
comparing overall response, tolerability and cost in a non-clinical
trial setting.”
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