por John R. Fischer
, Senior Reporter | June 24, 2019
From the June 2019 issue of HealthCare Business News magazine
He adds that while radiology in the U.S. is extremely efficient, it consequently is dominated by physicians who work primarily in a reading room, reviewing images of patients and writing reports based on what they see.
“Talking to patients, deciding if a treatment is right for them, and following up with them after therapy is outside the experience of many radiologists,” said Weber.
Another challenge is the perishable nature of radioactive drugs, which adds to the cost of producing these drugs in a field where reimbursement guidelines have still not been completely settled. This deters many from fully investing in it.
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“Once you have something approved, it has to also be reimbursed, which, especially for diagnostics, does not have the same payoff as a therapeutic,” said Dr. Ken Herrmann, chair and a professor of nuclear medicine in the department of nuclear medicine at the University of Essen. “Just because a diagnostic is approved by the FDA doesn’t mean it’s reimbursed.”
Hope stresses that theranostics is a form of “treatment”, not a “cure”, and that it cannot be used to combat all forms of cancer.
“Its success depends on its ability to target cancer, and there are certain cancers that can’t be targeted because they don’t have cell surface proteins that we can target,” he said. “Additionally, the biodistribution of the agent may not be optimized yet.”
The road ahead
Securing approval of new theranostic agents requires generating awareness of meaningful scientific evidence. While regulatory processes can be long, access to literature and clinical validations of these therapies can help speed up approval time.
Outside of the U.S., theranostics are sometimes used on a “compassionate-use” basis, in which new, unapproved drugs are used to treat seriously ill patients with no other available treatment options, according to Hope. This helps to validate substances, leading to publication of literature and evidence that can be used in assessments of the same drug in other countries.
“If you take a drug that’s currently in Phase III trials, such as Lutetium-177-PSMA-617, the drug never went through Phase I and Phase II trials in the U.S.,” said Hope. “The company was able to go straight to Phase III trials because there was a Phase II trial performed in Australia, and there’s also extensive experience in Germany using PSMA-617, which presumably allowed the FDA to let the company move forward to a Phase III trial based on that.”
The success of theranostics for treating thyroid and neuroendocrine cancers, along with its expected benefits for prostate, have prompted a number of ideas involving its use in treating other forms of cancer.