by Leslie Small
Earlier this month, the FDA approved a drug that the
manufacturer touts as "the first-and-only twice-yearly injectable for the
treatment of schizophrenia in adults."
The drug is called Invega Hafyera (six-month paliperidone
palmitate), a product produced by Janssen Pharmaceuticals, Inc., a Johnson
& Johnson unit. Before they transition to the newly approved, twice-yearly
injectable, however, patients must first be adequately treated by Invega
Sustenna (one-month paliperidone palmitate) for at least four months or Invega
Trinza (three-month paliperidone palmitate) for at least one three-month cycle.
Both products are also manufactured by Janssen.
What drug benefits experts say?
- "Invega Hafyera will provide patients and
providers another option for treating schizophrenia but will require
monitoring of the tolerability and side effect profile due it being the
first and only drug available dosed every six months," says Mesfin Tegenu,
CEO and chairman of RxParadigm. The drug "would be a good alternative
for patients who have previously been on extended-release paliperidone
that would further benefit from a longer acting therapy," he adds.
- Robert Kinyua, Pharm.D., Prime Therapeutics' clinical
program development director, says that coverage for Invega Hafyera
"is expected to mirror that of existing long acting injectable (LAI)
antipsychotics, especially Invega Sustenna and Invega Trinza." Those
drugs are 63% covered or better and 48% covered or better, respectively,
on commercial formularies, according to data from MMIT.
- "Second-generation oral antipsychotics" are
currently the standard of care for treating schizophrenia, Tegenu says.
Generics of those drugs are typically preferred, while branded versions
"are preferred/non-preferred with prior authorization or step through
requirements of trial and failure of generic alternatives first."
Emerging treatments:
- Biopharma is focused on developing new products
"that target multiple symptoms in schizophrenia but most importantly,
the negative and cognitive symptoms where the unmet need is most
significant," Leerink analysts wrote in a Sept. 24 note about the
recent virtual Psych Congress 2020. "Additionally, physicians still
welcome safer products that provide better compliance and improved
treatment outcomes, which is positive news for Alkermes' Aristada and
ALKS-3831, Acadia's Nuplazid, as well as Intra-Cellular's Caplyta."
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