Post by icemandios on Jul 16, 2021 17:56:04 GMT
July 15, 2021 05:09 PM EDTUpdated 6 hours ago FDA+
As investigations mount and controversy swirls, Biogen fights back against ICER — and then faces another unanimous slapdown
Max Gelman
Editor
There’s been no shortage of words written about Biogen’s new Alzheimer’s drug, Aduhelm, since its controversial approval last month. And on Thursday, the biotech attempted to push back against the narrative, blasting a report from the Institute for Clinical and Economic Review characterizing the evidence behind the drug as “insufficient.”
Maha Radhakrishnan
During a panel convened by the California Technology Assessment Forum, Biogen chief medical officer Maha Radhakrishnan vilified the ICER report as “inappropriate” and “fundamentally flawed.” Radhakrishnan particularly objected to ICER’s “blending” of the two Phase III trials in its analysis, leading to its flaws.
Nonetheless, the CTAF panel wasn’t swayed by that argument, as members unanimously sided 15-0 against the biotech, saying available evidence is inadequate to demonstrate that Aduhelm has a superior net health benefit compared to supportive care alone.
The meeting started off on a tame note, with ICER staffers methodically presenting their scientific and economic cases against the drug. Throughout over an hour and a half of argument, ICER walked the panel through the history of the Phase III trials, their designs, their results and the potential impact on patients’ and insurers’ wallets.
Following that presentation, Radhakrishnan made her rebuttal in a seven-minute statement. She noted ICER shouldn’t have considered the trials to be identical, arguing that hypothesis undermines the very foundation of its analysis.
“ICER’s models are based on assumptions,” Radhakrishnan said. “It makes a number of pessimistic [claims] and assumes patients will remain on therapy beyond the time period physicians would deem appropriate.”
But things got heated when ICER chief medical officer David Rind objected to Biogen’s account, pointing out the two Phase III studies were specifically designed to be identical and started enrolling patients one month apart. Backing up his colleagues, Rind blasted Biogen’s portrayal of the data and questioned why ICER should believe the company’s explanation at all.
“If we don’t blend the trials, we have to pick one, and the assumption has been to pick the positive trial,” Rind said. “Basically, if you do the analysis that Biogen did to try to find why the negative trial got it wrong, and to make it look like the negative trial shows that the high dose was better than low dose which was better than placebo, then as soon as you do that, the positive numbers look ridiculous.”
ICER had considered rating the evidence as “positive but inconclusive” but came to its “insufficient” conclusion — a more negative rating — thanks to two key points, Grace Lin said during the voting discussion period a bit later on. The group had serious concerns over the validity of Biogen’s post hoc analyses, as well as the 40% of patients receiving Aduhelm in the studies who suffered from ARIA brain swelling or bleeding events.
Panel members largely agreed with ICER’s viewpoints, especially when it came to the post hoc analyses of the placebo groups. CTAF voter Bob Collyar, explaining his votes, said the trials were “supposed to be virtually identical and pretty much are. If we switch the placebo groups, we’re going to end up with different results.”
In addition to unanimously deeming Aduhelm’s evidence to be inadequate, CTAF voted on other topics, including the drug’s ability to have an effect on patients’ major life goals and reducing inequities in the health care system. A plurality said Aduhelm would have a minor negative effect on patients’ goal-setting, while a majority deemed the drug would have a major negative effect on reducing inequity.
The panel vote and Biogen pushback comes as the storm surrounding Biogen doesn’t seem to be anywhere close to abating. Just this week, prominent Democratic lawmakers launched investigations into the drug’s approval, and some private insurers and hospitals have balked at covering and providing Aduhelm.
As investigations mount and controversy swirls, Biogen fights back against ICER — and then faces another unanimous slapdown
Max Gelman
Editor
There’s been no shortage of words written about Biogen’s new Alzheimer’s drug, Aduhelm, since its controversial approval last month. And on Thursday, the biotech attempted to push back against the narrative, blasting a report from the Institute for Clinical and Economic Review characterizing the evidence behind the drug as “insufficient.”
Maha Radhakrishnan
During a panel convened by the California Technology Assessment Forum, Biogen chief medical officer Maha Radhakrishnan vilified the ICER report as “inappropriate” and “fundamentally flawed.” Radhakrishnan particularly objected to ICER’s “blending” of the two Phase III trials in its analysis, leading to its flaws.
Nonetheless, the CTAF panel wasn’t swayed by that argument, as members unanimously sided 15-0 against the biotech, saying available evidence is inadequate to demonstrate that Aduhelm has a superior net health benefit compared to supportive care alone.
The meeting started off on a tame note, with ICER staffers methodically presenting their scientific and economic cases against the drug. Throughout over an hour and a half of argument, ICER walked the panel through the history of the Phase III trials, their designs, their results and the potential impact on patients’ and insurers’ wallets.
Following that presentation, Radhakrishnan made her rebuttal in a seven-minute statement. She noted ICER shouldn’t have considered the trials to be identical, arguing that hypothesis undermines the very foundation of its analysis.
“ICER’s models are based on assumptions,” Radhakrishnan said. “It makes a number of pessimistic [claims] and assumes patients will remain on therapy beyond the time period physicians would deem appropriate.”
But things got heated when ICER chief medical officer David Rind objected to Biogen’s account, pointing out the two Phase III studies were specifically designed to be identical and started enrolling patients one month apart. Backing up his colleagues, Rind blasted Biogen’s portrayal of the data and questioned why ICER should believe the company’s explanation at all.
“If we don’t blend the trials, we have to pick one, and the assumption has been to pick the positive trial,” Rind said. “Basically, if you do the analysis that Biogen did to try to find why the negative trial got it wrong, and to make it look like the negative trial shows that the high dose was better than low dose which was better than placebo, then as soon as you do that, the positive numbers look ridiculous.”
ICER had considered rating the evidence as “positive but inconclusive” but came to its “insufficient” conclusion — a more negative rating — thanks to two key points, Grace Lin said during the voting discussion period a bit later on. The group had serious concerns over the validity of Biogen’s post hoc analyses, as well as the 40% of patients receiving Aduhelm in the studies who suffered from ARIA brain swelling or bleeding events.
Panel members largely agreed with ICER’s viewpoints, especially when it came to the post hoc analyses of the placebo groups. CTAF voter Bob Collyar, explaining his votes, said the trials were “supposed to be virtually identical and pretty much are. If we switch the placebo groups, we’re going to end up with different results.”
In addition to unanimously deeming Aduhelm’s evidence to be inadequate, CTAF voted on other topics, including the drug’s ability to have an effect on patients’ major life goals and reducing inequities in the health care system. A plurality said Aduhelm would have a minor negative effect on patients’ goal-setting, while a majority deemed the drug would have a major negative effect on reducing inequity.
The panel vote and Biogen pushback comes as the storm surrounding Biogen doesn’t seem to be anywhere close to abating. Just this week, prominent Democratic lawmakers launched investigations into the drug’s approval, and some private insurers and hospitals have balked at covering and providing Aduhelm.
