Post by icemandios on Jan 14, 2022 18:19:05 GMT
January 13, 2022 05:34 PM ESTUpdated 5 hours ago Pharma
Exclusive: Biogen leaders warn sales teams: Only 2,000 patients might access Aduhelm over the next several years
Zachary Brennan
Senior Editor
Biogen execs on Thursday tried to level with their Aduhelm sales staff and prep for a 28-day blitz to convince CMS to reverse or loosen its recent decision to only cover the controversial Alzheimer’s drug in clinical trials.
Its back against the wall, the company faces an Aduhelm launch that never materialized and growing ire from investors as they try to generate some of the glittering billions in blockbuster sales analysts once so confidently forecast.
According to a recording of the Zoom call with sales teams, obtained by Endpoints News, Biogen VP of US market access and reimbursement Brendan Manquin slammed the implications of the draft NCD, and said it means that even if Biogen runs a large, randomized placebo-controlled Phase III trial, on the order of 2,000 to 3,000 patients (with 33-50% on placebo), that means only about 1,000 to 2,000 patients will access Aduhelm “over the next several years.”
“I’m not going to sugarcoat it. This is an extraordinarily restrictive proposal,” he said.
Manquin said Biogen is meeting with CMS next week to address some of the company’s questions and a “number of mischaracterizations and scientific inaccuracies” in the draft NCD.
“CMS has left a lot of questions unanswered. We don’t know if this were to be finalized, what will happen to patients currently on treatment? CMS has left that completely unanswered,” Manquin said. “Are we going make patients pay co-insurance and then put them on placebo?”
Other leaders stressed that Biogen would likely be on the hook for paying for the CMS-approved trial, with one senior leader noting that it’s likely that CMS would only pay for the cost of the drug and one PET scan, unless the patient has already had a PET scan in the past.
“But the rest of the cost of the study is going to be on Biogen’s dime. So things like setting up the protocol, working with the sites, covering administration costs, that would all fall under Biogen,” another unidentified exec said.
While characterizing the decision from CMS as essentially saying “the FDA made a mistake,” and echoing comments from Biogen top execs earlier in the day, Manquin said: “We’re going to be pushing back on them on this on a number of fronts.”
Biogen vows to fight CMS' draft coverage decision for Aduhelm before April finalization
For instance, he noted that CMS made no differentiation in its draft between drugs approved under FDA’s accelerated and the full approval programs.
Would other Alzheimer’s drugs like Eli Lilly’s donanemab or Biogen’s lecanemab, if they have “perfect Phase 3 readouts” still need to do another trial to gain access to coverage? He questioned.
“CMS wants to duplicate what the FDA asked for, but they haven’t figured out how to operationalize that and that’s why we have confidence we can move the needle,” another senior leader who did not identify himself said.
Another Biogen leader called the NCD “a large overswing by CMS” — saying it’s a “sobering message” to think FDA would approve a drug and CMS would reject the FDA’s process. He stressed that there will be “lots of noise from the broader industry,” but another exec confirmed that Biogen, Lilly and Roche do not have a coordinated messaging campaign for the comment period.
Eli Lilly promises five new approvals in next two years with Alzheimer’s at the forefront
Corey Thomas, Biogen’s senior product manager, joined the call after Manquin and went over “reactive” talking points with the reps regarding the NCD, telling them, “It’s critically important to make stakeholders aware of the comment period.”
In addition to offering instructions on the easiest way to direct doctors to the NCD docket, Thomas also stressed that staff should make physicians aware of the “tight timeline” to submit comments, but to not go so far as suggesting what physicians should write.
Later in the call, other Biogen leaders told the sales teams to continue to work with physicians to enroll patients on Aduhelm, as “nothing changes” from before the draft NCD.
Coverage determinations for Aduhelm will still be made by the Medicare Administrative Contractors and Medicare Advantage plans, the leaders said, as they were before, and providers can continue to submit claims and prior approvals.
“We should not be driving patients to clinical trial recruitment,” another unidentified leader said near the middle of the hour-long call. “Please do not go rogue on something like this.”
Biogen leaders also cautioned employees against personally submitting comments to CMS, even if they are not identified as Biogen employees, as one leader mentioned Endpoints coverage about how the company was planning to enlist doctors and others to flood CMS with comments.
Near the end of the call, one of the leaders stressed to the sales teams that they’re “on the right side of this.”
“This is a draft,” he said in closing the call, adding:
We believe this draft will move, and we need to do everything we can to get patients confirmed for amyloid data, which is something we’re doing, and try to get patients who are appropriate on therapy. We can’t make firm commitments right now, I wish we could, but what I can tell you is that Biogen does not leave patients in the lurch. We definitely understand some of our customers may have concerns about that.
Exclusive: Biogen leaders warn sales teams: Only 2,000 patients might access Aduhelm over the next several years
Zachary Brennan
Senior Editor
Biogen execs on Thursday tried to level with their Aduhelm sales staff and prep for a 28-day blitz to convince CMS to reverse or loosen its recent decision to only cover the controversial Alzheimer’s drug in clinical trials.
Its back against the wall, the company faces an Aduhelm launch that never materialized and growing ire from investors as they try to generate some of the glittering billions in blockbuster sales analysts once so confidently forecast.
According to a recording of the Zoom call with sales teams, obtained by Endpoints News, Biogen VP of US market access and reimbursement Brendan Manquin slammed the implications of the draft NCD, and said it means that even if Biogen runs a large, randomized placebo-controlled Phase III trial, on the order of 2,000 to 3,000 patients (with 33-50% on placebo), that means only about 1,000 to 2,000 patients will access Aduhelm “over the next several years.”
“I’m not going to sugarcoat it. This is an extraordinarily restrictive proposal,” he said.
Manquin said Biogen is meeting with CMS next week to address some of the company’s questions and a “number of mischaracterizations and scientific inaccuracies” in the draft NCD.
“CMS has left a lot of questions unanswered. We don’t know if this were to be finalized, what will happen to patients currently on treatment? CMS has left that completely unanswered,” Manquin said. “Are we going make patients pay co-insurance and then put them on placebo?”
Other leaders stressed that Biogen would likely be on the hook for paying for the CMS-approved trial, with one senior leader noting that it’s likely that CMS would only pay for the cost of the drug and one PET scan, unless the patient has already had a PET scan in the past.
“But the rest of the cost of the study is going to be on Biogen’s dime. So things like setting up the protocol, working with the sites, covering administration costs, that would all fall under Biogen,” another unidentified exec said.
While characterizing the decision from CMS as essentially saying “the FDA made a mistake,” and echoing comments from Biogen top execs earlier in the day, Manquin said: “We’re going to be pushing back on them on this on a number of fronts.”
Biogen vows to fight CMS' draft coverage decision for Aduhelm before April finalization
For instance, he noted that CMS made no differentiation in its draft between drugs approved under FDA’s accelerated and the full approval programs.
Would other Alzheimer’s drugs like Eli Lilly’s donanemab or Biogen’s lecanemab, if they have “perfect Phase 3 readouts” still need to do another trial to gain access to coverage? He questioned.
“CMS wants to duplicate what the FDA asked for, but they haven’t figured out how to operationalize that and that’s why we have confidence we can move the needle,” another senior leader who did not identify himself said.
Another Biogen leader called the NCD “a large overswing by CMS” — saying it’s a “sobering message” to think FDA would approve a drug and CMS would reject the FDA’s process. He stressed that there will be “lots of noise from the broader industry,” but another exec confirmed that Biogen, Lilly and Roche do not have a coordinated messaging campaign for the comment period.
Eli Lilly promises five new approvals in next two years with Alzheimer’s at the forefront
Corey Thomas, Biogen’s senior product manager, joined the call after Manquin and went over “reactive” talking points with the reps regarding the NCD, telling them, “It’s critically important to make stakeholders aware of the comment period.”
In addition to offering instructions on the easiest way to direct doctors to the NCD docket, Thomas also stressed that staff should make physicians aware of the “tight timeline” to submit comments, but to not go so far as suggesting what physicians should write.
Later in the call, other Biogen leaders told the sales teams to continue to work with physicians to enroll patients on Aduhelm, as “nothing changes” from before the draft NCD.
Coverage determinations for Aduhelm will still be made by the Medicare Administrative Contractors and Medicare Advantage plans, the leaders said, as they were before, and providers can continue to submit claims and prior approvals.
“We should not be driving patients to clinical trial recruitment,” another unidentified leader said near the middle of the hour-long call. “Please do not go rogue on something like this.”
Biogen leaders also cautioned employees against personally submitting comments to CMS, even if they are not identified as Biogen employees, as one leader mentioned Endpoints coverage about how the company was planning to enlist doctors and others to flood CMS with comments.
Near the end of the call, one of the leaders stressed to the sales teams that they’re “on the right side of this.”
“This is a draft,” he said in closing the call, adding:
We believe this draft will move, and we need to do everything we can to get patients confirmed for amyloid data, which is something we’re doing, and try to get patients who are appropriate on therapy. We can’t make firm commitments right now, I wish we could, but what I can tell you is that Biogen does not leave patients in the lurch. We definitely understand some of our customers may have concerns about that.