Boston, Massachusetts 2021-08-04 04:30:44 –
NSOr all the explosive controversy Approval of first treatment Few patients have actually developed Alzheimer’s disease for nearly 20 years.
Drug A stunning $ 56,000 annual price The suspicious benefit to the patient is a shock to the bureaucracy that operates the medical system, which has a clear impact on uptake. Some analysts estimated last month that less than 100 patients were treated in the first few weeks after treatment was approved, but availability may increase in the coming months.
The Food and Drug Administration said Aduhelm in the treatment approval, but the data show potential benefits, but the hospital and insurance committees are doing their own analysis and acting as another gatekeeper. doing. They regularly review new treatments, but the protracted questions about drug efficacy and the logistical challenge of delivering infused drugs complicate and prolong those discussions.
“This is an additional burden on the healthcare system,” said Isha Rana, a pharmacy management specialist in prescribing management for Houston Methodists. “You have a very controversial FDA approval, and now the healthcare system goes back and does the same review that the FDA did, deciding whether you think the benefits outweigh the risks. is needed.”
As some experts have explained, deliberations create a “waiting pattern” for patients, which can last for months as a doctor or insurance company. Medicare, organize their policies.. Usually, when the FDA approves a drug, Medicare will cover it immediately.
“The FDA’s decision is the first domino to fail,” said Anna Legreid Dopp, Senior Director of Clinical Guidelines and Quality Improvement at the Association of Health Systems Pharmacists ASHP.
Biogen, which makes aducanumab, does not say how many people have been treated with this drug since it was approved.
on Last month’s financial results announcementThe company executives claimed that there was enthusiasm from both the donor and the patient for the treatment. Michel Vounatsos, CEO, said one-third of the 900 sites the company said were ready to deliver the drug after approval had already completed a review “with positive results.” He said he had decided that he did not need to go through such a process. ..
However, he said he was “still in the early stages” of reimbursement decisions, and tests to confirm the presence of certain proteins in patients to confirm their eligibility were “time-consuming to schedule and adjust.” I admitted that.
From this year’s Aduhelm, Chief Financial Officer Mike McDonnell said, “The need for a site to prepare for patient diagnosis and treatment and the time it takes to secure payer coverage.” He said he was expecting “moderate” earnings.
The healthcare system looks to so-called pharmacies and treatment committees when considering adding drugs to the prescription drug list, assessing intended benefits, safety profiles, and costs.Committee — can consist of pharmacists, doctors, nurses, and financial with — set Issue all policies It describes how doctors prescribe treatment, how patients can receive treatment, how to handle side effects, and how to store and manage treatment. Practitioners can often set their own policies, either with their partners or on their own.
Already some The medical system says They are not going to offer Aduhelm (although their doctor can still prescribe treatments that patients will receive elsewhere) Desire for more data Or concerns about the process by which the FDA approved treatment.
Daniel Zlott, Senior Vice President of Education and Business Development, American Pharmacists Association, said:
The healthcare system also needs to decide whether to further limit Aduhelm’s potential patient pool. FDA prescription information For treatment it says it is for people in the early stages of Alzheimer’s disease who have been diagnosed with either mild cognitive impairment or mild dementia. However, the healthcare system may create policies in line with Biogen’s original clinical trial population and limit Aduhelm to patients who have also identified amyloid protein plaques that are designed to be cleared by the drug.
The need to test amyloid creates another hurdle in the health system. People are screened for amyloid by taking cerebrospinal fluid samples by PET scan or lumbar puncture and refer to another procedure and specialist who needs to evaluate the results. Not all clinics have access to PET scans and it is unclear if Medicare will cover them. (Amyloid blood tests under development are expected to make the process easier and cheaper.)
“In the absence of a target, it makes no sense to administer the drug,” Liana Apostrowa, a neurologist at the Indiana Alzheimer’s Disease Research Center, told a panel at the Alzheimer’s Association International Conference last week. Apostolova receives a consulting fee from Biogen.
Other doctors agree with the need to establish the presence of amyloid. Mia Yang, a geriatrician at Wake Forest Baptist Health, said many hospitals in North Carolina are discussing setting common clinical guidelines. Their original clinical trial criteria. “
Even when healthcare system pharmacies and treatment committees are working on strategies, many doctors say they wait for an insurance policy before prescribing aducanumab.
Most insurers haven’t said much, at least so far. Medicare officials are currently considering who is eligible for the drug and will not reach a final decision until 2022.
It all leaves patients with a black hole of uncertainty about how they can pay for treatment, even if their healthcare provider prescribes it.
Local Medicare contractors can make a statement about Aduhelm’s compensation policy before the national policy is announced, but have postponed it for now. All contractors refused to comment on their plans in response to STAT inquiries.
“This drug is a bit vague,” Lana said, referring to how the press works until a national decision is made.
James Chambers, an associate professor at Tufts Medical Center, said that if a patient wants to claim a denial of coverage, Medicare has an appeal process, but there is still plenty of real evidence for the patient to claim coverage. There is none.
Most commercial insurance plans are just as cautious. The largest health insurance lobby, AHIP, has called on Medicare authorities to develop a unified national policy on how to cover Aduhelm, with several major insurers, including UnitedHealthcare, Humana, CVS Health, Cigna and Anthem. Did not answer inquiries from STAT regarding the plan.
Ceci Connolly, President and CEO of the Alliance of Community Health Plans, said: Expert Advisory Board decision not to recommend Aduhelm’s approval and public announcement that major healthcare centers, including the Cleveland Clinic and Mount Sinai Health System, do not administer drugs has helped insurers hesitate to cover it.
“It gives us all the pauses, and at least suggests that we have to keep digging,” Connolly said.
While many plans are waiting, some are moving forward.Apparent draft Centene policy published online, This provides treatment to the patient, but only if the amyloid plaque is positive and no anticoagulant is being taken. Centene did not respond to a request for comment on the draft policy.
Harvard Pilgrim Healthcare Combined with Tufts Health Plan Threatened not to cover aducanumab Unless Biogen lowers the price tag. The plan has more resources and expertise to review drugs faster than some plans with less institutional support, and Connolly said smaller plans could follow federal decisions. Said it was expensive.
Some affiliates of Blue Cross Blue Shield Decided not to cover aducanumab, Biogen claimed that the classification was a misclassified feature, but said the drug was still under investigation and experimental.
Most patients eligible for aducanumab participate in the Medicare program, but Chambers said that drug prices and population could ultimately include a clear policy on how to compensate for the drug in the commercial program. Said it was expensive. We are waiting for the Medicare decision to be made.
“”Medicare [decisions like this] It is usually reserved for high-priced medications that may actually be inconsistent, “Chambers said. “It’s a controversial drug like aducanumab, and I’m surprised if anyone wants to come before it.”
Alzheimer’s patients are in limbo as hospitals, insurers weigh Aduhelm Source link Alzheimer’s patients are in limbo as hospitals, insurers weigh Aduhelm