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ICER Updates Report on Aducanumab Pricing, Affirms Agent Is Not Cost-Effective

Early in November 2020, the drug was denied approval after a marathon seven-hour long virtual meeting with the medical panel disagreeing with the claims. Ten out of 11 members of the federal panel of medical experts voted that it was “not reasonable to consider the research presented as “primary evidence of the effectiveness of Aducanumab for the treatment of Alzheimer’s disease,” the New York Times reported. Developed by Biogen, the drug named Aducanumab is said to slow down the progression of Alzheimer’s disease that affects the functioning of the brain. The approval came following months of debate within the medical circles over the procedures in recommending its use for the debilitating disease.

  1. Aducanumab therapy will be limited by the need for prior authorization, intravenous administration, and uncertainties regarding benefit-risk ratio and cost-effectiveness.
  2. Biogen also said Monday that it will start some cost-cutting measures that are expected to yield about $500 million in annual savings, most of which will be realized next year.
  3. A study by Salloway et al. reviewed the clinical and radiographic aspects of ARIA in both EMERGE and ENGAGE trials [49].
  4. The third major area of impact is the potential incoming marketplace competition of therapies making their way through the pipeline.

“There are some hyped medicines and it could be possible that when tried on the ground they may not be useful. Still, we are in a desperate situation and hope the drug is useful,” Dr Deshpande said. This narrative review did not include studies indexed in databases other than Google Scholar, Web of Science, and MEDLINE. Future AD management is likely to focus on passive immunotherapy, vaccines, and early diagnosis based on neuroimaging, CSF, and plasma biomarkers. Schematic representation of aducanumab targets (soluble and insoluble beta-amyloid peptides); source [73]. Some states, such as Massachusetts and Tennessee, have requested waivers and adjustments from CMS to offset this possibility, for now, the responsibility remains at hand.

The approval of this drug without a confirmed significant clinical impact has resulted in several debates. The approval is a departure from the FDA’s established process that requires two convincing studies before a drug is used. Scientists are worried that the decision could lower the standards required for getting a medical product approved. The American Food and Drug Administration (FDA) on Monday approved a drug for Alzheimer’s disease, the first in nearly two decades.

Do you have a prescription for Aduhelm (aducanumab-avwa) for your patient?

Before initiating aducanumab, the prescribing clinician should obtain brain imaging by MRI within a 12-months period. The healthcare professional administering aducanumab should carefully follow the titration schedule during the first seven infusions. During infusion administration of aducanumab, the provider should be prepared and equipped in a setting with appropriate management in the event of hypersensitivity-like reactions. Another MRI should be obtained during the seventh infusion (first 10 mg/kg dosage) and the twelfth infusion (sixth 10 mg/kg dosage). A study by Salloway et al. reviewed the clinical and radiographic aspects of ARIA in both EMERGE and ENGAGE trials [49]. The study found that 425 of 1029 individuals (41.3%) developed ARIA during the placebo-controlled trial period, with 14 patients developing significant events (1.4%) [49].

Now, the consecutive success of three therapies in two years in slowing cognitive decline in patients with early Alzheimer’s establishes more firmly the theory that one of the main causes of the disease are the abnormal clumps of amyloid beta protein around brain cells. Donanemab is a monoclonal antibody that targets the abnormal plaques of amyloid beta protein characteristically seen in brain images of those with Alzheimer’s. Its mechanism of action is similar to Lecanemab, the drug developed by Japanese and American companies Eisai and Biogen that received a fast-track approval from the FDA earlier this year.

However, there are currently four medications, approved by Health Canada, that can help manage symptoms of the disease. Aducanumab was administered as an intravenous (IV) infusion every four weeks. Patients receiving aducanumab treatment were required to undergo brain magnetic resonance imaging (MRI) prior to treatment and multiple times following treatments. In general, Canadians can travel out of country to seek medical treatment, but in most circumstances, drugs would be an out-of-pocket expense. You would need to check with your provincial or territorial drug plan to find out what costs, if any, may be reimbursed.

(3) The larger effect that was noted in the ApoE group in the amyloid PET sub-study was in contradiction to what was noted in the clinical outcome data in phase III. (4) In both studies, the correlation between week 78 cerebellum SUVR (standardized uptake value ratio) change and week 78 CDR-SB change was quite small in the high-dose group. (6) Data supported by randomization indicating that the low dose in Study 301 was numerically superior to the high dose despite none of the participants having received the 10 mg/kg dose. (7) The distribution of regional enrollment changing over the course of the studies may have confounded the impact of PV4, allowing the ApoE+ high dose to reach 10 mg/kg instead of only 6 mg/kg in earlier protocols.

The drugmaker said Monday that it will cut the wholesale acquisition cost of the drug by about 50% next month.

FDA’s decision on the approval of aducanumab is of great importance to AD patients and their families, which can increase the pressure on clinicians to prescribe this drug. Hence, it is important to identify the right patients who are more likely to benefit from this drug. To maintain optimal effectiveness and safety of the drugs, patients who are eligible to take the drug via long-term monthly infusion need to be carefully selected. Before initiating the drug, a recent MRI and a PET scan to visualize the density of β-amyloid aggregates are needed [51]. Periodic safety MRI after the seventh and twelfth infusion and anytime when ARIA is suspected is required [18].

The reviewers concluded that there was no convincing evidence from available data that there was a delay in clinical progression of cognitive or functional decline from these studies. They noted that the single positive timepoint was un-replicated and conflicted by the second study. Additionally, the delayed start design with termination for futility did not help with the completeness or interpretability of long-term follow-up data in these studies. Aducanumab at a high dose has the potential to slow down the cognitive decline linked with Alzheimer’s in patients with early-onset disease.

In June 2022, drug-maker Biogen announced it was withdrawing its submission from regulatory review by Health Canada. Sometimes there is no sympathy about the patient not being able to remember anything and their condition is attributed to mental weakness or depression. Once diagnosed after ruling out treatable causes of memory loss, there are usually four types of medications, including blood thinners for vascular blockages, and memory enhancing medicines (which do not increase memory power) to increase conduction between neurons. Since there is no treatment so far, the drug that can slow down the process holds much promise and is a ray of hope, said Dr Amit Dias, Assistant Professor, Department of Preventive Medicine, Goa Medical College, and a member of Alzheimer’s and Related Society of India. “The drugs we have so far only attempted to improve the function by acting at the level of neurotransmitters,” Dr Dias said.

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Some countries have a government fund providing financial assistance for citizens to access lifesaving medical treatment abroad. The best thing would be to check with your country’s own health ministry. We also highly recommend checking out local patient blogs, communities and patient organisations to find out more about your options. Aduhelm clears brain plaque thought to play a role in Alzheimer’s disease, and U.S. regulators gave their approval based on study results showing the drug seemed likely to benefit patients. The drug was tested in patients at the earliest stages of Alzheimer’s before the disease had a major impact in their ability to care for themselves.

Therefore, vaccines for the elderly might require a potent adjuvant to enhance the immune response [65]. However, vaccines provide cheaper and affordable alternatives to drugs [65, 66]. More importantly, the study found that there was no aducanumab price in india cognitive decline in 47% of the people who received the drug as compared with 29% of those who received a placebo. Over an 18-month period, the trial met the primary endpoint of slowing cognitive decline in those with early Alzheimer’s.

The disease has a physical, psychological, social, and economic impact not only on people who are suffering from it but also on immediate families. Alzheimer’s disease is the most common form of dementia and contributes per cent of the cases. According to the World Health Organisation (WHO), it is a syndrome in which there is deterioration in memory, thinking, behaviour and the ability to perform everyday activities. Other than that, doctors suggest that people, especially the elderly and those with family history, should keep their brains active and engaged. Solving puzzles, learning new languages or new skills, and going out and making friends can all help.

The agency said about half of that hike was due to the need for a contingency fund to cover Aduhelm. It’s believed that future treatments will involve risk reduction strategies and the combination of medications or devices that address several disease targets. As of January 1, 2022, the yearly cost of the drug was slated to be roughly $28,200 USD annually, with the exact cost varying depending on the weight of the patient and their dosing level.

The statistical review and evaluation of aducanumab by the FDA stated that the available data did not seem to provide sufficient evidence to support the efficacy of high-dose aducanumab amongst individuals with AD.10 The reviewers noted several issues with the trial data regarding aducanumab. (1) Both studies were terminated early for futility and were not fully completed, with the data cut-off date being 26 December 2018 and the public futility announcement date being 21 March 2019. (2) There was sporadic unblinding for dose management of ARIA cases, which was noted to be much higher in the drug-treated group.

Explained: The new drug for Alzheimer’s disease

The pressure on physicians to select patients who are most likely to benefit from the drug with available limited evidence [27] is anticipated to accelerate the development of less cumbersome and less costly serum-based tests to assess β-amyloid plaque. In addition, better collaboration with primary care centers is needed to screen and identify individuals at the early stage of the disease to offer disease-modifying intervention. “We believe that both the federal government and the states deserve better policy options in the face of a historic drug approval. Protecting state budgets shouldn’t require Medicare to cover an expensive drug with unproven clinical benefits, and Congress should take steps to fix this problem.