TIMELINE-Biogen’s Alzheimer’s drug hits brakes on Medicare coverage

April 8 (Reuters) – The U.S. government health plan for people over 65 on Thursday issued its final coverage policy for Biogen’s Alzheimer’s drug Aduhelm, moving forward with an unusually strict plan that would limited to patients in clinical trials.

Below are the events of the drug’s controversial and prolonged approval last June and developments since:

2007: Neurimmune Therapeutics, a spin-off of the University of Zurich, licensed the exclusive rights to aducanumab to Biogen. (https://bit.ly/3g3MlFm)

March 2014: Eisai Co Ltd agrees to collaborate with Biogen to develop treatments for Alzheimer’s disease, including an option for the Tokyo-based company to co-develop and commercialize aducanumab. (https://bit.ly/3JgMGRu)

March 2015: The first sign that aducanamab might work is seen when Biogen publishes interim data from a small study that showed a reduction in brain-destroying amyloid plaque and a decrease in clinical deterioration in patients with mild disease. (https://reut.rs/3g1HHHM) July 2015: Biogen’s trial of 6 milligrams of aducanumab, a dose it expected to be effective without producing the brain swelling seen at higher doses, failed to significantly slow the mental deterioration. (https://reut.rs/37xO1Gx)

September 2015: Biogen began testing aducanumab in people with early Alzheimer’s disease in its two late-stage global studies known as ENGAGE and EMERGE. (https://bwnews.pr/34IyKhd)

March 2019: An independent committee monitoring its large trials found Aducanamab unlikely to succeed. Biogen ended the studies and lost $18 billion in market value. (https://reut.rs/3cax98b)

Oct 2019: New analysis of two discontinued studies showed the drug slowed Alzheimer’s progression, and Biogen revived plans to seek US approval (https://reut.rs/3pgD8gZ)

July 2020 – Biogen completed the submission of a Biologics License Application to the US FDA for approval of aducanumab. (https://bit.ly/3E1aHLu)

November 2020 – FDA staff said Biogen showed “exceptionally persuasive” evidence that aducanumab is effective in published papers ahead of a meeting of outside experts who considered recommending approval. (https://reut.rs/3ujL4Cj)

November 2020: The FDA’s external advisory panel disagreed with agency staff, voting that aducanumab had not been shown to slow disease progression. (https://reut.rs/3rd58nN)

June 2021: The US health regulator approved aducanumab, branded as Aduhelm, saying reducing amyloid plaque is likely to slow the rate of cognitive decline in Alzheimer’s patients. The agency resorted to an accelerated path designed to bring promising drugs to market quickly to enable the switch.

June 2021: Biogen priced the drug at $56,000 per year for a person of average weight.

June 2021: The FDA released documents revealing disagreements within the agency over the decision to approve the drug. At least three members of a panel of outside advisers to the regulator have resigned in protest. July 2021: The FDA changed its initial blanket decision on the use of Aduhelm to restrict the drug to patients with mild cognitive impairment or mild Alzheimer’s stage dementia. The agency called for an independent federal investigation into its interactions with Biogen.

July 2021: Biogen posted second quarter sales of approximately $2 million from Aduhelm. The company said a “large portion” of that revenue reflected inventory buildup and had not yet been dispensed to patients.

August-September 2021: US lawmakers launched an investigation into the drug’s accelerated approval and requested documents from the FDA related to the decision.

Oct 2021 – Aduhelm generated much lower than expected sales of $300,000 in its first full quarter as doctors refrained from using the drug.

December 2021: The European Medicines Agency rejected Aduhelm, saying the link between the drug’s beta-amyloid reduction and a clinical improvement of the disease had not been established.

December 2021: The company cut the US price of the drug in half, to $28,200.

January 2022: US Medicare announced plans to cover Aduhelm only for patients enrolled in a clinical trial, limiting access to the drug.

February 2022: The Federal Trade Commission and the Securities and Exchange Commission began investigating Biogen for the drug.

March 2022: Tokyo-based partner Eisai reduces its role to a royalty deal, giving up the right to share Aduhelm’s profits.

March 2022: Biogen published data from its long-term studies in the less well-known Journal of Prevention of Alzheimer’s Disease. April 2022: The Centers for Medicare & Medicaid Services issued its final coverage policy for Aduhelm. (Reporting by Bhanvi Satija in Bengaluru; Editing by Bill Berkrot, Peter Henderson and Sriraj Kalluvila)

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