This week, the Food and Drug Administration (FDA) approved two drugs that made the headlines because they were drugs that were needed for the specific indications that did not have other effective alternatives drugs as treatment options.
On Monday June 7th, 2021, the FDA approved Biogen Inc’s (BIIB.O) aducanumab as the first treatment of Alzheimer’s disease (AD) despite the mixed clinical evidence that shows the drug’s efficacy. Aducanumab as an antibody against beta-amyloid removes this sticky deposits, a key factor in AD, from the brains of patients in earlier stages of the disease. This decision was not in keeping with the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee’s votes in November 2020. This delays and reduces the ravages of the disease including memory loss and the inability to care for oneself.
The FDA requested additional information from Biogen which then led to an Accelerated Approval which is a special pathway that lets the agency greenlight drugs based on so-called surrogate endpoints. This pathway was in the past used exclusively for cancer drugs, but FDA’s drug center chief Patrizia Cavazzoni told reporters Monday that she hopes it will be used more frequently for neurodegenerative disease. The surrogate endpoint was amyloid plaques, but other drugs cleared for AD have reduced amyloid plaques but not altered the course of the disease. It appears that Accelerated Approval was provided when the primary clinical endpoints in the trials did not reach the level needed for FDA approval. The implications of the Accelerated Approval are that it requires post-market evaluations of the efficacy of the drug.
There will be several obstacles for patient access to Aducanumab. Besides its high cost ($56,000 annual price) and copayment (approximately $11,500 annually) payer coverage and reimbursement will be likely obstacles that will need to be overcome. In September 2020, we had written about insurers not being willing to reimburse diagnostic scans given limited treatment options for AD. Even the value of testing for the disease is questioned by the payers so with the questionable evidence for Aducanumab, payers likely will wait for future studies to be published that provide evidence of the drug’s effectiveness.
The second drug approval that drew media attention was Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol), for use in addition to a reduced calorie diet and increased physical activity. This was the first drug approved since 2014 for weight management. Although supported by better studies than Aducanumab, some payers may need education and negotiations to cover weight management drugs. If viewed as a lifestyle drug, insurers may not reimburse for this new drug.
GIRS has a Technical Expert Panel (TEP) of insurer decision makers to introduce new drugs or other Products for input on payer desired criteria for coverage and payment. The GIRS Payer Advocacy Compass PAC® team also educates payers about the Value Proposition of drugs and other Products and helps develop short term coverage and payment solutions as the payers wait for longer term studies to be completed. Also review our new e-book that provides a proven framework for coverage and payment if you have a drug or other Product that is facing market access challenges.
The GIRS Payer Advocacy Compass PAC® team has over 17 years of experience tracking payer market trends and policies and educating providers and stakeholders about changes to ensure coverage and reimbursement of our clients’ medical technologies.
Please contact us by email or avail or avail of our Complimentary Review of your reimbursement needs at girsinc.com
Sources: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-set-rule-controversial-biogen-alzheimers-drug-2021-06-07/
The GIRS Payer Advocacy Compass PAC® team has over 17 years of experience tracking payer market trends and policies and educating providers and stakeholders about changes to ensure coverage and reimbursement of our clients’ medical technologies.
Please contact us by email or avail or avail of our Complimentary Review of your reimbursement needs at girsinc.com
About GIRS
For more than 17 years, GIRS has been assisting medical technology manufacturers with their market uptake and reimbursement strategies so that patients can have access to the care that they need. To implement successful market access strategies, the GIRS Value Discovery Landscape Assessments® team and the Payer Advocacy Compass® team work together to develop and implement foundation reimbursement landscape and payer advocacy strategies to obtain positive coverage, appropriate payment, and innovative payer contracting arrangements to improve market uptake. For more information, email us at info@girsinc.com or call us at 901-834-9119.