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The Impact of Razadyne’s Genericization and the Launch of Biologic Disease-Modifying Drugs on the Alzheimer’s Disease Market: Clinician and Payer Receptivity to Novel Agents

Authors
Andrea S. Witt, Ph.D.
Mary Fletcher-Louis, M.A., M.P.H.
Physician & Payer Forum -- July 2008

  In This Issue...

In 2007, agents prescribed to treat the symptoms of Alzheimer’s disease (AD) alone (excluding use for other forms of dementia) achieved more than $1.7 billion in ex-manufacturer sales in the United States alone. Market leaders, Eisai/Pfizer’s Aricept (donepezil), and Forest Pharmaceutical’s Namenda (memantine) achieved $912 and $500 million in U.S. ex-manufacturer sales for the treatment of AD, respectively, 2007. In December 2008, this market will undergo major upheaval when Razadyne (galantamine) becomes the first acetylcholinesterase inhibitor (AChEI) to lose market exclusivity in the United States. In 2011, the landscape will shift again as the first disease-modifying agents are launched, followed by imaging agents capable of detecting AD at earlier stages of the disease.

Decision Resources’ Physician and Payer Forum report, "The Impact of Razadyne’s Genericization and the Launch of Biologic Disease-Modifying Drugs on the Alzheimer’s Disease Market: Clinician and Payer Receptivity to Novel Agents" explores the impact of these disruptions. We surveyed 72 U.S. PCPs, 71 neurologists, and 20 managed care organization (MCO) pharmacy directors and compared their responses to assess similarities and differences. This survey enabled Decision Resources to achieve the following:

- Understand which brands will be hit, and which are best insulated from the entry of generic galantamine. Will there be unexpected winners?

- Understand variations in treatment rates for AD and other dementias, by disease severity, and clinician specialty. How will the availability of generic galantamine treatment rates, and will it engender earlier treatment or longer courses of therapy? Will it encourage wider use of combination therapy?

- Explore clinicians’ attitudes toward treating mild AD. What are the factors that currently limit prescriptions for mild AD?

- Determine how clinicians perceive the relative efficacy and tolerability of available agents and classes. Do clinicians consider that AChEIs have differential efficacy? How do they rank them? How does formulary coverage of the AChEIs impact clinician choice?

- Uncover alignments and misalignments in the attitudes and behaviors of clinicians versus MCO pharmacy directors in factors that will influence the uptake of disease-modifying therapies. What is the magnitude of impact on cognitive decline that would make PCPs and neurologists prescribe a novel agent? That would make pharmacy directors reimburse a novel agent? Do clinicians prefer oral or IV agents?

- Analyze the current formulary tier assignments of agents used to treat AD based on plan type (including Medicare PDP and private plans), and review the level of copayments associated with each tier and the cost controls imposed by agent and plan type.

- Understand the factors influencing formulary inclusion, and analyze the future tier assignments of emerging agents fulfilling hypothetical profiles.

- Explore clinician and payer attitudes to emerging diagnostics. Will clinicians refer patients? Will payers pay?

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