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Perspectives on Late Phase Pipeline Awareness

Posted by Matt Breese on Dec 6, 2016

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Monitoring drug launches is equally important for pharmaceutical manufacturers, payers and prescribing physicians. Typically, the late-stage drug pipeline is a good indicator for drugs that have a higher chance of getting approved in upcoming years.

Drug development requires a significant amount of financial investment and only a small portion of drugs make it to approval. Pharmaceutical manufacturers need to invest resources to ensure they are aware of drugs in phase 3 trials that could impact their competitive landscape or incite a change in payer coverage methodologies.

Payers must keep an eye on phase 3 drugs to make coverage decisions. In addition, prescribers must make decisions on how these new drugs will affect their prescribing behaviors.

The Pharma Drug Pipeline

Phase 3 drugs are typically tested over long periods in several different countries and compared to existing treatment options. Phase 3 clinical trials involve 300-3,000 volunteer patients who have the condition. These studies range from 1-4 years. The FDA, reports, “approximately 25-30% of drugs move to the next phase.”

Alzheimer’s Drug Development Pipeline

One specific example of the importance of the pipeline awareness is in the area of Alzheimer’s treatments. Alzheimer's disease has a significant impact on America’s population and healthcare systems. According to Researchers Against Alzheimer’s (RA2):

“In 2015, 5.3 million Americans were suffering from Alzheimer’s – and 5.1 million of them were over 65. Each year, dementia costs the United States roughly $200 billion – or roughly 42 percent of the 2015 U.S. budget deficit.”

The phase 3 pipeline for Alzheimer’s Drugs reveals innovative treatment options are on the horizon, which all stakeholders need to understand. In a March 2016 report, RA2 revealed, “Seventeen drugs in this final stage are likely to finish testing and could be available to people with the disease in the next five years.”

View the infographic below, created by Alzheimer’s Research UK, to learn more about the three main phases of clinical trials.


Preparing for New Treatments

When new treatment options receive approval, there are barriers to market access. In order for patients to receive adequate treatment, care providers must diagnose the condition correctly. According to Drew Holzapfel, study lead and RA2 director, there is an “approximately 50% diagnosis rate” for people with Alzheimer’s. In addition, there are commonly reimbursement issues with new drugs.

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