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Biogen Idec/Elan: Patient Pressure May Help Tysabri's Return

Posted on: Wednesday, 8 March 2006, 12:00 CST

One year after Tysabri's removal from the market, the FDA has given patients who want access to the Biogen Idec/Elan drug the chance to make their voices heard at a public meeting. This meeting, which points to the growing trend of consumerism in healthcare, will not only be key to Tysabri's future but may also increase the impact patients could have on future public policy decisions.

After three months on the market, Tysabri (natalizumab) was voluntarily withdrawn when two MS patients taking the drug died from a rare brain disease, progressive multifocal leukoencephalopathy (PML).

The FDA will soon decide whether to allow Tysabri to return to the market. As part of the agency's decision-making process, it has agreed to consider not only recommendations from independent advisors, but also testimonies from patients who have taken the drug and want to see it re-launched.

Patient support for the drug is understandable given its proven efficacy in MS. Although, at a cost of $23,000 a year, Tysabri was the most expensive drug regimen for MS, it still beats its rivals in terms of effectiveness, having shown the ability to reduce relapses by two-thirds and delay disability. Furthermore, although PML can be fatal, the disease has been confirmed in just three of the thousands of patients treated with the drug. Biogen Idec claims around 5,000 MS patients have been prescribed Tysabri, and about 3,000 patients have taken the drug in clinical trials.

Patients' involvement in the FDA review and support for Tysabri also reflect the changing role of patients, not only in their relationship with physicians but also within the overall healthcare system. Armed with a wealth of information - much of it gained via the internet - well-informed patients and caregivers want to be in control of their healthcare decisions. This is also evident in patients' ongoing battles to receive Genentech's cancer drug Herceptin in the UK.

Datamonitor research shows that many patients ask their doctors about specific drugs because of information they have gathered online, and physician prescribing decisions are influenced by patient requests.

In the case of Tysabri, patients want the choice to make an informed decision about taking or not taking the drug based on their own understanding of the risks involved. In the future, as patients come to bear greater responsibility for their own healthcare costs, they will demand more control over decisions that affect their healthcare, including those decisions made at the level of public policy.

Source: Datamonitor

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