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Possible reimbursement restrictions for antipsychotics in US

A number of atypical antipsychotics may suffer from reimbursement restrictions in the US on comparative effectiveness data when J&J's Risperdal patent expires

According to a Pharmawire report, a number of atypical antipsychotics could suffer from reimbursement restrictions in the US on comparative effectiveness data.

AstraZeneca's (AZ) Seroquel (quetiapine), Pfizer's Geodon (ziprasidone) and Eli Lilly's Zyprexa (olanzapine) may experience cost pressures in June 2008 when Johnson & Johnson's Risperdal (risperidone) patent expires.

Public and private health insurance bodies collect data, which allows them to compare different drugs within the same therapeutic category. The information then shapes reimbursement programmes, such as step therapy, where patients must try a cheaper drug before a more expensive one will be covered.

The National Institute of Mental Health (NIMH) is already sponsoring the large-scale Clinical Antipsychotics Trials of Intervention Effectiveness (CATIE), which have shown that older, less expensive drugs can be as effective as newer ones.

The concerns over cost will be doubled when the US government is scheduled to pass a revised Medicare bill by the end of 2008. About 71 per cent of patients who are eligible for antipsychotics are enrolled in a Medicare Part D plan, according to IMS Health data.

While CATIE data have been available since 2003, the new year could be the first time that an atypical antipsychotic will be available as a generic, potentially leading prescribers to favour that product on cost grounds.

Sales data
In Q3 FY07, Seroquel sales for AZ in the US were up 24 per cent to USD 760m, which included around USD 80m in launch stocks for the new Seroquel XR dosage form. The full promotional roll out for the extended release version began in August 2007. Seroquel XR is only labelled for schizophrenia.

Geodon sales totalled USD 400m in H1 FY07, according to Pfizer. The drug competes with J&J's Risperdal and Invega (paliperidone), which racked up USD 2.3bn in sales the same time period.

Lilly's off-label marketing of Zyprexa has come under scrutiny in the past several years. According to the company's SEC report, Medicaid fraud lawsuits filed against Lilly include the states of Alaska, Louisiana, Mississippi, Montana, New Mexico, Pennsylvania, South Carolina, Utah, West Virginia and Arkansas.

For Q2 and H1 2007, US sales of Zyprexa increased four per cent and five per cent, respectively, while international sales increased 14 per cent during both periods, according to Lilly's SEC filing.

2nd January 2008

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