Drop in first-cycle approvals may be “new reality,” says Parexel

26-Oct-2010 - Last updated on 27-Oct-2010 at 10:47 GMT

Parexel Consulting has released its annual analysis of FDA new drug review trends, which indicates there is a “new normal” emerging in the drug review and approval process.

In the white paper entitled, ‘Drug Innovation, Approval, Market Access, and the “New Normal”: Emerging FDA Review Outcome Trends for New Drugs,’ Parexel Consulting identified declines in first-cycle approval rates for priority drug applications and priority designation rates for new drugs.

During period under review, between 2008 and 2009, Parexel noticed a 25 per cent decline in first-cycle approval rates for priority-rated new drugs and a 17 per cent decrease in priority designations for new drug applications (NDAs).

“As we point out in the white paper,” explained Mark Mathieu, director of strategic research at Parexel Consulting, “priority drug applications are more likely to be affected by REMS, [which] are very difficult to develop and implement within a six-month first-cycle review for a priority product.”

He told Outsourcing-Pharma, “It remains to be seen if lower first-cycle approval rates for priority drugs will be part of a new reality in the regulatory landscape.”

Questioning whether the trends cited in the white paper do represent a “new normal,” Mathieu said this would suggest that first-cycle approvals, particularly for priority-designated drugs, may be more difficult to achieve.

Mathieu said priority-rated NDAs are continuing to obtain faster first-cycle approvals than standard-rated NDAs.

Though the gap has narrowed over the past two years, “There continue to be significant advantages for priority-rated drugs, which is what makes the lower priority designation rates over the last several years a concern,” he warned.

Fewer drugs designated a "priority”

Another contributing factor is the trend of lower priority designation rates for new drug applications; hitting only 13 per cent in Fiscal year (FY) 2009, which was less than half of the 30 per cent rate in FY 2005, and the lowest rate since FY 2002.

Charles Stevens, vice president and general manager of reimbursement and market access at Parexel Consulting, said this 13 per cent priority designation rate “mirrors the low rate at which some health care plans and other payers are finding true value in newly approved drugs.”

Stevens went on to cite a report by Regence Group, which revealed the health insurance firm has, over the last twelve months, added less than 15 per cent of all newly approved drugs to its formularies.

After assessing the value of drugs approved between July 2005 and June 2009, Regence said that 56 per cent lacked value beyond existing therapies, while just one per cent showed improved efficacy. Stevens suggested this illustrates “the need for companies to take into account market-based clinical concerns in the product development process.”