Drugmakers have told US President Barack Obama that they support plans to set up a public-private comparative clinical effectiveness research (CER) institute, with aim of “empowering patients and physicians with high-quality information.”
A good basis from which to establish policy in this area would be the Comparative Effectiveness Research Act (CERA) of 2008 which was introduced in the last Congress, the Pharmaceutical Research and Manufacturers of America (PhRMA) told the President on Monday. The Act seeks to establish a non-profit, private-entity institute to conduct such research, rather than a federal agency.
PhRMA’s comments come in a letter, signed by six associations representing various sector of the health care industry which, on May 11, pledged to cut $2 trillion from the nation’s health care spending over the next 10 years, slowing growth in expenditures 1.5% a year over the period. On June 1, the six again wrote to the President outlining the “solid progress” which they have made to tackling this goal so far.
In its contribution, PhRMA tells Pres Obama that medicines “have already begun to play a key role in bending the cost curve in the US.” IMS forecasts that the US prescription drugs market in 2009 will dip 1%-2% below 2008 – when sales rose just 1.3%, the lowest rate of rise since 1961 – and that annual growth rates will remain essentially flat to 2014. Moreover, PhRMA points out that, between 2008 and 2009, the Centers for Medicare and Medicaid Services (CMS) reduced its 10-year forecast of total drug spending by 14%, or $515 billion.
Contributors to these declining cost trends have included the generic use rate, which is now 72% and set to rise further as more major branded drugs lose patent protection. Also, “since 2007, over 130,000 global biopharmaceutical job losses have been announced,” the industry group reminds the President.
”At least 14 years’ data protection for biosimilars
To reduce over-, mis- and underuse of medicines, PhRMA recommends the following incentives: – development and use of performance measures; – expanded use of medication therapy management (MTM); and – an abbreviated regulatory approval pathway for biosimilars (generic versions of biologic drugs) “that assures patient safety, increases competition and provides responsible incentives for the R&D investment needed – including patent protection and at least 14 years of data protection,” it says.
CER efforts should, at all levels, help inform and support decisions made by patients and providers, it goes on, adding: “empowering patients and physicians with high-quality information on the full range of available treatments and health services will help ensure that our health system efficiently delivers the best possible results for all patients.”
CERA (Senate bill 3408), which was introduced in the Senate last August by Finance Committee chairman Max Baucus and Budget Committee chairman Kent Conrad, would establish a non-profit, private-entity Health Care Comparative Effectiveness Research Institute, to conduct CER studies. It would be governed by a public-private sector board of governors and would not be an agency of the federal government.
“Keeping it private would remove the potential for political influence on the development of national research priorities. Comparative effectiveness research will be more credible, and more useful, if it is done independently of political influence,” said the Senators, although at that time PhRMA warned that such moves should “avoid denying or delaying patients’ access to beneficial care.”
– February’s American Recovery and Reinvestment Act (ARRA) includes appropriations totaling $1.1 billion for CER studies, of which $400 million each goes to the National Institutes of Health (NIH) and the Office of the Secretary of Health and Human Services (HHS), while $300 million goes to the Agency for Healthcare Research and Quality (AHRQ)’s existing Effective Health Care programme.
On March 19, the Administration named the 15 members of the new Federal Coordinating Council for Comparative Effectiveness Research, which will help coordinate research and guide investments in such ARRA-funded research. The Council – which the government notes are mainly clinicians but critics point out are all federal employees – will not recommend clinical guidelines for payment, coverage or treatment.
