U.S. Government Study Finds Older Diabetes Drugs Are "Just as Good"

Old Metformin Comes Top in Meta-Analysis

The study by researchers from Johns Hopkins University in Baltimore and Washington University in St. Louis reviews the findings of 216 clinical trials, two systematic reviews of diabetes research and unpublished clinical data from the FDA and pharma companies available up until January 2006. The study was commissioned by the federal Agency for Healthcare Research and Quality, a unit of the U.S. Department of Health and Human Services, in 2005.

The study is undisputedly the largest and most exhaustive review of clinical outcomes for diabetes 2 drugs attempted to date. As a consequence, its findings are likely to have significant implications for the prescribing and reimbursement of drugs. Injectable insulin and drugs launched after January 2006 are not part of the analysis. However, all other available diabetes type 2 (characterised by insufficient insulin production) treatments have been included (see table).

The findings will come as a shock for an industry relentlessly focused on developing newer treatments. Older drug metformin—which is now available in many generic forms—came out as the best available treatment with "the best profile of benefit to risk". Sulfonylureas drugs—a class of treatment that has been around for 50 years—also performed well in the comparison despite a heightened risk of hypoglycaemia, reports TheStreet.com.

Compared to newer medications, metformin and sulfonylureas had the distinct advantages of "lower cost, longer use in practice and more intensive scrutiny in long-term trials", the researchers conclude. They further state that "compared with newer, more expensive agents…older agents have a similar-to-superior effect on [blood sugar] control and other cardiovascular risk factors". No definitive evidence of superior effectiveness on preventing cardiovascular complications or other causes of death has been found, largely due to the short duration (12 months or less) of most available studies.

Outlook and Implications

The findings give undisputable support to the treatment recommendations of the American Diabetes Foundation. The latter has long urged the use of metformin as a first line of treatment against diabetes type 2, and that newer treatments or combination treatments should only be used if and when patients become unresponsive to metformin. These guidelines have now been echoed in the newly-published diabetes medication guide from the Consumers Union in the United States.

Pharmaceutical benefit managers (PBMs) will be scrutinising the study findings closely as well. Metformin has been genericised and costs around US$100 per year, compared to treatment costs of thousands of dollars for newly-launched oral diabetes treatments. The rise in diabetes treatment costs is a serious concern for pharma bill payors; Medco Health Solutions recently forecast a 70% increase in the cost of diabetes therapies between 2007 and 2009 (according to TheStreet.com). The current study findings will allow payors to justify extended use of metformin and other older drugs before allowing patients to move onto the newer, substantially more expensive therapies. The Centers for Medicare and Medicaid Services (CMS) will apply a similar risk-effectiveness and cost-benefits analysis, and conclude that Medicare and Medicaid patients should be kept on metformin and other older drugs until they become ineffective before allowing a switch to expensive treatment alternatives.

Ultimately, the study findings will make it more difficult for pharma companies to secure preferential listing for their newer diabetes drugs on PBMs’ formularies. Applied outside the United States, the findings will make it more difficult to secure a price premium and justify reimbursement at the premium level for new diabetes therapies, unless companies can produce the data showing superior long-term efficacy for new treatments over the older generation of drugs. The onus of proof is now on the industry.

For a detailed review of diabetes drugs, see Global Insight's Gastrointestinal/Diabetes Therapeutic Group here.

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