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11:57 am CST - May 06, 2013

Posted under On The Record

Doctor-Pharmacist Relationship Under Attack in Texas?

Battle over ‘biosimilar’ drugs shouldn’t block cheaper versions

texas insider Cardle, Jim3dBy Jim Cardle

Texas Insider Report: AUSTIN, Texas – At a time when Texans are shopping for bargains and desperately learning how to live on a budget, it hardly seems appropriate for legislators in Austin to do something that would guarantee health care costs remain high. But that’s exactly what some are planning to do. One of the undercards of the health care battle is the issue of affordable biotech drugs – It hasn’t gotten as much attention as the overall health care reform topic, but it should.  

One in every 10 health care dollars is spent on prescription drugs, according to the Centers for Medicare and Medicaid. So how drugs are priced has a meaningful impact on our total health care costs.

Pharmaceuticals of particular importance are biologic drugs – those created using biological, rather than chemical properties. They represent an increasing share of the drugs used to treat illnesses.

Health care Employee Rates sosBut a legislative effort requiring pharmacists to inform doctors when they substitute generic “biosimilars” for name-brand biological drugs would quash consumers ability to access cheaper generic brands, and ensure the already high cost of badly needed medicines for many Texans.

Debra Barrett, senior vice president of government affairs for Teva North America, the world’s largest generic drug maker, put it this way:

“Washington is stifling competition, and this is hurting patients by saddling them with higher drug costs.

“Congress (and states) is missing an enormous opportunity to decrease the health care costs of Americans by refusing to allow a competitive biologics marketplace.”

Yes, larger, brand-name biological drug manufacturers are pushing the bill, saying it will help to track whether patients have adverse reactions to biosimilars. Two big biotechnology companies, Amgen and Genentech, are lobbying state legislatures to limit competition to their biological drugs because they will lose patent protection in the next several years.

In their lobbying campaign, revealed by Andrew Pollack in The Times recently, the two companies have persuaded legislators to introduce bills that would restrict the ability of pharmacists to substitute cheaper biosimilars in filling prescriptions. As the Times story notes, efforts by brand companies to erect barriers to competition from lower cost health blood Medical Test bloodgeneric versions of their drugs have been going on for decades.

In 2010, Congress  gave drug companies what amounts to a 12-year monopoly on the substances they developed. Today in 2013, developers of biologics are pushing lawmakers in Austin and other state capitals to put new hurdles in the way of the cost-conscious compounds, called “biosimilars.”

One of the most promising frontiers in healthcare is biologic medicines — complex substances derived from living cells that can help fight chronic diseases and cancers.

Biological drugs are made from large molecules, and the processes, involving living cells, are more complex than those used to make conventional drugs. The cheaper competitors to brand-name biological drugs are called ”biosimilars” to indicate that they are not exact copies but are close enough to work the same way.

On the other side stand the generic drug companies that want to make biosimilars. They see these under-the-radar lobbying efforts as a thinly veiled attempt by leading biologic manufacturers Amgen and Genentech to hold off competition. They’ve won support from U.S. Food & Drug Administration Commissioner Margaret Hamburg, who warned against reducing the public’s confidence in, or use of biosimilars. She recently predicted that competition from biosimilars would “spur innovation, improve consumer choice and drive down medical costs,” just as the generic versions of brand-name pills have done.

Generic drug makers and business groups are complaining about the legislative effort to impose paperwork generating and time-killing requirements that pharmacists inform doctors when they substitute generic “biosimilars” for name-health-care-pill-drugsbrand biological drugs, saying it is a needless hurdle that could persuade some pharmacists to just issue the more expensive drugs.

It doesn’t take a bio-chemist to see such requirements would quash consumers ability to access cheaper generic brands, and ensure the already high cost of badly needed medicines for many Texans.

American consumers, insurers and health care providers could potentially save billions of dollars a year by using cheaper versions of brand-name biologicals that now cost 10’s or 1,00’s of thousands of dollars a year per patient.

States should not move to limit access to biosimilar drugs, nor create barriers that increase costs in an already over-burdened doctor and pharmacist relationship. At a time when legislators are desperately seeking ways to keep their state fiscally sound, these bills will encourage needless and wasteful spending on name brand therapies.

Said Colorado Sen. Irene Aguilar (D-Denver,) during a Feb. 13 hearing before the Colorado House Health, Insurance & Environment Committee of a similar effort there:

“They’re concerned the clause will discourage pharmacists from suggesting a biosimilar substitution, thereby doing nothing to lower the cost of health care. 

“Right now, the bad guys on my list are the pharmaceutical guys.”

Lone Star Texas Austin State CapitolAccording to an analysis by IMS Health published August 2, 2012, generic medicines saved the U.S. health care system more than $1 trillion over the past decade, $192 billion in 2011 alone. Safe and effective biosimilars will achieve similar savings.

Clearly, patient safety has to be policymakers’ top priority. Balancing the very real needs of the Texas patients taking biologics against the public’s interest in affordable healthcare is why Austin’s legislators should be wary of impeding the arrival of biosimilars, not to mention adding an unnecessary requirement that a pharmacist obtain the permission of the prescribing physician in an already expensive, handcuffed system.

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