Any health care reform legislation seeking to reduce cost, broaden access, and improve quality must address the promise and the expense of biologic drugs. A debate has erupted over the best way to encourage research and production of these drugs while at the same time making them broadly available to the people who need them.
The National Cancer Institute defines "biologic drug" as:
A substance that is made from a living organism or its products and is used in the prevention, diagnosis, or treatment of cancer and other diseases. Biological drugs include antibodies, interleukins, and vaccines. Also called biologic agent and biological agent.
Biologic drugs are the newest form of "wonder drugs," and many of them are enormously expensive. According to an article by Alicia Mundy of the Wall Street Journal, the top six drugs sold through Medicare Part D are biologics. She states that the anti-cancer drug Herceptin costs $48,000 annually. Jane Hamsher of Firedoglake notes that Humira, which is used to treat active cases of Crohn's Disease, costs $22,000 per year.
The health care reform legislation under consideration in Congress prohibits exclusions for preexisting conditions and abolishes lifetime coverage limits. Essentially, the law will guarantee that these drugs will be available to persons who need them. But can we afford to pay for these modern miracles?
Both the House and the Senate reform bills contain provisions that protect the manufacturers of these drugs from competition for a period of twelve years after FDA approval of the drug, but also encourage the production of "biosimilar" drugs once the twelve-year period has expired. Mundy's article in the WSJ reported that this provision, sponsored by Representative Anna Eshoo, was adopted 47-11 by the House Energy and Commerce Committee. A House Committee on Education and Labor provided the following description of the relevant provision of the House bill:
Follow-on biologics. Creates an FDA licensure pathway for "biosimilar" generic biological products, allowing these products to come to market and compete with brand name biologics. The biosimilar product must have no clinically meaningful differences in safety, purity or potency from the reference product, and may not be licensed until at least 12 years after the date that the brand-name product was licensed.
Hamsher is extremely critical of the proposed law, calling it:
protectionist legislation that puts corporate profits over access to health care.
Hamsher favors shortening the period of exclusivity from 12 to 7 years, a period that President Obama has also called for.
Representative Eshoo responded to Hamsher's criticism on October 30 in an article in the Huffington Post. She contends that the provision she sponsored bill will actually speed up the development of cheaper "generic" biologic drugs by allowing competitors to rely upon the research conducted by the original manufacturer. Rep. Eshoo states:
Under the legislation that Senator Kennedy and I championed, prospective biosimilar manufacturers would be permitted to use an accelerated approval process and utilize the clinical trials and laboratory data of the innovative product to demonstrate the safety and efficacy of their product. Biotechnology products are highly complex and, unlike traditional chemical drugs, they cannot be precisely duplicated by a second manufacturer. Our amendment would allow these follow-on manufacturers to say, in essence, "my product is close enough to the original product, and the FDA can rely on the innovator's safety and efficacy data to approve my product."
The issue of how to pay for biologic drugs is emblematic for all of health care financing reform. It underscores that we are all in this together. Almost no-one can afford to pay for these drugs out of individual earnings or savings. Hopefully as a nation we can figure out how to ensure that everyone who needs these drugs will receive them.
