Pharmaceutical companies are starting to act like a lot of other for-profit organizations by offering money-back guarantees on their drugs. Companies such as Johnson & Johnson and United Healthcare are presenting "risk-sharing" programs to governments with single-payer, universal health care systems, as well as to private health insurance companies in the United States.
Risk-sharing agreements first started to gain international attention with the marketing of the cancer drug Velcade, generically marketed as bortezomib. A British advisory board originally ruled against administering the drug due to cost-effectiveness issues, even though it had been approved to treat relapses of the bone marrow cancer multiple myeloma. The board ruled that the drug's results, in relation to its overall costs, simply weren't worth it. A group of women diagnosed with the disease, known as the Yorkshire Three, protested the decision and took the government to court, forcing the board to reconsider. Johnson & Johnson subsequently proposed the risk-sharing agreement as a means to get Velcade on the market.
"If we didn't enter the risk-sharing scheme, we wouldn't really have a market here in the U.K.," said Pete Smith, British manager for Biogen Idec. Under Johnson & Johnson's proposal, all patients would be eligible to receive four cycles, at $24,000 cost per patient. If the tumors shrank sufficiently, measurable by a blood test, treatment would continue, usually for another four cycles, and the national health service would pay. If the tumors did not shrink, treatment would stop, and the government would get its money back.
Such agreements could have tremendous benefits for states like Texas, with an overburdened health care system, and over 25% of its population going without any health insurance whatsoever. Risk-sharing strategies may eventually lower the costs of certain treatments, thereby reducing risks to health insurers -- in turn, making coverage more affordable. It may also provide relief for cities like Austin, Dallas, and Houston, which are scrambling to conjure up ways to pay for the costs of treating all those without coverage coming in from rural areas to seek treatment.
As foolproof as such ideas sound, however, the proposal still has its glitches. The British government and Johnson-Cilag -- the unit negotiating the deal for the pharmaceutical company -- disagree on precisely what constitutes "sufficient" shrinkage. The British government wants to designate cost-effectiveness as "partial response," measurable as a 50% reduction in a particular protein produced by the tumors. Johnson-Cilag argue that a "minor response," or a 25% reduction in the protein, is enough to constitute continued treatments. Further complications come into play when experts argue that some patients show only a minimal response after four cycles, but later go on to have complete remission due to continued administration of the drug.
The need for risk-proposal strategies has become one criticism of single-payer, universal healthcare systems. Under such systems, a drug is often only given when it is deemed "cost-effective," meaning that the medication is evaluated based on "how much the health system must pay to achieve certain gains in length and quality of patients' lives." But quality of life is very subjective indeed. How much is a drug "worth" -- how "effective" is it -- if it only saves a few lives, or when the same effects leave some patients miserable, and others quite content? It would be difficult to explain to family members that their loved ones died because the drug that may have saved them wasn't "cost-effective" enough on a national level to administer.
The current American, privatized health insurance system has its own pros and cons. A major benefit is that state and federal regulations, as well as marketplace pressures, make it more difficult for an insurer to refuse to pay for a drug already approved by the Food and Drug Administration (FDA), regardless of price.
On the other hand, drugs are often approved by the FDA through similar "effectiveness" evaluations - i.e., at least partially, in terms of how effective the drug is statistically compared to its costs. A drug may show promising results for a few patients, but still may not be approved. "Market pressures," while pushing insurance companies to make FDA-approved drugs available, may influence the approval process itself through lobbyists and other organizations with a vested interest in the "cost-effectiveness" of pharmaceutical companies themselves.
Risk-sharing proposals would make it easier to allow doctors and health insurance companies to offer experimental and expensive treatments without great financial risk, thereby eliminating much of these back-and-forth market pressures. Drugs may also eventually be priced based on how well they actually work, making those with statistically lower results less expensive to try.
Cigna, a major health insurer in the U.S., is trying to force manufacturers of cholesterol-lowing pills, like Lipitor, to pay for the costs of treating patients who consistently take the drug, but still experience heart attacks. United Healthcare, another larger insurer, is also entering "risk-sharing experiments" with companies like Genomic Health, which administers a genetic test that may determine whether women with early-stage breast cancer would benefit from chemotherapy.
Some pharmaceuticals, like Genentech, maker of expensive cancer treatment drugs, refuse to enter into such agreements, saying they already try to make their drugs available to lower income patients. "The point is to try to make the manufacturer responsible for how their product is used in the medical marketplace," commented Dr. Lee Newcomer, senior vice-president for oncology at United Healthcare.
So what does the public actually think? Anthony Farino, pharmaceutical industry consultant at PricewaterhouseCoopers, is convinced it will be in support of risk-sharing proposals. "I think payers will say, 'If the product works and it creates value, we will reward you for it. If not, we won't reward you.'"
But thinking of a life-saving drug -- even if it only saves a few lives -- as a "product" to be "rewarded," chafes against many people's inclination toward compassionate care, no matter the cost or "reward."
"Personally, I think it's despicable to view these drugs as cost-effective products, on any level," said Anne, an administrative assistant with minimal health coverage. "Since when did my life and death become some commodity to be bought and sold at the right price? If I get some horrible disease and the technology exists to save me, shouldn't I be given that chance, regardless of how much it costs?"
Being aware of government policies affecting access to drugs is an important part of watching out for your health. How you take care of yourself will certainly affect you as you age, and eventually your wallet, as well.
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