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