The issues of appropriateness, compliance, cost-effectiveness, patient selection and symbiosis (ACCESS) are vital to both health care and pharmaceutical industries and define their possible relationship.
"At this moment, Medicare’s rules – yes, the same Medicare that’s slated to go broke in a decade or so – forbid it to consider cost in its coverage decisions. Rather, its mandate is to cover treatments that are 'reasonable and necessary.' So if Medicare comes to believe that a new chemotherapy will offer patients an extra week of life at a cost of $100,000 per patient, it is pretty much obligated to cover it. This is insane, obviously, but such are the rules."
Robert Wachter, MD, asks, Are We Mature Enough to Make Use of Comparative Effectiveness Research? 2/24/09.
What costs are reasonable?
Variation research, originally developed by Dr. Jack Wennberg and since by Elliott Fisher, MD, MPH has proven that cost and quality vary in unexplained ways from region to region, regardless of clinical evidence. Moreover, it does not explain health care outcomes. "In other words, plotting a 2x2 table with costs on one axis and quality on the other, we see a state-by-state Buckshot-o-Gram." The implication is that health care is unnecessarily costly, the results do not follow the investment and evidence-based medicine would help "move all providers and patients into the high quality, low cost quadrant on that 2x2 table." And then there's the matter of the "Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), which concluded:
"Thiazide-type diuretics are superior in preventing 1 or more major forms of CVD and are less expensive. They should be preferred for first-step antihypertensive therapy."
Nevertheless, returning to Wacheter: "The study, which took nearly a decade and cost over $100 million, was largely ignored – six years after its publication, the number of hypertensive patients on diuretics has bumped by an underwhelming 5% (from 35 to 40%)." The issues I will touch upon in this column are fundamental to health care reform and to survival of the Pharmaceutical and Medicine Manufacturing (PMM) industry, as we know it. Note: the "Pharmaceutical Research and Manufacturers of America (PhRMA), the lobbying group that helped push through the Medicare Modernization Act of 2003 — a bill that both prevented Medicare from bargaining over drug prices and locked in huge overpayments to private insurers....The point is that there’s every reason to be cynical about [some of the] players’ motives. Remember that what the rest of us call health care costs, they call income.
What’s presumably going on here is that key interest groups have realized that health care reform is going to happen no matter what they do, and that aligning themselves with the Party of No will just deny them a seat at the table."
Yes, some of the discussion is rather politcal, vested interests and all. To quote Andrew Grice, "Charles Clarke added: 'We need to talk straight to people, engaging the concerns and questions that they have, rather than appearing to evade and dissimulate.'"
Andrew Grice; Clarke: Brown Succession Is Not A Done Deal; The Independent (London, UK); Mar 29, 2007.
Some of this discussion is sticky, as well—affordability verses profits; how to get the right care at the right time and place and why managed care often has failed at that; and incentive alignment verses counterproductive or even inimical incentives. Solve these and all the critical players will have the best chance to meet their needs and achieve their personal and business objectives. This promise extends not only to patients and practitioners, but also to the PMM industry so that it can profit and grow even as it shifts its paradigm to indirectly and without a conflict of interest, helping patients.
Let me be clear - - I know the Fed doesn't know how to handle the 'conflict of interest part,' but it will when things are more transparent (and that is inevitable). I also know that diuretics are not state of the art and other medications may be incrementally or even overwhelmingly better. But, I'm also for market share and I want the PMM industry to recoup their investment and make a reasonable profit. I embrace GSK's motto: "Helping people do more, feel better, live longer." In other words, I want part of that and it comes in the form of help using your meds and approaches to better manage my patients. At the end of the day, I want the PMM industry to be about achieving optimal patient outcomes, first; shareholder happiness will result, as well, but to get to that objective, let's keep our eye on the ball! This column will review the situation, as it is for both our industries, the obstacles and the potential solutions.
I'd like to pose a question to those in the PMM industry: notwithstanding the FDA restrictions (which are, quite frankly hard to understand unless one views the Fed as a threatening parent), why aren't you helping me, a practitioner, better manage appropriateness, compliance (i.e., adherence to therapeutic regimes), cost-effectiveness, and patient selection as a symbiotic partner to my practice?