Guest blog: Connect the dots on the Provenges, the Makenas, robotic surgery systems & proton beam facilities

Harry Demonaco photo.jpgThe following is a guest post submitted by Harold DeMonaco, director of the Innovation Support Center at the Massachusetts General Hospital and one of our most active expert story reviewers on
Last week’s New England Journal of Medicine had two rather provocative and thought provoking perspectives.

The first relates to a decision by the Center for Medicare & Medicaid Services to re-evaluate its decision to reimburse for Provenge. It was entitled, “Listening to Provenge — What a Costly Cancer Treatment Says about Future Medicare Policy.” Provenge has the distinction of being the most expensive approach to the treatment of any cancer. It was approved by the Food and Drug Administration for the treatment of advanced prostate cancer and demonstrated a median improvement in survival of 4.1 months in clinical trials. The treatment costs are approximately $100,000.

Why is this important and why should journalists have picked up on this article in the NEJM? There were about 190,000 men diagnosed with prostate cancer in the United States in 2009. Twenty to forty percent of them will receive androgen deprivation treatment. That’s between 38,000 and 76,000 men annually who would presumably be eligible for treatment. The bill for those 4.1 months is $7.6 billion. Medicare spent about $500 billion in 2010. This one drug will add about 1.5% to that expenditure.

Given the debate about the future of Medicare and the proposals to replace it with a voucher system, one would have assumed that this would have been newsworthy. This is exactly where the debate of the future of Medicare should be focusing. Can we afford to continue to pay for treatments that provide what many would call a marginal benefit? Can we afford not to? Although the increase in survival was only 4 months (from 21 months to 25 months), some men survived longer. Of course some did not. The final decision on Provenge will be interesting and will likely provoke a maelstrom of complaints regardless of the outcome.

The second article relates to the recent approval of Makena. It was entitled, “Unintended Consequences — The Cost of Preventing Preterm Births after FDA Approval of a Branded Version of 17OHP.” Makena is a version of an existing synthetic progestin that has been used since a 2003 study demonstrated its value in preventing premature labor. 17OHP (the abbreviated version of the drug name) has been available from compounding pharmacies with a 20 week course costing about $300. Earlier studies demonstrated the Number Needed to Treat is 14 so the cost of preventing a premature birth is $4,200. The direct cost associated with a premature birth is $33,200. That was until the FDA approval. K-V Pharmaceuticals has priced Makena at $29,000 to the pharmacy for the same 20 week treatment. Based on this pricing, the direct costs for preventing a premature birth is $406,000.

These drugs represent significant health policy issues. Both deserve considerable thought and assessment prior to any judgment on the part of the public. So, while there has been some news coverage of these drugs, journalism could provide a better public service by dropping back to address the bigger picture for news consumers and health care consumers. Connect the dots on the Provenges, the Makenas, the robotic surgery systems and proton beam facilities – more often, more emphatically, more broadly – to help citizens understand why we lead the world in percentage of the GDP devoted to health care spending without a concomitant world-leading rank in health care quality and outcomes.

By Harold DeMonaco

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May 10, 2011 at 2:39 pm

I am shocked at how uninformed Delmonaco’s rant against Provenge and other medical breakthroughs was. In 1980 the average cost for treating colon cancer was $20K, about $42K in 2010. In 1980 the average five year survival rate for colorectal cancer was 50 percent for people age 45 and over among patients whose cancer had spread to lymph nodes Today the average cost of colon cancer therapy is $40K with a 5 year survival rate at a similar stage is 70 percent. The age-adjusted death rate was 17.6 per 100,000 men and women per year. These rates are based on patients who died in 2003-2007 in the US.
Advances in interceding years provided, as you described Provenge (which has extended the life expectancy of end stage prostate cancer patients by 2 years) marginal benefit. That’s on top of a decline in mortality rates from previous treatments and increase screening.
David Cutler noted that “age-adjusted cancer mortality increased by 8 percent between 1971 and 1990, twice the increase from 1950 through 1971. However, between 1990 and 2004, age-adjusted cancer mortality fell by 13 percent. This drop translates into an increase in life expectancy at birth of half a year–roughly a quarter of the two-year increase in life expectancy over this time period and a third of the increase in life expectancy at age 45.” Similarly, Murphy and Topel estimate that a 1 percent reduction in cancer mortality would be worth $500 billion. Since the death rate from prostate cancer has decline by 37 percent since 1992, the worth of that reduction is $18 trillion.
So would you not have spent more money on increasingly more expensive drugs because at that point in time the benefits were marginal.
That begs the question: would you (Schwitzer and DeMonaco) forfeit the gains in health derived by increased screening and better drugs over the past 30 years to buy more of the kind of cancer care we had in 1980.

Harold DeMonaco

May 11, 2011 at 8:11 am

I thank Dr. Goldberg of the Center for Medicine in the Public Interest, for his comments. My intent was to stimulate discussion and he has indeed provided a wonderful opportunity for ongoing dialogue. It is only through such dialogue that the public can in fact fully appreciate the costs and benefits of new therapies.
Having said that I should point out that my comments are in fact mine and not those of the MGH or Partners Healthcare. In his response, Dr. Goldberg provides a set of interesting statistics, some of which are relevant to my guest blog. My original comments were directed toward two articles in the New England Journal of Medicine, one discussing the ongoing Medicare review of Provenge coverage and the second on the fiscal impact of the FDA approval of Makena and the lack of news media coverage for either. Dr. Goldberg apparently takes umbrage with my suggestion that the costs and benefits of new pharmaceuticals should be part of a national debate on healthcare costs. This position is not surprising given his organizational affiliation and he is certainly entitled to his opinion. Again my intent was to question why the media did not cover two very important articles in one of the most prestigious medical journals published. I believe that the media has an obligation to inform the public on both sides of these issues.
In his comments, Dr. Goldberg suggests that Provenge has been demonstrated to improve prostate cancer life expectancy by 2 years. I am not aware of any supporting data for this level of effectiveness. Based on the data submitted by the manufacturer to the Food and Drug Administration, Provenge increased life expectancy by a median of 4.1 months. My source is the FDA and the manufacturers package insert. I am not aware of any published literature supporting the effectiveness suggested by Dr.Goldberg.
Open and honest dialogue is critical to any debate. There are always two legitimate sides to any debate. While I may disagree with Dr. Goldberg’s position and that of his organization, the national debate requires they be heard. I would hope however that hyperbole would be limited to rhetoric and not to data. Far from the Luddite that Dr. Goldberg suggests, I have been a technology geek all of my professional life. Innovation is indeed the lifeblood of our economy and the best possible answer for health care’s many ills. And for the record, the last name is DeMonaco.