Prostate Cancer Policy Update: The Advocate’s Prostate Cancer Battle

That battle against prostate cancer is fought on many fronts:  Patients, their families and medical providers actively fight the disease, researchers toil to find the right combination of molecules or technology to find, treat and prevent the disease, and advocates raise awareness and labor to change public policy.  This multi-theater struggle is to end suffering from the most common form of cancer in men according to the CDC.

Men do not provoke an altercation with prostate cancer.  It tragically enters men’s lives with little reason.  Similarly, the government seems to have taken on these same men, unprovoked and with little reason.  We need to look no further than the recent unconventional actions by the government surrounding prostate cancer.

Just at the end of last month, the U.S. Preventive Services Task Force (USPSTF) canceled a meeting for early November where a vote on prostate cancer screening was on the agenda.  The USPSTF currently does not recommend prostate cancer screening which means that it was not covered under the health insurers minimum requirements in the Patient Protection and Affordable Care Act citing insufficient evidence that the benefits outweigh the harms.

Following cancellation of the meeting, Kenneth Lin, a family practitioner, USPSTF task force member, and medical officer for the Association for Healthcare Research and Quality, indicated that the decision to cancel the meeting was political.  As a result of his perception that “politics trumped science,” Dr. Lin stated he would resign from AHRQ and the task force.  No one in the advocacy community knows the outcome of such a vote. The point is, an insider has described the process as political and this is a major lesson learned for new health care advocates.

If anyone thinks that Dr. Lin is being cynical, we only have to recall Secretary Sebelius’ successful advocacy that congress ignore the most recent USPTF mammogram recommendations.  The PPACA states that the guidelines from the USPSTF recommendations are to be followed when determining minimum preventive screening coverage, except for one line that is due in part to the Secretary’s advocacy.   Section 2713(a)(5) of the PPACA states “for the purposes of this Act, and for the purposes of any other provision of law, the current recommendations of the United States Preventive Service Task Force regarding breast cancer screening, mammography, and prevention shall be considered the most current other than those issued in or around November 2009.”  This should serve as a lesson to all advocates.  Healthcare is political.  The right combination of hard work, preparation and advocacy can result in Congress writing an exception into a major piece of legislation.

Given this truth, we know the same men, families, researchers, medical providers and advocates must now pull themselves through the swamp of Washington’s politicians and bureaucrats to achieve the changes that will advance treatment and improve lives.  This theater is primarily the responsibility of advocates and given the evidence presented this is no time to relent.

Tomorrow, the advocacy community and patients will descend on Baltimore for a fifteen minute public comment period at the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting.  Some advocates and patients will travel many hours for their thirty second to one minute opportunity to speak the appointed committee members.

Unlike the USPTF meeting, this meeting will not be canceled.    Tomorrow, MEDCAC will consider if Medicare, the largest single healthcare payor, will cover Provenge, a new prostate cancer treatment option.  MEDCAC was established to provide independent guidance and advice to the Centers for Medicare and Medicaid Services (CMS). MEDCAC is supposed to supplement CMS’ internal expertise and to allow an unbiased and current deliberation of “state of the art” technology and science. Medicare is not supposed to take cost into consideration when making such decisions and rulings.

However…based on the evidence above, we might consider that, in fact, it is about cost. Provenge’s total cost is approximately $93,000.  A recent Milliman Consulting report (May 2010) shows the average annual cost of chemotherapy is $111,000. CMS may ration access to Provenge and other life-saving cancer therapies as a cost saving strategy.

Provenge was recently approved by the FDA after almost 15 years of development, $1 billion of funding, and more than 15 studies evaluating its safety and efficacy. Many were surprised (including Senators John Kerry and Arlen Specter) to learn CMS initiated the National Coverage Decision (NCD) process.  Many scientific and clinical experts at both the FDA and the National Comprehensive Cancer Network who support the use of Provenge for asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

Based on consistent results from multiple Phase III trials which showed this therapy improved a patient’s chances of being alive at the milestone 3-year mark by 38% and, for the first time ever in this advanced prostate cancer patient population, demonstrated that patients on treatment had a median life expectancy beyond two years (25.8 months), full FDA approval was granted on April 29th of this year.

A few short weeks later, the prostate cancer panel experts of the National Comprehensive Cancer Network designated this therapy as a Category 1 treatment. This is defined as “supported by high-level evidence (e.g. randomized clinical trials)” and for which there is “uniform NCCN consensus” among experts in prostate cancer treatment. Only 18% of all products reviewed receive Category 1 designation, demonstrating the value and importance of such a designation.

Aside from Provenge, the meeting will be a bellwether for other innovative drugs that have a high cost due to the investment in research.  Note that in metastatic cancers of any kind, only three drugs have ever been approved with a four month or greater survival benefit, and that each (Herceptin, Avastin, and Alimta) has revolutionized the treatment of that cancer.  If Provenge is unapproved for payment, it may lead pharmaceutical companies to take less risk on innovative products since it is not likely to be covered by Medicare.  While it is Provenge and prostate cancer that come before MEDCAC tomorrow, it may be an innovative biologic for breast cancer in the near future.  Or, if Provenge is not approved for payment, that innovative breast cancer drug may never be considered for development.

Well…we will see where the battle lines are drawn tomorrow.

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