In the setting of metastatic cancer, if you look at the NCI-recommended treatments, you’ll find that all patients in this setting are candidates for clinical trials of some sort.

This is just another way for the NCI to say that there is no single “best regimen” to give to the “average” patient and it is therefore entirely appropriate to consider novel drugs or drug combinations for different types of cancers.

Some new drugs are so expensive that insurance companies are discussing the possibility of not paying for them outside of settings in which they have been shown - in some patients - to have provided some benefit and have received specific FDA approval for use in that setting.

It has been very routine and well-accepted practice to prescribe drugs in cancer types and disease stages outside of those in which the drugs originally received FDA approval.

Generally, however, insurance companies have paid for drugs used outside of FDA-approved settings because the treating physician finds their use in those instances to be “medically necessary.”

I would think that having additional support of drug patient-specific activity as determined by extensive laboratory pre-tests could very well bolster an argument to the insurance company in seeking payment for treatments.

One place where the clinician disparity is most obvious is the delivery of cancer benefits, according to Dr. Scott Gottlieb, a former senior official at CMS and a fellow at the American Enterprise Institute.

In a June 24, 2008 Wall Street Journal op-ed piece, he said, “Medicare doesn’t have a single oncologist on staff, yet since the year 2000 the program issued, by my count, 165 restrictions and directives on the use of cancer drugs and diagnostic tools.”

Medicare has radically expanded its authorization for use of cancer drugs by putting off-label decision making in the hands of compendia writers in the private sector, many of whom are on the payrolls of the companies that make the drugs.

An estimated 60 percent of anti-cancer drugs are used off-label. I’m all for cancer patients, particularly at end-stages, receiving these needed drugs.

However, my personal belief is in having additional support of drug patient-specific activity as determined by these extensive laboratory pre-tests to bolster the clinical justification of the drug(s) chosen, with no economic ties to outside healthcare organizations; recommendations made without financial or scientific prejudice.

Sometimes I question an occasional guideline message on the basis of profit conflicts. Specialty medical societies work to insure their specialist members get reimbursement for common procedures/treatments, the drug industry works to produce evidence statements that promote use of their brands. I am not comfortable that many clinical trials are unobjective and balanced.

How long would a drug company pay researchers who continued to disappoint with poor drug efficacy trial results? And we know that poor outcomes in drug trials are often not reported to the FDA or the public.

I just love the way medical journals and medical education companies simply list the faculty physicians/authors with their pharmaceutical payment (conflict) history, like this makes every little statement authored, squeaky clean.

If so-called respectible Journals won’t publish articles because they have a lock-up on information, don’t lay blame on me for my thoughts. The use of clinical trials to establish prescribing guidelines for evidence-based medicine is highly criticized because such trials have little relevance for the individual patient in the real world, the individuality and uniqueness of each patient.

According to the chair of the Community Oncology Alliance’s QSP Committee, ASCO has technology assessments that are very limited and updates which are not timely, and NCCN guidelines are fine but many practices use other guidelines or develop evidence-based treatment guidelines for their own individual practices or modify guidelines based on evidence which they use as their defined evidence-based standards for their practices.

It’s a lousy system in cancer medicine. The best reform to the system is to totally remove the profit incentive from chemotherapy administration. Take medical oncologists out of the retail pharmacy business and force them to be doctors again. Continuing to do so is egregiously poor scholarship and an egregious disservice to cancer patients.

IMS anticipates and expects cancer to be the Number 1 drug money maker.—–Perhaps our government should change that—and work on projects to prevent cancer.

Lilli

3. Restrictions on Use.
You may not copy, transfer, reproduce, or create derivative works from, any part of the Guidelines for any reason. You may make and retain file copies of “Insubstantial Portions” of the Guidelines solely for your internal purposes. “Insubstantial Portions” means a quantity of data from the Guidelines that would not reasonably substitute for a comprehensive copy of the Guidelines and would not prejudice or diminish NCCN’s advantage in licensing the Guidelines for commercial gain.

The purpose of any clinical practice guideline is to improve patient care and outcomes–not to fatten the wallets of McGivney and his cronies at NCCN. Also note that their annual meeting and offical jounral JNCCN profits from drug industry funding.

It would be damaging if CMS were to use these guidelines as a basis for reimbursement, as private payers usually follow the government’s lead.