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March 18, 2009 - 05:03 pm Posted in Featured comments0 Comments


The NCCN annual meeting grew in attendance again this year. In these days of slashed budgets it is rare to see growth in travel, and perhaps that speaks to the relevance of the NCCN meeting, both clinically and economically, to today’s oncology environment. Increasingly, NCCN guidelines are playing an important role in the “value” discussion. With the watershed events in ’08, i.e., United Healthcare accepting NCCN guidelines as the basis for coverage decisions and CMS officially recognizing the NCCN guidelines as a mandated reference for coverage decisions, the NCCN is clearly being brought into the managed care/evidence-based medicine spotlight.

At the recently held NCCN meeting, one of the more exciting sessions was the roundtable discussion titled, “Finding and Achieving Value in Cancer Care”. Moderated by Clifford Goodman, PhD, of The Lewin Group, the panel included Dr. Joseph Bailes (ASCO), Dr. Stephen Edge (Roswell Park), Dr. A. Mark Fendrick (Univ of Michigan Comprehensive Cancer Institute), Dr. Scott Gottlieb (American Enterprise Institute), Dr. Robert Mass (Genentech), Dr. Lee Newcomer (United Healthcare), and Lynn Zonakis (Delta Airlines).

Setting the Stage for the Discussion
Lynn Zonakis of Delta Airlines represents approximately 200,000 insurable lives at Delta Airlines. In her analysis 449 of those people drive 77% of the cost of the health plan at Delta. Of the 449 people about 25% of them are cancer patients. This is probably typical of most large companies where a small number of beneficiaries drive health care costs, thus driving the importance of value in health care including cancer care.

Dr. Bailes and Dr. Edge agreed that the rise in the number and cost of single source drugs has brought the value discussion to the forefront in the last 4-5 years. At the same time there has been an awakening in terms of quality in the last 10-15 years. Value is that balance between cost and quality.

How is Value Measured in Terms of Cancer Care?
Dr. Newcomer emphasized that value has two components: 1) an improvement in outcome, and 2) reasonable cost. But what is an affordable/reasonable cost? Cancer care providers, amongst everything else they do, are not in the best position to determine a reasonable cost, so now we’re looking for something that providers can’t demonstrate. That simple fact, the fact that there isn’t sufficient data, is at the root of the problem when trying to identify value in terms of cancer care. The current stimulus package being introduced by President Obama does not contain recognition of cost. This makes it difficult to assess quality since decisions around cost and value should be made as close to the patient and the oncologist (or any physician) as possible. The government can’t do it effectively.

Dr. Fendrick thinks we should bring health back into the health care debate. Right now the debate seems to be centering on money, not quality. Value Based Insurance Design (VBID) accounts for heterogeneity of patients. “A patient in a high-risk group for colon cancer could actually be paid to get screened, while someone in a low-risk group has to pay for their colonoscopy,” he said.

As insurance companies forecast their costs, they are raising their premiums to cover the increased costs. This is forcing some people to leave the insurance company. “The insurance companies have to decide how much they can afford to spend on a given case or they will have to drop coverage of some people. If the trends continue, we’ll see a collapse of the health care system much like we saw mortgages cause a collapse of the economic system,” forecasted Dr. Newcomer.

Dr. Fendrick pointed out that consumers don’t buy products without information on both cost and quality, and yet, “this is not true for the purchase of health care.” He further said that doctor visits are down in the US reflecting sensitivity to cost – in this environment people will stop doing the things that are of high value and the things that are of low value.

Representing a manufacturer of high cost cancer drugs, Dr. Mass reflected that the value discussion does not make him nervous. “We provide products and data so that physicians can make informed decisions, and we set a price based on the value that Genentech perceives those products bring to market”, he said.

All the panelists agreed that the driver for quality in cancer care is improved survival, however, access to the drugs and screening that extend survival cost more money. “Cost is something we should be asking for, but value is something that should be assumed,” said Dr. Edge. “Cost isn’t measurable until we have a system that provides good, consistent, measurable, quality,” he further added.

Other Interesting Contributions Included:

  • We have a tort system that prevents us from setting up rigid access guidelines. This is nice to talk about but hard to operationalize. (Dr. Bailes)
  • Clinical outcomes are objective, and value is subjective. (Dr. Fendrick)
  • In cancer care we need evidence. For example, the use of Herceptin in adjuvant breast cancer should require a co-pay of $0 from the patient. But in the metastatic patient, where there isn’t as much efficacy evidence, the patients should pay a portion for their Herceptin therapy, and so on. But this creates a logistical problem for the insurer. Imagine trying to apply different co-pays to all the different patients in a plan. (Dr. Newcomer)
  • It is unlikely that we will have a system that puts a value on one year of life the way it is done in the UK, and instead comparative effectiveness will likely extract price concessions. (Dr. Gottlieb)
  • We have a limited pot of money making small employers want to drop insurance for their employees, and many more want to. (Zonakis)

Perspective
It isn’t often you can witness a group representing a broad group of stakeholders in the room together. The only group missing from the discussion was CMS, although I’m not sure they can say anything at this time anyway. The theme of value, cost vs. quality, is reaching into all aspects of cancer care. From insurance carriers to patients to politicians to providers, all stakeholders are impacted by this discussion as we try and configure a health care system that allows access to quality cancer care at a reasonable cost.

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March 05, 2009 - 05:03 pm Posted in Featured comments0 Comments

It’s notable that in President Obama’s recent, first speech before Congress, the only disease mentioned in addressing the country’s urgent need for health care reform was cancer. Obama pledged “to seek a cure for cancer in our time,” a tall order that has so far eluded researchers.

Each cancer drug approval and every trial represents yet another step towards achieving that elusive goal. Yet we were reminded again of the risks associated with cancer drug development last week with the negative outcome of the Phase 3 study evaluating elesclomol [Synta, GSK] in melanoma. With that in mind, we wanted to pique your interest in looking at OBR’s RADAR, just updated, to see what’s on the horizon in 1H09 for oncology drugs in the way of pending FDA decisions and anticipated key clinical trial data:

Pivotal Phase 3 results due:

  • Mid-April 2009: Avastin® [Genentech/Roche] adjuvant colon cancer data from the NSABP C-08 trial
  • April 2009: Provenge® [Dendreon] advanced prostate cancer data from the IMPACT trial
  • June 2009: picoplatin [Poniard] small cell lung cancer data from the SPEAR trial

Upcoming PDUFA action dates:

  • March 9, 2009: Afinitor® [Novartis] for advanced kidney cancer
  • May 24, 2009: Clolar® [Genzyme] for adult acute myeloid leukemia (AML)
  • July 2, 2009: Zevalin® [Spectrum Pharmaceuticals] as first-line consolidation therapy in B-cell follicular non-Hodgkin’s lymphoma (NHL)

OBR Radar was developed to keep our reading audience ahead of market moving events in oncology. For more information and the latest updates, go to http://www.obroncology.com/radar.php or just click on the RADAR icon in any edition of OBR daily.

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