NCCN backs pro-Provenge

The influential National Comprehensive Cancer Network (NCCN, has given Provenge its top rating. Although Medicare often follows NCCN guidelines, “In this climate I’m not sure that [NCCN] would have the same influence it has had in the past,” Dr. Pitre said, “but in the past, when the NCCN gave a new drug that kind of a rating, Medicare accepts that these very major cancer centers feel that it’s a worthwhile treatment and [goes] along with it [in terms of approving payments].”

Still, he observed, “I don’t know that [Medicare has] had to face anything at this price point. There’s not been anything that I’ve ever been asked to offer a patient that has been that costly.”

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However, Dr. Pitre said, “I think if a patient has the means and participates in his care and has choice involved, having these advances is a tremendous benefit to the advancement of treating cancer and advancements in medicine in general.”

Dr. Brody said he believes that the public-cost issue is at the crux of the ethical questions integral to the adoption of Provenge. “If this were just a question of people paying out of their own pocket, very few people would be able to get it, and that would be their own private choice,” he said. “But this is really a question of whether we as a society are prepared to spend this type of money. You might say, ‘Well, we can handle the cost of Provenge,’ but the question is, how much can we keep on paying for very expensive drugs, because there are plenty of them and there will be many more.”

Running counter to Dr. Brody’s prediction that most eligible patients will want to use Provenge is Dr. Pitre’s claim that most of his own patients probably would not choose that route. “At that point, where they’ve really fought the disease for as long as they have to get to the point [of being candidates for Provenge therapy], burdens of therapy are going to become increasingly prominent and the return for extending life in a battle where the cancer seems to be winning is often not necessarily something they want to continue,” Dr. Pitre said.

Even patients who are clamoring for Provenge are likely to have a long wait. “There’s going to be a shortage for a year or two,” Dr. Brody said. “There are a lot of people who could take this medication, but [the manufacturer doesn’t] have the production facility.

This situation poses a more immediate ethical consideration: Who will get the drug in the short term?

Strains on health-care resources notwithstanding, Dr. Pitre is glad patients have Provenge as an option. “One of the concerns that I have for any single-payer system, where we then are in de facto rationing mode, is that Provenge wouldn’t be something that we’d be talking about,” he said.

“But we’re in a country where patients still do have choices and individual resources and I think there’s nothing morally wrong or unethical about a patient wanting to avail himself of any treatment, even at this cost. I think that’s the beauty of our system, where we have a lot of incentives in place to develop newer and better technologies, and we have a very responsible consortium of cancer centers around the country that participate in these kinds of evaluations. So the system is alive and well in basically allowing for the development of advances and technologies, and in this case of an immune therapy, that’s sort of exciting.”

Dr. Pitre feels that another good reason to have access to a therapy like Provenge is the on-the-job research that usage provides. “Although Provenge isn’t a cure per se, we don’t know where these kinds of things will lead,” he explained. “Someone could get a good immunoresponse and go into a more sustained remission.”

Despite the NCCN’s support of Provenge, on June 30 the Centers for Medicare and Medicaid Services (CMS) initiated a National Coverage Analysis (NCA) of Provenge. Dendreon issued assurances that NCAs do not impact existing coverage decisions, nor do they restrict local Medicare contractors from covering Provenge. “Therefore, Medicare beneficiaries are still able to access Provenge and private payers can also still cover Provenge,” the company said in a press release (

With the NCA being an estimated 12-month process (which includes two public comment periods), CMS should issue a decision sometime around early summer 2011 as to whether paying for Provenge is “reasonable and necessary.” As to whether the high price tag of the vaccine will hurt its chances, “Price has nothing to do with our coverage decisions,” a Medicare spokesperson told Renal & Urology News. “We consider only if [the agent] works and is beneficial to patients in our population groups (mostly seniors).”

Coverage by private insurance

Oncologist Lee H. Newcomer, MD, MHA, senior vice president for oncology at UnitedHealthcare, one of the nation’s largest private health insurers, said the company’s policy is to cover a drug if the NCCN recommends it. Even without the NCCN’s blessing, however, UnitedHealthcare would reimburse for the vaccine. “Because Provenge is an FDA-approved drug, we have to approve it for patients who meet the [FDA] indication,” Dr. Newcomer explained. “So either way, we are covering the drug, but what we’ll do is limit the [coverage to recipients] who have the exact clinical situation the drug was approved for.”

In other words, off-label use will not be reimbursed. Patients being administered Provenge as adjuvant therapy or as a precursor to hormonal therapy will fall outside UnitedHealthcare’s coverage parameters. Yet even with these strict guidelines, and the fact that there are probably only about 30,000 men who meet the specific indications for Provenge use, premiums will no doubt rise.

“The best way I can reflect what has happened because of the Provenges of the world is to talk about a minimum-wage worker in California,” Dr. Newcomer said. “In 1970, that worker could buy a health plan that covered his family of four for 15% of his income. In 2007, that same minimum-wage worker would have to spend 102% of his income to buy the same insurance policy.”

As Dr. Newcomer sees it, the economic problems in prostate cancer extend far beyond Provenge. Consider radiation therapy for prostate cancer, he said. “I can get seeds implanted for about $8,000. I can get IMRT [intensity-modulated radiation therapy] for, what, $35,000? Or I can get proton therapy for $130,000 to $150,000. And guess which one is most popular: Everyone wants to do proton therapy.”

According to Dr. Newcomer, the benefit of proton therapy is far smaller than that seen with Provenge. “So one of the amusing things to me is that we’re concerned about Provenge therapy, which won’t affect very many people, but we’re more than willing to pay four times more than we should for proton therapy.”

As for Provenge, Dr. Newcomer described it as scientifically important but currently clinically insignificant. “This is a new way of approaching cancers, and it obviously does have a response,” he said. “But I don’t think it has enough of a response yet [such] that it’s ready to take to the clinic, particularly at the price point it has today.”

Perhaps one of the most remarkable aspects of Provenge is not what it does, but what it does not do. “It’s very important to understand that this vaccine has no known objective anti-tumor activity,” Dr. Dreicer, of Cleveland Clinic, said. It does not shrink lymph nodes, it does not decrease PSA levels and bone pain, and it does not make patients feel better. “We still don’t truly understand Provenge’s mechanism of action,” Dr. Dreicer said.

This clouds the bioethical matters even further “because we’re talking about somewhat of an ethereal experience: taking an asymptomatic patient with castrate-resistant metastatic prostate cancer, treating him, and understanding that there is the potential to improve his survival but that it does not change the other kinds of interventions that are going to be required to manage him,” Dr. Dreicer said.

The bottom line is that no precedent exists for this kind of intervention. “That—in addition to its costs, of course—is why Provenge is such a paradigm-shifting kind of development,” he said. It does not fit into the routine therapeutic paradigm in which the introduction of a new treatment delays the use of another treatment.

Dr. Newcomer compared Provenge to Avastin (bevacizumab), which costs about $60,000 for an average gain of three months of life for breast cancer patients and approximately $250,000 for one year of additional life for lung cancer patients. “And what is happening today is that insurance is becoming unaffordable because we don’t have an answer to that question of how much are we willing to pay. We just keep paying it, and raising premiums,” he said.

“I think the more important thing here for the United States to decide is how much are we willing to spend for a year of life gained. We have to raise premiums to cover the cost of these drugs—everyone’s premium. That includes a new infant, that includes a 20-year-old, that includes a 65-year-old. All of them will see premium increases as we pay for these new drugs.”

In a straight Medicare plan, the government pays for the patient. In a Medicare supplement plan, the government pays 80% and UnitedHealthcare pays 20%. In a Medicare Advantage plan, the risk is UnitedHealthcare’s, with Medicare paying the premium on behalf of the member. “The fact of the matter is, our failure to address a question like Provenge means more people won’t be able to afford insurance,” Dr. Newcomer warned.

Although other physicians have mentioned the possibility that Provenge could eventually come down in price, Dr. Newcomer disagrees. “I challenge you to find me a single new biologic drug whose price has dropped—I can’t name one.”

In fact, he remembers when two drugs similar to one another, Nexavar (sorafenib) and Sutent (sunitinib), both became available for the treatment of kidney cancer. “In a normal market, prices drop when the second drug comes out, but in this case, both prices went up. These are very specific drugs that don’t go generic and don’t have competitors. You don’t see prices drop with these new technologies; if anything, they increase. Avastin has been on the market for a very long time. Its price continues to rise.”

Bioethicist Dr. Brody observed: “We are unique, really, in the developed world, in that we have pricing just set by the company without any social input, and that’s why the pricing is that high.”

Compare the American system to that in Germany, where prices are controlled by the government, he said. “The German government just announced that they’re going to demand a 50% cut in the price of all generic drugs,” Dr. Brody said. “They’re saying, ‘That’s all we’re going to pay you.’ And essentially they’ve been able to do this in the past and their intention is to continue to do this in the future.”

Pricing is an issue society as a whole has to consider, Dr. Brody said. “Why do we allow pricing to take place in the way we do?” he asked. “Part of the incentive of the drug companies is that they need to recover the costs of research and development, but why are we the ones paying for research and development here, and European countries are not?”

Dr. Newcomer sees the situation this way: “As a society, we’re going to have to say, ‘Listen, all you very, very bright people who are creating new technologies: Find us one that either is affordable or that really makes a breakthrough and is worth the cost.’ For example, if Provenge caused a four-year prolongation of life instead of four months, I don’t think anybody would mind the $90,000 price tag. Do you?”