The Wrong Kind of Cancer

As he has been doing every Monday for the past six months, last Monday Shmuel Leib made his way from his home in Kiryat Bialik to the Rambam Medical Center in Haifa, a 45-minute trip.

As he has been doing every Monday for the past six months, last Monday Shmuel Leib made his way from his home in Kiryat Bialik to the Rambam Medical Center in Haifa, a 45-minute trip. His wife Michal drove him in the family car. The other times Leib made the trip to Rambam, he was sent straight back home without treatment. The drug that he needs, on his doctors' recommendation, is not included in the health basket - the package of benefits available to members of the compulsory national health insurance scheme through the health maintenance organizations. The cost of the drug is $1,500 for four treatment sessions at weekly intervals, and Shmuel Leib is unable to pay.

In 1998 Leib was diagnosed with prostate cancer. He was given radiation therapy and apparently recovered. Then the illness recurred. Leib underwent chemotherapy treatments, but there was no improvement in his condition. His oncologist, Dr. Eliyahu Gez, believed that the drug Taxol could help him. However, Taxol is listed in the health basket for treatment of lung cancer, metastasized breast cancer and metastasized ovarian cancer - not prostate cancer. But the cancer in Leib's prostate had grown worse and metastasized to his bones and his lungs.

It is true, and even regrettable, they told Leib at the Maccabi Health Services HMO and at the Ministry of Health, but in the health basket instructions it is explicitly stipulated: lung cancer - yes; metastasized ovarian cancer - yes; metastasized prostate cancer - no, even if it has metastasized to the lungs. It was Leib's misfortune simply to have come down with the wrong kind of cancer. In fact, Taxol is not even listed in the Israeli pharmacopeia as a medication for prostate cancer, a necessary stage before a drug can become part of the health basket.

With a donation from the company that imports Taxol to Israel and money he collected from friends and relatives, Leib paid for treatment with Taxol for a number of weeks and his condition improved considerably. But Leib's money ran out, as did the donation from the drug importer. Dr. Gez therefore wrote to Prof. Harry Brenner, formerly Maccabi's oncology consultant, and asked him to recommend that Maccabi pay for the treatment. But it turned out that administrative instructions are stronger than medical needs. Dr. Karny Rubin, the Health Ministry ombudsman, and Miki Halevi, the ombudsman at Maccabi, replied to Leib that, to their great regret, they could not help.

`With God's help'

"Maccabi will make every effort to help you within the framework of the National Health Law," concluded Halevi in her letter to Leib. Recently, the government decided that it would not allocate funds for expanding the health basket in 2003. This means that new medications and treatments, even those that save lives, will not be given with government funding. How then does Maccabi intend to help Leib in the framework of the law, as Halevi wrote? Will the committee for the expansion of the health basket convene to discuss which drugs to add with money it does not have? And, until such time as Taxol is recognized as a drug for the treatment of prostate cancer, will Leib remain alive?

Shmuel Leib is 55, the father of four children and the grandfather of five - two of them, twins, born two weeks ago. "I'm a crane operator for Israel Railways," he relates. "At first, after I fell ill, I was still working, but after two months the drug therapy began to affect me and I stopped working. Now the National Insurance Institute (NII) is supposed to determine my handicap for the purpose of receiving a stipend. My wife works and earns NIS 5,000 a month, and all the money goes to medications.

"You are dependent on a drug and without it, you can say goodbye," he adds. "I wouldn't wish what I'm going through on my worst enemy. Until you experience this, you don't understand. First of all, there's the nausea. Then you perspire even when it's cold outside. My head spins and I throw up all the time. Food tastes bad, you don't eat anything and you just have diarrhea all the time. My hair is falling out and I've lost 15 kilos. I don't know what to do. All I want is to live."

Leib pauses a moment, and then continues. "I pay supplementary insurance and Maccabi Zahav [upgrade] and everything is fine until it comes to serious illnesses. I've written letters to the health minister and everyone, but nothing helps. Everyone tells you that the drug isn't in the basket, and that's it. Am I going to make a scene? Overturn tables? It's not my nature. So I go home and eat my heart out. My wife sits there and cries and I, a secular person, all I have left to say is: `With God's help.'

"Next to me in the department there were men and women who were getting Taxol," Leib continues. "I don't know what their diagnosis is, or whether their illnesses are included in the health basket, or maybe there are people there with connections. I don't feel comfortable asking. What can I tell you? It's a nightmare. Who can I turn to? If it were one of their people, the director-general of a government ministry, someone from the Health Ministry - believe me, he'd be getting the drug. But that's how it is. There is medicine for the rich and there is medicine for the poor. If you have money you live and if you don't have money you die. Then they'll throw you out of the hospital and they'll give you morphine to ease the pain, until you die." Last week Shmuel Leib managed to raise the money from his children, and received the treatment that will perhaps give him an extension, a chance to request reconsideration of the death sentence imposed on him by his illness and the inflexible rules of the health basket.

The family will pay

There are many more cases like Leib's, some of them equally absurd. About a month ago the Association of Health Consumers - the representative organization for patients in Israel - was contacted by the father of a 22-year-old cancer patient. The father told Medad Gissin, the chairman of the organization, that two years ago, Maccabi helped fund a liver transplant in France for his son, at the cost of NIS 1 million. Now the son needs a certain drug for the treatment of lymphoma, which is not included in the health basket. The cost of the drug treatment is NIS 40,000, and Maccabi is refusing to pay.

"This is thoroughly absurd," fumes Gissin. "I told Maccabi: `You've already invested money in him for the transplant, you saved his life. For the NIS 40,000 that the medication costs either he will die or he will need another transplant, which will cost you more money. Forget the health basket,' I said to them, `you've already invested money in him and you've saved his life.' But they are afraid of the precedent."

Gissin knows full well what the fate of the son will be: "Who is going to let his son die? The family will make every possible effort to get the money."

Two and half years ago, H. underwent a bone marrow transplant at the Hadassah University Hospital in Ein Karem, Jerusalem. For years after the transplant he was treated at Hadassah with the drug Doxil and his condition improved gradually. Doxil is included in the health basket, but the diseases it is designated to treat do not include the illness from which H. suffers, so Hadassah Ein Karem bore the entire cost of the treatments. At a certain stage, the funding stopped. H. turned to the Kupat Holim Clalit HMO, with which he is insured, and asked to be provided with the drug. He received a negative reply. True, it is a matter of life or death, but the drug is not in the basket.

The chair of the Society for Patients Rights in Israel, Adina Marx, wrote to Health Minister Nissim Dahan last June about the case of H. "At our organization, heartbreaking appeals have accumulated from people who are condemned to terrible suffering and severe handicaps because of the limited designations or because a drug is not in the health basket," she said. She has received no reply to that letter nor to other letters she has sent to Dahan concerning other patients in similar distress.

In another case, Marx was contacted by a patient who needed a drug that is also not in the health basket and costs more than NIS 1,000 per month. She had failed in her attempts to obtain the drug through her HMO. Marx was unable to help her. A few months later, when she wanted to inquire how she was, Marx phoned the patient's home. The patient's daughter answered. Her mother was on the way to the hospital, where she would have an operation to have her foot amputated. This operation could have been avoided, or at least delayed by a number of years, had the patient been treated in time with the medication that is not in the basket.

Behind all these shocking cases is the fact that the designations listed for drugs in the health basket are clear and inflexible, but reality is far more complex. The condition of patients and treatments that might help them are even more complicated. Often a drug is registered in pharmacopeia and designated for a specific purpose in the health basket. But further research into the drug reveals that it is effective in treating other illnesses. In other cases, a drug is found to be effective in treating an illness that is very rare; the chances of getting it through the health basket for those patients who need it are very slim.

Funds running out

The health system has created two mechanisms for dealing with exceptional cases: getting the drug through Form 29-G, and the "exceptions committees" at the HMO. Form 29-G enables a physician at a hospital to request authorization from the Health Ministry to administer a drug that is not registered in the Israeli pharmacopeia or is not in the health basket. Authorization of the request is accompanied by payment for the drug by the HMO of which the patient is a member.

Prof. Yehoshua Shemer, CEO of Maccabi Health Services, says that in recent years doctors at the hospitals have been making increasing use of the 29-G process, at a cost of millions of shekels annually. The HMOs are complaining about what they term excessive use of this means and its economic effect on their budgets. According to a senior source at one of the HMOs, the lack of supervision of the use of the form by the Health Ministry has led to a situation in which "the hospitals are conducting clinical trials, about the efficacy of which there is no proof, by means of Form 29-G. A great many of the drugs that are administered by means of Form 29-G are not life-saving treatments."

HMO exceptions committees also deal with patients who need drug treatments that are not in the health basket. Most of the rulings in favor of the insured patients are issued when an urgent treatment is needed to save a life. Shemer estimates Maccabi's expenditure on exceptional treatments at about NIS 60 million annually. But he hastens to clarify that in light of the fact that the government is refraining from allocating a budget for the expansion of the health basket and in light of the constant erosion of the HMO budgets, the money for funding for exceptional treatments "will run out at some point."

Shemer is not talking through his hat. About two years ago, the Clalit HMO decided to stop giving treatments that are outside the health basket and cancelled its exceptions committee. Clalit made the decision after the courts had related to these authorizations as precedents that obligated Clalit to provide the drug to other patients.

The following case illustrates how severe the problem is at Kupat Holim Clalit. About two weeks ago, members of a patient's family attacked the medical director of the Kupat Holim Clalit HMO, Dr. Nicky Lieberman, after he refused their request to fund a treatment for them that is not in the health basket. They threw a chair at his head; Lieberman needed medical treatment at a hospital. In his capacity as medical director, Lieberman is one of the most powerful people at Clalit and in the health system as a whole. He belongs to the small group of the HMO's senior leadership that has the authority to decide which patients will get treatments that are not included in the health basket, and which of them will not, and also to decide on limitations on medical treatments and drugs, even when they are in the health basket. This is the sort of bureaucratic hassle that most members of the HMOs know so well.

"I can understand those people who attacked Lieberman," says Prof. Mordechai Kremer, director of the lung institute at the Rabin Medical Center (Beilinson) and Ichilov Hospital and chairman of Israel Association of Pulmonology. The Rabin Medical Center is owned by Clalit. It is not every day that a senior doctor expresses such harsh criticism of another senior doctor in the health system. What led Kremer to do so?

"Lieberman does not consult with specialists and cuts off lives in an illogical way," says Kremer. "This happens with respect to many drugs that are important for treating patients. He is not prepared to authorize the treatments and the patients' frustration is understandable. It is untenable that a person takes decisions only on the basis of the letter of the law. The HMO needs to establish committees of specialists, who will decide, when drugs are not in the health basket, whether to fund the treatment for the patient, and not according to the arbitrary whims of a bureaucrat."

It should be emphasized that the situation at Clalit is not essentially different from the reality at the other HMOs, which over the years have gradually been cutting back on the extent of exceptional services they provide their patients.

The spokesperson of Kupat Holim Clalit, Etty Schilling, has replied to Kremer's remarks on behalf of the HMO and Dr. Kremer: "Clalit vigorously protests Prof. Kremer's severe attack on Dr. Lieberman, which [expresses...] understanding of violent steps against a doctor or anyone who holds a position in the system. As a rule, decisions concerning technologies and drugs at Clalit are taken after consultations with doctors in specific fields both within and outside the HMO. This policy has been examined several times by the National Labor Court, which has approved it in a number of rulings."

Apparently, the interpretation by the Clalit HMO of its obligations toward its policy-holders is not accepted by the state, including the Health Ministry, which by law is supposed to supervise the HMOs. The state's reservations about the position of the Clalit HMO were expressed in its reply to a suit against the HMO and the Health Ministry brought by A., a patient who has cancer of the digestive tract, to the District Labor Court in Haifa (by law, it is the labor courts that deliberate on suits concerning the National Health Insurance Law). A. demanded that she be provided with a certain drug that is included in the health basket only for the treatment of leukemia.

"The HMOs are authorized and entitled to grant medical services or drugs beyond those included in the basket," stated the State Prosecutor's Office in response to the petition. "The HMOs must exercise judgment in examining the specifics of each exceptional case before deciding whether to grant a patient's request to receive a medical treatment or drug that is not in the health basket."

However, the state went further: "A sweeping decision whereby the HMOs refrain from considering exceptional requests is not in accordance with the aforementioned need to exercise judgment," it ruled. Several weeks ago Clalit informed the court that it had reinstituted an exceptions committee.

Decide and postpone The Health Council advises the health minister on setting health policy, according to the National Health Insurance Law. It has no executive authority, but it is supposed to represent the public interest. The summary of a meeting held recently by the council's committee for patients' rights stated: "It is untenable that a patient should die because the treatment that could have saved his life is not included in the health basket. The committee is demanding that within the health budget a certain amount be set aside for isolated cases that need new drugs or treatments - the clinical efficacy of which has been proven - to save their lives. It must be demanded of the HMOs that a patient for whom his doctors have prescribed a drug that is not in the basket will be subsidized at the value of a drug that is listed in the basket."

The Kupat Holim Clalit Health Maintenance Organization, which canceled its exceptions committee and only recently re-established it, also does not dispute the need to solve the problems of those patients for whom the health basket provides no relief. These problems will become particularly acute during the coming year, in which there will be no expansion of the health basket. However, Clalit would prefer that the solutions come from the national budget and not its own.

In its reply to A.'s petition (see main article) Clalit submitted to the court a practical proposal for operating a public fund for exceptional treatments.

The aim of the fund is "finding a financial solution for patients who need potentially life-saving or life-prolonging drugs ... and cannot afford them," said the Clalit proposal. The money would come from various sources, including estates, government ministries, drug companies and the HMOS.

To date, no central fund for financing exceptional treatments has been established because of opposition from the Health Ministry. The ministry felt that if funds have been found for financing drugs it would be preferable to transfer them into an expansion of the health basket.

Each of the HMOs has a different idea for the fund and so do the patients' organizations. No one disputes the need to find a solution to the problem of financing exceptional treatments that are not in the health basket, yet three years after the idea of establishing a public fund first came up, a mechanism for dealing with exceptions has not yet been worked out. It is reasonable to suppose that many of those who needed the services of such a fund three years ago are no longer alive.

The chance of a solution to the problem of the exceptional treatments came up about three months ago. In a letter that Health Minister Nissim Dahan sent to Dr. Yitzhak Peterburg, at the time director-general of Clalit, Dahan stated that he agreed with Clalit's position that "a public fund must be established as soon as possible for drugs that are outside the health basket." But recently Dahan told Ha'aretz that he was freezing the move to establish the fund. "Everything has been stopped because of the elections. I have no intention of dealing with this at the moment. The financing of the fund involves raising donations, and someone might interpret this as raising money for the elections," said Dahan.