New listing cuts the costs of leukaemia drug
11 September 2002
Sufferers of chronic myeloid leukaemia (CML) in the chronic phase of the disease will have cheaper access to the once-daily drug Glivec (imatinib mesylate) from 21 October 2002.
The Federal Minister for Health and Ageing, Senator Kay Patterson, said that the Government had acted quickly on the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC), which recommended last Thursday that Glivec be made more broadly available on the Pharmaceutical Benefits Scheme (PBS) to sufferers of CML (cancer of the white blood cells).
Glivec, a once-a-day capsule that has been hailed as a significant treatment breakthrough, has been available on the PBS since last year for sufferers of CML in the later or accelerated and blast phases of the disease, but the broader listing on the PBS will allow sufferers of the early stages of CML access to subsidised treatment through the PBS, cutting the costs to patients from about $50,000 a year to less than $270 a year.
'This treatment gives hope to the sufferers of this terrible disease. The treatment costs around $50,000 for each patient every year and without the PBS this medicine would be too expensive for most people to afford,' Senator Patterson said.
'I wish all patients well and look forward to the real difference that the broader listing of this medicine on the PBS can make for sufferers of CML and their families.'
What is chronic myeloid leukaemia (CML)?
Certain leukaemias are caused by the swapping of genetic material between 2 chromosomes (chromosomes 9 and 22). This leads to the formation of an abnormal chromosome known as the ‘Philadelphia’ chromosome (so called because of its place of discovery).
The defective chromosome contains a new gene which produces an abnormal protein (an enzyme). This protein drives uncontrolled production of white blood cells in the bone marrow, resulting in an enormous increase in their numbers in the blood. This abnormal condition is known as leukaemia.
CML progresses through 3 distinctive phases: the chronic phase (typically lasting from 3 to 4 years), the accelerated phase (typically lasting from 3 to 9 months) and the blast crisis (typically lasting from 3 to 6 months). These phases are marked by a progressive increase in the number of white blood cells. As the patient moves through these stages, the disease usually becomes increasingly resistant to therapy and therefore more difficult to treat.
How many people have CML?
About 350 new patients are diagnosed with CML every year in Australia. It is thought that about 1500 to 2000 people in Australia have CML at any one time. The worldwide incidence is about one to 2 cases per 100,000 people per year. It is one of the 4 most common types of leukaemia and is frequently fatal within 5 years of diagnosis.
What are the current treatment options for CML?
- Bone marrow or stem cell transplant: A bone marrow transplant using healthy stem cells from the bone marrow of a closely matched donor (known as an allogeneic bone marrow transplant) offers the best treatment hope for many people. The problem is that most CML patients aren’t eligible for such a transplant because a suitable donor cannot be located. Another option for some people is a transplant using their own stem cells (an autologous bone marrow transplant) after they have undergone intensive chemotherapy and radiation treatment.
- Drug therapy: A range of drugs is used in the treatment of CML, including interferon-alfa, hydroxyurea, cytarabine and busulfan. Interferon, given via injection, is the current standard therapy for most people who are not candidates for a bone marrow transplant.
Imatinib (brand name Glivec) is the first of a new type of drug, known as a tyrosine kinase (pronounced tyro-zeen kin-ase) inhibitor. Taken as a once-daily capsule, it is designed to interfere with the signal of a protein known to cause CML. Imatinib selectively blocks the action of this enzyme so that it eliminates abnormal leukaemia cells without harming normal cells. The precision with which it targets the cancer cells is what makes the new drug different from other cancer therapies.
Like all medications, the new drug is not without side effects, which include nausea, vomiting and some swelling of the legs. However, the majority of patients tolerate it very well.
How effective is imatinib?
Trials with patients with CML began in 1998. Results from the first studies revealed that nearly all of the patients in the early stage of CML who had already failed standard therapy with interferon had their blood counts return to normal. This is called a complete haematological response.
Results from a much larger subsequent trial were consistent with the early trials, indicating that about 90 per cent of the people taking the drug had a complete haematological response.
Is the drug effective for other types of cancer?
The drug has been designed to target the abnormal Philadelphia chromosome, so it is expected to benefit patients with leukaemias caused by this abnormality.
The Philadelphia chromosome is most commonly present in chronic myeloid leukaemia, but may also, less commonly, be present in other forms of leukaemia, such as acute lymphocytic leukaemia (ALL) and acute myeloid leukaemia (AML).
Last Reviewed: 11 September 2002
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