teaser
Leon Kerkhofs MD
Consultant Oncologist,
Adm. De Ruyter Hospital ADRZ,
Vlissingen, The Netherlands
Luctor et emergo (I struggle but emerge), the motto of the province of Zeeland, refers to the floodings of 1404, 1421 and 1953. This prompted the Dutch government to commission and deploy a flood defence system called the Delta Works. It is now considered one of the modern wonders of the world.
The province’s motto could very well be applied to the current state of mind of many health care professionals and policy makers, as they are faced with the enormous economic burden of growing cancer costs. Drastic measures are needed.(1,2)
With transparent guidelines from the government and professional bodies still to come, doctors would be prudent to introduce local cost-saving measures.
Our hospital, located some 15 miles from the Delta Works, has 450 beds and employs 170 specialists in two locations, and has a budget of €130 million. It serves a population of 250,000.
There is a radiation oncology unit in Vlissingen, employing six radiation oncologists. In 2011, €10,143,000 was spent on medication, 30% of which was for oncolytics. To withstand the financial pressures it is faced with, the hospital and its staff have embarked upon a program of cost-saving measures. This is very important because, in the Netherlands, from the point of competition, a hospital stands to gain work if a certain treatment is offered at a competitive price, but might lose patients to another hospital whenever a treatment is too expensive.
Insurers will buy procedures and treatments in the hospital that is most competitive. The downside for the patient is that he or she could be forced to undergo treatment in another hospital, not always nearby, or risk no-payment by the insurer. Hospitals in the Netherlands negotiate a price for a specific treatment with the medical insurers.
In the case of breast cancer, this also means the cost of Herceptin is covered for the proportion of patients that are Her2-positive.
Oncolytics given in hospital and in the oncology unit are now fully reimbursed (for expensive drugs reimbursement was only 80% before 2012) but we do not know if this policy is sustainable. Probably not.
Several treatments have become less expensive because of fierce competition. Because this also affects income, some specialists have set up private treatment centres, for example for eye-surgery, dermatology or orthopaedic surgery. This, in turn, is also extra competition for the hospital.
Special attention has been given to the field of medical oncology and haematology, because this speciality is associated with high costs of medication. Every year the budget for oncolytics has risen, but the need for a durable solution to this increment is evident.
Cost-saving measures
The pharmacy has adopted a policy to buy cheaper drugs (generics if available), and this also applies to chemotherapeutics; this enables the oncologists, haematologists and pulmonary physicians to treat patients according to their professional guidelines.
The downside is that if you were to ask many clinicians the name of the company that produces, for example, the paclitaxel that they use, they would not be able to do so.
In the last few years, however, we have observed a rise in anaphylactic reactions in patients receiving (generic) chemotherapy, although it is not known if there is a causal relationship.
Other cost-saving measures have been the reduction of nursing-staff.
Efforts have been made to reduce in-hospital days and a larger short-stay facility has been created to accommodate all admissions to the emergency room and clinic. Acute care and in-hospital care is concentrated in one location of the hospital; the other location is in use for elective low-risk surgery and the outpatient department.
Recently a refurbished PET-scanner became available at 10% of the list price, which is considerably less expensive than our current contract for a mobile unit.
In order to deliver high-quality cancer care, or health care in general, it is wise to take the initiative to seek a sustainable and therefore affordable and acceptable solution to the financial threat that is the cost curve in medicine.
Rising cost of cancer care
The price of new cancer therapies, especially biologics, is one of the factors of the rising cost of cancer care, as there are other cost drivers, such as the ageing population with growing numbers of cancer patients, in part resulting from the successful treatment of heart disease, and the fact that patients are treated more intensively and for longer.(1-3)
A total of 40% of all cancer patients is over 70 years old, and 60% has significant co-morbidity; still we use a significant proportion of our budget for the treatment of this group of patients. It cannot be denied that progress has been made and the death rate from cancer has declined but these small gains come at a huge price. There is also a tendency for defensive medical practice and overuse, or futile care.(4)
Defining biosimilars
Biosimilars are alternative versions of biologic agents that have gone off-patent; however, they are not merely generic drugs. They differ from conventional generic drugs because of their complexity and size, and because of the way they are manufactured, as they are derived from cultures of living cells.(5-7)
The European Medicines Agency (EMA) defines biosimilars as medicines that are similar to a biological medicine that have already been approved with demonstrated similarity in physicochemical characteristics, efficacy and safety, based on a comprehensive comparability exercise.
These products will therefore display a certain degree of variability (microheterogeneity); this is also true for the originator or reference product.
A biosimilar is intended to be used at the same dose and dosing regimen to treat the same disease as the reference product.
Because these drugs are less expensive then their reference products, they have the potential for important cost savings in cancer drug budgets.(5-8)
In 2006, the first biosimilar was introduced – somatropin.
Approved biosimilars in oncology that are used in supportive care are erythropoietins and filgrastims.
Managing costs through biosimilars
One obvious way of managing costs, and a solution that is available to all physicians treating cancer patients, is the switch from originator biologicals to biosimilar biological drugs. Biopharmaceuticals are more expensive than small-molecule drugs, and their use is increasing. An important benefit of biosimilars is that they could provide cost savings.(2,3,5-8)
Our hospital has using biologics for several years, mainly epoetin (Eprex; Orthobiotech) in elective orthopedic surgery. In supportive care in oncology and haematology, we used filgrastim (Neupogen; Amgen), PEG-filgrastim (Neulasta; Amgen), and erythropoietin (Eprex; OrthoBiotech). These drugs are covered by the patients’ health insurance because they are prescribed in the outpatient department and oncology unit; the same is true for oral oncolytics such as capecitabine and sunitinib.
Expensive biologicals, for example, monoclonals such as bevacizumab, given intravenously, are paid for by the hospital and are now fully reimbursed.
However, not all patients will respond to these expensive new treatments, so to avoid the unwanted squandering of insurers’ and taxpayers’ money, a certain degree of tailored therapy is necessary.
In an effort to further reduce expenditure on these drugs we have started using biosimilars in supportive care in oncology, mainly epoetin and filgrastim.
Biosimilar epoetin (Binocrit; Sandoz) has been used in orthopaedic surgery in our hospital.
In 2011 we initiated a multicentre, retrospective survey of Binocrit for the treatment of chemotherapy-induced anaemia in patients with cancer. Response rates were similar to those published in studies with the reference product, Eprex, which we also used extensively before biosimilars became available. The results of this analysis were reported at the European Multidisciplinary Cancer Conference in Stockholm in 2011.(9) The study has now led to the preferential use of Binocrit in favour of Eprex, Aranesp and NeoRecormon.
The introduction of biosimilar epoetin on the market has since led to a marked price reduction of all epoetins, with the exception of Aranesp. We have observed the same effect with the use of the biosimilar filgrastim, Zarzio.
An analysis of GCSF-use showed that using a biosimilar GCSF was the most cost-effective approach in reducing the incidence of febrile neutropaenia in cancer patients receiving chemotherapy.8
As mentioned previously, both drugs are used preferentially in the outpatient clinic and oncology unit and are therefore of no consequence for the hospital pharmacy’s budget. However, we wanted to make it clear to the insurance companies that we are serious with our plans to reduce expenditure.
When therapeutic biosimilars reach the market in the coming years, we will treat our patients with these compounds as well, thereby allowing our organisation to allocate the funds saved by using a biosimilar drug to other use, for example, expensive biologics that have not gone off-patent.
When the patents of the monoclonal antibodies for the treatment of B-cell lymphoma, CML, colorectal cancer and breast cancer expire in the next few years, it is expected that also biosimilar versions of these drugs will be approved. Predicted cost savings of 25–30% could be expected.(2,7)
A sustainable solution
It is important that national governments, health policy makers, insurers and healthcare professionals recognise the immediate need for a transparent and sustainable solution to the economic burden that is the cost of cancer treatment.
It is important that institutions such as the National Institute for Health and Clinical Excellence in the UK or the Institute for Medical Technology Assessment in the Netherlands can advise policy makers regarding reimbursement of a treatment, based on transparent values such as quality adjusted life years or incremental cost effectiveness ratios (ICERs).
Threshold ICERs differ from one country to another, and it is important to realise that this has its effect on the cost of a given treatment or drug. This means that cancer therapies are priced differently according to a country’s willingness to pay for a treatment.(2,4) For example Sutent, which is an oral small molecule multitargeted receptor kinase inhibitor for the treatment of metastatic clear cell renal cancer, is at least 20% more expensive in some countries on the continent than in the UK. In this inequality lies an opportunity for policymakers and pharmacies to negotiate better prices for expensive drugs.
Until that time, physicians themselves can have an important impact on health budgets by using biosimilars, allowing for further access to modern cancer therapies, because it is the task of oncologists to ensure that they can, and will, provide current and future cancer patients with equal and affordable cancer therapies.
References
- The Lancet Oncology Commission: Delivering affordable cancer care in high-income countries. Lancet Oncol 2011;12:933–80.
- Cornes P. The economic pressures for biosimilar drug use in cancer medicine. Targ Oncol 2012;17 January [Epub ahead of print].
- Dutch Society for Medical Oncology. NVMO-consensus: The treatment of cancer with expensive drugs. Version 6, Aug 2010.
- Uyl-De Groot C. Inaugural Lecture. Expensive diagnostics and cancer medication: the other side of the in-equality. Faculty of Medicine and Health Sciences, Erasmus University Rotterdam: May 20, 2011.
- European Generic Medicines Association. FAQ on biosimilars. www.egagenerics.com.
- Weise M. Biosimilars – why terminology matters. Nat Biotechnol 2011; 29:690–93.
- Grande E, Carrato A. Biosimilars: what they are and their use in oncology. Cancer Chemother Rev 2011;6:23–30.
- Aapro M, Cornes P, Abraham I. Comparative cost-effectiveness across the European G5 countries of various regimens of filgrastim, biosimilar filgrastim, and pegfilgrastim to reduce the incidence of chemotherapy-induced febrile neutropenia. J Oncol Pharm Practice 2011;DOI: 10.1177/1078155211407367 [Epub ahead of print].
- Kerkhofs LGM et al. First use of biosimilar epoetin to increase haemoglobin levels in patients with chemotherapy-related anaemia: a multicenter retrospective clinical analysis. European Multidisciplinary Cancer Conference; 23–27 September 2011, Stockholm: Poster presentation 4022.
