2012 EDUCATIONAL BOOK - American Society of Clinical Oncology

LUNG CANCER IN ROMANIA
● Protection of people from tobacco smoke by banning
smoking in public places, including bars and restaurants.
The legislation has improved. From a total allowance
of smoking to being permitted in public places only
in separated, ventilated rooms and totally banned in
medical care units and transportation.
● Offering assistance for quitting tobacco use. Treatment
for tobacco addiction has been freely available in the
framework of a national program funded by the Ministry
of Health since 2007. A toll-free quit-line is also
available.
● Warning about the dangers of tobacco. The health warnings
are covering 30% to 40% of the main surfaces of
tobacco products, according to the provisions of the
European Union Tobacco Directive. In 2008, Romania
became the second European Union country implementing
the pictorial health warnings on all tobacco products.
● Enforcement of bans on tobacco advertising, promotion,
and sponsorship on radio, TV, outdoor and indoor billboards,
mass media, toys, nontobacco objects, and
minors-intended events.
● Raising taxes on tobacco, according to the European
Union Tobacco Taxation requirements. A part of the
funds collected finances the tobacco control program
and the treatment of some smoking-related diseases.
The National Tobacco Control Program implemented in
2007 by the Ministry of Health includes prevention (coordinated
by the National Center for Health Promotion), treatment,
and monitoring activities (coordinated by the National
Institute of Pneumology). Educational programs and communication
campaigns are organized throughout the year,
but special interventions are prepared on May 31 and
November 17 (No-Tobacco Day). A toll-free quit-line is
manned by psychologists. The medical treatment is free-ofcharge
and prescribed by 60 doctors trained in smoking
cessation.
The State Sanitary Inspection and the National Authority
for Consumer Protection are mandated by law to control the
implementation of the regulations. Some public health campaigns
conducted by nongovernmental organizations and
professional associations associate the stop-smoking component
in their programs, addressing lung disease, cardiovascular,
or cancer prevention programs.
Media campaigns, in collaboration with international
partners, such as the “HELP campaign” are periodically
organized. These integrated programs use television, Internet,
and mobile phones to build capacity for “a life without
tobacco” for youngsters and young adults. Currently, funds
available do not allow for comprehensive mass-media campaigns.
Community-based campaigns are difficult to organize
because of limited resources and lack of coordination
between institutions.
Health Care Financing in Romania
The treatment of insured patients with cancer is free. A
National Program of Oncology was created in 2003. The
budget allocated for this program raised continuously from
2003 to 2009 and then reached a plateau. All approved
anticancer agents are included on a special list of drugs that
are 100% reimbursed, financed by the National House of
Insurance. A special budget is prospectively allocated for the
National Program of Oncology, which is covering all anticancer
drugs. The acquisition is done following a national
auction. Each oncology department is periodically buying
the drugs needed according to a planned budget. Oral drugs
may also be obtained from the pharmacies outside hospitals.
However, for the expensive new drugs such as pemetrexed,
MoAbs (i.e., bevacizumab), and TKIs (i.e., erlotinib),
the reimbursement is subject to an individual approval from
a National Commission. The number of patients who benefited
of systemic treatments covered by the National Program
of Oncology, raised from 75,000 in 2007 to 96,700 in
2010 for all cancers. Approximately 3,400 patients are
treated concomitantly with expensive drugs in Romania.
There is a mismatch between the new published guidelines
(including CECOG) 6 and the lack of reimbursement for
the newly registered drugs or indications. First-line TKIs for
patients with EGFR mutations are not yet reimbursed.
Maintenance chemotherapy is not yet reimbursed, even
though Romanian centers were among the most active in the
pivotal maintenance registration trials for pemetrexed and
erlotinib. 10,11 The Romanian legislation foresees the yearly
update of the list of compensated drugs. However, this has
not happened since 2008, and about 30 oncology drugs still
wait for the reimbursement decision. The way from registration
to reimbursement is a multistep bureaucratic
process. Additionally, a new drug may be proposed for
compensation only after a minimum of 1 year of use in at
least three European countries.
In an attempt to provide the new drugs to patients,
different risk-sharing strategies (such as cost-volume, costresult,
headroom agreements, and discounts) were initiated
between authorities and the pharmaceutical companies with
variable success. At the moment of this writing, a radical
reform in the Romanian Health System is expected, which
will probably include the privatization of many hospitals
and the transfer of the financing of all medical activities
(including oncology) to several private Insurance Companies,
besides the public National House of Insurance.
The Research Structure at the Cancer Institute
Ion Chiricuta
The oldest Cancer Institute in Romania was founded in
1929, located in Cluj, and is called “Ion Chiricuta,” after the
name of a famous Romanian cancer surgeon, who was
awarded by the Heidelberg University as the pioneer of the
use of the omentum in plastic surgery and who was integral
to the development of the Institute. It is a comprehensive
cancer center that offers cancer diagnosis and treatment
(with 550 hospital beds). The clinical departments are represented
by surgery, radiation oncology (external beam
radiotherapy with two linear accelerators and one cobalt
unit and brachytherapy with low-dose rate and high-dose
rate), medical oncology (continuous hospitalization and day
hospital), and pediatric oncology. There are dedicated histology
and cytology departments, a certified clinical laboratory,
and an imagery plateau with computed tomography
(CT) scans, ultrasound, and scintigraphy. All categories of
personnel are represented, but there is a work overload
because of an increasing number of patients (from 727 new
patients in 1955 to 7,156 new patients in 2008). The Institute
has basic science/translational research departments,
with cellular biology, immunology, and radiobiology platforms.
It is an active member of OECI (Organization of the
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