LMI Policy document.
- LMI is in favour of using HTA in the health sector.
- HTA must be carried out in transparent processes against a
background of agreed guidelines.
- HTA must not be an obstacle that delays patients' access to
new, innovative drugs
- Financing must be secured for drugs that are recommended as a
result of an HTA process
Health technology assessment
Health technology assessment (HTA) is a process that involves
medical, financial, social and ethical evaluation of the use of a
medical method. HTA used on drugs will entail assessing clinical
efficacy, cost-effectiveness and broader consequences for patients,
the health service and the community in general. An HTA process in
the area of pharmaceuticals should help the authorities to make the
correct decisions regarding the use and financing of drugs.
The purpose of the cost/benefit analyses of that the industry
undertakes to append to reimbursement applications is to
demonstrate the cost-effectiveness of a new treatment compared with
the established treatment. An assessment of the relative efficacy
of different drugs forms a central part of the authorities'
assessments regarding the reimbursement status of a drug.
The terms health economics/pharmaceutical economics and HTA are
often used interchangeably. The health economics processes carried
out by the Norwegian Medicines Agency contain elements of HTA, but
cannot really be called complete HTA processes. A complete HTA
process should take the overarching social perspective - and it is
upon this perspective that the authorities should base an
assessment of the reimbursement status of drugs.
LMI recognises the use of HTA in connection with
Because the pharmaceuticals market is characterised by third-party
financing and asymmetric information, LMI recognises that
government regulation is necessary. LMI also recognises the use of
HTA, including economic analyses, in the work of determining the
reimbursement status of drugs in Norway. Economic analyses have
been mandatory in connection with applications for reimbursement in
Norway since 2002, and are a key factor underlying the authorities'
decisions regarding pricing and reimbursement for drugs in a number
of European countries.
Health economics evaluations must not only take into account
direct costs and effects, but also indirect effects such as
productivity gains. The Medicines Agency's guidelines for
applications for reimbursement allow for this. This is essential
for avoiding undesirable "silo thinking" which causes the social
perspective of the analyses to be lost.
LMI understands that the authorities wish to promote the use of
the most cost-effective drugs on the market. However, in the work
of evaluating health economic analyses and in the focus on
cost-effectiveness, one must not forget considerations such as:
- identifying the drugs that are of GREATEST BENEFIT to the
- assuring the general public of RAPID ACCESS to these
- assuring the AVAILABILITY of several alternative medicines
- valuing INNOVATION which gives added therapeutic value to
There is broad agreement on these considerations among European
The placing of value on innovation is critical for enabling a
pharmaceuticals market to develop new and better drugs. Innovation
in the pharmaceuticals market tends to come in small steps - small
improvements for large or small patient groups. Innovation may be
valued in a number of ways - through pricing, assuring turnover
volume, therapeutic guidelines and effective access to the
Guidelines and transparent processes
Health economics analyses must be carried out against a backdrop
of agreed guidelines based in health economics environments. The
analyses must be assessed in transparent, balanced and open
processes. The processes surrounding health economics analyses must
include the pharmaceutical industry, medical and heath economics
expertise and the patients. Thus the Blue Prescription Board plays
an important supporting role in the Norwegian Medicines Agency's
case processing, and in some processes, for example in connection
with review of reimbursement status, it will be natural to
circulate cases to the parties concerned for comment.
Handling of uncertainty in health economics analyses -
There will always be uncertainty associated with health economics
analyses. Decision-makers should show flexibility in the handling
of uncertainty, and act in a risk neutral manner so that the
uncertainty in itself does not become the deciding factor for the
outcome of a health economics assessment.
In some cases it will not be possible to document the
cost-effectiveness of a drug before it has been on the market for a
while. This is because parts of the studies must be done in real
life. In cases where there is limited documentation on
cost-effectiveness, temporary financing schemes should be
established in anticipation of - and conditional on - the provision
of new and better documentation. It is important that extensive HTA
processes do not substantially delay patients' access to new,
innovative drugs. There will always be uncertainty, and regular
revisions of documentation are therefore justified.
Drugs that are found through an HTA process to be cost-effective
must be assured of financing, also drugs that are charged to
hospital budgets. The so-called "bagatelle limit" for budgetary
influence on the pharmaceuticals budget which prevents the
Norwegian Medicines Agency from making a decision on reimbursement
status should be abolished or substantially increased. Spending on
drugs must be regarded as an investment that yields returns for
both patient and society - not purely as an expense item.
Further use of health economics analyses
At present drugs are in a special position as an input factor in
the health service with respect to the need to document
cost-effectiveness. As a result there is a risk of attaching more
stringent requirements to using drugs than to other input factors
in the sector. Health economics analyses should gradually be
applied to a broader field of treatment options - not just drugs.
Where priority has to be established between drugs and other input
factors, an HTA process should be required to apply the overarching
social perspective to these resources as well.
Continued distinction between approval procedures and
health economics analyses
The use of health economics analyses to assess cost-effectiveness
must continue to be a process that is kept separate from approval
of the drug - where efficacy, safety and quality are assessed.