The Spring Session Agenda of Seimas [the Lithuanian parliament – Ed.] includes long-promised changes, namely amendments to the Pharmaceutical Law, which will legitimize the system of inclusion of medicines in the reimbursable medicines’ lists. After adopting the amendments at Parliament, the Minister of Health will still have to adopt a new order which will detail this new system. Manufacturers, doctors, and patients are eagerly awaiting it. It is not yet clear whether the new procedure will complicate and damage Lithuanian patients’ access to the newest and most effective medicines
These changes will provide the basis for the introduction of an innovative medicines’ evaluation mechanism, the so-called Health Technology Assessment (HTA), which puts the focus not only on a medicine’s price but also on its value in relation to its price and other direct costs. The evaluation of cost-effectiveness is an important element of the new medicine assessment scheme because the costs of treatment will be compared to the patient’s additional qualitative years of life, i.e. cost-effectiveness will be measured as the additional cost per quality-adjusted life year (QALY) gained.
The purpose of HTA is to ensure the efficient use of costs, i.e., to determine whether the added therapeutic value of the new medicine is proportional to the overhead costs. A more effective assessment of reimbursable medicines should ensure the more efficient use of both the Compulsory Health Insurance Fund’s (CHIF) and State Social Insurance Fund’s (Sodra’s) budget.
Unfortunately, although the introduction of HTA to the medicine evaluation system is positive, Lithuanian policymakers have left ambiguities, loopholes, and other issues within the legislation. These raise reasonable doubts about the prospects of proper implementation of the much-anticipated and necessary system.
Unrepresented interests of the patients: uncertainty about the ICER threshold and ‘disease burden’
It is commendable that the comments by pharmaceutical manufacturers, healthcare professionals, and patient associations were taken into account when preparing the Health Ministry’s draft order, which aims to introduce HTA.
One of the comments was that, in cases of serious illnesses, the objective of comparing a treatment’s cost-effectiveness with the incremental cost-effectiveness ratio (ICER) threshold should not be limited to one specific amount for all patients and all diseases, as it would merely prevent new medicines, especially for oncological and rare diseases, from entering the reimbursable medicines list. In response to this, the authors of the project have introduced a new indicator – ‘disease burden’, i.e. the severity of underlying illness – to the assessment system. This indicator would theoretically allow for an objective assessment and comparison of the specific medicine’s impact on different diseases and conditions, as well as life expectancy and quality.
However, as this is an entirely new concept, it would be worthwhile establishing the procedure for calculating and applying this indicator, either by a separate Minister’s Order or by making it an addition to the same order. Until a more concise methodology is prepared, the draft order must include a provision stating that the defined incremental cost-effectiveness ratio (ICER) threshold shall not be applicable in such cases (or otherwise, proportionally increased depending on the burden of the disease). Unfortunately, such clarity is not yet present.
Otherwise, the barrier mentioned above – the incremental cost-effectiveness ratio (ICER) threshold (the total, and the only one amount in the draft order, is indicated as EUR 30,000 per QALY gained) will automatically prevent Lithuanian patients’ access to a large proportion of medicines that do not comply with this threshold. It is regrettable that this has not been taken into account from the outset, as there were no attempts to evaluate the new mechanism’s effect on patients’ access to certain medicines.
A significant increase in administrative and financial burden: solutions exist
Unfortunately, the Pharmaceutical Law’s explanatory memorandum indicates that no negative consequences are foreseen after the adoption of the legislation.
The authors of the project have failed to identify that the administrative and financial burden for the manufacturers will increase significantly. Not only will there be a substantial increase in the amount of information that must be provided along with the application, but the direct costs of preparing the application will also increase. Assuming there will be about 50 manufacturers’ applications per year, the total financial burden alone will amount to around EUR 900,000 (the cost of preparing one application amounts to about EUR 14,000, and a further EUR 4,000 is paid for the evaluation of the application).
At least a slight reduction of the administrative burden is possible. It can be done, firstly, by eliminating the unnecessary paperwork (e.g. by waiving the requirement to submit a full application if the proposed changes to the prescription are of an administrative nature and do not affect the budget of the CHIF). Secondly, the process can be made easier by waiving the requirement to provide information on the reimbursement of medicines in other countries, because such information does not affect decision-making and may be misleading if not updated regularly. Thirdly, it must be stated clearly which application parts must be filled out and which are optional. Finally, it is necessary to indicate which parts of the application can be filled out in English, thus avoiding time-consuming Lithuanian translations.
It is also necessary to improve the legislation itself to make it more precise and understandable. Ambiguous wording and duplicated points must be removed. The terminology, such as “treatment guidelines,” etc. should be explained in detail. The Pharmaceutical Law itself must regulate the essential principles of the medicines reimbursement system, including one of the most important criteria for transparency: the recordings of the Medicines Reimbursement Commission’s meetings, the obligation for the commission to make objective and reasonable decisions, and the need to define the frequency of the meetings themselves.
Involving patients and healthcare professional organizations, no new medicine assessment system can be sustainable without the proactive involvement of patients and/or competent healthcare professionals. This should be ensured not only by publishing information about the applications in question, but also by informing relevant organizations proactively by e-mail or similar means. Feedback is important too. After receiving these organizations’ opinions and observations, it should be mandatory to follow up on the progress of their proposals and adopted decisions.
Conclusion: do not damage
The inclusion of medicines in the reimbursable medicines list has always been a Kafkaesque process: long-lasting, costly, and rarely bringing benefit to the patients as quickly as needed. It is commendable that the Ministry aims to improve this process by amending the Pharmaceutical Law and the future Minister’s order. However, some details still raise doubts, not only among pharmaceutical manufacturers and their representatives, but also among patients and healthcare professionals.
It seems that, sometimes, it is forgotten that the procedure for reimbursing medicines and the decision-making process is not a race, nor a fight between the decision-makers and drug manufacturers. This is, first and foremost, a process that must serve the interests of patients. It should ensure that the medicines needed by Lithuanian patients are reimbursed quickly and that budget funds are being saved.
This cannot be done without the involvement of all the stakeholders in the decision-making process, without ensuring maximum transparency, without removing the unnecessary paperwork and administrative burdens, and without removing unjustified economic barriers to the reimbursement of medicines for oncological and rare diseases.