We do not provide early detection of oncological diseases and the necessary medicines compensation for patients now

20.09.2023.

After the audit, one can conclude that the measures implemented by the Ministry of Health do not ensure early detection of oncological diseases and compensation of necessary medicines for patients. It has a significant impact on Latvian public health indicators, which do not improve for a long time although this area of healthcare is among priorities of the country.

The list of compensated medicines for the treatment of oncological diseases complies with international clinical guidelines only partially, and only part of the diagnoses is provided with state-paid basic therapy and treatment follow-up.

BRIEFLY

  • Early detection is an underappreciated and underutilized tool that can lead to more successful treatment, but patient compliance is critical.
  • The accelerated procedure “Green Corridor” does not work because 195 days pass instead of the 65 intended days until a diagnosis is established, that is, three times more time than planned.
  • The prices of compensated medicines for the treatment of oncological diseases are the highest in the Baltic States. The Ministry of Health cannot justify how the limits of allowable wholesale and pharmacy mark-ups are determined, which affect the final price directly.
  • The Cancer Register does not work as intended, as the collected data on oncology patients are not of high quality and complete, and there is no clarity about the development of the new Cancer Register.

Early detection of an oncological disease is crucial to ensure more successful treatment. However, since 2017, the proportion of early detected oncological diseases has not increased. A disease can be detected early (1) in healthy people through regular annual preventive examinations at a general practitioner and screening, or (2) in patients who already have symptoms or complain about their health. In its turn, in the event of slightest suspicion, further medical examinations should be conducted in an accelerated manner, that is, within the “Green Corridor” as well as post-screening.

An annual preventive medical examination at a general practitioner is the first missed opportunity. A general practitioner is obliged to provide adults with a preventive examination once a year, which is fully paid for from the state budget. However, between 2017 and 2021, such examinations were performed on an average of only 14% of adults, and their proportion decreases every year. These data also confirm the critically low patient compliance in Latvia.

“Taking into account the mandate of a general practitioner and the confirmation obtained during the COVID-19 pandemic that the society trusts general practitioners, exactly their contribution matters into the education of patients and the creation of a compliance culture, which can have a significant impact on public health indicators in Latvia in the long term. Unfortunately, currently, doctors’ practices do not have an established procedure for inviting patients to preventive examinations systematically,” explained Ms Maija Āboliņa, Council Member of the State Audit Office of Latvia.

The number of general practitioners is decreasing year by year, generational change and succession are not taking place on a sufficient scale and there are still areas where general practitioners are lacking. Also, the situation in the practices of general practitioners included in the audit sample confirms that at least 22% of the practices of general practitioners included in the audit sample do not employ the two additional medical personnel needed according to the number of patients. This trend affects the availability of primary healthcare services negatively.

State-organized screening for early detection of oncological diseases is the second missed opportunity. Four types of cancer screening are performed in Latvia: cervical cancer, breast cancer, bowel cancer, and prostate cancer screening. Although the data analysis conducted in the audit also confirms the self-evident fact that oncological diseases are detected early more often in patients who have previously been screened, the response of patients is low, as it lags behind the indicators planned by the Ministry of Health and recommended in European guidelines significantly. Critically insufficient public participation in screening is also confirmed by the fact that only a small part of patients diagnosed with an oncological disease have previously undergone screening with the proportion varying from 2% for prostate cancer to 14% for cervical cancer.

One of the causes identified in the audit is a disorganized institutional structure and division of responsibility. Only 14 years after the introduction of screening, the health sector has come to understand that the Centre for Disease Prevention and Control is the responsible institution for screening management, although its mandate has always included policy implementation in the subfield of disease prevention (and prevention also includes screening). As a result, invitation letters are only sent out and statistics are obtained on residents who respond to invitations and undergo screening examinations in Latvia, but there is no targeted action to improve responsiveness and the prevention process.

The auditors consider that the activities of the Ministry of Health to address the target groups are passive and formal. Paper-based invitation letters are an outdated tool whereas general practitioners do not engage and motivate patients sufficiently to undergo screening, and general practitioners are the only medical professionals who invite patients for bowel and prostate cancer screening. For example, 15% of general practitioner practices have not issued any bowel cancer test kits. Thus, according to the auditors’ estimates, approximately 56,000 patients have not received those test kits. Also, no one makes sure that the target groups have actually received the invitation to the screening.

Screening is pointless and it does not achieve its goal if further medical examinations and treatment are not promptly conducted at the slightest suspicion after the first examinations. Unfortunately, there is no uniform procedure in the country for patients to receive information about screening results. The notification of the results is left to the discretion of each medical institution, and, while the most insistent patients find out the results themselves, others remain without an answer, not realizing their risk at all.

The so-called “Green Corridor” principle does not actually work either. The Ministry of Health introduced the “Green Corridor” in 2016 so that patients suspected of having an oncological disease could receive the state-paid healthcare services necessary for diagnosis in priority order, outside the general waiting line and in 10 working days maximum. However, (1) only 25% of patients received services in 10 working days and (2) the average time from the visit to the general practitioner to the diagnosis was 195 days instead of the intended 65 days, that is, three times longer.

One of the reasons is the lack of a solution for patients for whom an oncological diagnosis has already been confirmed, but the need for relevant healthcare services also remains reasonably during treatment. The auditors do not question the need for these services for patients with a confirmed diagnosis but they draw attention to the fact that all the patients in the “Green Corridor” actually end up in a single waiting line again because 92% of examinations have been performed on patients with an already confirmed oncological diagnosis.

Similarly, even though the Ministry of Health has implemented state-organized screening, it does not monitor and analyze the sequence of receiving services within the framework of post-screening. The auditors have established that some patients did not undergo state-paid post-screening examinations when it was necessary. In such cases, the screening examinations and the resources used for them have been in vain. For example, state-paid post-screening examinations were performed only by 25% of patients who were diagnosed with a positive finding or suspected malignancy during cervical cancer screening. Probably, some of the patients had further examinations for a fee, but the health sector has no information about this.

Although oncology is one of the priority areas of healthcare, the Ministry of Health does not plan funding for reimbursement of the costs for the purchase of medicines according to the needs of oncology patients, and neither the health sector nor oncology patients can count on stable additional funding in the long term. Despite the fact that the Ministry of Health takes measures to increase funding for the reimbursement of medicines for the treatment of oncological diseases, it is not allocated as planned, and moreover, additional funding is not always included in the state budget base expenses, as a result of which it is requested again the following year. Also, the plan for improving healthcare services in the field of oncology for 2022-2024 is without full-fledged funding.

At the same time, the prices of compensated medicines for the treatment of oncological diseases in Latvia are the highest in the Baltic States. When including a medicine in the list of compensated medicines, wholesale and pharmacy mark-ups calculated according to certain formulas are added to a manufacturer’s price of the medicine, as well as VAT of 12% is applied. The Ministry of Health cannot justify how the limits of allowable wholesale and pharmacy mark-ups are determined, which directly affects the final price for which the state compensates for the purchase of medicines, and how many medicines and how many patients can be provided due to limited state funding. In addition, while upon reaching a certain price for medicine, a fixed wholesaler’s and pharmacy’s markup is applied in Lithuania and Estonia, the procedure in Latvia allows the wholesaler’s markup to increase without limit. The VAT rate in Latvia is also the highest in the Baltic States. In the audit, assuming that a manufacturer’s price of medicines is the same in all Baltic countries, a final price of medicines was modelled according to the calculation algorithm of the prices of medicine used in each country, resulting in the conclusion that the highest price was determined in Latvia. For example, in Latvia, a wholesaler’s and pharmacy’s mark-up for medicine named “Tafinlar” together with VAT constituted 12% of its final price, while it was 8% and 5% in Estonia and Lithuania, respectively. Namely, the final price of medicines in Latvia is 271 euros more than in Estonia and 529 euros more than in Lithuania.

Currently, the procedure established in the country allows that in the case of a widespread life-threatening oncological disease, patients are not provided with equal opportunities to receive the necessary medicines. In Latvia, reimbursement of medicines is not based on the needs of patients. It is not enough that the medicines are therapeutically effective and cost-effective, as they are included in the list of compensated medicines only if additional funding is available. Although the medicines included in the list of compensated medicines as suitable for the treatment of cancer diagnoses, in some cases, these medicines are not used at all for the treatment of the respective diagnoses, they are no longer used, or they are outdated and non-compliant with international clinical guidelines. As a result, a situation arises where patients with one diagnosis have the opportunity to be treated, but not with another diagnosis. In addition, in the opinion of the auditors, a decision to include medicines  in the list when they are recognized as therapeutically effective and cost-effective, but their inclusion in the list requires additional state funds, is not traceable and open to the public, as there is no publicly available information about which medicines and in what order will be included in the list of compensated medicines.

If the list of compensated medicines does not have an appropriate medicine for a patient’s diagnosis and treatment, the patient should have a chance to apply for the reimbursement of necessary medicine individually, also in the event when a medicine is not included in the list of compensated medicines due to lack of funding but is therapeutic and cost-effective. Although the reimbursement procedure stipulates that in such a case the costs for the purchase of medicines are compensated in the amount of 100%, there is a limit at the same time because the purchase of medicines for one patient is compensated for no more than 14,228.72 euros in a 12-month period. This limit has not been revised since 2006, and the Ministry of Health has neither historical data nor considerations on the basis of which it was determined. Meanwhile, for oncology patients with a diagnosis for which medicines in the list of compensated medicines are included, they cost 49,560 euros in a 12-month period on average.

Not all cancer diagnoses are treated in accordance with the international clinical guidelines, as when comparing the medical therapy paid for by the state and prescribed in the international guidelines for the treatment of the 11 most common cancer diagnoses, it was found that the treatment paid for by the state was incomplete or inadequate and ineffective in almost all cases, namely, from the 11 diagnoses included in the audit sample, only ovarian and non-metastatic bowel cancer were treated in Latvia according to the guidelines. Also, although apparently there are compensated medicines for all cancer diagnoses, only 39% of diagnoses are provided with basic therapy and 35% with follow-up treatment in Latvia while both basic therapy and follow-up treatment are fully provided only to 27% of the diagnoses. In addition, there is no rational connection between the list of compensated medicines and reimbursement of medicines in an individual order. For example, if the list of compensated medicines includes medicines for a specific cancer diagnosis that are not used for treatment at all or if the medicine is envisaged for a relevant diagnosis but a specific patient with such a diagnosis does not qualify for the compensation of medicines due to specific restrictions on prescribing medicines set by the National Health Service of Latvia, the patient is refused the reimbursement for the purchase of medicine on an individual basis as well because the list “seems to include medicines”. “Most likely, this is a consequence of the limited state funding, but, according to the auditors, this action is both unfair, illogical, absurd, and humiliating to oncology patients,” stated M. Āboliņa.

In Latvia, oncological diseases belong to mandatory registrable diseases when information about patients is collected in the patient register for statistical purposes, whose operation the Centre for Disease Prevention and Control ensures. Unfortunately, the register does not function properly because the data collected in it about oncology patients are of inferior quality and incomplete. For instance, in June 2023, the latest available data in the register was published in 2019, and the data is still marked “provisional”.

For data on oncology patients to be used more broadly, development of a new Cancer Register began in 2022 by entrusting it to the National Health Service of Latvia and Riga Eastern Clinical University Hospital Ltd. (RAKUS) and allocating funding in the amount of ~1.6 million euros. The auditors failed to receive information about a project management plan for the development of the new Cancer Register, and the Ministry of Health concluded during the audit that the RAKUS was not entitled to ensure the development and operation of a national patient register at all, as a result of which the responsibility for the register was transferred back to the National Health Service of Latvia but the allocated funding was invested in the share capital of RAKUS on 23 December 2022 by channelling around 900,000 euros for the purchase of a medical facility not planned in the budget. Unfortunately, the future prospects of the new Cancer Register project remained unclear during the audit.

State Audit Office recommendations #PēcRevīzijas

The State Audit Office has provided six recommendations to the Ministry of Health, the implementation timeframe of which are from 2025 to 2029.

 

Additional information

Ms Signe Znotiņa-Znota

Head of PR and Internal Communication Division

Ph. + 371 67017671 | M. + 371 26440185 | E-mail: signe.znotina-znota@lrvk.gov.lv