In January, the range of medicines reimbursed by the Estonian Health Insurance Fund expanded once again. New treatment options were added both to the list of reimbursable medicines and to the list of health services, improving access to treatment in particular for people living with severe and rare diseases.
According to Getter Hark, Head of the Medicines Reimbursement Service at the Estonian Health Insurance Fund, the newly added medicines will account for nearly four million euros of the total medicines budget in the first year of reimbursement. New medicines were added for the treatment of malignant diseases (colorectal, cervical, endometrial and lung cancer, lymphoblastic leukaemia and multiple myeloma), three severe chronic diseases (systemic lupus erythematosus, rheumatic polymyalgia and transthyretin-mediated amyloidosis) as well as three rare diseases (paroxysmal nocturnal haemoglobinuria, progressive familial intrahepatic cholestasis and Alagille syndrome).
Advances in lung cancer treatment
Small cell lung cancer is the most aggressive type of lung cancer and accounts for around 10–15% of all lung cancer cases. In most cases, the disease is detected only once it has already spread (stage III) or is advanced (stage IV). With previous treatment options, the average five-year survival rate for patients with stage III or IV disease was around 5%. “So far, patients have only had access to chemotherapy. The inclusion of atezolizumab in the Health Insurance Fund’s list of health services makes it possible, according to clinical studies, to extend life expectancy on average by two months. In addition, there is a small group of patients (10–12%) who benefit from long-term disease control lasting several years. This means that the previous average five-year survival rate increases to 12%,” explained Getter Hark, adding that the change will affect around 64 people per year.
New option in cervical cancer treatment
Around one third of cervical cancer cases are diagnosed when the disease is already advanced. In such cases, the first-line treatment option is the active substance pembrolizumab, but only for patients whose tumour expresses a specific biomarker (PD-L1). “Other patients must start with platinum-based chemotherapy, and for these people we have now, from January, made the active substance cemiplimab available with reimbursement as a second-line treatment. Previously, for these patients, the only option in the second line – that is, after first-line chemotherapy – was again chemotherapy,” Hark noted.
According to Hark, the problem is that in the second line the tumour may no longer respond to chemotherapy, and switching between or combining different chemotherapy regimens no longer produces results. Research shows that the average survival of patients receiving chemotherapy is up to nine months. With the active substance now added to the list of reimbursable medicines, it is possible to significantly improve quality of life and prolong survival by an average of 3.5 months.
In addition, the Health Insurance Fund will now reimburse pembrolizumab for a new indication – as first-line treatment for advanced endometrial cancer, both in patients with mismatch repair deficiency and in those with proficient mismatch repair. Around 240 new cases of the disease are diagnosed in Estonia each year. “Unlike several other types of cancer, the incidence of endometrial cancer is increasing. We have decided to reimburse pembrolizumab, which helps to delay disease progression by about four months,” Hark explained. In total, around 30 patients per year will benefit from this new treatment option.
Innovation in metastatic colorectal cancer treatment
In the treatment of colorectal cancer, chemotherapy is currently the main option in both first- and second-line settings. “There is a strong need for more modern medicines because for patients whose disease is associated with a specific mutation (BRAF), the average survival after receiving first-line chemotherapy is less than six months. From the new year, patients will have access to a combination of encorafenib and cetuximab, which extends survival for these patients by 3.4 months. In total, 19 patients per year are expected to need this treatment,” Hark said.
Treatment of severe chronic diseases
The Health Insurance Fund has also improved treatment options for people living with rheumatic polymyalgia (RPM). This disease is characterised by rapidly developing and, over days or weeks, worsening severe pain in the shoulders, shoulder girdle, hips and thighs. The pain is inflammatory in nature and is particularly severe at night and in the early morning. The disease is also marked by pronounced stiffness in the limbs, which can be so severe that a person is unable to raise their arms or perform everyday activities such as washing, dressing or combing their hair. Fatigue, fever and weight loss are also common.
“The disease has a very serious impact on a person’s quality of life – mobility is limited and it can lead to partial or total loss of ability to work. In older people, the disease may result in loss of independent functioning, meaning they need daily assistance and care,” explained Getter Hark. Previously, treatment relied on glucocorticosteroids, which help keep inflammation under control, but long-term use (for example 60 days or more) is associated with significant side effects: infections, osteoporosis, high blood pressure, diabetes, gastrointestinal ulcers, cataracts, skin changes and psychiatric disorders.
The introduction of tocilizumab offers patients with rheumatic polymyalgia an opportunity to receive anti-inflammatory treatment that reduces the need for glucocorticosteroids and thereby their serious side effects. More than 50 patients per year are expected to need this treatment.
Improved treatment options for haematological diseases
From the new year, the active substance teclistamab will be available for the treatment of multiple myeloma in patients whose disease has progressed after at least three previous lines of therapy. These patients previously had no effective treatment options, and the new active substance increases survival by ten months. Around 15 patients per year will benefit from this new treatment option.
Advances in the treatment of rare diseases
At the beginning of January, new treatment options were also added for two very rare diseases: progressive familial intrahepatic cholestasis (PFIC) and Alagille syndrome. These diseases are characterised by uncontrolled itching, disorders of bile flow, growth retardation and a potential need for liver transplantation. For the treatment of both diseases, the active substance odevixibat has been added to the list of reimbursable medicines. It reduces bile acid levels and alleviates itching, thereby significantly improving patients’ quality of life. “In Estonia, a child with PFIC has so far been born once every four to eight years, and a child with Alagille syndrome once every three to five years. Should the need for treatment arise, the necessary medicines are now already included in the Health Insurance Fund’s list,” Hark said.