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Life-saving treatments may not reach bulgarian patients in 2018 due to the moratorium on their payment imposed by the NHIF


27.10.2017, Sofia

Many new drug therapies that patients in most European countries receive may remain inaccessible to Bulgarian patients in 2018, the Association of the Research-Based Pharmaceutical Manufacturers in Bulgaria (ARPharM) warned. The reason is a moratorium on their payment by the National Health Insurance Fund in 2018 approved by the Supervisory Board of the NHIF and submitted for consideration by the Parliament. It appears that due to this sanction the widely proclaimed increase of healthcare funds by 400 million BGN will not lead to improvement in the drug treatment of Bulgarian patients. Some of the new therapies are life-saving, offering more treatment options, and in some cases they may even be more cost-efficient for NHIF.

Among the new therapies that the moratorium will affect are some already recommended for payment on the basis of health technology assessment and for which concession contracts have been concluded with conditions favourable to the NHIF. The assessment of health technologies vis-a-vis medicines is an assessment of the need for their payment by the NHIF on the basis of therapeutic benefit, prolonging life expectancy and improving the quality of life, reducing the complications of the underlying disease, benefits presented by extending the patient’s life, existence or lack of an alternative treatment of the disease, cost of therapy with the medicinal product and comparison of the cost of therapy with the available alternatives, cost-benefit ratio, economic evaluation of added benefits, and many other criteria.

Among the new therapies recommended for payment based on health technology assessment and covered by the moratorium are:

  • Obinutuzumab and Venetoclaxis for the treatment of chronic lymphocytic leukaemia (CLL), a cancer of the blood and bone marrow, offering new treatment opportunities for patients with CLL with concomitant diseases for which the therapeutic treatment options are limited or who have not been affected by previous therapies. The new therapies lead to a reduction in the risk of progression or death, to improvement in progression-free survival and increased time between anti-leukemic treatments.
  • Nintedanib (there is a contract for concession with NHIF) and Pirfenidone for the treatment of idiopathic pulmonary fibrosis, a rare, fatal, progressive lung disease leading to progressive worsening dyspnoea and irreversible impairment of pulmonary function. The new therapies delay the progression of the disease, reduce the annual loss of pulmonary function, improve control of disease symptoms and prolong the time without progression, as well as overall survival in patients with this disease, for which NHIF currently does not provide treatment.
  • Blinatumomab for the treatment of acute lymphoblastic leukaemia, which is a rare and fatal malignant condition. This completely new immunotherapy causes a rapid and lasting response in a population of patients previously treated intensively with chemotherapy by enabling the patient's own immune system to target and destroy malignant cells and achieve lasting remission or quality transplantation that increases the long survival of adult patients with acute lymphoblastic leukaemia.
  • Tofacitinib for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have had insufficient response or intolerance to previous treatment with one or more disease-modifying antirheumatic drugs. The new treatment is in the form of film-coated tablets, which is a significant advantage over drugs requiring injection or infusion, and results in a rapid, significant and clinically applicable improvement in disease symptoms and physical function.
  • Palbociclib is the first medicine, approved by the European Medicines Agency, a new class of medication for the treatment of hormone-receptor positive/ HER-2 negative metastatic breast cancer, which in combination with Letrozole or Fulvestrant, results in a statistically and clinically significant improvement in disease-proliferation compared with treatment with only one of the components, with a good safety profile with potentially tolerable and controllable side effects.
  • Carfilzomib (there is a concession contract with the NHIF) in combination with Dexamethasone for the treatment of patients with recurrent or refractory multiple myeloma. Multiple myeloma is a rare, complex and incurable cancer that is believed to have affected 240 newly diagnosed men and women in Bulgaria in 2012. Although several medicines have been approved in the EU, many of them are not yet reimbursed in Bulgaria, therefore there is a high unfulfilled need for new therapy that is better in terms of efficacy and tolerance than the present standard for treatment. Treatment with Carfilzomib in combination with Dexamethasone doubles progression-free survival as well as the ratio of patients with complete clinical response with a comparable safety profile.
Among the new therapies affected by the moratorium, which are still undergoing health technology assessment, are:
  • Trametinib in combination with Dabrafenib for the treatment of adult patients with inoperable or metastatic melanoma with a BRAF V600 mutation. The combination provides an increase in average overall survival versus monotherapy and an increase in overall survival, and significant progress has been made in responding to a malignancy with extremely poor prognosis such as inoperable or metastatic melanoma.
  • PasireotidLAR for the treatment of adult patients with acromegaly that provides a significantly improved clinical response, quality of life and adherence to treatment for inoperable adult patients
  • Everolimus for the treatment of adult patients with renal angiomyolipoma and for the treatment of patients with subependymal giant cell astrocytoma, both associated with tuberous sclerosis complex. In the absence of other therapeutic alternatives, the medicine has proven efficacy with practice data and is the only therapeutic option for patients with the tuberous sclerosis complex.
  • Mepolizumab for the treatment of asthma in patients who continue to have asthma symptoms despite the treatment they have had so far, suffering from so-called severe asthma. The new therapy significantly reduces the incidence of exacerbation as well as the use of oral corticosteroids and leads to a clinically significant improvement in quality of life in patients with severe eosinophilic asthma.
  • Osimerinib for the treatment of non-small cell lung cancer that slows the progression of the disease compared to chemotherapy and has a good tolerance profile. 

Against the backdrop of the lowest producer prices in the European Union, in 2017, pharmaceutical companies will provide the NHIF with pharmaceutical cost compensation in the form of concessions worth 130 million leva (compared to 47 million for 2015 and 87 million for 2016) or a total of 264 million over a 3-year period. For 2018 NHIF plans to receive a compensation of BGN 160 million. This substantial compensation of NHIF costs for medicines will be meaningless if it cannot help Bulgarian patients to gain timely access to new drug therapies.

NHIF payments for medicines are increased for objective reasons - aging population, increased morbidity, but also extended survival as a result of the achievements of medicine and the dissemination of new technologies. Budget considerations should not deprive patients of access to new therapies that can significantly improve their treatment. Behind the figures there are cured patients and saved lives for which institutions should be showing more concern.

Members of the Association