The program that provides patients with access to innovative, innovative treatments is the one that enables cost-volume contracts. Cost-volume contracts add access to medicines, this type of patient access to medicines works in parallel with national programs and is also funded by CNAS.
The first cost-volume contracts, which provide access to innovative new treatments, began to apply in 2015, and currently 41 cost-volume contracts and 3 cost-volume contracts , for a number of 25 drugs in oncology therapeutic areas, rare diseases, chronic viral hepatitis C, etc.
Some of these drugs are complementary to the national curative programs run by NHIC, and others target non-programmed disease such as cardiovascular disease and severe psoriasis
The specific legislation establishes that the cost-volume contracts are written agreements concluded by CNAS with the companies that put on the Romanian market some new innovative medicines for the insured persons who need this treatment. Innovative medicines generally have high prices, making it sometimes difficult, if not impossible, to fully settle them from the inevitably limited funds of the health insurance system.
Settlement only if new, innovative treatments have been successful
An advantage of legislation on cost-volume contracts is that the reimbursement of medicines may be linked to the outcome of treatment, ie only the amount of medication used for patients treated successfully.
At present, legislation regulates distinctly the mechanisms underlying cost-volume / cost-volume-outcome contracts, which has increased patient access to innovative medicines according to the therapeutic indication, disease status and associated conditions. For cost-volume contracts, fixed percent scales shall be applied progressively to the quarterly consumption of medication based on the ratio between the number of patients actually treated in one quarter and those of eligible patients under that contract. For cost-volume-result contracts, an actual / patient cost with a medical outcome, actual cost that applies to both single-drug cases and to situations where there are two or more substitutable drugs on the same therapeutic indication . For patients, there is no personal contribution, the difference between the marketing price and the actual / patient cost with medical result being borne by the marketing authorization holders, with the title of a quarterly contribution.
New, innovative treatments for chronic viral hepatitis C
This type of contract is currently used to provide interferon-free treatment for chronic viral C hepatitis, at which the success rate is around 99%.
As of September 1, 2018, the number of eligible patients was increased to 13,000, allowing access to medication and patients in F1 stage of liver fibrosis. Physicians have the opportunity to apply three therapies so that treatments can be personalized according to the clinical status of each patient.
Romania is considered as an example of good European practice in terms of action to combat hepatitis C infection and reduce the prevalence of the disease, in line with the objective set out in the WHO and the EU Strategic Document on the eradication of chronic hepatitis B and C by the year 2030