Hungarian reimbursement list includes 10 new innovative drugs, with long delays as reimbursement eligibility rules change

Legal amendment changes reimbursement rules, brings new drugs onto list

A legal amendment has been passed in Hungary that introduces new changes to eligibility for reimbursement as well as creates a novel reimbursement category in the country's pricing and reimbursement (P&R) system. At the same time, a group of 10 innovative medicines have been added to the reimbursement list, with the Hungarian Association of Innovative Pharmaceutical Manufacturers publishing a document showing the long delays to a final reimbursement decision that producers have to face in the country.

Access to reimbursed medicines enhanced with regulatory changes

Hungarian pharmaceutical news source Pharma Online reports that under the amendment, the "preferential" price band for medicines within reference pricing, subject to the "blind-bid" tendering system, within which drugs continue to be eligible for full reimbursement, has been broadened, so that drugs priced up to 15% higher than the reference-price product will still be eligible for full reimbursement. Furthermore, the price cut-off point above which no reimbursement is given has been increased: in the case of active-ingredient-based reference pricing, it has increased from 50% to 100% higher than the reference price and, in the case of therapeutic-group-based reference pricing, it has increased from 60% to 100%.

New reimbursement category introduced

A new reimbursement category, which gives certain drugs "beneficiary medicine status", has also been introduced, the source reports (see Hungary: 13 November 2013: Hungary to introduce new "beneficiary" reimbursement category for non-substitutable drugs). This new category applies to low-turnover medicines that are certified in particular therapeutic areas and are essential medicines despite their low prices. Pharma Online reports that the government decided to introduce the category in order to prevent domestic manufacturers from opting to stop producing these medicines simply because they are no longer economically viable. Among the benefits that producers of these medicines now receive for supplying them include exemption from fees, such as the 20% levy on the amount of reimbursement paid for reimbursed medicines. However, as the source reports, the new category comes with a maximum annual reimbursement amount of just HUF30 million (USD135,927) to be paid out by the National Health Insurance Fund Administration (OEP).

Ten new innovative medicines/indications gain reimbursement

Meanwhile, Central European Pharma News reports that 10 new innovative drugs/indications have gained reimbursement status under the amendment. These new drugs are included in a list published by the IGY, which provides details of the length of time between the start of the process of assessing them and the final reimbursement decision. The list can be accessed here, at the IGY's website.

As the IGY notes, in the case of each drug on its list, the official length of time that the procedure of reimbursement assessment should take is a maximum of 90 days. In reality, in the case of the drugs and indications reportedly added to the reimbursement list, their assessment procedures extended beyond 90 days in every case. The shortest assessment duration was 167 days, for Strattera, and the longest was 519, for the new indication of Procoralan.

Outlook and implications

The broadening of the preferential price range is positive for patients and producers, and will mean that a greater number of medicines are fully reimbursed, access for patients will increase, and shortages of particular drugs will be prevented. This is especially good news for Hungary's generics producers, which have emphasised their difficulties in matching the prices of producers from low-cost-production countries. This is now the third time in which these preferential ranges have been increased. The addition of the new reimbursement category is another attempt by the Hungarian authorities to ensure that the supply of medicines is maintained, particularly in the case of those with a high therapeutic value but a low economic worth.

The addition of these new medicines and indications to the Hungarian reimbursement list follows many complaints from the pharmaceutical industry that delays in reimbursement procedures have been getting worse. Their addition is a positive development for the innovative pharmaceutical industry, although it would be premature to expect this to be a precursor of greater numbers of innovative medicines gaining reimbursement more rapidly in the country. The ever-increasing complexity and intensiveness of the Hungarian reimbursement assessment procedure means that this is unlikely.