Seven new innovative oncology drugs/indications and a number of other innovative medicines are set to be added to the basic (essential) reimbursement list of Croatia's HZZO in its imminent update.
IHS Life Sciences perspective | |
Significance | The Croatian Health Insurance Fund (HZZO) is set to add seven new oncology medicines/indications as well as a number of innovative medicines in other therapeutic areas to its basic reimbursement list in its imminent update. |
Implications | This represents an important boost for Croatian cancer patients in particular, although it should be emphasised that many of the drugs and indications concerned have been approved for marketing in the European Union for several years and their submission for reimbursement approval in Croatia has also been subject to considerable delay. |
Outlook | This represents a continuation of the gradual improvement in access to newer innovative treatments in Croatia, although it remains to be seen to what extent the country's accession to the EU will speed up the process of obtaining reimbursement in the country, which still appears to be especially slow in the case of innovative drugs. |
Boost for access to innovative oncology treatments
Seven new innovative oncology medicines, or new indications of already reimbursed innovative oncology medicines, are to be added to the basic (essential) reimbursement list of the Croatian Health Insurance Fund (HZZO), following the publication of the decision in the official gazette of the Republic of Croatia, which was due to have taken place on 9 April, reports Croatian business newspaper Poslovni Dnevnik. According to the source, a total of 14 new medicines (new active ingredients or combinations) or new indications of already reimbursed medicines will be added to the basic reimbursement list in the forthcoming update.
The new innovative oncology medicines and indications that are to be added to the basic list are listed below. Croatian newspaper Vecernji list has also provided information regarding the year in which the drugs and indications concerned were submitted to the HZZO for inclusion in its reimbursement lists.
New oncology medicines/indications added to HZZO's basic (essential) list in latest update | ||||
Name of drug | Producer | Indication | Month and year of EU approval | Year of submission for reimbursement in Croatia |
Zelboraf (vemurafenib) | Roche (Switzerland) | BRAF V600-mutation positive unresectable or metastatic melanoma | February 2012 | 2012 |
Iressa (gefitinib) | AstraZeneca (United Kingdom) | Locally-advanced or metastatic, EGFR-mutation positive non-small-cell lung cancer | July 2009 | 2011 |
Yondelis (trabectadine) | PharmaMar (Spain) | Soft tissue sarcoma, in patients for whom treatment with anthracyclines and ifosfamide has failed or is not appropriate | September 2007 | 2013 |
Votrient (pazopanib) | GlaxoSmithKline (GSK, United Kingdom) | Advanced or metastatic renal cell carcinoma (RCC) | June 2010 | 2011 |
Afinitor (everolimus) | Novartis (Switzerland) | Advanced RCC in patients whose disease has worsened despite treatment with a VEGF-targeted therapy | August 2009 | 2011 |
Mozobil (plerixafor) | Genzyme (United States) | Stem-cell mobilisation in lymphoma or multiple myeloma patients | August 2009 | 2011 |
Evoltra (clofarabine) | Genzyme (United States) | Treatment of children and adults aged up to 21 years with acute lymphoblastic leukaemia, when the disease has not responded to or has relapsed after a minimum of two other treatments | May 2006 | 2010 |
Source: Poslovni Dnevnik, Vecernji list | ||||
Other new innovative medicines set to be added to basic list
Several other innovative medicines previously not reimbursed in Croatia are set to be added to the basic list. These are:
- Lyxumia (lixisenatide; Sanofi, France) – for the treatment of type-2 diabetes.
- Mycamine (micafungin; Astellas, Japan) – for the treatment of invasive candidiasis.
- Celsentri (maraviroc; GlaxoSmithKline, UK) – for the treatment of HIV.
- Lonquex (lipegfilgrastim; Teva, Israel) – for the treatment of neutropaenia.
- Eylea (aflibercept; Bayer, Germany) – for the treatment of age-related macular degeneration.
New additions to supplementary list
According to Poslovni Dnevnik, the type 2 diabetes treatment Forxiga (dapagliflozin; AstraZeneca, UK) is set to be added to the supplementary reimbursement list. Furthermore, the Servier (France) drug is reported to have been approved for the additional indication of chronic heart failure in the supplementary reimbursement list.
Outlook and implications
Considering the fact that these oncology medicines/indications were not available with reimbursement previously, their addition to the basic list in Croatia is an important breakthrough for patients. For pharmaceutical companies, it is another step towards Croatia reaching the standards of care in place in many other European Union member states. Considering the fact that a number of the medicines and indications involved were approved in the EU several years ago, and were submitted for reimbursement approval in Croatia as far back as 2011, the challenges that face pharmaceutical companies in the country in terms of getting drugs approved for reimbursement are apparent. The accession of Croatia to the EU in July 2013 was associated with an easing of the administrative challenges for pharmaceutical companies operating in the country, although it is possibly too soon to assess whether this has happened yet (see Croatia - Europe: 1 July 2013: Croatia's EU accession eases administrative burden for pharma companies).