Table 3. Medicines on the Croatian Institute for Health Insurance (CIHI) Basic List that were rejected by the WHO Essential Medicines List (EML).

Medicine/Disease group	Technical Report Series (TRS), year	Explanation – reason for rejection
amantadine/CNL	TRS958, 2009	The Committee recommended not including any of the antivirals on the Model List at the present time. However the Committee endorsed the proposal for an emergency meeting mechanism to consider one or more of the antivirals, including for paediatric use, should a pandemic occur.
clozapine/CNL	TRS958, 2009	The applications did not provide sufficient information regarding the comparative effectiveness and safety of the proposed medicines (clozapine, olanzipine, risperidone, quetiapine, aripiprazole and ziprasidone).
ziprasidone/CNL	TRS958, 2010
darunavir/INF	TRS965, 2011	Given the relatively limited evidence of efficacy, safety, and cost– effectiveness in both adults and children in a diversity of settings, that the optimal use of darunavir is still being defined, and uncertainty regarding the best combinations of medicines for third-line regimens, the Committee recommended that darunavir should not be added to the Complementary List. Further development of darunavir is clearly required, including fixed-dose combination products of darunavir/ritonavir especially for children.
escitalopram*/CNL	TRS958, 2009	Overall the Committee decided that the evidence provided in the application did not support the public health need or comparative effectiveness, safety and cost-effectiveness for the addition of escitalopram, paroxetine or sertraline to the Model List at this time.
lamotrigine/CNL	TRS958 2009	The Committee did not recommend the inclusion of lamotrigine on the Model List based on the lack of evidence of its superior efficacy and safety and cost-effectiveness with respect to comparators, and the availability of suitable alternative first-line antiepileptics which are already on the Model List. The Committee recommended a review of second-line antiepileptics for a future meeting, including a review of topiramate, lamotrigine and gabapentin as a second-line therapy for children and adults.
levonorgestrel-releasing IUD/UG	TRS933 2005	The Committee recommended rejection of the application for inclusion of the levonorgestrel-releasing IUD for contraception because of the lack of evidence for better efficacy, its higher discontinuation rate and because it is more expensive than the copper IUD already in the Model List.
paroxetine/CNL	TRS958 2009	The Committee decided that the evidence provided was not sufficient to recommend the addition of paroxetine and sertraline or addition of a square box to fluoxetine.
pentazocine/CNL	TRS825 1992, TRS850 1995, TRS867 1997	The Committee has rejected a request to add pentazocin to the list, since it would have been endorsing to use an inferior analgesic for victims of large scale emergencies or disasters because of regulatory requirements. Rather, the Committee strongly urged that administrative and regulatory requirements be modified to permit the use of essential drug morphine in emergency health care.
quetiapine*/CNL	TRS958 2009	The application did not provide sufficient information regarding the comparative effectiveness and safety of the proposed medicines.
raltegravir/INF	TRS 965 2011	Raltegravir was rejected due to the comparatively limited efficacy, safety, and cost–effectiveness in both adults and children in a diversity of settings and because the optimal use of raltegravir is still being defined, as well as the best combinations of medicines for third-line regimens.
risperidone/CNL	TRS882 1998, TRS958 2009	The application did not provide sufficient information regarding the comparative effectiveness and safety of the proposed medicines.
sertraline*/CNL	TRS958 2009	See paroxetine.
sumatriptan/CNL	TRS946 2007, TRS958 2009	Sumatriptan 50 mg tablet – rejected on the grounds that the comparative efficacy, safety and cost-effectiveness of sumatriptan versus other triptans and aspirin were not established.

Disease groups: CV – Cardiovascular, CNS – Central nervous system, GI – Gastrointestinal, ONCOL – Oncological and immunomodulatory, INF – Systemic infection, B – Blood/hematopoietic, RESP – Respiratory, MS – Musculoskeletal, UG – Genitourinary.

*Newly added to CIHI list.