Closed programs

Commercial name Active substance Indication
Ozurdex® Intravitreal implant with dexamethasone 700 microgram Diabetic macular edema
Vargatef® Nintédanib In combination with docetaxel adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer of adenocarcinoma tumour histology progressing after one prior line of chemotherapy
Imbruvica® Ibrutinib Patients suffering from relapsed or refractory lymphocytic leukaemia/small lymphocytic lymphoma
Enbrel® Etanercept Psoriatic arthritis in children aged 12-17 years
Gazyvaro® Obinutuzumab In combination with chlorambucil for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy
Entyvio® Vedolizumab Patients with ulcerative colitis that have failed at least 2 previous anti-TNF or for whom anti-TNF are contra-indicated
Mepolizumab® Mepolizumab Eosionophylic granulomatosis with polyangitis (EGPA or churg-Strauss Syndrom)
Xtandi® Enzalutamide Asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer in adult patients whose disease progressed during or after androgen deprivation therapy (ADT) but for whom chemotherapy is not yet clinically indicated
Zydelig® Idelalisib In combination with rituximab for relapsed chronic lymphocytic leukemia in adult patients who cannot be treated with chemotherapy
Avastin ® Bevacizumab in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, in adult patients with persistent, recurrent, or metastatic carcinoma of the cervix
Zydelig® Idelalisib Follicular lymphoma (FL) refractory to two prior lines of therapy
Entyvio® Vedolizumab Patients with Crohn disease that have failed at least 2 previous anti-TNF or for whom anti-TNF is contra-indicated
Keytruda®
 
Pembrolizumab – MK 3475 Unresectable or metastatic melanoma in patients who are refractory to treatment with ipilimumab
Keytruda® Pembrolizumab – MK 3475 Advanced (unresectable or metastatic) melanoma in first line or after BRAF inhibitor 
Pixuvri® Pixantrone monotherapy for the 3rd or 4th line treatment of adult patients with multiply relapsed or refractory aggressive Non‐Hodgkin B‐cell Lymphomas (NHL) (DLBCL and transformed indolent lymphoma)
Raxone® Idebenone For the treatment of yung patients with Duchenne Muscular Dystrophy who are not taking contamitant glucocorticoid steroids
Humira ® Adalimumab Active moderate to severe Hidradenitis Suppurativa (HS) in adult patients with an inadequate response to conventional systemic HS therapy
Kyprolis® carfilzomib in combination with lenalidomide and dexamethasone (KRd) for the treatment of adult patients with relapsed multiple myeloma who did receive at least 1 prior therapy
Cobimetinib® Cobimetinib In combination with Zelboraf® (vemurafenib) in patients with unresectabel or metastatic BRAFV600 mutation-positive melanoma
Tagrisso® Osimertinib Tagrisso® is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC)
Opdivo® Nivolumab Medical Need Program with Opdivo (nivolumab) for the treatment of anti-PD-1-treatment naïve patients with advanced renal clear-cell carcinoma who have progressed after or failed at least one prior treatment with an anti-angiogenic agent
Zepatier® Elbasvir / grazoprevir Treatment of Chronic Kidney Disease stage 4/5 patients with hepatitis C  genotype 1 or 4 infection
Opdivo® Nivolumab locally advanced and metastatic Non-Small-Cell Lung Cancer (NSCLC) in patients who have documented progression on or after prior chemotherapy
Opdivo® Nivolumab Classical Hodgkin lymphoma in adult patients who have relapsed after ASCT and brentuximab vedotin treatment.
Zykadia® Ceritinib ALK positive NSCLC patients that have received prior therapy with crizotinib
Revolade® Eltrombopag Thrombocytopenia in patients with severe aplastic anemia
Darzalex® Daratumumab Patients who have relapsed and refractory multiple myeloma (MM), who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or whose disease is double refractory to both a PI and an IMiD
Orkambi® lumacaftor/ivacaftor Cystic fibrosis in patients 12yrs and older who are homozygous for the F508del CFTR mutation
Entresto® Sacubitril/Valsartan
 
Medical Need Program with Entreso (Sacubitril/Valsartan) for the treatment symptomatic chronic heart failure with reduced ejection fraction in adult patients.
Abraxane® paclitaxel in combination with gemcitabine for the first line treatment of metastatic adenocarcinoma of the pancreas
KEYTRUDA® pembrolizumab First‐Line treatment of metastatic Non‐Small Cell Lung Cancer (NSCLC) in adults whose tumors express PD‐L1 with a ≥50% tumor proportion score (TPS) with no EGFR‐ or ALK‐ positive tumor mutations
Repatha® Evolocumab Severe uncontrolled familial hypercholesterolemia (FH), despite treatment with a maximum tolerated dose of a statin in combination with ezetimibe, or with ezetimibe without a statin in case of statin intolerance or contra‐indication
Humira®  Adalimumab Active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant to, conventional therapy
Humira®  Adalimumab Treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies
Kyprolis®

carfilzomib

in combination with dexamethasone (Kd) for the treatment of adult patients with relapsed multiple myeloma who did receive 3 or more prior therapies

Stelara® Ustekinumab

Treatment of moderate to severe active Crohn’s disease who have failed TNFα antagonists (infliximab/infliximab biosimilar, adalimumab) and the integrin inhibitor vedolizumab, or who are intolerant to, or have a contraindication to these treatments.

Humira®

Adalimumab

Treatment of non-infectious intermediate, posterior and pan-uveitis

Revolade® Eltrombopag

Thrombocytopenia in patients with myelodisplastic syndrome.

Ofev® Nintedanib Idiopathic pulmonary fibrosis (IPF) in adult patients
Venclyxto® Venetoclax Treatment of chronic lymphocytic leukaemia in adult patients who are unsuitable for or have failed other treatments.
Kisqali®

Ribociclib

In combination with letrozole for adult postmenopausal women as initial endocrine-based therapy for hormone receptor-positive (HR+) HER2-negative (HER2-) locally advanced or metastatic breast cancer.

Alprolix®

Eftrenacog alfa

Treatment and prophylaxis of bleedings in hemophilia B patients (deficiency= Factor IX coagulation factor)

Lartruvo® Olaratumab

In combination with doxorubicin for the treatment Advanced soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy and not previously treated with doxorubicin

Cabometyx® Cabozatinib Advanced renal cell carcinoma in adults following prior vascular endothelial growth factor (VEGF)- targeted therapy
Tecentriq®

Atezolizumab

locally advanced or metastatic urothelial carcinoma in adult, previously untreated patients who are considered cisplatin ineligible
Trisenox® Arsenic trioxide In combination with alltrans retinoic acid (ATRA) for the first‐line treatment of low or intermediate risk acute promyelocytic leukemia (APL)
Blincyto®

Blinatumomab

Adults with Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL)

Wakix® Pitolisant Second-line treatment of adult patients with narcolepsy with or without cataplexy
Lenvima®

Lenvatinib

Radioiodine-refractory differentiated thyroid cancer.

Halaven®

Eribulin

Treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.

Blincyto®

Blinatumomab

Adults with Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL)

Xalkori®

Crizotinib

ROS1-positive non-small cell lung cancer (NSCLC)

Ilaris®

Canakinumab

Hereditary periodic fever

Ibrance®

palbociclib

patients suffering from advanced/metastatic breast cancer hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative with endocrine therapy

Bavencio

Avelumab

Treatment of adult patients with metastatic Merkel cell carcinoma whose disease has progressed after receiving at least one prior chemotherapy or who are ineligible for chemotherapy

Spinraza® Nusinersen Infantile-onset (Type I) Spinal Muscular Atrophy (SMA)
Alecensa® Alectinib

First-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)

Zytiga®

Abiraterone acetate

Treatment of newly diagnosed with high risk Metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) and prednisone or prednisolone.

Rydapt® Midostaurin (PKC412) Newly diagnosed FLT3 mutated acute myeloid leukemia patients eligible for standard induction and consolidation chemotherapy.

Xermelo

 

Telotristat etiprate

Treatment of carcinoid syndrome diarrhea in combination with somatstatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.

Tafinlar + Mekinist

Dabrafenib + Trametinib

Traitement de patients atteints d’un cancer bronchique non à petites cellules (CBNPC) avancé porteur d’une mutation BRAF V600.

Humira Adalimumab Treatment of paediatric chronic non-infectious anterior uveitis patients (from 2 years of age) who have had an inadequate response to conventional therapy including topical corticosteroid and an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Zavicefta®

Ceftazidime/Avibactam

Treatment of infections due to aerobic Gram-negative organisms in adult patients with no other treatment options available.

Ocrevus® Ocrelizumab Primary progressive multiple sclerosis.
Keytruda® Pembrolizumab - MK 3475 In combination with chemotherapy (carboplatin + paclitaxel) for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 with a tumour proportion score (TPS) between l%-49% or no PD-L1 (TPS <1%).
Imfinzi

durvalumab

Treatment of locally advanced (stage III), unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy.

Dupixent Dupilumab Treatment of moderate-to-severe atopic dermatitis in adult patients coming from the Open Label Extension study (OLE)R668-AD-1225 and who are candidates for systemic therapy
Dupixent® Dupilumab Treatment of severe atopic dermatitis in adult patients, uncontrolled with immunosuppressive systemic therapy during the last year.
Vimpat®

Lacosamide

Partial-onset or generalized tonic clonic seizures in patients ≥ 16 years of age coming from the SP0994 clinical trial

Mylotarg ®

Gemtuzumab Ozogamicin

CD33-positive relapsed or refractory acute myeloid leukemia (AML) or CD33-positive relapsed or refractory acute promyelocytic leukemia (APL).

Perjeta® Pertuzumab In combination with Herceptin® (trastuzumab) and chemotherapy for the adjuvant treatment of adult patients with HER2 positive early breast cancer at high risk of recurrence defined as lymph node positive disease.
Besponsa®

inotuzumab ozogamicin

relapsed or refractory CD22-positive B-Cell precursor acute lymphoblastic leukemia (ALL) in adult patients

Tafinlar + Mekinist

Dabrafenib  + Trametinib

adjuvant treatment of high-risk BRAF V600 mutation-positive stage III melanoma after complete surgical resection.

Cablivi caplacizumab

acquired thrombotic thrombocytopenic purpura.

Entresto

sacubitril / valsartan

heart failure with preserved fraction (HFpEF) for patients who participated in study CLCZ696D2301 (PARAGON-HF)

RoACTEMRA® Tocilizumab

Systemic sclerosis.

Xeljanz®

Tofacitinib citrate

Treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

Tecentriq

Atezolizumab

In combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small-cell lung cancer (ES-SCLC).

Raxone ®

Idebenone

Leber’s hereditary optic neuropathy (LHON)  

Lynparza®

Olaparib

Treatment of patients with deleterious or suspected deleterious germline BRCA1 or BRCA2 mutation and who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting for TNBC or HER2-/ HR+ breast cancer unsuitable for further anti-hormonal therapy.

Onpattro

Patisiran-LNP

hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy

Gilenya®

Fingolimod

Relapsing multiple sclerosis (RMS) in for pediatric patients aged 10 to less than 18 years old of 40 kg or above.

Yervoy®

Ipilimumab

Treatment-Naïve Intermediate and Poor Risk Patients with Advanced or Metastatic Renal Cell Carcinoma in combination with Opdivo® (nivolumab)

Aimovig®

erenumab

Treatment of patients diagnosed with migraine, who are in need of prophylactic treatment and for whom no acceptable alternative prophylactic treatment is available.

RoActemra®

tocilizumab

Giant cell arteritis (GCA or temporal arteritis)

Hemlibra

Emicizumab

Routine prophylaxis of bleeding episodes in patients with hemophilia A with factor VIII inhibitors. Hemlibra can be used in all age groups.

Hemlibra

Emicizumab

Routine prophylaxis of bleeding episodes in patients with severe haemophilia A without factor VIII inhibitors and with inadequate response on their current treatment.

Tecentriq® Atezolizumab In combination with bevacizumab, paclitaxel and carboplatin, for the first-line treatment of adult patients with stage IV or recurrent metastatic non-squamous non-small cell lung cancer (NSCLC) and whose tumors express PD-L1 < 50% with no EGFR or ALK positive tumors.
Opdivo

nivolumab

Treatment of adult patients with unresectable Malignant Pleural Mesothelioma who have progressed after at least one line of treatment including a platinum-based doublet chemotherapy.

Polivy® Polatuzumab vedotin In combination with bendamustine and rituximab for relapsed or refractory adult patients with diffuse large B-cell lymphoma (DLBCL) who are not candidates for hematopoietic stem cell transplant and have been treated with at least two prior lines of therapy.
Signifor LAR®

Pasireotide

Patients with acromegaly who are inadequately controlled with 1st generation somatostatin analogues

LYNPARZA

olaparib

maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy

Keytruda®

Pembrolizumab

In combination with platinum and 5-fluorouracil (5-FU) chemotherapy for the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in adults with a PDL-1 CPS score=0.

COR-003 (2S,4R-ketoconazole)®

COR-003 (2S,4R-ketoconazole)

Endogenous Cushing’s Syndrome.

Xarelto Rivaroxaban Co-administered with acetylsalicylic acid (ASA), for the treatment of patients with coronary artery disease (CAD) at high risk of ischaemic events.
Briviact® Brivaracetam

Adjunctive treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.

Ipatasertib (MO40153)

Ipatasertib (MO40153)

In combination with paclitaxel in PIK3CA/AKT1/PTEN altered, locally advanced or metastatic, triple-negative breast cancer or hormone-receptor-positive, HER2-negative breast cancer.

Lonsurf®

trifluridine/tipiracil

monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.
Raxone®

Idebenone

Patients with Duchenne Muscular Dystrophy (DMD) who completed DELOS study (SNT-III-003/ EudraCT 2009-012037-30)

Vimpat®

lacosamide

Adjuvant therapy in the treatment of partial seizures with or without secondary generalization in adults, adolescents and children from 4 years old with epilepsy.

Lorlatinib Lorlatinib (PF-06463922) Metastatic NSCLC (Stage IV, AJCC v7.0) that carries an ALK rearrangement or that carries a ROS1 rearrangement
Bavencio avelumab first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) without disease progression following first-line platinum-based induction chemotherapy
Keytruda® pembrolizumab first-line treatment of adult patients with Microsatellite Instability-High (MSI-H) or Mismatch Repair-Deficient (dMMR) metastatic Colorectal Carcinoma (mCRC)
Ajovy® fremanezumab Prophylaxis of migraine in adult patients who suffer from at least 8 monthly migraine days and who previously failed on at least 3 preventive treatment classes and cannot be satisfactorily treated with the other approved and commercially available alternative treatments, in accordance with clinical guidelines, because of efficacy and/or safety issues.
Kadcyla trastuzumab emtansine as a single agent for the adjuvant treatment of adult patients with HER2 positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy.
Yescarta® Axicabtagene ciloleucel Treatment of aggressive conditions in adults with primary mediastinal B-cell lymphoma (PMBCL) affecting your lymph tissue (part of the immune system) that affects a type of white blood cell called B lymphocytes and other organs in your body.
Tecentriq Atezolizumab Treatment of first line for adult patients with locally advanced or metastatic, positive PD-L1, triple negative breast cancer, in combination with nab-paclitaxel.
Tecentriq® Atezolizumab in combination with bevacizumab, is indicated for the first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy
Libtayo Cemiplimab Treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.
Adcetris Brentuximab vedotin in combination with cyclophosphamide, doxorubicin and prednisone (CHP) for the treatment of adult patients with previously untreated systemic anaplastic cell lymphoma (sALCL)
Orkambi® lumacaftor 100mg / ivacaftor 125mg Treatment of cystic fibrosis (CF) in patients 6 through 11 years of age who are homozygous for the F508del mutation in the CFTR gene.
Vitrakvi Larotrectinib Treatment of adult and paediatric patients with locally advanced or metastatic solid tumors with a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion that cannot be treated satisfactorily with the available treatment options
Cyramza® ramucirumab treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have a serum alpha fetoprotein (AFP) of ≥ 400 ng/ml and who have been previously treated with systemic therapy.
Last updated on 19/04/2021