Over 30 drugs waiting for authorization from the Portuguese National Competent Authority INFARMED

By Marcio Barra

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More than 30 new drugs, some with novel mechanisms of action which are already used in other European countries, are currently waiting for authorization by the Portuguese National Competent Authority, some for more than a year. The president of the board of APIFARMA, João Almeida Lopes, in a newspiece on the SIC tv channel commented that he believes these delays are due to economic reasons.

Some of the delays extend over a year, whereas current law sets a 75 day time limit for approval.

Below is a list of the drugs currently waiting for commercialization approval in Portugal:

 

Brand name Molecule Indication Marketing Authorization holder Reported reason for delay
Zydelig Idelalisib Zydelig is a cancer medicine that is used to treat chronic lymphocytic leukaemia (a cancer of a type of white blood cells called B lymphocytes) used in combination with another medicine (rituximab) Gilead The first contract proposal was presented by INFARMED in September 2015
Affinitor Everolimus Affinitor is a cancer treatment for advanced breast cancer in women who have been through their menopause. Novartis Contract was received. Process not yet concluded
Votubia Everolimus Used to treat benign tumours caused by the genetic disease tuberous sclerosis Novartis Economic study not yet started
Cosentyx Secukinumab Moderate to severe plaque psoriasis Novartis Parity with the comparator
Cosentyx Secukinumab Ankylosing spondylitis when conventional treatments do not work well enough. Novartis Economic evaluation not yet started
Xolair Omalizumab Chronic urticaria Novartis  –
OFEV Nintedanib Idiopathic pulmonary fibrosis (IPF) Boehringer-ingelheim Orphan indication
Vargatef Nintedanib Cancer medicine used to treat adults with non-small cell lung cancer. Boehringer-ingelheim  –
Praxbind Idarucizumab Reversal agent for Pradaxa Boehringer-ingelheim  –
Giotrif Afatinib Non-small cell lung cancer boehringer-ingelheim  –
Xofigo Radium-223 dichloride Treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases Algeta and Bayer Waiting for a cost minimization analysis from INFARMED. Waiting opinion from the Comissão Nacional de Farmácia e Terapêutica
Stivarga Bayer Gastrointestinal stromal tumor  Bayer Currently under economic evaluation and Waiting the opinion of the Comissão Nacional de Farmácia e Terapêutica
Stivarga  Bayer Colorectal cancer  Bayer Reportedly looking for solutions to assure accessibility to patients. Waiting opinion from the Comissão Nacional de Farmácia e Terapêutica
Zytiga Abiraterone acetate Treatment of prostate cancer  Janssen Accelerated approval by the EMA.

Recognition of added therapeutic value.

Imbruvica Ibrutinib Chronic lymphocytic leukaemia  Janssen Breakthrough therapy designation by the FDA. Recognition of added therapeutic value.
Imbruvica Ibrutinib Mantle cell lymphoma  Janssen Breakthrough therapy designation by the FDA. Recognition of added therapeutic value.
Olysio  Simeprevir  Chronic hepatitis C   Janssen Recognition of added therapeutic value. An estimated 300 patients missing Harvoni (sofosbuvir)
Velcade Bortezomib Patients with non-previously treated multiple myeloma  Janssen
Velcade Bortezomib Previously untreated patients who are going to receive high-dose chemotherapy followed by a blood stem-cell transplant. In this group of patients, Velcade is used in combination with dexamethasone, or with dexamethasone plus thalidomide;  Janssen Therapeutic standard in all guidelines. Recognition of added therapeutic value.
Sylvant Siltuximab Treatment of multicentric Castleman’s disease in adults who tested negative for the human immunodeficiency virus (HIV) and the human herpesvirus-8 (HHV-8)  Janssen Orphan disease –roughly 9 patients each year. Recognition of added therapeutic value
Sirturo Bedaquiline Sirturo is used in combination with other tuberculosis medicines in adults with tuberculosis that is affecting the lung and that is multi-drug resistant (resistant to at least isoniazid and rifampicin, two standard tuberculosis medicines).  Janssen New molecule for tuberculosis. Orphan disease –roughly 3 patients each year. Recognition of added therapeutic value
lynparza Olaparib First oral treatment for women with BRCA-mutated advanced ovarian cancer who have received 3 or more prior chemotherapy medicines  AstraZeneca Oprhan drug. Currently undergoing economic evaluation. Waiting opinion from the Comissão Nacional de Farmácia e Terapêutica
Toujeo Insulin glargine injection Used to treat diabetes in adult patients  Sanofi-Aventis New formulation. Waiting decision on charges limit.
Keytruda Pembrolizumab used to treat adults with melanoma that has spread to other parts of the body or cannot be surgically removed.  Merck Formal negotiations with INFARMED have begun, and a final proposal has been reached.
Zontivity Vorapaxar Used to reduce the occurrence of atherothrombotic events such as further heart attacks or strokes in adult patients who have already had a heart attack. It is given in combination with aspirin and clopidogrel.  Merck Under pharmacoeconomic evaluation
Isentress Raltegravir Isentress is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents, children,toddlers and infants from the age of 4 weeks  Merck Under pharmacoeconom ic evaluation
Genoya Elvitegravir/Cobicista/Emtricitabine/Tenofovir alafenamide HIV-1 Gilead
Zerbaxa Ceftolozane and tazobactam. Antibiotic used to treat adults with complicated (difficult to treat) bacterial infections affecting:

·        tissues and organs within the belly (intra-abdominal infections);

·         the kidneys (pyelonephritis);

·         the urinary tract (structures that carry urine, such as the bladder).

 Merck Waiting opinion from the Comissão Nacional de Farmácia e Terapêutica
Adempas Riociguat It is used to increase the ability to carry out physical activity in adults with Chronic thromboembolic pulmonary hypertension and Pulmonary arterial hypertension  Bayer
Jardiance  Empagliflozin  Type 2 diabetes Boehringer Ingelheim
Pradaxa´s third indication Dabigatran etexilate Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent
DVT and PE in adults
Boehringer Ingelheim
Eylea  Aflibercept Diabetic macular edema  Bayer Currently in contract negotiation. Waiting opinion from the Comissão Nacional de Farmácia e Terapêutica
Eylea  Aflibercept Occlusion of the central retinal vein  Bayer Currently in contract negotiation.
Stelara  Ustekinumab  Janssen New indication. Equivalent added therapeutic value
Rezolsta Darunavir / cobicistat Human immunodeficiency virus type 1 (HIV-1)  Janssen New fixed association. Equivalent added therapeutic value
Triumeq Abacavir, dolutegravir and lamivudine Human immunodeficiency virus type 1 (HIV-1)  ViiV Healthcare New fixed association. Equivalent added therapeutic value

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