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Dolutegravir / lamivudine

Dovato

Extended indication Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents above 1
Therapeutic value Possible equal value
Total cost 41,040,000.00
Registration phase Positive CHMP opinion

Product

Active substance Dolutegravir / lamivudine
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Viral infections other
Extended indication Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.
Proprietary name Dovato
Manufacturer ViiV
Mechanism of action HIV inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional remarks HIV integrase inhibitor + nucleoside reverse transcriptase inhibitor (NRTI)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New therapeutical formulation
Submission date October 2018
Expected Registration June 2019
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Nieuwe formulering (single tablet regimen) van 2 bestaande losse componenten. Positieve CHMP-opinie april 2019.

Therapeutic value

Current treatment options Tenofovir/ emtricitabine/ dolutegravir
Therapeutic value Possible equal value
Substantiation Verwachte waarde duo therapie vergelijkbaar met triple therapie. Verwacht dat de duo therapie minder toxisch is. Non-inferior in vergelijking met tenofovir/ emtricitabine/ dolutegravir.
Frequency of administration 1 times a day

Expected patient volume per year

Patient volume

< 3,800

Market share is generally not included unless otherwise stated.
References Monitoring Report 2017 (HIV Monitoring, pagina 41), SHM.
Additional remarks 19.035 betreft de patiëntenpopulatie die met HIV die behandeld wordt. Deze behandeling met twee geneesmiddelen gaat ongetwijfeld ook in de switch worden ingezet. Per jaar worden 1.000 nieuwe HIV-patiënten verwacht. Maximaal verwacht marktaandeel is 20 %.

Expected cost per patient per year

Cost 9,600.00 - 12,000.00
Additional remarks In dezelfde orde grootte als huidige behandelopties die variëren tussen de €800 - €1.000 per maand (gelijke kosten verwacht). Mogelijke kosten besparing (van 3 geneesmiddelen naar 2). De kans bestaat dat dit middel bestaande middelen vervangt (relevant voor BI).

Potential total cost per year

Total cost

41,040,000.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.