Dolutegravir / lamivudine

Active substance
Dolutegravir / lamivudine
Domain
Infectious diseases
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Viral infections
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.

1. Product

Proprietary name
Dovato
Manufacturer
ViiV
Mechanism of action
HIV inhibitor
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Extramural (GVS)
Additional comments
HIV integrase inhibitor + nucleoside reverse transcriptase inhibitor (NRTI)

2. 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 comments
Nieuwe formulering (single tablet regimen) van 2 bestaande losse componenten. Positieve CHMP-opinie april 2019.

3. Therapeutic value

Current treatment options
Tenofovir/ emtricitabine/ dolutegravir
Therapeutic value
Potential 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.
Duration of treatment
Not found
Frequency of administration
1 times a day

4. 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 comments
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 %.

5. Expected cost per patient per year

Cost
9,600 - 12,000
Additional comments
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).

6. Potential total cost per year

Total cost

41,040,000

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.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.