Extended indication Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatmen
Therapeutic value Possible equal value
Total cost 21,600,000.00
Registration phase Registered

Product

Active substance Doravirine
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Viral infections other
Extended indication Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults infected with HIV-1 without past or present evidence of resistance to the NNRTI class.
Proprietary name Pifeltro
Manufacturer MSD
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional remarks Non-nucleoside reverse transcriptase inhibitor.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date December 2017
Expected Registration November 2018
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP-opinie september 2018. Geregistreerd in november 2018.

Therapeutic value

Current treatment options Een combinatie van twee of drie antivirale middelen (cART) uit verschillende groepen met verschillende werkingsmechanismen en niet-overlappende resistentieprofielen.
Therapeutic value Possible equal value
Substantiation Doravirine in combinatie andere HIV-remmers is vergelijkbaar met de huidige behandelopties.
Duration of treatment continuous
Frequency of administration 1 times a day
Dosage per administration 100 mg
References clinicaltrials.gov, NCT02275780

Expected patient volume per year

Patient volume

< 2,000

Market share is generally not included unless otherwise stated.

References Monitoring Report 2017 (HIV Monitoring, pagina 41), SHM.
Additional remarks In 2016 waren in Nederland 19.035 mensen met HIV in zorg. 97% hiervan (18.552) was ooit gestart met de antiretrovirale combinatietherapie (cART). Per jaar worden ongeveer 1.000 nieuwe HIV-patiënten verwacht. Doravirine is een mogelijk alternatief voor de bestaande non-nucleoside reverse-transcriptaseremmers (NNRTI). Doravirine moet toegevoegd worden aan andere antiretrovirale middelen om een cART te vormen. De schatting is in dat er maximaal 2.000 patiënten zullen worden gezet op dit middel. Naast dit monopreparaat met doravirine is ook een vast combinatiepreparaat beschikbaar met doravirine/lamivudine/tenofovirdisoproxil.

Expected cost per patient per year

Cost 9,600.00 - 12,000.00
Additional remarks In dezelfde orde grootte als huidige STRs die varieren tussen de € 800,00 - € 1.000,00 per maand (gelijke kosten verwacht).

Potential total cost per year

Total cost

21,600,000.00

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

Indication extension No
References SPS

Other information

There is currently no futher information available.