Reason for request
Reassessment
Summary of opinion
Favourable opinion for reimbursement in the treatment of HIV-1 infection only in adults and adolescents above 12 years of age weighing at least 40 kg:
- who are treatment-naive, with a CD4 count of more than 200/mm3, a viral load (VL) of less than 500,000 copies/mL and with no known or suspected resistance to either of the two drugs;
- previously treated, with a stable VL < 50 copies/mL for at least one year, a CD4 count of more than 350/mm3 and with no known or suspected resistance to either of the two drugs.
Unfavourable opinion for reimbursement in the other situations covered by the MA indication.
Clinical Benefit
| Substantial |
The clinical benefit of DOVATO (dolutegravir/lamivudine) is substantial only in adults and adolescents above 12 years of age
weighing at least 40 kg:
- who are treatment-naive, with a CD4 count of more than 200/mm3, a viral load (VL) of less than 500,000 copies/mL and with no known or suspected resistance to either of the two drugs;
- previously treated, with a stable VL < 50 copies/mL for at least one year, a CD4 count of more than 350/mm3 and with no known or suspected resistance to either of the two drugs.
|
| Insufficient |
The clinical benefit is insufficient to justify public funding cover in the other populations of the MA. |
Clinical Added Value
| minor |
Updating of the reimbursement scope in view of the long-term follow-up data from the GEMINI 1 and 2 studies and in line with current HAS recommendations, does not modify the clinical added value level of DOVATO (dolutegravir/lamivudine) according to the opinion of 8 January 2020:
- minor clinical added value (CAV IV) in the treatment of HIV-1 infection in adults and adolescents above 12 years of age who are treatment-naive, with a CD4 count of more than 200/mm3, a VL of < 500,000 copies/mL and with no known or suspected resistance to either of the two drugs,
- no clinical added value (CAV V) in the treatment of patients infected with HIV-1, who are previously treated and virologically suppressed, compared to the proprietary medicinal product JULUCA.
|
| no clinical added value |
Updating of the reimbursement scope in view of the long-term follow-up data from the GEMINI 1 and 2 studies and in line with current HAS recommendations, does not modify the clinical added value level of DOVATO (dolutegravir/lamivudine) according to the opinion of 8 January 2020:
- minor clinical added value (CAV IV) in the treatment of HIV-1 infection in adults and adolescents above 12 years of age who are treatment-naive, with a CD4 count of more than 200/mm3, a VL of < 500,000 copies/mL and with no known or suspected resistance to either of the two drugs,
- no clinical added value (CAV V) in the treatment of patients infected with HIV-1, who are previously treated and virologically suppressed, compared to the proprietary medicinal product JULUCA.
|
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