PAXLOVID (PF-07321332 / ritonavir) - Covid-19

Key points

Favourable opinion for reimbursement in the treatment of coronavirus disease 2019 (COVID-19) in adults who do not require supplemental oxygen and who are at increased risk for progression to severe COVID-19.

Refer to the national guidelines in terms of the strategy for the use of curative treatments for COVID-19.

What therapeutic improvement?

Therapeutic improvement in the management of the disease.

Role in the care pathway?

Currently, vaccination combined with protective measures are the main pillars in the management of COVID-19, in order to prevent infection with SARS-CoV-2 and the development of symptomatic COVID-19 that may potentially progress towards a severe form of the disease.

However, recent studies have shown that approximately 50% of immunocompromised individuals (depending on the type of immunosuppression) having received a complete vaccination regimen were seronegative after the third dose of vaccine. Furthermore, in view of the emergence of new variants of concern (which may be less sensitive to currently available vaccines), other preventive and curative antiviral treatments that can help reduce the risk of developing severe forms of the disease, hospitalisations and deaths, constitute an additional weapon to that of vaccination in order to effectively fight the pandemic, particularly in individuals demonstrating no or low response to vaccination.

Role of the medicinal product in the care pathway

Based on available data from the EPIC-HR clinical study, having demonstrated:

• a beneficial effect on reduction of the risk of progression to a severe form of COVID-19 (COVID-19 related hospitalisation or death from any cause on D28) of 87.8% in patients with onset of symptoms ≤ 5 days before the first dose;
• virological data suggesting a significant reduction in viral load on D5 compared to placebo (around 0.7 log₁₀ copies/mL);
• in vitro data suggesting maintenance of the activity of PAXLOVID (PF-07321332/ritonavir) against circulating variants of concern, in particular the Omicron variant;

the Committee considers that PAXLOVID (PF-07321332/ritonavir) may be a therapeutic option in the curative treatment of COVID-19 in adults who do not require supplemental oxygen and who are at high risk for progression to severe COVID-19, as defined by the national guidelines.

Early administration after the onset of symptoms (within 5 days following the onset of symptoms) is an important point.

The Summary of Product Characteristics (SPC) and the Risk Management Plan (RMP) must be complied with due to the numerous drug interactions related to ritonavir, contraindicating its use with numerous medicinal products.

The use of this medicinal product in pregnant or breast-feeding women, or in women of childbearing potential not using contraception must comply with the SPC.

Special recommendations

The Committee highlights the fact that the use of anti-COVID-19 treatments does not dispense with the need for patients to comply with protective and physical distancing measures in the context of control of COVID-19 and that PAXLOVID (PF-07321332/ritonavir) is not intended to be used as a substitute for vaccination against SARS-CoV-2.

The Committee endorses the requests of patient associations relative to the need to facilitate access to COVID-19 treatment in the non-hospital setting.

Due to the rapidly evolving epidemic context, the Committee would like to see regular updating of national guidelines in order to adapt the management strategy for COVID-19 based on data on the sensitivity of circulating variants to available treatments.

Given the major risk of drug interactions related to ritonavir in polymedicated patients, particularly those with risk factors associated with a very high risk of progression to a severe form of the disease (immunosuppression, cancer, chronic kidney disease), the Committee would like prescribers to have access to a prescription aid document or device to facilitate the management of drug interactions.

Avis économique(s)

Ce produit a fait l'objet d'un premier avis économique rendu par la Commission d'évaluation économique et de santé publique le 26 avril 2022. La CEESP n’a pas été en mesure de conclure sur le niveau d’efficience du produit en l’absence d’analyse économique permettant d’évaluer l’efficience de Paxlovid.

> PAXLOVID - Avis économique - 26 avril 2023 (pdf)

Ce produit a fait l'objet d'un avis économique rendu par la Commission d'évaluation économique et de santé publique le 17 janvier 2023. L’avis économique concerne PAXLOVID (PF-07321332/ritonavir) dans le traitement de la maladie à coronavirus 2019 (COVID-19) chez les patients adultes qui ne nécessitent pas de supplémentation en oxygène et qui présentent un risque accru d’évolution vers une forme sévère de la COVID-19 ».  

La demande de remboursement est superposable à l’indication de l’AMM conditionnelle obtenue le 28 janvier 2022 en procédure centralisée.  

Selon les analyses de l’industriel, au prix revendiqué pour le traitement d’une durée de 5 jours par PF-07321332 300 mg /ritonavir 100mg (PAXLOVID) retenu dans la modélisation, PF-07321332/ritonavir (PAXLOVID) est associé à un RDCR de 25 878,39 €/QALY versus soins standards sur un horizon temporel de 5 ans [non retenu par la CEESP]. L’incertitude autour de ce résultat est majeure. 

L'impact budgétaire estimé sur 3 ans et associé à l'introduction du traitement par PAXLOVID (PF-07321332/ritonavir) dans son indication d’AMM ne peut être validé. L’impact budgétaire à 1 an est très incertain et à prendre avec précaution. 

> PAXLOVID - Avis économique - 17 janvier 2023 (pdf)