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HAS ASSESSMENT OUTCOMES | FRANCE PHARMA NEWS | médicament nouvelles | 2023 | iPharmaCenter

Updated: Jun 26, 2023

March 10, 2023

HAS stated that Tecartus showed no improvement versus SoC in ALL patients

HAS (Haute Autorité de Santé) evaluated Tecartus (brexucabtagene autoleucel) for adult patients with acute lymphoblastic leukemia treated with at least two prior lines of treatment.

HAS stated that there is no improvement in clinical benefit compared to the current standard of care for these patients due to uncertainties regarding the treatment's clinical efficacy and long-term tolerance. There was a lack of non-comparative Phase 1/2 data and uncertainties with the quality of the effect.

However, HAS acknowledged the high unmet need for patients who have undergone at least two lines of treatment and notes that the overall remission rate for Tecartus was 54.9%, including a 43.7% complete remission rate in the ITT (intent-to-treat) population.

In light of these findings, HAS is committed to informing patients and caregivers about the complexity of the CART (chimeric antigen receptor T-cell) procedure.


March 10, 2023

HAS, in its reevaluation, agreed to reimburse Fasenra for severe eosinophilic asthma.

The reevaluation conducted by HAS resulted in an agreement to reimburse Fasenra, a medication used to treat severe eosinophilic asthma in adult patients. However, reimbursement will only be provided to patients who cannot control their condition despite high-dose inhaled corticosteroid therapy and having a blood eosinophil level of 150/μL or higher. Additionally, these patients must have experienced at least two asthma exacerbations or been treated with oral corticosteroid therapy for at least six months in the previous 12 months.

AstraZeneca submitted new data was submitted, including the results of the ANDHI, PONENTE, and MELTEMI studies and the SMR. The ANDHI study showed that the annualized exacerbation rate was 0.94 in the group treated with benralizumab, compared to 1.86 in patients who received a placebo.

The European Respiratory Society and American Thoracic Society have both recommended using Fasenra to treat severe eosinophilic asthma, but only in cases where the blood eosinophil level is 150/μL or higher.


February 17, 2022

HAS agreed to continue reimbursement of Rekambys for HIV-1 infection treatment.

HAS continued positive opinion for reimbursing Rekambys (rilpivirine) to treat patients with HIV-1 infection. It is reimbursed only in adult patients who have virologically controlled infection and are on stable antiretroviral treatment for over six months. Rekambys can be given only to patients who have not failed on non-nucleoside reverse transcriptase inhibitors (NNRTIs) and integrate inhibitors (INIs).

Rekambys can be given to patients for whom switching therapy was considered appropriate. It is recommended to consider genotype testing before initiating the treatment.

Rekambys is a suspension for injection, and it is considered an option for patients who don't prefer taking tablets every day or have problems with oral intake.

HAS further confirmed that there was no benefit with Rekambys compared to dual therapy taken orally.


February 17, 2022

HAS said NO to Retsevmo as first-line therapy for RET-positive NSCLC

HAS gave an unfavorable recommendation for treating adult patients with RET-positive non-small cell lung cancer (NSCLC) as monotherapy for first-line patients.

The recommendation was based on the

  • lack of robustness in Phase 1/2 data

  • lack of direct comparison with chemotherapy

  • a larger Phase 3 trial is underway, evaluating Retsevmo versus the combination of pemetrexed, platinum-based chemotherapy with or without pembrolizumab. The results are expected at the end of 2023.

The French guidelines recommended using Retsevmo and Gavreto as second-line therapy in patients with RET-positive NSCLC. Both the treatments received 'low' SMR and ASMR V during the assessment. The American guidelines have recommended the use of both therapies in the first and second lines.


June 30, 2022

HAS agreed to continue reimbursement of Kymriah for DLBCL

Kymriah (tisagenlecleucel) was reassessed for the patients with refractory or relapsed diffuse large B-cell lymphoma. It was reimbursed for patients whose cancer has returned after two or more systemic therapies.

HAS mentioned that immunochemotherapy of the R-CHOP is a standard first-line therapy; nearly 2/3rd of patients achieve remission.

The reassessment of Kymriah was based on the pivotal JULIET study - where Kymriah showed a median overall survival of 8.2 months. HAS agreed that Kymriah showed benefits compared to the standard of care based on the indirect comparison.

HAS retained the SMR important for Kymriah.

May 20, 2022

HAS gave a favorable opinion for Xeljanz in patients with polyarticular juvenile idiopathic arthritis

HAS given position opinion for reimbursement of Xeljanz for treating patients with active polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis, who had an inadequate response to DMARD therapy.

A3921104 and A3921145 trials supported the recommendation. In the A3921104 trial, the percentage of patients who had at least one disease flare was lower in the Xeljanz group (29%) compared to the placebo group (53%).

Xeljanz can be administered in combination with methotrexate and as monotherapy if patients are intolerant to methotrexate.


April 12, 2022

HAS gave an unfavorable opinion to reimburse Kineret for COVID-19 patients

HAS not recommended using Kineret (anakinra) for adult COVID-19 patients who require supplemental oxygen and are having pneumonia.

HCSP recommended using tocilizumab for patients who require a high flow of oxygen.

The recommendation was because of

  • Uncertain significance of clinical efficacy at 28 days observed in terms of oxygen supplementation

  • lack of robust data on mortality and morbidity

  • modest impact on the organization of care

  • unable to transfer the clinical data to transfer to the French population

  • availability of therapeutic alternatives, in particular, tocilizumab in combination with corticosteroid therapy


April 12, 2022

HAS said no to BeiGene's Brukinsa for Waldenström’s macroglobulinaemia

HAS gave an unfavorable opinion for reimbursing BeiGene's Brukinsa (zanubrutinib) for treating adult patients with Waldenström's macroglobulinemia. Brukinsa was not recommended as monotherapy for first-line patients who are ineligible for chemotherapy.

The factors considered for the recommendation are:

  • Only 18% of patients are first-line patients; others are relapsed or refractory patients

  • No superiority in terms of complete response

  • Not differentiating from ibrutinib in terms of progression-free survival or overall survival

  • uncertainties in demonstrating the safety profile versus ibrutinib

HAS recommended the combination of rituximab, an alkylating agent, or proteasome inhibitor as first-line therapy in the first intention. Imbruvica (ibrutinib) as monotherapy or chemo-immunotherapy was recommended as second-line treatment.


April 12, 2022

HAS didn't recommend Sanofi's Aubagio in pediatric multiple sclerosis patients

HAS did not recommend Aubagio (teriflunomide) in pediatric patients aged ten years and over suffering from relapsing-remitting forms of multiple sclerosis (RRMS). The recommendation was due to

  • In the TERIKIDS study, there was a lack of statistically significant improvement versus placebo in the primary endpoint

  • Lack of head-to-head trials versus comparator when it was feasible

  • Lack of long-term safety data

HAS recommended the use of beta 1-a interferons (Avonex and Rebif), beta 1-b interferons (Extavia and Betaferon), and glatiramer acetate (Copaxone) as first-line therapy for pediatric RRMS. Rebif (interferon beta 1-a) was the only therapy recommended for patients two years and older. Gilenya was also recommended for ten years and older.


11 Jan 2022

Sarclisa is recommended for treating multiple myeloma

HAS published guidance recommending the use of Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone to treat adult patients with multiple myeloma as a second-line option.

HAS mentioned that there are several therapeutic options for multiple myeloma. Daratumumab (Darzalex), ixazomib (Ninlaro), carfilzomib (Kyprolis), or pomalidomide (Imnovid) in combination are recommended in the second line.

For the first relapse, refractory status to the lenalidomide and the prior exposure to daratumumab is considered for selecting the drugs.

For the second relapse, Imnovid in combination with dexamethasone is recommended in patients who were previously treated with Velcade (bortezomib) and Revlimid (lenalidomide). However, with the availability of new drugs, the therapeutic position of Imnovid is limited. Fardyak in combination with bortezomib and dexamethasone is recommended in patients who have relapsed or multiple refractory myeloma, and who were treated previously with two therapeutic options. Darzalex is another therapeutic option for patients with relapsed or refractory multiple myeloma.

Sarclisa (isatuximab) in combination with Kyprolis and dexamethasone showed superiority in progression-free survival compared to Kyprolis plus dexamethasone combination. The result of the overall survival was not available. Based on the available information, HAS recommended Sarclisa combined with Kyprolis plus dexamethasone over Kyprolis plus dexamethasone in adult patients who received at least one prior treatment.

Sarclisa is not recommended in patients who are refractory to anti-CD38 antibodies. There is a risk of immunodeficiency in the long term, so HAS asked the prescribers to be cautious. In the IKEMA study, respiratory tract infections were observed in patients on Sarclisa.

HAS has given SMR Important and ASMR IV for Sarclisa in patients with multiple myelomas who were treated with at least one treatment.

HAS criticized the lack of overall survival data and robust quality of life.

December 2021

BioCryst's Orladeyo received favorable reimbursement decision in France

In France, HAS gave a positive reimbursement decision for BioCryst's Orladeyo to prevent recurrent attacks of hereditary angioedema (HAE) in adults and adolescents.

The product received ASMR V and is reimbursed only as a second-line option. It received 'Insufficient' SMR for first-line patients.

HAS commented that the place versus Cinryze (c1 inhibitor -human esterase) and Takhzyro (lanadelumab) cannot be determined due to lack of direct comparison.

EMA approved Orladeyo in April 2021 for preventing the attack of HAE in adults and adolescents.

HAS says OK to continue the reimbursement of Zykadia (ceritinib) for ALK + NSCLC

HAS gave a positive opinion to continue the reimbursement of Zykadia (ceritinib) for patients with ALK-positive non-small-cell lung cancer. The drug is reimbursed for patients who were previously treated with crizotinib.

Crizotinib is the first product approved for ALK-positive NSCLC, which demonstrated its superiority over chemotherapy.

Alecensa (alectinib) had demonstrated superiority in progression-free survival and the risk of brain progression over crizotinib; it is the preferred treatment option for the first-line treatment of ALK+ lung cancer.

HAS has recommended Zyadia as a second-line treatment option after failure of the first treatment (preferentially alectinib).

Zyadia received ASMR V considering the gain in progression-free survival versus chemotherapy. However, HAS believed that the trial result does not reflect the current treatment strategy.

The product has achieved SMR ‘Important.’


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