HAS Provides Conditional Reimbursement for Pirtobrutinib and Restricted Use for Upadacitinib | iPharmaCenter
- ipharmaservices
- 11 hours ago
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HAS Issues Conditional Reimbursement for JAYPIRCA (Pirtobrutinib) in Relapsed or Refractory Mantle Cell Lymphoma
The French Health Authority (HAS) delivered a favorable opinion for reimbursement of JAYPIRCA (pirtobrutinib) only when used as monotherapy for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received a Bruton's tyrosine kinase (BTK) inhibitor and are ineligible for treatment with TECARTUS (brexucabtagene autoleucel).
In other clinical settings covered by the marketing authorization, HAS issued an unfavorable opinion regarding reimbursement.
While pirtobrutinib offers a potential third-line option for patients unsuitable for CAR-T cell therapy, the Commission cited insufficient efficacy data and limited comparative evidence versus available alternatives. It emphasized that JAYPIRCA currently has no established role in the therapeutic strategy for patients eligible for TECARTUS.
The medical value (SMR) was rated low, conditional upon future reassessment by 2027, following the submission of results from the phase III BRUIN-MCL-321 study, which the manufacturer must provide to the EMA as part of the conditional approval.
In its assessment of additional clinical value (ASMR), HAS concluded that JAYPIRCA provides no improvement (ASMR V) in medical benefit. The Commission highlighted several limitations, including:
Modest evidence from the non-comparative phase I/II BRUIN-18001 trial.
Lack of robust head-to-head or indirect comparisons with TECARTUS.
A tolerability profile showing serious adverse events in nearly 39% of patients.
An unmet but partially addressed need in patients unable to receive CAR-T therapy.
HAS expects new clinical data from BRUIN-MCL-321 to clarify the drug's comparative performance against covalent BTK inhibitors by the end of 2026, after which a re-evaluation is scheduled in 2027.
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RINVOQ (Upadacitinib) Recommended with Restrictions for Giant Cell Arteritis
HAS has issued a favorable reimbursement opinion for RINVOQ (upadacitinib) in the treatment of giant cell arteritis (GCA), but only under specific circumstances and in combination with tapering corticosteroids for adult patients requiring corticosteroid sparing and lacking suitable therapeutic alternatives such as tocilizumab (ROACTEMRA).
Eligible patients include those who:
Are corticosteroid-dependent with repeated relapses.
Require rapid corticosteroid reduction due to intolerance or severe comorbidities (e.g., uncontrolled diabetes, psychiatric disorders, osteoporotic fractures, or hypertension).
Despite its approval, HAS determined that RINVOQ provides no additional therapeutic benefit (ASMR V) over existing options. The medical benefit (SMR) was rated moderate, acknowledging its utility where alternatives are unsuitable but emphasizing safety considerations commonly associated with JAK inhibitors.
HAS noted that upadacitinib should be used only when no appropriate alternative exists, especially for:
Patients aged 65 years and older.
Those with cardiovascular disease or significant risk factors (e.g., long-term smokers).
Individuals with a history or risk of malignancy.
Upadacitinib may be continued as monotherapy after corticosteroid discontinuation for up to one year, though there is no clinical experience beyond two years of treatment in GCA.
HAS concluded that, based on current data, tocilizumab remains the preferred option, while RINVOQ may serve as an alternative for select corticosteroid-dependent patients without access to or suitability for tocilizumab.