Reason for request

First assessment

Key points

Favourable opinion for reimbursement in the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.

What therapeutic improvement?

KESIMPTA (ofatumumab), in the same way as OCREVUS (ocrelizumab), provides:

  • A therapeutic improvement compared to teriflunomide (AUBAGIO) in patients with early-stage RRMS in terms of disease duration and inflammatory activity,
  • No clinical added value in the management of highly active or severe RMS.

 Role in the care pathway?

As soon as the RR (relapsing-remitting) MS diagnosis has been established, rapid initiation of long-term treatment is recommended to reduce relapse frequency and the progression of the disability in the short term. Several first-line therapeutic options may be proposed: beta interferons (AVONEX, REBIF, BETAFERON, EXTAVIA, PLEGRIDY), glatiramer acetate (COPAXONE), teriflunomide (AUBAGIO), dimethylfumarate (TECFIDERA), ozanimod (ZEPOSIA).

In the event of RMS with active disease, irrespective of the progressive form (RR, SP, PP), ocrelizumab (OCREVUS) may be used as first-line treatment.

The choice of treatment should be made on the basis of the safety profile of the medicinal products, their method of administration and patients’ preferences.

When the disease’s inflammatory activity, assessed clinically (number and severity of relapses) and by MRI criteria (T1 Gd+ lesions, T2 lesion load, etc.), becomes or remains high, despite first-line long-term treatment, initiation of a more active treatment is recommended. The modified Rio score is validated to assess the response to certain first-line treatments. The following medicinal products may be used as second and later-line treatment in these highly active forms, according to the conditions defined by their MA and following consultation of a resource and expertise centre:

  • Fingolimod (GILENYA) and natalizumab (TYSABRI) have an MA restricted to highly active forms of RR-MS; these are the reference treatments at this stage of the disease,
  • Alemtuzumab (LEMTRADA) has been restricted by the Committee to highly active forms of RR-MS despite first or second-line treatment,
  • Ocrelizumab (OCREVUS) may also be used in highly active RMS (RR or SP), if it has not been used as first-line therapy. However, no robust data have assessed its efficacy and safety as an alternative to second-line treatments or in the event of failure of these products,
  • Ozanimod (ZEPOSIA) in the treatment of RR-MS (active, also including the highly active form) in the absence of comparative data versus the other proprietary medicinal products available in the treatment of RR-MS, it is not possible to rank the use of these proprietary medicinal products compared to one another.
  • Finally, mitoxantrone (ELSEP – NOVANTRONE and generics) is a salvage treatment that has an MA in highly active forms of RMS (RR or SP) associated with rapidly progressing disability where no therapeutic alternatives exist.

In rare cases, where RR-MS is severe and rapidly progressing from the outset, treatment with natalizumab or fingolimod may be recommended as first-line therapy in accordance with the MA of these medicinal products. However, the use of alemtuzumab or mitoxantrone should not be considered as first-line therapy in the absence of sufficient data given the frequency of serious adverse events associated with these medicinal products. In addition, the Committee highlights the fact that no robust data is available confirming the therapeutic benefit and safety of use of an induction strategy compared to an escalation strategy.

Stabilisation of the disease under either of these treatments is assessed by the number and severity of residual relapses, as well as the development of new lesions on MRI. There is no robust data assessing the benefit of long-term continuation of these powerful immunosuppressive therapies in stabilised patients. Their safety and efficacy in terms of the prevention of disability in the long term have yet to be established.

Role of KESIMPTA (ofatumumab) in the care pathway:

KESIMPTA (ofatumumab) is a first or second-line treatment in all active forms of recurrent multiple sclerosis (RRMS or SPMS with relapses), in the same way as OCREVUS (ocrelizumab).

Its superiority has been established versus teriflunomide in patients with early-stage RRMS in terms of disease duration and inflammatory activity.

There is no available comparative data versus the other medicinal products available in the first-line treatment of RMS, including anti-CD20 antibodies (rituximab off-label and ocrelizumab), making it impossible to rank it at this stage in the strategy compared to the other products. It should be noted that ocrelizumab could not be used as a comparator in the studies supplied due to its concomitant development with ofatumumab.

A comparative study versus rituximab could clarify the role of ofatumumab in the care pathway.

Hence, the choice between the various treatments in RMS should be made on the basis of the safety profile of the medicinal products, their method of administration and patients’ preferences.

Clinical Benefit


The Committee deems that the clinical benefit of KESIMPTA (ofatumumab) is substantial in the MA indication.

Clinical Added Value


The Transparency Committee considers that KESIMPTA (ofatumumab):

  • provides a moderate clinical added value (CAV III) compared to teriflunomide (AUBAGIO) in patients with early-stage RRMS in terms of disease duration and inflammatory activity,
  • provides no clinical added value (CAV V) in the care pathway for patients with highly active or severe RMS,

In the same way as OCREVUS (ocrelizumab).

no clinical added value

Avis économique

Ce produit a fait l'objet d'un avis économique rendu par la Commission d'évaluation économique et de santé publique le 8 juin 2021.

Le périmètre de l’évaluation est superposable au périmètre de l’autorisation de mise sur le marché.

Les limites de l’évaluation proposée ne permettent pas de valider le niveau de RDCR estimé par l’industriel et empêchent de valider une estimation avec un degré de confiance suffisant.

L’introduction d’ofatumumab conduit à une augmentation de 0,9% à 5 ans du budget de l’assurance maladie consacré à cette indication.

> KESIMPTA - Avis économique (pdf)


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