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PALFORZIA (poudre de graine d'Arachis hypogaea L.)

Opinions on drugs - Posted on Jan 27 2022 - Updated on Oct 13 2022

Reason for request

First assessment

Key points

Favourable opinion for reimbursement in the treatment of patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy. PALFORZIA (powder of Arachis hypogaea, semen) may be continued in patients 18 years of age and older. PALFORZIA (powder of Arachis hypogaea, semen) should be used in conjunction with a peanut-avoidant diet.

What therapeutic improvement?

Therapeutic improvement in the management of the disease.

Role in the care pathway?

Wherever possible, it is recommended to implement targeted allergen avoidance for a given patient, particularly in children (professional consensus).

For the symptomatic treatment of severe allergic reactions following accidental exposure to the allergen, adrenaline should be administered as a matter of urgency.

No immunotherapy can be started without an accurate diagnosis of allergic sensitisation and determination of the burden of this sensitisation in the patient’s symptoms (professional consensus).

In the event of severe allergic reactions or anaphylactic shock, the use of adrenaline is required.

Role of PALFORZIA in the care pathway:

PALFORZIA is a therapeutic option in the treatment of peanut allergy in patients aged 4 to 17 years in conjunction with a peanut-avoidant diet.

The Committee highlights the fact that this treatment should be weighed up in view of:

  • the more frequent and expected occurrence of anaphylactic reactions under PALFORZIA treatment than in the well-managed avoidant diet group,
  • a demonstrated efficacy in the short-term, subject to daily compliance and the provision of patient information, optimised by the study conditions,
  • uncertainty with respect to maintenance of efficacy in the event of treatment discontinuation.

PALFORZIA (powder of Arachis hypogaea, semen) should be administered under the supervision of a physician qualified in the diagnosis and treatment of allergies. The prescriber should inform the patient of the importance of compliance with their treatment and should put in place close monitoring to ensure the motivated participation of the patient.

Initial dose escalation and the first dose of each new up-dosing level are to be administered in a healthcare setting prepared to manage potential severe allergic reactions.

Self-injectable adrenaline (epinephrine) must be available to the patient at all times.

Special recommendations

The Committee would like to receive the results of the ARC008 study, an open-label follow-on study assessing the long-term safety of PALFORZIA for which the preliminary results are expected in 2024.

The Committee emphasises the need to ensure the continuous availability of this treatment in view of the uncertainties related to it, requiring appropriate stock management to avoid any shortages.

           

 

 

 

 

 

 

 

 

 

 


Clinical Benefit
Moderate

The Committee deems that the clinical benefit of PALFORZIA (powder of Arachis hypogaea, semen) is substantial in the MA indication.

Clinical Added Value
minor

Considering:

  • the quality of the research evidence (two double-blind, randomised, comparative placebo-controlled studies) demonstrating the superiority of PALFORZIA compared to placebo, on the percentage of patients aged 4 to 17 years who tolerate a single maximum dose of at least 1,000 mg (cumulative total of 2,043 mg including the titration period) of peanut protein, with only mild allergic symptoms at the exit DBPCFC (primary endpoint);
  • the effect size observed in favour of PALFORZIA versus placebo for the primary endpoint (50.3% versus 2.4% in one study, and 58.3% versus 2.3% in another study);
  • the safety profile of PALFORZIA, in particular assessed in a placebo-controlled study, primarily characterised by mild to moderate and temporary allergic local reactions, although marked by more frequent anaphylactic reactions, which are expected since they are associated with the action mechanism of this medicinal product,

but in view of:

  • the risk of severe anaphylactic reaction, which leads to administration of PALFORZIA:
    • under the supervision of a physician qualified in the diagnosis and treatment of allergies,
    • for each new up-dosing level in a healthcare setting prepared to manage potential severe allergic reactions;
  • the lack of data of robust quality of life in a condition that significantly impacts this;
  • the absence of robust efficacy data beyond 12 months;
  • the absence of robust data on emergency recourse to maintenance treatment;

the Committee considers that PALFORZIA provides a minor clinical added value (CAV IV) in the treatment of patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy.  

 

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