There is no set criteria for dupixent (dupilumab), but there are guidelines in place that Regeneron and Sanofi recommend to get patients enrolled through their insurance companies. Every insurance company has their own criteria, but under Regeneron and Sanofi’s, Dupixent My Way, they set out guidelines which would help get approval easier for Dupixent.
Being a very expensive drug of upward of $3000/month, many insurance companies do not readily want every atopic dermatitis/eczema enrolled to get Dupixent (dupilumab). It should be reserved for the more severe patients. The criteria set forth by the manufacturers of Dupixent are;
- Patient is over 18 years old
- Patient has moderate to severe atopic dermatitis (defined as moderate to severe erythema and moderate to severe papulation/infiltration)
- Body Surface Area is 10% or more
- Sensitive Areas Affected should be affected including some but not all, hands, feet, face and neck, genitals/groin, scalp and intertriginous areas.
- They want to know all topical therapies past and present. In this category the topical therapies that should have been tried are topical steroids. Many insurance companies are also requesting the patient has tried Elidel/Protopic and Eucrisa. Documentation of all 3 types of medications may be necessary. In addition to trying them, the patient would have also had to fail using them, meaning it hasn’t worked or there are side effects that prohibit the patient to using them again in the future.
- The last category is systemic therapy. Documentation of systemic corticosteroids, immunosuppressants and phototherapy is also requested. The enrollment process asks if a patient has tried these therapies and if they haven’t, the rationale of why it is inappropriate for the patient.
- Some insurance carriers also want a baseline evaluation using one of the following scoring tools.
- Investigator’s Static Global Assessment (ISGA)
- Eczema Area and Severity Index (EASI)
- Patient Oriented Eczema Measure (POEM)
- Scoring Atopic Dermatitis (SCORAD)
As you can see the criteria for Dupixent (dupilumab) is pretty extensive, which it should be as it is a very expensive medication and other alternatives should be used first. That being said, there are many atopic dermatitis patients who have already benefitted from Dupixent (dupilumab).
If you have moderate to severe eczema that is not well controlled despite trying many of the above therapies, speak to your allergist or dermatologist about Dupixent (dupilumab).
If you do qualify for Dupixent, the first dose is usually given in the doctors office, two 300mg injections (total 600 mg). Then the patient can administer the next dosages themselves, 300 mg every 2 weeks (1 injection only). Eczema improvement is not seen immediately, but gradually over the series of injections a patient will start noticing an improvement of their skin. The first sign of improvement is the itching goes away.
Update June 9th, 2022:
A recent study titled “Dupilumab Treatment Reduces Hospitalizations in Adults with Moderate to Severe Atopic Dermatitis” came with a few conclusions. There was a significant reduction in all cause and atopic dermatitis related hospitalization rates and shorter duration of atopic dermatitis related hospitalization. Overall there was 49% reduction in all-cause hospitalizations and a 60% reduction in eczema related hospitalizations with the approved dose of 300mg every 2 weeks.
The main difference in cause/diagnosis of hospitalization between dupixent and control patients was skin and soft tissue infections which were 71% less frequent.
Bacterial colonization with Staph Aureus are well known triggers of eczema exacerbations.