Introduction
Legal background
Adcetris specialty
HAS Transparency Committee opinion
Ministry of Health decision
French Administrative Supreme Court ruling
Comment


Introduction

On 21 October 2019 the French Administrative Supreme Court cancelled the Ministry of Health's decision to refuse to include Adcetris's extension of indication on the list enabling healthcare establishments to invoice drugs directly to the French health insurance system, which was based on a National Authority for Health (HAS) opinion.(1)

Surprisingly, in doing so, the French Administrative Supreme Court did not limit its control to assess whether the ministry and the HAS had acted within their power, but rather challenged the factual analysis that the HAS had carried out.

It notably ruled that assessments of public health interests concerning drug indications could not be limited solely to the appreciation of prevalence.

Legal background

In France, healthcare facilities are awarded lump sums which correspond to the usual treatment of patients' conditions. However, in order to grant access to unusual and costly medicine in case of hospitalisation, Article L 162-22-7 of the Social Security Code provides that innovative and expensive medication can be invoiced directly to the French health insurance system if certain conditions are fulfilled.

The drug's actual benefit must be major or substantial and its clinical added value must be at least moderate. However, if the clinical added value is minor and the drug lacks relevant comparators, it can nevertheless meet the criteria if it presents an interest for public health.

Adcetris specialty

Initially, Adcetris had marketing authorisation for the treatment of:

  • adult patients with relapsed or refractory CD30+ Hodgkin lymphoma following autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option; and
  • adult patients with relapsed or refractory systemic anaplastic large cell lymphoma.

Adcetris was also included in the list provided by Article L 162-22-7 of the Social Security Code for this pre-existing indication.

Its indication was then extended to the treatment of adult patients with CD30+ Hodgkin's lymphoma at increased risk of relapse or progression following ASCT.

HAS Transparency Committee opinion

The HAS Transparency Committee, which is tasked with assessing pharmaceuticals for national reimbursement listings, issued an opinion on Adcetris's extension of indication on 3 May 2017.

The committee determined that Adcetris's actual benefit was substantial; however, it considered that the drug's clinical added value was minor due to:

  • the drug's superiority to its placebo regarding progression-free survival, without any benefit demonstrated regarding overall survival; and
  • potentially serious adverse events which could occur during treatment.

The committee also found that Adcetris was not of public health interest in light of:

  • the seriousness of CD30+ Hodgkin lymphoma when relapse or progression after ASCT;
  • the small number of patients concerned by this indication (ie, around 110 new patients per year);
  • the poorly covered patients' medical need when lack of full and stable remission after ASCT;
  • the lack of response to identified medical need; and
  • the potential negative impact of Adcetris in maintenance treatments on patients' quality of life.

Ministry of Health decision

To refuse the inclusion of Adcetris' extension of indication to the list provided by Article L 162-22-7 of the Social Security Code, the Ministry of Health relied on the HAS Transparency Committee's decision, in accordance with the terms of Article R162-37-3 III of the Social Security Code. The ministry determined that, although Adcetris's extension of indication's actual benefit was substantial, its clinical added value was below moderate and the drug did not present an interest for public health.

French Administrative Supreme Court ruling

The marketing authorisation holder of Adcetris, Takeda France, applied to the French Administrative Supreme Court to cancel the Ministry of Health's decision on the ground that the ministry had exceeded its power.

The claimant argued that the ministry's assessment of the notion of public health interest was tainted with manifest error, and notably claimed that the fact that the drug's extension of indication concerned only a small number of patients should not have been considered.

The French Administrative Supreme Court upheld Takeda France's argument, stating that a disorder's prevalence could not be taken into consideration as a single factor when assessing public health interests.

The court also highlighted that this drug's extension of indication allowed an increase of at least 18 months in progression-free survival and enabled patients to carry on normal activities.

Comment

This ruling is noteworthy as the French Administrative Supreme Court imposed tight control over an administrative body's exercise of powers in the public health sector.

The court did not simply check that the HAS had carried out the appropriate analysis within its powers when assessing Adcetris's extension of indication, but rather carried out a new assessment based on the scientific elements examined by the HAS Transparency Committee – which comprises practitioners, methodology specialists and epidemiologists – to challenge this authority's opinion in a specific, factual and sensitive field.

For further information on this topic please contact Armand Aviges or Delphine Lapillonne at Altana by telephone (+33 0 1 79 97 93 00) or email ([email protected] or [email protected]). The Altana website can be accessed at www.altanalaw.com.

Endnotes

(1) French Administrative Supreme Court, 21 October 2019, 419169.