Thomas Sannié, Association francaise des hemophilies
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Sannié, member of the patients' consultative group of the French National Agency for Medicines and Health Product Safety, France, for European Patients' Rights Day 2017
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Thomas Sannié, Association francaise des hemophilies
- 1. European & National Medicines Regulatory Systems: challenges for an equitable, timely and suitable access to innovation – 10th May 2017 Round table 3rd sessions Patient Associations from countries with an official patients’ committee in the National Medicines Agency Thomas Sannié, président Association française des hémophiles, France
- 2. 4 Ministry of Health Haute Autorité de Sante Health Professional Unions Negotiation with Advice/public health policy ! Maximum spending targets Pricing Committee (CEPS) PARLIAMENT Votes laws and oversees implementation Advice/p rice Advice/reimbursement National health insurance funds (compulsory and voluntary) Source: HAS 2013 ANSM
- 3. Source: Haute Autorité de Santé 2013 Economical assessment Medical assessment CEESP Transparancy Committee CNEMITS CEPS
- 4. Involvement? User/patient representative in ANSM and HAS as member of board/collège (ANSM and HAS) or working groups or Committees (ANSM and HAS) : ANSM in charge of the marketing authorization (benefit and risk), HAS in charge of - Medical benefit, therapeutic added value and efficacy and safety (CT) - Efficiency (CEESP) New opportunity for patient’s organisations: during the assessment of a medicine or a medical device. Since November 2016, HAS has asked to patient’s organisations to write contributions and answer questionnaire: - impact of the disease or the state of health of the patients/family caregivers, their perceptions, their quality of life and families ones, - experience of patients treated with other therapies already avaible, - experience of patients with the product assessed Evaluation in september 2017. CEPS : no user/patient representative member of the committee. Until now, only hearings.
- 5. Evaluation patients' involvement in terms of impact and efficacy? What are its strengths, weaknesses and challenges? - Challenges : take into account the patient’s objectives and preferences (cultural thing for Health agencies, methodology), management of potential conflict of interest, competition between disease, fair pricing (heterogeneity across Europe of methodologies to fix the price), access to care (weight of the cost of drugs). - Patients organization, particularly in rare diseases, must provide/must be asked 1. Their analyses about the real burden of a disease (QoL) and real efficacy actual treatment (among them adverse events) and the role of patients’ education (experience) 2. evidence from scientific articles, patients registries, patients testimonies (experience about illness and treatment and real case example), own survey questionnaires - It requires an access to data from specific registry/National Health Insurance Funds and knowledge of the price of medication - Drug analysis and Health economic analysis require expertise but also involvement of individuals («lay experts») in the collective decision making process impacting individuals and public health
Editor's Notes
- We won’t describle the hole slide. You only have to remember that National Authority for Health (HAS) advises the Pricing Committee (CEPS) by provinding economical guidance on the most efficient care strategies. Starting next month, the HAS will have a new mission : the industry will have to submit economic report based on HAS guidelines (see the guideline choices in Methods for economic evaluation) for first listing/application. Under two conditions, First. Only applies for drugs and medical devices for which the company asks for a high to moderate medical benefit (therapeutic added value -TAV) Second. the forecasted expenditure must be significant for the health budget (current discussion with the industry, more than 10 million €). Does it affect the industry working on hemophilia ? CEESP will produce and publish guidance for the Pricing Committee on expected efficiency within 90 days, as well as medical guidance.
- Transparency committee => drugs => medical effectiveness, Medical devices committee (Cnedimts) => technological devices => medical effectiveness CEESP => expected economic effectiveness => the most efficient care strategies
- As patient’s organisation : New procedure (since november 2016) : during the assessment of a medicine or a medical device this information is published on the HAS website and patient associations have 30 days to submit their contributions to the HAS. These contributions will be based on a standard questionnaire available on the HAS site. Association will be able to provide their perspective in a formalised and collective manner. The contributions will be passed onto the expert members of the various commissions that assess health products. What is the purpose? Formalising this new type of patient contribution to the assessment of health products should provide the commissions’ experts with a broader view concerning: > the impact of the disease or the state of health of the patients, their perceptions, their quality of life (or that of their families), >the experience of patients treated with therapies other than those assessed, > the experience of patients with the product assessed (if the patients have experience using the products or the association knows the results of clinical trials relative to the product)
- : quality of life of a pwh with or without treatment, unsafe and safe products). Economists have to understand that the decision making process in HTA, their methodology and if it is necessary, their finding must be challenged. The final decision is the fruitfull results of consultation, debate and argumentation. A patient organisation can/has to play its place. - second argument : HTA Agencies must ask Patient organization and if not, patients organization need to provide evidence and it is particularly important in rare diseases. - theird : Patients organization need to have a full access to datas from their national haemophiliac and patient with bleeding disorders registry (in France called FranceCoag) but also from their National Health Insurance Funds (which might be difficult) - Fourth : Patients organization need to know the price of medications (price of reimbursement and eventually new and lower prices after negotiation between the industry and hospitals) - Fifth: Public involvement is crucial. Experts must be challenged. Maximum expenditure threshold