Survey on good practices and obstaclesto the uptake of the biosimilars marketin Member States and EFTA CountriesMedicamentos Biosimilares: Present y futuroMichele UdaMember of the EGA Board and Chair of the Transparency working group12th of February, Madrid
Stakeholders ContactedAll EU MS and EFTA countries;Represented either by: Health authorities and/or Health insurers
Question 1 – Does your country have specialprescribing rules for biologicals and/ or forbiosimilars?
Question 2- In your country, do you havespecific clauses removing biologicals fromautomatic substitution?
Question 3 - Does your agency communicateinformation on biosimilars via their websiteto the general public? If yes, what are therecommendations put forward?
Question 4 - Does your country havemeasures in place targeting the uptake ofbiosimilars? When were these introduced?
Question 5 - Obstacles Listed by Member StatesQuality, safety and efficacy General perception that biosimilar medicines are inferior to innovators; Biosimilars concept not fully accepted/ understood by doctors; Prescribers concerns regarding primarily safety and efficacity of biosimilars; Currently, doctors are reluctant to prescribe biosimilars due to hypothetic uncertainties in safety and effectiveness of biosimilars; Patients’ misperceptions regarding biosimilar medicines;
Question 5 - Obstacles Listed by Member StatePrescription practices Reluctance by physicians to prescribe/ deliver biosimilar medicine; Reluctance by doctors to switch brands; There is a widespread belief that biosimilars are inferior to innovators and that they are not interchangeable;
Question 5 - Obstacles Listed by Member StateLegislative Issues Lack of regulation;Lack of incentives Lack of incentives to prescribe/deliver biosimilar medicines; No incentives are provided to doctors to use biosimilars through the (hospitals) reimbursement scheme;
Question 6 - Uptake Measures Listed by Member StatePrescription rules and Incentives Prescription target/ quota; Enhance the prescription of biosimilars in hospitals; Set-up procedures for usage and substitution; Introduce some incentives for doctors to increase prescription of biosimialrs in patients who are starting the treatment.
Question 6 - Uptake Measures Listed by Member StateProcurement procedures (1/2) National and regional hospital tenders for biologicals including biosimilars; Bidding system every year for the status of preferred biological products (biological products grouped together with their biosimilars);
Question 6 - Uptake Measures Listed by Member StateProcurement procedures (2/2) Transparent pricing of pharmaceuticals in hospitals; Introduction of a daily lump sum for pathologies treated with biologicals in out-patient care; Another model is "preferred drug" that one drug, the least expensive will be the normal choice; Introduce more price incentives;
Question 6 - Uptake Measures Listed by Member StateInformation campaigns (1/2) Provide specific information about biosimilars targeted at the prescribers; Clear and unbiased information from an independent source on the "concept" of biosimilars, their approval process and their safety, will be central; Create awareness for biosimilars;
Question 6 - Uptake Measures Listed by Member StateInformation campaigns (2/2) Improve the knowledge of healthcare professionals on biosimilars (e.g. organisation of conferences with all stakeholders); Patient targeted information on the same issues as for doctors is thought to have added benefits;
Question 6 - Uptake Measures Listed by Member StateSubstitution (1/2) Clear statement from EMA on the safety of substitution; Clear decisions on automatic substitution- possible or not- is also of importance; Automatic substitution will be reconsidered when biosimilar monoclonals enter the market, at the latest; Define procedures for usage and substitution;Note: 1 ) Substitution: refers to the practice of dispensing one medicine instead of another equivalent and interchangeablemedicine at the pharmacy level without consulting with the prescriber. 2) Automatic Substitution: refers to the practicewhereby a pharmacist is obliged to dispense one medicine instead of another equivalent and interchangeable medicine due tonational or local requirements without consulting with the prescriber.
Question 6 - Uptake Measures Listed by Member StateSubstitution (2/2) There is a proposal of the law for implementing therapeutic reference groups; Automatic substitution when initiating treatment with a biological drug; (…), automatic substitution triggers price reductions ("step price"), and it is a very transparent and robust system with appropriate safety mechanism, i.e. doctor’s reservation. Various models are being considered: automatic substitution without limitations, substitution at start of treatment, but not later;
Question 6 - Uptake Measures Listed by Member StateOthers Shorter deadline for deciding on the price and inclusion in the system of reimbursement (60 days); A robust regulatory framework is likely to be the best measure to foster uptake, doctors are likely to be somewhat slow in moving towards biosimilars; Increased role of clinicians as fund holders or service managers.
EGA Conclusions (1/2)There is a need for clear and unbiasedinformation from independent sources,targeting doctors, on the scientificconcept of biosimilars, their approvalprocess and their safety and efficacy.
EGA Conclusions (2/2)Member States should put in placeprescribing guidelines that incentivizephysicians to increase the prescriptionof biosimilars, in addition toreimbursement rules that create thecondition for the uptake of thebiosimilars market.