Survey on good practices and obstacles to the uptake of the biosimilars market in Member States and EFTA Countries

Medicamentos Biosimilares: Present y futuro

Michele Uda Member of the EGA Board and Chair of the Transparency working group12th of February, Madrid

Stakeholders Contacted

All EU MS and EFTA countries;

Represented either by: Health authorities and/or Health insurers

Responding Countries = 24

Outstanding Countries = 5

Question 1 – Does your country have special prescribing rules for biologicals and/ or for biosimilars?

Question 2- In your country, do you have specific clauses removing biologicals from automatic substitution?

Question 3 - Does your agency communicate information on biosimilars via their website to the general public? If yes, what are the recommendations put forward?

Question 4 - Does your country have measures in place targeting the uptake of biosimilars? When were these introduced?

Question 5 - Obstacles Listed by Member States

Quality, 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 State

Prescription 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 State

Legislative 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 State

Prescription 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 State

Procurement 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 State

Procurement 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 State

Information 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 State

Information 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 State

Substitution (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 interchangeable medicine at the pharmacy level without consulting with the prescriber. 2) Automatic Substitution: refers to the practice whereby a pharmacist is obliged to dispense one medicine instead of another equivalent and interchangeable medicine due to national or local requirements without consulting with the prescriber.

Question 6 - Uptake Measures Listed by Member State

Substitution (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 State

Others 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 unbiased information from independent sources, targeting doctors, on the scientific concept of biosimilars, their approval process and their safety and efficacy.

EGA Conclusions (2/2)

Member States should put in place prescribing guidelines that incentivize physicians to increase the prescription of biosimilars, in addition to reimbursement rules that create the condition for the uptake of the biosimilars market.