Section 1 - Introductory Statements and Governance: Statements 1.3,1.6 Section 2 - Selection, Procurement and Distribution: Statement 2.3
New drugs are coming to the market with promise of better care for patients in serious diseases, but with soaring prices that may endanger the access of patients to them.
On the other hand, the regulators are under some criticism for facilitating the approval of drugs with weak evidence of relevant clinical efficacy. A published study (1) states that "From 2009 to 2013, the EMA approved the use of 48 cancer drugs for 68 indications. Of these, eight indications (12%) were approved on the basis of a single arm study. At the time of market approval, there was significant prolongation of survival in 24 of the 68 (35%). The magnitude of the benefit on overall survival ranged from 1.0 to 5.8 months (median 2.7 months). At the time of market approval, there was an improvement in quality of life in seven of 68 indications (10%)."
Thus, Health Technology Assessment after-market authorisation is becoming widespread practice in Europe, because healthcare providers have to choose carefully where they spend their money.
Also, pan European initiatives are ongoing, from the EunetHTA group, and also in cooperation with EMA in an attempt to coordinate member states, industry and EMA to achieve approvals based on data useful for the healthcare provides decision.
In this seminar, we will review concepts such as PICO (Patients, Intervention, Comparison, Outcome), added value, and willingness to pay. We will focus on the reasons why regulatory approval is not enough and why HTA is needed. We will also describe the EuneHTA/EMA efforts and other coordinated initiatives in Europe, such as the "La Valetta" group.
After the seminar, participants should be able to: • Address reasons for performing HTA evaluation; • List elements that are part of an HTA report.
Educational need addressed
Hospital pharmacists need to be familiar with the HTA process and methods, when making decisions at local level on the introduction of new drugs in the hospital formularies, and when implementing monitoring of drug use.
Keywords: HTA, medicine added value, drug expenditures, drug formularies, patient outcomes.