Prioritization of Drugs

Transcription

1 Prioritization of Drugs Head of Department of Clinical Pharmacology prof., ph.d., MD Hanne R Christensen

2 Assessments of drugs The present situation The Council of New Hospital Medicine (KRIS) The Council of Expensive Hospital Medicine (RADS) Amgros (purchasing medicine for the hospitals through tenders) Institute for Rational Pharmacotherapy (IRF) primary care Regional Drug Committees Clinical Pharmacologists and Pharmacists

3 Present situation is unsatisfactory and unsustainable Regional variation in the use of new drugs (not even assessed in RADS & KRIS) compassionate use Variation in the use of guidance s Prolonged assessment procedures The regions haven t coordinated their rules for use of drugs Nobody (in particular no politicians) wishes to prioritize Lack of involvement of economic aspects (KRIS/RADS) results in very high drug prices Followed by invisible economic reductions in other fields And so on

4 What to do?

5 We need to intensify and aggregate knowledge, reduce the variation, increase the quality of decisions with prioritizations with a greater involvement of health economics After decision and implementation based on costeffectiveness analyses we need to reflect and follow up and adjust to real life settings Ready to change the decision based on new knowledge

6 We need to establish an institute of prioritization (or just another name!) Consisting of: KRIS RADS IRF governed by an advisory board and a strong secretary

7 Advisory Board Who Chairmanship Health economists Clinical Pharmacologists Representative from drug companies (LIF) Representative from Danish Patients Hospitals pharmacists Evaluators from abroad, e.g. NICE, Norway?

8 Advisory Board Duties Decide the right category for new (and older) drugs Establish relevant prices for each category Follow the development of new effects and adverse reactions after introduction No need for silent partners, people too shy or politically correct

9 Secretary Secretary with professional specialists in clinical pharmacology and health economy evaluating new and old drugs (and treatments) and making proposals to the Advisory Board concerning ranking of drugs in categories with regard to efficacy and costs

10 Scenarios for a new drug Yes No For the time being compared with established treatment

11 Alternatives If No: 1. No use at all with no exceptions 2. Conditional accept with recorded use (protocol) to be closely monitored by the Advisory Board with regard to later yes or no Predetermined efficacy parameters and issues of special interest 3. No in general, but with yes for some individuals ( cat flap model )

12 Cat flap model Advantages: Biological and ethical the right thing to do Favor the development of new drugs and indications (more acceptable by patient associations and drug Companies) Disadvantages: Difficult to administer (emotionally sensitive) Risk of differential treatment Time consuming

13 Time has come to stop talking we should now act to establish an independent, transparent, scientifically well qualified institute which will consider both efficacy, adverse reactions and price of new and old drugs. No more room for shy, evasive, empty and shallow speeches with no constructive content