International comparisons
32. Many organisations concerned with the evaluation
of medicines and other health interventions exist elsewhere. The
Committee visited Scotland, France and Canada to learn about the
arrangements in place in those countries.
Scotland
33. NICE guidance applies in England, and much of
its guidance also applies in Wales and Northern Ireland. Although
some NICE guidance applies in Scotland (such as that relating
to interventional procedures), the Scottish Executive has established
its own arrangements for the assessment of medicines (equivalent
to NICE technology appraisals) through the Scottish Medicines
Consortium (SMC). Advice on clinical practice (equivalent to clinical
guidelines) is produced by the Scottish Intercollegiate Guidelines
Network (SIGN).
Scottish Medicines Consortium
34. The SMC assesses and makes recommendations on
all new drugs. That is, it provides advice to NHS Boards and their
Area Drug and Therapeutics Committees across Scotland about:
- all newly licensed medicines;
- all new formulations of existing medicines; and
- all new indications (ie. conditions) that existing
medicines are licensed to treat.
35. Unlike NICE health technology appraisals, SMC
recommendations are not mandatory. The following classification
system is used:
- Unique: all NHS Boards should
make these drugs available within three months;
- An advance on alternatives/the same as alternatives:
Area Drugs and Therapeutics Committees within each Board will
decide whether to allow the use of the drug in their area;
- Worse than alternatives: Boards are advised not
to use the medicine.[18]
36. In comparison with NICE technology appraisals,
less in-depth analysis informs SMC decisions. There are no published
processes and methods to which SMC must adhere. It has no scoping
phase and public consultation is limited. The whole process is
swifter, lasting around 4 months.[19]
37. The pharmaceutical industry is represented on
the committee that evaluates the drug. There is more dialogue
between the Consortium and the manufacturer throughout the SMC
process compared to that of NICE. Perhaps for this reason, appeals
are rare. When they do occur, SMC will review a decision on the
basis of process or scientific issues.
Scottish Intercollegiate Guidelines Network
38. SIGN develops national guidelines for use by
clinicians working within NHS Scotland. Like NICE clinical guidelines,
they are not mandatory. Guidelines take between 24 and 30 months
to compile.
39. Topics are selected on the basis of clinical
uncertainty, strength of the evidence of treatment efficacy, risk,
priority for NHS Scotland and perceived need. Anyone can propose
topics for consideration by SIGN. Topics are sent to one of a
number of speciality subgroups, overseen by the Guideline Programme
Advisory Group. SIGN Council, which comprises representatives
from medicine, nursing, healthcare management, research, social
care and patient groups, makes the final topic selection.
40. SIGN guidelines are then developed by multidisciplinary
working groups, which include healthcare professionals, NHS managers,
researchers and patients. The guideline development groups are
selected in consultation with the member organisations of SIGN.
41. There is no formalised relationship between SMC
and SIGN.
France
42. In France, the French Haute Autorité de
la Santé (HAS) is an independent body that provides medical
and scientific advice to the French Government. Much of its remit
mirrors that of NICE including:
- The production of health technology
assessments;
- The production and promotion
of clinical guidelines;
- The provision of public health
guidance.
43. HAS assesses more technologies than NICE and
performs its assessments more quickly; as a result, its assessments
tend to be based on less evidence than those of NICE. See the
box below for details of the HAS appraisal process.
