New Medicines Reviews 2013

Appendix 1

NEW MEDICINES REVIEW

The New Medicines Review announced by the Cabinet Secretary for Health and Wellbeing announced on the 14 November 2012 responds to concerns raised in the Scottish Parliament and the media regarding concerns of patients, clinicians and other stakeholders regarding access to new medicines - particularly cancer medicines and medicines to treat rare diseases.

The New Medicines Review will examine every aspect of the processes for introducing new medicines within the NHS in Scotland to assess their effectiveness and to identify what further improvements can be made.

The review comprises three main strands of work:

(iv) an independent examination of the Scottish Medicines Consortium (SMC) appraisal processes; (Annex A);

(v) an examination of the role and remit of NHS Board Area Drug and Therapeutics Committees (ADTCs) and a separate examination of the current Individual Patient Treatment Request (IPTR) arrangements (Annex B); and

(vi) an audit of NHS Board formulary decisions regarding medicines which have been accepted or accepted for restricted use by the SMC (Annex C).

A key aim of the review will be to achieve consistency in the application of national policy throughout NHSScotland. A fuller description and the scope of each strand of work are set out in the attached annexes.

The New Medicines Review will report early in 2013.

Pharmacy and Medicines Division

ANNEX A

Review of the Scottish Medicines Consortium (SMC) Processes

Description and Scope

Professor Philip Routledge, Professor of Clinical Pharmacology at Cardiff University and Mrs Karen Samuels, Programme Director for the All Wales Therapeutics and Toxicology Centre will examine the current Scottish Medicines Consortium (SMC) appraisal processes and methodology from horizon scanning of new pharmaceutical products in the pipeline through to provision of SMC advice to NHSScotland to see what further improvements can be made.

This will include a broader view of the cost and benefits of new, innovative medicines - specifically to assess whether the Quality Adjusted Life Year (QALY) methodology represents an effective tool to calculate cost-effectiveness of these in terms of off-setting the cost of the medicine against potential savings when they displace existing treatment(s) and prevent possible hospitalisation.

Timeframe

The Review will commence on 5 December 2012 and Professor Routledge and Mrs Samuels will report on their findings to the Chief Pharmaceutical Officer of the Scottish Government early in the New Year.

ANNEX B

Refresh of NHS Board Area Drug and Therapeutics Committee Short Life Working Group (SLWG)

Description and Scope

Professor Charles Swainson will chair a Short Life Working Group (SLWG) to refresh and agree the role and remit of NHS Board ADTCs, building on and strengthening the existing work and structures in NHS Boards.

This will include an examination of whether there is a need for 14 sets of criteria for prescribing medicines which have been accepted for use by the Scottish Medicines Consortium (SMC) and what further improvements can be made to achieve consistency of application of national policy across NHSScotland.

Output

The findings of the SLWG will be reported to the Chief Pharmaceutical Officer of the Scottish Government.

Timeframe

The SLWG will report on their findings early in the New Year.

Review of NHS Board Management of Individual Patient Treatment Requests (IPTRs)

Description and Scope

Professor Charles Swainson will examine the extant Individual Patient Treatment Request (IPTR) arrangements and provide comment on:

• their effectiveness - specifically whether this is a reasonable approach in relation to orphan medicines and cancer medicines;
• the benefits of establishing a single national protocol for consideration of IPTRs across NHSScotland; and
• whether there is scope for further improvements to the existing arrangements including consistency in the application of national policy.

Output

Professor Swainson will report his findings to the Chief Pharmaceutical Officer of the Scottish Government.

Timeframe

Professor Swainson will report on his findings early in the New Year.

ANNEX C

Implementation of SMC "Accepted" Advice within NHS Boards in Scotland

Description and Scope

Healthcare Improvement Scotland will undertake an audit of medicines which have been accepted or accepted for restricted use by the SMC for a 5 month period and will examine for each:

• the decision taken on each medicine by each NHS Board;
• the date of the decision; and
• the date the decision was published on the NHS Board website

The timescales for making the decision and publishing it will be measured against the timelines contained in the Scottish Government guidance document published under cover of SGHD/CMO(2012)1 on 13 February 2012 which took effect from 1 April 2012.

Accessibility of standard advice about formulary decisions and rationale for these for patients and the public will also be assessed for each NHS Boards to ensure they are complying with the guidance.

Output

The output from this piece of work will help support the New Medicines Review and will be provided to the Chief Pharmaceutical Officer of the Scottish Government.

Timeframe

Healthcare Improvement Scotland will report on their findings early in the New Year.