Review of Access to New Medicines

Appendix 3: Remit and Scope of the Review

Review of Access to New Medicines - independent review by Dr Brian Montgomery

Context

In October 2013 the Cabinet Secretary for Health and Wellbeing directed the Scottish Medicines Consortium ( SMC) to undertake a rapid review to establish more flexible approaches in evaluating medicines for treatment at end of life and for very rare conditions. The SMC established a Task and Finish Group with representatives from key stakeholders including clinicians, patient interest groups and the pharmaceutical industry and in consensus recommended a new approach for the assessment of end of life, orphan and ultra-orphan medicines to deliver substantially improved access to these medicines for patients in Scotland ("the new approach"). In January 2014, following consultation with other parties in the Scottish Parliament, the Scottish Government asked SMC to deliver the new approach set out in the Task and Finish Group Report. The new approach was put in place for submissions received after noon on 7 April 2014 and the first decisions made under the new approach were published in October 2014. In February 2015 the Scottish Government indicated its intention to formally review the new approach in 2015/16. The Scottish Medicines Consortium has adopted a continuous improvement method to the implementation of the new approach and this review builds on that and will take account of the views of the Health and Sport Committee from March 2016.

The review will also consider the wider context of how SMC decisions for these medicines are implemented by NHS Boards, including those orphan, ultra-orphan and end of life medicines not recommended by SMC.

The Cabinet Secretary for Health, Wellbeing and Sport, Shona Robison, has asked Dr Brian Montgomery to lead the review.

Scope of Review

The review should consider the progress made in substantially improving access to orphan, ultra-orphan and end of life medicines for patients in Scotland compared to the former system. The overarching policy aim of the review is providing safe and timely access to clinically effective medicines at as fair price. The review will be forward looking to anticipate, where possible, future developments which will influence this landscape. In particular the review should consider and make any recommendations it considers appropriate in the following areas:

• How the agreed definitions for end of life, orphan and ultra-orphan medicines are working in practice;

• How the views from the Patient and Clinician Engagement process are taken into account in decision making;

• How the new approach to assessment of ultra-orphan medicines is operating in practice;

• How the acceptance rates for end of life, orphan and ultra-orphan medicines have changed as a result of the new approach;

• How the transparency of SMC has improved and what further opportunities there are for patient and clinician engagement;

• How NHS Boards are implementing SMC decisions under the new approach (both accepted and not recommended) including utilisation of the New Medicines Fund;

• How the new approach has had an impact on reliance on access to medicines on an individual patient basis (through individual patient treatment requests and peer approved clinical system);

• Whether there are further opportunities to take a 'once for Scotland' approach in any aspect of access to newly licensed medicines;

• How the SMC process should be adapted to include commercial negotiation with the aim of (1) ensuring best value for the NHSS and (2) getting to a pharmaceutical companies' best offering on price earlier;

• Whether there have been unintended consequences of any aspect of the new approach, the potential of which was noted by the Task and Finish Group Report;

• How the new approach will accommodate advances in new medicines and a developing regulatory framework;

• Whether the progress made to date provides a solid basis for developing further a Scottish Model of Value.

Approach

The review will be undertaken independently of the Scottish Medicines Consortium and the Scottish Government and consult widely with those who have been engaged in the new approach, building on feedback already received by the Scottish Medicines Consortium, Scottish Government and Health and Sport Committee of the Scottish Parliament.

The review will have access to commercial in confidence information held by the Scottish Government on the basis that the confidentiality of this information is strictly upheld. The review will not significantly impact on the ability of the SMC to continue its work, and subject to this, is expected to report to the Scottish Government in around four months.