MAP Conference - A Success to Help you Plan for 2017!

Thank you to all those who attended the MAP conference and especially to our speakers who all presented fascinating and insightful talks!

Please find below a summary of the day...

Lord Andrew Lansley

Lord Andrew Lansley began the conference with an interesting insight into the origins of the Cancer Drugs Fund, and the evolution of health policy and the effect of this on the NHS.

Brexit Panel

Chris Mockler initiated the Brexit panel which discussed the implications of the referendum decision between the UK and each of its devolved nations and Europe, and considered possible opportunities relating to mutual recognition between the MHRA and the FDA and/or EMA.

Mark Flannagan

This was followed by Mark Flanagan's talk from the health charity Beating Bowel Cancer, where he provided insight into how the life sciences industry should approach and engage with patient groups.

Andrew Walker

Andrew Walker then spoke about the SMC, the Montgomery review and what would be expected to change, concluded by a useful checklist on how to be successful in HTA submissions.

Jenniffer Prescott

Jenniffer Prescott from NICE then spoke about the plans that NICE has made for the next 4-5 years and how this might impact Technology Appraisals, Highly Specialised Technology Appraisals and Topic Selection Processes.

Andy Rawson

Andy Rawson then provided an interesting talk on how he has made the most of the MAP BioPharma website and his experience as a subscriber.

Christian Hill

Christian Hill, managing director of MAP BioPharma then spoke about legal solutions to market access barriers and provided some useful MAP insights on the processes that do and don't work well.

Brian Gavin

This was followed by a talk from Brian Gavin, MAP's consultant based in Ireland. Brian spoke about the IPHA agreement in Ireland and the implications that this has for 2017.

Stuart Saw

Stuart Saw then finished the conference with a talk about the state of NHS England finances, critical success factors and the Sustainability and Transformation Plans.

We hope that those of you who attended the conference found it as engaging and as useful as we did and please note that all of the presentation slides are now available to subscribers on our conference page.

What's new to MAP in September

ICER Calculator Tool

This tool which is new to the MAP site, is a simplified ICER calculator that can help to provide an estimated ICER for your product by taking into account aspects such as discount rates, time horizon, interventions and comparators.

ASK MAP

The Ask MAP page has been updated so that when you challenge us with your market access related questions, you can now chose one or multiple persons from our team to respond.

MedTech Innovation Briefings

This new section on the MAP MedTech UK site has been created to provide a simple overview of MIB production and aims to answer common questions such as:

What is a MIB?
Who is the key audience for a MIB?
What does creating a MIB involve?
Who is involved in producing a MIB?
How are topics identified for MIB production?
When does MIB production become Public?
How long does the process take?
What information will manufacturers be expected to provide?
What are the benefits of a MIB and how should it be used?

A Public Affairs Update from MAP MedTech

Brexit: Timing, EEA and Implications for Life Sciences

When will we leave the EU?

Article 50 notification is likely to be delayed until Spring 2017, which would lead to an exit from the EU in Spring 2019, unless the remaining EU countries agree unanimously to extend this deadline. A long-term relationship will then be established under a new Treaty, but it may take years to complete this transition.

What is the most difficult issue?

A crucial issue is whether the UK joins the European Economic Area (EEA) as a non-EU member, like Iceland, Liechtenstein and Norway. This option would give the UK access to the single market, combined with the free movement of capital and labour. This is seen by many as a highly desirable aim, and would avert many of the disadvantages of leaving the EU.

The main problem with the EEA is that the free movement of labour is incompatible with the aim of cutting UK immigration from within the EU. This issue was a driving force behind the EU referendum result and the Government has made clear that this is an absolute necessity. The EU leaders have made clear that the free movement of labour is an essential precondition for joining the EEA. As David Davis, the Secretary of State for Exiting the European Union, told Parliament on 5th September, his personal view is that it is improbable that all EU countries (the final negotiated agreement has to be unanimous) would agree to such an arrangement.

How is healthcare affected?

If EEA membership is not possible, the life sciences industry may be adversely affected by restrictions on capital markets access, reduced inward investment and moving the location of the European Medicines Agency (EMA) away from the UK.

However, the EU external tariff on medicines, vaccines and blood is nil, so it would be a simple question of maintaining this approach for the UK.

In bilateral trade negotiations, the UK could aim to secure EMA and / or FDA approvals via the Medicines and Healthcare Products Regulatory Agency (MHRA). Other countries such as Australia, New Zealand and Switzerland have negotiated fully operational Mutual Recognition Agreements with the EMA, so this seems a reasonable aim and could be extended to include the FDA.

Mutual recognition and common standards in others areas, e.g. devices, are likely to be agreed, and UK participation in multi-national research activity will be essential. For UK healthcare, and the life sciences industry, access to skills and staffing is vital, and the key will be how visas can be secured in the numbers needed.

What are the opportunities?

The forthcoming Accelerating Access Review (AAR) paper from the Government is expected to address many of the key issues facing the UK science base and how a more competitive business environment can be created. Of particular interest is whether the Government will look at speeding up the NICE and NHS processes for new medicines, and whether a lower low level of Corporation Tax will be introduced – perhaps building upon the UK Patent Box which provides a 10% Corporation Tax rate on qualifying profits subject to certain restrictions.

The NHSE’s paper on Commissioning Intentions 2017/2018 and 2018/2019 For Prescribed Specialised Services

MAP Summary:

(This document accompanies the NHS Operational Planning and Contracting Guidance 2017-19 issued in the same day.)

Its general purpose is to set out the ways by which NHSE can improve commissioning and contracts as well as review and transform specialised services. Much of what the document puts forward is already in place or announced, but some points are worth noting.

Spending

Although NHSE has set overall financial spending targets for NHS providers to address their deficits (aiming for a balancing starting position for 2017/18), no specific targets have been set for specialised services.

Instead there is a general statement that “Specialised services make up over 15% of the NHS spending, and judicious stewardship will be crucial to meeting the financial challenges facing the NHS, both nationally and locally.” (p 9)

Transfer of responsibilities

For contracts agreed for April 2017 NHS England is not intending to transfer commissioning responsibilities and budgets for any of the 149 services to CCGs. However Appendix B (p 49-50) sets out a long list of the services that might be most appropriate for locally-led commissioning.

Cancer services

During the next two years a review of cancer services will be completed to enable the development of innovative new care models and strengthened provider networks. The review will include radiotherapy, chemotherapy, cancer surgery, children and young person’s cancer services and a second phase of PET CT scan. (p 11)

Contractual Requirements

NHSE will remain the contracting body for all patients across England treated for services within the scope of specialised commissioning for contracts awarded from April 2017. (p17)

This NHSE paper on specialised services paper can be accessed by clicking here.

Market Access News - September Highlights

New Government Bill – Health Service Medical Supplies (Costs)

A new Government health Bill is being introduced today called Health Service Medical Supplies (Costs).

This bill is to make provision in connection with controlling the cost of health service medicines and other medical supplies; to make provision in connection with the provision of pricing and other information by those manufacturing, distributing or supplying those medicines and supplies, and other related products, and the disclosure of that information; and for connected purposes.

France - Publication of notice of proposed rate reductions for a range of medical devices by Economic Committee for Health Products (CEPS)

The Official Journal (French Official Gazette) on Friday September 2nd published a Notice of Proposed rate reductions for a range of categories of medical devices, especially for the treatment of apnea hypopnea syndrome obstructive sleep (OSAHS) by continuous positive airway pressure (CPAP).

See the publication here.

A Quarter of CCGs Predict 2016/17 Deficit

GP Online reports that 23% of CCGs and 47% of NHS trusts have said they expect to end 2016/17 in deficit – meaning that the proportion of CCGs predicting a deficit has doubled since this time last year. One of the main problems is believe to be NHS workload.

NHS England Publishes Advice for Sustainability Transformation Plans

NHS England have published national advice for local health and social care leaders preparing local Sustainability and Transformation Plans. The advice sets out how to put the communities they serve at the heart of their work.