Your monthly round-up of market access news

New on MAP in April

Three Tier Menu

We at MAP are always trying to simplify market access, in an attempt to do this we have created a new three tier layout to our menu. This new layout will hopefully help our subscribers find their way around the MAP site more easily.

New Cancer Drugs Fund

The Cancer Drugs Fund page on our MAP UK site has been updated to include information about the new cancer drugs evaluation methodology under NICE.

This page also includes useful flowcharts mapping the process in England and provides summaries of the various steps required to make requests to the fund.

NCPE Outcomes

This page outlines the realistic outcomes that you can expect/aim for if you are accepted, restricted or not recommended by the NCPE.

International Reference pricing

The prices of pharmaceuticals differ across the various European Member States. In this section in MAP Europe, we explain the different nationally dependant factors that determine these prices, parallel trade and dual and free pricing systems.

SMC Appeals Process

The SMC aims to promote a transparent appraisal process. This means that when a company disagrees with the conclusions of an SMC assessment they theoretically, have the option to appeal. There are different processes based on the nature of the appeal, which are explained on the Scotland HTA section of our MAP UK site.

UK Market Access Overview

The MAP overview of UK Market Access provides a flowchart that shows the steps you will need to take in the Market Access pathway and also a detailed diagram outlining the different routes to reimbursement, including timelines, relevant stakeholders and strategies based on our experience and analogues.

UK Policy Maker Engagement

You can expect to find information to:

Help identify government stakeholders and parliamentary contacts,
Prioritise contacts,
Develop and track your meetings programme,
Write to parliamentarians and much, much more.

We also provide a useful slide deck to help you to understand who you need to be engaging with in order to get the best response to your product.

All subscribers can access the MAP EU section which now contains a new Government Affairs Strategy section.

Ireland Market Access

We explain the major steps in reimbursement in Ireland , and provide you with a view of the 4 main pricing schemes available through the Primary Care Reimbursement Service. This page also provides a useful flowchart which will show you the steps that you may need to take in the Market Access pathway.

UK Medicines Information

UKMi is an NHS pharmacy based service aimed to support the safe, effective and efficient use of medicines by the provision of evidence-based information and advice on their therapeutic use. In our Horizon Scanning page on the MAP UK site we provide information about UKMi, who provides the UKMi service and what the service offers.

Structure and Finance - CRGs

This page on the MAP UK site has been updated to include the recent revisions to the Clinical Reference Group (CRG) structure and the accountability arrangements that are now in place.

April Market Access News

Pharmacy dispensing models and displaying prices on medicines

This consultation is requesting views on the proposed changes to medicine legislation.

The changes to legislation include:

allow independent pharmacists to make use of ‘hub and spoke’ dispensing models – a ‘hub’ pharmacy dispenses medicines on a large scale, often by making use of automation, preparing and assembling the medicines for regular ‘spoke’ pharmacies that supply the medicines to the patient
allow the price of medicines and a statement on how the costs of medicines are met to be published on dispensing labels should this be required for NHS medicines dispensed as part of the NHS pharmaceutical services
clarify the current dispensing label requirements for monitored dosage systems and medicines supplied under patient group directions
amend the pharmacists’ exemption in section 10 of the Medicines Act, regarding the preparation and assembly of medicines, following a judgment of the Court of Justice of the European Union.

To view this consultation please click here.

NHS England – Methodology on Prioritising new Specialised Treatments

NHS England has finally revealed how it will choose which new specialised treatments it will fund.

The new methodology, (currently under consultation), allows NHS England’s clinical priorities advisory group (CPAG) to categorise each treatment proposal on whether it delivers a “high”, “medium” or “low” benefit to patients.

The treatment is then to be placed on a “matrix” which evaluates the benefit to the patient against the cost of the treatment. The cost is to be measured as the cost per patient over five years, and based on this, each treatment will be ranked on whether they are “high”, “medium” or “low” cost.

The cost thresholds are subject to the range of treatments in each commissioning round, meaning they are likely to differ from year to year.

To see NHS England’s methodology paper, please click here.

Drug costs could bankrupt Scottish NHS

Patients may miss out on vital drugs due to high costs which could result in the Scottish health service falling behind other UK nations. Expensive new medicines could “bankrupt the NHS” creating a postcode lottery.

Diana Jupp, of cancer charity Bloodwise, said: “Many of the new treatments will not cure cancer, but when taken daily will minimise the impact of the disease to allow people to live normal lives for years, even decades.”

New medicines targeted at individual patients could help to save money and some manufacturers have slashed their prices after negotiations with the NHS, but she said these measures were not enough to resolve the situation alone.

Read the whole story from the Scotsman.

CDF Begins Transition to New Scheme

The new Cancer Drugs Fund (CDF) scheme is scheduled to start from 1 July 2016. However, the transition from the current scheme to the new scheme started on the 1st April 2016.

In preparation for the operational start of the new scheme, NICE will begin using their proposed new methodology for appraisals from 1 April 2016, subject to consideration and approval by the NICE Board.

Drugs from the current CDF list will roll over to the new list which will remain closed to new drugs pending the start of the new scheme in July.

Click here to read the final amendments to the NICE technology appraisal processes and methods guides to support the proposed new Cancer Drugs Fund arrangements.

Final Report of the Accelerated Access Review - Delayed

As a result of the EU referendum, the final report of the Accelerated Access Review will now be launched shortly after 23 June.

This report was due to launch in April 2016, but unfortunately, this date has now been pushed back.

EMA - Proposed framework for data extrapolation from adults to children

The EMA has released a reflection paper outlining the framework for extrapolating data from adults to children to facilitate development of paediatric medicines.

Manchester Vanguards to be Funded from the Transformation Fund

The new care model vanguards which are in development in Greater Manchester will not be funded from the national fund, but funded instead from the region’s already allocated £450m transformation fund, with £60m available in 2016-17.

Better safety for patients through EU-funded research

The finding from the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) project are improving benefit-risk monitoring of medicines.

The results of the project were published in a series of different medical journals and are making a difference in the assessment of the advantages and potential risks of medicines available for patients in Europe.

European Parliament votes to lessen European Commission’s control

The European Parliament has voted for the structure and level of fees charged by the European Medicines Agency (EMA) to be set by members of Parliament and European Union (EU) ministers, instead of the European Commission.

“Members felt that matters relating to the structure and level of [EMA] fees should be decided through the co-decision procedure rather than through implementing acts.”

The amendment package also seeks to clarify how EMA is funded and operates. Members clarified and separated EMA’s sources of revenue, stating that revenue will consist of:

A contribution from the EU
A contribution from any European third country with which the EU has agreements
The fees paid by undertakings for obtaining and maintaining EU marketing authorisations for human and veterinary medicinal products and for other services provided by the agency
Charges for any other services provided by EMA
Other sources of income, including ad-hoc grants

For more information see the full article on RAPS.

New CCG improvement and assessment framework launched

NHS England has today launched a new Improvement and Assessment Framework for Clinical Commissioning Groups (CCGs), which will include ratings published online to show patients how their local health service is performing in six important areas.

From June, an initial assessment of CCG performance will be available online that will cover six crucial areas including cancer, dementia, diabetes, mental health, learning disabilities and maternity care.

As well as the six areas verified by the panels, the new framework will also report CCG performance in 29 key areas, including new models of care, efficiency and conflicts of interest management.

The framework is intended as a focal point for joint work and support between NHS England and CCGs, and was developed with input from NHS Clinical Commissioners, CCGs, patient groups and charities. It draws together the NHS Constitution, performance and finance metrics and transformational challenges and will play an important part in the delivery of the Five Year Forward View.

Click here to read the full article from NHS England.

PRAC recommends that fusafungine-containing medicines are no longer marketed

The EMA’S Pharmacovigilance Risk Assessment Committee (PRAC) has suggested that fusafungine-containing medicines have their marketing authorisation revoked. This will mean that the medicines can no longer be marketed within the EU. It was decided by PRAC that the benefits of the treatment did not outweigh the risks as there was the potential for patients to have serious allergic reactions.

First Patient Recruited to World Leading Genomics Project

The 100,000 Genomes Project, which is undoubtably a revolutionary leap forward in modern medicine, has truly begun, as the NHS Genomic Medicine Centre (GMC) has recruited its first patient to the programme.

The ground-breaking 100,000 Genomes Project, launched by the Prime Minister in 2012, will hopefully transform diagnosis and treatment for patients with cancer and rare diseases and drive forward improvements in the fast-emerging field of genomic medicine.

To read the full article please click here.