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Leela Barham is a freelance health economist and policy expert. She has published in peer-reviewed journals and presented at national and international conferences. She has provided advice to the Department of Health and Social Care on policy on pricing of branded medicines to inform the negotiation of a successor to the UK’s Pharmaceutical Price Regulation Scheme (PPRS), the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), as well as worked with patient groups, the NHS, pharmaceutical companies and many others internationally on the economics of healthcare and pharmaceuticals. Contact Leela on firstname.lastname@example.org
Leela Barham looks at what the rival parties are promising for healthcare ahead of the UK General Election next month.
Access to medicines - especially those for cancer - has remained a political hot topic and it’s no surprise that it’s come up again as the main political parties set out their stall in the run up to the General Election. With Labour, Conservatives and the Liberal Democrats having now published their manifestos there’s a glimmer of what might be in store for access, in the short term and in the more distant future.
A host of policies affect products just about to come to market and during launch. Based on what the politicians are saying now, there doesn’t look to be major changes ahead.
The CDF looks likely to stay…at least for a little while longer
The Cancer Drugs Fund has its origins in the last General Election when the Conservatives pledged the fund in 2010 as a temporary measure. It was to be a ‘bridge’ to the pledged reform of pricing (Value Based Pricing/Value Based Assessment) which had some merit at the concept stage, but working it through left pretty much everyone confused or outraged, and sometimes both. The CDF has outlasted pricing reform but has caused a lot of tension for industry, patient groups, and with NHS England who now run the fund.
The Conservatives say that they will keep the CDF – after all they can cite the 60,000 people the fund has helped in this year’s manifesto.
Labour too say they’ll keep it, except it will be a fund to cover not just cancer drugs but other cancer treatments too – morphing into the Cancer Treatments Fund (announced in December 2014, and the commitment retained in their Manifesto). They also say it’ll be part funded by Pharmaceutical Price Regulation Scheme (PPRS) payments. Under the current PPRS companies pay back if NHS spend on branded medicines goes above a pre-agreed growth rate – some £310million (US$458m) for 2014 alone, although the Department of Health is waiting for £5 million ($7.4m) of that to be paid to them. The Lib Dems don’t touch on it.
NICE to stay, but may evolve
Its clear that NICE will stay, although there may be some changes. Labour has said that they will make sure NICE is ‘fit for the future’. Although no detail is given, but the hope is that this will evolve NICE to be able to respond to stratified medicines and the complexities of the burgeoning knowledge of genes and the role they play in both how likely people are to get a disease (or a specific variant of it) as well as tailoring treatment.
For the Conservatives, changes are also not detailed, but instead they commit to implementing the results of the on-going Innovative Medicines and Medical Technology Review (also known as the Accelerated Access Review, End to End Review or even the Freeman Review reflecting the setting up of the review by George Freeman as Minister for Life Sciences). That is due to report by the end of this year, although ‘quick wins’ might be tabled sooner. Given the focus on accelerating uptake, speeding up NICE could be part of reform.
The Lib Dems haven’t mentioned NICE in their Manifesto.
Tackling uptake will remain a focus
The Innovative Medicines and Medical Technology Review will also look at uptake, and the Conservatives have already committed to taking their suggestions forward whatever they may be.
On uptake, Labour say that there will be tougher rules. Currently the rules are pretty clear: medicines given a positive recommendation as part of a positively Technology Appraisal (TA) and Highly Specialized Technologies programmes must be funded by the NHS. Funding for these medicines should be made available by commissioners within 3 months, unless there are good reasons the NHS needs longer. That has happened; the implementation of the TA for Solvadi (sofosbuvir) for Hepatitis C has been delayed by a request by NHS England (NHSE) for a longer preparatory period. Whilst NHSE say this delay is about basically about capacity and appropriate planning, others suggest it’s a money issue (that same money issue that the PPRS should have helped with?). What might be more of an issue is checking that the NHS actually follows through: there’s no routine checking of implementation and efforts such as the Innovation Scorecard are limited in how far they can explore whether TAs are being followed in practice. We’ll have to wait and see exactly what ‘tougher’ rules means and whether it might just be making other forms of NICE guidance, such as clinical guidelines mandatory as has been trailed by Shadow Secretary of State for Health Andy Burnham.
Labour also expressly say that they’ll maintain the Pharmaceutical Price Regulation Scheme (PPRS), which in its current form has quite a bit about access in it; from measuring it via the Innovation Scorecard to working with industry through a new NICE Industry Council and another NHSE Industry Council.
Getting a product to the market - and actually available to patients – is the result of a long haul through R&D, regulation as well as NICE and the local NHS. The Conservatives table some changes that will affect future medicines including encouraging large-scale trials of innovative technologies (although perhaps that’s more about tech?) and commit to fostering research, innovation and jobs in the life science industry. The Lib Dems commit to doubling innovation spend (again though, this maybe more about tech).
Innovative Medicines and Medical Technology Review will shape the future
It may well be that the Innovative Medicines and Medical Technology Review will also set the agenda for the long term, especially as it can consider changes to the PPRS past 2018 (when the current agreement ends) as well as look at progress with the Early Access to Medicines Scheme (giving early signals about the promising nature of a product before formal licensing) and Evaluation through Commissioning (explore real world value in a time limited window before a final decision on routine funding is made). All parties will want to take a look at the findings of the review, and if it’s properly researched and well thought out, it might withstand political spinning by whoever is in Government by the time it comes out later this year.
Affordability will be the biggest issue
The other issue that can’t be ignored that will inevitably impact on access is affordability. Affordability is linked to the wider economy (as the Conservatives make clear) as well as what to spend on the NHS versus other areas of Government spend.
Committing more money to the NHS is not a dividing line between the main parties; they’ll all spend more. But maybe none of it will be enough as productivity has declined in the NHS and even giving the NHS the £8bn ($12bn) that the head of the NHS wants must also come with productivity improvements that it’s hard to believe are possible, and most certainly are not comfortable for the NHS. With integration with social care, more local involvement also on the cards, affordability will be about affording not just health care but social care where medicines will face tough scrutiny. Demonstrating value will remain vital whoever is in power.