HDA UK MEDIA AND POLITICAL BULLETIN – 15 August 2017

MEDIA SUMMARY 

Three quarters of drugs in Cancer Drugs Fund now approved for routine use
The Pharmaceutical Journal, 14 August 2017

The Pharmaceutical Journal, and the European Pharmaceutical Review (Dr Zarra Kassam, 14 August 2017) have reported on the recent NICE approval of three quarters of the drugs currently in the Cancer Drugs Fund. This means that over 75% of the drugs included in the CDF are now available for routine use on the NHS. The National Institute for Health Care and Excellence (NICE) ok’ed the drugs.The CDF was originally implemented in 2010 to ensure that patients were able to access drugs not available for regular use. However, the scheme quickly overran its £200 million budget, and thus NICE was asked to review all the drugs under the program and assign some for routine use. So far at least 24 drugs have been approved for regular prescription.

PARLIAMENTARY COVERAGE

There is no parliamentary coverage.

FULL COVERAGE 

Three quarters of drugs in Cancer Drugs Fund now approved for routine use
The Pharmaceutical Journal, 14 August 2017

The National Institute for Health and Care Excellence (NICE), the health technology assessment body, has now approved three quarters of the drugs in the Cancer Drugs Fund (CDF) for routine NHS use, and has not rejected any drug outright.

Liver cancer drug sorafenib (Nexavar; Bayer) is the 18th of the 24 drugs in the CDF that NICE was asked to appraise and has recommended should be routinely available for some patients on the NHS.

The CDF was established by the government in 2010 as a temporary solution to help patients access cancer drugs that were not widely available on the NHS. However, the fund quickly exceeded its budget, and in 2016 reforms were put in place which required NICE to carry out appraisals for the drugs in the existing fund and all newly licensed cancer drugs.

Professor Carole Longson, director of the NICE centre for health technology evaluation said: “More cancer drugs than ever are being recommended for routine use because companies are working hard to provide cost-effective solutions. We are also applying flexibility in cases where drugs show promise, meaning people get access through the new CDF while further data is generated.”

Sorafenib has been recommended for some people with liver cancer that has progressed. It is estimated that the drug extends life by up to three months.

NICE approves three quarters of the Cancer Drugs Fund
The European Pharmaceutical Review, Dr Zarra Kassam, 14 August 2017

The Nation Institute for Health Care and Excellence (NICE)  has recommended sorafenib, to be routinely available for some patients on the National Health Service (NHS), sorafenib is one of the 24 drugs NICE was asked to appraise from the Cancer Drug Fund (CDF), all of which have been approved so far for routine use.

The CDF is a source of funding for cancer drugs in England, that provides patients with faster access to the most promising new cancer treatments as well as helps to ensure more value for money for taxpayers. Additionally CDF offers pharmaceutical companies a new fast-track route to NHS funding.

“More cancer drugs than ever are being recommended for routine use because companies are working hard to provide cost-effective solutions. We are also applying flexibility in cases where drugs show promise, meaning people get access through the new CDF while further data is generated.”

The CDF was established by the Government in 2010 as a temporary solution to help patients to access cancer drugs that were not widely available on the NHS. However, the fund quickly exceeded its original £200m budget. In 2016 reforms were put in place which required NICE to carry out appraisals for the drugs in the existing fund and all newly licensed cancer drugs.

Sorafenib is recommended for some people with liver cancer that has progressed. It is estimated that the drug extends life by up to 3 months. The guidance is now with consultees who have the opportunity to appeal against it.

Companies, such as Bayer have provided discounts and in some cases additional evidence meaning the drugs can be considered as cost effective for routine NHS. Professor Carole Longson, director of the NICE centre for health technology evaluation said: “Working closely with companies and NHS England, we are delivering our promise to give people fast access to the most cost-effective cancer drugs.”

Media Summary

Pharma criticises ‘heavy handed’ NICE affordability test

Pharmaphorum, 23 January 2017

The National Institute for Health and Care Excellence (NICE) and NHS England have outlined measures to cut the costs of expensive new medicines. Part of the plan involves fast-tracking medicines with a low budgetary impact to patients. Alongside this, proposals for a budget impact assessment – an ‘affordability check’ – constitute a less welcome part of the plan. This would mean that any drug looking to cost the NHS £20m or more per year would raise affordability discussions between a pharma company, NICE and NHS England. Above all, NHS wants to keeps its budget impact down. Proving to be a point of controversy with pharma companies and patient organisations, this NHS objective – manifested in the new affordability check – has already stirred considerable calls for renegotiation.

Simon Harris is trying to lure EU medicines agency to Dublin

The Irish Examiner, Stephen Rogers, 23 January 2017

Today, Irish Health Minister Simon Harris will visit London with the hope of convincing the European Medicines Agency to relocate to Dublin. In the wake of the Brexit vote, various countries have been courting the Agency. “I am mindful of the consequences of Brexit for the agency and I believe that it will be essential to minimise the impact of a relocation, in particular by finding a solution that maximises retention of existing staff,” said Mr Harris. Mr Harris has said he will follow up today’s visit with a series of meetings in early February with officials and stakeholders in Brussels. Staff retention and Dublin’s English-speaking status are being presented as highly beneficial in providing a smooth transition for the Agency’s departure from Britain.

Parliamentary Coverage

Pharmaceutical Price Regulation Scheme PPRS Payment for 2017: Written Statement

Parliament UK, Nicola Blackwood (Parliamentary Under-Secretary of State for Health), 20 January 2017

The Department of Health and the Association of the British Pharmaceutical Industry are to amend the 2014 Pharmaceutical Price Regulation Scheme (PPRS) to ensure that the scheme continues to deliver its objectives of predictability and stability to Government and industry. Additionally, it looks to safeguard costs, so that branded medicines to the NHS stay within affordable limits. Implicit in this is the Government’s recognition of the pharmaceutical industry’s contributions, and the financial challenges facing the NHS. The Department of Health has published a document setting out further details entitled “Pharmaceutical Price Regulation Scheme (PPRS) 2014: revised payment percentages at December 2016”. It can be read in full here.

Full Coverage

Pharma criticises ‘heavy handed’ NICE affordability test

Pharmaphorum, 23 January 2017

Plans to cut the cost of expensive new medicines could mean delays getting them to patients in England, according to the UK pharma industry.

NICE and NHS England have been consulting on changes to processes that will fast-track medicines with low budgetary impact to patients.

But also included is a proposal for a budget impact assessment – a kind of ‘affordability’ check.  This would mean any drug set to cost the NHS £20 million or more a year would trigger affordability discussions between a pharma company, NICE and NHS England.

Above that threshold, NHS organisations will begin talks with drug companies to try to get the price down.

NHS England has pushed for the new budget impact assessment to prevent problems similar to those caused by hepatitis C drugs such as Gilead’s Sovaldi (sofosbuvir). NICE ruled Sovaldi to be cost effective – but this didn’t reflect the overall, upfront cost – the affordability of the drug.

NHS England has resorted to rationing to keep its budget impact down, something which has proven controversial with pharma companies and patient organisations.

In 2015/16 NHS spending on Gilead’s Harvoni (sofosbuvir+ledipasvir) and Sovaldi for hepatitis C was £154 million, although AbbVie’s Humira (adalimumab) inflammatory diseases drug had the largest budget impact, costing the NHS almost £417 million.

The industry says that the new affordability check is unfair – as NICE already screens new medicines for cost effectiveness, and the PPRS pricing system limits overall NHS drug spending.

ABPI chief executive, Mike Thompson, said: “The ABPI agrees with the NHS England’s objective of developing a workable solution for managing the introduction of new medicines which are likely to create significantly high costs to the NHS.”

“However, given that all new drugs approved by NICE have already gone through a process to ensure they are cost-effective and clinically beneficial, the proposal to impose a £20million budget cap on these medicines is both heavy-handed and unrealistic and will mean more patients face delays in accessing appropriate NHS care.

“Better long term planning by the health service would ensure that major breakthroughs are managed into the NHS in an appropriate and affordable way and with less disruption.”

The ABPI said it supports plans to fast-track medicines with an estimated budget impact of less than £10,000 per Quality Adjusted Life Year.

But it and UK biotech industry association the BIA both warned that NICE’s proposals could delay or prevent access to drugs for ultra-rare diseases.

The consultation also proposes a £100,000 cost per QALY threshold for rare and ultra-rare disease drugs would receive automatic funding.

Above this threshold, ultra-rare disease drugs would receive cost-effectiveness assessments and the BIA and ABPI are concerned this could lead to many such drugs being rejected or delayed.

“We believe that this will have a detrimental impact on the development of new products for those who desperately need them and that this this proposal should be paused while a better solution is identified,” said Thompson.

These new checks on affordability send out a message is in clear contradiction to the government’s proposed life sciences industrial strategy.  Theresa May’s government is promising to help make the UK a world leading life sciences market, but pharma and biotech says this can’t be fully achieved if the NHS doesn’t use its new medicines.

This argument is one that will be clearly played out behind the scenes, but as the government is currently refusing to give the NHS extra money to cope with growing demand, it is also unlikely to give way on the new proposals for NICE.

There is some hope that the ABPI and the government could negotiate a new ‘value-based’ pricing system, but this is unlikely to emerge until 2019, after the existing PPRS pricing system expires.

Simon Harris is trying to lure EU medicines agency to Dublin

The Irish Examiner, Stephen Rogers, 23 January 2017

Health Minister Simon Harris will today travel to London to try to convince the European Medicines Agency of the merits of relocating to Dublin.

The EU agency will have to leave Britain as a result of Brexit and the Government has made no secret of its desire to attract it to Ireland.

Today, Mr Harris will meet with the agency’s executive director, Professor Guido Rasi, and members of his team.

“I am mindful of the consequences of Brexit for the agency and I believe that it will be essential to minimise the impact of a relocation, in particular by finding a solution that maximises retention of existing staff,” said Mr Harris.

“The Government has endorsed my request that Ireland would seek to have the EMA relocate to Dublin.”

Dublin is being presented as a viable location on the back of its ability to maximise retention of existing staff; the fact that it is an English-speaking location and English is the agency’s working language; and the fact that the Health Products Regulatory Authority here would be able to provide strong support.

Mr Harris has said he will follow up today’s visit with a series of meetings in early February with officials and stakeholders in Brussels.

Media Summary

NICE ‘pauses’ plans to introduce charges for pharma

Pharmaphorum, Andrew McConaghie, 19 January 2017

Proposals by NICE to charge pharma companies for appraising their medicines are to be paused while the government completes its life sciences strategy. Significant sums were going to be introduced by the NHS cost-effectiveness watchdog from April this year, but the pause is welcomed by many in the industry. The UK pharma industry hopes that the government will respond to demands to review NICE methods, alongside putting together a Life Sciences Strategy – a new overarching plan for the sector which Theresa May’s government hopes will boost the industry, and secure confidence in a post-Brexit UK.

The Community Pharmacy Forward View: ‘Making it Happen’

Pharmacy Voice, 19 January 2017

Pharmacy Voice and the Pharmaceutical Services Negotiating Committee, with the support of the Royal Pharmaceutical Society, have launched the next phase of the Community Pharmacy Forward View (CPFV) project, with a new website and a report outlining an implementation framework for delivering the CPFV vision. Within this, proactivity is pivotal. They are inviting feedback from community pharmacy leaders, frontline teams and their local partners on implementation pathways for each of the three future roles for community pharmacy that are described in the CPFV. The initiative runs alongside national pharmacy organisations’ drive to improve community pharmacy.

To deliver the Community Pharmacy Forward View, and to secure an integrated health and care system, it is deemed necessary to:

  • Raise awareness of community pharmacy services with the public, and strengthen relationships with service users
  • Support local leaders to build partnerships with colleagues across the health and care system
  • Harness technology and secure digital integration
  • Empower the workforce to develop their skills, manage change and work effectively within new structures, cultures and systems
  • Establish new ways of working and delivering integrated care, supported through appropriate funding and contracting mechanisms

Proactively support and facilitate sector-development and change management.

Parliamentary Coverage

House of Commons, Oral Answers, 19 January 2017

Pharmacy: Funding

Diana Johnson (Kingston upon Hull North) (Lab)

I am sure that the Leader of the House will agree that community pharmacies are a very important part of taking the pressure off over-stretched A&Es at the moment, despite them seeing cuts to their funding just last month. The Government have introduced a pharmacy access scheme to help deal with some of the cuts in communities. I was really surprised to see that, in the Prime Minister’s constituency, 37% of pharmacies will be able to apply for that additional funding. In the three Hull constituencies, only 1% of pharmacies will be able to apply. May we please have a debate about why the most disadvantaged communities still suffer the biggest cuts from this Government?

Mr Lidington

I clearly do not know the details of the situation in Hull, but I am happy to ask the relevant Health Minister—I think it is my hon. Friend the Member for Warrington South (David Mowat)—to write to the hon. Lady. The principle is that there are now 15% more pharmacies than there were just a decade ago, two fifths of pharmacies are within 10 minutes’ walk of two or more other pharmacies, the average pharmacy receives roughly £220,000 a year in NHS funding and, even after the recently announced changes, the community pharmacy budget will be 30% more than it was a decade ago, so I think that the Government have demonstrated that they remain committed to community pharmacies and their importance.

A full transcript can be found here.

Full Coverage

NICE ‘pauses’ plans to introduce charges for pharma

Pharmaphorum, Andrew McConaghie, 19 January 2017

Plans by NICE to start charging pharma companies for appraising their medicines are to be ‘paused’ in order to allow the government to complete its life sciences strategy.

The NHS cost effectiveness watchdog had planned to introduce hefty new charges to the pharmaceutical industry from April this year, but announced the pause earlier this week.

The proposal was for each single technology appraisal (TA) and highly specialised technology appraisal (HSTA) to come with a mandatory fee of £142,000, rising to £282,000 for a ‘complex’ multiple technology appraisal.

The new charges are necessary because NICE has seen its workload rise and its budget squeezed over the last few years, and it was advised by the government to consider the charges. While the charges are well within the means of large pharma companies, the industry objected to the introduction of fees without a wider consultation about NICE and its processes.

Breaking the news that NICE would proceed with the charges last August, pharmaphorum spoke to Paul Catchpole, director of value and access at industry association the ABPI.

He said at the time that NICE needed to evolve further in order to be the ‘fit for the future’.

“The ABPI’s position is that industry is keen to see NICE and some of its methods evolve. Once that has taken place we’d be happy for fees for service, potentially.”

The government and NICE now appears to have listened to these objections, and NICE’s chief executive Sir Andrew Dillon has confirmed the pause in implementing the charges.

“We have been working to create a new funding model for technology evaluation to meet the government’s challenge to drive efficiency and deliver better value,” said Dillon.

“We’ve agreed with the Department of Health to wait for the Government’s life sciences strategy to be completed before we move forward with our plans.”

Dillon added that NICE would continue to test its existing proposal against the suggestions and challenges made in consultation responses received.

Life Sciences Strategy

The pause is to allow the government to put together a Life Sciences Strategy – a new overarching plan for the sector which Theresa May’s government hopes will boost the industry, and secure confidence in a post-Brexit UK.

Reform of NICE and its methodology – its QALY cost effectiveness thresholds in particular – has been at the top of pharma’ swish list for some time, but until now the government has made it more or less out of bounds.

The UK pharma industry will hope that it the government will listen to demands for a root-and-branch review of NICE methods, which could help innovative new medicines gain faster uptake on the NHS.

Business minister Lord Prior told pharmaphorum in December that a life sciences industrial strategy would be ready by spring 2017. This tight timetable won’t be enough for a comprehensive plan, but could produce some high-level pledges to boost the sector.

However a burgeoning crisis in the NHS, caused by growing demand and static funding , is directly affecting pharma. NICE and NHS England are planning to introduce a new budget impact threshold of £20 million, which could see new restrictions on many cancer, specialised and rare disease drugs.

This could easily undermine gains made elsewhere, and the UK biotech association the BIA and the ABPI have made their opposition to the changes clear this week.

 

The Community Pharmacy Forward View: ‘Making it Happen’

Pharmacy Voice, 19 January 2017

Pharmacy Voice and PSNC, with the support of the RPS, have today launched the next phase of the Community Pharmacy Forward View (CPFV) project, with a new website and report outlining an implementation framework for delivering the CPFV vision. 

The bodies are inviting feedback from community pharmacy leaders, frontline teams and their local partners on implementation pathways for each of the three future roles for community pharmacy that are described in the CPFV.  They are also calling on national NHS leaders and the Government to commit to working with the sector to develop and implement the CPFV plan.

In August 2016 the national community pharmacy bodies published the Community Pharmacy Forward View as their shared vision for the future of the community pharmacy network.  Many of the ideas set out in this sector-led vision were reflected and reinforced in the recommendations of the recently published Independent Review of Community Pharmacy Clinical Services (the Murray Review).

In ‘Making it Happen’ the national pharmacy organisations take the next step toward turning both the Community Pharmacy Forward View vision and the Murray Review recommendations into reality, by setting out pathways for the policy change, professional development and partnership working required to enable community pharmacy to play its full role within an integrated health and care system.

To deliver the Community Pharmacy Forward View, we need to:

  • Raise awareness of community pharmacy services with the public, and strengthen relationships with service users
  • Support local leaders to build partnerships with colleagues across the health and care system
  • Harness technology and secure digital integration
  • Empower the workforce to develop their skills, manage change and work effectively within new structures, cultures and systems
  • Establish new ways of working and delivering integrated care, supported through appropriate funding and contracting mechanisms
  • Proactively support and facilitate sector-development and change management

Over the past year, the community pharmacy sector has repeatedly called for a different type of dialogue with the Department of Health and NHS England; a partnership approach to implementing change that is based on a shared vision for the future, and builds from the existing strengths and value of the community pharmacy network. In publishing the Community Pharmacy Forward View, community pharmacy sector leaders showed that they have ambition and vision.  The framework in this outline version is being published in order to test the concept, and get the dialogue going on how we implement the Community Pharmacy Forward View. A vision and framework have now been set to guide the decisions and actions of stakeholders in the process of realising it.

We have the starting point for a different conversation about community pharmacy in 2017/18 and beyond; about how we can truly put community pharmacy at the heart of an efficient, effective and thriving NHS.  Feedback can be given via the newly launched CPFV micro site which explains the Community Pharmacy Forward View and the implementation framework in more detail, as well as showcasing pharmacy organisations who are pioneering new ways of working.

Commenting on this launch, Pharmacy Voice Director of Policy, Elizabeth Wade, said: “The Community Pharmacy Forward View vision has been well received by community pharmacy leaders, patient groups and politicians, as well as by colleagues in the NHS, local and national Government.  The recently launched Murray review supported the vision’s central idea of community pharmacy having an expanded role in the delivery of clinical and public health services and for genuine involvement of community pharmacy leaders in initiatives such as STPs. The launch of ‘Making it Happen’ shows that the sector not only has this broad ambition and vision, we also have a plan.  Working with colleagues across the community pharmacy network, and based on feedback on the initial vision document, we have been developing an outline implementation framework to start turning that vision into reality. Achieving this will require coordinated effort from leaders within the community pharmacy sector, local and national commissioners, health and care partners, the Government and national NHS bodies and other stakeholders.

This has been a difficult year for community pharmacy. With this plan we now have the starting point for a different conversation about community pharmacy in 2016/17 and beyond; about how we can truly put community pharmacy at the heart of an efficient, effective and thriving NHS.  We hope the Government and NHS will accept our invitation to join it. “

Read the full ‘Making it Happen’ report here.

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