HDA Media And Political Bulletin – 22 November 2016

UK could seek ‘transitional deal’ to cushion Brexit

21 November 2016, Pharmaphorum, Andrew McConaghie

 

The Prime Minister, Theresa May, has alluded that the UK may seek a transitional deal for Brexit. Business leaders have previously raised concerns that the 2 year period evoked by triggering article 50 will not be enough time to establish favourable trading relations.  Speaking at the Annual Conference of the Confederation of British Industry (CBI), Theresa May said that the Government are working to avoid what Paul Dreschler, President of the CBI, described as a cliff edge effect upon leaving the EU.

 

Pharma’s new ‘sensible pricing’ behind cancer drug approvals, says NICE

Pharmaphorum, Andrew McConaghie

 

The National Institute for Health and Care Excellence (NICE) has said that the recent uplift in drugs being approved by the Cancer Drugs Fund (CDF) is mostly due to companies offering price cuts. NICE’s Chief Executive Sir Andrew Dillon said that as the reappraised drugs move to routine commissioning it frees up funding in the CDF to be used for newer, innovative cancer treatments.

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UK could seek ‘transitional deal’ to cushion Brexit

21 November 2016, Pharmaphorum, Andrew McConaghie

 

Prime Minister Theresa May has hinted that the UK could seek a transition deal to allow the country to avoid a ‘cliff edge’ effect of leaving the European Union.

 

The prime minister is today addressing the annual conference of the Confederation of British Industry (CBI), and has unveiled several policy developments aimed at soothing Brexit fears.

 

Business leaders are concerned that there won’t be enough time to establish favourable trading relations in the two year period allowed once Article 50 is triggered.

 

The government is expected to trigger Article 50 in spring next year, which would mean the UK would automatically leave the EU two years later in 2019 – regardless of whether a mutually satisfactory deal has been struck.

 

Speaking this morning, Theresa May appeared willing to respond to pleas made by Paul Dreschler, the CBI president.

 

“I understand the point that Paul has made, others have made this point, that people don’t want a cliff edge, they want to know with some certainty how things are going to go forward. That will be part of the work that we do in terms of the negotiation that we are undertaking with the European Union.”

 

This is assumed to mean that the UK would seek a transitional deal, allowing it to stay in the single market, or preserve many aspects of single market membership for a period after leaving the EU.

 

However, while this is appealing to many in business, those negotiating Brexit from the EU side are unlikely to be in the mood to compromise with the UK. Many European leaders are urging the EU to enforce a ‘Hard Brexit’, to help ensure the negotiations don’t drag on for years, and to discourage other countries from considering an exit or renegotiations.

 

Such a plan is also likely to face opposition from within May’s own cabinet, where senior Brexiteers will fear such an approach will inevitably lead to a ‘Soft Brexit’. They believe this means the UK will retain what they see as the worst aspects of EU membership, and never break free of its dominance.

 

The UK pharmaceutical industry has been careful not to publicly back either of these different factions – but it will nevertheless want to minimise the risk to the sector.

 

However, behind the scenes, many business sectors are fearful of a hard and indeed rapid Brexit. Brexit-sceptic and Conservative ex-minister Anna Soubry MP says one pharmaceutical company has privately informed her that if the UK leaves the single market (as would be the case in a Hard Brexit) it would relocate to Europe, taking with it 1,000 jobs.

 

Support for innovation

 

Meanwhile May has also suggested the government could cut corporation tax even further than planned by the former Chancellor George Osborne. Corporation tax is due to fall to 17% by 2020, but she says this could dip further – even below the 15% promised recently by President-Elect Donald Trump for the US.

 

At the same time, May appears to be backtracking on an earlier-announced policy to put workers on the boards of all companies.

 

An extra £2bn a year has also been promised to fund scientific research and development by 2020, a move which May says would make the country “profoundly pro-innovation.”

 

This is very encouraging news for the UK pharma industry, however it also wants to see increased investment in the NHS – to all and intents and purposes its only customer in the country, and one being squeezed by unprecedented financial pressure.

 

New Chancellor Philip Hammond makes his crucial Autumn Statement this Wednesday, which is likely to include announcements of investment in multi-billion road and rail infrastructure projects. Measures to ease financial pressure on the so-called ‘Just About Managing’ (JAM) segment of UK society, working age households on low-to-middle incomes are also expected.

 

However despite pleas from the NHS for more funding, Hammond is expected to pass over the health service. This will leave the health service facing increasing pressure on services and few options to avert more debt in the system, increasing the risk of patient care being undermined and reducing budgets for medicines.

 

Pharma’s new ‘sensible pricing’ behind cancer drug approvals, says NICE

Pharmaphorum, Andrew McConaghie

 

A string of ‘yes’ decisions from NICE on cancer drugs – but what has changed?

 

After years of a deadlock between NICE and the pharmaceutical industry on cancer drugs, recent months have seen a wave of positive approvals from the cost-effectiveness watchdog.

 

But is this a significant shift in pharma pricing policy? Many companies are probably being persuaded to cut prices for older drugs, with the hope of creating ‘headroom’ for a rush of newer medicines.

 

Following a decision to reform the CDF earlier this year, England’s cost effectiveness watchdog began to reappraise, or appraise for the first time, most drugs currently in the CDF in April 2016.

 

NICE has been re-appraising 31 existing cancer drugs over the last few months, and today announced 9 out of 11 reviewed so far have been recommended.

 

The list of 31 drugs must now either gain NICE approved or be removed from the CDF and have all funding taken away.

 

NICE says price cuts offered by companies on these cancer medicines are the prime reason why it has been able to say yes to so many.

 

Welcoming the shift, NICE’s chief executive Sir Andrew Dillon also acknowledged better data in some cases, but the emphasis on pricing was clear.

 

“Sensible pricing and in some cases better data, is helping to secure access to important cancer medicines as they move out of the old Cancer Drugs Fund, following reappraisal by NICE,” said Dillon

 

“As reappraised drugs now move to routine commissioning, funding in the CDF can be freed up and used for newer, innovative cancer treatments. This is good news all round for patients.”

 

NICE and the pharmaceutical industry have been at loggerheads for years over cost-effectiveness of cancer drugs, but now pharma companies look to be offering deeper discounts in order to gain market access.

 

One of the latest examples is Bristol-Myers Squibb’s chronic myeloid leukaemia drug Sprycel (dasatinib).  As part of its reappraisals of Sprycel in two CML indications, BMS submitted a revised discount, which meant that NICE could recommend the drug for use in the NHS for both patient populations. Around 700 patients will be eligible for treatment with the drug per year.

 

This decision brings the total of approved reappraised CDF treatments to seven: Bosulif (CLL) Afinitor (breast cancer) Xalkori (NSCLC) Sprycel (two CML indications) Alimta (NSCLC) Xofigo (prostate cancer).

 

Erbitux in head and neck cancer and Nexavar in hepatocellular carcinoma are the two currently slated for rejection in the process – though further discount from their manufacturers could sway NICE on these as well.

 

Pharma still wants NICE reform

 

However this new ‘sensible approach’ to pricing doesn’t mean pharma is happy with the NICE process. Indeed reform of NICE’s core appraisal methodology remains a key industry demand.

 

But pharma companies operating in oncology know that a wave of new drugs are being launched, and both sides want to move on to tackling this new generation – which are high cost drugs.

 

These include flagship immunotherapy treatments, Merck’s Keytruda and BMS’ Opdivo. Both of these drugs may soon end up in the new ‘managed access’ Cancer Drugs Fund for use in non-small cell lung cancer (NSCLC).

 

The CDF budget has been fixed at £340 million, and once this limit has been reached, no new drugs will be admitted. Faced with a new generation of drugs being blocked from England’s market, pharma companies are settling for access for established drug at lower prices.

 

This battle reflects similar negotiations going on in developed markets around the world over cancer drugs. In Japan, the government has just announced that a 50% price cut will be imposed from February 2017 on BMS’s Opdivo – a response to its growing use in melanoma and NSCLC.

 

GSK’s chief executive Sir Andrew Witty this week urged the industry to follow his company’s strategy of focusing on volume rather than price. He made this recommendation particularly in light of growing pressure on US prices, where heavy discounting is also now becoming a fact of life for pharma.

 

Chemist and Druggist further reports on the government’s planned cuts to community pharmacy funding.

 

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House of Commons, Written Answers, Cancer: Drugs, 21 March 2016

 

Asked by Heidi Alexander (MP): If his Department will publish a patient-friendly guide to inform responses to the consultation on proposals for a new Cancer Drugs Fund.

 

Department of Health

 

Answered by George Freeman (MP): NHS England and the National Institute for Health and Care Excellence’s (NICE) consultation on draft proposals on the future of the Cancer Drugs Fund closed on 11 February 2016. The NHS England Board agreed a way forward, on 25 February 2016, which will see the new arrangements for the Fund going live on 1 July 2016.

NHS England and NICE adopted a number of different approaches to engage with audiences. This included holding four webinars for stakeholders and two face-to-face events in London and Manchester alongside a number of individual meetings with key stakeholder groups including patient organisations and cancer charities.

NHS England has advised that it will publish a consultation report on its website in due course. Further information is available at:

www.engage.england.nhs.uk/consultation/cdf-consultation

 

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Community pharmacists have ‘professional obligation’ to adopt automated dispensing, says chief pharmaceutical officer

18 March 2016, The Pharmaceutical Journal, Harriet Adcock

 

England’s chief pharmaceutical officer Keith Ridge gave evidence to the All-Party Pharmacy Group on Wednesday 16 March that community pharmacies should adopt automated dispensing processes, stating “That type of large-scale technology is both safer and more efficient”. Keith Ridge added that the government would soon launch a consultation on hub-and-spoke dispensing, a model “well-established” in other countries.

 

Further coverage on the planned Government cuts to community pharmacy funding can found in Chemist and Druggist here and here.

 

England’s revised Cancer Drugs Fund to begin in April

18 March 2016, Pharmaphorum, Richard Staines

 

Pharmaphorum reports on the newly approved Cancer Drugs Fund which will come into effect in July. The new model means that NICE, the cost-effectiveness body will begin issuing draft guidance on new cancer drugs before they have received marketing approval in the UK. The new arrangements aim to speed up the approval process and give patients faster access to new medicines.

 

March NCSO/Price Concessions update

18 March 2016, PSNC

 

The Department of Health granted the following price concessions for March 2016:

The price concession only applies to the month that it is granted.

 

Drug Pack size Price concession
Bumetanide 1mg tablets (new) 28 £2.50
Celiprolol 200mg tablets 28 £19.83
Celiprolol 400mg tablets 28 £39.65
Cimetidine 400mg tablets 60 £19.99
Clindamycin 150mg capsules 24 £12.49
Desmopressin 10micrograms/dose nasal spray (new) 60 dose £25.02
Ferrous Sulfate 200mg tablets 28 £2.85
Flecainide 50mg tablets (new) 60 £5.61
Flecainide 100mg tablets (new) 60 £5.88
Lamotrigine 5mg dispersible tablets sugar free 28 £7.99
Lercanidipine 10mg tablets 28 £5.99
Lercandipine 20mg tablets 28 £9.85
Mefenamic acid 500mg tablets 28 £10.25
Pioglitazone 15mg tablets (new) 28 £24.00
Pioglitazone 30mg tablets 28 £34.99
Pioglitazone 45mg tablets 28 £39.55
Procyclidine 5mg tablets 28 £14.00

 

No additional endorsements are required for price concessions.

Please note that PSNC cannot provide details of generic products that are suspected of being affected by generic supply problems unless and until the Department of Health grants a concession.

Contractors will be alerted to any updates through our website and via our e-news email.  If you wish to subscribe to our email list, you can receive an email as soon as any announcements are made.

If you have problems obtaining a Part VIII product or problems obtaining the product at the set Drug Tariff price, please report the issue to PSNC using the online feedback form on the PSNC Website.

If you have been able to source the product, please provide full details of the supplier and price paid. PSNC will investigate the extent of the problem and if appropriate discuss the issue with the Department of Health.

Any further concessions will be posted here on the website.

 

 

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Community pharmacists have ‘professional obligation’ to adopt automated dispensing, says chief pharmaceutical officer

18 March 2016, The Pharmaceutical Journal, Harriet Adcock

 

Keith Ridge tells All-Party Pharmacy Group inquiry that error rates suggest hub-and-spoke dispensing is ‘so much safer’ than a traditional system approach

 

Chief pharmaceutical officer Keith Ridge told an APPG inquiry that evidence suggests that dispensing error rates in England are higher than in countries using an automated system

 

Community pharmacists have a “professional obligation” to adopt automated dispensing processes, according to England’s chief pharmaceutical officer Keith Ridge.

 

“That type of large-scale technology is both safer and more efficient,” said Ridge, who was giving evidence to the All-Party Pharmacy Group’s inquiry into primary and community care at Westminster on 16 March 2016.

 

Ridge said the UK government wants to ensure that the infrastructure within community pharmacy is as efficient as possible. “Among that is ‘hub-and-spoke’ dispensing, something that is well established in some other countries,” he said, adding that the government’s planned consultation on hub-and-spoke dispensing would be launched “very soon”, and would create a level playing field for the sector.

 

Ridge cited evidence from the literature that suggests error rates in community pharmacy in England are far higher than in countries that have adopted automated dispensing. “With the traditional system approach to dispensing, the error rate in community pharmacy is around 3%,” he said. “In other countries, that rate is much lower: you need several zeros before the decimal place. It is so much safer. At that point it becomes a professional obligation to use those systems.”

 

Speaking to The Pharmaceutical Journal after the evidence session, Gareth Jones, public affairs manager at the National Pharmacy Association, said Ridge’s statement was “highly questionable”.

 

“We suspect the chief pharmaceutical officer is not comparing like with like. He should publish the evidence to back up the claim he made to MPs about error rates, or retract his comments,” he said.

 

Also speaking after the APPG event, Duncan Rudkin, chief executive of the General Pharmaceutical Council (GPhC), said that the use of technology could act “positively” to improve efficiency, quality of care and support a focus on outcomes.

 

He pointed to the GPhC’s Standards of Conduct, Ethics and Performance, which say that a pharmacy professional has a duty to make the best use of available resources. “[Resources] includes technology, data, time and the capacity and capability of all members of the pharmacy and wider healthcare team.”

 

But Rudkin added that technology could sometimes bring risks, which need to be managed appropriately. “If pharmacy owners use technology to support the delivery of pharmacy services, they must make sure they continue to meet our standards for registered pharmacies, and this includes identifying and mitigating any risks, and working with the pharmacy team to make sure they have the necessary training and skills to use the technology safely and effectively.”

 

Ridge made clear at the APPG meeting that his focus was for community pharmacy to make use of “large-scale” automated dispensing technologies. He added that he is concerned about the deployment of smaller scale automation in the traditional community pharmacy setting, arguing that the necessary efficiencies can’t be achieved. “We’re taking about tens of [prescriptions] per hour whereas with large-scale automation we’re talking about hundreds of prescriptions per minute.”

 

Ridge said that, on average, about 60% of a community pharmacist’s time is spent on dispensing, adding that 95% of community pharmacy funding is spent on supply functions, with 5% going to clinical services. “That, in many ways, is what we are trying to address,” he said. “Pharmacists are trained as clinicians and should be allowed to practice clinically irrespective of setting – whether that’s general practice, in someone’s home, in hospital or within a community pharmacy.”

 

However, Stephen Pound, Labour MP for Ealing North, said that the prospect of losing face-to-face consultations because of the introduction of “robo pharmacies” was terrifying.

 

Health minister Alistair Burt, who was also giving evidence to the APPG inquiry, sought to reassure Pound that the government considered such consultations as important. “We want pharmacists’ time to be spent on those face-to-face consultations,” he said. “We want the patient who goes to his GP to talk about his medicines to go to his pharmacist instead, because the pharmacist is likely to know more about the medicines. We want face-to-face time to be maximised.”

 

During the APPG evidence session, Burt confirmed that the Department of Health will extend its consultation on the proposals for the community pharmacy sector until 24 May 2016.

 

The Department of Health is now expected to hold another round of meetings with stakeholders, including the Pharmaceutical Services Negotiating Committee, Pharmacy Voice and the Royal Pharmaceutical Society.

 

 

England’s revised Cancer Drugs Fund to begin in April

18 March 2016, Pharmaphorum, Richard Staines

 

NICE will begin a new method of assessing drugs on England’s Cancer Drugs Fund (CDF) from 1 April, when it will decide whether the medicines on the existing scheme have enough new cost-effectiveness data to support routine funding.

 

The changes, approved by NICE’s board earlier this week, are in preparation for a new methodology coming into effect from July, when the cost-effectiveness body will begin issuing draft guidance on new cancer drugs before they have received marketing approval in the UK.

 

NICE said it will appraise drugs transferring from the old fund over the next 18 months, starting with those that have already been assessed.

 

From July, NICE will begin assessing new cancer drugs ahead of marketing authorisation so any drug given a positive draft recommendation would be funded by the NHS from the point of licence.

 

If the case for routine use is not clear, and more evidence is needed to prove cost effectiveness, NICE can recommend the drug for temporary, conditional use paid for by the CDF.

 

The drug will remain available within the fund for up to two years while the manufacturer gathers cost-effectiveness data.

 

After two years NICE will conduct a shortened review to consider the drug for routine funding on the NHS.

 

Under existing arrangements, the CDF is funding some drugs rejected by NICE, and some that have yet to be appraised.

 

The new arrangements are intended to speed up NICE’s decision making and give patients faster access to innovative new cancer drugs.

 

This will either result in routine funding or, if the company has not been able to demonstrate its case, the drug will be made available on an exception basis only.

 

NICE said the changes are designed to be fairer to industry and the taxpayer, giving an opportunity for manufacturers make a case for funding while giving patients fast access to drugs deemed to be cost effective.

 

But the Association of the British Pharmaceutical Industry trade body’s value and access director, Dr Paul Catchpole, said the changes “confirm a seemingly reduced level of ambition” for providing patients with access to the latest cancer drugs.

 

Catchpole added that minister for life sciences George Freeman’s Accelerated Access Review, which is considering ways of making new drugs available in the UK, is due to publish findings in April.

 

This could “provide a further opportunity to consider the UK’s ambition to provide patients with access to all new medicines, in a more coordinated way,” said Catchpole.

 

The CDF was originally introduced in 2011, and provided £200 million per year for cancer drugs rejected by NICE.

 

But it consistently overspent and has now grown to £360 million a year, even though NHS England has removed many drugs following additional cost-effectiveness assessments.

NEW CANCER DRUGS FUND CHANGES LITTLE, SAYS ABPI

17 March 2016, Pharmacy Biz

Dr Paul Catchpole, value and access director at the ABPI, stated that the new approved Cancer Drugs Fund showed reduced ambition from NICE, noting that the decision making process remained largely unchanged. Under the new Cancer Drugs Fund, NICE will issue draft guidance on new drugs before they receive marketing approval whereas in the past final guidance was issued within 90 days of license.

Dr Paul Catchpole’s full statement is available here.

Biotechs and pharma praise pro-business budget

17 March 2016, Pharmaphorum

UK biotech and pharma companies have welcomed George Osbourne’s pro-business measures in the 2016 Budget. In particular, the extension of entrepreneurs’ relief was seen as responding to the sector’s calls for increased support for “high risk entrepreneurial companies that are the lifeblood of the UK’s life sciences sector”, according to BioIndustry Association (BIA) chief executive, Steve Bates.

Chemist and Druggist (here and here) and The Pharmaceutical Journal report on the sector’s reaction to the Department of Health’s extension of the consultation period for community pharmacy proposals.

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NEW CANCER DRUGS FUND CHANGES LITTLE, SAYS ABPI

17 March 2016, Pharmacy Biz

Dr Paul Catchpole, value and access director at the Association of the British Pharmaceutical Industry, has criticised the finalised version of the new Cancer Drugs Fund and claimed NHS England has “a seemingly reduced level of ambition” in providing patients with the latest cancer medicines.

Under the new CDF, which was approved by the board of the National Institute for Health and Care Excellence, it is thought patients will gain access to cancer drugs much faster because NICE will be able to make decisions on treatments quicker than they have been able to.

Now NICE will issue draft guidance on new drugs before they receive marketing approval in the UK and any drug receiving a positive draft recommendation will be funded from the point of licence. Until now NICE has issued final guidance within 90 days of licence.

“Patients in this country will now have access to clinically and cost effective, innovative new cancer drugs faster than ever before,” said Sir Andrew Dillon, the chief executive of NICE.

“In a first of its kind approach, NICE will issue draft recommendations on the use of cancer medicines before they receive their licence, with funding from NHS England available if approved. No other country in Europe does this.”

The new approach held little sway with Catchpole, who said: “(The) now finalised proposals for the new Cancer Drugs Fund confirm a seemingly reduced level of ambition from NHS England for providing NHS patients in England with access to the latest cancer medicines because the NICE decision making process remains largely unchanged.

“Developing the detail of the proposals, including how the new conditional approval and data collection process will actually work in practice, is already underway. ABPI will work with NICE and NHS England to ensure the new process can be optimised to ensure patients get early access to new cancer medicines.

“When the new CDF opens for new applications in July there will be a significant backlog of cancer medicines waiting to be evaluated – some for over a year.

“Prioritising this backlog appropriately, whilst at the same time evaluating cancer medicines already nearing launch will be hugely challenging and resource intensive. The pharmaceutical industry will do its utmost to help.”

He added: “When the Accelerated Access Review (AAR) – the Government’s initiative to help speed up access to medicines and technologies – publishes in April, there will be a further opportunity to consider the UK’s ambition to provide patients with access to all new medicines, in a more co-ordinated way.

“ABPI will continue to make the case for more substantial changes to be made to the decision making processes for all medicines, including those for cancer.”

Biotechs and pharma praise pro-business budget

17 March 2016, Pharmaphorum

UK biotech and pharma trade bodies have praised pro-business measures in chancellor George Osborne’s budget, including reductions in corporation tax and capital gains tax rates, and protection of the patent box tax incentive scheme.

In his budget, announced yesterday, Osborne said that corporation tax will be reduced to 17% in 2020, further to previous announcements that reduced the rate to 19% in 2017 and 18% in 2020.

The higher rate of capital gains tax for most assets will be cut from 28% to 20% and the basic rate will be cut from 18% to 10%, Osborne said, although there will be an 8% surcharge for gains on residential property and carried interest for fund managers. This is to steer investment towards companies instead of buy-to-let property.

Entrepreneurs’ relief will be extended to longer term external investors in unlisted companies. From 17 March, this will provide a 10% tax rate for external investors holding shares in unlisted companies for at least three years.

Osborne intends this as a further incentive for longer term investment into unlisted companies, helping them access finance.

BioIndustry Association (BIA) chief executive, Steve Bates, welcomed the changes, stating that they responded to calls for support for “high risk entrepreneurial companies that are the lifeblood of the UK’s life sciences sector”.

Bates said he was disappointed not to see more information on innovation policy in Osborne’s announcements, although he added that the BIA will work with the government on a forthcoming National Innovation Plan.

Documents outlining budget plans also show that the existing patent box scheme, which gives tax breaks on sales of technology developed in the UK, will be modified to comply with Organisation for Economic Co-operation and Development (OECD) rules.

The UK pharma industry has supported the scheme, which is seen as a way of encouraging investment in the country’s life sciences industry.

The Association of the British Pharmaceutical Industry said: “We welcome and support the government in protecting the patent box and we’re awaiting clarity from the chancellor on the details of the new scheme as a result of the recent OECD changes.”

Department of Health extends consultation period for community pharmacy proposals

16 March 2016, The Pharmaceutical Journal, Harriet Adcock

Health minister confirms extension after the Pharmaceutical Services Negotiating Committee dubs consultation length as “inadequate”.

Health minister Alistair Burt has confirmed that the Department of Health will extend its consultation on proposals for the community pharmacy sector until 24 May 2016.

The two-month extension will “allow us more time to develop our proposals with the Pharmaceutical Services Negotiating Committee (PSNC), informed by the views of other stakeholders”, Burt said on 16 March 2016.

The decision to extend the consultation, originally scheduled to end on 24 March 2016, follows a request from the PSNC.

Sue Sharpe, chief executive of the PSNC, comments: “The initial time given for a consultation of this scope and complexity was inadequate, and we had asked for a more realistic timescale.

“We will now continue our ongoing discussions with the Department of Health and NHS England, seeking to understand the rationale for the various proposals and to find ways to ensure that the services and value provided by community pharmacies are recognised and expanded in future.”

Burt announced the extension during a meeting of the All-Party Pharmacy Group in Westminster where he was giving evidence to the group’s inquiry into primary and community care.

“The only part of the consultation process that will formally conclude on 24 March 2016 will be the consultation on the pharmacy integration fund,” he explained.

The aim of the pharmacy integration fund, at least initially, will be to support the deployment of clinical pharmacists in a range of community care settings. These will include GP practices, urgent care hubs, care homes and NHS 111. The fund will be worth £20m in 2016–2017, and will rise by £20m per year, meaning that by 2020–2021 £300m will have been invested.

Concluding this part of the consultation by 24 March 2016, will enable arrangements for the distribution of money from the fund to be put in place in the first part of the 2016/17 financial year, Burt explained. “There will continue to be opportunities for informal discussions about these arrangements once the fund is formally established.”

Burt added that he hoped the extension “demonstrates good faith on our part that we want to engage”.

“People are coming forward with ideas,” he said. “We want to make sure that the consultation period feels as long as is necessary for people to make their responses.”

During the APPG meeting, Burt also explained some of the thinking behind NHS England’s proposals for the sector, which include a cut to the pharmacy budget of £170m in 2016/17. He highlighted the intention to allow pharmacists to practise more clinically, irrespective of setting, and to introduce efficiencies into the dispensing process.

“I want to emphasise that our proposals are about improving services and securing efficiencies and savings,” he said. “A consequence may be the closure of some pharmacies but that is not our aim.”

Burt said that the changes being proposed for the sector could be made “without compromising the quality of services or public access to them”.

Keith Ridge, chief pharmaceutical officer for NHS England, who also spoke at the APPG event, argued that there were “more pharmacies than necessary to maintain good access”.

Burt was questioned about the proposed community pharmacy access scheme, which is being proposed as a way of protecting pharmacies at risk of closure because of the funding cuts but which are deemed necessary because of their location and the needs of the local population.

Burt said: “We want to ensure that extra NHS resources go to pharmacies that must be retained in order to serve the public.

“Ultimately, there has to be a national, public, transparent formula. It can’t be done on an arbitrary basis.”

Details of the formula, which would take into account location, isolation, deprivation and other population demographics, would be made public, probably towards the end of the negotiating period, said Burt. “It can’t be set out in detail yet because it’s not finalised. But it will be public so people can see how decisions are being made.”

The Department of Health is now expected to hold another round of meetings with stakeholders, including the PSNC, Pharmacy Voice and the Royal Pharmaceutical Society.

Hub-and-spoke ‘not a panacea’ for independents

C&D, Beth Kennedy, 11 February 2016

Martin Sawer, on behalf of HDA UK, speaks to Chemist and Druggist about hub-and-spoke dispensing, warning that this model is not “a simple solution” for the community pharmacy.

 

DDA responds to pharmacy consultation

DDA, Ailsa Colquhoun, 15 February 2016

The Dispensing Doctors’ Association issued a response to the community pharmacy consultation, noting that while the consultation does not directly involve GPs, certain aspects of it would have an impact on them. The statement welcomes the Pharmacy Integration Fund to promote pharmacists working in GP practices. The full response is available here.

 

Electronic repeat dispensing service at heart of PSNC’s proposals for clinically focused pharmacy service

The Pharmaceutical Journal, Debbie Andalo and Harriet Adcock, 11 February 2016

The PSNC has proposed, as part of its suggested plan for community pharmacy, to roll out an ‘e-service’ to become the default option for long-term repeat prescriptions. This proposal will serve as a starting point for negotiations with NSH England and the Department of Health.

The PSNC proposal was also covered by Pharmacy Biz.

 

MPs take the funding fight to Westminster

C&D, Annabelle Collins, 12 February 2016

MPs across the political spectrum are questioning the consequences of the Department of Health’s plan for community pharmacy, with David Amess, Conservative MP for Southend West, requesting a debate in the House of Commons.

 

The new Cancer Drugs Fund: sticking plaster 2.0 or a model for the future?

pharmaphorum, Andrew McConaghie, 12 February 2016

The revised Cancer Drugs Fund aims to move away from a “sticky plaster” type solution to an effective system promoting accelerated access to the best cancer treatments and ensuring the best patient outcomes. The new proposal, resulting from the consultation launched in November, was received with mix appraisal, such as several pharma companies deploring its flaws.

 

Europe introduces rules to fight falsified medicines

Out-Law.com, 12 February 2016

Out-Law.com reports on the publication of the Falsified Medicines Directive delegated regulation on Tuesday 9 February, welcoming the measures to tackle the issue of falsified medicines entering the supply chain.

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DDA responds to pharmacy consultation

DDA, Ailsa Colquhoun, 15 February 2016

The DDA has responded to the Department of  Health’s consultation into proposed changes to community pharmacy from 2016/17.

The DDA’s response makes clear that while dispensing doctors are not within the scope of the consultation – as they are part of the NHS GP Contract – certain aspects of the consultation could affect dispensing doctors. The consultation closed on Friday, February 12. The DDA’s points are discussed below:

Reimbursement

Should proposals affect the Drug Tariff, the DDA expects to be involved in the subsequent negotiation.

The Pharmacy Integration Fund

This is described as an excellent means to fund the introduction of pharmacists working in GP practices

Modernising the system

‘Click and Collect’ requires a decent internet connection, which is sadly lacking in many rural communities.

Many dispensing practices already offer home delivery services to their patients, as part of a personalised service that their patients value and trust.

The Innovation Fund should be used to fund the implementation of EPS in dispensing practices.

Making efficiencies

To promote innovation in the dispensing process, the DH may wish to examine minimum staff levels of the current contract in order to be able to stimulate innovation.

‘Hub and spoke’ legislation relating to dispensing doctors should be amended in line with amendments affecting community pharmacies, so that rural patients are not disadvantaged.

Longer prescription durations: 28 days is still the norm for most patients and we are not aware of any significant demand to increase this.

Access to pharmacies

The Access Scheme must take into account patients’ access to dispensing practice

Final agreements on elements including the Access Scheme must be ‘rural proofed’ by means of an Impact Assessment.

 

Electronic repeat dispensing service at heart of PSNC’s proposals for clinically focused pharmacy service

The Pharmaceutical Journal, Debbie Andalo and Harriet Adcock, 11 February 2016

PSNC puts patients with long-term conditions at centre of three-phase proposals to change role of community pharmacists.

Community pharmacy negotiators have put forward a three-phase plan for changing how the sector operates

An electronic repeat dispensing service for people with long-term conditions should become routine for community pharmacists in England, according to proposals for a more clinically led profession drawn up by national negotiators.

The Pharmaceutical Services Negotiating Committee (PSNC) suggests the proposed ‘e-service’ would become the default option for repeat prescriptions when the prescriber wants to prescribe long-term.

Offering inhaler technique support to patients who receive at least two e-repeat prescriptions annually could also be delivered by community pharmacists, as well as a national Pharmacy First service that would include both minor ailments and emergency supply services, the PSNC says.

These new ways of working would be the first of a three-part action plan that would be introduced gradually to increase the clinical role of community pharmacists, according to the PSNC.

Phase two would involve an enhanced patient care package, including monitoring patients with asthma and chronic obstructive pulmonary disease and those who are frail and at risk of a fall.

The final phase suggests that pharmacists should offer increased support to patients with other long-term conditions, such as hypertension.

The PSNC’s proposals, published on 9 February 2016, were produced after the Department of Health (DH) and NHS England announced that they wanted to see a more clinically focused community pharmacy service as part of the government’s proposals for pharmacy, but they failed to put forward any suggestions.

“The outline proposals set out here represent a starting point for discussions with the DH and NHS England,” the PSNC says. “They describe how community pharmacy teams could make a more significant contribution to patient care. At this time of financial strain and increasing demand we believe they are ideas that DH and NHS England cannot afford to ignore.”

How community pharmacy will operate will be dependent on a combination of what the public wants, what the NHS needs and what pharmacy can offer, says health minister Alistair Burt

Alistair Burt, health minister with responsibility for pharmacy, welcomed the PSNC’s proposals but said it was “too early” to provide an initial response to them as they had “just arrived” with the DH.

“I’m very pleased with the engagement we’ve seen with the PSNC,” Burt said on 11 February 2016. “How community pharmacy will operate will be dependent on a combination of what the public wants, what the NHS needs and what pharmacy can offer.”

The PSNC’s proposals come as the negotiating body and other pharmacy organisations are campaigning against government plans, announced in December 2015, to slash the community pharmacy budget in England by 6% this financial year.

Consultation on the government’s proposals for community pharmacy, which include the budget cuts, runs until 24 March 2016.

 

PSNC RESPONDS TO GOVERNMENT’S PHARMACY CUTS WITH CLINICAL PLANS

Pharmacy Biz, 12 February 2016

The PSNC has responded to the government’s attempt to generate efficiency savings within community pharmacy by putting forward a series of proposals designed to develop clinical pharmacy services.

Describing its plans as being carried out “within the context of government drives for efficiency,” the PSNC said it wanted to see the introduction of a care package in which repeat dispensing is “a default option when medicines are needed on a long term basis.”

The package also proposes patient registration at pharmacies and calls for pharmacies to offer “enhanced” medicines optimisation to patients, inhaler checks and advice “routinely,” targeted prescription interventions, support for patients following their discharge from hospital and minor ailments and emergency supply services.

“The document comes as part of the discussions with the NHS following the 17th December open letter in which the government announced a number of plans for community pharmacy including a £170m reduction in funding. The government highlighted the need for efficiencies but also stated that it wanted to develop a clinically focused community pharmacy service,” the PSNC said.

“It has been PSNC’s ambition to develop a clinically focused community pharmacy service since 2004 when we agreed what was intended to be a dynamic framework for the development of services. Sadly this has not been taken up by the government in subsequent years.

“The government’s letter sent in December lacked detail on its proposals so PSNC’s service proposals are intended to fill that gap, showing how we can offer value and cost savings for the NHS as well as meeting the government’s professed ambitions for community pharmacy services.

“The proposals have been presented to the Department of Health and the NHS but we have not received any feedback on them.”

The PSNC added: “PSNC’s proposals offer a possible way to develop the pharmacy service in order to meet the NHS and government’s stated aims for patient care, and PSNC will undertake further development work on them subject to the response they receive from DH and NHS England.

“The proposals are set out in three phases, in recognition of the need to allow the wider NHS and community pharmacy to adopt them in a controlled manner that also allows time for other enablers, such as IT, to be put in place.

“We recognise that implementing these service development proposals would have substantial implications for DH’s planned restructuring of funding delivery and this would require detailed consideration.”

 

The new Cancer Drugs Fund: sticking plaster 2.0 or a model for the future?

pharmaphorum, Andrew McConaghie, 12 February 2016

A new, value-based Cancer Drugs Fund is set to be launched in England soon, but pharma companies fear it will be a step backwards for access to new cancer medicines.

England’s National Health Service (NHS) is preparing to launch a novel way of reviewing new cancer drugs – a value-based approach increasingly being considered by healthcare systems around the world.

The country’s Cancer Drugs Fund (CDF) has been around since 2010 but, until now, this system has simply paid for drugs which NHS cost-effectiveness watchdog NICE had rejected.

The fund was criticised from many sides as being a ‘sticking plaster’ solution to problems with cancer drugs access in England. Even more importantly, ballooning expenditure meant budget holders, NHS England, wanted a new system, which can deliver value for money for the health service and patients.

Major departure

The new proposals are a major departure. NICE will prioritise the review of new cancer drugs, and accelerate access to the best new cancer treatments. The CDF will become a ‘managed access fund’ – this will give promising, but as yet unproven, drugs up to two years to prove their value for money. They will do this by generating extra data, including ‘real-world’ evidence. Significantly, NHS England is proposing a kind of ‘money back guarantee’: if a company’s drug fails to show value for money at the end of two years, it will be obliged to pay back the cost of treatment to the NHS.

Launching a 12-week consultation on the plans back in November, the chief executive of NHS England Simon Stevens delivered a frank message about the aim of the new system.

“Over the next five years we’re likely to see many new cancer drugs coming on to the worldwide market – some of which will be major therapeutic breakthroughs, and some of which will turn out to offer little extra patient benefit but at enormous cost,” he said.

Mr Stevens added that the new CDF was a way of “sorting out the wheat from the chaff” so patients in England get faster access to the genuinely most promising new treatments.

He concluded: “For those drug companies willing to price their products affordably while sharing transparent information about ‘real-world’ patient benefit, the new CDF will offer a new fast-track route to NHS funding.”

While this may sound like a progressive, nuanced system based on value that pharma could embrace, this is not the case.

Three companies in particular, Novartis, AstraZeneca (AZ) and Pfizer spoke out this week, ahead of yesterday’s deadline for comments on the new plans.

They say the proposals are badly flawed, with the managed access fund putting an unfair burden of risk on them. Moreover, they say problems with NICE’s drug appraisal methods have still not been addressed.

Erik Nordkamp, Pfizer UK’s Managing Director put it most strongly: “The cancer drugs fund proposals are unfortunately doomed to fail cancer patients. The proposed changes will not solve the fundamental problem of poor access to new cancer medicines unless we reform the way NICE assesses medicines.”

Pfizer cites analysis by the Office of Health Economics which suggests the new CDF could cut access to cancer medicines. The pharma-funded research organisation estimates that a maximum of 27% of current CDF medicines would have a chance of meeting the proposed entry criteria for the new CDF, whilst the majority would not be recommended (67%).

Industry association the ABPI has taken a measured tone but it, too, says the plans still need ‘significant revisions’ and echoed the calls for more change at NICE.

The key features of the proposed new CDF:

  • NICE will appraise all cancer drugs expected to receive Marketing Authorisation
  • NICE will normally issue draft guidance ahead of Marketing Authorisation
  • NICE will normally publish its final guidance within 90 days of Marketing Authorisation
  • NICE will make a recommendation falling into one of three categories:
    • Recommended for routine use
    • Not recommended for routine use
    • Recommended for use within the CDF.

Commenting on the plans, AZ and Novartis have raised concerns about many elements of the proposed system.

“AstraZeneca supports accelerated patient access to new cancer therapies, one of the original objectives of the CDF. However, despite European approval of a number of truly breakthrough treatments over the last 18 months, patients have been denied access,” said Lisa Anson, Country President, AstraZeneca UK and Ireland.

“We welcome the proposal to use the CDF as part of a ‘managed access’ system while further data are gathered for review by NICE, but significant reform of the NICE methodology is fundamental for these treatments to have a realistic chance of eventually becoming readily available to NHS patients,” she stated.

On the money-back guarantee proposal, Novartis has made it clear that it believes this rule is unfair. It thinks that the ‘risk’ of a drug being a success or not in these patients should be shared between a pharma company and the NHS.

“Novartis believes that this is unreasonable and calls for a fairer balance of risk between the pharmaceutical industry and the NHS to maintain patient access to the widest possible range of treatment options.”

The shape of things to come

On one hand, these are radical and brave plans. By attempting to once-and-for-all end delays to patients accessing cancer medicines, and build in immediate funding for these drugs, NHS England is trying to eliminate layers of unnecessary regulatory bureaucracy.

On the other hand, there are plenty of obvious flaws and potential pitfalls. One of the clearest flaws is that cancer drugs will get priority treatment ahead of drugs for any other condition. A new drug for Alzheimer’s disease or diabetes, for example, won’t be given rapid appraisal and funding like this.

This is obviously unfair, and not in keeping with the principles of the NHS or NICE. This is also despite backing for a wider ‘new medicines fund’ – Novartis and pharma association the Ethical Medicines Industry Group (EMIG) are among those that have supported such an idea.

It is clear that NHS England wants to keep a better grip on costs. In the 2015/16 financial year ending in March, spending on the old CDF is expected to hit £410 million, taking it £70 million over its budget. It will be aiming to cut this overspend in the next financial year, so the bottom line is likely to be further squeezes on cancer drugs spending.

The new arrangements will also allow NHS England to negotiate on the price of each new cancer drug entering the system. Pharma will fear that NHS England will take this opportunity to drive down prices at launch.

NHS England says that there will be a cap on total CDF funding, and a cap on how much will be spent on any individual drug while in the managed access scheme CDF. AZ has spoken out in particular against a rule which says CDF funding won’t necessarily go to all eligible patients, but only a large enough number of patients in order to prove its cost effectiveness via real world data collection.

Pharma is expressing concerns about many more issues, including NICE’s capacity to take on an increased workload, and how drugs for rare cancers will be assessed.

Meanwhile, the apparent lack of co-ordination between the CDF consultation and the Accelerated Access Review (AAR) is hard to explain. The AAR covers very similar ground to the new CDF proposals, and aims to link together the current fragmented route to market for innovative drugs. The AAR is due to report in April, and it is difficult to see how the two sets of plans won’t tread on each other’s toes.

Despite some well-grounded fears from UK pharma, it is clear that value-based systems are the future direction for some, if not all, drugs in the future. A ‘money-back guarantee’ approach for cancer drugs is already in operation in Italy, and payers in the US are investigating similar approaches. Novartis has entered into a new ‘outcomes-based contract’ with US health insurers for its new heart failure treatment Entresto.

NHS England has promised to have its new system up and running by 1 April this year, but this will be hard to achieve if it wants to resolve some of the concerns raised by pharma.

 

Europe introduces rules to fight falsified medicines

Out-Law.com, 12 February 2016

New safety measures are to be introduced to the packaging of medicine in Europe, including a unique identifier and tamper-evident features. 12 Feb 2016

The European Parliament has approved and published regulations that build on the Falsified Medicines Directive in helping to verify and secure medicines along the supply chain.

A barcode acting as a unique identifier will be added to all medical products, along with human-readable information, by the manufacturer. This will be scanned at fixed points along the supply chain, and linked to a repository system to check the identity of the product.

Packaging will also now includes features that make it obvious if the product has been tampered with.

Falsified medicines are medicines with false sources such as names or ingredients; histories, such as batch numbers, or false source information.

These medicines may contain low quality ingredients, or the wrong dosage or component ingredients, or may even be entirely counterfeit with no active pharmaceutical ingredients, and can thus be a major health threat, said intellectual property expert Louise Fullwood of Pinsent Masons, the law firm behind Out-Law.com.

“This move is welcome. It supplements the Falsified Medicines Directive with practical details, and will improve the safety reputation of the industry,” Fullwood said.

“The barcodes will make substitution and falsification of medicines harder, and will also make it easier to track a batch of medicine that turns out to be non-compliant,” Fullwood said.

The move will add some costs for smaller manufacturers, Fullwood said, but it has been discussed for some time and should not come as a surprise.

“There is also a substantial time period for manufacturers to introduce any new technology and processes before this comes into force,” she said.

The delegated regulation comes into force in the UK on 9 February 2019.

The new packaging features are also likely to reduce IP infringements in medicine, Fullwood said.

The European Commission published draft regulations on medicine packaging in September 2015. Falsified medicines have been found in all areas of the supply chain, legal and illegal, prescription and over-the-counters, and in both branded and generic medicine, the Commission said at the time.

An impact assessment run by the Commission looked at the benefits, costs and cost-effectiveness of the proposal, at the technical options for the identifier, at how authenticity would be verified, and at how the repository system would be managed, it said.

It was decided that the unique identifier should be the same across the EU, and placed in a 2D barcode containing the product code, serial number, batch number and expiry date.

Medicines should be systematically verified by pharmacies before being supplied to the public, and those at higher risk should also be checked by wholesalers.

Steps should also be taken to make sure that personal data is protected, although the initial proposal does not involve any personal data being stored in repositories, the Commission said.

EXPECT MORE FUNDING CUTS, PSNC MEMBER WARNS COMMUNITY PHARMACY

Pharmacy Biz, Neil Trainis, 11 February 2016

There is an increasing concern amongst community pharmacy that budget reductions will go beyond the 6% funding cut the government has announced for 2016-17. Kirit Patel, from Day Lewis and a member of the PSNC negotiating team, stated that he was hopeful that the funding cut proposal would be revisited.

 

PSNC responds to funding cuts with ‘clinical’ vision

Chemist and Druggist, Annabelle Collins, 11 February 2016

In response to the announced 6% funding cut, PSNC has released a plan for community pharmacy which proposes to expand the clinical role of the sector. The proposal, rolled out in three phases, aims to paint a picture of the pharmacy service with 6% less funding.

You can review the full proposal here.

 

Bar codes to be added to medicines packaging

P3 Pharmacy, 11 February 2016

P3 Pharmacy reports on the introduction of safety features to be added on packaging following the publication of the Falsified Medicines Directive delegated regulation on Tuesday. These measures aim to tackle the threat of falsified medicines entering the supply chain.

 

Ministers scramble to introduce new NHS cancer drugs scheme

FT, Andrew Ward, 11 February 2016

The Financial Times discusses the future of the Cancer Drugs Fund as it is set to expire on March 31. The scheme, which aims to ensure access to the latest treatments, has come under scrutiny as the industry warns that the United Kingdom is a hostile environment for medical innovation and the country is lagging behind European counterparts in cancer treatment.

The ABPI has issued a statement calling on the government to seize the opportunity to transform patient access to cancer treatments in the UK.

 

Parliamentary Coverage

Medicines and Healthcare products Regulatory Agency: New rules to help fight falsified medicines

HM Government – Press Releases, 11 February 2016

 

New rules approved by the European Parliament will require safety features on the packaging of medicines at risk of falsification.

The European Parliament and Council has approved and published a Delegated Regulation (EU2016/161)  in the Official Journal of the European Union. This supplements the Falsified Medicines Directive (FMD) and introduces two mandatory safety features that will allow medicines to be verified and authenticated.

These safety features are:

• a unique identifier (a 2D data matrix code and human readable information) to be placed on medical products that can be scanned at fixed points along the supply chain

• tamper evident features on the pack

The delegated regulation comes into force in the UK in 2019. Marketing authorisation holders will be required to place the safety features on the packaging of medicines which fall within the remit of the delegated regulation no later than 9 February 2019.

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health will continue to work with the European Commission and other Member States on implementation plans for the new regulation. We will also be working with stakeholders throughout the supply chain to secure implementation within the three years.

Further guidance will be published as it becomes available.

 

Full Coverage

EXPECT MORE FUNDING CUTS, PSNC MEMBER WARNS COMMUNITY PHARMACY

Pharmacy Biz, Neil Trainis, 11 February 2016

 

Kirit Patel, the chief executive of Day Lewis and a member of the PSNC negotiating team, has warned that community pharmacy is likely to suffer further cuts to its revenue on top of the £170 million the government has pledged to take out for 2016-17.

Fears that the government intends to take an even larger slice of money beyond the 6% reduction that has already been earmarked arose after Sue Sharpe, the chief executive of the PSNC, accused NHS England and the Department of Health last month of failing to meet her request for future funding figures for community pharmacy.

That vagueness generated apprehension within the ranks of the PSNC and concern that ministers will take a bigger slice of pharmacy revenue for 2017-18.

Patel reinforced those concerns by suggesting community pharmacists should expect further reductions. The figure he came up with was at least another £80 million taken out of community pharmacy over the next five years.

“The DH announced a 6% reduction in pharmacy remuneration in the year April 2016 to March 2017, the intention being that the whole 6% totalling £170 million would be taken out over six months from the beginning of October 2016,” he told Pharmacy Business.

“The letter (sent by NHS England to the PSNC in December explaining the funding cut) went on to say this was the maximum they would take out in the year, implying there would be more to follow. So let’s examine how much more is likely to be taken out.

“The NHS target of £22 billion in savings announced by Simon Stevens in the NHS forward plan was in a five-year plan and hence it’s safe to say that all the funds they intend to take out from pharmacy would be within five years.

“The clue lies in the rest of the three-page letter. The letter goes on to say that all establishment payments totalling £25,000 per pharmacy is to be phased out. With over 11,500 pharmacies this totals £270 million.

“So there is every likelihood of at least another £80 million being withdrawn from pharmacies over the next five years, bearing in mind £20 million is being put back for integration funds.

“On average that will work out at approximately £15,000 per pharmacy, going up to £25,000. This reduction in establishment payments will affect every single pharmacy in England.”

Patel added: “All the pharmacy bodies and the whole profession have united to fight back and many are confident that some of these proposals may be watered down and some revisited.

“I am hopeful that once the DH realises that pharmacy does far more for patient care than is obvious to the DH, they may not be so keen to throw out the baby with the bath water.”

He refused to say whether the community pharmacy profession should strike in protest at the cut or whether he would encourage Day Lewis pharmacies to strike.

Patel did, however, express his hope that the Pharmacy Integration Fund, set at £20 million for 2016-17 and described by chief pharmaceutical officer Keith Ridge as designed “to help transform how pharmacists, their teams and community pharmacy will operate in the NHS,” will specifically benefit community pharmacy. Sharpe has said the fund will be geared more towards pharmacists working in general practice.

“We should ensure that all this money does not go to GP surgery pharmacists alone and that hopefully a fair amount of it will end up back in community pharmacy,” Patel said.

“At Day Lewis we own 275 pharmacies and our reduction of revenue in the first year alone is £3.4 million, possibly rising to £5 million in the fifth year. I cannot see how we can recover from this loss of income and at the same time be expected to invest for the future.”

 

Bar codes to be added to medicines packaging

P3 Pharmacy, 11 February 2016

 

An implementation plan for the Europe-wide introduction of measures to protect patients from fake or “falsified” medicines has been released by The European Medicines Agency. Safety features to be added to medicines packaging include a 2-D barcode and an anti-tampering device.

Falsified medicines could contain ingredients, including active ingredients, which are of low quality or in the wrong dosage, and could potentially put patients’ health at risk, says the EMA. The measures are being taken to help prevent falsified medicines from entering the legal supply chain and posing a risk to patients and to ensure that any medicines bought online are supplied through verified sources.

The new measures must be introduced for all medicines for human use across Europe by February 2019 – three years time.

It has previously been suggested the pharmacies may be required to scan the 2-D barcode.

Martin Sawer, executive director of the UK’s Healthcare Distribution Association, representing organisations in the medicines supply chain, commented: “It is good news to finally see the publication of the Delegated Regulation that sets the clock ticking in the UK and other EU member states.”

He welcomed the model chosen for the initiative, after long debate in Europe. “Alternatives would have placed unnecessary burdens on the supply chain, including delays in being able to supply life-saving medicines speedily to patients,” he said.

 

Ministers scramble to introduce new NHS cancer drugs scheme

FT, Andrew Ward, 11 February 2016

 

Ministers have less than two months to thrash out a new system for financing cancer drugs in the NHS as the clock ticks towards expiry of a £340m-a-year fund set up by David Cameron to plug gaps in treatment.

A consultation on the future of the Cancer Drugs Fund, launched by the prime minister in 2010, closes at midnight on Thursday, seven weeks before the scheme is due to run out of money.

The government now faces a scramble to introduce a replacement scheme in the face of fierce lobbying from the pharmaceuticals industry, charities and patient groups over how it should work.

Erik Nordkamp, UK managing director for Pfizer, the US drugmaker, told the BBC on Thursday that the system for funding drugs in England was “really broken” and the country was a “hostile environment” for medical innovation.

The Cancer Drugs Fund was intended to ensure access to the latest treatments by paying for cancer medicines deemed too expensive under the usual criteria for assessing cost-effectiveness in the NHS.

However, the fund’s annual budget has soared from £200m to £340m and dozens of drugs have had funding removed in an attempt to control costs.

NHS England announced proposals in November for a system that would provide temporary funding for some new drugs while evidence was collected to decide whether they offered value for money in the long term.

Final details are due before the existing scheme expires on March 31 — although there will be a transition period before full implementation.

Sir Harpal Kumar, chief executive of Cancer Research UK, the charity, said he was hopeful of swifter access to breakthrough treatments. “The Cancer Drugs Fund hasn’t been fit for purpose for some time, so the proposed reforms are a promising step.”

However, the plans would involve tougher scrutiny of new drugs — with funding removed from those that fail to prove their cost-effectiveness during an initial trial period.

Mark Hicken, managing director of Johnson & Johnson’s UK pharma business, said the proposals would raise, rather than lower, barriers to market access. “This will have a significant impact on the availability of many new cancer medicines and we are very worried for patients in England.”

Drugmakers have become increasingly vociferous in their warnings that the NHS is falling behind the rest of Europe in cancer treatment.

Critics blame the industry for excessive pricing with some new cancer drugs costing thousands of pounds a month. The Association of the British Pharmaceuticals Industry said UK prices were among the lowest in Europe.

Under the NHS England proposals, new cancer medicines would be evaluated by the National Institute for Health and Care Excellence, the drug cost watchdog, within 90 days of regulatory approval. Those showing clear cost-effectiveness would be immediately recommended for use, while others would be granted temporary funding while further evidence was collected.

NHS England said: “For those drug companies willing to price their products affordably while sharing transparent information about ‘real world’ patient benefit, the new [fund] will offer a new fast-track route to NHS funding.”

Cancer drugs pose especially difficult economic and ethical dilemmas for the NHS because the most expensive ones are those usually used in the last few months of life — requiring pharma companies to recoup high development costs in relatively short periods of treatment. Some critics have questioned why cancer drugs — and patients — are given special funding unavailable for other conditions.

 

Cancer Drugs Fund consultation – an opportunity to introduce a sustainable, affordable solution that benefits patients and the economy

ABPI, 12 February 2016

 

As the consultation on the way forward for the Cancer Drugs Fund (CDF) closes, the Association of the British Pharmaceutical Industry (ABPI) urges the government to seize the opportunity and transform the way cancer medicines are assessed by the National Institute for Health and Care Excellence (NICE) and commissioned and funded by NHS England. If we do this, we can achieve a sustainable, affordable solution that will provide rapid access to new medicines for NHS patients.

​​​The role of the CDF has been to fund medicines while they are undergoing assessment, that have been rejected, or are not going to be assessed by NICE, in order to ensure that NHS patients have access to them as they do in other EU countries.

Everybody agrees that the current approach to the Cancer Drugs Fund is no longer workable. We need wholesale evolution of the medicines assessment process used by NICE to address this.

 

Dr Paul Catchpole, Director – Value and Access, said,

“We remain committed to working with the Department of Health, NHS England, NICE, charities and patient groups to evolve the way that NICE assesses innovative medicines so that they can be made more rapidly available to NHS patients. Compared to other EU countries, the UK has some of the lowest prices for medicines, and a unique national pricing scheme in place which, since 2014, has seen the pharmaceutical industry pay over £1billion to the NHS to support investment in the latest medicines.

“We want the best for all cancer patients so they can get sustainable and rapid access to new medicines. The aim needs to be to get the right medicines to the right patients at the right time, but significant revisions are needed to the current proposals to permit new medicines to fully deliver their potential in improving NHS cancer outcomes.”

From Factory to Pharmacy

As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.

See the Infographic

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