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HDA Media And Political Bulletin – 15 February 2016

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.

Parliamentary Coverage

 

There is no Parliamentary coverage today.

 

Full Coverage

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.

HDA Media And Political Bulletin – 15 February 2016

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