HDA UK MEDIA AND POLITICAL BULLETIN – 14 August 2017

MEDIA SUMMARY 

PSNC tells contractors to ‘exert maximum pressure on wholesalers’ to drive down price of pregabalin
The Pharmaceutical Journal, Ingrid Torjesen, 14 August 2017

The Pharmaceutical Services Negotiating Committee (PSNC) has told contractors in the NHS to “exert maximum pressure on wholesalers” to drive down the price of pregabalin. This comes after the drug was moved onto Category M on August 1st. Director of Pharmacy Funding for the PSNC, Mike Dent, said that pregabalin met all the criteria for M after the patent expired in July. This means that pharmacies will get reduced funding to buy the drug, but wholesaler prices have not caught up. Dent said “when the Category M reimbursement price for a particular product is reduced, it may take time, and sustained pressure from pharmacies, for wholesale prices to respond.”

GPhC signs joint statement on conflict of interest guidelines
P3 Pharmacy, 11 August 2017

The Royal Pharmaceutical Society has welcomed a recent statement from the General Pharmaceutical Council that outlines more clearly policies concerning conflicts of interest. The RPS agreed that those in the healthcare industry should “refuse all but the most trivial gifts, favours or hospitality”. The statement also includes the following recommendations:

  • Put the interests of people in their care before their own interests or those of any colleague or organisation
  • Consider where potential conflicts of interest may arise and be open about them
  • Be open about, and declare, any conflicts of interest they face
  • Reflect on their own learning and CPD needs regarding conflicts of interest
  • Ensure patients have access to visible information on any fees or charging policies for which they are responsible

The General Pharmaceutical Council said that “as health and care regulators, we share a commitment to collaborating on issues that affect patient safety and care…we are underlining the consistent expectations of health professionals in managing conflicts of interest”.

MHRA and Making a Success of Brexit
MHRA, 14 August 2017

The MHRA has released a summary press release covering recent Brexit developments, saying that it is “working closely with the Government to analyse the best options and opportunities available for the safe and effective regulation of medicines and medical devices in the UK”. It notes that while negotiations continue, the UK remains a “full member of the EU”. It also notes that is will seek to “maintain a close working partnership” with the EU. The MHRA plans to “continue to cooperate with all involved”.

PARLIAMENTARY COVERAGE

There is no parliamentary coverage.

FULL COVERAGE 

PSNC tells contractors to ‘exert maximum pressure on wholesalers’ to drive down price of pregabalin
The Pharmaceutical Journal, Ingrid Torjesen, 14 August 2017

Contractors struggling to source pregabalin at list price since restrictions placed by NHS England limiting the use of generic pregabalin were lifted have been told by the Pharmaceutical Services Negotiating Committee (PSNC) to “exert maximum pressure on wholesalers” to drive down its price.

In a letter to community pharmacies dated 21 June 2017, NHS England said previous dispensing guidance on pregabalin, which instructed pharmacists to return all prescriptions for generic pregablin for pain to the prescriber, was being withdrawn.

It informed pharmacists that from 17 July 2017 “when dispensing pregabalin for the treatment of any condition, you should dispense in accordance with your normal practice”.

Mike Dent, director of pharmacy funding at PSNC said pregabalin met all the criteria for inclusion in Category M (where the Department of Health calculates the reimbursement price of readily available generic drugs based on information submitted by manufacturers), so it was moved from 1 August 2017, following the patent expiry on 17 July 2017.

But some contractors claim they are now being forced by wholesalers to pay several times more than the drug tariff price for each pack of pregabalin.

Dent said: “The DH sets Category M prices at levels above the prices notified by manufacturers,” he explained. “But when the Category M reimbursement price for a particular product is reduced, it may take time, and sustained pressure from pharmacies, for wholesale prices to respond.

“During this period, it is essential that contractors exert maximum pressure on wholesalers. There have been a number of examples where manufacturers’ prices were below the Drug Tariff price but a product could not be obtained at the Drug Tariff price from a number of wholesalers.”

“We are aware that sometimes Category M medicines are difficult to obtain at the reimbursement set in the Drug Tariff and apply for price concessions as needed.”

The issue arose after a long-running patent dispute by Pfizer against generic drug manufacturers Actavis and Mylan over its product Lyrica. NHS England issued guidance on 2 March 2015 stating that any prescription for generic pregabalin for pain should be returned to the prescriber.

Pfizer developed Lyrica for the treatment of generalised anxiety disorder (GAD) and epilepsy but the patent for this indication expired in 2013. When Pfizer discovered that pregabalin could relieve pain, it took out a second medical use patent for Lyrica to cover this use, which expired in July 2017. When the first patent expired, Actavis and Mylan launched generic versions of the drug to treat GAD and epilepsy and the long-running court battle ensued.

GPhC signs joint statement on conflict of interest guidelines
P3 Pharmacy, 11 August 2017

The comment from the RPS came as the General Pharmaceutical Council joined other healthcare regulators in signing a statement setting out how conflicts of interest should be avoided, declared and managed across all healthcare settings.

Among the expectations outlined, the joint statement says healthcare professionals should “refuse all but the most trivial gifts, favours or hospitality” if accepting them could be seen as an attempt to gain preferential treatment or could go against their professional code of practice.

The statement also includes the following expectations of healthcare professionals:

  • Put the interests of people in their care before their own interests or those of any colleague or organisation
  • Consider where potential conflicts of interest may arise and be open about them
  • Be open about, and declare, any conflicts of interest they face
  • Reflect on their own learning and CPD needs regarding conflicts of interest
  • Ensure patients have access to visible information on any fees or charging policies for which they are responsible.

Case studies

The regulators have also published case studies to illustrate these principles. GPhC worked with the General

Medical Council and the Pharmaceutical Society of Northern Ireland to produce a case study scenario involving a private practice GP whose employer has told her to encourage patients to take their prescriptions to a pharmacy it has bought recently. This could also apply to a range of healthcare professionals who may have a direct or indirect financial interest in another business, GPhC says.

GPhC chief executive Duncan Rudkin said: “As health and care regulators, we share a commitment to collaborating on issues that affect patient safety and care, and the trust they place in the professionals who provide that care. By working closely with our fellow regulators, we are underlining the consistent expectations of health professionals in managing conflicts of interest, to help give patients and the public the assurance that their interests will always be put above any other interest a health professional may have.

“The joint statement supports the principles and guidance outlined in our standards for pharmacy professionals, and I hope the statement and case studies will provide helpful insight for our registrants when facing potential conflicts of interest.”

‘If in doubt, find out’

When contacted by P3, the Royal Pharmaceutical Society offered this advice for pharmacists: “There are well known concerns about actual and potential conflicts of interest across the NHS. If you are ever in doubt about whether you should declare a conflict or how to do it, find out. Transparency and openness will enhance the reputation of pharmacy and pharmacists and assure professional integrity and public confidence, while enabling collaborative working and constructive dialogue with suppliers of goods and services to the NHS.”

A professional guide on identifying and appropriately making declarations of interest is available to RPS members.

MHRA and Making a Success of Brexit
MHRA, 14 August 2017

Following the outcome of the EU referendum, the Medicines and Healthcare products Regulatory Agency (MHRA) is working closely with the Government to analyse the best options and opportunities available for the safe and effective regulation of medicines and medical devices in the UK.

While negotiations continue, the UK remains a full and active member of the EU, with all the rights and obligations of EU membership firmly in place. Working with our partners, stakeholders and customers, our focus remains: protecting health and improving lives.

Playing a full, active role in European regulatory procedures for medicines remains a priority. We contribute significantly in both the centralised and decentralised regulatory procedures, including new rapporteur and reference member state (RMS) appointments, and maintain our programmes for implementing EU legislation as required by our obligations as a Member State. We are also fully engaged in European and national scientific advice services and in delivering our EU inspection-related duties.

Our role in regulating medical devices and in vitro diagnostic (IVD) devices remains integral. We oversee the essential work of the five UK Notified Bodies; together they are responsible for assessing the majority of devices currently placed on the EU market. Our preparations to implement proposed new Regulations for Medical Devices and IVDs continue.

We maintain our role in vigilance, market surveillance and taking direct action, where needed, to protect patients and public health, and we continue to co-ordinate with other Competent Authorities, across Europe and internationally, in these and other areas.

Statements are also available from the British Pharmacopoeia and the National Institute for Biological Standards and Controls (NIBSC)

On 4 July the UK Government gave a clear, public statement of its desire to retain a close working partnership in respect of medicines regulation after the UK leaves the EU, in the interests of public health and safety. The statement, published in the Financial Times, by the Secretary of State for Health and Secretary of State for Business, Energy and Industrial Strategy laid out the three principles which will underpin the development of a post-Brexit regulatory system for medicines and devices: patients should not be disadvantaged; innovators should be able to access the UK market as quickly and simply as possible; and we will continue to play a leading role in both Europe and the world in promoting public health.

These principles and the government’s position were developed further in a speech by the Parliamentary Under Secretary of State at the Department of Health, Lord O’Shaughnessy, at the BIA/MHRA conference in London on 14 July.

We are aware of the recent notices to Marketing Authorisation Holders issued by the EMA/EU-27 and CMDh advising of preparations MA holders may want to consider ahead of the UK’s exit from the EU.

Until the exit negotiations are concluded, the UK remains a full member of the EU and all the rights and obligations of EU membership remain in force. We therefore continue to play a full role in the network and to undertake our work as a Reference Member State (RMS) in the decentralised procedure, and as (co-) rapporteur in the centralised procedure. If, however you do want to consider preparation for any potential changes to marketing authorisation or RMS, please see the information provided by the EMA and the HMA.

Whatever the outcome of the negotiation we will continue to collaborate with all involved to deliver the current speed of authorisations, access to new and innovative medicines and devices and to continue to ensure the quality, safety and efficacy of all medicines and devices, to safeguard an uninterrupted level of public health protection.

MEDIA SUMMARY 

Growth in next-generation sequencing informatics market fueled by big data
European Pharmaceutical Review, Steve Bremer , 25 July 2017

The European next-generation big data genetic informatics system is predicted to be worth $500 million by 2021. The use of genomic data-sets to craft tailored prescriptions has become increasingly prevalent in Europe, leading to the more widespread use of end-to-end genetic mapping in prescribing and diagnosing illnesses. The current informatics systems are currently providing substantial benefits to life sciences and diagnostic firms, where competitive pricing has made genetic data much more easily available and harvestable. This comes after intensifying demand in the industry for genomic data. At the moment, further commercialization is prevented by country-level data protection laws, but most states are currently developing their own genetic data storage systems. In particular, Britain’s 100,000 genomes project is one of the leading programmes of its kind in Europe, and looks set to grow in the coming years.

Medicines and Healthcare Products Regulatory Agency (MHRA) Inspectorate Blog – Do wholesale distributors require pharmacovigilance agreements?
MHRA, Peter Twomey, July 26 2017

MHRA Good Distribution Practice (GDP) inspectors have received a number of queries from wholesaler distributors asking in what instances agreements are required between the marketing authorisation holder (MAH) and wholesale distributors for the purposes of fulfilling pharmacovigilance requirements. The Good Pharmacovigilance Practice (GPvP) Inspectorate has provided clarification on the MHRA Blog, and the full statement can be found in Full Coverage below.

PARLIAMENTARY COVERAGE

There is no parliamentary coverage.

FULL COVERAGE

Growth in next-generation sequencing informatics market fueled by big data
European Pharmaceutical Review, Steve Bremer , 25 July 2017

The European next-generation sequencing informatics market is predicted to be worth over $500m by 2021, supported by big data-driven clinical interpretation in novel areas, according to a new report.

Frost & Sullivan’s report predicts that strong demand from the biopharma Industry will encourage NGS informatics providers to deliver customised solutions. Reduced costs of sequencing costs have led to burgeoning genomic datasets, and these, coupled with data from multi-omics and electronic medical/health records (EMR/EHR), are fueling the adoption of big-data methodologies in data analysis, it says.

Growth Opportunities in the European Next-generation Sequencing Informatics Market‘ details unmet needs and highlights potential opportunities across the secondary analysis, tertiary analysis and storage solution segments.

“As the industry matures, users of NGS informatics services will seek seamless end-to-end genetic solutions in an easy-to-use format at competitive prices,” said Frost & Sullivan Analyst Neelotpal Goswami. “Intensifying demand from pharmaceuticals, biotech, and diagnostic firms will propel NGS informatics providers to develop customised solutions that address user needs – from sample analysis to actionable informatics.”

Trends supporting market development include:

  • Focus on personalised medicine across European nations such as France, Germany, and the UK, along with a number of pan-Europe initiatives
  • National-level genomics data collection and analysis initiatives, such as the UK’s 100,000 Genomes Project and the French Plan for Genomic Medicine 2025
  • Strong research and development and wider application of NGS informatics-based services in Benelux and the Nordics
  • Presence of cutting-edge NGS technology infrastructure in the region, like the Wellcome Trust Sanger Institute, a highly-educated population receptive to NGS technologies and significant government support.

“Europe is a fragmented market, where revenue potential varies significantly in individual countries,” said Mr Goswami. “Additionally, at a pan-European market level, countries have differing regulations and reimbursement practices that may hamper successful commercialisation of NGS informatics solutions. However, innovative approaches such as storing genomic data for analysis within specified geographic borders to match data storage regulations, and evolution in reimbursement policies that increase clarity and coverage for NGS-based tests, will support growth opportunities.”

Medicines and Healthcare Products Regulatory Agency (MHRA) Inspectorate Blog – Do wholesale distributors require pharmacovigilance agreements?
MHRA, Peter Twomey, July 26 2017

MHRA Good Distribution Practice (GDP) inspectors have received a number of queries from wholesaler distributors asking in what instances agreements are required between the marketing authorisation holder (MAH) and wholesale distributors for the purposes of fulfilling pharmacovigilance requirements. The Good Pharmacovigilance Practice (GPvP) Inspectorate has provided clarification below:

According to Article 1(17) of Directive 2001/83/EC, wholesale distribution of medicinal products is “all activities consisting of procuring, holding, supplying or exporting medicinal products apart from supplying medicinal products to the public…”. If a wholesale distributor could potentially receive safety-related information on behalf of the MAH, or if they are providing a service relating to pharmacovigilance, then they are effectively part of the MAH’s pharmacovigilance system. In this situation, contracts or agreements between the MAH and wholesale distributor need to exist, in order for the MAH to ensure that activities performed and services provided by these third parties are in accordance with applicable legislation and guidelines, and in order to ensure that all parties understand and formally agree to the tasks that have been contracted. In this blog post, the terms contract and agreement are used synonymously.

The good pharmacovigilance practices (GVP), are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union.
GVP Module VI.2.2 states that “Each marketing authorisation holder shall have in place a system for the collection and recording of all reports of suspected adverse reactions which are brought to its attention”. As indicated earlier, wholesale distributors may be a potential source of safety information. Hence, the MAH will need to have a mechanism to collect reports of adverse reactions received by wholesaler distributors.

GVP Module VI.B.7 outlines the reason why agreements between the MAH and wholesale distributors may be required “Where the marketing authorisation holder has set up contractual arrangements with a person or an organisation, explicit procedures and detailed agreements should exist between the marketing authorisation holder and the person/organisation to ensure that the marketing authorisation holder can comply with the reporting obligations. These procedures should in particular specify the processes for exchange of safety information, including timelines and regulatory reporting responsibilities and should avoid duplicate reporting to the competent authorities”.
As reports of suspected adverse reactions may be brought to the attention of wholesale distributors, agreements between the MAH and the wholesale distributor support the fulfilment of the collection and recording of these reports by the MAH.

Indeed, section 6.3 of the European Commission Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01) states “In the event of a complaint about the quality of a medicinal product and a potential product defect, the manufacturer and/or marketing authorisation holder should be informed without delay”. Complaints received by wholesale distributors may include reports of suspected adverse drug reactions and should be forwarded to the MAH, the implementation of an agreement between the parties may help facilitate this activity.

Factors influencing whether an agreement is required

The MAH needs to assess if the wholesale distributor they have engaged with are a potential source of safety information (such as reports of adverse reactions, medical enquiries or product quality complaints), and/or are providing pharmacovigilance services on behalf of the MAH, and whether an agreement is required to fulfil pharmacovigilance requirements. Some factors which are likely to result in an agreement being required include:

  • if the name and/or contact details of the wholesale distributor appears on product packaging, the patient information leaflet (PIL) or the MAH’s website,
  • if the MAH does not have a contactable presence in the market where the product is being distributed, which may increase the likelihood of the wholesale distributor becoming a point of contact by a member of the public or health care professionals (HCPs),
  • if the wholesale distributor is providing services which may increase their interaction with HCPs and the likelihood of receiving safety information, such as actively promoting products via a sales team,
  • if the wholesale distributor is performing pharmacovigilance services on behalf of the MAH, for example, undertaking follow-up of adverse events in their territory on behalf of the MAH, undertaking local literature searching activities or distributing risk minimisation materials.

The above list is not intended to be exhaustive and the MAH should consider all factors which may result in the wholesale distributor becoming part of the MAH’s pharmacovigilance system.
There may be situations when an agreement is not required, for example, if the wholesale distributor is not in a contractual relationship with the MAH and would not be regarded as a potential source of safet

safety information and thus would not form part of the MAH’s pharmacovigilance system.

Content of agreements

If an agreement between the MAH and the wholesale distributor is required, it should contain sufficient detail to ensure that pharmacovigilance requirements are met. It is the responsibility of the MAH to decide what provisions need to be included in these agreements, particularly considering the content required in agreements may vary depending on the parties involved. Some provisions which the MAH may wish to consider in agreements are outlined below, however, this list is not intended to be exhaustive and the MAH should use their judgement when deciding what information should be included in agreements:

  • the roles and responsibilities of each party
  • the types of safety information which should be collected and forwarded to the MAH by the wholesale distributor (e.g. suspected adverse reactions, lack of efficacy reports, product quality complaints etc.)
  • timeframes for the exchange of safety information between parties and case confirmation and/or reconciliation provisions
  • contact details of where the wholesale distributor should send safety information received to
  • how the transfer of outstanding safety information to the MAH will be handled should commercial arrangements be terminated
  • provision for the oversight of the wholesale distributor by the MAH (e.g. in process compliance measures and the right of the MAH to audit the wholesale distributor).

The MAH should consider how to ensure all parties are complying with the terms of the agreements, such as including wholesale distribution partners on the MAH’s risk-based audit programme, or implementing routine checks of pharmacovigilance relevant wholesale distributor activity, such as periodic reconciliation of reports of adverse events between the distributor and the MAH which may identify discrepancies in information exchanged.

Conclusion

In conclusion, when deciding if an agreement between the MAH and the wholesale distributor is required, the MAH needs to consider if the wholesale distributor is a potential source of safety information and/or performing pharmacovigilance tasks on behalf of the MAH, and implement agreements as appropriate. Provided the aforementioned factors have been considered, it is anticipated that there may be instances where an agreement between the MAH and the wholesale distributor is not required. The MAH should ensure that where an agreement is required, these agreements contain sufficient detail and provisions relative to the relationship between the MAH and the partner.

MEDIA SUMMARY 

UK bioscience companies form Rare Disease Industry Group
European Pharmaceutical Review, Dr Zarra Kassam, 24 July 2017

A group of bioscience companies who focus on pharmaceutical development for rare and very rare diseases have formed an industry group. Entitled the Rare Disease Industry Group (RDIG), it is committed to inform the public about rare diseases and offer pragmatic solutions to ensure access to orphan and ultra-orphan medicines. Orphan medicines are generally research intensive to develop, and usually treat a very limited group of rare illnesses each. In the UK, 1 in 17 people are expected to be affected by a rare disease in their lifetimes. There are currently 143 orphan medicines available in the UK, but only 68 are reimbursable on the NHS. By contrast, 116 orphan medications are reimbursed in France, and 133 in Germany. The RDIG will exist under the auspices of the BioIndustry Association.

NHS should pay for medicines based on outcomes, argues Novartis-backed report
Pharmaphorum, Neil McConaghie, 24 July 2017

Pharmaphorum further covered on the July 21st report from the Social Market Foundation, which was funded by the UK-based operations of Novartis. The report’s findings endorse a results-based approach to drug funding and pricing. The major UK drug pricing scheme, the PPRS, is due for renewal at the end of 2018, and many companies have expressed their dissatisfaction with the current model. Novartis has pioneered the results-based model in the United States for heart medicine, and Italy currently employs a variation on the pricing system for the majority of pharmaceuticals. The ABPI is currently consulting with members, and there is growing appetite in the industry for a greater use of outcome based mechanisms.

PARLIAMENTARY COVERAGE

There is no parliamentary coverage.

FULL COVERAGE 

UK bioscience companies form Rare Disease Industry Group
European Pharmaceutical Review, Dr Zarra Kassam, 24 July 2017

A group UK bioscience companies that specialise in treatments for rare and very rare diseases have launched a Rare Disease Industry Group (RDIG).

Formed under the umbrella of the BioIndustry Association (BIA), the RDIG is committed to developing recommendations that can pragmatically inform and improve the challenge of ensuring patient access to treatments for rare and very rare conditions, sometimes referred to as orphan and ultra-orphan medicines.

In the UK, it is estimated that 1 in 17 people – approximately 3.5 million people – may be affected by a rare disease at some point in their lives. The impact that rare diseases have on patients, their families, and society is profound, as many are severe, chronic and progressive, with high mortality rates.

In England, there is no dedicated process to assess orphan medicines and uptake of these medicines is varied. According to the Office of Health Economics, of the 143 orphan medicines that were available in the UK, only 68 of these medicines were reimbursed and made available to NHS patients in England. In contrast, 116 orphan medicines are reimbursed in France and 133 are reimbursed in Germany.

Commenting on the launch of the group, BIA CEO and Chair of the Rare Disease Industry Group, Steve Bates OBE, said:

“The BIA has long been a vocal advocate of the need to improve access to treatments for patients with rare and very rare diseases. In 2014, the BIA published the report Very Rare Diseases, Complex Issues, calling for a separate approach for evaluation and commissioning of ultra-orphan medicines. The RDIG will now continue and build on the BIA’s previous work in this important area.”

Peter Kuiper, General Manager UK and Ireland at Sanofi Genzyme, the speciality care global business unit of Sanofi, and Vice-Chair of RDIG said: “There is strong public support for treating patients with very rare diseases as part of the comprehensive offer of the NHS. Almost three quarters of the UK public agrees that patients with a very rare disease should have the same access to treatment based on clinical need as patients with common diseases. The RDIG looks forward to developing recommendations and initiatives that can help move the dial on this important issue.”

NHS should pay for medicines based on outcomes, argues Novartis-backed report
Pharmaphorum, Neil McConaghie, 24 July 2017

A new report from the Social Market Foundation think tank argues that the UK’s National Health Service should switch to paying for medicines based on patient outcomes.

The report, Outcomes-based reimbursement of medicines, was sponsored by Novartis’ UK operations, but was independently authored by the think tank.

Its message is certainly in line with Novartis’ thinking in the UK and beyond however, as the company is among the leading pharma exponents of ‘pay for performance’ and similar deals.

While outcomes-based payment clearly has some potential risks for pharma, Novartis believes the switch could save the NHS money, and allow patients to access new medicines faster.

The UK has one of the slowest uptakes of new medicines among developed nations, but the report suggests it could learn from pioneers in outcomes-based payment, such as Italy.

Report author and SMF research director Nigel Keohane said:

“With pressure on the health budget growing, the NHS should adopt the principle of only paying for what works when it buys medicines. This would simultaneously drive better value for money and mean that patients could be given earlier access to new treatments.”

“Given the NHS spends £17bn on medicines each year, the reforms would also steer manufacturers to develop innovative drugs that can make the largest improvements to patient health.”

Drawing on international experiences in countries such as Italy, lessons from other UK public services and the wider NHS reform agenda, the report recommends that:

  • New drugs that meet specific criteria – such as addressing ‘unmet need’ among patients – would be eligible to go through the new purchasing scheme and fast-tracked to patients.
  • The NHS and the manufacturer would agree the health outcomes that should be achieved and the basis on which the manufacturer would be paid if and / or when the drugs are successful.
  • The NHS should lead an exercise towards better outcomes measurement and data to enable performance to be tracked properly. The report says this would be of wider benefit to NHS commissioning reforms.

The report comes at a confusing time for the UK pharma industry, its future clouded by the many uncertainties of Brexit.

Theresa May’s government has stressed that the life sciences sector is one of UK’s most important, but new budget control measures enforced by NHS England are causing consternation in the pharma industry.

The key UK pricing agreement, the PPRS , is due to renewal from December 2018, and many pharma companies have expressed their dissatisfaction with the system, which has capped spending but not delivered on promises to accelerate new medicines uptake.

Meanwhile the next few months are due to see the Government belatedly publish its response to the Accelerated Access Review, while Sir John Bell is set to unveil the Life Sciences strategy.

Commenting on the report, Barak Palatchi, Oncology General Manager, Novartis UK & Ireland, indicated that outcomes-based reimbursement was the way forward.

“We know that our health system is incredibly stretched. The NHS is being asked to do more with less funding, and patients are, rightly, demanding swift access to the effective, innovative treatments, they deserve. We need a different approach so the health system is sustainable, delivering better economic value over the long-term, and ensuring better patient outcomes”, said Barak Palatchi.

“We are working in partnership with the medical and patient communities to bring our science-based innovation and pioneering approach to deliver novel treatments to more people when they need them”, he concluded.

Novartis has pioneered outcomes-based payment in the US for its heart failure drug Entresto, with many other companies agreeing similar deals with health insurance companies there.

The report also gathers insights from Italy, which already uses two different outcomes-based agreements: since October 2012, there have been16 ‘Payments-by-Results’ deals and two ‘Risk Sharing’ contracts.

The UK industry association the ABPI is currently consulting with its members on what they want from the next PPRS agreement. It is far from certain that the industry would back a move to an entirely outcomes-based system, though there is growing appetite from the NHS and the industry for a much greater use of such mechanisms.

Read the full Social Market Foundation report here

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