HDA UK MEDIA AND POLITICAL BULLETIN – 10 August 2017

MEDIA SUMMARY 

NMS could save NHS £500m in the long-term, academics predict
Chemist and Druggist, Annabell Collins, 9 August 2017

Chemist and Druggist, Pharmacy Business (Neil Trainis, 9 August 2017), and Dispensing Doctors (Charles Gladwin, 10 August 2017) further reported on the Manchester University study that showed that the New Medicines Service could save up to £517.6 million. The study showed that the short term savings would be £75.4 million, and overall 179,500 quality of life adjusted years (QALYs) would be gained by the new scheme. The regimen is supported by The Pharmaceutical Services Negotiating Committee (PSNC), who noted that “The New Medicine Service is provided by community pharmacists in pharmacies across the country.” The PSNC fully endorsed continued use of systems like the NMS to help patients, insisting that “it is vital to use community pharmacists to help support GPs”.

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New Medicines Service saves costs and improves quality of life
Dispensing Doctors Association, Charles Gladwin, 10 August 2017

The New Medicines Service offered as part of the community pharmacy contract in England saved the NHS potentially over £500 million in its first five years.

An economic evaluation of the service, part of the community pharmacy contract in England, indicates that pharmacy interventions to support patients prescribed new medicines improves medicines concordance. This has concomitant quality of life benefits and associated overall cost reductions.

Between its launch in 2011 and the end of August 2016, there have been 3.59 million NMS consultations, with over 820,000 in 2015-16. “From the results of this economic evaluation, this suggests £75.4 million short-term savings to the NHS, £517.6 million long-term cost savings to the NHS and 179,500 QALYs gained,” said the researchers.

The NMS is targeted at specific conditions – asthma/COPD, type 2 diabetes, hypertension or antiplatelet/anticoagulant treatment. Researchers based at Manchester, Nottingham and London Universities “simulated the effect of observed adherence increases on patient outcomes and NHS cost by designing economic models for each drug–disease pair study.”

They concluded: “Our study suggests that the NMS increased patient medicine adherence compared with normal practice, which translated into increased health gain at reduced overall cost.”

Sue Sharpe, PSNC Chief Executive, commented: “With the current pressures on the NHS it is vital to use community pharmacists to help support GPs and other parts of the health care system, using their expertise in medicines and the relationship they have with their patients.”

At the Royal Pharmaceutical Society, Sandra Gidley, Chair of RPS England, has called for the list of medicines covered by the service to now be extended to cover all long-term conditions including mental health issues.

Previous University of Nottingham research estimated that non-adherence costs NHS England over £930 million per year for five diseases: asthma, type 2 diabetes, high cholesterol/coronary heart disease, hypertension and schizophrenia.

“We’d also like to see more patients referred into the service by primary or secondary care providers to ensure the service is used as widely as possible. All patients prescribed new medication should be encouraged to take part in the New Medicine Service by their prescriber,” said Ms Gidley.

New Medicine Service saves NHS £517.6 million in long term, claims report
Pharmacy Business, Neil Trainis, 9 August 2017

The New Medicine Service (NMS) generates long-term savings of £517.6 million for the NHS and improves patients’ adherence to their medicines by 10% according to a study funded by the Department of Health Policy Research Programme.

The evaluation carried out by the universities of Manchester and Nottingham and University College London examined the impact of non-adherence for medicines treating conditions under the NMS such as hypertension, type 2 diabetes, chronic obstructive pulmonary disease and asthma.

Researchers concluded the NMS “increased patient medicine adherence compared with normal practice which translated into increased health gain at reduced overall cost.” They also found the NMS generates short-term NHS cost savings of £75.4 million.

Over 3.5 million consultations were claimed on the NMS between its introduction to the community pharmacy contractual framework in October 2011 and the end of August 2016. Over 820,000 were claimed in 2015-16.

“This economic evaluation suggests that NMS will deliver better patient outcomes than normal practice at overall reduced costs to the NHS in the long term. In the short term, extra costs incurred by remunerating community pharmacists were absorbed by small reductions in other NHS contact-related costs,” the study said.

Sue Sharpe, chief executive of the PSNC, said: “The New Medicine Service is provided by community pharmacists in pharmacies across the country. Pharmacists recognise that helping patients when they first receive a prescription for a new medicine can be pivotal to ensuring that they get the best possible outcomes.

“With the current pressures on the NHS it is vital to use community pharmacists to help support GPs and other parts of the health care system, using their expertise in medicines and the relationship they have with their patients.

“Many people, particularly as they get older, depend on medicines to keep them well, and we are committed to developing community pharmacy’s support for them.”

MEDIA SUMMARY 

Pharmacy service will save NHS £517.6m, finds study
Rachel Elliott, University of Manchester, 8 August 2017

A study from the University of Manchester, also covered in The Pharmaceutical Journal and P3 Pharmacy has found that an NHS regimen to encourage patients to stick to their drug programme has been so successful it could save the NHS £517.6 million over the long term. The New Medicine Service, the scheme in question, has improved medicines adherence by 10 percent. Even in the short term, the program has saved the NHS £75.4 million. The study was conducted by the Universities of Manchester, Nottingham, UCL and community pharmacists. The study involved 504 patients. The study’s lead, Professor Rachel Elliott from Manchester, said the results were “good news for community pharmacists”, and will likely “improve patients’ quality of life” in the long term.

Professor Sir Michael Rawlins re-appointed Chair
MHRA Announcement, 8 August 2017

Professor Sir Michael Rawlins has been re-appointed chair of the MHRA. He was originally appointed in 2014, and will now serve a further 3 year term. Earlier this year, Sir Michael was appointed Knight Grand Cross of the Order of the British Empire (GBE) for the services to the safety of medicines, healthcare and innovation. Sir Michael said that he was delighted on the re-appointment and that he looks forward “to taking on the next challenge, as we seek to continue to play a leading role in both Europe and the world on promoting public health.”

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Pharmacy service will save NHS £517.6m, finds study
Rachel Elliott, University of Manchester, 8 August 2017

A scheme launched by the Department of Health in 2011 to help patients stick to their drug regimens has been so successful, that in its first five years, it will save NHS England £517.6m  in the long-term, a team of health economists has found.

Lead researcher Professor Rachel Elliott from The University of Manchester says the New Medicine Service – a free scheme where community pharmacists help patients take new medicines  – has improved medicines adherence by 10%.

The study was conducted by experts at The Universities of Manchester, Nottingham, UCL and a Patient and Public Representative.

Even in the short term, say the team, the scheme –where pharmacists are paid £24.60 each time they look after a patient as part of NMS has saved the NHS £75.4m.

The team used self-reported adherence at 10 weeks, considered the minimum time required to demonstrate behavioural change in a sample of 503 patients.

She said “On the basis of the evidence we have gathered for this research, we strongly  recommend that NMS should continue to be commissioned in the future.

“Our study suggests NMS  increased patient medicine adherence compared with normal practice, which translated into increased health gain at reduced overall cost. “This is a simple intervention which has been popular with community pharmacists and patients, and is transferable into most therapeutic areas. “Some medicines, for example,  can have early adverse effects but they subside over time such as anti-depressants. “And we also believe these findings are likely to have applicability to other health care systems, including those based on insurance.”

From inception of the NMS to the end of August 2016, 3.59 million consultations have been claimed for with over 820 000 in the year 2015/16 – according to the researchers.

Of 11,495 community pharmacies in England, 91.2% had delivered the NMS to at least one patient between November 2011 and January 2014, according to NHS Business Services Authority.

She added: “These are significant  benefits for two reasons because so many patients have experienced the service.

“We also think our figures are probably on the conservative side given probable patient recruitment bias, use of self-report of adherence, and the assumption that all the patients in the intervention arm actually received the NMS.”

Non-adherence is common in diseases such as chronic obstructive pulmonary disease where only 33% of patients continue their drugs after 10 weeks. In  schizophrenia the figure is  52%,  asthma: 67%; and diabetes 78%.

According to previous research, the costs to NHS England of non-adherence is over £930 million per year  in just five diseases: asthma, type 2 diabetes, high cholesterol/coronary heart disease, hypertension and schizophrenia.

To tackle the problem –which causes reduced quality of life, increased hospitalisations and premature deaths –  the Department of Health launched  the service six years ago.

NMS set to save the NHS £517m, study finds
P3 Pharmacy, 8 August 2017

A team of health economists from the Universities of Manchester and Nottingham and UCL examined the benefits of NMS, through which pharmacists offer free advice and support to patients who are newly prescribed treatment for certain long-term conditions. Using a sample of 503 patients, the team examined self-reported adherence at 10 weeks; this is considered to be the minimum time needed to demonstrate behavioural change.

The team says that the NMS has improved medicines adherence by 10 per cent since its 2011 launch, which as well as saving NHS England more than £500 million in the long term has already delivered short-term savings of £75.4 million.

Lead researcher professor Rachael Elliott from the University of Manchester said; “On the basis of the evidence we have gathered for this research, we strongly recommend that NMS should continue to be commissioned in the future.

“Our study suggests NMS increased patient medicine adherence compared with normal practice, which translated into increased health gain at reduced overall cost.”

‘The holy grail of medicines optimisation’

RPS England chair Sandra Gidley said: “This research provides a resounding endorsement of the benefits to patient care and to the NHS of the New Medicine Service. Better health outcomes combined with significant savings to the NHS budget is the holy grail of medicine optimisation.

“The list of medicines covered by the service should now be extended to cover all long-term conditions, including mental health issues, so that more patients can benefit in a structured way from the support a pharmacist can offer. We’d also like to see more patients referred into the service by primary or secondary care providers to ensure the service is used as widely as possible. All patients prescribed new medication should be encouraged to take part in the New Medicine Service by their prescriber.”

The researchers say that 3.59 million NMS consultations have been claimed for since the scheme launched in 2011, with over 820,000 in the year 2015/16. At least 95 per cent of pharmacies in England had held a consultation with at least one patient between November 2011 and January 2014, according to NHS Business Services Authority.

Previous research from the University of Nottingham has found that the cost to NHS England of non-adherence is over £930 million in just five diseases: asthma, type 2 diabetes, high cholesterol/coronary heart disease, hypertension and schizophrenia.

New Medicines Service could save the NHS £517.6 million, economic study finds
The Pharmaceutical Journal, Debbie Andalo, 8 August 2017

The new medicines service (NMS), delivered by community pharmacists in England, has the potential to save the NHS hundreds of millions of pounds and could be expanded to cover more long-term conditions, according to UK researchers[1].

The researchers, who came from the University of Manchester and University of Nottingham, found that in its first five years the NMS saved the NHS £75.4m.

The evaluation was based on the results of a randomised controlled trial involving 504 patients (251 who received the NMS service and 253 who received a normal service) which assessed the effectiveness of the NMS over 10 weeks. According to patient reports, it was found that the NMS “significantly” increased the proportion of adherence by 10.2% (70.7 % compared with normal practice of 60.5 %).

They also discovered that the NMS generated a mean of 0.05 (95% confidence interval [CI] 0.00–0.13) more Quality Adjusted Life Years (QALYs) per patient, at a mean reduced cost of -£144 (95% CI -769 to 73).

Writing in the journal PharmacoEconomics (online, 3 August 2017), the researchers said that their economic evaluation suggests £75.4m short-term savings to the NHS, £517.6m long-term cost savings to the NHS and 179,500 QALYs gained. They recommended that on the basis of their evidence the NMS should continue to be commissioned.

Lead researcher, professor of health economics and pharmacist, Rachel Elliot, said the study shows that the NMS works and is successful in the current NHS climate.

“It’s very good news for community pharmacists,” she said.

“When people start taking medicines it’s at about two weeks that they start to make decisions about whether they will carry on with them. Under the NMS, pharmacists get in early and discuss some of those issues and if necessary refer back to the GP.

“We have confirmed that it saves money, and, looking further into the future, that it is going to improve patients’ quality of life,” she added.

According to the study, community pharmacists have carried out 3.59 million NMS consultations since the scheme was introduced in 2011 to the end of August 2016. Under the NMS, community pharmacists support patients when they are first prescribed medicines for the management of hypertension, type 2 diabetes, chronic obstructive pulmonary disease, asthma and anti-platelet regimens.

But Elliott said the service could bring similar benefits to other long-term conditions and that there is already interest expressed from patient charities supporting people with Alzheimer’s disease, mental health conditions and glaucoma.

Liz Butterfield, member of the Royal Pharmaceutical Society’s English pharmacy board says GPs and practice pharmacists have to recognise the new medicines support that community pharmacists can offer

Liz Butterfield, a member of the Royal Pharmaceutical Society’s (RPS) English pharmacy board with an interest in medicines optimisation, said that the results are very encouraging.

“This sort of service should be routinely integrated into care pathways to ensure that outcomes are as successful as possible,” she added.

But Butterfield said that there needs to be a cultural shift to achieve this — GPs and practice pharmacists have to recognise the new medicines support that community pharmacists can offer and patients also have to appreciate the accessible medicines advice and support that community pharmacists provide.

“This is about proper integrated care and this report is a fantastic start to enable that,” she said.

Alastair Buxton, director of NHS services at the Pharmaceutical Services Negotiating Committee (PSNC), said that he was delighted to see yet another piece of analysis supporting the benefits of the NMS, with researchers this time concluding that the service improves patient outcomes and can reduce costs for the NHS in the long term.

“This will, of course, come as no surprise to the community pharmacists offering the service every day, and seeing the positive difference that it makes for their patients,” he said.

Professor Sir Michael Rawlins re-appointed Chair
MHRA Announcement, 8 August 2017

The Medicines and Healthcare products Regulatory Agency announced the re-appointment of Professor Sir Michael Rawlins as its Chair yesterday for a further 3 years.

Since taking up the position of chair at the Agency in 2014, Sir Michael has overseen the Agency’s work as an effective regulator of medicines and medical devices across the UK. He has promoted the first-class science and research carried out in each of the Agency’s centres; the National Institute for Biological Standards and Control (NIBSC), the Clinical Practice Research Datalink (CPRD) and MHRA.

Earlier this year, Professor Sir Michael Rawlins was appointed Knight Grand Cross of the Order of the British Empire (GBE) for the services to the safety of medicines, healthcare and innovation.

Professor Sir Michael Rawlins said:

“I am delighted to serve as the Agency’s Chair for a second term. One of the joys of this job is seeing each part of the Agency continue to deliver innovative science and protect public health.

“I am looking forward to taking on the next challenge, as we seek to continue to play a leading role in both Europe and the world on promoting public health.”

Chief Executive Dr Ian Hudson said:

“Sir Mike has overseen a very successful period in the Agency’s history, and I’m delighted to see his re-appointment, as we move into an equally crucial next stage.

“He has been at the forefront of innovation, development and leadership in the public health sector for more than 3 decades.”

MEDIA SUMMARY 

Wholesalers also affected by pregabalin ‘market shock’
Chemist and Druggist, Annabelle Collins, 7 August 2017

Both wholesalers and pharmacists have been hit by the price changes affecting pregabalin, the Healthcare Distributors Association has said. Pregabalin has entered category M, two months after the NHS announced in could be prescribed “in accordance with normal practice”. Contractors have told C+D that they are being ‘forced’ to pay up to £20 for the drug from wholesalers, even though it ranges between £1.87 to £4.17 per pack. In response, HDA executive director Martin Sawer said “Not only will pharmacists be losing out in the short term, but so will wholesalers, as the market adjusts.” At the moment, there is a shortage of the pregabalin molecule, which will hopefully be rectified in the next few months.

Brexit relocation of EU medicines regulator ‘will hit UK researchers hard’
The Guardian, Daniel Boffey, 8 August 2017

Two of the UK’s foremost research institutions, the Veterinary Medicines Department (VMD) and the Medicines Health and Regulatory Agency (MHRA) are set to lose out quite substantially in the relocation of the EMA. The MHRA currently receives about 20 to 30% of the EMA regulatory and research work, known as “licensing and vigilance work”. The UK government has said it expects to maintain “a close working partnership” in medical regulation, but what is clear is that Amsterdam has made quite a persuasive case for EMA relocation. As the Dutch PM, Mark Rutte said, “We are not that different… we also have a very stylish Queen and enjoy fish and chips. Besides our grasp of your language is outstanding.” 19 countries have applied to host the EMA.

Medicines watchdog warns leaving EU is threat to health
The Times, Caroline Wheeler, 6 August 2017

The MHRA has warned that leaving the EU could “impact on the ability of the agency to undertake its public health protection role”. Currently, the EU provides a third of MHRA income. Experts already fear that leaving the EU could mean that UK citizens have to wait an extra two years for drug approval, but the MHRA recent warnings compound uncertainty. The Department of Health responded to the announcement by stating that “we continue to play a full role in the EU medicines regulatory framework, and we will work closely with our European counterparts to ensure continued cooperation, in the best interests of business, citizens and patients across the EU and the UK.” The MHRA noted that such cooperation needed to find a successor regime, once the terms of Brexit are fully negotiated.

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Brexit relocation of EU medicines regulator ‘will hit UK researchers hard’
The Guardian, Daniel Boffey, 8 August 2017

Two of the UK’s foremost research organisations will lose much of their business to Amsterdam if the city is successful in securing the relocation of the EU’s medicines regulator, the Netherlands’ formal bid for the prized agency claims.

Amsterdam, which has been tipped as an early favourite to secure the European Medicines Agency (EMA), says in its application submitted to the European commission that losing the agency will prove a double blow to London when Brexit forces its move.

“The relocation of the agency will have considerable impact, not only because it has to move its headquarters and personnel, but also because the relationship with the UK Medicines Health and Regulatory Agency [MHRA] will change and potential risks need to be minimised in the event of a hard Brexit”, the document says.

The MHRA, which regulates UK medicines and healthcare products, enjoys a lucrative relationship with the EMA, for which it currently carries out between 20% and 30% of the vigilance and licensing work the agency is responsible for. The Amsterdam bid says this could change after Brexit and that the Netherlandswas well-placed to provide an alternatives.

“Brexit will not only result in the relocation of EMA to another EU member state, but also very likely in a dramatic reduction, or withdrawal, of the work of the MHRA and the Veterinary Medicines Department [VMD] in the assessment of medicinal products for human and veterinary use.

“The MHRA and VMD currently also provide various services to the agency, including scientific support and [small] research assignments, regulatory advice to EMA experts and the uptake of unclaimed scientific procedures. The Dutch Medicines Evaluation Board is able to provide a similar level of service to EMA in the event of its relocation to the Netherlands.”

Nineteen countries have lodged official applications to host the EMA once the UK leaves the bloc in March 2019. A decision on the winner will be made in November.

A spokesman for the MHRA said it did not necessarily believe the work it currently carried out would be lost post-Brexit.

“We currently lead between 20% and 35% of the EMA’s licensing and vigilance work. However, the outcome of the negotiations are currently unknown and the final location of the EMA will not necessarily led to a direct transfer of the scale of that work.

“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 question of the scale of that arrangement remains open to discussion.”

The EMA and the European Banking Authority (EBA), both based in Canary Wharf, east London, offer prestige to their host and an influx of high-spending officials and experts on visits.

Britain has been given no option on retaining the organisations, which employ about 1,000 staff, despite some demurring by the Brexit secretary, David Davis. The British government is expected to stump up the bill for the removal costs.

Amsterdam’s bid, fronted by its prime minister, Mark Rutte, made much of the similarities between the UK and the Netherlands in a tongue-in-cheek video accompanying its application. “We are not that different,” the narrator of its official video says. “We also have a very stylish Queen and enjoy fish and chips. Besides our grasp of your language is outstanding.”

David Mowat appointed pharmacy minister

21 July, The Pharmaceutical Journal

David Mowat has been announced as the new Parliamentary Under Secretary of State for Community and Healthcare. His portfolio includes pharmacy among others. He joins the Department for Health along with Philip Dunne, who is now Minister of State for Health, and Nicola Blackwood as Parliamentary Under Secretary of State for Public Health and Innovation.

MHRA data integrity guidance: 18 months on

21 July, MHRA Inspectorate, David Churchward

Eighteen months have passed since the MHRA published its GMP data integrity guidance. Following this the pharmaceutical industry has been seen to make significant effort to implement the guidance globally. The MHRA is supporting the World Health Organisation and the European Medicines Agency for the preparation of regulatory guidelines, as well as working to raise awareness of data integrity challenges that face the industry and its regulators. The MHRA are also working towards the next phase of guidance, with a good practice (GxP) focus building on the past 18 months, to address gaps and clarify expectations.

Multi-indication pricing: no longer mission impossible?

              Pharmaphorum: Deep Dive, Leela Barham,

Economic consultant Leela Barham investigates the potential for the use of multi-indication pricing (MIP) to becoming more widespread as we see a push for a value-based approach to drug pricing coupled with a smarter use of data. Under MIP, the prices of drugs with more than one indication differ depending on value in each use. The concept of MIP has appeal because it aims to send a clear signal to the market about the different values in use for a single product.

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David Mowat appointed pharmacy minister

21 July, The Pharmaceutical Journal

David Mowat, Conservative MP for Warrington South, has been announced as the new Parliamentary Under Secretary of State for Community Health and Care.

Mr Mowat’s portfolio includes pharmacy and all other aspects of primary care, as well as adult social care, community services, cancer, dementia and learning disabilities.

He succeeds Alistair Burt MP, former Minister of State for Community and Social Care, who announced his resignation from the post after the EU referendum. Burt had previously stated he intended to carry on his duties until September but Mowat’s appointment to the role was announced during the finalisation of Theresa May’s cabinet reshuffle since taking over as prime minister.

Mr Mowat, who grew up in the Midlands, was elected to Parliament at the 2010 general election, gaining the seat from Labour. He previously trained as a chartered accountant and worked at the consulting firm Accenture for a number of years, going on to become one of its leading partners. He previously sat on the Scottish Affairs Select Committee, and has also served as private secretary to Greg Clark MP.

He joins the Department of Health alongside two other newly appointed junior ministers: Philip Dunne MP for Ludlow, who is now Minister of State for Health, and Nicola Blackwood MP for Oxford West and Abingdon, who is Parliamentary Under Secretary of State for Public Health and Innovation.

In a message posted on Twitter, Mowat said he was “delighted and honoured” to be joining the department.

MHRA data integrity guidance: 18 months on

21 July, MHRA Inspectorate, David Churchward

Eighteen months have passed since the MHRA published its GMP data integrity guidance. Since then we have seen pharmaceutical industry make significant effort to implement the guidance globally. It has been encouraging to see industry stakeholders and regulatory partners adopting a common approach in their own publications and the messages and themes being echoed in online discussions, workshops and conference presentations.

International convergence

Convergence is important in facilitating common expectations for industry. It also enables regulators to work together more effectively by facilitating information sharing and supervision of the global pharmaceutical development and supply chains.

The international hot topic of data integrity continues to develop. In the past year MHRA has supported the preparation of regulatory guidance from the World Health Organisation and the European Medicines Agency inspectors working group.

Together with colleagues in the Australian Therapeutic Goods Administration, MHRA is co-chairing a data integrity working group within PIC/S. This group of representatives from fourteen authorities spread across four continents has been working to produce guidance for participating inspectorates. This is developing existing convergent requirements into a harmonised approach to data integrity in the context of GMP and GDP inspections.

Our team has also been working with stakeholders in the international GLP and GCP networks to raise awareness of the data integrity challenges facing industry and regulators.

But we haven’t stopped there.

Revision of data integrity guidance with GxP focus

During this busy period we have also been working on the next phase of MHRA guidance, which has a GxP focus (good laboratory practice, good clinical practice, good manufacturing practice, good distribution practice and good pharmacovigilence practice). Data integrity is important throughout the pharmaceutical lifecycle, and GxP regulatory requirements have a common focus of requiring confidence in the quality and the integrity of the data used for decision-making.

Availability of GxP guidance is an important step forward, as media reports and regulator websites continue to describe serious data integrity failures in clinical trial conduct and laboratory practice as well as in medicines manufacture.

The revised MHRA guidance builds on experience over the past 18 months; addressing some gaps in our previous guidance, and clarifying expectations where inspections have shown an unexpected interpretation of the requirements. In common with other regulatory partners, we have cross referenced to other relevant guidance, to avoid repetition.

Good manufacturing practice stakeholders may note that the revision contains less GMP-specific examples than the 2015 guidance. In the GxP version we have used examples applicable to more than one regulated area where illustration was important. This also demonstrates how the principles of data governance, and the way in which they can be implemented, can be very similar across all areas of the pharmaceutical lifecycle. This is important for organisations participating in research and commercial supply to consider when reviewing risks and control measures. Shared learning and common systems can save resources and avoid common failures.

Three month consultation on GxP data integrity guidance

Data integrity is everyone’s responsibility. There will therefore be a three-month public consultation on the GxP guidance which is your opportunity to engage with MHRA in developing guidance.  The consultation documents can be found on our website, with a closing date of 31 October 2016. Our data integrity team looks forward to your contribution to driving forward this important initiative.

Multi-indication pricing: no longer mission impossible?

                Pharmaphorum: Deep Dive, Leela Barham,

Will the push for value-based approaches to pricing, coupled with smarter use of data, mean multi-indication pricing becomes more widespread? Economic consultant Leela Barham examines the question.

MIP could help deliver more access for patients and incentivise more indications that offer value

If a single price reflects a higher-value indication, reimbursement agencies may not recommend use in a lower-value indication, restricting patient access

Italy illustrates that the infrastructure can be put in place for multi indication pricing – but it can take years to embed

Multi-indication pricing (MIP), also known as indication-specific pricing, is the simple idea that prices for drugs with more than one indication differ depending on value in each use.

However, though the idea may be simple, in practice having different prices for the same branded drug has proved less than straightforward.

More multi-indication drugs coming

Interest in the concept of MIP has been around for some time. It ties in with the general debate about how best to pay for new drugs. The difficulty lies in determining what is a reasonable price to pay in light of what the drug can really do, avoiding paying too much when times are tough, yet still paying enough to ensure incentives for more new drugs come through. All this has to be considered in the context of maintaining access for patients. This is hard enough when a product is for one indication; it is even harder when it is for more indications and where its value can differ markedly, yet there is a single price.

It is likely that many future drug launches will be for drugs with several indications. In oncology, for example, there could be a rise from 2014 levels, when just over half of products had more than one indication, to reach more than 75 per cent by 2020 (Figure 1). Not only that, but many will have more than three indications (Figure 2).

The appeal of MIP

The idea of MIP has appeal. For economists, price is a signal to the market place about a product. In multi-indication products with different values in use with the same price, that signal is not clear; those differences in value can be significant too. For example, according to the media, Roche’s Tarceva generates a 3.5-month extension in life versus chemotherapy in lung cancer. In pancreatic cancer, however, it is less than two weeks versus placebo.

If the single price reflects the higher-value indication, countries’ reimbursement agencies may not recommend use in a lower-value indication. Patients could be missing out. As the Organisation for Economic Co-operation and Development (OECD) noted back in 2013, ‘When medicines are approved for several indications which display very different cost-effectiveness ratios, most often the price of a medicine is unique, set at market entry and countries make a ‘yes or no’ decision for each new indication.’

If the single price reflects the lower-value indication that, in turn, may discourage the manufacturer from developing further, potentially higher-value, indications. Companies may also add that having a lower price than the value being delivered does little to reward innovation.

Future uses

The underlying issue for companies is the absence of perfect foresight in markets that only allow a single price; companies won’t necessarily know the full range of indications, nor specific timings, when they bring the first indication to market. They must try their best to determine a price that is likely to work across all indications over time, at launch of the first indication. They are, in essence, trying to set an average price across indications that will optimise access and maximise revenue at a single point in time.

On the other side, reimbursement agencies tend to assess use in a single indication (which is hard enough in itself, let alone trying to do that across multiple indications). When they look at price and value they are not, typically, concerned with the broader uses of a drug and whether, overall, the price makes sense ‘on average’ across all indications.

Of course companies have a lot of pricing freedom (buffered by much market intervention) but, understandably, they are seeking a commercial return. The solution of low prices for every indication isn’t particularly attractive for them. Nor is seeking separate marketing authorisations using different brand names, given the time, cost and inconvenience.

MIP could help deliver more access for patients and incentivise more indications that offer value

Moving to a system that permits MIP could help deliver more access for patients and incentivise more indications that offer value (even if lower value than existing higher-value indications). Systems would avoid over- or underpaying at the indication level.

The downside could be more money spent by the system overall (as more uses are reimbursed and brought to market) but, so the theory goes, it should offer value for money at the margin. This is the issue at a conceptual level; the practical issues of how to have many prices for the same drug are significant too.

Lack of clarity

What MIP would really mean for prices is unclear as it depends on how the price for each indication is worked out; prices could go down, or in some cases, up (Figure 4). As Peter Bach from the Memorial Sloan Kettering Cancer Centre pointed out, indication-specific pricing would “cut both ways. A relatively ineffective indication would not weigh down a value-based price if the drug were highly effective in another setting. Likewise a follow-on indication, for which the drug worked less well, would not drag down a value-based price set when the first indication was highly effective.”

The reality of MIP: limited

MIP may not be a widespread practice, but it has been done. For example, aflibercept is marketed as two separate products for use in ophthalmology and oncology. Perhaps having separate prices reflects differences in concentration and route of administration, so the product is somewhat different in physical terms.

Aside from ‘one-off’ examples of a handful of individual products, it is in Italy where MIP seems to have the infrastructure needed to operate.

Most innovative drugs used in Italian hospitals are included in web-based patient registries. They collect data on use by indication, not just by total volume. Over 100 registries cover thousands of patients – totalling over 350,000 in 2014 – so by now it must be more. In oncology alone, the registries covered 41 cancer drugs in 81 indications in 2014.

The registries were not set up to introduce MIP, but it seems a useful by-product; they are managed by the Italian Medicines Agency, so enable safety monitoring as well as managing reimbursement issues. The registries already mean that the transaction prices paid can change over time in light of results, since they include different performance-related schemes from the outset. There is no reason why these cannot be indication-specific.

The issue for companies is that they have to pay to add their product to the registry, and they may not get access to the data, as it is owned and analysed by the Italian Medicines Agency. There is also the obvious risk that pay-for-performance could hit their bottom line. However, it provides access (and revenue) where otherwise there would be none. The Italians set up the registries back in 2005 and the Agency stresses that time is needed to move from an administrative tool to an evidence-generating tool.

Mixed support

There are some who are in favour of MIP. The PharmaDiplomacy Group included the practicality of indication-specific pricing as part of an on-market price review in its proposed checklist for collaborative, mutually acceptable drug pricing in September 2015. IMS concluded, in its 2015 review of oncology, that ‘payment-by-use methodologies are required to match price with clinical value’, pointing out that ‘paying separate and distinct prices for patient groups, based on clinical value demonstrated by real-world evidence, may be preferred by payers and manufacturers’. There are reports that Germany could be interested in applying indication-specific pricing, partly to target use in appropriate sub-groups of patients.

Not everyone is convinced, though. The US-based Institute for Clinical and Economic Review’s (ICER) work, published in March 2016, outlines the challenges and risks and, on balance, suggests piloting the approach. US pharmacy benefit manager organisation Express Scripts seems to be doing just that.

In the UK, experts have highlighted that underpinning implementation of MIP would be data on use by indication and ways to reconcile the money. For example, rebates could be used and not necessarily different headline prices.

Although there are challenges, companies like Roche have projects in place to work through how MIP can be delivered in practice. The company has been focusing on using the Systemic Anti-Cancer Therapy (SACT) dataset and working with some English hospitals. That dataset should be collecting information on use by indication, as well as a host of other data across England. Not only would data challenges need to be overcome, but perhaps the attitudes of some working in the NHS too. When asked by Strategy&, PwC’s strategy consulting group, they thought indication-based pricing was one of the least attractive of the pricing and reimbursement options. However, the very small sample size – just 42 responses overall – should be taken into account (page 48 in linked document).

The future?

MIP could be one of a new wave of funding approaches to help respond to the myriad challenges for pricing and reimbursement for new drugs seen in health systems today. It has the potential to piggy-back on existing efforts to digitise health, and build on the long-running, value-based-pricing debate.

Perhaps the biggest threat to implementation is that of overall affordability; will payers accept an approach which could add to their drug spend, even if that offers value for money at the margin?

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