Biosimilars could make EU big cost savings after slow start

Report says biological copies could cut health spending in region by $11bn

The emergence of biosimilars could cut EU health spending by $11bn to $33bn by 2020, claims a new Thomson Reuters report.

While the analysis reveals that the availability of biosimilars has not had a massive impact on some of the reference biologic brands so far – with most maintaining market share while biosimilars have taken business from alternative therapies – but has placed downward pressure on pricing.

In the case of Amgen’s once-daily white blood cell stimulator Neupogen (filgrastim), however, the drug has now been overtaken by its biosimilar rivals – led by Sandoz’ Zarzio – and the EU market for these products is expected to decline from more than $6bn to around $4.6bn by 2019.

The report also notes that a number of factors are holding back the development of the global market for biosimilars, not least the lack of products reaching the market in the US, which it attributes to later patent expiries for first-wave biologics in Europe.

“Sandoz filed the first Biologic License Application (BLA) for a biosimilar with the FDA in July 2014,” it notes. That application was for Zarxio, a biosimilar of Neupogen that lost US patent protection in 2013, five years after Europe.

Similarly, Celltrion has already secured approval of a biosimilar referencing Janssen Biotech’s Remicade (infliximab) in the EU but is having to challenge patents on the drug which does not expire until 2018 in the US.

The report says “by 2018, $31bn-worth of biologic sales are expected to come from off-patent drugs in the US and $43bn from off-patent biologics in the rest of the world”. By the end of the decade, patents will have expired for originator biologics accounting for about $100bn in global sales, it adds, citing figures from biosimilar developer Sandoz.

The reality is that biosimilar sales will lag behind the market size, however, in part because the discounts for biosimilars compared to their branded counterparts are less than for small-molecule generics – typically 20-30% – which reduces the incentive for wholesale adoption in the market.

Thomson Reuters predicts however that the slow market uptake of biosimilars in the EU may not also hold true for the US.

“Unlike most of the EU, the US will allow interchangeability, which is expected to speed adoption and lead to lower prices,” it notes. The World Health Organization’s recently proposed voluntary, global naming scheme could also level the playing field for biosimilars and their reference biologics, says the report.

Biosimilars are expected to account for approximately one quarter of the $100bn market by the end of the decade.

There are currently 700 follow-on biologics therapies moving through pipelines and 245 biopharma companies and institutes developing or already marketing these products in markets throughout the world.

Jon Brett-Harris, managing director of Thomson Reuters Life Sciences, said: “Rather than forgo the benefits of biologics, governments and payers are counting on biosimilars to dramatically change drug development and patient costs by reducing the price tag of important biologics and increasing access to life-saving drugs.”

“For this to happen, biosimilars must deliver the power of the reference drugs at a price developing countries can afford and gain the confidence of the marketplace,” he added.

Source PMLive http://www.pmlive.com/pharma_news/biosimilars_could_make_eu_big_cost_savings_after_slow_start_603230

Biosimilars could make EU big cost savings after slow start

The benefits of Big Data

Using real-world patient outcomes data

Big Data is big business. As technology advances and more information about healthcare is recorded and stored, the opportunities for turning information into insight to improve outcomes have never been greater.It is no surprise that it is those most able to collect and, crucially, interpret this data who are pushing the boundaries of what is possible in market access. In the new health economies, biopharma needs to work much harder to meet the demands of stakeholders for robust evidence of exactly how a product will lead to better patient outcomes in the real world. Compelling data lies at the very heart of this challenge.

Turning a buzzword into real value

There is one major barrier that currently stops biopharma realizing the full potential of Big Data: at the moment, there is no consensus on exactly what it is, nor how to effectively use it. It is a buzzword that is high up on every company’s agenda, but as an industry, we are perhaps two years away from understanding exactly how it can deliver improved commercial and clinical outcomes.

There is an unprecedented wealth of information out there, be it national, such as hospital episode statistics (HES) and prescribing figures, or local, including patient-reported outcomes (PROMS), patient reported experience measures (PREMS), quality of life, patient level clinical notes and local hospital systems. When Big Data is discussed in the context of the NHS, the assumption often is that ‘big’ means ‘national’, implying that insight comes solely from HES and other large and structured historical data sets.

I believe the real value comes when you are able to unpick this huge volume of data and hone in on what is most relevant to local clinicians, in a unique local health economy, for a specific patient population. This would not be too much of a challenge if Big Data described perfectly comprehensive, accessible and clean data with no gaps and contradictions. If that was the case, drilling down to pull out the local context would be a relatively simple task.

However, Big Data is just the beginning of a complex process of segmenting, analyzing and interpreting. HES data can provide an overview, presenting the ‘what and when’ in healthcare, but what we really want to know is ‘why’. The latter is far harder to pinpoint, but certainly worth searching for.

Where are we now?

There is no doubt that market access already achieves a lot from data. Outcomes audits utilise in-the-field nurses and analysts to gather national and local information, giving biopharma a highly detailed understanding of the entire care pathway. It can reveal gaps in that pathway, where adherence is unsustained, where extra patient support is needed, and where clinicians need clearer communication about a product’s benefits.

Similarly, simulation modeling uses multiple sources of data to create a virtual, near-live local pathway. Stakeholders can then see how this pathway’s performance and outputs compare against national and international pathways, and test scenarios to see what impact modifications would have on budgets, adherence and outcomes.

This modeling can be hugely important for biopharma, as it allows them to demonstrate to payers and providers the potential value of their product within a wider therapy pathway and within this specific local health economy. These stakeholders want to see the impact on outcomes in their very specific geography, and modeling fuelled by this data can help them make effective decisions to change  local care pathways (perhaps supported by the biopharma company through a joint working programme), or to develop the intelligence and insight to make cases-for-change with local commissioners.

The logical follow-on from pathway analysis and simulation modeling is service redesign. If running these simulations has revealed where new approaches would improve outcomes, then biopharma can present a powerful case for change to the local providers in this specific geography. Because the proposed service redesign is informed by localised, real-world data, and considers a product’s impact on the therapy pathway as a whole, stakeholders can be confident that there is strong evidence to back-up these proposed modifications. Biopharma can then combine an enhanced understanding of current and possible future care pathways with consultancy and change implementation expertise services to help implement any recommendations, and support the delivery of new services in a local health economy.

Finally, patient outcome studies and patient services is another market access area that relies on big data, because pragmatic analysis of real-time patient outcomes data can deliver an extremely valuable snapshot of the use of treatment in a specific local health economy. Combining patient-reported and clinical outcomes with patterns of resource allocation can assist in developing a clearer understanding of current medicine use, associated clinical practices and potential impact of a therapy across the local health economy. This insight can inform the development of patient-focused services ranging from local review clinics and remote patient support, to adherence support services and the deployment of managed clinical workflow tools.

What does the future look like?

What do payers and providers want to see from Big Data? Where are the gaps, and how can the information be better manipulated and localized? Should we be expanding our frame of reference, moving from PROMS and PREMS, and delving more into quality of life? There is clearly huge potential in social media too. Do we need a shift in focus towards non-health specific lifestyle data sets so we can understand not just the clinical impact of a drug on a patient, but how that patient’s exercise levels and diet, for example, are affecting outcomes?

Patients are just as likely to blog or tweet about their health as tell their GP directly, so social media could be seen as a major source of real-world experiential information.

It is exactly these sorts of questions that I want to tackle in an upcoming webinar with Dr Junaid Bajwa, GP and board member for Greenwich CCG. Big Data is a big opportunity for every market access stakeholder, so now is the time to open up a discussion and take an active role in shaping the future.

Source PMLive http://www.pmlive.com/blogs/smart_thinking/archive/2014/september/the_benefits_of_big_data

The benefits of Big Data

EMA wants to embed patient viewpoint within drug assessment

Will pilot CHMP benefit-risk evaluation project

The European Medicines Agency (EMA) has launched a pilot project to involve patients in the assessment of the benefits and risks of medicines in its scientific advisory committee.

The project is one of the first of its kind to include patients’ views and values in the assessment stage for medicines.

As part of the project, patients will be invited to present their views on medicines for which there is an unmet medical need and where the Committee for Medicinal Products for Human Use (CHMP) still has concerns or doubts.

Patients may also be invited to give their views in cases where the CHMP is considering the withdrawal, suspension or revocation of a marketing authorisation or a restriction of indication of an authorised medicine.

Guido Rasi, EMA executive director, said: “As patients live with their condition on a day-to-day basis, their views on the therapeutic effect of a medicine and its impact on their quality of life – particularly when these are balanced against the risks – may differ from those of other stakeholders.”

“Involving patients in CHMP discussions brings the patients’ voice into the decision-making process and ultimately contributes to the safe and rational use of medicines,” he added.

Patients who participate will give their views and may actively take part in the discussion, including posing questions to the company. They will, however, not take part in any decision-making process.

The first medicine to be included in the project is the orphan drug afamelanotide and its use to treatment a rare genetic blood disorder which causes an absolute intolerance to light called erythropoietic protoporphyria (EPP).

The pilot project will run for at least one year to allow a full assessment of the feasibility of involving patients in the CHMP explanations. A report on the experience will be presented to the CHMP at the end of the pilot phase and will address issues including organisational aspects, feedback from the CHMP and patients involved and areas for improvement.

Source PMLive http://www.pmlive.com/pharma_news/ema_wants_to_embed_patient_viewpoint_within_drug_assessment_602494

EMA wants to embed patient viewpoint within drug assessment

Novartis named digital pharma company of the year

Takes prize at the PM Society Digital Media Awards

Novartis was announced the first winner of digital pharmaceutical company of the year at last night’s PM Society Digital Media Awards in London.

The company beat off competition from Bayer, Boehringer Ingelheim, Genentech (Roche), GSK and Sanofi to take the new prize, the result of which was based on an assessment of social media presence, website quality, digital tools and other digital initiatives.

The honour follows a successful awards event for Novartis in 2013 when they picked up four awards, including integrated multichannel campaign and digital patient communications programme – patient education.

Shire Pharmaceuticals also had a prosperous night at the event, taking home two gold awards for its work with McCann Manchester. The partners picked up best healthcare professional website for the ADHD resource Full Attention UK and best corporate communications for the Elvanse Playbook app.

The World Hepatitis Alliance and Red Door Communications also picked up two gold awards with prizes for their Know It. Confront It campaign to raise awareness of hepatitis in the integrated multichannel campaign and social media categories. (Read a case study of the campaign.)

Red Door Communications and the World Hepatitis Alliance used the three wise monkeys in a video campaign to raise awareness of World Hepatitis Day

Companies that won gold in the other categories included Rosemount Pharmaceuticals, AstraZeneca, Roche, SPMSD, Actavis+Warner Chilcott, Novo Nordisk, Takeda, Galderma and Bayer Healthcare.

As for the individual awards, digital pioneer went to Adam Boucher of Novo Nordisk. He serves as medical education at the company in the UK and played a vital role in Novo’s Decisions in Time series of workshops to bring patient case studies to life.

Best digital project or account manager went to Rebeka Morley from Health iQ.

See the full list of gold winners below.

Digital sales aid

ImpactZone – ClinACCESS

By: M3 with MSA Media and Rainmaker

For: Rosemont Pharmaceuticals Limited

Healthcare professional educational programme

nasalspraylearning

By: nitrogen

For: AstraZeneca

Healthcare professional website

Full Attention UK

By: McCann Manchester

For: Shire Pharmaceuticals Ltd

Digital tools for use in a practical setting

Roche Clinical Trial Training Portal

By: go digital health / Virgo Health

For: Roche

Digital patient communications programme – patient education

Are You Ready 2 Go? Website and Travel Planner

By: Cherry

For: SPMSD

Digital patient communications programme – patient adherence/compliance

Assure Patient Support Programme

By: Actavis + Warner Chilcott UK Ltd

Social media

Know It. Confront It.

By: Red Door Communications

For: World Hepatitis Alliance

Digital solution for congress / symposium

Decisions in Time

By: emotive 
For: Novo Nordisk

Integrated multichannel campaign

Know It. Confront It.

By: Red Door Communications

For: World Hepatitis Alliance

Corporate communications

Elvanse Playbook App

By: McCann Manchester

For: Shire Pharmaceuticals Ltd

Craft Award – Film and animation

The Boy I Used to Know

By: Real Science Communications

For: Takeda

Craft Award – Mobile

MyRosacea mobile app

By: RFA Advertising & Marketing

For: Galderma UK

Craft Award – Gamification

Aiir

By: Langland

Innovation Award ‘pushing boundaries’

Influencer network mapping

By: Inspired Science

For: Bayer HealthCare

Digital Project or Account Management Award

Rebeka Morley

Company: Health iQ

Digital Pioneer Award 2014

Adam Boucher

Company: Novo Nordisk

Digital pharmaceutical company of the year

Novartis

Source PMLive http://www.pmlive.com/pharma_news/novartis_named_digital_pharma_company_of_the_year_601800

Novartis named digital pharma company of the year

The onward march of the century makers

There are more and more 100 birthday parties

Austerity may be gripping Whitehall but one department is increasing staff numbers – the Department for Work and Pensions.

The new employees are needed to organise the growing number of congratulatory cards for centenarians.

The increasingly long lists are dispatched to Buckingham Palace so officials can get the Queen’s birthday messages in the post.

Figures from the Office for National Statistics, noted by the DWP, show there are now 13,780 people aged 100 or more in the UK, an increase of 70% over the last decade.

That number is dominated by women with men accounting only for around 2,000.

Current estimates suggest that one in three children born today will reach the age of 100.

‘Inexorable rise’ in costs

Some will spend up to 40% of their lives in retirement

Beyond the birthday celebrations and all those candles, what is the significance of all this?

Longevity and the ageing of society have profound implications for health and social care, pensions and public spending”

Quite simply the growing army of centenarians illustrates one of the most important economic and social trends of our time.

Longevity and the ageing of society have profound implications for health and social care, pensions and public spending.

DWP ministers have been quick to point out that there have been pension reforms to underpin and sustain pensioner incomes.

They also note that many of those who reach the age of 100 will have been in retirement for more than 30 years.

For some, it will be more than 40% of their adult lives since they last received their final pay packet from work.

Even with people working longer and a rising state pension age, the costs to the public purse will rise inexorably.

The Office for Budget Responsibility predicted this year that state pension costs will increase from 5.5% of annual economic output (GDP) in 2018-19 to 8.5% in 2063-64.

Life expectancy – up or down?More older people with multiple ailments are adding to the workload of the NHS.

Some are living through their nineties with several conditions, any one of which might have caused their death in previous generations.

Over the same time period (2018/19-2063/64), according to the OBR, health spending rises from 6.5% of GDP to 8.5% and long term social care from 1.2% to 2.3%.

An ageing population means a larger chunk of national income devoted to their well-being.

There may be a time when the DWP and the Palace have to quietly drop the idea of those cards for centenarians”

The UK is by no means alone in facing these demographic pressures.

Some leading economies such as Japan and Germany have a higher number of elderly people expressed as a percentage of the working population (the “dependency ratio”).

But longer life-spans and the growing number reaching their century will present continuing challenges to the economy and public services.

There is a view that lifestyle factors such as diet and lack of exercise could slow or reverse the steady increase in longevity seen over recent decades.

Others argue that life expectancy will continue its upward trend.

The gerontologist Aubrey de Grey has been a regular guest at pension industry conferences with his argument there is someone alive now who will live to the age of 1,000.

In the worlds of health and pensions policy most debates lead back to longevity.

There may be a time when the DWP and the Palace have to quietly drop the idea of those cards for centenarians – or perhaps raise the qualifying bar to somewhere above that 100 year milestone.

Article written by Hugh Pym Hugh Pym Health editor

Source BBC News/Health http://www.bbc.co.uk/news/health-29375577

The onward march of the century makers

Nursing tech fund 2 to be open to all

Further details about the second round of NHS England’s Nursing Technology Fund, including an expansion of eligible organisations, are set to be released shortly.

Caroline Alexander, NHS England’s regional chief nurse for London, told the Healthcare Efficiency Through Technology conference that the organisation is “at the final stages of decision-making” for the second round of the fund, with an announcement expected soon.

NHS England received more than 220 applications from 140 trusts for the first round of the fund, with 85 projects from 75 trusts chosen to receive a share of the £30m on offer.

Alexander said NHS England is aware of frustrations from care providers about the limitations of the first round, which was open only to trusts and foundation trusts.

She said she “anticipates” that the second round will be open to any providers of NHS-funded nursing care, including social enterprises and local authorities.

“In the future, when care is delivered in a range of different settings, there needs to be that backing there for everyone.”

Alexander said the second round of the fund will also allow applications for a wider range of projects than the first round, which focussed on mobile working, digital pens and bedside monitoring.

“The first round was very quick, but we had to get it up and running quickly to help make changes in the most systematic way possible.”

She added that she hoped the second round will encourage collaboration between the nursing profession and healthcare IT professionals.

“It’s not about the technology people; it’s about the nursing and the technology people working together to get things right.

“We don’t want people to fail in this, so we need innovators who will help the nursing profession to take technology seriously.”

Alexander said applicants will also need to show that they can implement the technology they request in such a way that it is put to the best use possible. She said they will have to show there is a strong clinical benefit underpinning it.

“We need to make sure they’ve thought through how to implement stuff – you see cases where they’ve bought a lot of new kit but it never gets delivered, because they don’t have the structures in place.

“People are still thinking about it as bits of kit; they’re not embedding it in temporal thinking about what we can do.”

Despite this, Alexander said community health is one area set to undergo a technology transformation.

“We’ve got a great opportunity: we’re at the heart of a time where the community revolution is about to start, and it’s time to get some really innovative community technology out there.”

Source EHI http://www.ehi.co.uk/news/EHI/9652/nursing-tech-fund-2-to-be-open-to-all

25 September 2014   Sam Sachdeva

Nursing tech fund 2 to be open to all

Pharma spent $342m on journal advertising in first half of 2014

J&J led spending and Invokana was most advertised brand

Pharma companies spent more than $342m on print advertising in professional health journals in the first six months of this year, according to new figures.

Kantar Media says its research shows a 1% rise in pharma’s print journal advertising and it names Johnson & Johnson – whose spending of almost $23m on advertising drugs products accounts for 7$ of the total advertising share – as the industry’s single biggest spender.

GlaxoSmithKline was the second highest spender investing $9m, less than half that spent by Johnson & Johnson, but up 110% for the company compared to the 2013 period.

Takeda, Pfizer and Novartis were the next highest spenders, each investing $7m in print advertising.

Kantar says the total number of advertising pages purchased in medical journals was down, year-on-year, by 2% to 53,094.

On a therapy basis, oncology brands lead the spending, accounting for $25m and making up 7% of the total market share, followed by oral diabetes drugs ($14m), up 52% from July 2013, and forming 4% of sales.

Meanwhile, in brand terms Invokana, the first-in-class type 2 diabetes drug from J&J’s Janssen unit was the most advertised drug product in the first six months of 2014.

J&J spent $12m to advertise the drug, which was approved in the US in April 2013, was up 84% on the same period in 2013, while Lundbeck’s antidepressant Brintellix was next in spending terms with $7m.

Behind those two came Bayer’s blood clot drug Xarelto and Forest’s anti-depression treatment Fetzima, each of which spent $5m on print journal advertising.

Source PMLive http://www.pmlive.com/pharma_news/pharma_spent_$342m_on_journal_advertising_in_first_half_of_2014_598144

Pharma spent $342m on journal advertising in first half of 2014