Dear All,
please find below an interesting opening in Germany. The contact for this opportunity is Christine Sands (see below post)
Regards
Ulf
Client
Our client is a globally focused research driven pharmaceutical company. Headquartered in Germany, their operations are underpinned by a commitment to excellence in all aspects of their operation. They are driven by a desire to focus on the creation of novel solutions in a team orientated and ambitious and positive environment. The client has affiliates in 34 countries and is seeking to expand its presence in Europe by means of further internationalisation, development and business evolution. The strategy is driven forwards by a management team that is committed to the ensuring that they retain their scientific focus whilst ensuring that they are able to compete effectively in a global market place.
The company has production sites in seven countries which supply the global market and are committed to ensuring that every external interaction generates a positive impression.
On a scientific level they are known as specialists in a number of therapeutic areas including the pain/analgesics and CNS. They are also involved in the development and production of novel drug delivery systems. The focus in R&D is centred on a quality lead approach which seeks to ensure that all development activities meet the highest global regulatory standards. The client markets its products all over the world. At the same time they in-license products in target indications and out-license their own successful products. In 2004 they employed more than 2,000 people in Germany alone, this figure rose to 5,200 FTEs on a global basis. As a sign of their international penetration and reach the client now market their products in over a 100 countries.
It is vital that we source individuals who keen to develop themselves and their career and who can operate effectively in a goal-focused and solutions orientated environment.
Role
The Head of Pricing & Reimbursement is responsible for managing the strategic pricing and reimbursement of our client, reporting to the Head of Global Market Access. This means ownership for the pricing & reimbursement strategy for our client’s global brands and management of all their prices. This requires a clear perspective of value argumentation, evidence requirements and knowledge on trading off risks and opportunities in the European health markets. The Head of
Pricing & Reimbursement is responsible for supporting the senior commercial leadership team in decision making and supporting our client’s subsidiaries. The role will directly manage one Pricing & Reimbursement Manager (position vacant) and potentially additional team members.
Key Responsibilities:
• To develop and implement international pricing strategies, taking ownership of developing the strategy, updating documentation and aligning the strategies with the commercial centre and international teams;
• To support assessment of the value argumentation to payers, co-developing the value story, evidence and gap assessments with HEOR, Medical and Marketing colleagues;
• To assess and advise the commercial senior leadership team on the commercialization of our products particularly with regards to: the impact of international pricing & reimbursement systems on marketing and market access strategies; the assessment of pricing and market access risks arising from price changes, particularly focused on EU vs local opportunities and
risks; communication of pricing and reimbursement strategies to senior management;
• To lead the recently implemented global price management process and global market
access strategy process;
• To support market access strategies with pricing studies, advise on projects that support the value argumentation and be the contact lead for all pricing and reimbursement related issues;
• To advise on the price potential for business development opportunities;
• To ensure the cross functional cooperation with our product teams regarding all questions about pricing and reimbursement and value argumentation.
Skills & Experience required:
• University degree in the medico-pharmaceutical field, natural sciences and/or business management, master degree in economics or statistics desirable
• A minimum of 5-10 years' experience in pricing in the pharmaceutical industry or a relevant consultancy firm
• Demonstrated expertise with pricing and reimbursement of pharmaceuticals with in depth knowledge of European pricing and reimbursement systems
• Health care industry experience and in-depth knowledge of the pharmaceutical business including R&D, clinical and marketing
• Strong ability to assess the economical and healthcare political environment and a keen sense to anticipate new trends and market opportunities
• An excellent written and oral command of English
• High degree of computer literacy and knowledge of computer modelling
• Excellent analytical skills, judgment and problem solving skills
Our client offers an exciting and challenging role in a future-oriented environment as well as excellent possibilities for personal and professional advancement.
Christine Sands | Project Manager | AspirionPharma
T + 44 (0) 132 230 3483
M + 44 (0) 789 670 0589
F + 44 (0) 132 230 3033
christine.sands@aspirionpharma.com
www.aspirionpharma.com
8.25.2010
Avastin patient access scheme too complicated, says NICE
from www.inpharm.com
Avastin patient access scheme too complicated, says NICE
Published on 25/08/10 at 09:56am
NICE is set to say no again to Avastin for use in patients with colorectal cancer.
Avastin was first launched in the UK in 2005, but was eventually rejected by NICE two years later, a block on NHS use that continues to this day.
Now the drug looks set to be rejected by NICE once again, with the watchdog saying a ‘patient access scheme’ offered by Roche in January to help cut costs is too complicated and may not offer value for money.
The review is looking at Avastin (bevacizumab), in combination with chemotherapy (oxaliplatin and either 5-fluorouracil or capecitabine) in metastatic colorectal cancer (mCRC).
The patient access scheme would have supplied Avastin at a fixed cost of around £20,800 per patient for one year, with a further 12 months of treatment free of charge, and with the cost of chemotherapy agent oxaliplatin also paid by Roche.
Roche then added to this an additional upfront payment to the NHS for each person starting first line treatment with Avastin. Despite these efforts, NICE’s committee has concluded this scheme too complex to accurately assess its cost-effectiveness.
NICE concluded: “The committee felt the proposed patient access scheme was complex and the administrative costs were likely to be higher than in [Roche’s] calculations. It was therefore uncertain what the impact of the scheme would be on the cost-effectiveness of bevacizumab.”
Sir Andrew Dillon, chief executive of NICE, said that it has already approved several treatments for mCRC, including Merck Serono’s Erbitux as a first line treatment, indicating that patients do have a number of choices beyond Avastin.
Dillon added: “We are disappointed not to be able to recommend bevacizumab as well but we have to be confident that the benefits justify the considerable cost of this drug.”
Charities disappointed
Mark Flannagan, chief executive of UK charity group Beating Bowel Cancer, said: “This preliminary decision by NICE is a great blow to patients with advanced bowel cancer.
“While we understand that it may not be a suitable treatment for all advanced bowel cancer patients, Avastin has been shown to increase survival by an average of five months, and can offer patients a better quality of life at a time when every day counts.”
A spokesperson for Bowel Cancer UK said that it was “naturally disappointed” that Avastin was turned down by NICE in its preliminary guidance. The charity added that it hopes the introduction of the new Interim Drugs Fund in October and the Cancer Drugs Fund next April will “enable patients and their clinicians to gain greater access to effective treatments like Avastin on the NHS”
The spokesperson concluded this should be done in order to “create a fairer, more timely and more efficient system that puts patients’ health needs first”.
New cancer funding
The Cancer Drugs Fund (CDF), an election pledge of the Conservatives, is targeted to add an extra £200 million to this process. In August, the health minister Lord Howe said that this figure was “aspirational” and is subject to a spending review in October.
In July the coalition government introduced an ‘emergency’ Interim Drugs Fund (IDF) to help ‘top up’ the CDF before it comes into force next year. This IDF will be worth £50 million to primary care trusts across the country.
Both funds are intended to be used to ‘by-pass’ NICE restrictions on certain cancer drugs and allow greater patient access to oncology treatments.
This additional funding could potentially help Avastin gain access to the UK market even if NICE does not approve of its use in the NHS. The industry is however still in the dark on the specifics of how these funds will work and how they can be accessed effectively.
Ben Adams
Avastin patient access scheme too complicated, says NICE
Published on 25/08/10 at 09:56am
NICE is set to say no again to Avastin for use in patients with colorectal cancer.
Avastin was first launched in the UK in 2005, but was eventually rejected by NICE two years later, a block on NHS use that continues to this day.
Now the drug looks set to be rejected by NICE once again, with the watchdog saying a ‘patient access scheme’ offered by Roche in January to help cut costs is too complicated and may not offer value for money.
The review is looking at Avastin (bevacizumab), in combination with chemotherapy (oxaliplatin and either 5-fluorouracil or capecitabine) in metastatic colorectal cancer (mCRC).
The patient access scheme would have supplied Avastin at a fixed cost of around £20,800 per patient for one year, with a further 12 months of treatment free of charge, and with the cost of chemotherapy agent oxaliplatin also paid by Roche.
Roche then added to this an additional upfront payment to the NHS for each person starting first line treatment with Avastin. Despite these efforts, NICE’s committee has concluded this scheme too complex to accurately assess its cost-effectiveness.
NICE concluded: “The committee felt the proposed patient access scheme was complex and the administrative costs were likely to be higher than in [Roche’s] calculations. It was therefore uncertain what the impact of the scheme would be on the cost-effectiveness of bevacizumab.”
Sir Andrew Dillon, chief executive of NICE, said that it has already approved several treatments for mCRC, including Merck Serono’s Erbitux as a first line treatment, indicating that patients do have a number of choices beyond Avastin.
Dillon added: “We are disappointed not to be able to recommend bevacizumab as well but we have to be confident that the benefits justify the considerable cost of this drug.”
Charities disappointed
Mark Flannagan, chief executive of UK charity group Beating Bowel Cancer, said: “This preliminary decision by NICE is a great blow to patients with advanced bowel cancer.
“While we understand that it may not be a suitable treatment for all advanced bowel cancer patients, Avastin has been shown to increase survival by an average of five months, and can offer patients a better quality of life at a time when every day counts.”
A spokesperson for Bowel Cancer UK said that it was “naturally disappointed” that Avastin was turned down by NICE in its preliminary guidance. The charity added that it hopes the introduction of the new Interim Drugs Fund in October and the Cancer Drugs Fund next April will “enable patients and their clinicians to gain greater access to effective treatments like Avastin on the NHS”
The spokesperson concluded this should be done in order to “create a fairer, more timely and more efficient system that puts patients’ health needs first”.
New cancer funding
The Cancer Drugs Fund (CDF), an election pledge of the Conservatives, is targeted to add an extra £200 million to this process. In August, the health minister Lord Howe said that this figure was “aspirational” and is subject to a spending review in October.
In July the coalition government introduced an ‘emergency’ Interim Drugs Fund (IDF) to help ‘top up’ the CDF before it comes into force next year. This IDF will be worth £50 million to primary care trusts across the country.
Both funds are intended to be used to ‘by-pass’ NICE restrictions on certain cancer drugs and allow greater patient access to oncology treatments.
This additional funding could potentially help Avastin gain access to the UK market even if NICE does not approve of its use in the NHS. The industry is however still in the dark on the specifics of how these funds will work and how they can be accessed effectively.
Ben Adams
8.23.2010
CBI’s Risk-Sharing and Innovative Contracting for Bio/Pharmaceutical conference, 20-21 October 2010 in London
Dear All,
summer is almost over and it's time to get back to some business. I would like to highlight an interesting upcoming event in October.
CBI (The Center for Business Intelligence) is organizing a Risk-Sharing and Innovative Contracting for Bio/Pharmaceutical conference scheduled for 20-21 October 2010 in London at the Hilton London Canary Wharf. They have received much excitement from the market thus far.
I am providing the link with more detailed information.
Best wishes
Ulf
summer is almost over and it's time to get back to some business. I would like to highlight an interesting upcoming event in October.
CBI (The Center for Business Intelligence) is organizing a Risk-Sharing and Innovative Contracting for Bio/Pharmaceutical conference scheduled for 20-21 October 2010 in London at the Hilton London Canary Wharf. They have received much excitement from the market thus far.
I am providing the link with more detailed information.
Best wishes
Ulf
7.26.2010
NHS missing out on cancer drug payments
By Emma Wilkinson Health reporter, BBC News
Cost-sharing schemes for expensive new drugs are becoming increasingly common
The NHS may be missing out on millions of pounds of reimbursement for cancer
drugs because of onerous paperwork, say researchers.
Schemes to share the cost of expensive new drugs with pharmaceutical companies
are becoming increasingly common. Yet a survey of 31 English health trusts
showed up to 50% of the costs had not been recovered.
The Department of Health said it was working to make the schemes as simple as possible.
Writing in Clinical Pharmacist, Steve Williamson, consultant pharmacist at Northumbria Healthcare NHS Foundation Trust, said he welcomed wider access to cancer drugs.
But added that the complexity of reimbursement procedures risked making
schemes unworkable.
Continue reading the main story
“Start Quote
We're delighted to have these schemes because they allow patients access to drugs but they have not been executed very well”
End Quote Steve Williamson Study leader
With more of these deals being put in place, the NHS is coming under increasing pressure to track patients, fill in the correct forms and meet the deadlines set by pharmaceutical companies, he said.
The survey asked pharmacists for details of refunds on four of the first so-called 'patient access schemes'.
It included bortezomib for multiple myeloma, in which the NHS is entitled to a refund if patients do not respond to treatment, and sunitinib for kidney cancer, where the first cycle is free followed by a discount.
The responses showed that for these two drugs, refunds may not have been received in up to 50% of cases.
Seven-in-10 respondents said that they did not have capacity to take on any more schemes.
Potentially millions
The researchers said missed payments were in the thousands, and could even add up to millions.
Mr Williamson said the NHS needed to set some basic templates for how such schemes should work rather than each company coming up with their own paperwork.
And he said there needed to be more flexibility, with time-limits on reimbursement.
"The bottom line is we're delighted to have these schemes because they allow patients access to drugs but they have not been executed very well.
"For example with bortezomib, in principle this is a very good scheme because if it doesn't work you get the money back, but if for some reason you miss making one claim within the timeframe allowed it costs £12,000."
Survey co-author David Thomson, lead pharmacist for Yorkshire Cancer Network, said: "I would continue to support any mechanism that improves patients' access to effective cancer drugs at cost-effective prices to the NHS.
But he said an "inappropriate amount of NHS staff time" is being diverted from clinical roles into dealing with bureaucracy.
He also raised concerns that proposals for a £200m cancer drug fund for treatments not available on the NHS would further increase bureaucracy.
A Department of Health spokesman said it continued to work with the pharmaceutical industry to make the schemes as easy as possible to implement.
"We have - through the National Institute for health and Clinical Excellence (NICE) - now set up an expert advisory panel with strong NHS representation which is consulted when schemes are proposed and which provides advice to the department on their implementability.
"Primary care trusts and hospital trusts need to agree locally between them how any rebates paid by drug companies are dealt with."
Cost-sharing schemes for expensive new drugs are becoming increasingly common
The NHS may be missing out on millions of pounds of reimbursement for cancer
drugs because of onerous paperwork, say researchers.
Schemes to share the cost of expensive new drugs with pharmaceutical companies
are becoming increasingly common. Yet a survey of 31 English health trusts
showed up to 50% of the costs had not been recovered.
The Department of Health said it was working to make the schemes as simple as possible.
Writing in Clinical Pharmacist, Steve Williamson, consultant pharmacist at Northumbria Healthcare NHS Foundation Trust, said he welcomed wider access to cancer drugs.
But added that the complexity of reimbursement procedures risked making
schemes unworkable.
Continue reading the main story
“Start Quote
We're delighted to have these schemes because they allow patients access to drugs but they have not been executed very well”
End Quote Steve Williamson Study leader
With more of these deals being put in place, the NHS is coming under increasing pressure to track patients, fill in the correct forms and meet the deadlines set by pharmaceutical companies, he said.
The survey asked pharmacists for details of refunds on four of the first so-called 'patient access schemes'.
It included bortezomib for multiple myeloma, in which the NHS is entitled to a refund if patients do not respond to treatment, and sunitinib for kidney cancer, where the first cycle is free followed by a discount.
The responses showed that for these two drugs, refunds may not have been received in up to 50% of cases.
Seven-in-10 respondents said that they did not have capacity to take on any more schemes.
Potentially millions
The researchers said missed payments were in the thousands, and could even add up to millions.
Mr Williamson said the NHS needed to set some basic templates for how such schemes should work rather than each company coming up with their own paperwork.
And he said there needed to be more flexibility, with time-limits on reimbursement.
"The bottom line is we're delighted to have these schemes because they allow patients access to drugs but they have not been executed very well.
"For example with bortezomib, in principle this is a very good scheme because if it doesn't work you get the money back, but if for some reason you miss making one claim within the timeframe allowed it costs £12,000."
Survey co-author David Thomson, lead pharmacist for Yorkshire Cancer Network, said: "I would continue to support any mechanism that improves patients' access to effective cancer drugs at cost-effective prices to the NHS.
But he said an "inappropriate amount of NHS staff time" is being diverted from clinical roles into dealing with bureaucracy.
He also raised concerns that proposals for a £200m cancer drug fund for treatments not available on the NHS would further increase bureaucracy.
A Department of Health spokesman said it continued to work with the pharmaceutical industry to make the schemes as easy as possible to implement.
"We have - through the National Institute for health and Clinical Excellence (NICE) - now set up an expert advisory panel with strong NHS representation which is consulted when schemes are proposed and which provides advice to the department on their implementability.
"Primary care trusts and hospital trusts need to agree locally between them how any rebates paid by drug companies are dealt with."
7.09.2010
Oncology drug price cuts announced in Italy related to perfomance based schemes
The Financial Times reported yesterday the potential reduction of oncology drug prices in Italy starting in 2011 after an initial analysis of registry data from the outcomes based schemes implemented in Italy since 2006/2007. Italy is one of the most active markets for risk sharing agreements, and has been launching performance based risk sharing schemes in the recent years. Guido Rasi, dircetor of AIFA, the Italian drug agency stated that according to this preliminary analysis of two year data selected drugs could be reduced by 30 to 40 percent. The full data is expected to be publsihed in the next few month. Among the drugs that could be affected by the plans are in my view Tarceva, Dasatinib, Sutent and Nexavar, of all which have been subject to the risk sharing agreement since 2006/2007 - especially since the FT cited Guido Rasi that price cuts were likely on the first batch of drugs authorized in these pay for performance schemes.
7.01.2010
Cutting drug prices hampers new development: study
(Reuters) - Cutting pharmaceutical prices in the way European governments are doing now will severely reduce the number of new drugs making it to market, according to a study of the sector by a Berlin-based business group.
Health
A report by the European School of Management and Technology Competition Analysis (EMST CA), and commissioned by the drugmaker Novartis, said there was a direct link between strict regulation and low innovation in the sector.
New medications likely to be hit hardest under tough pricing regulation include antibiotics, as well as treatments for heart disease and immune system disorders such as multiple sclerosis and chronic meningitis, it said.
The report comes as governments across Europe are seeking to slash drugs prices as they reign in spending to try to tackle runaway budget deficits.
Germany's government approved a draft bill on Tuesday which aims to eventually save some 2 billion euros ($2.4 billion) each year on the cost of patented drugs by breaking up drugmakers' pricing power, and Greece has also moved to slash drug prices by more than a fifth on average.
"Our study shows the consequences that pricing and reimbursement regulation can have on pharmaceutical innovation. It also shows that, incorrectly applied, regulation can reduce the value of pharmaceutical projects and curtail the resources available to carry them out," Hans Friederiszick of ESMT CA said in a statement with the report.
"Rational investors will naturally look for the most profitable investment choices, which is why regulation has a direct impact on the number and characteristics of the medications developed."
This means the more innovative drugs were like to get the most attention he said, whilst important areas like the development of new antibiotics may get left behind.
Drugmakers, such as GlaxoSmithKline and AstraZeneca are already cutting back on research and development (R&D) as they try to position themselves for a huge "cliff" of patents on big-selling drugs that are set to expire over the next five years.
The EMST report said that while European governments predominantly see pharmaceutical pricing models as a way of controlling public health costs, they may not realize or acknowledge the implications for product value, and therefore for the development of new drugs.
It said that internal reference pricing (IRP) -- a system used within Europe whereby prices in one country are taken as a reference point for others in negotiations -- could result in an almost 12 percent drop in prices.
Beyond that, another pricing system called external price benchmarking (EPB) -- a model widely used across OECD countries -- can lead to an almost 6 price drop.
"Having some regions of the world under IRP and others under EPB magnifies the problem, since internal prices are then exported to external markets, leading to a 19.8 percent drop in portfolio value," the report said.
Reference pricing is common throughout the Europe Union and even beyond, with countries including Japan and Canada also taking account of European prices when deciding reimbursement.
(Editing by Louise Heavens)
Health
A report by the European School of Management and Technology Competition Analysis (EMST CA), and commissioned by the drugmaker Novartis, said there was a direct link between strict regulation and low innovation in the sector.
New medications likely to be hit hardest under tough pricing regulation include antibiotics, as well as treatments for heart disease and immune system disorders such as multiple sclerosis and chronic meningitis, it said.
The report comes as governments across Europe are seeking to slash drugs prices as they reign in spending to try to tackle runaway budget deficits.
Germany's government approved a draft bill on Tuesday which aims to eventually save some 2 billion euros ($2.4 billion) each year on the cost of patented drugs by breaking up drugmakers' pricing power, and Greece has also moved to slash drug prices by more than a fifth on average.
"Our study shows the consequences that pricing and reimbursement regulation can have on pharmaceutical innovation. It also shows that, incorrectly applied, regulation can reduce the value of pharmaceutical projects and curtail the resources available to carry them out," Hans Friederiszick of ESMT CA said in a statement with the report.
"Rational investors will naturally look for the most profitable investment choices, which is why regulation has a direct impact on the number and characteristics of the medications developed."
This means the more innovative drugs were like to get the most attention he said, whilst important areas like the development of new antibiotics may get left behind.
Drugmakers, such as GlaxoSmithKline and AstraZeneca are already cutting back on research and development (R&D) as they try to position themselves for a huge "cliff" of patents on big-selling drugs that are set to expire over the next five years.
The EMST report said that while European governments predominantly see pharmaceutical pricing models as a way of controlling public health costs, they may not realize or acknowledge the implications for product value, and therefore for the development of new drugs.
It said that internal reference pricing (IRP) -- a system used within Europe whereby prices in one country are taken as a reference point for others in negotiations -- could result in an almost 12 percent drop in prices.
Beyond that, another pricing system called external price benchmarking (EPB) -- a model widely used across OECD countries -- can lead to an almost 6 price drop.
"Having some regions of the world under IRP and others under EPB magnifies the problem, since internal prices are then exported to external markets, leading to a 19.8 percent drop in portfolio value," the report said.
Reference pricing is common throughout the Europe Union and even beyond, with countries including Japan and Canada also taking account of European prices when deciding reimbursement.
(Editing by Louise Heavens)
6.29.2010
Methodology on value based pricing?
Dear all,
I just posted below question on linkedin and would be delighted to hear your opinion.
Thanks
Ulf
"There is an increasing debate around the introduction of value based pricing systems for pharmaceuticals in certain markets, some more detailed and methodological while others are very fluffy and vague. What in your opinion would be a fair and sound methodological concept for the establishment of value based pricing for both industry and health authorities/society?"
I just posted below question on linkedin and would be delighted to hear your opinion.
Thanks
Ulf
"There is an increasing debate around the introduction of value based pricing systems for pharmaceuticals in certain markets, some more detailed and methodological while others are very fluffy and vague. What in your opinion would be a fair and sound methodological concept for the establishment of value based pricing for both industry and health authorities/society?"
6.03.2010
The Perfect 'Pricing' Storm
Dear Readers,
so much is going on these days that it is difficult to decide what to discuss here (although a nice problem to have ;). We are having the "Perfect Storm" on the pricing front, first with Greece's major cuts, many companies now are withdrawing products, exchange rate devaluations with international price referencing consequences, than followed by Spain price cuts and other measures, twice actually, now Italy and France as per FirstWord article below. In addition to that the German health minister has brought foreward the new proposal of the reform of the drug law (Arzneimittelgesetz) that also will have major implications if approved. It will now go through discussions and voting in the Bundestag.
Best,
Ulf
France, Italy announce drug pricing cuts
by Lianne Dane
France and Italy announced plans to reduce healthcare spending, with a particular focus on cutting drug prices in a bid to close budget shortfalls. France plans to reduce drug prices by 100 million euros ($122 million) this year, while the Italian government aims to cut off-patent generic drug prices by 12.5 percent from June 2010 until the end of the year.
Other measures introduced in Italy include the establishment of a drug tendering system beginning in 2011 where reimbursement of generics will be limited to the least expensive medicine within four therapeutic categories.
Commenting on France's decision, Noël Renaudin, an official in the health ministry, said "we have to stop the infinite growth in prices for drugs. It’s no longer reasonable.” The announcements follow a recent decree by Greek authorities to lower drug prices by about 25 percent in the country. Citigroup analysts predicted that drug price cuts in Europe's five largest economies could measure between 5 percent and 10 percent.
Commenting on the news, an international health policy expert from the London School of Economics, Panos Kanavos, said “in the face of adversity, commodities like drugs are an easy place for decision-makers to start [cutting] …. and there is considerable scope to cut in many cases." GlaxoSmithKline CEO Andrew Witty noted that "a few European countries hit us every year with big price cuts. I’m not terrified.”
so much is going on these days that it is difficult to decide what to discuss here (although a nice problem to have ;). We are having the "Perfect Storm" on the pricing front, first with Greece's major cuts, many companies now are withdrawing products, exchange rate devaluations with international price referencing consequences, than followed by Spain price cuts and other measures, twice actually, now Italy and France as per FirstWord article below. In addition to that the German health minister has brought foreward the new proposal of the reform of the drug law (Arzneimittelgesetz) that also will have major implications if approved. It will now go through discussions and voting in the Bundestag.
Best,
Ulf
France, Italy announce drug pricing cuts
by Lianne Dane
France and Italy announced plans to reduce healthcare spending, with a particular focus on cutting drug prices in a bid to close budget shortfalls. France plans to reduce drug prices by 100 million euros ($122 million) this year, while the Italian government aims to cut off-patent generic drug prices by 12.5 percent from June 2010 until the end of the year.
Other measures introduced in Italy include the establishment of a drug tendering system beginning in 2011 where reimbursement of generics will be limited to the least expensive medicine within four therapeutic categories.
Commenting on France's decision, Noël Renaudin, an official in the health ministry, said "we have to stop the infinite growth in prices for drugs. It’s no longer reasonable.” The announcements follow a recent decree by Greek authorities to lower drug prices by about 25 percent in the country. Citigroup analysts predicted that drug price cuts in Europe's five largest economies could measure between 5 percent and 10 percent.
Commenting on the news, an international health policy expert from the London School of Economics, Panos Kanavos, said “in the face of adversity, commodities like drugs are an easy place for decision-makers to start [cutting] …. and there is considerable scope to cut in many cases." GlaxoSmithKline CEO Andrew Witty noted that "a few European countries hit us every year with big price cuts. I’m not terrified.”
5.27.2010
NICE backs Iressa after Astra sets fixed cost
from Reuters 27.05.2010, Ben Hirschler
AstraZeneca Plc's cancer pill Iressa has been recommended for use in the National Health Service (NHS) after the drugmaker agreed an unusual fixed cost deal.
The arrangement highlights the mounting pressure on firms to agree favourable "patient access schemes" in order to win approval from the National Institute for Health and Clinical Excellence (NICE), which decides if drugs are cost effective.
Iressa will be supplied at a fixed cost of 12,200 pounds, irrespective of the duration of treatment, and there will be no charge for patients who are treated for less than three months.
"It has been designed to ensure value for money for the NHS and to enable the budget impact to be predicted more accurately," said AstraZeneca spokeswoman Abigail Baron.
While NICE does not negotiate or set prices, it does take special offers into account when deciding whether to recommend drugs for reimbursement on the NHS.
In future the watchdog could play a more direct role in determining prices under government plans to move to a system of "value-based pricing."
NICE said on Thursday its draft recommendation on Iressa, which is also known as gefitinib, was open to consultation before publication of final guidance later this year.
NEW PRICING
The agency had asked AstraZeneca in January for information on Iressa. This was provided along with the new pricing offer.
Lung cancer is one of the most common cancers in Britain, with around 38,000 people diagnosed every year. The most common type is called non-small cell lung cancer.
Iressa -- a once-daily pill -- was approved by European regulators last July for adults with locally advanced or metastatic lung cancer whose tumours have an EGFR mutation.
A mutation in the epidermal growth factor receptor (EGFR) is a characteristic occurring in around 13 percent of lung cancers in Europe, and studies have shown these types of tumours are particularly sensitive to Iressa.
The European regulator's decision effectively revived the fortunes of a drug that had been largely written off after it failed to show significant benefits in the overall population of lung cancer patients in a clinical tests five years ago.
In Britain, NICE has already recommended various injectable treatments for lung cancer, but Carole Longson, health technology evaluation centre director at NICE, said Iressa offered an advantage because it is taken in tablet form.
Separately, NICE said it had also recommended Roche's
established cancer drug Xeloda as a first-line treatment for inoperable advanced gastric cancer, when used in combination with platinum-based chemotherapy.
Gastric, or stomach, cancer affects approximately 8,200 people in Britain every year.
(Editing by David Holmes)
AstraZeneca Plc's cancer pill Iressa has been recommended for use in the National Health Service (NHS) after the drugmaker agreed an unusual fixed cost deal.
The arrangement highlights the mounting pressure on firms to agree favourable "patient access schemes" in order to win approval from the National Institute for Health and Clinical Excellence (NICE), which decides if drugs are cost effective.
Iressa will be supplied at a fixed cost of 12,200 pounds, irrespective of the duration of treatment, and there will be no charge for patients who are treated for less than three months.
"It has been designed to ensure value for money for the NHS and to enable the budget impact to be predicted more accurately," said AstraZeneca spokeswoman Abigail Baron.
While NICE does not negotiate or set prices, it does take special offers into account when deciding whether to recommend drugs for reimbursement on the NHS.
In future the watchdog could play a more direct role in determining prices under government plans to move to a system of "value-based pricing."
NICE said on Thursday its draft recommendation on Iressa, which is also known as gefitinib, was open to consultation before publication of final guidance later this year.
NEW PRICING
The agency had asked AstraZeneca in January for information on Iressa. This was provided along with the new pricing offer.
Lung cancer is one of the most common cancers in Britain, with around 38,000 people diagnosed every year. The most common type is called non-small cell lung cancer.
Iressa -- a once-daily pill -- was approved by European regulators last July for adults with locally advanced or metastatic lung cancer whose tumours have an EGFR mutation.
A mutation in the epidermal growth factor receptor (EGFR) is a characteristic occurring in around 13 percent of lung cancers in Europe, and studies have shown these types of tumours are particularly sensitive to Iressa.
The European regulator's decision effectively revived the fortunes of a drug that had been largely written off after it failed to show significant benefits in the overall population of lung cancer patients in a clinical tests five years ago.
In Britain, NICE has already recommended various injectable treatments for lung cancer, but Carole Longson, health technology evaluation centre director at NICE, said Iressa offered an advantage because it is taken in tablet form.
Separately, NICE said it had also recommended Roche's
established cancer drug Xeloda as a first-line treatment for inoperable advanced gastric cancer, when used in combination with platinum-based chemotherapy.
Gastric, or stomach, cancer affects approximately 8,200 people in Britain every year.
(Editing by David Holmes)
5.04.2010
New reference pricing rule in Greece
After much debate the Greek Ministry of Economy, Competitiveness & Shipping has announced a new reference pricing law for pharmaceuticals. The struggling Greek economy is looking for opportunities to realize savings in the health care sector and has introduced a decree of mandatory price reductions. Depending on wholesale price reduction from -3% to -27% (drugs of over €100.01) will be implemented. Orphan drugs and blood derivates are excempted from that decree. This is supposed to be a temporary measure. At the same time a referencing rule of the lowest three countries in the Eurozone is being discussed and for orphan drugs three lowest plus Uk. I must say it is very confusing..it will be interesting to follow how this unfolds.
Cheers
Ulf
Cheers
Ulf
3.23.2010
New "Health Pact" in Spain
The Spanish health minister, Trinidad Jiménez, announced after the last Interterritorial Council meeting in Madrid a new agreement ("gran acuerdo") that will help to save 1.500 million Euros for the Spanish health system. Major parts of the savings are supposed to come from pharmaceutical expenditure cuts via measures such as:
- New therapeutic reference price system for drugs more than 10 years on the market
- Price decrease for generic medicines (25% on average)
- Price freeze / cap for medications for minor symptomatic treatments
etc...
Several other changes are also being implemented especially in relation to equality of access and efficiency of the system. The PP (Partido Popular)at the same time announced that economic evaluations will have to become a key component in order to sustain the Spanish NHS and urged the creation of a Spanish NICE...
Right after Germany's announcements a week earlier, Spain has now followed suit in targeting pharmaceutical expenditures as a main source for cost savings. Farmaindustria, the local industry association, is deeply concerned about the effects on R&D activity as well as employment in the sector - so far one of the remaining ´locomotives´ for growth in a widening economic downturn.
For the Spanish speaking readers I post below link with some more info on the topic.
http://www.elglobal.net/articulo.asp?idcat=641&idart=469995
- New therapeutic reference price system for drugs more than 10 years on the market
- Price decrease for generic medicines (25% on average)
- Price freeze / cap for medications for minor symptomatic treatments
etc...
Several other changes are also being implemented especially in relation to equality of access and efficiency of the system. The PP (Partido Popular)at the same time announced that economic evaluations will have to become a key component in order to sustain the Spanish NHS and urged the creation of a Spanish NICE...
Right after Germany's announcements a week earlier, Spain has now followed suit in targeting pharmaceutical expenditures as a main source for cost savings. Farmaindustria, the local industry association, is deeply concerned about the effects on R&D activity as well as employment in the sector - so far one of the remaining ´locomotives´ for growth in a widening economic downturn.
For the Spanish speaking readers I post below link with some more info on the topic.
http://www.elglobal.net/articulo.asp?idcat=641&idart=469995
3.12.2010
The End of Free Drug Pricing in Germany?
Dear All,
below article from invivoblog is a nice summary of the issue that was widely discussed yesterday in the German press. I would just like to add that several health ministers before him have made the attempt to implement price regulations, therefore it remains to be seen what the legal framework is but I am amazed about the tone the Minister used in the press and the selective targeting of pharmaceuticals... the other thing is that IQWIG and is cost-benefit asessment has not produced much so far. All in all will have to see what is coming but certain is that things are changing in Germany...
Cheers
Ulf
from http://invivoblog.blogspot.com/
According to local press, Germany's health minister Philipp Roesler is about to open fire against the branded drug industry with a proposal to break the sector's so-called 'price monopoly' and force them to negotiate lower prices directly with insurers.
Until now, Germany has been one of Europe's last bastions of "free" upfront drug pricing. Sure, the hurdles come afterwards, but both there and in the UK drug firms have--until now--been allowed to set more or less the price they like for new drugs.
"Focus" magazine reported on Saturday that Roesler would impose upon the branded sector fixed price ceilings for their products, should they not come to an agreement with the insurers. Either way, he's gunning for annual health care cost savings of €2 billion.
Direct price negotiations between insurers and drug firms have been legal since 2007. Unsurprisingly though, few if any branded companies have engaged in price-centric dealmaking (or indeed any dealmaking). Most prefer instead to focus on providing other benefits such as supporting compliance.
Meanwhile, as we reported in-depth last year in IN VIVO, the country's largest insurers have already squeezed out over €500 million in savings from the generics sector through inviting best-deal bids for two-year 'preferred supplier' contracts. That trend looks set to continue as firms compete for the next round of contracts.
This is also very likely what's prompting Roesler to try twist the branded sector's arm into likewise negotiating more competitive deals with insurers. We can't imagine that Christopher Hermann, chief negotiator and deputy CEO at the country's largest insurer, will have much to complain about. Frustrated up until now by the branded sector's reluctance to negotiate on price, he nevertheless appeared to see this coming when, back in early 2009, he told us: "I expect contracts around on-patent drugs to become more numerous, as in the next months and years there will be more contracts between health insurance funds and independent doctors' associations in Germany."
His point: insurance funds' negotiating clout is increasing as they wield more and more influence over precisely what drugs doctors prescribe (even though they're not allowed to dictate what drugs are prescribed, as they are in the case of generics).
Lesser of Two Evils?
If Roesler's plan is put into action, drug firms are unlikely to be able to afford to resist, given the alternative: imposed price ceilings that could impact prices not only in Germany, Europe's largest market, but also more broadly across Europe given that Germany service as a reference price market in several other (fixed-price) countries. Negotiating with sick funds may offer industry a little squeeze-room, for instance to provide or fund supplementary services. Such agreements also exempt them from an assessment by IQWiG, Germany's cost-benefit watchdog.
Indeed, another element of Roesler's plan--due to be presented this Wednesday--will allegedly require drug firms to submit, in parallel with a new drug application, a benefit-assessment study of their product, showing which patients the product will serve and which comparator drugs, if any, are already available.
None of this is particularly surprising in today's era of government spending cuts and (continued) targeting of drug manufacturers to make their quick-wins. But whilst it tastes bitter, it may also be an (the last?) opportunity for firms to avoid government-imposed price cuts.
Indeed, Novo Nordisk's CEO Germany, Willi Schnorpfeil , told us in mid-2009 that he would like to see a de-regulated market in Germany with price negotiations between drug firms and payors permitted from day one, as soon as a drug is authorized. Such a system—replacing the current set-up of free up-front pricing with complex rebate solutions and, potentially, centrally determined cost-benefit assessments slapped on thereafter--would allow faster market access to be a negotiating factor, too, he argued
below article from invivoblog is a nice summary of the issue that was widely discussed yesterday in the German press. I would just like to add that several health ministers before him have made the attempt to implement price regulations, therefore it remains to be seen what the legal framework is but I am amazed about the tone the Minister used in the press and the selective targeting of pharmaceuticals... the other thing is that IQWIG and is cost-benefit asessment has not produced much so far. All in all will have to see what is coming but certain is that things are changing in Germany...
Cheers
Ulf
from http://invivoblog.blogspot.com/
According to local press, Germany's health minister Philipp Roesler is about to open fire against the branded drug industry with a proposal to break the sector's so-called 'price monopoly' and force them to negotiate lower prices directly with insurers.
Until now, Germany has been one of Europe's last bastions of "free" upfront drug pricing. Sure, the hurdles come afterwards, but both there and in the UK drug firms have--until now--been allowed to set more or less the price they like for new drugs.
"Focus" magazine reported on Saturday that Roesler would impose upon the branded sector fixed price ceilings for their products, should they not come to an agreement with the insurers. Either way, he's gunning for annual health care cost savings of €2 billion.
Direct price negotiations between insurers and drug firms have been legal since 2007. Unsurprisingly though, few if any branded companies have engaged in price-centric dealmaking (or indeed any dealmaking). Most prefer instead to focus on providing other benefits such as supporting compliance.
Meanwhile, as we reported in-depth last year in IN VIVO, the country's largest insurers have already squeezed out over €500 million in savings from the generics sector through inviting best-deal bids for two-year 'preferred supplier' contracts. That trend looks set to continue as firms compete for the next round of contracts.
This is also very likely what's prompting Roesler to try twist the branded sector's arm into likewise negotiating more competitive deals with insurers. We can't imagine that Christopher Hermann, chief negotiator and deputy CEO at the country's largest insurer, will have much to complain about. Frustrated up until now by the branded sector's reluctance to negotiate on price, he nevertheless appeared to see this coming when, back in early 2009, he told us: "I expect contracts around on-patent drugs to become more numerous, as in the next months and years there will be more contracts between health insurance funds and independent doctors' associations in Germany."
His point: insurance funds' negotiating clout is increasing as they wield more and more influence over precisely what drugs doctors prescribe (even though they're not allowed to dictate what drugs are prescribed, as they are in the case of generics).
Lesser of Two Evils?
If Roesler's plan is put into action, drug firms are unlikely to be able to afford to resist, given the alternative: imposed price ceilings that could impact prices not only in Germany, Europe's largest market, but also more broadly across Europe given that Germany service as a reference price market in several other (fixed-price) countries. Negotiating with sick funds may offer industry a little squeeze-room, for instance to provide or fund supplementary services. Such agreements also exempt them from an assessment by IQWiG, Germany's cost-benefit watchdog.
Indeed, another element of Roesler's plan--due to be presented this Wednesday--will allegedly require drug firms to submit, in parallel with a new drug application, a benefit-assessment study of their product, showing which patients the product will serve and which comparator drugs, if any, are already available.
None of this is particularly surprising in today's era of government spending cuts and (continued) targeting of drug manufacturers to make their quick-wins. But whilst it tastes bitter, it may also be an (the last?) opportunity for firms to avoid government-imposed price cuts.
Indeed, Novo Nordisk's CEO Germany, Willi Schnorpfeil , told us in mid-2009 that he would like to see a de-regulated market in Germany with price negotiations between drug firms and payors permitted from day one, as soon as a drug is authorized. Such a system—replacing the current set-up of free up-front pricing with complex rebate solutions and, potentially, centrally determined cost-benefit assessments slapped on thereafter--would allow faster market access to be a negotiating factor, too, he argued
2.24.2010
Cost of Cancer
Dear All,
please find below link of an interesting piece of work on the cost of cancer in the UK.
best
Ulf
http://www.policyexchange.org.uk/images/publications/pdfs/The_Cost_of_Cancer_-_Feb__10.pdf
please find below link of an interesting piece of work on the cost of cancer in the UK.
best
Ulf
http://www.policyexchange.org.uk/images/publications/pdfs/The_Cost_of_Cancer_-_Feb__10.pdf
2.17.2010
Survey points to an increase in spending on pharmacoeconomics
... am sure that will be very welcomed news by the consultants among the readers ;)
Cheers
Ulf
Pharmacoeconomics to Get Bigger Budgets, According to Preliminary Survey Results
Marketwire News Releases
Published: 02/15/10 12:12 PM EST
Cutting Edge Information Reports Findings From Ongoing Study
RESEARCH TRIANGLE PARK, NC -- (Marketwire) -- 02/15/10 -- This year, drug makers' pharmacoeconomics groups will spend more money than ever before -- a clear sign of the function's growing importance to success in the pharmaceutical and biotechnology sectors.
Early results from Cutting Edge Information's (http://www.cuttingedgeinfo.com) ongoing survey, "Improving Pharmacoeconomics and Health Outcomes," show that 2 out of 3 respondents will increase pharmacoeconomics spending throughout 2010. Zero respondents plan to reduce their budgets.
"As governments and payers worldwide keep a close eye on climbing healthcare costs, drug brands need to prove more than efficacy and safety," said Jason Richardson, president of Cutting Edge Information. "They need to show cost effectiveness."
Pharmacoeconomics, the intersection of health outcomes and financial considerations, has grown in prominence as costs and reimbursement issues pose challenges to drug makers. Just two years ago, the majority of surveyed companies waited until Phase 3 trials to launch their pharmacoeconomics work. Nowadays, teams kick off studies in Phase 2 and even in Phase 1, and more money is flowing to these early-stage endeavors.
Teams do this early work to ensure that they collect the right data, which eventually goes before regulatory agencies and payer organizations to establish a drug's overall benefit -- and win placement on payer formularies.
According to Richardson, "Neither patients nor bottom lines benefit from therapies that get buried."
The survey, open until February 19 at http://www.cuttingedgeinfo.com/surveys/pharmacoeconomics/pharmacoeconomics.htm, identifies how pharmacoeconomics strategies are changing to meet the growing demand for health outcomes data. Findings will allow survey respondents to:
-- Benchmark spending and staffing levels
-- Learn how top companies customize pharmacoeconomics strategy to meet
the needs of individual brands
-- See how the function has grown by coordinating with numerous other
internal functions
-- Understand the growing importance of health outcomes liaisons and
risk-sharing agreements
-- Discover how effective pharmacoeconomics teams measure ROI through
quantitative and qualitative assessments and prove their value to
their organizations
In exchange for completing a survey, respondents receive a complimentary copy of the results when they become available.
"This study will provide pharmacoeconomics professionals with ammunition to promote their groups and gain the resources necessary to best support brands," said Shaylyn Pike, lead analyst for the study. "Without an effective pharmacoeconomics strategy in place early in development, brands can launch at a disadvantage."
MEDIA CONTACT:
Stephanie Swanson
Email Contact
919-433-0212
Cheers
Ulf
Pharmacoeconomics to Get Bigger Budgets, According to Preliminary Survey Results
Marketwire News Releases
Published: 02/15/10 12:12 PM EST
Cutting Edge Information Reports Findings From Ongoing Study
RESEARCH TRIANGLE PARK, NC -- (Marketwire) -- 02/15/10 -- This year, drug makers' pharmacoeconomics groups will spend more money than ever before -- a clear sign of the function's growing importance to success in the pharmaceutical and biotechnology sectors.
Early results from Cutting Edge Information's (http://www.cuttingedgeinfo.com) ongoing survey, "Improving Pharmacoeconomics and Health Outcomes," show that 2 out of 3 respondents will increase pharmacoeconomics spending throughout 2010. Zero respondents plan to reduce their budgets.
"As governments and payers worldwide keep a close eye on climbing healthcare costs, drug brands need to prove more than efficacy and safety," said Jason Richardson, president of Cutting Edge Information. "They need to show cost effectiveness."
Pharmacoeconomics, the intersection of health outcomes and financial considerations, has grown in prominence as costs and reimbursement issues pose challenges to drug makers. Just two years ago, the majority of surveyed companies waited until Phase 3 trials to launch their pharmacoeconomics work. Nowadays, teams kick off studies in Phase 2 and even in Phase 1, and more money is flowing to these early-stage endeavors.
Teams do this early work to ensure that they collect the right data, which eventually goes before regulatory agencies and payer organizations to establish a drug's overall benefit -- and win placement on payer formularies.
According to Richardson, "Neither patients nor bottom lines benefit from therapies that get buried."
The survey, open until February 19 at http://www.cuttingedgeinfo.com/surveys/pharmacoeconomics/pharmacoeconomics.htm, identifies how pharmacoeconomics strategies are changing to meet the growing demand for health outcomes data. Findings will allow survey respondents to:
-- Benchmark spending and staffing levels
-- Learn how top companies customize pharmacoeconomics strategy to meet
the needs of individual brands
-- See how the function has grown by coordinating with numerous other
internal functions
-- Understand the growing importance of health outcomes liaisons and
risk-sharing agreements
-- Discover how effective pharmacoeconomics teams measure ROI through
quantitative and qualitative assessments and prove their value to
their organizations
In exchange for completing a survey, respondents receive a complimentary copy of the results when they become available.
"This study will provide pharmacoeconomics professionals with ammunition to promote their groups and gain the resources necessary to best support brands," said Shaylyn Pike, lead analyst for the study. "Without an effective pharmacoeconomics strategy in place early in development, brands can launch at a disadvantage."
MEDIA CONTACT:
Stephanie Swanson
Email Contact
919-433-0212
Oncology Market Access Summit Europe
Dear Readers,
a lot is going on in the Oncology environment at the moment. There is plenty to be discussed regarding health economics & pricing, market acess and patient advocay etc. and therefore I have accepted to speak at this event. It should become an interesting meeting as it is focussed on Oncology matters only therefore I thought I bring it to your attention in case you haven't seen it yet.
Cheers
Ulf
Oncology Market Access Summit Europe: 13th-14th April, London
eyeforpharma's Oncology Market Access Europe Summit brings together a top selection of pharma specialists and experienced professionals to share their knowledge and views on dealing with the challenges and opportunities presented by the massive growth of oncology treatment. Join our event and gain insights into enhanced market access strategies, innovative pricing agreements and effective stakeholder communication. This two day meeting is about hearing from a range of companies, learning from case studies and exchanging best-practice ideas. I look forward to seeing you there!
Camilla Ohlsson
Download the full programme here
a lot is going on in the Oncology environment at the moment. There is plenty to be discussed regarding health economics & pricing, market acess and patient advocay etc. and therefore I have accepted to speak at this event. It should become an interesting meeting as it is focussed on Oncology matters only therefore I thought I bring it to your attention in case you haven't seen it yet.
Cheers
Ulf
Oncology Market Access Summit Europe: 13th-14th April, London
eyeforpharma's Oncology Market Access Europe Summit brings together a top selection of pharma specialists and experienced professionals to share their knowledge and views on dealing with the challenges and opportunities presented by the massive growth of oncology treatment. Join our event and gain insights into enhanced market access strategies, innovative pricing agreements and effective stakeholder communication. This two day meeting is about hearing from a range of companies, learning from case studies and exchanging best-practice ideas. I look forward to seeing you there!
Camilla Ohlsson
Download the full programme here
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