Lancet Volume 375, Issue 9716, Pages 708 – 709, 27 February 2010
Jing-Bo Wanga, Jeff J Guob, Li Yangc, Yan-De Zhangd, Zhao-Qi Sune and Yan-Jun Zhang
Public awareness of rare diseases is increasing in China. People with rare diseases and their families, patients’ advocacy groups, health-care professionals, lawyers, and representatives of the People’s Congress are working together to establish a Rare Diseases Prevention and Treatment Law. On the basis of WHO’s definition of a rare disease, at least 10 million people are living with rare diseases in China. This estimate seems conservative for a population of more than 1·3 billion in China.
Pharmacoeconomics 2010: 28(3) 175- 184
Bridges, John F.P.; Onukwugha, Eberechukwu; Mullins, C. Daniel
Abstract
The application of cost-effectiveness analysis in healthcare has become commonplace in the US, but the validity of this approach is in jeopardy unless the proverbial $US50 000 per QALY benchmark for determining value for money is updated for the 21st century. While the initial aim of this article was to review the arguments for abandoning the $US50 000 threshold, it quickly turned to questioning whether we should maintain a fixed threshold at all. Our consideration of the relevance of thresholds was framed by two important historical considerations. First, cost-effectiveness analysis was developed for a resource allocation exercise where a threshold would be determined endogenously by maximizing a fixed budget across all possible interventions and not for piecemeal evaluation where a threshold needs to be set exogenously. Second, the foundations of the $US50 000 threshold are highly dubious, so it would be unacceptable merely to adjust for inflation or current clinical practice.
Upon consideration of both sides of the argument, we conclude that the arguments for abandoning the concept for maintaining a fixed threshold outweigh those for keeping one. Furthermore, we document a variety of reasons why a threshold needs to vary in the US, including variations across payer, over time, in the true budget impact of interventions and in the measurement of the effectiveness of interventions. We conclude that while a threshold may be needed to interpret the results of a cost-effectiveness analysis, that threshold must vary across payers, populations and even procedures.
For an interesting and basic introduction to API manufacture, process innovation and associated costs, this article may be of interest. The full article is available here
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Pharmaceutical Costs, Technology Innovation, Opportunities & Reality
By Girish Malhotra, President, EPCOT International
Pharmaceutical (branded or ethical, and generic) companies, like other companies, have the following code of conduct:
• Maximize profits through invention and marketing of drugs.
• Market safe drugs and comply with expected performance and regulatory standards.
• Minimize environmental impact.
As long as companies are able to achieve the above objectives any inefficiencies in the product development, marketing, and manufacturing processes become irrelevant as the related costs are absorbed. Until recently, the priority has been to invent a new molecule, get it approved by regulatory authorities and get it to market. If profits are threatened, the development of additional and alternate markets is the first choice to regain revenue. With upcoming losses due to patent expirations, we are seeing the start of consolidation, acquisition, and relationships with biotech companies and with companies in the developing countries.
Branded (ethical) pharmaceutical companies have believed in product innovation rather than process innovation. Based on pure financial numbers, this has been their ethos. Due to the need to develop new molecules and speed them to the market, the pharmaceutical business model has had little incentive to develop innovative process development and manufacturing technologies. In addition, the current regulatory conditions are also not conducive to process innovation. Technocrats and bureaucrats would most likely say that should not be the case now or in the future.
Regulatory oversight for the pharmaceutical industry is critical and necessary. In recent years, regulatory agencies have promoted innovation in process development, API (Active Pharmaceutical Ingredients) manufacturing, and formulation methods. Companies might try to innovate, but the financial justifications for innovation are weak unless the API and formulation costs are totally out of line. For innovation to occur and to hold, it has to come from within rather than being driven by regulatory bodies and others.
As good corporate citizens, pharmaceutical companies should have the best technologies so that their customers’ needs are met, profits maximized, and environmental impact minimized. Most would agree that pharmaceutical companies do deliver on new drugs, service, and profits; however, their process development and manufacturing technologies are not state of the art. They are low on the priority chart in the pharmaceutical business. We have seen, and will continue to see, minimal effort in this area. The rationale for this posturing is discussed and explained later in this article.
The best way to discuss this is to review the pharmaceutical business model and the costs and various relationships from a different perspective. This discussion is focused on small molecules but could be extended to pharmaceuticals in general.
When next you have a few spare moments, please read this report with startling estimates of global consumption. The numbers are very worrying. It begs the question – for how long can we continue consuming at this rate until the environment is unable to support life?
Joao
Poorest in England ‘live seven years less on average
People in England’s poorest areas live an average of seven years less than those in the richest ones, says a major report on health inequalities.
Epidemiologist Sir Michael Marmot, says the NHS must spend much more on preventing illness.
And he calls for an increase in the minimum wage to allow everyone to have a healthy lifestyle.
Health Secretary Andy Burnham has welcomed the government-commissioned report and said more work was needed.
The Marmot Review shows that although life expectancy has risen in poor and rich areas, inequalities persist.
Poorest neighbourhoods
People in the poorest neighbourhoods will also spend a greater proportion of those shorter lives unwell.
The report estimates up to 202,000 early deaths could be avoided, if everyone in the population enjoyed the same health as university graduates.
Doing nothing to tackle these inequalities would cost the economy more, according to the review, which says inequality in illness accounts for £33bn of lost productivity every year.
The report says “action is essential” because more than three-quarters of the population experience significant illness by the age of 68 – which will by 2046 be the pensionable age for men and women in England.
And there’s a call for NHS spending on preventing illness to be much higher than the current 4%, with more money going to initiatives such as providing statins and helping people to stop smoking.
‘Best start’
The authors feel their most important recommendation is giving every child the best start in life.
Sir Michael Marmot, from University College London, said: “Every child needs to be nurtured at an early stage.
“In one study, mothers were asked whether it was important to cuddle and talk to a child.
“I would have thought every mother would have said yes to that – but not all of them did.
“That made my hair stand on end.
“And it follows the social gradient – women from less well-off families are less likely to see this as important.
“But then by the age of three, these children had more behavioural problems and worse cognitive skills.
“Then they have less readiness to learn, and the problems continue.”
Read the full article here
Billy Tauzin to leave job as president of PhRMA drug industry trade group
By Jonathan Tilove
Former Louisiana Rep. Billy Tauzin will announce Friday that he will be leaving his job as president of the Pharmaceutical Research and Manufacturers of America, the drug industry trade group. Tauzin will remain on the job until the end of June to help with the search for a successor, and will remain a consultant to PhRMA afterward.
Former Rep. Billy Tauzin“We are grateful to Billy for his strong leadership and many accomplishments at PhRMA during these past five years, including his efforts to bring about health care reform,” David Brennan, chief executive officer of AstraZeneca, and chairman of PhRMA, said in a statement to be released Friday.
“Under his leadership, PhRMA has been a steadfast advocate of policies that support research and development and expand access to new medicines. Billy launched the Partnership for Prescription Assistance program to provide financial support to patients with the greatest need, and strengthened our voluntary codes on direct-to-consumer advertising, on clinical trials and on interactions with health care professionals.”
“In addition,” Brennan continued, “Billy brought a new openness to PhRMA’s advocacy, ensuring that we partner with anyone willing to join us in our fight against disease. We wish him the best as he turns the page on another successful chapter in his career. With Billy’s strong leadership and commitment to PhRMA’s mission, the Board is confident that we can ensure a smooth transition to new leadership.”
Tauzin’s decision to step down comes at a politically precarious time for the drug industry, which under Tauzin’s leadership committed its support to the Obama administration’s health care overhaul effort that now faces a very uncertain future.
Tauzin’s deal with the White House caught flak from liberal Democrats in Congress, who thought the conditions of the deal were too generous to the drug industry, and with Republicans in Congress and some members of the PhRMA board, who felt he had conceded too much.
In a letter to Tauzin in August, House Minority Leader John Boehner, R-Ohio, accused Tauzin, a former chairman of the House Commerce Committee, of an act of “appeasement” to “big government.”
“The simple truth is, two wrongs don’t make a right,” Boehner wrote in the letter which he also sent to the heads of PhRMA’s member companies. “And the short-sighted health care deal PhRMA struck with the Obama Administration at your urging provides confirmation of this time-tested maxim on an epic and tragic scale.”
Under the deal, the drug industry’s contribution to the reform effort in lower drug prices was not to exceed $80 billion over 10 years.
In a statement explaining his decision to step down, Tauzin, who has fought his own winning battle against cancer, said, “In January 2005, after a full year successfully battling a killer cancer, I was given a second chance at life, and appropriately chose to commit my next five years to the life-saving work of the people whose miracle medicines had just saved my own. For the past five years, I have given my all to that effort at PhRMA, and believe we have made a significant difference together.”
Read full story here
