Showing posts with label pharmaceuticals. Show all posts
Showing posts with label pharmaceuticals. Show all posts

Tuesday, July 3, 2012

Downward pressure on drug costs intensifies risks for Big Pharma in China

March 2011 was an exciting period for China as the country adopted its 12th five-year plan and embarked on its latest reform expedition. Amidst the rhetoric of strategic restructuring and opening of its economy, there was also an explicit target to fix the healthcare system which has clearly lagged in comparison to gains in other sectors. According to the UN, the over 60 population in China amounted to 178 million people in 2009. Increased urbanization and the one-child policy have decimated the tradition of family care, with the burden now being shifted onto the state. Additionally, not counting rural shortcomings, an estimated 800 million do not have access to hospitals in major cities. Understandably then, the latest reform measures are geared towards meeting the countries massive healthcare demand, including - the expansion of basic health insurance,  capacity building in terms of physical infrastructure and human resources, and the inevitable cost cutting.  While greater penetration and acceptability of modern medicine by this generally traditional medicine oriented society could be a windfall for foreign pharmaceutical companies, simply covering the basic health needs of the population by the centralized schemes will be incredibly expensive. With the pharmaceutical market growing at around 25% p.a, and sales projected at $125 billion by 2015, industry understands only too well that the Chinese opportunity is a double edged sword.

The challenge then, from the payers’ perspective, is to increase access while controlling costs. Consequently, for manufacturers, the opportunity cost now involves balancing lower margins with larger volumes. It is this margin versus volume trade-off that the government wishes to exploit in order to control drug costs- evidenced by the increasing popularity of the Anhui model of reimbursement. Over the past two years, the rural province of Anhui has made waves in the political sphere due to their success in controlling drug costs. They have done so primarily by legislating a 0% mark-up for drugs on the Essential Drug List (EDL), and by implementing a centralized bid/tender process.  This has completely disrupted the national policy of allowing doctors and hospitals to mark-up prescription drugs, as a method of generating revenue and operating profits.  It is evident how such an arrangement could conflict with cost-control efforts.  Hence, 18 of China’s 23 provinces have now adopted all, or part of the Anhui model. Furthermore, the promotion of policy pioneer Sun Zhigang, from vice-governor of Anhui province to director of the Office of Health Reform, signifies the central governments’ approval of such fiscally prudent policies.

Anhui’s approach to controlling costs could have adverse implications on several fronts across the entire supply chain. Firstly, its fixation with pursuing the lowest possible price overlooks the relationship between price, quality and effectiveness. Although the bidding system does involve a review of each manufacturer’s technical capacity and quality controls, justification behind the winning bid ultimately filters down to who can supply at the lowest price. The incentive to compete solely on price could come at the cost of decreasing quality standards. With lower price margins, the temptation to maximize returns by cutting corners on quality is immense. Secondly, the 0% mark-up has, in some cases, resulted in products not being locally stocked. Distributors and clinics can’t afford to carry these products as they cannot make any money on them, and doctors hesitate to prescribe them as they cannot make money nor can they trust their quality. Thirdly, the possible expansion of drugs on the EDL or the drifting of such a policy to cover other classes of premium priced products, could limit access to product portfolios of both local and multinational firms alike. More importantly, the Anhui model demonstrates the disconnect between achieving short term financial sustainability and long term national objectives such as public hospital reform , retention of trained professionals, and improvement of quality standards. While individual provinces could be better placed, eliminating a key revenue stream may prove to additionally burden the central government who will struggle to adequately fund and incentivize doctors and hospitals, hence weakening the very foundations of its reform targets.

Like many strategic sectors targeted by a state-driven reform process, China’s domestic pharmaceutical industry simply does not have the process capability to be self sufficient without the presence and participation of the established multinationals. A hard-line approach that strains relationships with big pharma could be disastrous to the sustainability of any reform policies. In the future, a more flexible and balanced plan is essential in order to restore confidence in foreign players who  cannot compete on price against generics, and are wary of  China’s poor track record on enforcing intellectual property rights. The Anhui model certainly has its merits in terms of lowering costs, increased purchasing efficiency and securing supply for an expanding list of essential drugs. However, in its current form, its implementation fails to recognize some of the wider downstream effects it could impact on. As is often the case in healthcare, a myopic focus on the bottom-line could threaten greater reform objectives as well as tarnish China’s attractive proposition for foreign investment.

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Wednesday, January 13, 2010

Another Annual Report



Recently, I was sent an Annual Review conducted by Citeline Intelligence Solutions. This concise report offers readers a brief summation of pharmaceutical R&D trends and an analysis of industry wide product development strategies and clinical trial success rates. There were not too many talking points amongst the majority of findings presented, however there was the odd statistic that buckled recent trends & a couple of surprise ones that I could not have predicted. Following is a rapid-fire synopsis of their findings:

* A total of 9605 drugs in active development for 2008, a 4.3% increase from the previous year.
* An above average 32 market entrants (New Active Substances) globally, although none of them seem to be really big sellers.
* The US remains the premier market with 15 of 32 debuts.
* Six new biotech product launches for the year.
* In 2007, anticancer drugs accounted for a third of the total launches. In 2008? Despite oncology being the biggest area of R&D, the grand total is a big Zero!
* CNS, the next big R&D area also had a laggardly year with 3 new drugs (but none first in class).
* Cardiovascular & Blood/Clotting disorder drugs had the greatest success with 10 new market entrants. Gastrointestinal drugs come in second with 5 product launches.
* Innovation levels remained discouragingly low with only 1 new market entrant for HIV/AIDS and 2 new anti-infectives.
* At the clinical stage, virtually the entire 4.3% increase in drug candidates is at the preclinical stage. The trends for post-preclinical phases remain flat, with a modest 2.6% increase at Phase II being the only noteworthy statistic.


* More disturbing is the decrease in the number of drugs at the pre-registration and registered but awaiting launch phases.
* 28% of all drugs in development have an anticancer therapeutic activity. 19.8% of the total pipeline has a neurological activity.
* The gradual ascent of biotech continues with 23.7% of the drugs placed under a biotechnology therapeutic category.
* Some positive news is a 6.2% increase in the number of drug protein targets under investigation.
* The J&J Empire, GSK and Genzyme enjoyed the most first launches in 2008.
* GSK remains the biggest company in R&D terms (240 drugs), but looks to surrender this position with the recent mega-mergers.
* The trend seems to be for the biggest companies to have shown slight declines in pipeline sizes, indicating that further segmentation and specialization seems to be the new motto of the industry.
* Despite the financial climate, it is encouraging to see a 6% rise (a total of 2084 companies) in the number of companies involved in pharma R&D. The recession does not seem to have dampened the spirits of start-ups & small companies with 836 of them listing one or two drugs in their portfolios.




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Tuesday, January 27, 2009

Pfizer-Wyeth: Why nobody wins


In an otherwise headline sluggish industry (lawsuits apart), the Pfizer-Wyeth deal certainly has lit up the newswires and sparked some much needed debate. The announcement of the $68 billion dollar deal was as much of a shock to some as it was the culmination of months of predictions for others in the industry. The merger is being touted as an “ideal marriage”, with the potential to save billions for both companies, as their most profitable products face patent expiration from 2011 onwards. They may have others buying into this hogwash, but I see this deal for being what it actually is – Twisted. The formation of Pfyeth benefits nobody- not the stockholders, not the employees, not consumer sentiment, definitely not drug development, and even misles the common tax-payer! Actually that is not completely true. It does benefit one person – Pfizer CEO Jeffrey Kindler. Kindler played his cards well and the announcement formed a welcome distraction from the news that Pfizer was also paying a $2.3 billion settlement to make the Department of Justice stop investigating the company’s illegal promotion of discontinued Cox-2 painkiller Bextra, and a 90% drop in income.

Kindler: "We're in a much better position to bring on board the scientists and programs and projects that Wyeth has"
The last couple of times Pfizer went appliance shopping, buying Warner –Lambert in 2000 and swallowing Pharmacia-Upjohn in 2003, it was faced with serious alignment and integration issues. Pfizer's "big corporation" image was at definite odds against Warner’s consumer health focus and there was a serious culture clash that was eventually only solved by new management. While corporate image may not be the issue at hand in this case, Pfizer thinks they can swiftly integrate an entirely new field of therapeutics! Wyeth alone with its expertise in biologics barely made it past facility inspections and product safety audits. One can only imagine the tensions in the hallways as Pfizer deploys its managers to oversee and “align” operations. Kindler mentions bringing aboard scientists, programs, and projects, he will also be bringing aboard the many lawsuits against Wyeth for the Hormone Replacement Therapy debacle.

Kindler: "In one single transaction, the combination with Wyeth advances every single one of (our) strategies,"
Really? Like the halving of stock dividend? Probably the only reason investors would consider having Pfizer stock in their nest egg post Lipitor. What about manufacturing capacity? Oh that’s right, you are shutting down 5 plants. Or maybe you are referring to sales? Together, the two companies will have 17 products with annual sales of $70 billion or more. Reasonable, but that’s only until 2012. This purchase is not transformational and as much as Pfizer would like to think that this will solve their pipeline problems, it is simply not acquiring a robust R&D model. As Derek Lowe of In the Pipeline fame says “as a research-driven company grows larger, everything scales except research productivity”.

Behind the Scenes
Despite all the above grievances with respect to this merger, there is one poorly publicized issue that troubles me the most. The deal is being financed by five banks: Bank of America Merrill Lynch, Barclays, Citigroup, Goldman Sachs and J.P. Morgan Chase. The billions that will be lent to Pfizer are coming from the Troubled Asset Relief Program (TARP) program- set up by the US government to purchase assets and equity from financial institutions in order to strengthen the financial sector. It is the largest component of the government's measures in 2008 to address the subprime financial crisis. That’s right. The money for this deal is coming from the American taxpayer! The money that will eventually be used to eliminate 20,000 jobs! So not only does Pfizer jip you on meds, but they take your money and punish you for helping? How is this right? Although meant to increase lending by banks, the only restrictions set on TARP money are that participating banks can't increase their dividends without Treasury's approval and must agree to certain limits on executive compensation. Few other strings are attached.

I am however hopeful. Hopeful that the Obama administration takes some steps in ensuring public rescue funds are used ethically, that the FTC investigates this deal closely, that Wyeth shareholders vote against this offer, and that the creation of Pfyeth does not send the industry into a desperate feeding frenzy.

UPDATE:
Pfizer currently has six Alzheimer drugs under development and one on the market, while Wyeth has four of Elan’s Alzheimer drugs and five Alzheimer drugs of its own in development. Pfizer will now control 16 Alzheimer drugs, which represents a majority of all Alzheimer drugs currently in clinical development and on the market, creating a virtual monopoly for itself.

If allowed to control all these drugs, Pfizer would undoubtedly be forced to determine which of these compounds would receive priority in clinical development and which would be slowed down. As a result, Pfizer will likely favor those drugs in which it holds a 100% interest.
Ultimately, the biggest loser in this situation would be Alzheimer patients, along with their caregivers and physicians, who may have fewer treatment options available to them.




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