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, March 28, 2012

Market Access : Clearing the ambiguity

I must admit that during the first few months of my MSc, I was quite confused about the term "Market Access". I did know it was synonymous with translating one's skills as a health economist into practice, particularly in an industry sponsored role, but it was quite difficult to come by a definitive synopsis of what it is one actually does. What are the specific tasks and activities one is involved in? What level of complexity is involved? What skills does one need to possess? So here is my attempt at dissemination, clarification, & education. I hope it is useful to those considering it as a career and for the layperson who has mistaken it (& me) to be some sort of pharma lobbyist !

The concept of market access (in healthcare) is fundamentally similar to that in other sectors - Introduction to, and uptake by the market, of a new product offering improved value or competition to the current alternative(s). However it is the execution of this strategy which varies substantially (and requires some specialist skills). Some key questions which pose challenges - How to obtain information about target population? Which parameters of efficacy, safety, effectiveness do we measure? What competitive edge does the product hold? How to demonstrate overrall value ( to both payer & consumer)? How to negotiate in a highly restrictive regulatory environment?

Because drug development is an incredibly long process, answering these questions requires collecting data and its analysis at various stages of the products life cycle. To this effect, planning the coordination and sequential timing of activities is a core deliverable in a MA role. Pre-approval, during the clinical trial 1-3 phases, the objectives are largely to incorporate MA issues during development to create the "value proposition" and to gather data in support of  or informing product-specific decision making by upper management (i.e. invest vs disinvest, study types, trial population, approval/reimbursement strategy etc). During the phase 1/2 stage the HE/MA activities tend to focus on analysis of the disease area and associated pricing research. This includes conducting cost-of-illness studies, mapping studies, literature & systematic reviews (on outcomes/competitors disease management/policies as per discretion), and possibly even observational studies. On the pricing side, research efforts tend to be focused on assessing the payer landscape and price anchoring, providing an initial insight into the likelihood of reimbursability. Additional activities at this stage may include development of an early cost-effectiveness study, conceptual model, and patient reported outcomes (PRO) tools.

The value story of a drug starts taking shape during Phase 3 / pre-launch stage. Adjacent to maintaining up-to-date knowledge, desk research activities can now become a lot more focused on local issues and populations, and the process of dissemination through publications and scientific stakeholder or key opinion leader management begins to be emphasized. Increased use of piggy-back CE studies means that it is not uncommon to find a formal economic analysis and PRO analysis being conducted at this stage in preparation for a health technology assessment (HTA).  On the P&R front, price sensitivity studies, sequence & strategy analysis, and risk evaluations are just some of the acitivities.

Input from the MA unit is especially essential during the post approval & launch stage of the products life.  The objective now is to demonstrate the products value to payers and secure reimbursement status on formulary lists. This is most commonly done by providing the necessary evidence and data to either government agencies or independent bodies for them to conduct an HTA. A positive HTA recommendation can go a long way towards determining the success of a drug, as evidenced by the recommendations of NICE (England), SMC (Scotland), CADTH (Canada) to name a few. These dossiers need to not only present clinical evidence data, but also evidence on cost-effectiveness, comparative effectiveness and increasingly, PRO data. Since requirements can vary across geographical jurisductions, local adaptation of dossiers can be a labour intensive process. The pricing life cycle is also largely determined at this stage, as risk sharing agreements and payer negotiations occur. Reaching consensus at the optimal price - which is largely an acceptable ROI for both the manufacturer & payer - could be considered the key outcome. With eventual entry and possible acceptance of the drug, the MA professional has the on-going responsibility of collecting relevant real life effectiveness data to increase product value (and bargaining power), and updating dossiers in anticipation of HTA re-evaluation.

This is by no means an exhaustive list of activities pertainining to MA. Job descriptions can indeed vary depending on organizational capacity, and there are many soft deliverables such as scientific lobbying, patient advocacy, competitive intelligence and management of HTA decisions which need to be incorporated at various stages. However, I hope this article better illustrates the complexity and dynamic nature of MA in healthcare. If I am missing something please feel free to comment and add. I am sure input from working professionals would indeed be invaluable to newcomers in the field.



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Wednesday, March 7, 2012

A new market for vaccines

One of the drivers behind the success of biological divisions of several big pharma players, is the development of second and third generation vaccines. Recent examples of publicly funded vaccines are those targeting HPV (cervical cancer), H1N1(influenza). Approval of others for malaria and ovarian cancer are anticipated within the next couple of years. Its quite evident that the scales of administration for these vaccines could result in one of the better success stories for healthcare - both in terms of industry and payer ROI, as well as health outcomes.

But whilst the general target market for vaccines is healthy people not in treatment, one new candidate is positioning itself within the nosocomial infection market. Novadigm Therapeutics is developing the NDV-3 vaccine against Staphylococcus aureus & Candida albicans - two of the most troublesome pathogens for hospital infections. In what would be the first ``cross-kingdom`` vaccine of its kind (staph is a bacteria whereas candida a fungus), investigators have targeted the Als3 surface protein which is common to both. Another related target market for its use could also be immune-compromised infection-prone patients. Studies showing efficacy against MRSA would indeed make this an incredibly valuable treatment, and a welcome respite in the battle against antiobiotic resistance. Positive phase 1 results look promising, but significant challenges still remain on issues of proof-of concept, clinical adoption and public acceptance of what would appear to be yet another vaccine loaded with toxic excipients.









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Tuesday, March 6, 2012

The BIGger issue


The controversial NHS reforms continue to receive flak in the public eye. In their latest efforts, the opposition and media are now playing up the "privatisation" clauses within the bill. Albeit a very effective move on their part (the very mention of paying for treatment unleashes clan like fury in the English), I cant help but feel that if the bill is shot down in Parliament, it would ultimately be for the wrong reasons. When the original draft was presented, the biggest issues were in fact the increased budgeting responsibility GP's would have to take on as both doctor & accountant, the moral & ethical dillema this situation presents, and the feasibility of the mandated 5 year cost saving targets. This efficiency program - QIPP is now 10 months into implementation. There are some success stories, but there are other regional clusters that are in real trouble. Read on here. The reality is that the issue of privatisation shouldnt even make it into the top three. The repercussions of clusters & trusts being unable to hit their savings targets could completely transform accessibility of services in these troubled regions. The impacts of such worst case scenarios should be the real debating point.

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Up & running again


After a 2 year break, the nexus blog is back in business again. Just to clarify, I wasnt really on a "break". During this time, I relocated to England, obtained a MSc in Health Economics & Policy, worked on my dissertation project with the WHO, and did some long overdue backpacking to 8 countries across 3 continents. Its been a good adventure, and I look forward to sharing some of the insights, knowedge & experiences with you. Happy investigating !

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