Talk about the access creativity of innovative drugs from sovaldi

Source: e drug manager on January 15, 2015, if we talk about the most popular innovative drug in 2014, it is probably the new hepatitis C treatment drug sovaldi of Gilead company The blockbuster new drug with a cure rate of more than 80% was launched in the United States in the fourth quarter of 2013 From the first quarter to the third quarter of 2014, it has reached more than $8.5 billion in sales, and it will be a fact without any suspense to win $11 billion to $12 billion in sales throughout the year What is the concept? In the first year of IPO, sales have left Lipitor, which had a fabulous sales volume of 1 billion US dollars in the first year, behind Don't forget how many patients there are to treat Lipitor with hyperlipidemia, and how many patients there are to treat the special drug sovaldi for hepatitis C! There are many reasons why sovaldi can create such a myth, one of which can't be ignored: in the United States, a 12 week cycle of sovaldi treatment costs 84000 yuan One pill a day, equivalent to 1000 dollars a pill a day In Chinese, it's equivalent to swallowing a few golden beans a day It's not to do free advertising for Gilead, or to analyze in-depth what marketing myths, but to lead to a problem that we have been facing: what will happen to the price and access of such a high-priced medicine when it comes to an emerging market like China? Over the years, innovation and access have always seemed to be a pair of irreconcilable contradictions, with different stakeholders holding their own Pharmaceutical companies that have paid a lot of human and material resources and financial resources for new drugs should get rich returns Otherwise, who has the motivation to research and develop new drugs of "nine dead lives", and who will gnaw at such hard bones as cancer and Alzheimer's disease? Business is not only reasonable, but also reasonable! On the other hand, the payers who pay for the drugs must, of course, live within their means Since new drugs are often expensive, in the calculation of the payer, "everyone can use drugs" is obviously more important than "everyone can use new drugs" So we always hear that drug companies are slow to admit Tucao, and patients make complaints about the fact that Chinese people are slower than foreign countries in the use of new drugs, and the financial difficulties in payment are often too much for their ability to say yes to many new drugs Is this really a knot that can never be solved? Of course not! There are always more ways than difficulties For example, Gilead announced in the third quarter of 2014 that it would market sovaldi in 91 countries, including Egypt and India, at a price of 1% of the price in the United States, that is to say, the entire treatment cost only $800 to $900 For a while, the whole world roared! What we admire, what we blame, and the general public opinion is that the voice of crusade is more than the words of praise The central idea of the crusade is to let the United States, Britain, France, Canada, Australia and other rich countries pay for the poor countries Another focus of spitting is that this posture is not to make money in the developed countries, but to make money in the backward countries Who can't understand the famous and beneficial tactics of both fame and wealth? Most of them are media people Is that right? Yes! Is it the place under the spitting stars? It's the place! But wait a minute, read carefully the 91 countries that Gilead announced low-cost marketing, and you will find that important emerging markets, such as China, Brazil, South Africa, Turkey, Russia, are all in the list Everyone knows that Gilead company will enter these markets sooner or later, and which company will give up such a big country of hepatitis C as China! Not long ago, the Insight China Pharma data database of DXY reported that sovaldi had applied for clinical application in China in August 2013, and now it is progressing smoothly And no matter when sovaldi is approved in China, as long as it is approved, it will face price problems and access problems According to the definition of who, most of the important emerging markets are middle-income countries, and Gilead has tricks in both low-income and high-income countries, but the price access strategies of the middle-income countries that account for the majority in quantity have not yet been published, and we can foresee that in these important emerging markets, Gilead is bound to be in a dilemma The payers of these countries will surely take Egypt and India as their target and demand equal treatment If Gilead says yes, it will lose a large part of the profits that could have been obtained without much effort After all, there are many groups of patients in these countries If Gilead says no, the negotiation with the payer will be deadlocked, and access may be far away, which not only gives up the market to competitors, but also is not conducive to the global management of product cycle Don't know if Gilead has taken global access strategy into account in its high-profile promotion of its non-profit marketing model in 91 countries? The author tries to cast a brick to attract jade Give Gilead and other pharmaceutical companies with innovative drugs as their lifeblood some references, and welcome to clap bricks The reason why emerging markets are called emerging markets is that most of them are countries with rapid economic development These countries have the same characteristics: some people get rich first, but there are still a large number of poor groups China is not only a typical emerging market, but also a leader in emerging markets In such a market, there are two steps: before the new drugs enter the reimbursement catalog, patients purchase drugs at their own expense There are two ways to consider: first, fees can be differentiated according to the income level of patients It can be said that many multinational pharmaceutical companies carry out an expanded version of charity drug donation for tumor drugs, just to divide the income level into more details, which is equivalent to Gilead In developed countries and backward countries, two approaches are copied to one country; second, subsidies can be given to patients at their own expense, which is equivalent to coupons in commercial promotion, and the time of granting subsidies can be discussed This not only protects the price, but also helps patients to reduce the burden What's more, how to enter the medical insurance catalogue With the reform of the medical insurance system, it is the general trend for you to re-enter the reimbursement catalogue through negotiation We must see that the impact of expensive drugs on the health insurance fund is huge, and a few patients can eat up the health insurance fund When pharmaceutical companies negotiate with payers, they can set a cap on the annual use of certain drugs by medical insurance funds For example, how many medical insurance funds this medicine occupies in a year is set as the upper limit, and the drug companies are responsible for some or all of the drug use of the patients who are more than enough; there is another way of negotiation, in the field of special drugs, the same type of disease can be used to cap the drug use For example, the three kinds of drugs produced by the same pharmaceutical enterprise belong to the same disease field, which can be negotiated with the medical insurance fund This year, the upper limit of the medical insurance fund for the three drugs in the same disease field of the enterprise is how much On the one hand, the risk of the medical insurance fund is controllable, on the other hand, it will urge the pharmaceutical enterprise to accelerate the metabolism of the same kind of drugs, and the speed of patients using new drugs may be accelerated These practices are based on accurate patient group calculation and sincerity of mutual benefit Once a consensus is reached through negotiation, it will be a win-win situation for pharmaceutical companies, patients and payers Of course, in order for these practices to work, they must be matched in the business model The participation of agents of current pharmaceutical enterprises and the participation of third-party management institutions when charging according to the patient's income gradient are necessary, which is a systematic project In many mature markets, for valuable new drugs, we can also implement a risk sharing scheme based on the efficacy to decide how much to pay But the premise of this approach is: first, the definition of efficacy is clear and accurate; second, efficacy information needs to be transparent and have clear measures to prevent fraud This approach is still difficult to promote in most emerging markets where the comprehensive online electronic medical record is not mature, but it can be pilot in some developed regions For pharmaceutical companies that live on innovative drugs, it is not only necessary, but also urgent to be prepared for the new drug access strategy in China According to Bain & company's forecast, in 2012, patent drugs accounted for only 5% of China's total drug market, and expired original research drugs accounted for 35% By 2021-2024, patent drugs will account for 20%, while expired original research drugs will be squeezed to only 5%, which is both an opportunity and a challenge for pharmaceutical enterprises, especially multinational pharmaceutical enterprises, which take the production of innovative drugs as the global main business If today's past due original research drugs are still the mainstream business of many multinational pharmaceutical companies in China, it will be difficult to reproduce this scene in a few years In view of the high threshold of making innovative drugs, enterprises with innovative drugs as their blood should adhere to the innovation driven main business If such enterprises want to achieve sustainable success, they must work hard to find innovation in access, so that they can seize share in the high-end market in a few years, rather than go to the low-end market to fight price war.