Social media to denounce drug pricing being unreasonable died down。
September 2015, US presidential candidate Hillary Clinton hastened to bring claims drive up the price of a particular drug acts surgery – alluding to in the industry as a pest Shike Lai (MartinShkreli), he was in charge of the Turing pharmaceutical company (TuringPharmaceuticals) just a there are decades of history, part of the essential AIDS drugs to let the market caught in a passive, the night before the drug price increase to $ 750 dollars from each and。
  While Hillary Clinton issued a limited threat from the presidential election more than a year, but FACTSET biotech stocks index fell one week 17%。 In contrast, the President of the United States in early March at the Trump issued a document that will implement an extensive program of enhanced pharmaceutical competition: "American drug prices will drop!"A week later biotech stocks was up 1%。
  Why this time results to differ materially?Perhaps investors believe that Trump and too pro-business Republicans, will not release the pharmaceutical industry profits drop policy。 Or perhaps because, after so many years of drug prices soaring, investors believe that reform is too difficult, pharmaceutical industry lobbyists forces are too strong。   Investors should think again。
Changes in drug prices will slow growth in the next few years is already in progress。 Some of these changes are subject to market changes, without the need of politicians to take action。 Other changes only need to fine-tune the policy, not completely fresh start。
Until recently, investors profited rose in a series of stocks, such as (Abbvie), (Amgen) and genetic。 But now they are to be alert。
In turn, to favor those whose income depends mainly on the introduction of new drugs, the company's patient population growth, such as renewable yuan (RegeneronPharmaceuticals) and VertexPharmaceuticals。   According to Pharmaceutical Payment Management (PBM) ExpressScriptsHolding, since 2008, the most widely used brand-name prescription drug prices increased by 208 percent, compared to the same period consumer prices rose only 14%。
During this period generic drug prices have fallen, but limited to reduce the pressure on drug prices: although the United States issued patent medicines account for only 10% of prescription drugs, but drugs accounted for 72% of total expenditure。
Abbvie of rheumatoid arthritis drug Humira (Humira's) is the world's best-selling drug, with sales of $ 16 billion last year, which is a typical example of how synthetic biology drug prices Yiqijuechen。
Different drugs with the traditional chemical synthesis, biological synthesis of biopharmaceuticals made。   Humira sold in the form of injections, the price of a needle from 2008 to nearly $ 700 up to $ 2200 today。
The main patent on the drug expired last year, but in January this year, Abbvie announced drug price increases of 8% – the same day, US Secretary of Health and Human Services nominee Price (TomPrice) response to Congress on drug prices rose questioned。
  Drugs planning department and other payers to negotiate drug prices discounted drug prices。 Even so, the United States Humira discounted price is more than twice as Canada and France。
  Development of new drugs, especially expensive biological drug development, in order to encourage innovation in the industry, it is necessary to implement high drug prices。
However, according to an analysis report "Journal of the American Medicine" (JournaloftheAmericanMedicalAssociation) published last year, the number of R & D costs associated with the signs of drug prices does not exist, the US pricing of prescription drugs is mainly to see the market will bear。
  The market will bear a lot of things。 Promote drug prices drop two key strength is the strength of competition and drug price negotiations between the payer drugmakers。
From 2010 to 2012, an unusually large number of brand-name drugs lose patent protection, a relatively modest increase drug prices。
Theoretically biotech drugs more intense competition。
By 2020, seven big selling drug patents will expire。   For example, last year only to lose the Abbvie Humira synthetic patent。
There are 70 kinds of other patent medicine: 20 producing several patents, patent 10 kinds of pharmaceutical preparations, as well as dozens of indications, therapy Patent。 When briefing to investors, Abbvie claiming at least 2022 years ago can avoid competition。
Abbvie Amgen sued for patent infringement to prevent the latter to launch a biosimilar。   It is not clear how noisy protest Amgen, the company itself is jump "patent ballroom dancing" Protecting arthritis drug Enbrel 2015 Annual lose the main patent。
Professor at Harvard Medical School, one of the aforementioned "Journal of the American Medical" report author JerryAvorn that the company is more brazen, aggressive, not only to pursue these strategies, but this boast。   FederatedInvestors portfolio manager MartinJarzebowski said patent expiration will not only make the second reason is the decline in drug prices, biopharmaceutical very difficult, only a few companies have the appropriate size and expertise。 Compared with traditional generics, biosimilars development, greater manufacturing, marketing costs。 And because biosimilars similar brand-name drugs rather than brand-name drugs precise replication, companies must allow doctors to believe that biosimilars exactly the same effect with the original study medicine。 In a recent competitive analysis report bio-generic drugs is expected, biosimilars market profits would fall short of Wall Street expectations。   Other sources of pressure drug prices – the bargaining power payers – as great as in other countries in the United States。
Other countries decided to experts appointed by the Commission to implement universal health care system of drug price negotiations, acceptance made in accordance with the effect of drugs or medicines rejected。 The United States has a lot of drug prices payers, including Medicare (health care) and Medicaid PBM (medical) institutions, the private health insurance companies and ExpressScripts, CVSHealth (CVS, like UnitedHealth Group。
Medicare spending accounted for 29% of total pharmaceutical expenditure, but the law of that system agencies shall negotiate drug prices d drugs, and Medicare must cover most of the drugs – this is a concession to fears that the government made offside Members。 At the same time PBM to use its purchasing power to obtain a discount drug prices, but these companies sometimes also by certain drugs into the drug list and get a discount from pharmaceutical companies, resulting in a conflict of interest。
  According to reports, Trump institutions to support Medicare to negotiate drug prices, which could make Trump with congressional Republicans and not difficult by the relevant Act。 Fortunately, simpler way to control drug prices increased presence, some of which way the industry has been in practice。   For the prices of medicines which make more reasonable and effective evaluation is a good starting point for control of drug prices。
Over the years, "Consumer Reports" (ConsumerReports) published a straightforward opinion in this regard, for example, which treat asthma inhaled steroids highest price。 For more complex drugs, by the United States Institute of Economic evaluation of clinical (InstituteforClinicalandEconomicReview, ICER) assessment。 Clinical data for research ICER of doctors and researchers, writing including synthetic drugs, including biopharmaceuticals comparative study。
As the saying goes health is priceless, but the ICER is the use of quality adjusted life years, called (QALY) standardized measure of the value of drugs。 QALY = 1 represents full health life year。
  For example, ICER a recent report on rheumatoid arthritis immunomodulatory drugs, he said the old analogy found a drug more effective drug, but its price was too high。
With the QALY measure, Humira highest price for every $ QALY23 million and the monoclonal antibody was $ QALY20 per million and Roche's Actemra about every ten thousand dollars。
The report concluded that Humira drug prices need to fall by 50% -69% was reasonable。
  ICER of funds provided by non-profit organizations, the growing influence。 Last year Medicare pilot announced that the competent authorities report quoted ICER of different payment methods B drug, known as an example of the department is exploring the reasonable pricing of medicines。 B medicine is a doctor's office or hospital outpatient department issued drugs, such as certain cancer drugs。
New York and ICER were related to explore, and later governor Cuomo (AndrewCuomo) announced a proposal in January this year, the establishment of a drug utilization evaluation committee to evaluate the fair price of expensive drugs。 2015 ICER published right, regeneration and $ Amgen price hereditary high cholesterol PCSK9 inhibitor drug jointly manufactured questioned the report, PBM will be less willing to pay。
  As it now appears Amgen drugs and existing drugs do comparative tests of new evidence, said it would review its analysis ICER。
At the same time renewable yuan CEO Shi Leifu (LenSchleifer) investigate new drugs Dupixent atopic dermatitis and contact ICER fair price。
Renewable yuan final price of the drug at the low end of the price range given fair ICER recommendations, significantly lower than those of atopic dermatitis-label prescription drug prices, including Humira (arthritis and skin itching belong inflammation)。   ICER founder Pearson (StevenPearson), said regeneration yuan examples fully illustrate some pharmaceutical companies are admitted the situation had changed。 Renewable yuan not to increase the price of the best-selling drug Eylea, Eylea 2011 approved eye disease wet age-related macular degeneration drug。
Shi Leifu years of industry status quo criticism。
He said last week, referring to the correspondents drug prices rose, some people turn a blind eye to this, the Constitution limited patent protection time。   Nevertheless, Dupixent pricing marks a departure from the old way of。 Shilei Fu said in the past pricing model is to make a decision, then the reasons; Dupixent pricing is we decided to organize talks payer, PBM and ICER like, come up with a reasonable price we think。   Patients also need more competing drugs。
In January, the independent Senator Sanders (Bernie Sanders) proposes to allow pharmaceutical distributors and pharmacies import prices lower drug bill, narrowly passed by the Senate – to get 12 Republican senators in favor, which is traditional front of a sign of being transferred。
Another view is to prevent severe early patent medicines, to stop "patent ballroom dancing" (patentdance) phenomenon。   JanneyMontgomeryScott pharmaceutical market analyst DebjitChattopadhyay believe that this approach may not be implemented recently, but whatever it is a goal, a comprehensive health care reform much more difficult。
US Food and Drug Administration (FDA) must address the backlog of generic drug applications, and signed a reciprocal agreement with the European and other strict control of the drug market。
European market launch of biosimilars is much faster than the United States。
Drug regulatory authorities may also expand the category, allowing the use of similar effect, but not necessarily fully replace similar drugs。
  Whether driven by members, employers or trade unions, PBM transparency must be improved。 With plenty of alternative medicines and fuller information on drug prices, PBM and health insurance plans side will have the ability to enter into contracts more favorable, an analyst at investment bank LeerinkPartners Boggs (GeoffreyPorges) think this is a key way to significantly control of drug prices one。
Porges said, must enable them to say, "This is the same two drugs, the drug kicked out, leaving a kind of medicine."。 Such as arthritis?The price of drugs has decreased significantly, to less than $ 40,000 per patient from $ 90,000。 This aspect can look at the example GileadSciences, most of the company made a profit of arthritis?Drugs contributions in the past year its share price has fallen by a third。   GileadSciences is an extreme example, but it is possible slowdown in drug prices put pressure on pharmaceutical stocks。
Since October last year, prescription drug prices have edged down。
Biotechnology and traditional pharmaceutical industry profit is expected to continue to drop。
If the price drops extensive growth, the rapid price increases of companies or difficult to keep Wall Street's expectations。
Boggs research has pointed out, Abbvie, Amgen, Biogen and other traditional pharmaceutical companies relatively aggressive growth in drug prices。
  Renewable yuan is another scene, although the company in the past did not mention how the price, but is expected the next few years will be double-digit percentage growth in earnings per share。
Drug Approval Dupixent dermatitis which is possible to obtain a plurality of treating allergic disorders (including asthma)。
Reproducing element 28 times the current price-earnings。   Vertex is another example of biotechnology companies win by patients and drug prices too high and rising rapidly。 Because cystic fibrosis drug test two together to get a positive result, it is possible through the approval, the company's share price this year rose more than 50% of the cumulative。
  The two drugs with more vertices now cystic fibrosis drug efficacy Orkambi slightly forward, shortness of breath, can significantly reduce the incidence of side effects。
Vertex also tested a triple drug is expected data released later this year, it is possible to make the company achieve greater progress in cystic fibrosis drugs。
Vertex year after adjusting for stock compensation expected earnings per share of $ only, but within five years, analysts expect earnings per share of more than $ 700, the pursuit of growth stocks for investors reasonable stock price。
  More generally, however, the rapid growth in the number of patients is difficult enlisted, drug prices rose less dependent on the core pharmaceutical company, which is a problem。 Past due to a significant increase in profits in the industry and favored investors may need to reduce exposure。   Asthma nebulizer medication albuterol (salbutamol) 40 years ago for the first time by the launch, then known as salbutamol (albuterol)。
Recently listed a generic drug albuterol, 200 priced at $ 21。
In the United States there is no generic albuterol, only salbutamol, PROAIR of drugs。 200 PROAIR atomized drug US drug price comparison website recently listed for $ 67 US dollars -80。
  Why such a big price gap?In the United States, FDA since mid-2009 to disable the chlorofluorocarbons used as aerosol propellants。
Originally from asthma aerosol phase out chlorofluorocarbons (destruction of the ozone layer) extensive program of impact, because these drugs are important asthma medication, and the release of chlorofluorocarbons much。
  Pharmaceutical companies smell opportunity from which new patents reportedly has successfully lobbied the FDA to abolish asthma aerosol exemptions。
Today, the United States use a hydrofluoroalkane as a propellant。
Environmental concerns pharmaceutical giant to generate returns。
Ventolin is expected this year will bring GlaxoSmithKline million (US $ 0.1 billion) in revenue, up 5% compared with 2016。   Another asthma drug Seretide (ADVAIR) containing steroids and bronchodilators, is used for daily asthma prevention。 The main drug patent expires in 2010, Diskus inhaler of discoid patent expires this year。
It is available for one month using the minimum dose of Seretide Diskus is priced at more than 350 US dollars。 Mylan company has a generic Seretide ready to launch, but it is not clear when the drug is approved for sale。 Generic drug companies must first prove its precise dose inhaler。
  A year ago researchers published a research article in the journal "Clinical Pharmacology and Therapeutics" (ClinicalPharmacologyTherapeutics), said different batches inhaled dose of Seretide。
This creates a problem, namely how generic drug companies to prove their bioequivalence inhalation device in itself, even Seretide bioequivalence unclear circumstances。
(Lemon Nan / compiler)。