Thursday, 7 July 2016

PoliticalSpeak: drug prices outstrip the consumer price index

In relation to MS DMTs pricing in the US are Pharma running a covert cartel? #MSBlog #PoliticalSpeak #MSResearch

"The descriptive study below chews over a old material; DMTs are expensive in the USA and the inflation in their price is well above what you would expect when comparing it to the consumer price index, or even general healthcare inflation. Why? I think the American healthcare market is perverse and creates incentives that support a covert cartel. If a market was functioning normally entry of competition should drive prices down; in the USA it does the opposite. Similarly, when a generic drug enters the market the prices should plummet. This has not been the case in the US. Glatopa, or generic glatiramer acetate, costs almost the same as Copaxone the innovator product. Are Pharma taking the piss? No wonder politicians are starting to take notice of Pharma shenanigans in relation to the costs of MS DMTs. The good news is that this seems to be a US-specific phenomenon and does not occur in the UK and the rest of Europe. Once the price of a high-cost drug has been set in the UK it usually stays fixed. I can't understand why the US politicians don't drive a harder bargain with Pharma? I assume it is because they worship at the alter of neoliberalism; any attempt to interfere with the market will reduce incentives and innovation. The problem I have with this attitude is that it means a significant proportion of pwMS don't have access to DMTs due to the high-cost of drugs. Yesterday's post on this subject has generated a lot of heated debate, which is ongoing, and has even touched on the subject of Pharmaceutical Imperialism. The fundamental question underpinning the debate is whether or not access to healthcare is a fundamental human right, or should it be subject to market forces and classed as a consumer service, or in the case of DMTs a consumer product? I know on which side of this argument I sit, what about you?"


Bin Sawad et al. Price Analysis of Multiple Sclerosis Disease-Modifying Therapies Marketed in the United States. Curr Med Res Opin. 2016 Jun 30:1-22. 


OBJECTIVES: This study assessed trends in the average wholesale price (AWP) at the market entry of disease-modifying therapies (DMTs) approved by Food and Drug Administration (FDA) in the period 1987-2014.

METHODS: DMTs regulatory information was derived from the FDA website. The AWP per unit at market entry data were derived from the RedBook (Truven Health Analytics, Inc.). The AWP history for each DMT was collected from its date of approval to December 31, 2014. The FDA approved label defined daily dose (DDD) for adult patients was obtained from FDA approved labels. The AWP per DDD and the AWP/DDD per year of therapy were computed. Descriptive statistics, Wilcoxon tests, t-test, multiple linear regression were performed. Statistical significance level was set at 0.05.


RESULTS: The FDA approved 12 MS DMTs, including five new drug applications (NDA) and seven biologic license applications (BLA) as of December 31, 2014. The FDA granted orphan designation to 5 DMTs. There was one DMT approved by the FDA in the 1980s, 3 in the 1990s, 3 in 2000s, and 5 in the period 2010-2014. The market entry inflation-adjusted AWP per DDD was $10.23 for the first DMT (mitoxantrone hydrochloride) that was approved in the 1980s. The median market entry inflation-adjusted AWP per DDD was $12.41 (interquartile range [IQR] = 4.51) for DMTs approved in the 1990s, $71.26 (IQR = 58.35) in the 2000s, and $172.56 (IQR = 84.97) in the period 2010-2014. The median AWP per DDD was statistically significantly different (p = 0.011) for orphan (median=$41.82, IQR = 56.077) compared to non-orphan drugs (median=$171.32, IQR = 199.29). Year of market entry was positively associated with DMT prices at US market entry (p = 0.01).

CONCLUSIONS: The AWP per DDD for DMTs at market entry increased substantially over time. The increase in DMTs prices exceeded the general consumer price index.

6 comments:

  1. I think we should start a petition and demand that at least 5% of all MS drug profits go into a cure fund. We need to start a movement. Time is something those of us with MS do not have.

    Here in the US I have learned that my life is only of value to Big Pharma.

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    1. There are many universities attempting to cure MS including two in my back yard. One can start as many petitions as one might like but it will not speed up things.

      MS has made more progress in managing the disease than most all other chronic diseases. The myriads of medications on the market is proof if nothing else in comparison to other chronic diseases especially neurological ones.

      MS is not an enormous market per se. In the USA for example Lupus numbers our well in excess of a million people.

      The key in helping manage MS (if able) is to change lifestyle as soon as one can.

      As was recently published in this blog. A cure for MS is no more disease activity. Regenerative medicine to try make gains against whats lost is a whole different matter and that too is being explored in many facets and diseases.

      Until that is done people can make significant gains especially if the treatment they are on results in no disease activity. It takes dietary and exercise regimen, engaging learning, staying clear of TV and wasting of time. If I have free time, I am doing something to fight MS.

      I dont look at my MS as a disease anymore. I look at my MS as a living thing, something that is trying to destroy me. So I fight it and I mean I really fight it. I dont talk about fighting it. I dont have the time to read things like, "It will get better" or others anecdotal mindsets. I engage in beating MS as I am the only person that can.

      Since I have had that mindset change. I've made many good gains by doing the work. Its far from easy but I am worth it.

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    2. Im sure more than 5% goes on neuro jollies is that a cure fund:-)

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  2. If US politicians were interested in free markets, they would allow Medicare to negotiate for better drug prices and allow citizens to pick up prescriptions in Mexico and Canada. We're not players in a free market so much as hostages. I like your proposal, but raised objections in yesterday's post because I can totally hear my neuro, nurses, politicians, and activist friends all frame drugs like Clad as "unproven", and therefore unsafe. I was looking for strong comebacks I can use when talking to them about it.

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  3. The costing of MS (and several non-MS drugs) in the USA would pretty much be illegal in the USA if it were applied to any other form of product.

    I do expect that present tax-based paper rebate and incentives systems will change in the next few years. Several reasons most too complex to issue over multiple blog entries.

    The bigger question in the changes is how much more costing will then be passed along to the consumer and from what I hear it may be quite significant and access to the more effective meds by those who cannot afford this may be somewhat more limited.

    Its a crazy setup now that has several benefits and several pitfalls but it has tended to work for the majority of people.

    I fear its one of those "Be careful what you ask for you just might get it scenarios." The public has no concept of how these vertical market meds here are costed out nor why. Right now, the neurologist and patient tend have alot more choice than they would for say a Cardio med such as say Brilinta .vs. Plavix which both have a larger target market. Brilinta a 30 day supply is about $350, my fiance's co pay is more than I pay for my $55K a year Tecfidera.

    According to his Cardio Doc. if these vertical market meds are not afforded the rebate sort of paper deal that benefits both insurer and Pharma (to an extent) the costing of the copays will place many beyond reach of citizens even if costing were to match care systems where costing is negotiated such as Canada.

    In Canada Aubagio costing is about $17,000 a year (CAN). A average co-pay here for a med that is $17,000 (US) will be beyond the range of most people with MS and treatments such as Lemtrada which is a initial one time charge at near 100,000 place it completely out of reach of most people with MS.

    This same formula applied to Stem Cells and regenerative medicine when it comes to bare will also place it out of reach of most people with MS.

    There will be changes coming that is certain as the overall burden of care in the USA is dragging government insure to its knees while private insurers continue to opt out.

    The costs of the meds will end up declining but in tune with that so insurers are able to make money (where-as they currently enjoy some nice writeoffs as does Pharma) will result in higher copays.



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