Plant closures

A thought crossed my mind as I read in the local paper about yet another company closing a number of plants. What impact do these job losses have on other industries? I'm not thinking about suppliers to these businesses as we can all imagine the direct impact there. But what about its impact on industries not related in any way.

Well, there is something in the insurance industry called coordination of benefits or COB. If for example an employee or plan member has access to a spousal plan for drugs, often there is a sharing of the costs. Each plan will cover a portion of the cost of prescription drugs , or dental services etc. It is a way in which a plan actually can save money while providing employees and plan members a higher level of service.

So in the case of a business closing and perhaps hundreds or even thousands of employees effected by this, the net result will be to increase costs on a spousal plan. Even though the two industries may not be related , the job loss is felt by the other industry. If two plans were each covering $50 of a monthly drug spend , one will now have to cover the full $100 thus premiums will rise faster than anticipated.

Another area impacted by this is at the physician level. Some of these folks are not going to have a drug plan and they may end up at the physicians office looking to change medications or help with samples (Only the new products are found there and usually at a higher price) . Some, patients may stop taking their medications all together thereby increasing their risk of more serious events. Both of these add to the cost of our public plans.

Off Patent wars

The National Post reports today about a recent deal in Saskatchewan between Gen Med (a Pfizer Generic Company) and the provincial government for the supply of generic Norvasc. It appears that a tendering process was followed and that the bid was won by GenMed . Now , there are several things that are quite new here. One is that the government will restrict the choice of Pharmacy on which generic they will dispense for the public plan. This restriction is sure to raise a reaction of pharmacy as they typically had the choice of which company they would stock. Another is , what will happen to the private payers? In Ontario and across the country , typically the private payers saw increases in their rates after Ontario did a similar thing with a limited number of drugs. With a large number of blockbuster drugs due to come off patent in the next several years ,will we see more of this perhaps even on the private side?

It's a matter of choice

No matter what way you slice it , consumers want choice. It doesn't matter if the products are cell phones, automobiles, gas, electronics, internet, TV, radio , food , and I think you get the picture. So too do industries want choice. For example and I'll build on my earlier post. Retailers want choices. They want to decide which products they carry and which they don't. The manufacturer can create awareness of a product prompting the end consumer to ask for specific products, but it is the retailer that decides if they will indeed carry the product.

The end consumer can decide to shop at a store which carries a particular brand or they can choose to go elsewhere. That is the power of choice.

Now what if your choice was restricted in some way? Here is a far fetched example of this . Let's say a Municipality creates a bylaw that restricts your choice of automobile to only North American company manufacturers. What would be your reaction be to this? I believe the outcry would be huge. That was a far fetched example but let's look at a more realistic model of restriction in choice. What if you were restricted on choice of prescription pharmaceutical? This is a very interesting case , as you probably know that this , does exist. The crisis in healthcare spending being the key reason . The issue with such restrictions are varied as the impact on choice is felt in several silos in Health care. The obvious one is the end consumer's choice is restricted, but lets examine the implications of this further.

If we start with the Physician as writing a prescription , most often they have been detailed on newer products and will write a brand product. (Only Brand Name Pharmaceutical companies call on Physicians) The prescription goes off to pharmacy where the formulary is enforced. So, if a product is not covered the pharmacist and patient have to go through a number of issues ,which can include ,the patient footing the bill, a call back to the physician, increased paperwork for the physician, perhaps even another visit to the physician. In essence the restriction has added cost to the health care field . So who in this scenario feels the most restricted. I suggest it is the physician and the Patient. They want choice.

World of retail

In that world, shelf space is key. Eye level is where everyone wants to be and manufacturers actually count facings (number of units displayed) as they pay for such space. If a large manufacturer comes out with a new line of product or even a line extension of one product, they must pay the retailer to carry it (a listing allowance) then they must pay them for the amount of space they want, and at what level (eye level being the most expensive). Then they have to work out a deal for a promotion or end isle display etc all with volume expectations and more cost.

Now consider the retailers and drugs. The front of the store runs like above, but behind the counter, the brand manufacturer does not pay a listing allowance or anything like the above scenario. At least not to my knowledge. The store is obligated to carry the new product if a physician writes it. These products are the most expensive so they drive up the retailers inventory level and cost of goods sold. If the new product is accepted by the physician community, and takes off in sales, a larger space is required to store the product but still no manufacturer financial support for this. Unlike the front of the store, there are some extra fees the retailer charges the customer for; i.e. dispensing fees. Really the retailer is dictated to by the manufacturer of the patent protected products.

Once the product is off patent however, there is competition and the retailer gets rebates by the generics. It becomes much like the front store scenario with listing allowances, incentives or rebates. The cost of goods goes down as these products are less expensive but so too does retail sales. If they lower the price of these products they have to make up the sales dollars elsewhere as investors would hammer them if retail sales decline year over year. (a catch 22). So unlike the front store, where manufacturers pay for shelf space etc in the hope to increase sales and market share of their product, these manufacturers know that the overall market is going to decline or not grow as physicians switch to other promoted agents. And the cycle continues.

Power of promotion

An interesting Article from PharmExec.com back in August, discussed the situation with Statins in Belgium.

Belgium's statin stalemate

I think it clearly demonstrates that , whatever controls are placed on pharmaceuticals, you must bring physicians and pharmacies on side. If a drug with ample scientific research, major market share , and physician preference goes off patent, should we not encourage its continued usage? It is all well and fine to attack the pharmaceutical industry for their promotional activity but why not look at how we treat drugs that have faced the patent cliff. Currently , there are over 1000 drug plans across this country. Physicians can't and don't know which third party plan any patient has! There is a level of frustration with plans as controls most often mean more paperwork, callbacks, delays in therapy , etc. They have an obligation to give the best standard of care they can and that includes the best drug they believe available. The pharmaceutical companies direct the education toward their new products (some of which offer little or no advantage over existing medications) Perhaps it is time that we look to changes in how the conversion over the patent cliff is handled by the plans. Put in place, physician focused positive techniques rather than the negative methods currently used or a combination of these as controls are necessary too. To do this , Payers need to direct some attention to helping the primary decision maker (The Physician) .

The above example from Belgium clearly shows that you can lower prices but the primary decision maker must be part of the solution.

Health Care at the Forefront

I'm just back from a trip to Bethesda, Maryland and Washington, D.C., where Health care issues are front page news each and every day. Last night ABC had a one hour special featuring Oboma as he answered questions from a group of people at the East wing of the White house . It was really interesting and I think he spoke very clearly about the challenges to this reform. But, I was left thinking about how this issue is not a US issue , it is an issue facing virtually all countries. Here in Canada our Industries and governments are sharing in the pain. provincial budgets are hovering around 50% going to health care. Corporations, organization , unions, and private payers are all struggling with the rising cost of drugs. There does not seem to be any sort of Federal direction on reform and the provinces are individually dealing with the public side of things .

Now just recently, at the 2009 Western Premiers’ Conference , the premiers announced they were taking action on Pharmaceuticals and forming a buying group. So It would appear that they will tender for drugs which will increase competition between the Generic companies and now the Brand companies as well. So we will have a large public buying group out west, then the tendering in Ontario and most likely Quebec These three buying groups would represent over 90 % of the public drug spends in Canada. Unfortunately , Atlantic Canada doesn't seem to have moved in this direction yet but perhaps soon. In any event, they will remain a small piece of the puzzle and most likely to see higher prices than with the other larger groups.

So, what about the Private Plans that are actually footing a larger portion of the drug spend across the country? What will these changes mean to them? Most likely higher costs and as we have seen in Ontario , two prices for a particular drug. One price for the public insurance and another higher cost for third party.

Will the Plans react to this? Perhaps. There is an initiative developing in Atlantic Canada that is gaining momentum. But more on that later.

Another interesting , development is with GM and Chrysler. They have their service provider de-listing the generic versions of the following drugs.

Zocor, Vasotec, Fosamax, Neurontin, Zoloft,Diane-35, Adalat-XL, Zithromax.

They will be covering the brand drugs only here. So it is reasonable to assume that a deal was struck for better pricing of these products. It is unclear if the deal is with the insurance provider or with the individual companies. This move has major implications for the pharmaceutical industry , plan payers and insurance.

This is similar to what an Atlantic Canada based provider attempted to do with one pharmaceutical company last year but the attempt failed with pressure from several groups. This move may be smoother as it involves more than one pharmaceutical company, a need for cooperation by the pharmacies due to GM and Chryslers economic position and the sheer size of the business in the Ontario region.

Dependent upon how the deal above is structured, it gives the Brand companies stronger ties with the payer groups, allows them to better manage loss of patent, increases competition directly with the generics. But, It also gives them the opportunity to better manage their core business in the Physicians office.

If one manufacturer is supplying both the Patent drugs and off patent, and is also directing the physician education and marketing to the new products, they then have even more control over the supply chains. If GM and Chrysler don’t make a concerted effort to educate physicians to help then nothing has changed. The Pharmaceutical companies will educate the physicians that they can now get this new product as they just listed it directly with GM. Or help them walk through the process required to have it covered. It points to need of having a voice for GM and Chrysler and their employees directly involved with physician and employee education. Now is the time to initiate this.

No more free Samples

If you were about to purchase a new vehicle, you may want to test drive a number of cars to see which you liked best , felt the safest , liked the gas mileage, had the smoothest ride,  wanted a hybrid, etc.  Then you decide and with the assistance of your financial institute you make your purchase.   Just imagine, instead of being able to test drive a number  of vehicles, you are automatically directed  to test drive only the newer expensive models. If you want to try a less expensive model , you have to go down the street and you have to pay to try these models.  To make matters worse, these models have foreign names that you find confusing .  In fact the dealer may not even know the names!  

Nowadays, your choice of drug may cost as much as a new car over the course of several years.  Or in some case in just one year. 

Well, there is an article on Plos Medicine with the above title , you can click here for the link.  It makes the case for eliminating pharmaceutical samples or even vouchers from physicians offices.  I feel this is too big a change and one which may never occur.  One area not explored by this story is to actually increase the sampling to physicians.  If you read the article this sounds like a wild idea, but, consider that the article talks about samples that are the higher priced new drugs with relatively little number of studies .  So, what if there were samples of drugs with huge volumes of data behind them and that they were lower cost.  Now the physician would have to choose... Do I (A) write this drug that is being marketed by the industry  or  (B) continue to write this product that I have learned so much about.  I know its safety profile and efficacy and can leave the newer agent as my second choice or even third choice.  If evidence is provided to show the new drug does amazing new advances then the Physician may consider it.   

Here in Atlantic Canada  we have tried this very thing in our projects and have had great success with physicians and local pharmacists  but have been met with significant push back from some areas you never would have guessed.  We used a voucher system through the pharmacy to obtain the lower cost meds.  Physicians like the approach and so do patients.  A much larger trial is needed now.  

update

More charges laid in alleged Ontario drug reselling scheme... Canadian Press 

Travel

I had a very interesting and productive trip recently to Saskatchewan and had the opportunity to hear the deputy Minister of Health , Dan Florizone speak about their "Patient First Review " program.  He focussed on the difficulties of running the health system and the specifics to wait times within the system.  He made a humorous analogy to opening three restaurants (the only three in town) and waiting in line to get a table.  It really was an effective way to demonstrate the complexities and issues with wait times.  He cited lack of communication and respect as a major barrier and an abundance of administrative duties as some key areas. They recognize that it is the Patient that actually experiences the full process from beginning to end and they are trying to learn from this.  Fixing one area which may cause disruption in another is not the answer.  They are still struggling to make changes but certainly they appear to be seeking answers. 

Charges in Ontario for Drug resale plot

Yesterday , the Ontario government announced that charges were being laid against a number of Generic companies, pharmacies and drug wholesalers.  There is a good story at the Star.com   This once again points to the need for changes in the way we deliver pharmaceuticals in this country.  Transparency is necessary if we are to deliver the best value.  The rebating system in the US causes them to have the highest brand name pricing in the world and these rebates of generic drugs have the same effect here.   

The Power of Personal Contact

In this age of twitter, facebook, text messaging, e-mail, media, and all sorts of IT and high tech ways of communicating with one another, what has happened to face-to-face contact?  Who, in business still uses this ancient method to communicate with clientele or customers and is it still effective?

 

In sports, it is about the personalities.  Just look at how hockey has Wayne Gretzky and now Sidney Crosby. One could say they are the face of hockey. Most of us would love to meet them and for those fortunate enough to do so, it only reinforces their perspective and love for the game. The clubs know they have to do things for the fans to keep the sales up at the gate, and it is why, early on, in the careers of hockey players, programs and awards are set up for community involvement.  Wayne or Sid are well versed in Media and fan support techniques and so are their fellow players. These fan face-to-face exchanges are an integral part of sports.

 

 

Love them or hate them, politicians are experts at the art of personal contact.  If this is an election year in your province, you certainly will see efforts by the political parties to take every advantage of getting in front of a camera, a podium, or a group gathering.  Door to door contact is still a big undertaking even if the candidate themselves can't get out. Representatives will knock at your door and ask for support. In an effort to sway voters, these face-to-face contacts are as much about listening to the concerns of the electorate as it is about getting your platform across.  This is because often voters have not all made up their minds and just want to be heard by the politicians.  Some of these folks will vote based on the candidate that seams to listen the best, or said the right response to the concerns.  It is often the defining moment in how a voter will vote.  In the American election last year of President Obama, this face-to-face, eye-to-eye contact was visible each and every day. Obama certainly used the Internet as an effective tool to augment his efforts but it was his face-to-face efforts, and on the ground support where they really added shine.

 

One industry that most people know little about is the Brand Pharmaceutical Companies.  This group has taken the art of personal contact to levels that perhaps Obama could learn from.  The marketing efforts of these companies utilize, all of the typical media, Internet, and other support initiatives but the power of personal contact is the cornerstone to their success.  The industry may have pushed this contact to the extreme in the last few years which has lead to a bit of a backlash by physicians, academics, and politicians. They essentially had so many personal contacts that physicians began to see fewer representatives.  However the industry is adjusting to more acceptable levels, and make no mistake about it, personal contact remains the focus of these companies. They implement numerous face-to-face, eye-to-eye contacts with the physician to build business.  After all, it is the physician that will cast the vote (in this case a prescription).   These contacts are positive in nature and the companies listen to the needs of the physician much the same as the politician looking for support.

 

A recently released Report by the Canadian Institute for Health Information, “Drug Expenditure in Canada 1985 to 2008”  stated  “Over the last 20 years, drugs have consistently remained one of the major cost drivers in health care,” says Michael Hunt, Manager of Pharmaceutical Programs at CIHI. “Spending on pharmaceuticals has more than doubled over the past 10 years, outpacing growth in health spending by hospitals, physicians and other health professionals.”

 

This certainly points to the success of the Pharma business model and to the success or power of personal contact.

 

 

 

In an effort to control these rising costs, individual benefits groups have focused on a defensive strategy of adding restrictions, slowing authorization of drugs, cost shifting to members, plan management, and reduction of benefits where possible.  From the above report, this defensive strategy has not attained the desired effect.  We have all heard the old adage, “The best defense is a good offence”.  I suggest that the strategies currently in place neglect the prime decision maker the physician (who is equivalent of a voter or fan) and do little or nothing to garner their support.   To bring this back to hockey, this strategy is like having two teams in a constant rivalry and one team has a number of high scoring forwards and the second team has mostly defensive players and may include the best goalie in the league and perhaps some goon players.  The fans are supporting the team which continually is shooting at the net, winning the most games, constantly looking to please the fans,  .   Go Sid Go. 

 

So with all of the new technology and communication techniques , it appears from the above examples that the power or personal contact still reigns supreme.  If personal contact wasn’t so powerful, Hockey would ignore the fans, Politicians would only do advertising, and Brand pharmaceutical Companies would not spend detailing efforts on Physicians.

 

 

 

The new CIHI Report

Drug spending estimated at $30 billion in 2008 was released today  by the CIHI.  Clearly this report validates my earlier post (A Quick comparison of Canada and the US ). 

Canada ranks #2 behind the US in a per Capita spending on drugs.  This makes perfect sense when one compares the drug mix differences between the countries .  In another earlier CIHI document  there was a pie chart showing  that Canada was 3.8 % of the global spend on drugs .  I wonder if that now  has increased? That same report showed Britain as having 4.2% of the global pharmaceutical spend .  Considering the population of Britain is about 66 Million vs Canada's 33 Million , it clearly  displays  something is  not working.   

Drug pricing confussion

Back in February, Mike Sullivan had an article in Benefits Canada that centered around drug pricing issues in Canada and the wide swings in charges to plans vs the more stable pricing to the public plans here in Canada.   Dr. Adam Fein  had an article yesterday in his Drug Channels blog discussing pricing concerns in the US.  He demonstrates a wide variation in drug pricing.  So it appears that both in Canada and the US , consumers must shop around to find the best pricing.  However , I really don't know of too many people in my area that do this. Am I wrong?  In the first place, the patient or consumer usually has a pharmacy that they frequent and never really question the bill.  Here in Canada , I'm not aware of any site which posts comparative pricing for local pharmacies like Dr. Fein references in his article.  Most physicians here in Canada are not that aware of drug pricing  .  So we have a situation where a patient or consumer is diagnosed and given a prescription and neither knows the cost or comparative cost between alternatives.  If you are a Senior on the government plan or an employee with coverage, the actual cost may not be important as they just look at how much is out of pocket at that time.    In fact I had a recent discussion with a few seniors that said exactly that.  They were going to pay the same amount out of pocket if they got a drug for $150 as they would have if they shopped around and got it for $100.  Added to this was that the store they frequented offers a reward point system that kept them coming back.  So to their point, why would they even care about the cost, they pay the same amount, get reward points, and don't have to worry about anything and the Government picks up the bill.  We should learn something about the positive incentives vs using negative incentives to control costs.  

So, the question maybe this.  Which is the point of sale?  Is it at the physicians office when pen is put to paper, or is it at the retail Pharmacy when  the patient presents the prescription?   Brand name manufacturers concentrate on the pen to paper point of sale, generic companies concentrate on the Pharmacy and ignore the physicians.  Close 80% of our pharmaceutical expenditures are on Brand name products and 20 % on generic drugs.   

The PolyCap

Further to my last post, here are some considerations about the Polypill, which is five drugs combined into a single capsule. Firstly, the man behind the phase  2 testing of the drug.  Dr. Salim Yusuf, his bio can be found here, is a very, very respected investigator and physician in Canada.  In fact, it was through his work with the HOPE study (I think every physician in Canada knows this study inside and out), that lead to Ramipril becoming the #1 Ace Inhibitor in Canada.  Of course with a lot of marketing by the manufacturer.  Actually this points to another difference between Canada and the US.  The Number of total prescriptions for Ramipril in Canada was 4,736,000 for the one manufacturer that made the top 20 list from my previous post.  There are of course other manufacturers so that number is even higher.  It is the only ACE to make the list.  If you look at the US data you see that Lisinopril is the only ace to make their list and has 75.5 M prescriptions.  So the marketing efforts in the US for Ramipril were not as good. Two different companies had the marketing rights for Canada and the US.  

Ok, now back to the Polycap.  You can watch an ABC News story here to get more info, but I want to discuss what is next.   

They are suggesting a large follow up study.   This is a perfect time for Canada's Health bodies to get behind this world leader in his field and make the follow-up study happen.  It is most likely not a study that the BIG PHARMA group is going to fund.  These are drugs that have gone off Patent.  The Generic Industry most likely will not do this either.  One of the cornerstones of this product is that it can save $ and lives.  If, it saves dollars, then someone is not making as much.  That is a simple fact.  So who could see lost revenue from the introduction of such a pill.  I suspect the list includes the following, Big Pharma, Pharmacy (one prescription as opposed to 5), Insurance (if they are based on % of book of business), wholesalers, Generic companies (lost revenue of selling 5 products),  and perhaps even Consultants dependent on how their payments are structured.   So really it encompasses the whole supply chain.  But look at the masses that could potentially benefit.  Imagine, Benefit plans  and government plans could save money thereby  allowing more new break through drugs on their formularies.  The potential benefits may well be there in the end for the supply chain.  

The US Health structure promotes a desire to reduce pharmaceutical expenditures .   If a study is going to happen in the US , I hope we are getting behind Dr. Yusuf and helping him make this happen here in Canada. 

Something for future consideration is the following.... If the Study is done and indeed it proves that it saves lives, reduces expenditures, improves compliance,and makes it to market, how will it be promoted? Or Who will Promote it?  As from the Ramipril vs Lisinopril explanation, marketing is very very necessary.  

A Quick comparison of Canada and the US

IMS Health released the numbers last week for both Canada and the US .   It is interesting to compare some of the results as it gives a bit of insight into the differences between the two countries.   Firstly the US market as a whole is $291 B while Canada is $21.4 B.  So nothing startling there, Canada  is equivalent  7.3 % of US  Market.   

But we know that there are major differences in pricing between the US and Canada.  For example , US Brand pricing is the highest in the world and Canada is less due to our Price regulations.  The US has some of the lowest generic prices as seen with the Walmart introduction of $4 and $10 prescriptions which has lead most other retailers to follow suit.   In Canada, we have some of the highest generic prices in the world as there is little competition and a MAC pricing across the country.  So it is difficult to compare on $.  So lets look at Prescriptions.   ( I'll concentrate on statins here) 

If we look at Top 15 Drugs dispensed in the US you see 66.7 Million Prescriptions for Simvastatin (Primarily generic, trade name Zocor) and 57.9 Million Prescriptions for Lipitor.  Now compare this to The Top 20 Drugs Dispensed in Canada Table 6  .  Simvastatin is nowhere on that list, Lipitor has 14.8 Million Prescriptions and Crestor is there with 6 Million prescriptions.  My understanding is that Simvastatin has drastically declined in prescriptions in Canada while it has grown 39% in the US!   If you just look at Lipitor alone, as it is the only one with the high level data for both countries,  Canada is equivalent to 25% of the US usage. Think about that for a minute..... Canada is equivalent to 7.3 % of the total US Market in terms of dollars  but on a prescription basis for the #1 product in the world, Canada is equivalent to 25% of the prescriptions!!!!!  Obviously , Crestor has to have an even higher percentage and Simvastatin a really low number.     

So , some of the questions we need to ask are,  

1. Are all of these Americans at significantly greater risk than Canadians? 
2. Why is there such a difference? 
3. Why do Canadian governments and Industry not take advantage of the price reductions?
4. Can we learn from what is happening in the US ?
5. Are there ways the Canadian health Care system can save $?
6. etc. etc. etc

I've concentrated on Statins here but , we could have discussed other classes of drugs as well.  Perhaps my next post will be on the PolyPill .  You can read about it  here at the Lancet... 

Could save lives and money! 

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AZ going to battle again

This story just out from Reuters about the patent challenge on Crestor.  Quite a list of companies seeking to produce the generic form.  As the article states this is just the start of the battle.  You will recall that AZ has already inked a deal with Ranbaxy on some of their other products , such as   Nexium .  Perhaps this will lead to a deal on Crestor... Only time will tell. 

Pfizer is now increasing its Generic Business

Indeed things are very grey.  No longer can you assume that Brand and Generics are separate businesses..  Most if not all of the major Brand companies have either their own Generic Business or arrangements with generics.  Here is the latest from Reuters " Pfizer to license generics from India's Aurobindo"

Funny new commercials by TEVA in the US

This is cute.... TEVA for those of you who don't know it is called NovoPharm in Canada.  Here is a link to the you tube broadcast. "TEVA's Year of Affordable Healthcare"  There is a second video that you can watch called , Where am I?

A look from a global perspective

This article at Seeking Alpha, entitled" Biotech Going Generic Like Big Pharma?" is a great look at the movement within pharmaceuticals.  

Ed

Drug Adverse event database

Why is it that our federal government database of reported adverse events for drugs is not kept current?

I just did a search here and the Data is only showing for 2007. If a drug is promoted heavily to Canadian physicians , its usage can soar quickly. Just look at the Vioxx case... Now if physicians and patients had timely access to this , would that not be a good thing?
Ed

You can access the database below. Check the drugs you currently are taking, compare the number of events from one drug to another.



Health Canada Drug Adverse event database

Canadian Medical Association (CMA)

Dr. Ouellet lets hope something comes of this.



CMA Calls for Attitude Shift to Transform Health Care System

TORONTO, Feb. 10 /CNW Telbec/ - Canadian Medical Association (CMA)
President Dr. Robert Ouellet is urging Canadians to set aside old attitudes
and instead seek transformative change within the health care system.
"Making our health care system both sustainable and accessible for
patients requires that we make fundamental changes in how we think about
health care," said Dr. Ouellet in a speech to the Economic Club of Toronto
today. "We have tried to throw money at the problem, but money is not the only
solution."
In recent months, Dr. Ouellet and a team of CMA researchers have visited
several European nations to meet with doctors, nurses, patient associations,
researchers, government and other officials to see what has worked within
their health care systems, and why it has worked.
Preliminary findings and discussions show that these countries -- the
United Kingdom, Belgium, the Netherlands, France and Denmark -- face many of
the same issues that Canada does: aging populations, difficulty providing
timely access to quality care, and increasing demand for services.
Dr. Ouellet cited several key points that the CMA will be bringing to
Canadians for discussion, including:

<<
- the fact that European states use the private sector within their
health care systems yet strictly adhere to the principle that no
citizen will go without health care because of an inability to pay;
- the fact that in the European systems studied there is no difference
for patients between public and private systems because the interchange
between the two is transparent, with patient need -- not ideology or
cash -- determining how and where care is provided;
- the fact that Europeans face short, or no, wait times, yet spend less
money on health care than Canada;
- the fact that, for these countries, there is a real solidarity against
suffering and a commitment to ensure not only equal but also timely
access to health care for everyone;
- The fact that options such as funding hospitals based on activity
rather than just block funding can dramatically improve efficiency
within our system.
>>

"In Canada we focus on turning the funding tap on or off depending on our
economic situation instead of on improving efficiency and boosting
productivity within the system," added Dr. Ouellet. "Something has to suffer
in this scenario, and all too often it is the patient."
In the coming weeks the CMA will begin a consultation with Canadians that
will include doctors, other health care professionals, patients, governments
and policymakers. The Association will use this input to formulate a plan -- a
"Made in Canada" solution -- to make transformative change in the health care
system possible.

Interesting week at Pharmacanada

There were a couple of really interesting reports this week that I'll share with you. One is the The Health Council of Canada Report entitled The National Pharmaceuticals Strategy: A Prescription Unfilled

This followed by Dr. Neil MacKinnons article in CMAJ on the above. The National Pharmaceuticals Strategy: Rest in peace,
revive or renew?
You certainly get a sense of the frustration of trying to get all sides working together.

Then there was the report from the University of Calgary (Department of Economics and Institute for advanced Policy Research) entitled " Generic Drug Pricing and
Procurement: A Policy for Alberta"
Aidan Hollis

This is a terrific explanation of the situation across this country . Each province doing their own thing. When will we learn?
Ed

What is GFR?

Recently, I was presenting to a group that brought up the term GFR. In particular they were stating that the GFR for there plan was at 48% up from 38% the year before. Now for those of you who don't know what GFR is , it simply means Generic Fill Rate.
Now , If this is the case in your Drug Benefit Plan, it should be expected that this % has gone up. Why? Well, here in Canada we have had a few, very large drugs lose patent. When this occurs you see a spike in your GFR. The real question is can your plan sustain it. In the US today , the GFR is approaching 70 % while here in Canada it sits at about 50%.

What is GFR?

Recently, I was presenting to a group that brought up the term GFR . In particular they were stating that the GFR for their plan was at nearly 100%. The plan board thought that GFR was the same as Generic substitution. I really think that their insurance carrier or paid consultant should have explained the difference until I realized that the consultant did not fully understand the terminology difference. So let me explain. Here in Canada most plans have a Generic Substitution policy where once a drug goes off patent then the plan will pay for the less expensive alternative. This is Generic Substitution Rate or GSR. Thus you should currently see Atorvastatin commonly known as Lipitor which is just facing several Generic equivalents have a high GSR. This just occurred in the last week or so, so you may not see it in your current carrier reports but it will impact future reports and should be at 95% +. The GFR rate refers to the number of prescriptions written or filled generically in your plan. In Canada last year the combined average GFR for Public and private plans was at about 54%. In the US that percentage is much higher at over 70% pointing to most prescriptions being written as a generic. Canada is ahead of the US in terms of the number of blockbuster drugs that have gone off patent so we have not done enough to try to take advantage of the lower costs with generics. Much debate is currently going on , as to how we get better pricing on these off patent medications.

From: In the pipeline: Drugs to watch in 2009

For Those of you interested in what to expect in the future , here is an article from Modern Medicine at the following address
http://formularyjournal.modernmedicine.com
We can expect that as these blockbuster drugs come off patent a big shift is going to occur. In Canada we have a group called the Common Drug Review (CDR). A program funded by the FPT Ministries of Health that operates under the aegis of the Canadian Agency for Drugs and Technologies in Health. It reviews and makes recommendations but the provinces are free to make there own decisions. It will be interesting to watch for these new products as they come to market and our Health Care System struggles with the costs.


The article can be found below.


http://formularyjournal.modernmedicine.com/formulary/In+the+Pipeline/In-the-pipeline-Drugs-to-watch-in-2009/ArticleStandard/Article/detail/575687?contextCategoryId=44264

In the pipeline: Drugs to watch in 2009


Jan 20, 2009
Formulary ENews

Several blockbuster drugs will fight to hold onto their top spots in 2009 as new products come before FDA for marketing approval, reported Brian W. Kolling, PharmD, at a recent meeting of the Academy of Managed Care Pharmacy (AMCP) in Kansas City, Mo. Key therapies to watch as they move through the pipeline include medications for cardiovascular (CV) disorders, central nervous system (CNS) disorders, respiratory disease, and diabetes, he said.

According to Keith Bradbury, executive director of drug information at Medco Health Solutions Inc., FDA has delayed approval of many NDAs while the agency struggles with implementing new regulations established by the 2007 FDA Amendment Act (FDAAA).

“We are at a historic time in terms of the number of products the FDA has delayed or allowed the user end-date to pass and extended the review period,” Bradbury said.

For this reason, he said, as many as 62 NDAs could be submitted in 2009. Of these, perhaps 25 will be approved. “There are about 40 to 45 drugs sitting at the FDA today waiting for action,” Bradbury said.

According to Bradbury, a home run might occur in the CV field. Bradbury was referring to rivaroxaban (Bayer/Johnson & Johnson); if approved, this agent will be the first new anticoagulant oral drug to reach the market in more than 40 years, with the potential to replace warfarin.

“This is potentially a multibillion-dollar drug. It looks very promising,” Bradbury said. The benefit of rivaroxaban is the potential elimination of the costly monitoring associated with warfarin.

Another important CV agent in the pipeline is prasugrel (Daiichi Sankyo/Lilly), which, if approved, will compete with clopidogrel. The Cardiovascular and Renal Drugs Advisory Committee is scheduled to meet on February 3 to discuss prasugrel.

“The $64,000 question is: Is the FDA going to be able to tease out from the data whether the drug is in the net beneficial and not harmful? If this happens, then [clopidogrel] is going to have some...competition,” Bradbury said.

Although most of the new drugs expected to hit the market will inevitably carry hefty price tags, the introduction of several key generics should offset some of the medication costs consumers face. “It is our expectation that in 2009, about $11 billion of prescription drugs will be subject to generic competition,” Bradbury said.

The following therapeutic areas are the ones to watch for emerging therapies.

Cardiovascular
During the next several years, generic products will continue to make inroads into the CV market as the top statin, angiotensin II receptor blocker (ARB), and antiplatelet drug all go off patent by 2012. There is also a full field of factor Xa inhibitors, several of which are now in phase 3 trials.

Statins will still dominate cholesterol management, but combination products and several agents with new mechanisms of action are in development. New products to watch for include GlaxoSmithKline’s darapladib, which targets lipoprotein-associated phospholipase (Lp-PLA2), an enzyme linked to artery-clogging plaque, and Isis and Genzyme’s mipomersen, an apolipoprotein B100 antisense inhibitor designed as a lipid reducer for high-risk CV patients. Two new cholesteryl ester transfer protein (CETP) inhibitors, Merck’s anacetrapib and Roche’s dalcetrapib, are also on the horizon.

There has been a push to develop new antiplatelet and antithrombotic agents to replace less effective and more costly products. As mentioned above, if approved, prasugrel, a platelet inhibitor used for the prevention of CV events in patients with acute coronary syndrome (ACS), could rival clopidogrel, which is set to see its patent expire in 2011. Clinical trials demonstrated that prasugrel may be more effective than clopidogrel in preventing CV death, nonfatal myocardial infarctions (MIs), and strokes, but also that it was more likely to cause serious bleeding. If FDA calls for additional clinical trials to study the bleeding issue, the drug’s approval would be delayed.

SCH-530348 (Schering-Plough), an oral antiplatelet drug, would be the first in a new class of thrombin receptor antagonists. SCH-530348 prevents blood clots by inhibiting the action of thrombin, a key coagulation factor that converts fibrinogen into fibrin. This agent is in phase 2/3 trials.

Another new antiplatelet formulation is ticagrelor, the first reversible oral adenosine diphosphate (ADP) receptor antagonist. Developed to reduce the risk of thrombotic events in ACS patients, ticagrelor inhibits platelet aggregation, which may reduce clot formation. Clinical benefits of reversibility are unclear; however, results of phase 2/3 trials now under way may shed light on the issue.

With limited clinical choices for the prevention of thromboembolic disease, 2 new anticoagulants could meet the need for new products in this area: rivaroxaban, a once-daily direct Xa inhibitor being studied for the prevention of venous blood clots in adult patients undergoing elective hip- or knee-replacement surgery, and dabigatran etexilate (Boehringer Ingelheim), an oral reversible direct thrombin inhibitor being studied for acute venous thromboembolism (VTE) treatment and secondary prevention of VTE, as well as prevention of CV events in ACS.

Dronedarone (Sanofi-Aventis), a multichannel blocker with antiadrenergic properties that is chemically similar to amiodarone, is being studied in patients with atrial fibrillation or atrial flutter. Clinical trial results indicate that this agent may be better tolerated than amiodarone.

Central nervous system
Researchers are aggressively working to develop new products that will eliminate some of the undesirable side effects associated with many currently available CNS drugs. Several new migraine treatments are under investigation, as are new fibromyalgia agents. The CNS market will also see several top drugs going off patent in 2010 and 2011.

Existing antidepressants often have negative side effects, efficacy problems, and poor patient compliance. One new drug in the pipeline is saredutant (Sanofi-Aventis), a neurokinin-2 receptor antagonist with a mechanism of action different from any employed by existing drugs. It blocks the effects of neurokinin-2, thereby preventing the neurochemical changes induced by stressful conditions in various brain regions.

Melatonin receptor agonists are also in the pipeline, with one of the lead compounds, agomelatine (Novartis), now in phase 3 trials. Compared with existing antidepressants, agomelatine is the first melatonergic agent to demonstrate favorable results in its effect on sleep, weight, and sexual function.

Although antipsychotic drugs are the mainstay of schizophrenia treatment, common side effects such as metabolic disturbances, sexual dysfunction, hyperprolactinemia, and cardiotoxicity lead to poor long-term adherence. As a result, researchers are working to develop a third generation of antipsychotics that may provide broader efficacy, reduced side effects, and improved tolerability. Several NDAs have been submitted, among them applications for sertindole (Lundbeck), which is associated with less sedation when used to treat schizophrenia, and asenapine (Schering-Plough), a new 5-HT2A/D2 receptor antagonist for treatment of schizophrenia and bipolar mania disorder. FDA issued a complete response letter for asenapine earlier this month; the letter asked for supplemental data but not for additional clinical trials.

Two migraine treatments are in late-stage development: telcagepant (Merck), an oral calcitonin gene-related peptide (CGRP) receptor antagonist, and botulinum toxin A (Botox; Allergan), which is injected every 12 weeks in trials. Both agents are in phase 3 trials, and the manufacturers hope to file for FDA approval in 2009.

Milnacipran (Savella, Forest/Cypress), a selective norepinephrine serotonin reuptake inhibitor (NSRI), was approved earlier this month for the management of fibromyalgia. [S,S]-reboxetine (Pfizer), a norepinephrine reuptake inhibitor, is also in development for this indication. Reboxetine is in phase 3 clinical trials.

The sleep-disorder market may see the arrival of 2 new insomnia drugs: doxepin (Somaxon) and eplivanserin (Sanofi-Aventis). Unlike existing sleep aids, doxepin selectively blocks the neurotransmitter histamine and may improve insomnia symptoms without serious adverse effects. The PDUFA date for the doxepin NDA was recently extended to February 29, 2009. Eplivanserin, a selective 5HT2A receptor antagonist, is in phase 3 trials. Zolpidem tartrate extended release (Ambien CR; Sanofi-Aventis) is scheduled to go off patent in March 2009.

Respiratory agents
Respiratory drug development is focused on a wide range of potential combination therapies. A new class of drugs is not likely to be available for at least 3 to 5 years.

Novartis is developing indacaterol, an ultra-long-acting beta agonist inhaler, for the treatment of chronic obstructive pulmonary disease (COPD) and asthma. An NDA for aclidinium bromide (Forest/Almirall), an inhaled muscarinic antagonist for COPD, is expected to be filed in the fourth quarter of 2009 or the first quarter of 2010.

Tadalafil (Cialis, Lilly) has demonstrated promising results for the treatment of pulmonary hypertension. An NDA for inhaled treprostinil (United Therapeutics) for the treatment of pulmonary arterial hypertension was submitted in June 2008. Pfizer is awaiting FDA approval for sitaxsentan, an endothelin receptor antagonist for pulmonary arterial hypertension treatment.

Diabetes treatments
Few patients with diabetes achieve their target goals for blood glucose, cholesterol, and blood pressure, and many of these patients are undertreated. Drugs are being developed to meet the needs of this population as the incidence of diabetes assumes epidemic proportions.

Two new dipeptidyl peptidase (DPP-4) products, alogliptin (Takeda) and saxagliptin (Bristol-Myers Squibb/AstraZeneca), have demonstrated favorable results in patients not adequately controlled with existing insulin products. Alogliptin is pending FDA approval; the PDUFA date for this NDA was recently extended to June 26, 2009. An NDA was submitted for saxagliptin on June 30, 2008.

Novo Nordisk’s liraglutide, a GLP-1 analog, has demonstrated a risk of hypoglycemia much lower than that connected with many existing drugs. In phase 3 trials, more than half of the participating patients achieved a glycosylated hemoglobin A1c (HbA1c) of <7%. A benefit that liraglutide shares with other GLP-1 analogs is its potential to significantly reduce weight. An NDA was filed for liraglutide on May 23, 2008; the Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to discuss this agent on April 2 or 3.

Dapagliflozin (Bristol-Myers Squibb/Astra-Zeneca), a highly selective inhibitor of sodium glucose cotransporter 2 (SGLT2), has a dose-dependent effect on HbA1c levels and fasting plasma glucose (FPG). In clinical trials, the drug produced slight weight loss but was also associated with a higher incidence of urinary tract infections.

In a field of failed attempts to market inhaled insulin, MannKind is hoping to gain approval for a delivery system that administers a dry-powder insulin formulation through a palm-sized inhaler. Phase 3 trial data comparing this powder formulation with injected insulin have demonstrated similar efficacy between the 2 formulations.

CMA President Seeking Health Care Answers

OTTAWA, Jan. 15 /CNW Telbec/ - Dr. Robert Ouellet, President the Canadian
Medical Association (CMA), will begin the second stage of his European health
care fact-finding mission on January 19.
"The goal of this project is to suggest compatible and efficient measures
that could improve access to our own health system and address lengthy wait
times," said Dr. Ouellet. "The current economic climate demands that we look
for ways to increase efficiency and provide value for money in health care
service delivery. There could be no better time to suggest to Canadians a
positive transformation of the health care system."
Dr. Ouellet's research will focus on finding concrete examples of how
certain measures were implemented and have contributed to improving the health
care system of various European countries. By drawing on the experience of
European countries that have been top performers in terms of value for money
and access to heath care, we can address the problems afflicting Canada's
health system.
Dr. Ouellet and CMA representatives will be meeting with key individuals
who have played a major role in improving their country's healthcare system
and will witness firsthand how certain programs or projects have been
implemented. The team will visit Denmark, Belgium, the Netherlands and France.
Stage 1 of this mission began in November 2007 with a visit to the United
Kingdom.
"It's important that we look at the practices of countries that rank at
the top in terms of comparative international health policy studies. We're
going without any preconceived ideas, and we're keeping an open mind about all
types of practices," Dr. Ouellet stresses. "The first stage of the tour, to
the UK, revealed several interesting models. I'm looking forward to the second
stage."

A series of regional and national consultations with the Canadian public
will follow the first draft of the report of this study mission. The final
report should be made public in June 2009.


For further information: Lucie Boileau, Media Relations Manager, 800
663-7336, (613) 731-8610 ext. 1266

Here is a story from the CMA about Dr.H. Visser and how he uses EMR's.  

http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Future_Practice/English/2009/14-ahead-CS-10Crapaud.pdf

Post #2 Government of Canada Works to Improve Knowledge About the Safety and Effectiveness of Drugs

From the Health Canada site:    Part of the discussions at the Conference in Boston centered around this issue.  The presentation from the FDA certainly made it clear that it is a global concern and that because of todays global outsourcing by both Brand and Generic companies , it is imperative that more controls are needed. 
Government of Canada Works to Improve Knowledge About the Safety and Effectiveness of Drugs
">http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2009/2009_03-eng.php"

First Post Jan 15, 2009

I read a really interesting Blog this morning by Dr. Fein of Drug Channels (http://www.drugchannels.net/2009/01/pharmacy-profits-and-wal-mart.html) .  The US has exactly the same concerns  as we do here in Canada.  It appears from the Third Party Plan description that they are feeling the pinch.  

Take a look.