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Lonza
Thanks for the info.
Long time Dew. Hope all is well.
RPh
FOB question
Anyone know of a name of a company in the Netherlands that might be able to provide FOB manufacturing of Humira and Enbrel when the time is right?
Trying to confirm some info I heard today. Person thought the company name might start with "L".
Hoping to tap the I-Hub Brain.
RPh
RE: CVS is having second thoughts about MinuteClinic:
I wonder if there is difficulty finding qualified NP's to man the shop or has the public not been utilizing the service? With the amount of acute infections we have seen this year, I am surprised that utilization would be the issue. It certainly is an interesting (and welcome) development..
RPh
RE: timing of announcements
Thanks for your answer. My question really isn't about GTCB in particular, even though I honestly expected a positive announcement in the AM.
I guess I needed a diversion while I await the next couple of days. I also find my predispositions, that have no basis in fact, interesting.
Soul searching in Milw.
RPh
General Question Regarding the Timing of Company News.
I have always thought that it was better to make negative announcements after hours and positive announcements before the bell. I don't know why I assumed this, I just did. Does anyone have any insight that would educate me on the best psychological timing of announcements?
Just trying to explain my own beliefs to myself,
RPh
Should we then complain when the 'game' opens up just a bit??
If these "quick" clinics were opening in response to a shortage in primary care or an outpouring of need from the community, I would have no problem. The ONLY reason the Walgreens of the world are doing this is because this business model increases RX volume. Unfortunately, the PA's and NP's that are running these clinics, in general, do not understand this.
"That will decrease patient access to patient care at a time when many parts of the United States are experiencing a shortage of primary care physicians," she said
What she doesn't say is that the vast majority of these types of clinics are not positioned in the low primary care MD areas!
Hafner said MinuteClinics do dispense some prescriptions, but said staff at her clinics are trained to instruct patients that they are free to fill prescriptions wherever they like.
Anyone here believe this changes anyones decision on where to take their RX? Nobody, including Hafner!!!
Long Time-No Rant,
RPh
RE: Fire the PBM
It's nice to see the WSJ acknowledging the real trouble with our healthcare system. The approach they talk about is pretty much the course of action my company teaches and implements for mid to large sized companies. The fact that the PBM trade guy's only rebuttal is to focus on untapped savings from manufacturers indicates that I need to start marketing outside of the Milwaukee area!
Sometimes it's nice to hear pundits like the WSJ affirm my opinions.
RPh
P.S. I haven't forgotten your question about Adderall. I have been off with a terrible bout of stomach flu. First days missed of work in 6 years.
RE: Generic Adderall
Dew,
If you feel that it is different, then for you it is. Listen to what your body is telling you. My question to you is, is the difference worth the higher cost to you. Only you can answer that. See message 39816 for further background.
BTW, could your insomnia be due to the use of adderall or others in the same class? I'm sure this is unrelated but it is too obvious of a cause for me to ignore.
Feel free to e-mail me if you want to discuss off board.
Merry Christmas to all,
RPh
RE:Adderall takes roughly 3-4 days to reach steady state
While I agree with your facts, I would say that clinical efficacy doesn't always correspond. For instance, I have some patients who swear that generic Lasix (a common water pill) doesn't work as well for them as brand, and are more than willing to pay more for it. Both brand and generic lasix have such modest moderations in bioequivalence that there should be no clinical difference. So what explains the difference?
Remember that if there is no variation in the drug, then the variation must be attributed to the specific patient. The most common patient variations could be due to metabolism issues (kidney/liver), absorption issues (enviromental-stomach acidity or inactive ingredient incompatibility, mechanical-tablet compression as too hard or soft), and distribution issues (fluid volume). Greatly divergent patient variables are usually avoided in bioequivalence testing for FDA approval.
It's taken me years to not question a patient when they observe these differences. In fact, I have taken to tell all my patients to listen to their bodies. You'll be suprised at how much it's telling you!
I hope my pharmacology and therapeutics profs don't think my time was wasted in their classes!
RPh
RE: two questions
Does BRL now furnish two different Adderall lines: the “branded” line they got from Shire as well as their own generic line?
I wish I knew the answer off the top of my head, but I don't. I will check it out when I return to work next week.
If yes, is there a difference in efficacy that you are aware of based on customer feedback or other sources?
If yes, I would doubt that there would be any diference as they both would probebly come off the same line. While there has been known to be some inter-lot differences between batches of other meds, but these are usually in the 3-4% range and rarely mean anything clinically. An example of this would be brand and generic Zocor. Dr. Reddy's generic is made by Merck and as such, would have little veriation from the brand.
I will check on your first question.
Hope this answers your second question and GO PACK
RPh
Thanks Dew,
I unfortunately have less time to read here as family care has taken me away. I remember a related topic a couple of years ago where I pontificated about the high cost/unknown worth of Aricept and alike. I now find myself having to help my Dad with these very decisions. It's sometimes hell getting old.
RPh
P.S. Merry Chritmas and Happy Holidays to all who make this board work.
RE:Express Scripts
I certainly like this deal better than the CVS deal on conflict of interest grounds. I would bet this would cause my next Express Script contract to be brutal!
RPh
RE: Medicaid payments
[Disclaimer: As a pharmacist, I do have an obvious bias]
these changes to Medicaid are relatively non-controversial
And completely nonsensical if you really look at it. Wisconsin has been proposing further cuts in reimbursment for years. In 2002, I reviewed the costs of our state's plan and found out something interesting. The cost of the plan had seen double digit increases for the previous 8 years. Pharmacy reimbursment rates remained the same over those same years. Hence, the reimbursment rate was not the cause of the escalating cost of Medicaid. The actual cost of medications are the bastard child that no one wants to acknowledge. Any change in rate is only a short-term easy bandaid that really won't solve the issue.
more than 90 percent of the savings would come from pharmacies.
As stated above, the reductions won't accomplish the desired effect. 90% of the effect will be on 5% of the problem. IMHO.
So what is the solution? Since the problem is associated with the escalation of prescription costs, ultra high pharmacy utilization, and the chronic multiple disease state patients, the only true solution is to run Medicaid like an insurance. Get your state to use strict formularies, get more pharmacy company rebates, and limit patient ability to get brand name drugs. Unfortunately, Wisconsin has only recently initiated the above requirements.
Lastly, the law of unintended consequences will turn up here. There is no reason why any pharmacy has to accept Medicaid. This will leave only a few chain pharmacies for the states to deal with. I would love to be Walgreens when they negotiate their contract, being the only pharmacy willing to deal with the state.
Soapbox over,
RPh
RE: Copaxone patent
According to the FDA's Orange Book of bioequivalency, Copaxone injection's patent expires May 24, 2014 for all available MS patents. I'll try to include the link:
http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=020622&Product_No=002&...
If that didn't work google "orange book" and search by proprietary name Copaxone.
RPh
RE: Pozen has one in trials
See NapraPAC. Naproxen and Prevacid in a UD pack. Problem is the price for these types of combo products are usually more than the price for two versions seperately. Also, Arthrotec has been out for a long time (diclofenac and misoprostel) with little market share.
Thanks for the link,
RPh
RE: CVS and Caremark Rx Unveil Stock-Swap Deal
Dew et al,
The news caught myself and others a little off-guard when we heard about this. I have the same type of reservations about this merger as I did when Merck bought Medco in the 90's. In the Merck-Medco case, a supplier controlled the supply, formulary approval and with mail order, the final distribution of the drug to the patient. The FTC didn't seem to have a problem, although history shows that our worries over the potential abuses from the direction of formulary decisions to Merck's drugs had been legitemate. I don't forsee the FTC having a problem with this merger either.
CVS maintains that there will be no exclusive contracts nor preferred reimbursement, and that they will strive to make the PBM industry more transparent. One pharmacy spokesman said that if CVS actually does make changes to the industry, then the merger could be good for everyone. I will believe that when I see it.
Hope all is well in your world,
RPh
RE: Naproxen prescribed at 1000mg
Sorry to butt in but the normal dose of Naproxen is 500mg twice daily. Lower doses are usually not effective as an anti-inflamatory. Because it is one of the most irritating NSAID's,if you have a history of GI ulcer or have a "weak" stomach, there is nothing wrong with taking a PPI with it. Always take it with food as this may be more efffective than additional meds at preventing irritation.
Hope this helps and always check with your doctor if you feel that something is not right.
RPh
RE:increase in Part D-funded prescriptions should come as little surprise
David Gratzer, a senior fellow at the Manhattan Institute who opposes Part D because of the program's cost, said the steady increase in Part D-funded prescriptions should come as little surprise because, for many seniors, the program provided access to prescription drugs they could not have otherwise afforded.
I disagree with the thinking that the increase in utilization is due to the increased affordability of previuosly unobtained needed medications. Utilization of prescription drugs goes up because people always use more medication when they are only paying for a small percentage of their bill. This is why there was no way to accurately estimate the cost of medicare part D, and why so many people were against it in the first place.
RPh
RE: Walgreen to open more in-store health clinics
I find the inclusion of "screenings for conditions such as diabetes and vaccinations for flu, hepatitis B, meningitis and tetanus/diphtheria" a distracion from the real purpose of these clinics, which is to increase script volume. Pharmacists already can screen for diabetes and, with proper certification, can give vaccines. There is no other reason to add a clinic except to impact thier own "locked in" prescription volume.
BTW, in Wisconsin, it is against the regs to even put a pharmacy name, address or phone number on the prescription blank because of a conflict of interest. I wonder how/if these clinics will be accepted by our board? Talk about the quintessential conflict!
RPh
RE:eye exams in a corner of the eyeglasses showroom
Anyone else old enough to remember physician dispensing? After more than a few complaints about overcharging and med errors, the AMA finally came out against the practice. They pointed to the blatant conflict of interest and it's effects on public safety. This had to be in the late 80's or early 90's.
RPh
RE:incentives to prescribe inappropriately are perverse
Urche,
I agree with you and can site examples of pressure that large chain pharmacy puts on it's pharmacists. All too often the pharmacist is either in agreement with managemnet or too ethically mushy to stand up for what is right for the patient. It is not a stretch to assume this same pressure for increased RX numbers will be pushed on the chain RNP at patient expense. This focus on numbers was one of the reasons I will never work for a chain again.
Gosh, I think I have too many soapboxes!
RPh
RE: Healthcare At The Drugstore
I am currently working at an outpatient pharmacy in a hospital which is really only open for employees. The hospital uses nurse practitioners, one of which I would have more faith in than some MD's, as their occupational health professionals. This saves the hospital tons of money. It also has increased the pharmacy business as they are writing, not only for acute care, but are taking over as primary providers. Needless to say, pharmacy is very concerned over an NP writing for psych meds and controlling complicated blood pressure/diabetes cases. I know that the AMA is terrified of this becoming any more common of a way to hold down costs.
From my experience, I have little doubt the advance into acute care clinics in pharmacies should increase prescription volume and make these pharmacies more profitable. My concern is for the quality of service provided.
RE:I think the issues are too complex to be resolved without legislative intervention
See, I knew we agreed :) I've proven it's way to complex for me!
RPh
RE:The insurers are the evil ones in my book.
While I would use a different term than evil, I have often wondered which came first, the high prices for medicine or the insurance companies that act to "hide" the costs to consumers. The documentation regarding the broken nature of the entire PBM system is overwhelming.
RPh
RE:How much of an economic incentive should there be to challenge a patent?
Dew,
I agree with you that some of the patent challenges are needed as some companies have made every attempt to lengthen thier patent through the use of their own loopholes. It seems to me that we should be looking at the loopholes. The problem I have is that all patents seem to be challenged. This does push up the costs to everyone for all versions of a product. It seems to me that without the 180 days rule, only the blockbusters would be challenged, and, as happpened throughout the 80's and 90's, we still would get a couple of generics out for each minor drug.
The only thing that keeps overall U.S. drug prices from going through the penthouse roof is the ample use of substitutable generics, which is something that many countries do not have.
I contend that the 180 day rule actually inflates prices. I believe that the same number of generic versions would ultimately be available without the 180 day rule. In the case of Zocor, before the judge overturned the FDA and restored the 180 rule, there were 7-8 versions approved. The price per pill was reported to be around 20 cents. Because of the judges reversal, the price is over $2.00 a pill with no chance of lowering until after the first of the year.
Remember, the proof required to bring a generic to market is low compared to the brand. There is no reason that a company needs to charge brand prices to recoup years of pricey clinical costs, IMHO.
RPh
the Law of Unintended Consequences
I do agree with you that most of the laws regarding any technology should be revisited from time to time. In this case, I fail to see the difference between a brand product choosing to lower it's price to meet exclusivity prices or an in-house authorized generic being produced that profits the branded company. One way or another competition forces prices down and the "world benefits".
One last thought, since the cost for bringing a generic to market is small compared to the cost of a full NDA, what justifies the awarding of the 180 days exclusivity in the first place? Generic pravachol was more expensive than brand by a couple of cents for the first couple of weeks it was out. The price has come down a little since. Business ethics should go both ways on this one.
By the way, my opinions may be colored by the fact I own stock in none of the generic houses.
Thanks for the good conversation,
RPh
RE:PBM to give customers a better deal
Dew,
I would argue that there is very little independant proof that the PBM's provide any cost savings. The recent litigations and quarterly profits of the PBM's all actually point to them being a major cause of the skyrocketing growth in total pharmacy spending for benefit sponsors.
180-day Hatch-Waxman exclusivity
Honestly, I should read the act before I pontificate. If the act reads that the ex-patentholder has no rights to market, then I agree with you. If there are still some rights afforded them, I stand by my original pontification.
the distinction between an in-house authorized generic and any cut-rate product
LOL. In my way of thinking that would mean the brand was a cut-rate generic. It's too late at night for me to get my mind around that one!
RPh
RE:how to fix this mess
I would differentiate between the two approaches to patent expiration. I find the use of authorized generics as not only an acceptable option, but, IMO, a required approach to protect shareholder equity by those companies that also own a generic subsidiary. The use of an authorized generic made in your own facility and distributed by your own generic company not only moves people into using your generic after patent expiration but lowers costs to benefit sponsors, cash customers, and local pharmacies. I see no down side to this approach.
Now compare the use of authorized generics with Mercks approach. By negotiating rebates with PBM's, Merck protects it's brand AWP status for all pharmacy purchases. Because the majority of these PBM rebates rarely get passed on to benefit sponsors (see any recent legal actions against the PBM's by California, Ohio, and NY) and the increased carrying costs to retail pharmacies due to increased inventories of both brand and generic, I forsee a backlash from many pharmacy groups. I can't tell you if the reaction will ever get beyond the head shake level but I can hope.
I guess the only solutions would be to get rid of the PBM's or for a court to rule that Merck's actions were anti-competetive, but I'm just not legally minded enough to evaluate the chance of that. Since Merck's approach doesn't save anyone but Merck and the PBM's money, I fear that this may become the preferred approach to beating the generic threat.
RPh
Re: Pfizer to Make Generic Version of Its Zoloft
Back in October of last year I asked the question, why would zocor be offering a huge discount to pharmacies now, when thier patent is scheduled to lapse? I thought they were moving as much business to the brand as possible and would then "pull a pfizer" and produce thier own authorized generic. At the time I was told that they had no intention of doing this. We have recently seen their approach.
From a business point of view, I understand each approach, although from an implementation perspective, MRK's price reduction that only benefits the fairly corrupt PBM's and has no cost savings for cash customers, leaves me a little suspect. Let alone the implementation fiasco deciding which HMO requires brand and which requires generic. Authorized generics are a more straight forward and fair way to go, IMHO.
BTW, guess who makes DR Reddy's version of Zocor? Even the labels look the same!
RPh
A very belated thanks.
Just a thanks to Dew and all who helped educate me on GTCB. This news shocked me as I had been holding on to my investment with the hope of a buyout. While I have only 1/4 of my peak investment, it's great to see that the research and DD that we did actually paid off.
I have to admit that February turned me off to biotech investing, as I couldn't understand the logical or scientific reasoning behind the decision. Today's turnabout may rekindle my interest in these companies.
Thanks again to all,
RPh
RE: the approval process has major shortcomings
When evaluating what went wrong, who do you blame for this rejection?
GTCB's loose dosing protocol, if not discussed with the EMEA beforehand, would be an immediate red flag. In the CC GTCB sounded like the need for repeated dosing adjustment was unexpected and that they now have a standard protocol. Their inability to understand the need for a standardized protocol may be due to the EMEA guidance or their own inexperience. I do understand that lives were saved by this dosing, but it is no way to run a study.
THe EMEA casts great suspicion on their motivations by the inclusion of some very obvious straw men (ie: filtration and antigenicity)in their rejection notice. As already discussed, these worries are weak and act only to draw attention away from a problem with the study group. The 2 year delay only reinforces the perception of ulterier motives and casts doubt on the integrety of the organization. Whether it is a discomfort with goat-derived medicine or a conspiracy to aid Pharming, the conspiracy folks certainly have the fodder.
So who dropped the ball?
RPh
RE: Splitting out the childbirth indication smacks of looking for a rationale
Agreed. I may be naive, but I beleive the company when they say that this opinion was a surprise. It's hard to know when you've fulfilled your requirments when the goal is moved.
RPh
RE:It’s astonishing that the EMEA took two years
I thought I had read that the EMEA helped design the standards for the application. What changed?
RPh
GTCB and CBS News???
From the CBS News Website! Could only help for the opening on Tuesday.
RPh
Up Next: Weekdays
NEW YORK
(CBS) Here's a look at a story we are working on for Monday:
We’ll show you some goats like none you've ever seen before. Man had a hand in creating them... and they could help save human lives. The story Monday on the CBS Evening News.
OT-More thoughts and prayer
Dew,
My family will keep your father in our prayers. If there is anything that I can help with, let me know.
RPh
RE: Long time, no post.
I've been lurking. Not much to add to the current debates as all my investment cash is tied up and I am busy starting a new business that helps, in a unique way, large businesses pay for their prescription benefits. Part D hasn't given me much chance to relax either.
Lurking is still enjoyable, (I try not to talk too loudly to the computer in response), and try to stay slightly up-to-date with current trends. As always, I appreciate this forum as an example of the power of the internet when used appropriately.
Regards to all,
RPh
Anyone have an opinion on GENOMIC HEALTH, (GHDX)?
My sister, who has had a cancer scare, has been watching for developements in the field. It appears that the short-term pop has been missed. Any thoughts on long-term outlook?
I don't know if this was ever discussed but shows another case of the benefits to being able to search the list with a paid membership:)
RPh
Unhappily struggling through another 20 minute call to hopefullly solve another medicare part D problem!!!
RE: Confusion Is Rife About Drug Plan as Sign-Up Nears
It's not just the consumer thats confused. Every pharmacist that I work with or have talked to has a different interpretation of the new plans. I can't imagine someone making a bigger mess of it if they tried. How we ever thought it was wise to have a system run by the PBM's, who have just been sued again, this time in California, for their fraudulent practices. If you want to read something that will shock many of you, get a copy of the suit and see why the system will never get better until the current PBM system is changed. As a conservative, the choices that were made bogel my mind!
Rant over,
RPh
RE:market launch of ATryn® in Europe in the first half of 2006
After looking through the last PR, I still am not sure if this is a consistant statement. I seem to remember an earlier estimate. Anyone know if this timeline has slipped as of this PR?
TIA
RPh
Re: Lexapro and Celexa
Are you suggesting that generic drug companies are offering big rebates on Celexa
Absolutely not. Generics get first tier with no therapeutic or rebate constraints. As far as celexa and Lexapro, my point about the therapeutics taking a back seat to other concerns still stands. Rebates are not the only financial incentives. The incentive in this case is lowering the actual cost for drugs in this category by driving market share towrd the lower cost generic Celexa.
#1 The antidepressant category is one of the most expensive to insure and is very closely watched. There are few hard and fast DUR's that can be used to limit prescribing and thus lower costs. Dosing ranges can vary and are usually limited by side effects or symptom resolution.
#2 With few ways to limit costs though DUR's, PBM's have no other way but to enforce more punitive formularies. In the case of Celexa and Lexapro, both brands are lumped together because of Lexapro being the active half of Celexa. If you didn't have first-hand knowledge of the difference, you may have agreed with this logic.
Also remember that you, as the insured, are NOT thier customer, the sponsor is. The more money that they can save the sponsor, the more money they can demand for thier services.
I do agree that Lexapro is better tolerated than most and is absolutely the SSRI of choice if I'm asked.
RPh