Medication costs are one problem (amongst many) which plague our current health care system. We (physicians) often look forward to the time when medications lost patent protection. Simvastatin (Zocor) loses protection very soon – Lipitor or Generic? Billion-Dollar Battle Looms
Starting next June, insurers and government agencies will have the opportunity to save billions of dollars by moving patients from Lipitor, a cholesterol-lowering drug by Pfizer that is the world’s top-selling medication, to an inexpensive generic version of Zocor, a similar but less potent drug now made by Merck.
Some insurers are already planning ways to move patients from Lipitor to generic cholesterol drugs after Zocor loses its patent protection. But Pfizer, which plans to use marketing muscle and clinical data to fight that migration, says that Lipitor has unique benefits and is worth a premium price, especially for patients at high risk of heart attacks.
Both medicines belong to a class of drugs known as statins, which are the nation’s best-selling medications, with almost 150 million prescriptions expected to be filled this year at a cost of $16 billion. The insurers, and some cardiologists, say that switching patients from Lipitor to generic Zocor will be a safe way to cut costs in an era of skyrocketing pharmaceutical prices.
In many cases, they say, patients who now take the most commonly prescribed dosage of Lipitor – 10 milligrams daily – can reduce their cholesterol just as much with Zocor. Lipitor costs $2 or more a day, while generic Zocor will probably cost 35 cents or less.
“If I was taking a statin, I’d want to take the cheapest one, as long as I get to the goal that I wanted to get to,” said Dr. Scott Grundy, a researcher who has consulted for both Merck and Pfizer. Dr. Grundy led a federal panel that in 2001 wrote guidelines for treating people with high cholesterol.
What do we really know? We know that statins lower cholesterol and stabilize plaques. For the non-phyisican readers let me explain in more detail.
Evidence over the past 15 years shows that lowering LDL (bad) cholesterol decreases the production of atherosclerotic plaques (fatty deposits) in blood vessels. Thus, having a lowered cholesterol decreases the risk of heart attacks. But we also know that for those plaques already present patient on a statin less often have plaque rupture.
Plaque rupture is important, because when plaques rupture they send out signals to platelets. Platelets (the blood cells which initiate clotting) then stimulate the formation of clots. These clots are the actual causes of heart attacks.
Thus, statins help us in 2 ways, decrease plaque formation, and making plaques less likely to cause heart attacks. Now please remember that I have carefully couched my explanation in decrease and less likely. Patients on statins can still have heart attacks, statins only lower the probability of such events.
Simvastatin is a very good statin. It is possible (although I am not convinced) that Lipitor has some advantages. However, the advantage of Lipitor is unlikely to be so great as to justify the extraordinary cost difference.
If cost does not matter, then I would probably use Lipitor. However, for most patients saving money on a medication will allow the patient to also eat, or fill another prescription. Thus, when examining the totality of the average patient, I will favor generic simvastatin. In fact, simvastatin is the preferred statin in the VA formulary – so I used it regularly already.
The big news here is that the savings for patients on fixed incomes is substantial. These savings will impact overall quality of life – and that is good news!
Please read the entire article to understand the marketing battle which will ensue.
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{ 6 comments… read them below or add one }
Is there an existing generic statin?
The big picture:
Statins do not have a Role in Primary Prevention.
http://ti.ubc.ca/pages/letter48.htm
Don’t stress Gramma out by telling her she even needs a statin. There is no Overall Mortality benefit for patients taking statins. Patients dont want to take pills – don’t make them (needlessly).
If statin patients have reduced CAD and don’t live one hour longer … what are they dying of ? [SHOCK]
simvastatin is OK. I do like atorvastatin better. The cheapest way to use statins is to use 10mg of simvastatin with grapefruit juice.
The grapefruit juice makes it equivalent to 30mg !
Two comments- If you subscribe to NEJM, search for stories about “torcetrapib” and you can read how Pfizer is going to try to keep its Lipitor market share by coformulating a new HDL-raising drug with Atorvastatin and not release it as a stand-alone drug. Be sure to read my letter to the editor!
As to primary prevention, it’s really about risk, isn’t it? You wouldn’t reat a 30 yr old female with an LDL of 150 but you should treat a 55 year old diabetic hypertensive who smokes whose LDL is 130.
Probably the patients with the highest risk, (with lower LDL targets), and highest LDL levels will need the newer stuff like Lipitor and Crestor, the rest would do fine and reach their targets comfortably with simvastatin!
However, these companies that are still holding the patents have been telling interesting stories about how well their drugs do compared to simvastatin? Are there any evidence to it? No. That is why they resort to telling “stories” like other “anti-inflammatory” properties…. etc etc.
Why would you use the more expensive drug, if the cheaper one will do?
simvastatin increases my Tryglyceride and decreases my cholesterol ( HDL ) Itherefore, stop taking it. I found lipitor more tolerating as it improved my HDL from 31 to 40 and reduced my TRLGLYCERIDE LEVEL from 306mg/ld to 202mg/ld within 30 days of use. Literature review indicate that lipitor has some clinical effect on the liver but the benefits is great and one can have a stopage within a short time to allow for liver repair. WHAT DO I REALLY NEED TO RISE MY HDL AND LOWER MY TRYGLYCERIDE?
Doctors are now paid by managed care PBMs to switch from a brand drug to a generic:
The Benefits of Generic Medications
Often when one goes to seek medical attention from a health care provider, that provider usually writes a prescription for that patient for medication to either treat the symptoms of the disease that may be present, cure the disease, as with the case regarding antibiotics, or the provider may prescribe medications to delay the progression of a disease that may exist with their patient.
The actual cost of that medication the patient receives from a pharmacy can vary greatly, and here is why:
More now than in the past, generic medications have been encouraged and selected by prescribers at a much higher rate. Health care providers are aware that generic drugs are less expensive than branded drugs that are equivalent to the generic drug prescribed as far as safety and efficacy are concerned. Nearly two thirds of all medications prescribed to patients in the United States are now for generic medications.
Generic medications are copies of branded medications that previously existed, yet no longer have a patent on these medications, which allows generic drug companies to produce these formally expensive drugs and a much lower cost
Why aren’t generic medications prescribed all the time, then? The branded drugs have representatives who leave samples of these branded medications with the health care provider, with the intention and belief that this provider will select this branded drug as a result. Generic medications, while much less expensive than branded medications, do not have samples of these drugs to be left with health care providers.
Around 4 billion prescriptions filled every year, so cost savings is rather important. Generic medications are about two thirds of this total pharmaceutical market with the drugs included in this market. However, while most prescriptions are for generic medications, this still is less than 15 percent of the total money spent on prescription drugs.
With branded medications, about 75 percent of these newly approved drugs by the FDA are similar in efficacy as drugs that already exist in this market, so there is no benefit with many of these expensive branded drugs. Finally, about half of all newly approved prescription drugs have had serious side effects soon after they have been approved, so newer is clearly not always better, of course, as it relates to safety for the patient taking the drug.
Most recently, certain managed health and prescription providers have been actually paying doctors to initiate if not switch their patients from branded medications they may be taking to generic medications, if possible. This may be due to a reaction caused by branded pharmaceutical companies offering similar inducements to health care providers to select their promoted medications. Both financial inducements that occur are remarkably legal, overall. Yet I find financial inducements in health care inappropriate and unethical when a health care provider treats a patient with prescribing medications for them.
Not long ago, generic drugs were not prescribed that often, or produced to a great degree, because of the cost of bringing such a med to the market, which at the time required the same clinical trial protocols as branded meds.
Fast forward to 1984, as this is when the Hatch-Waxman Act was introduced, and this Act only required generic meds to demonstrate bioequivalence to the branded med that they desire to reverse engineer, and nothing else was now required in the approval process that is mandated by branded medications to be completely developed and approved by the FDA. This reduced cost of generic manufacturing and approval allowed for more of these meds to saturate the pharmaceutical market, and doctors started prescribing more generic meds as a result.
Branded pharmaceutical companies were not pleased in large part with this new act, so they devised schemes to extent the patents of their branded meds through such tactics as reformulation or combining their branded medication with another generic drug to create a new combination medication, which is called evergreening, of their meds, which allows for them to continue the patent lifespan of their branded medication.
Additional branded drug company tactics include frivolous patent infringement lawsuits, which delays generic availability for a longer period because of these lawsuits. Also, branded pharmaceutical companies have been known to actually pay generic manufacturers to not release the equivalent of a branded medication.
The pharmacies that fill the prescriptions for the patients written by the health care providers support generic use, as pharmacies make more money off of generic prescriptions they fill for others compared with branded drugs. So delays will not prevent the utilization of generics, overall, or for a long period of time.
Generics seem to remain a concern to branded companies in spite of their efforts of avoiding their access, as branded companies have progressively started producing their own generic meds along with their branded ones due to the increased use of generics, or have acquired generic pharmaceutical companies entirely because of the progressive impact generic drugs are having on the business of branded drug companies.
Also, other reasons for increased generic prescribing may be due to the awareness and clinical experience of the previous branded med that has now been replicated by the generic medication.
Newer drugs at times are not a desirable choice of treatment for patients because of lack of confidence- as safety of these new drugs have not been overall established. This is concerning to several different health care providers. The familiarity of the generic drug accessible to them after the patent expiration of possibly the branded drug the health care provider had prescribed in the past assures the provider often that there will not be any safety or efficacy concerns by selecting such a generic drug.
Many clinical studies have proven that generics are as effective compared with branded medications for particular disease states. The ALLHAT trial showed this, with generic diuretics showed equivalence if not superiority over the branded medications it was compared with during this 4 year trial funded mostly by the NIH. Drugs utilized in this trial were cardiovascular drugs, and the examination of these both branded and generic drugs showed that the least expensive drugs, the generic drugs, provided the most benefit for the patients studied in this trial.
Most encouraging for even greater use of generic meds is that at least one company has created vending devices for doctor’s offices for dispensing both generic and over the counter meds. This may discourage the use of branded equivalent meds at a greater amount with generic samples available as well as the branded meds. In addition, and in some cases, doctors can order generic samples from the manufacturers directly. Both mechanisms for obtaining samples of generic drugs by a health care provider remain quite rare, however.
Then there are some health care providers who insist that you get what you pay for, so they are convinced that branded drugs are always more efficacious and tolerable than generic medications. This misconception is a fallacy, since both forms are identical from a bioequivalence and bioavailability paradigm, as required for approval. I’m sure it’s possible others have encouraged such doctors to take such a stance void of fact and reason. However, there may be some truth to decreased efficacy of generic drugs over their previously branded equivalents, yet not to a the point where it is a clinical concern.
In the U.S. Health Care System, cost is a rather large concern for members of the public health, and those who attempt to restore their health as it needs to be at times. Generic medications provide financial relief for patients in need of drugs to improve their health. And both the health care provider as well as the patient can be assured that a generic drug prescribed to, and taken by, a patient will provide the efficacy needed to address the medical problems of the patient. More importantly, the patient saves money, without compromising their safety,
Dan Abshear