Insurers Force How Much Generic Switching?

Ed -

Perhaps you should have asked a few more questions about this survey before uncritically reporting its results.

There were 6,536 members in the SCMA (according to the SCMA's 2009 Annual Report: http://www.scmanet.org/sphere/PUBLICATIONS/AnnualReport/tabid/99/Default.aspx).

The survey had 117 "validated responses." this equals a very unimpressive response rate of 1.8%.

The sample is probably biased, too. I expect that physicians who feel strongly about the issue may have been more likely to respond.

Based on this weak data, the survey concludes: "We found that restrictions from health insurers are greatly interfering with the physician-patient relationship and the ability of the physician to administer the care he/she was trained to provide."

Based on these data, the survey results can make no such claim.

And to preempt the inevitable "but this happened to me" rebuttals to my comment, let me remind Pharmalot readers that the plural of anecdote is not statistically sound data.

Adam

The trouble with many news release surveys is they are skewed to support a point from their sponsoring agency.

This is certainly the case here. Quantitative data shows nowhere near this level of switching.

Real data is out there; truth is usually the first casualty when folks start angling for advantage. SDI is one of your sponsors and they have such data, perhaps you can impose on them to provide a fact-based perspective

Agree with Adam on possible sampling bias, but the low response rates makes the survey essentially worthless.

I'm ethical pharma born and bred but I'm the first one to say that except for NTI drugs, 99% of generic switches are safe and efficacious. There will always be the PHRMA flaks who point to things like Chinese rodent pellets in the drug supply, but this is way overblown.

I hate to agree with pharmavet, but 99.99999% of generics are safe. 100% of what we make.

Hi Adam,

Thanks for the note and that's a very fair point. I agree that the South Carolina survey contains a low response rate and there could well be sampling bias. If nothing else, I should have noted the small sample size in the post.

Would the outcome have been substantially different with a higher response rate? Without further study, we have no way of knowing, although given the topic and the crowd that was queried, I have a hunch - just a hunch, of course - that it probably would not.

Anyway, I included the one-line reference to the South Carolina study simply because it appeared pertinent. Although I recognized - but didn't mention - the small response rate, I did so because it offered a window, however small. But again, the small response rate should have been mentioned.

As to the issue concerning generic safety, I understand, of course, that bioequivalency is, sometimes, disputed as we have seen recently with epilepsy meds - the Pfizer Dilantin case is an interesting one. But I have asked GHLF to respond to the broader point, since this is their survey.

Thanks, everyone, for your commments, ed

Ed, please clarify what GHLF stands for? I assume it is a generics-focused nonprofit but you should identify them...

The GHLF survey is also questionable. The 70% figure surely mixes generic substitution with therapeutic substitution. In the Pharmacy Times article, the head of GHLF complains that switches occur so that "the health insurance company can save a few pennies." This is completely misleading because the payer--primarily employers, the government (taxpayers), or the patients--get most of the benefit from any savings, not the insurance company.

I did a quick search of GHLF on guidestar. Their most recent tax return (from 2008) shows that they earned some money by selling glucosamine. They also got most of their revenue from unspecified "grants." See http://www.guidestar.org/FinDocuments/2008/204/039/2008-204039120-055e2de0-Z.pdf.

There is more to this story than meets the eye.

Adam

I think the term "forcibly switching" is misleading. Insurers cannot change a medication prescribed by a physician. They can however suggest a change.

Although I seriously doubt a "70% change" rate, this practice has been in place for quite some time and is not a novel concept. Insurers have been asking physicians to try cheaper generics in place of more expensive brand medications for years. Conditions like hypertension, depression, and pain management come to mind as examples of this practice. For example, insurers will routinely only pay for a generic SSRI for first line therapy for depression even if the treating physician feels the patient may benefit from a more expensive brand medication. I too would like to see the full results of the survey and am interested to see how widespread this survey will be distributed in the mainsteam media.

Hi Everybody:

I’m Louis Tharp, the executive director of the Global Healthy Living Foundation. We’re a patient advocacy group with funding from government, other foundations, a few individuals, pharmaceutical companies and other companies outside of pharma. We’re very transparent and proud of our funding sources. We do not take advertising on our sites which include www.creakyjoints.org, www.failfirsthurts.org, www.takingchargeofpain.org, www.redpatch.org, www.creakybones.org . Our disease-specific sites are social networking gathering places with news, columns and discussion boards.

We have national grassroots programs that reach out to people with chronic diseases, helping them understand the value of exercise, diet, personal responsibility, a strong patient/physician relationship and how to blog, and how advocate for themselves with payers.

We’ve taught thousands of people with arthritis to swim, and worked with thousands more who have diabetes, Parkinsons, COPD, neuropathic pain and other conditions so they might improve their quality of life. We spend significant time working with underserved people, showing them how to get free or reduced-cost drugs from pharmaceutical companies. We work hard to influence Medicaid and Medicare policy, too, so that patients benefit.

We have no position on generics vs. branded drugs. We love them both. Our focus is access to care. We do not like anyone – government, private health insurance companies, employers, or PBMs inserting themselves into the doctor patient relationship. We do not believe therapeutic substitution necessarily saves money, but we would yield to a philosophy that sometimes it does and sometimes it doesn’t. Often though, the real cost of productivity, outcomes, hospital readmission, follow-up physician visits, and quality of life are not factored into the simple math mindset of product price at the pharmacy cash register.

We paid for this survey from internal funds. Nobody and no company sponsored or has an interest in this survey. There’s nothing here that doesn’t “meet the eye”. The purpose of the survey is to find out what folks who use medications regularly are encountering when they fill their prescriptions. And basically, what we’re finding is that these people are angry and frustrated. Health insurance companies are generally where this anger is directed. They also don’t think much of pharmaceutical TV advertising, but we’re still studying that data, so I don’t want to talk too much about it until I have all the facts.

In the face of rising health insurance premiums and profits, we believe that saying insurance companies engage in switching in order to save money which is returned to policyholders or taxpayers is specious. But this topic isn’t covered in the survey, so it is simply the opinion of management, not our members. We might include this topic in our next survey, however.

I’m not sure why Guidestar doesn’t have our 2009 tax return listed. Our 990 is public. I will contact them and see if I can remedy that. It’s pretty much like our 2008 return, but I’ll feel better when it is posted and public.

I stand by the term “forceably switching” when referring to survey results. Patients do not have a choice, or their choice is so difficult to implement that they do not engage the effort. This, to us is a textbook example of force. To say that all insurers can do is “suggest a change” is like saying all Joe Namath could do was throw a ball. If it truly were a suggestion, then the process of therapeutic switching would be reversed. If the insurance company wanted to contest a prescription as written, they would have to appeal to the physician’s staff, and accept the resulting decision based on the insurance company’s ability to promote a compelling medically based narrative that convinced the physician to reconsider the original drug choice.

We will be releasing more results from the survey as soon as we analyze the remaining sections. We’re a small non-profit with a big mission so we respectfully ask for your patience.

I think I’ve covered the comments so far, but if I’ve missed anything, let me know and I’ll be happy to engage in comments conversation. I appreciate the thoughtful activism that Pharmalot and Ed Silverman encourage.

In New Jersey there is the "Law of Implied Consent", which basically says that a prescription for a brand name drug MUST be filled with a generic, if available, unless it is written as DAW or the patient specifically requests only the brand name drug at the time of filling.

"We do not like anyone – government, private health insurance companies, employers, or PBMs inserting themselves into the doctor patient relationship. We do not believe therapeutic substitution necessarily saves money, but we would yield to a philosophy that sometimes it does and sometimes it doesn’t."

Wow. No one dislikes PBMs more than big pharma. Industry Insider is correct that 99% of generics are fine. NTI (narrow therapuetic index) drugs, although providers will say they are not equivalent, most likely are.

If we are to believe that generics are even periodically inferior to branded, then we have much larger issues at the FDA.

Since over 40% of big pharma sales are to the U.S. Govt (i.e. taxpayers) in one form or another, I say use generics every possible place you can. The bigger issue is not quality of generics, but access (which lower generic costs help solve) and patient compliance, which is mostly an education issue.

Funding from big pharma for this 501(C)3 is an issue Mr. Tharp. As a vetern of over 35 years in multiple pharma corporations and aspects of big pharma, they do not donate to causes not in their own interest - their interest, not patient interests.

Finally, the single most insidious influence in the doctor/ patient relationship is big pharma. Make no mistake, they put their profits ahead of your patient well being.

"NTI (narrow therapuetic index) drugs, although providers will say they are not equivalent, most likely are."

What about this do you not understand?

Say you need a medication that, even branded, takes 2 months of careful titration to get you stable and in the therapeutic range. Say all of a sudden another product is thrown at you, a generic, with FDAs looser criteria for consistency. Say it's a generic and has somewhere near a 25% difference in absorption rates. What do you suppose happens to that carefully adjusted level you spent 2 months of toxicities and subtherapeutic levels to achieve? Or shall we ignore the therapeutic range. It's impossible to ignore if you take them, but feel free.

After all, we can always just accept the one or two dose studies done, using healthy people, to prove absorption rates for drugs that require long titration periods.

The only reason these drugs come into question is because not everyone taking them has a NTI. I do. Some people will handle a change just fine. A reported 30-40% will not. But hey, as long as our drugs are safe for EVERYONE they are indicated for and as long as 60-70% success rate is good for you.

Ya'll aren't in the habit of prescribing these, I suspect. No neurologists specializing in epiliepsy here, and hopefully no one with a prescription pad changing someone from Warfarin to Coumadin.

As anecdotal evidence goes. Unless something is sufficiently studied there will be no acceptable evidence. One dose or real life? Tough choice. I'd bet drug makers take the anecdotal evidence at least as seriously. Unless they simply don't care.

I have never had an insurer refuse to cover the medication I need. Pfizer refused to make it anymore. FDA refused to worry themselves with it and allowed the change. Pfizer even said FDA encouraged the change. Nice for Pfizer, they get to save a couple of pennies to no longer meet their own criteria. The cost to insurers however, is much higher with ER visits, many more doctor visits, lab and imaging tests, add on drugs, etc..

That being said, I do take a generic, I have no choice. They differ practically from lot to lot, but what's a seizure or toxicity here and there if you don't have to endure them? The thing being left out of this conversation is consistency. It happens to be the most important thing.

Just as long as a one dose study was done... what more evidence could anyone possibly need?

Pardon the sarcasm but this isn't exactly rocket science. Just common sense.

FDA should guarantee the use of generics, if they pass the testings then the expensive labels is the only difference.

JaT, "No neurologists specializing in epiliepsy here, and hopefully no one with a prescription pad changing someone from Warfarin to Coumadin."

Coumadin (the branded product) only has about a 10-12% market share. Generic warfarin (by multiple maunfacturers) has the rest. Most providers are satisfied with the generic and the variability in INRs.

Again, if the FDA is allowing generics to be approved that are not equivalent, we have a much larger problem than PBMs and insurance companies trying to reduce costs.

Anecdotal stories do not a study make. Drug makers always say that generics are inferior, but then they have no pig in this race.

JaT, forgive me but what is the difference between Warfarin and Coumadin? It's the same chemical last I looked. Variability in its degree of action is more likely that piece of broccoli or fork of coleslaw supplying some vitamin K that makes the difference in coagulation.

Agree, playing with the coagulation cascade ain't easy.

Then again, it's easy to interchange statins [an expense in the tens of billions], from dirt cheap [not in the U.S.] lovastatin to $5.50/pill Lipitor 80, both drugs inhibit the same enzyme, lower cholesterol synthesis and have never saved a human vs placebo in a trial. What's wrong with switching?

P.S. If U.S. law dictated ALL statin prescriptions be automatically changed to any-dose lovastatin [once called Mevacor] bought from an Indian or Chinese source [where probably most [in tonnes] of statins are made anyhow], the U.S. would instantly save at least $b10/year without it altering mortality. Stroke of a pen.

Eddie I think that maybe what JaT mean was a switch from the generic form of Warfarin Sodium to the brand name Warfarin Sodium, aka Coumadin. Also, the term NTI refers to small differences in bioavailability of a drug such as phenytoin to cause disporportionately larger changes in pharmacodynamic effect, which in a patient with a low seizure threshold maybe critical. Although differences in absorption may also magnify the effects of the differences in BA of two different NTI drugs of the same moiety, strictly speaking, NTI refers to a property of the drug, not the person taking the drug. We also see this with levothyroxine, where differences in absorption of LT4 also magnify differnces in pharmacodynamic effects of different LT4 preparations.

insider, thanks for that note and clarification. My point re Warfarin was that the patient is also a moving target, possibly mores so than the form of the vitamin K antagonist.

Going 'generic', and you said that 99% are identical to Brand, with the shot gun drugs such as statins, beta/calcium blockers, aspirin and most mee-too drugs are the no-patient-harm switches that may be required by law to save the system as whole. That leaves 1% of drugs i.e. the NTI ones.

Thanks, Industry Insider.

Who knew imitating Regan MacNeil could translate in type? (gastroenteritis)

So sorry about the snippiness folks.

Atella Pharmaceutical US, Inc., is the U.S. affiliate of Astellas Pharma Inc., Japan’s second largest pharmaceutical company and ranked within the top 20 in the global market.

Eddie, as you may know, in Canada these days NTI drugs are referred to as "Critical Dose Drugs", and have tighter bioequivalence standards with respect to AUC (see link). I agree with the tighter standards and think they should be adcapted by OGD at FDA.

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/bio/critical_dose_critique-eng.php