This post contains my comprehensive report on the Concerta generics downgraded by the FDA in 2016.
It explains many facts consumers need to understand about generics, consumer rights/options, and more. It was thanks to ADHD Roller Coaster readers that the FDA downgraded these generics as not “bioequivalent” to brand Concerta.
In 2014, I contacted the FDA to see what we could do. The FDA representative advised me to open an FDA MedWatch complaint. I did and asked ADHD Roller Coaster readers to report any adverse effects from these generics. They did, and the FDA listened.
Then, the White House changed occupants in 2017. The new FDA Chief overrode FDA scientists’ concerns about lack of bioequivalence and pushed through many Concerta generics. It’s been a hot mess medication roller coaster ever since.
That started with three new generics for Concerta released in 2017 and even more in 2019. By last count, there are about 20. I detail those events in two other posts:
Update December 2022: What’s Changed?
This ever-evolving story hit a crescendo in November. That’s when Janssen announced it would eliminate the authorized-generic for Concerta.
Bottom line: the authorized-generic is no longer available. Period.
Is this post now completely outdated? Yes, mostly. I’ve noted in a few spots exactly why and how it’s outdated. But for the latest news, it’s best to check out my more recent posts:
Janssen Quietly Ends Concerta Authorized-Generic
Liquid and Chew “Ritalin” – Quillivant and Quillichew
That said, you might find this post worth reading for background about the complex world of generic medications. Specifically, the Concerta generics. I’ve done my best to organize the issues. But hey, this is complex material. And I’ve been covering this since 2011. As an unpaid advocate who has never accepted pharma industry support. Overt or covert.
You might also still find Q&A #13 still relevant: My insurance company has removed Concerta from its approved list (formulary). Now what?
And Q&A#14 suggests three cost-saving avenues.
The First Concerta Generics — Questions and Answers Covered
Here are the questions I will answer below:
- Hey, what’s the problem with generics? Aren’t they the same as brand by law?
- So, what’s the specific problem with the Concerta generics?
- What exactly did the FDA say in downgrading the two generics from Mallinckrodt and Kudco?
- Is this downgrade permanent?
- Does this FDA action affect other currently approved methylphenidate hydrochloride ER products (e.g., Ritalin LA)?
- How did FDA learn that the two generics might not be therapeutically equivalent?
- Why did it take such an effort by consumers? Why weren’t these problems discovered before the products were released for public consumption?
- Will the FDA further study generic methylphenidate hydrochloride ER products?
- What does all this mean to me or my child, as users of Concerta?
- Is there any word on the contract between Actavis and Janssen, which allows Actavis to market the brand Concerta as the authorized generic? The original contract expired recently.
- Any tips for dealing with shortages or pharmacies that don’t carry the authorized generic?
- Argh! My pharmacy is still substituting the downgraded generics for my Concerta prescription? What can I do?
- My insurance company has removed Concerta from its approved list (formulary). Now what?
- Hey Gina! How about some cost-saving tips?
To Recap First Concerta Generics History:
First, brief background bits:
- November, 2014: The FDA downgraded the two Concerta generics. The manufacturers are Mallinckrodt and Kremers-Urban. It was determined that the medication in these products is released more slowly than with brand Concerta. The manufacturers were given a time period in which to show their product’s bioequivalence.
- October, 2016: Neither Mallinckrodt nor Kremers Urban has voluntarily withdrawn its product from the market. Neither has provided data confirming its product’s bioequivalance consistent with the revised recommendations. As a result,they remain downgraded. The FDA’s next step might be withdrawing them from the market entirely. You can download the FDA’s full report here.
- Complicating matters: Janssen has long made available an authorized generic of Concerta. That means it’s actually Concerta — but marketed as a generic by Actavis under a licensing agreement. The FDA decision does not affect this authorized-generic because it’s not a “true” generic. Confused? Read below.
- These downgraded generics created an inferior response for people who did well on brand Concerta. You can read their stories here: Sound Off: Users of Generic Concerta Share Their Stories
- Last I checked, these downgraded generics remain on the market. There are no safety issues per se. But pharmacies can no longer automatically substitute these downgraded generics for brand (if generic is required by insurance). For now.
- December 2017: The marketing deal between Janssen and Watson/Actavis, to distribute the Concerta brand as an authorized-generic expired shortly after December, 2017. Subsequently, generic giant Teva purchased. For a while, it distributed the authorized generic but then switched to its own Concerta generic.
- November 2022: Janssen eliminates the authorized-generic for Concerta. We are in a “perfect storm” of typical year-end raw material shortages, dirt-cheap generics mostly made off-shore, insurers eliminating brand Concerta coverage. And so much more.
Other Factors Affecting Access to Concerta in 2017—and 2022
The ongoing story remains complex. It was further complicated then and now by outside factors, including:
• Raw-material shortages:
The U.S. Drug Enforcement Agency (DEA) limits the amount of the raw material used to make stimulant medications. This is apparently due to concerns about “diversion” — these pills getting into the hands of people who sell or abuse them.
Historically, this has created general end-of-year shortages for stimulant medications. More recently, this has been complicated by COVID-related supply chain issues as well as surging diagnosis/treatment rates.
There are reported shortages of methylphenidate, the raw material used in all the Concerta pills, brand and generic.
In 2018, however, much of the annual raw-material allocation was tied up in the now-downgraded generics. As a result, some consumers were unable to fill their Concerta prescriptions.
[Right now, in December 2022, we are also experiencing insufficient supplies of many methylphenidate stimulant products.]
• Insurance companies reacting to loss of cheaper generics:
Insurers and pharma benefit managers regularly revise their formulary (list of covered medication). The customary calendar-year changes in December-January 2017, specifying which medications are approved for or dropped from their formulary, resulted in many readers losing affordable access to Concerta.
With the two cheap generics downgraded, insurance companies faced ponying up for the brand or the authorized generic. (Remember: the authorized-generic IS the brand; it’s just sold as a generic; more about that in a minute). The authorized-generic price has reportedly gone up due to less competition. The regular generics are much cheaper than brand and the authorized generic. Thus, pharmacies typically make a higher profit on them, and insurance companies pay less.
Questions About the First Concerta Generics
Below you’ll find questions and answers, followed by a tips summary.
Reader feedback is appreciated. If you share useful information (or point out inaccuracies) in a comment, I will update this post. I’m aiming to provide my readers with one-stop shopping on this issue, because all these med changes are confusing enough!
Q 1: Hey, aren’t generics same as brand by law?
No, generics are not the same as brand. No matter what some misguided pharmacists might tell you. There are two key differences, and they are particularly relevant to psychiatric conditions.
First, let’s distinguish between the two types of generics:
• Authorized generic:
These are brand medications marketed as a generic solely for price and insurance purposes.
This tends to happen when the brand is nearing the expiration of its patent. To forestall competition from a generic manufacturer, they strike a marketing deal: The competing company can market its brand-manufactured pills as a generic.
It’s a win for each company and a win for consumers because these authorized generics are typically cheaper than brand.
• True generic:
Here’s another confusing term: True generic. This is a generic in the commonly understood sense. That is, a medication formulated and manufactured independently of the brand, typically for a lesser price, but is said to be “bioequivalent” to it. Once a brand medication goes off patent, generic manufacturers can produce their own version.
I hope it is obvious by now. The problem with these “true generics” is that they weren’t true. It’s that they were a cynical exploitation of FDA loopholes on drugs with highly sophisticated delivery systems (e.g. Concerta’s patented OROS technology, “Alza”).
One highly placed source told me:
If the Mallinckrodt version is the one I was consulted on, then the story is this.
All the company had to do is replicate the pharmacokinetic curve of Concerta without the OROS technology, which is patented.
Simply defined, a pharmacokinetic curve is a graph that plots the concentration of a drug in blood plasma against time. This graph below plots, over almost 32 hours, the plasma concentration of Concerta vs. an immediate-release methylphenidate product.
Important Differences between “True” and “Authorized” Generics
Here are two key differences between brand/authorized generic and the true generics:
1. Variable dose of effective ingredient:
Bioequivalence does not mean true generics are exactly the same as brand. In the U.S., the FDA requires the bioequivalence for the generic product to be between 80% and 125% of the original product. Yes, that’s roughly 20 percent up or down—a huge window of variance.
This variability alone can wreak havoc for the many people with ADHD. They might do best with a specific dosage; taking much more or less than that dosage is not as effective—and can even be very problematic. Especially when you’re not expecting it. And especially when you question the pharmacy about the different-looking pill and you’re told that generics are the exact same as brand. Wrong.
For example, you and your prescribing physician have established that 30 mg of medication X is best for you. You’ve tried 40 mg and 20 mg, both to poor effect. It is 30 mg!
Given this allowed ”bioequivalence” generic range of 80 to 125 percent, your generic pill could be anywhere from 24 mg to 37.5. Even that number will not be constant; it might vary each time the prescription is filled, because pharmacies often switcher suppliers.
2. Different dyes, fill material, and binding
Moreover, branded drugs and their true generics almost always contain different dyes, fillers, and binders. These are all ingredients to which many people are allergic or have other adverse reactions. (I cannot cite research to support it, but abundant anecdotal reports indicate that people with ADHD might be more prone to these sensitivities.)
Imagine when your physician has no clue that the filler is the problem, not the medication—and not some additional condition, such as bi-polar disorder.
Q 2. So, what’s the problem with the Concerta generics?
Again, we must be specific. There is no problem with the authorized generic of Concerta.
Why? Because it is identical to the brand. In fact, it is the brand, but it is marketed by Watson (now Actavis).
The problems are with the true generics from two other companies: Mallinckrodt and Kudco (Kremers-Urban).
You can read the stories from readers. Their or their children’s lives went off the rails when they didn’t know to suspect the problems with their “Concerta” refills. They had done so well on the real thing.
Just to confuse you, for both types of Concerta generic (authorized and true), the bottle will read methylphenidate hydrochloride extended-release. The same is true for some other methylphenidate generics, including that for Ritalin LA. To know exactly what you have on hand (or what you used in the past), some photos (below) are worth a thousand words.
Let’s examine the differences among the two Concerta generic products:
1. Concerta’s one “authorized generic” (from Watson/Actavis):
Remember, an authorized generic is the brand drug marketed as a generic. The only difference is in price and name. Period.
Backstory: In 2010, Watson (now Actavis) struck a deal with Concerta’s manufacturer, Janssen: Watson would delay introducing their own generic to compete with Concerta. In return, Janssen would manufacture and supply Watson with brand-name Concerta.
This deal allowed Watson to market at a cheaper-than-brand price, with Janssen getting a piece of the profits they might have otherwise lost. This deal was originally set to expire in December 2014.
Recently, a new agreement extends the arrangement until December 31, 2017.
Janssen will continue to manufacture and supply Actavis with all dosage strengths of the authorized generic Concerta. In return, Actavis will continue to market and distribute the product in the United States. As part of this deal, Janssen will receive 50 percent of the net sales from Actavis.
Name on the Rx: methylphenidate hydrochloride extended-release tablets.
Appearance: exactly the same as Concerta. Look for a capsule imprinted with “Alza” (the makers of Concerta’s unique delivery-technology, called OROS). It features a laser-drilled hole. (See photos below; color will vary with dosage strength)
Bottom line: If your generic Concerta is imprinted with “Alza,” you have the brand medication. Just to be sure, look for the little hole at the end. That tells you this capsule incorporates OROS technology, the laser-drilled osmotic pump that is the proprietary Concerta delivery-system technology.
2. Concerta’s two “true generics”
These generics are manufactured by Mallinckrodt and Kudco. This is a generic in the traditional sense. In other words, this generic medication is deemed “bioequivalent” to the brand, according to the FDA.
(Note: An entirely different Concerta generic is available in Canada, and there are problems with that as well, explained in this post.)
These true-generic Concerta manufacturers are:
1. Mallinckrodt
Name on the Rx: methylphenidate hydrochloride extended-release tablets
History: Mallinckrodt received FDA approval of its abbreviated new drug application (ANDA) on December 28, 2012, for the 27-, 36-, and 54-milligram strengths.
Bottom line: This generic does not use brand-name Concerta’s OROS delivery system. You’ll find no laser-drilled hole on the end of these capsules, pictured below.
Remember: It is the OROS delivery system that distinguishes Concerta. The less-sophisticated delivery system with this generic is thought to more resemble Ritalin LA.
Mallinckrodt’s generic of Concerta depicts an “M” in a square, followed by the milligrams. The color varies by dosage. Here are the 27 mg and 36 mg pills.
2. Kudco (Kremers-Urban)
Name on the Rx: methylphenidate hydrochloride extended-release tablets
History: Kudco received FDA approval on July 9, 2013, for the 18- and 27-milligram strengths, and September 23, 2013, for the 36- and 54-milligram strengths.
Bottom line: As with the Mallinckrodt offering, this generic does not use brand-name Concerta’s OROS delivery system. You’ll see no laser-drilled hole on the end of these capsules.
Remember: It is the OROS delivery system that distinguishes Concerta.
The box looks like this (the color varies by dosage strength); note the company name in the lower left corner:
And the pills look like this, in the 18 and 27 milligram dosages.
Q 3. What exactly did the FDA say, in downgrading the Mallinckrodt and Kudco generics?
To summarize, the FDA said the true generics might deliver the medication at a slower rate than the brand Concerta. Therefore, this can affect the effectiveness of the medication.
Specifically, the FDA said, in part:
“An analysis of adverse event reports, an internal FDA re-examination of previously submitted data, and FDA laboratory tests of products manufactured by Mallinckrodt and Kudco have raised concerns that the products may not produce the same therapeutic benefits for some patients as the brand-name product, Concerta, manufactured by Janssen Pharmaceuticals, Inc.
“Methylphenidate hydrochloride extended-release products approved as generics for Concerta are intended to release the drug in the body over a period of 10 to 12 hours. This should allow for a single-dose product that is consistent with the effect of a three times per day dose of immediate-release methylphenidate hydrochloride.
“In some individuals, the Mallinckrodt and Kudco products may deliver drug in the body at a slower rate during the 7- to 12-hour range. The diminished release rate may result in patients not having the desired effect.
“As a result, the FDA has changed the therapeutic equivalence (TE) rating for the Mallinckrodt and Kudco products from AB to BX. This means the Mallinckrodt and Kudco products are still approved and can be prescribed, but are no longer recommended as automatically substitutable at the pharmacy (or by a pharmacist) for Concerta.”
Q 4. Is this downgrade permanent?
The downgrade remains in effect. Both companies countered the FDA’s decision. Mallinckrodt’s CEO threatened lawsuits against the FDA.
Let’s back up a bit.
Consider this, from the original FDA statement:
“Consequently, FDA has revised its draft guidance for industry for bioequivalence testing for methylphenidate hydrochloride extended-release tablets (Concerta). FDA has asked that within six months, Mallinckrodt and Kudco confirm the bioequivalence of their products using the revised bioequivalence standards, or voluntarily withdraw their products from the market.
“FDA has changed the therapeutic equivalence (TE) rating for the Mallinckrodt and Kudco products in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly referred to as the “Orange Book”) from AB to BX. This means that the data are insufficient to show that the Mallinckrodt and Kudco provide the same therapeutic effect as Concerta (or the authorized generic marketed by Actavis). A drug with a BX rating is still approved and can be prescribed, but is not recommended as automatically substitutable at the pharmacy (or by a pharmacist) for the brand-name drug.
“FDA will continue to evaluate its testing and approval standards and bioequivalence guidances for other generic methylphenidate hydrochloride extended-release products and revise as needed.”
By October 17, 2016, the two companies had not succeeded in showing bioequivalence. The FDA re-instated its position.
Q 5. Does this FDA action affect other methylphenidate hydrochloride ER products (e.g., Ritalin LA)?
No. This action only pertains to generic drugs referencing Concerta. It does not affect other methylphenidate hydrochloride ER products.
Q 6. How did the FDA learn that the first two Concerta generics might not be therapeutically equivalent?
I’m not sure. I know some ADHD experts were complaining about the initial decision to approve these medications.
All I know is this: When I contacted the FDA, the MedWatch complaint had not been opened. So, I opened it.
From there, my blog readers, along with those of Kansas pediatrician Kristen Stuppy made valiant efforts in completing those tedious MedWatch forms—contributed mightily to the downgrading of these generics. How’s that for responsive government?
I first wrote about generic Concerta in October 2011. What’s Up With Generic Concerta?
A few years later, troubling reports starting coming from ADHD Roller Coaster readers. After months of effort, including getting the royal runaround by the generic manufacturers, I finally contacted the FDA. The representative listened as I explained the complaints being reported from ADHD Roller Coaster blog readers.
Then this FDA representative explained how we could open a MedWatch complaint. I was skeptical: Would such an effort only waste my readers’ time? Would anyone at the FDA really take these complaints seriously? If sufficient numbers of people experiencing adverse effects filed a complaint, the FDA contact assured me, it definitely was possible to have this issue revisited.
The 2012 Precedent with Wellbutrin Generic
In 2012, the FDA declared that certain generics of Wellbutrin XL were not therapeutically equivalent. Teva Pharmaceuticals and other manufacturers had to remove their products for re-testing.
Those products were later back in the supply chain. Tut the FDA had at least softened its stance that approved generics were necessarily bioequivalent.
In February 2014, Bloomberg reported in Generic Drugs Evaluated in First Broad Test Effort by U.S. FDA. Congress approved $20 million for a new FDA program aimed at boosting testing of generic drugs. Partially funded by generic manufacturer fees and slated to run through 2018, it involved about dozen universities and academic centers. The initial focus was to be on generic antidepressants, medications for ADHD, and a few others.)
Generic Concerta FDA Medwatch
Kansas City pediatrician Dr. Kristen Stuppy and I subsequently wrote several blog posts, urging readers to register any complaints with the FDA. Bless ‘em, they/you did! It wasn’t wasn’t an easy form to complete. Especially if you didn’t have your best medication on board, or your child was running off the rails and you were frantic with worry.
If you were one of those people, I salute your public service! (Victory! Concerta Generics Downgraded)
Between May 2013 and June 2014, the FDA Adverse Event Reporting System (FAERS) database received reports of “insufficient therapeutic effect”—nearly 200 about the Mallinckrodt product and more than 100 about Kudco’s.
The FDA says the total number of these reports is very small compared to the overall usage of the products. But when it evaluated the number of complaints for these two generics compared to those for the brand-name and authorized generic products, it found substantially more complaints for the two generic products. Next: the investigation.
After learning of concerns with the products, FDA’s Office of Generic Drugs reported that it conducted a multi-disciplinary review of the products, including
- An evaluation of adverse event reports
- A review of the data that were submitted originally
- Testing of the drug products in FDA labs, including drug stability and dissolution testing to determine the drug release rate and the stability of the two methylphenidate isomers and their degradation products
- Broad interdisciplinary consultation with FDA physicians, pharmacists, chemists, and other agency scientists and experts to discuss the new information
Q 7. Why did it take such an effort by consumers? Why weren’t these problems discovered before?
The short answer: It seems the FDA didn’t know how to measure bioequivalence to a novel delivery system such as Concerta’s (the OROS osmotic pump). ADHD experts I interviewed said, lacking the OROS technology in Concerta, it would be unlikely the generics could duplicate the delivery.
Here is the long answer, from the FDA:
Before approving any generic drug product, FDA requires many rigorous tests and procedures, in addition to the bioequivalence testing of the product against the reference listed drug (brand-name drug), to assure that the generic drug is substitutable for the brand-name drug. The original draft guidance recommendations for bioequivalence testing for this product (published in September 2012) were developed using the best information available at the time of issuance. This included, among other information, a comprehensive discussion of the issue by an FDA Advisory Committee on April 13, 2010.
In addition to tests performed prior to market entry, once approved, FDA regularly and thoroughly evaluates reports of alleged drug product inequivalence, such as lack of effect, as in this case. In some cases, such reports can lead to a re-evaluation of equivalence in light of new scientific approaches and methodology that have been developed subsequent to the initial draft guidance publication.
Mallinckrodt and Kudco provided data that met FDA’s approval standards at the time of approval, consistent with FDA’s best understanding of how to demonstrate bioequivalence to Concerta. The data showed the methylphenidate hydrochloride ER products to be bioequivalent to Concerta based on FDA’s understanding, at that time, of how the pharmacokinetics of Concerta contributed to the therapeutic efficacy.
The previous draft bioequivalence guidance on generic methylphenidate hydrochloride ER tablets (Concerta) recommended measuring the total amount of drug absorbed into systemic circulation from initial dosing until three hours after taking the drug and from three hours post-dosing until the last measurable time. The total amount of drug absorbed during these two time periods were thought to capture the initial immediate release of the drug as well as the extended release of the drug during the latter part of the day. Through the investigation of post-marketing reports with Concerta’s generic products, FDA determined that these recommendations should be updated to help ensure bioequivalence and support a demonstration of therapeutic equivalence.
FDA’s understanding of the relationship between the drug release characteristics of generic versions of Concerta and their impact on therapeutic effect has evolved, and FDA has revised its draft guidance for methylphenidate hydrochloride ER (Concerta). FDA will continue to evaluate and revise other testing and approval standards, as well as bioequivalence guidances for other generic methylphenidate hydrochloride ER products as needed.
Q 8. Will the FDA further study generic methylphenidate hydrochloride ER products?
That question and this answer come directly from the FDA:
“Studying generic methylphenidate hydrochloride ER tablets has been identified as a priority by stakeholders and FDA.
Under the Generic Drug User Fee Act of 2012 regulatory science grants, FDA commissioned two studies: a bioequivalence study in healthy adult volunteers, which started in October 2014 and is expected to finish by April 2015, and a pharmacokinetic and pharmacodynamic study in children with ADHD, which started in October 2014 and is expected to finish by September 2017.”
Q 9. What does all this mean to me or my loved one, as users of Concerta?
For now, it means that:
- You are no longer vulnerable to receiving, unawares, the two true generics shown to be inferior in delivery to Concerta.
- If your insurance coverage stipulates that your prescriptions must be filled with available generics, you will no longer be forced to take the downgraded generics or nothing (or pay full price for brand). You should be able to receive the Actavis authorized generic, if the pharmacy uses that supplier and if supply is available.
- If you are one of the minority that actually prefers one of the true generics, each is still available. It just won’t be automatically substituted if your MD does not specify “brand only.”
- You might experience difficulty in filling your Concerta prescription due to overall shortages (lots of raw material is tied up in those two downgraded generics). These shortages are expected to last into the second quarter of 2015; check here for updates.
[Remember: This all changed in 2017. This story is for background.]
Q 10. What about the Actavis-Janssen deal that brought us the authorized generic? The contract expired recently.
Good news!
Recently, a new agreement extends the arrangement until December 31, 2017.
Janssen will continue to manufacture and supply Actavis with all dosage strengths of the authorized generic Concerta. Actavis will continue to market and distribute the product in the United States. In turn, Janssen will receive 50 percent of the net sales from Actavis.
Q 11. Any tips for dealing with shortages or pharmacies that don’t carry the authorized generic?
- Ask the pharmacy to carry the Actavis authorized generic.
- Consider a mail-order pharmacy; they tend to have more abundant supplies. (Tip: Home Delivery of Stimulants)
- Remember: If you get a mail-order supply for 60 or 90 days, that means much less hassle over the course of the year.
- Shop around. Readers have reported better luck at certain drugstore chains than others (Walgreen’s over CVS, for example) and at independently owned or big-box stores such as Costco and Sam’s. (For Costco, you needn’t be a member to purchase prescription medicine; though members might receive a slightly larger discount.)
Q 12. My pharmacy is still substituting the downgraded generics for my Concerta prescription?
Despite the FDA’s ruling, some pharmacies have persisted in foisting the downgraded generics on unsuspecting consumers.
Here are your options (with a little repetition from the previous question):
- ALWAYS check your pills before you pay for them. You typically cannot return them once you pay for them and especially after you leave the store.
- Ask your pharmacy to carry the Watson/Actavis/OROS authorized generic (same as brand).
- If the pharmacy refuses, call other pharmacies. Independent stories might be more helpful. Also, there are the big-box stores, such as Costco (where you don’t need a membership to use the pharmacy) or Target.
- Present the pharmacy manager with this latest FDA Drug Safety Report. If you print it, note my yellow highlights and replicate them on the photocopy.
- Contact your mail-order pharmacy (if applicable): If your health insurance includes a mail-order option (typically, 60- or 90-day supply), ask if that pharmacy carries the OROS “authorized” Concerta. If not, ask how much more the brand Concerta will be. (Tip: Home Delivery of Stimulant Medications.)
- Complain to your health insurance carrier.
- Ask your physician to write a note to your health insurance company saying that you or your child experienced intolerable side effects to the downgraded generic and you must have brand or authorized generic. (Be prepared to pay the brand price, though.)
- Ask your physician to write “OROS only” on the prescription; Watson is in the process of changing names to Actavis, so it’s likely that confusion will result if either name is used instead of OROS (the technology that makes Concerta unique).
- Ask your physician to indicate “no substitutions” on the Rx script if the OROS generic is unavailable and you are willing to pay for the brand.
Q 13. My insurance company has removed Concerta entirely from its approved list (formulary). Now what?
If your insurance company has removed Concerta from its formulation, that means one thing: It is not willing to pay the price for brand or the authorized generic (which, now lacking competition, seems to be raising its prices). At least not without putting up a fight!
This insurance-coverage situation might correct itself in time. The downgrading of the generics happened only recently, in November 2014, about the time when insurance companies typically revisit their formularies. There’s bound to be an adjustment period. In the meanwhile, keep calling your insurance company to learn of any updates to the formulary or to ask for an exception. [update 10/2016: The same is true now with last week’s FDA announcement, near the end of the year.]
Insurance companies direct their formulary to direct patients to “cost effective” alternatives, often generics. This selection depends on the deals they receive from the pharmaceutical company. This is why generics within a pharmacy may change periodically, depending on the latest deal struck.
If a patient demonstrates a poor response on a generic, a doctor can appeal to the insurance company for brand medication. But the patient will pay a higher copay. That tends to discourage patients from higher cost medication.
As a patient, you can always decline a prescription, usually because of unexpected cost. Sometimes patients will contact their doctor for an alternative. Sometimes patients just say, “Forget it, I won’t take it.”
If the insurance representative is not forthcoming, request a “generic appeal program” form. Sometimes insurance companies want you to try an alternate medication first (such as Ritalin LA). You’ll receive the costlier brand (or authorized generic) only after the alternate has proved insufficient. Sometimes this is simply a hoop you have to jump through.
More tips from the Texas Medical Society:
- Ask your doctor to request an “exception” based on medical necessity
A doctor can request that the plan cover the medicine “by exception.” Even though it is not on the plan’s formulary, the physician contends that another medicine will not work as effectively for you. For example, you are allergic to the other medicines on the formulary. - Ask your doctor if a different medicine – one that is covered – will work for you
Sometimes, another medicine, one your insurance will pay for, will work to effectively treat your condition. Discuss with your doctor the risks and benefits of taking a different medication. [Note: Some people with ADHD who have done well on Concerta will do equally well on another methylphenidate product with a sustained time release, such as Daytrana, or even an amphetamine-class medication such as Vyvanse. Others absolutely will not. If you’ve never tried, it might be worth a try.] - Pay for the medicine yourself
Sometimes there is little significant difference between the cost of the medicine if you pay for it yourself and your insurance plan “co-payment,” (the cost you are required to cover as part of your plan). In rare cases, it is actually less expensive to pay for the medicine without plan coverage than with plan coverage. - File a formal, written appeal
If your doctor requests an exception and it is denied, you can further appeal that decision by submitting a letter of appeal to your insurance company.
Q 14. Hey Gina! How about some cost-saving tips?
For those who now find the cost of Concerta brand or authorized generic prohibitive, here are three avenues to explore:
- Janssen’s Concerta savings program.
- Janssen’s patient assistant program (to those who financially qualify)
- Discount coupons and a survey of local pharmacy prices for Concerta at GoodRx
Enter the drug name and your location (e.g. ZIP code).
Updated information: please also read the most recent development, Janssen Quietly Ends Concerta Authorized-Generic
—Gina Pera
My son has been on brand Concerta for 4 years and was placed on generic for the first time in Jan. 2018. In that short space of time his life has imploded. He no longer is able to maintain focus in school—particularly for the afternoon classes, can’t bring himself to complete his homework, (even for the classes he enjoys) and has lost interest in activities that he has enjoyed for three years. Grades are slipping and apathy is big.
So—this brings me to your research and your statement here: Recently, a new agreement extends the arrangement until December 31, 2017.
Given the end of the contract how has this affected the Activas generic that looks the exact same as the brand, and as you have said: is the brand. Period.
I have seen a radical shift in my son and the only that has changed in his life is that the box “brand only” is no longer checked on his prescription.
Hi Julie,
Your son has a smart mom!
Here is a recent blog post on more recent Concerta related issues: Three new generics.
https://adhdrollercoaster.org/medication/7977/
If possible, you might want to ask the doc to check the “brand only” box.
Good luck,
Gina
What is the round white generic for Concerta (36 mg)? I believe that CVS has been filling my prescriptions with a substandard generic for a long time. Nice to see these articles. (Sad to know but it is validating to know that I’m not imagining it) Great information. Thank you. I’ve just switched to Ritalin LA because I can get a generic and even generic Concerta will cost me $10/pill due to a change in my insurance. (I’m self employed-deductible $6650 and Rx isn’t covered before deductible) So I can’t afford even the generic Concerta. Such a mind numbing racket and run around that I have been on to trying and figure out this game played by the pharmaceutical companies causing the consumer to suffer. Very sad.
Hi Alita,
I should be posting more info on the new generics soon. Have been delayed by a bad cold.
Your round white pill generic could be anything. CVS is still filling prescriptions with the downgraded Concerta generics, and there are three NEW generics on the market.
Pharmaceutical companies …one thing. Generic manufacturers…quite another. They are being increasingly brazen at exploiting the loopholes created by these novel delivery systems, such as Concerta’s OROS capsule.
Best,
g
Alita – The manufacturer name should be listed on the CVS label. My son’s has a rectangle that describes the color and shape of the pill. Under that is a line with some info and then MFR. Manufacturer name is listed after that. Just had a huge mess this week at CVS trying to get script filled. He can’t take 2 of the new generics due to red dye sensitivity. I’m not aware of 3rd one, except just mentioned here. CVS said Actavis brand is blocked at corporate and would not fill. Went 3 days without meds. Thankful for local pharmacy that got meds for us, even though they usually fill downgraded generics. Gina – Interested to read post about new generics. Get well soon!
Thanks, Holly!
I was just diagnosed with ADHD in my 40s, and received my first ever prescription for methylphenidate ER today. I thought I’d done plenty of reading and watched plenty of experts discuss the various medications, and happily filled my prescription at a local CVS. Took the first dose, and went to my new ADHD online support group to share my experience. A quick search for “Concerta” in the group pulled up the FDA announcements about the generics problem. A quick check of my bottle showed that indeed I’d received the Kremers Urban generic.
I was/am so upset! If the FDA has been at this for three years now, and downgraded this generic, and we as consumers have the RIGHT to the authorized generic, why are newbies like me STILL being introduced to likely medication failure right out of the gate? I went back to the pharmacy and had to firmly argue my case that I did NOT want this dubious generic and wanted the Actavis generic instead. Eventually the pharmacist worked with me to take back the Kremers Urban–but didn’t have the right mg of Actavis in stock. So I went to a third pharmacy (the first one didn’t even have any methylphenidate ER in stock) and learned that I had to pay $60 more for the Actavis than for the Kremers Urban. I’m still working toward my deductible, but after paying $155 for a 3-week supply, I’m less than $50 away from meeting that.
THANK YOU, Gina and ALL of the consumer activists who filed formal complaints and built up this amazing website with real information and resources for people who want and deserve proper ADHD treatment. I’m furious that I had to spend almost an entire day working to fix this problem and now I’m fired up to help others learn about and fight these subpar generics.
Maybe now I’ll have a fair chance of learning whether or not these meds will work for me–now that I don’t have to worry that I’m not even taking what the doctor intended to prescribe.
Hi CJ,
I’m furious for you.
I think I’ll go shame CVS (again) on Twitter.
Hang in there. You’ll be okay. Just keep on finding the facts.
g
Is there a new Concerta generic on the market? Tri…..?? I got my son’s script filled today at CVS where I normally get the Actavis pills. I opened the bottle before leaving the store to find a dark gray pill. WHAT!?!! That was not the 27mg Actavis pill, but a different brand. And it contained red dye which my son is sensitive to. Thankfully they took the pills back, called another CVS which had the actavis brand. Hopefully I can pick up the right meds tomorrow. Beware of new generic if you or your child has dye sensitivities. Seriously, red dye in ADHD meds?? Ugh.
Hi HF,
Yes, there are two new Concerta generics out. Their FDA rating was a bit higher than the downgraded generics. But who knows…it might just be a matter of time.
Concerta is a major brand. There are going to be those who want to cash in. And red dye? Oh dear.
Good for you, for paying attention.
Gina
I just dont get it, many of my local pharmacies are still substituting the downgraded medicines for generic Concerta.
We mentioned the downgrade to the pharmacist and their response of course was these were bio equivalent and the FDA ruling just meant they could not automatically substitute these for generic Concerta.
Umm What… So I give you a prescription and you fill that with the downgraded generic and that is not automatically substituting it?
Of course we learned the hard way to always ask who they are filling the script with before handing it over.
This is so frustrating even after all the work Gina and others put into fixing this issue we still cant get the medicine that works for our child.
I dont get it….
Hi Jeff,
It’s infuriating, isn’t it?
But that’s today’s climate, unfortunately: Flout rules and regulations.
I’m glad you are on the watch.
I have my husband’s MD specify “OROS only” on the script. So far, it’s worked, despite our new mail-order pharmacy being CVS, one of the worst offenders.
Good luck!
g
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Fast forward a year or so, and BCBS just sent us a notification that Methylphenidate HCL ER (we’ve been getting the Actavis) is being removed from the formulary. According to the BCBS RX website, the Actavis is actually more expensive than “real” Concerta.
Our pediatrician is recommending Metadate, but we’re very concerned about how our daughter will react to a different dosage and delivery system.
I’m looking for alternatives that are still on the formulary, but all of these meds have almost exactly the same name. Are there any true Concerta generics on the market besides Actavis?
HI John,
Oh dear.
Can you get the “real” Concerta?
Just to be clear: Actavis is an authorized generic of Concerta, not a “true” generic. (Meaning, it IS the brand, marketed as a generic. The “true” generics are medications that are similar to the brand, but not exactly.) There are no “true” generics of Concerta, not since the inferior generics were downgraded.
I’d make a nuisance of myself with your pharmacy benefit organization. Then, if no luck there, see if you might qualify for the patient-assistance program with Janssen: http://www.janssenprescriptionassistance.com/concerta-cost-assistance
Meantime, if you missed this part of the article, here are more tips:
Q: My insurance company has removed Concerta from its approved list (formulary). Now what?
If your insurance company has removed Concerta from its formulation, that means it is not willing to pay—at least not without putting up a fight—the price for brand or the authorized generic (which, now lacking competition, seems to be raising its prices).
This insurance-coverage situation might correct itself in time. The downgrading of the generics happened only recently, in November 2014, about the time when insurance companies typically revisit their formularies. There’s bound to be an adjustment period. In the meanwhile, keep calling your insurance company to learn of any updates to the formulary or to ask for an exception.
Insurance companies direct their formulary to direct patients to “cost effective” alternatives, often generics. This selection depends on the deals they receive from the pharmaceutical company. This is why generics within a pharmacy may change periodically, depending on the latest deal struck.
If a patient demonstrates a poor response on a generic, a doctor can appeal to the insurance company for brand medication but the patient will pay a higher copay. That tends to discourage patients from higher cost medication.
As a patient, you can always decline a prescription, usually because of unexpected cost. Sometimes patients will contact their doctor for an alternative. Sometimes patients just say, “Forget it, I won’t take it.”
If the insurance representative is not forthcoming, request a “generic appeal program” form. Sometimes insurance companies want you to try an alternate medication first (such as Ritalin LA), giving you the costly brand (or authorized generic) only after the alternate has proved insufficient. You might respond along these lines:
“Insufficient how? Must I get in a disabling car accident before you decide I need the medication that works best for me? Do you realize how much that claim will be? Must my child be expelled from school? How far must my life downspiral before you allow my doctor and me to have control of this important decision? How much is the insurance company willing to risk?”
If that doesn’t work, here are some tips from the Texas Medical Society:
Ask your doctor to request an “exception” based on medical necessity
A doctor can request that the plan cover the medicine “by exception,” even though it is not on the plan’s formulary if he or she feels that another medicine will not work as effectively for you, or if, for example, you are allergic to the other medicines on the formulary.
Ask your doctor if a different medicine – one that is covered – will work for you
Sometimes, another medicine, one your insurance will pay for, will work to effectively treat your condition. Discuss with your doctor the risks and benefits of taking a different medication. [Note: Some people with ADHD who have done well on Concerta will do equally well on another methylphenidate product with a sustained time release, such as Daytrana, or even an amphetamine-class medication such as Vyvanse.]
Pay for the medicine yourself
Sometimes there is not a significant difference between the cost of the medicine if you pay for it yourself and your insurance plan “co-payment,” (the cost you are required to cover as part of your plan). In rare cases, it is actually less expensive to pay for the medicine without plan coverage than with plan coverage.
File a formal, written appeal
If your doctor requests an exception and it is denied, you can further appeal that decision by submitting a letter of appeal to your insurance company.
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Great article! Totally full of the precise information I needed to know about Concerta. I’m an auto accident, tbi – 9 day coma, survivor, that 10 years after my injury, learned about and began taking methylphenidate. Initially, it was a bumpy road, having two withdrawal periods and a night of nightmares each day. That was from being prescribed two 5mg pills per day. That went on for two months until I learned that these 5mg tablets only lasted for three hours. I didn’t know any better; I was young and dumb, and just learning. Even with them double withdrawals and nightmares, then pills allowed me to have two periods of mind clarity which I never imagined could be possible. This also allowed my local memories to begin to stick in my brain, rather than disappearing. That is how it has been for the previous twelve years.
After learning about the torturous pills duration, I moved on to many 5mgs per day, then on to two then three 20mg SRs. Then on to Concertas, 18mgs then to 27mgs, twice per day.
This is my level of Ritalin … methylphenidate. After Concerta went generic, I was lucky enough to be able to stay with them name-brand Concerta, as my recovery and medications are and are supposed to be covered by the auto insurance company (in effect, at the time of my accident). Getting my medications can still have its ups and downs.
My methylphenidate quest began in 1999, twelve years after my accident and near their end of my ten year college experience. I hadn’t been able to take more than two college classes at one time, per semester, without confusion difficulty. This was because of my limited ability to remember anything. Then I found out about Ritalin, known as an ADHD medication. Ritalin and Concerta are marketed as a once per day ADHD medication. I’m a TBI person, not ADHD, although without medication I have similar symptoms as an ADHD person. I’m not sure how ADHD people react without a second 12 hour dose of Concerta, per day, but I know that I would experience a mentally traumatic withdrawal.
Years ago, I found a medical study article showing that people that experienced a week-long coma, from a traumatic-force injury, had a dopamine level of only 25% of what is normal. They determined this by measuring something else, which estimated they dopamine concentration/level.
This explained why my thoughts were always running around in my head. I described it as having two minds running around at once, extreme difficulty in making decisions. I had extremely low dopamine, actually, I was maintaining a low level because my dopamine regulatory system was damaged. The methylphenidate, a dopamine re-uptake inhibitor, helps to normalize my neural transmitter level.
After I first went to an excellent neurologist, he immediately put me on two Concertas per day, along with a serotonin upper, Effexor, an anti-Alzheimers medication, and a blood-pressure medication.
I stuck my personal story in here, in between getting to the Effexor part, because I have told it many times and maybe it could help someone with their struggles.
My struggles recently were about Effexor and having a painfully wrapped mental experience when I was mailed the just-approved generic, instead of the brand name medication. That was a bad experience. I have been very cautious about generics from then on. That was two years ago. After being mailed a generic Effexor once again and after running out of Effexor, I tried the generic Effexor. It wasn’t messed up this time, but then I just looked into the prices for this medication along with the brand name and they are incredibly distorted. For 60-75mg capsules of Venlafaxine there a generic for as low as $25, but then the brand name Effexor is as high as $800 to $1050, in different pharmacies. Wow, I was blown away when I saw these prices. I need to figure out where I need to find my Effexor and who the quality manufacturers are, just as you did in you article on Concerta.
That would be a great subject to look into, if you haven’t already. From asking and sometimes having to demand that I need Concerta b.i.d., every twelve hours, I was seen by some non-neurologist doctors with suspicion, as a possible drug dealer and such. The advertising for Concerta talks only about ADHD, as once per day and does not address the tens of millions of T.B.I. Americans, that have no idea that this medication will help them. There are Gulf-war explosion injuries where they no ability to remember,,, this is the medication for them. Effexor should be given, also for these blunt force injuries, as it deals with the depression, probably from lowered serotonin levels. I heard that there are around two million t.b.i. injuries in the U.S., every year. Retired football players are also part of this group, I believe. Thanks , sorry about the long post. Good luck!
Dear Richard,
I greatly appreciate your telling your story. You bring up an excellent point.
I can’t imagine going through such an ordeal, especially because it took so long for the docs to realize that your TBI might respond to stimulants.
Among ADHD experts, the risk of developing ADHD-like symptoms from TBI is well-known, as is the possibility that the stimulants help some cases. Of course, this would be a difficult thing to study, as brain injuries vary as widely as do individual human brains. Also, researchers would need to know if ADHD was present at baseline.
Here is one paper examining the topic:
http://www.bcmj.org/articles/pharmacological-interventions-traumatic-brain-injury
Also, the stimulants often help cancer patients who are suffering “chemo fog”— neurocognitive symptoms from chemotherapy.
You’re right. I should write about this. I’ll put it on my blog calendar.
Interesting about Effexor. I hadn’t heard about the generics for that medication, though I’ve often warned about generics for any psychiatric condition. Best to be cautious, especially if symptoms are severe.
Thank you so much for your comment,
Gima
I’m still confused. Even though Watson / Actavis may have raised prices due to no competition, since it’s still considered a generic then wouldn’t patients still pay the generic co-pay?
Hi Chris,
I’m not sure how insurance companies devise their “formularies.” It probably varies by company.
There might be exclusions for “authorized generics” (the brand sold as a generic).
In the case of Concerta, the delivery system (Alza’s OROS) is patented — that is, more expensive than the rudimentary mechanisms of Concerta generics,.
g
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Thank you for your very informative article.
Just an update on your tip to shop around. Today I went to refill my son’s Concerta prescription in the Walgreen’s by his ABA therapy place, in a town about 10 miles from where we live. On few occasions, I had filled his prescription there with no problems. Today, I was told that there is a new rule that Concerta prescriptions can only be filled for patients living in that town. CVS had the same rule.
Not sure if it’s a new rule for my area only (we are in South Florida). But if this is a new trend, for sure it will make it harder to fill out prescriptions. It limits where we can shop around locally.
Hi Danielle,
That sounds crazy, and possibly illegal.
If you have the option, you should definitely look into your insurance plan’s mail-order pharmacy.
good luck,
g
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My son takes Focalin XR 2x a day and I know that is also methylphenidate HCl. I have not had any issues with getting his meds as long as I stay at the same pharmacy so they know I will be coming for it every month so they keep it in stock. Is the delivery system just different in this drug than the Concerta? And since the Focalin comes from Novartis it’s not an issue yet? I think we are still getting the name brand because I know it says on the pharmacy receipt that it would have been 2 hundred and some dollars without the insurance.
Hi Andrea,
Yes, the delivery system is different, between Focalin and Concerta.
Concerta uses the OROS technology — an osmotic pump that squirts medication out one end as gastric liquids come in the other. Very sophisticated.
It seems there are several generics for Focalin; the generic name is dexmethylphenidate. But if yours is coming from Novartis, that is the brand.
There might not be issues as severe with the Focalin generics; it’s a simpler delivery system.
Focalin is very similar to Ritalin/methylphenidate. The different is in isomers—in other words, slightly different molecular structures:
Whereas Ritalin contains both the d and l isomers of methylphenidate, Focalin contains only the more active d-isomer. Isomers are compounds that contain the same number and type of atoms, but have different structures.
https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/734/focalin-dexmethylphenidate-hcl
best,
g
Just wanted to say thanks… checked my pills and they’re the authorized generic. I have had ADD… well my whole life… but only known since 2001. I have just recently started taking medication for it and it has made such a positive impact in my life. Thanks for taking care and watching out for us!
Hi Jennifer,
I’m glad to hear that, and that you don’t have to jump through hoops now to get the Rx that you need.
And thanks for acknowledging my work in this area. It’s been a huge time investment, when I had other work to do. But it was just so critically important—potentially affecting millions of lives—that I made it a priority and never looked back!
In my wildest dreams, I didn’t think we’d actually succeed in getting the generics downgraded by the FDA. But the team came through with filing reports. Definitely a group effort!
Best,
g
My son was hospitalized in September 2014 , and I’ve always believed it was from him being on Concerta. when the medication water off he acted in a very violent way ,he was easily agitated he did things that led to his hospitalization. Then. we switch to ritalin a few months but that caused him to have tics so the dr put him back on Concerta 18 milligrams. My son, family and I suffered a lot and went thru hell!!! I truly believe it was from the meds, concerta. Can I sue ? Who would I sue?? I am furious over this!! I could have lost my son forever over this. This is not acceptable!!
LeeAnn,
That must have been so frightening, to see that happen to your son.
If it were a problem with the Concerta itself, many people would have had a similar reaction.
Instead, it sounds like it was simply the wrong medication for your son.
The hard truth is, the brain is the most complicated organ imaginable. And we are only beginning to understand how to treat brain-related problems.
Sometimes there is no way to know, beforehand, how a person will react to ADHD medications, especially because there are so many co-existing conditions. Bi-polar disorder, anxiety, depression, Tourrette’s…not to mention nutritional deficiencies, unrecognized brain trauma (from “bumps to the head”), and so much more.
Personally, I don’t think it’s a good idea to start a child on a long-acting medication. If there is a bad reaction, you’ll have to wait too long for it to wear off. I would find it wiser to try perhaps a very low dose of Ritalin (similar medication) and see the response.
If the physician was careful, that is one thing. If he or she was not, that is quite another.
I hope you’ve found satisfactory care for your son.
best,
g
Thanks for the info, we went through this switching of generics. That was the end of concerta for my son because he had terrible headaches and we had to find a pharmacy that carried the Watson brand. It became a lot of trouble. I used to call concerta the miracle cure for my son but it became a nightmare switching generics and doses. We’ve been on 3 different adhd medications now and at 17 he no longer wants to take the stuff. Concerta was great but all the switching to find the right meds put a bad taste in his mouth about trying new meds. Ruined it for him. It’s a shame !
Hi Barbara,
I am very sorry to hear that.
The games these generics companies have played with real people’s lives.
It’s infuriating.
Now, I’m really confused . My sons medication says methylphenidate Hcl Cd Cr. Also says metadate Cd. Is this also a version of Concerta?
Melissa – Methlyphenidate is the name of the medication in one class of stimulants: Ritalin, Concerta, Metadata, Daytrana, etc.
It is the basic ingredient.
The differences among these methylphenidate medications is in how they are delivered to the system. For example, Daytrana uses a patch, Concerta a pump-capsule, and the others various means of releasing the medication.
So, no, metadate CD is not a version of Concerta. The two medications share the same basic ingredient (methylphenidate), but have other important differences.
I hope that helps.
Gina
Thanks!
Simon,
Wow, your strategy is brilliant! As I paid my $100 last week for the Actavis brand, I wondered what the price difference was between that one and Janssen’s brand. Going forward, I will be requesting the brand name only and I will be making your exact point when I am discussing my appeal.
I sent the paperwork off last week so I should hear about the appeal shortly. Please keep us posted on BCBS of NC’s response. When all else fails, hit them with the $$numbers$$$!
Thanks,
Samantha
Power to the People! 🙂
g
It’s been 9 months since I started my one-sided argument with BCBS over copays between brand Concerta and the generic (Actavis/Watson). I think they have forgotten me or decided to ignore me. To avoid further pointless conversations (and make sure that I stuck it to the company) my last 8 refills have all been brand Concerta. I’m paying the same $100 copay either way so why not reduce the aggravation and misinformation at the pharmacy. While BCBS hasn’t budged my emploter has shifted insurance comapnies. My initial research on the plans was worrisome as Cigna treats Concerta as a non-preferred brand and my plan sticks that with a $200 copay!! The good news? Cigna recognizes Actavtis/Watson as a generic. So in the end my copays have shrunk back down to $10! Happy New Year!
Victory!!!
That’s fantastic, Simon.
But how aggravating having to deal with such migraine-inducing labyrinthine details.
“ADHD medication as an easy way out” — indeed!
Happy 2016!
g
I thought I would update you on our situation. After going back and forth with BCBS of NC, they continue to insist that the FDA “forced them to make this change”. I just picked up another rx for my son of the Actavis brand Concerta generic and it was again, $100 (instead of $10).
The reps on the phone simply have a script to read and can do nothing further for me. I’m now filing an appeal with BCBS of NC via their appeal process and I will keep you updated. I’ve also asked my DR to let me know when the Actavis rep comes to visit again, I would like to speak to them. Actavis needs to hear how the patients are getting railroaded while they duke it out with the insurance companies.
Concerta works amazing for my son, so we aren’t willing to change meds. My hope is that if I make enough noise, it will make some small difference. If you have any updates or additional information on the raw material shortage, FDA action, etc, I would appreciate it!
Thanks again,
Samantha
Hi Samantha,
Thanks for the update, “squeaky wheel” — good for you! 🙂
Well, the good news is, you’re paying only $100. I know that’s a lot more than $10, but compared to what some people are paying (or unable to even find the Actavis), it’s not bad. In the scheme of things. For now.
Have you tried a mail-order pharmacy?
Let’s hope for better news at the end of Q2 2015.
Meanwhile, I see no updates on the FDA Drug Shortage Page:
http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Methylphenidate%20Hydrochloride%20ER%20Capsules/Tablets&st=c&tab=tabs-1
best,
g
Hi Samantha,
I am having exactly the same conversation with BCBS of NC. My son was taking the “true generic” from Mallinckrodt and last year he switched to the one from Actavis. What a difference. The Actavis (like branded Concerta) lasts all day, no running out at the end of school. No way we’re going back.
I am also filing an appeal with BCBS of NC. My point with them is that they are giving me no financial incentive to fill his prescription with the generic from Actavis. The Actavis retail cost comes in at least $140 less than branded Concerta per month for his dosage. BCBS wants me to pay the same $100 co-insurance for either option rather than the $10 if they recognized Actavis as a generic. I’m letting them know that they can expect me to fill future prescriptions with branded Concerta (no difference to my wallet) but that it’s going to cost them an additional $1680 over the next year. They could chose to split that with me – I’ll pay $10 per month, they have to payout $1080 more but still payout less over the year if I’d chosen Concerta brand. They’ll still save $480 for themselves.
If enough people can pick the Concerta brand over the Actavis, insurance companies like BCBS will have to give us a reason to help them save money.
Regards
Simon
Interesting idea, Simon.
My understanding is that each BCBS has different contracts with the pharma suppliers, and more different still depending on the negotiations with employers (for employer-provided/subsidized plans)…and pharmacies themselves? So, who knows how the numbers are really adding up on the BCBS spreadsheet. Not me, that’s for sure.
Good luck with your strategy!
g
I have been in complete disbelief since I stumbled upon your site last night! I’m a RN for 20+ years and knew something was not right! I was switched to Concerta in June of 2014 and doses increased every month along with Ritilin. I tried to kill myself 4 times this past fall. I was still given the Concerta with the M last month by a local hospital pharmacy. I’m now trying to go back and see when I had the OROS type and what months I didn’t. I have a family with a awesome husband and 3 beautiful children who have had to put up with 8 months of complete hell and almost losing me due to this! It’s all making sense to me now! Thank you doesn’t quite seem like enough right now!
Oh Shayla, I am so sorry to read your story.
Yes, it’s very important to discern if it was the generic that caused problems for you — or the Concerta itself.
Remember that stimulants alone can exacerbate “serotonin” issues around anxiety and depression.
Best of luck in sorting this out quickly.
g
I am still going round and round with BCBS of NC about this issue. My doctor has requested an “exception” for my son to keep using the Actavis/Watson generic version at a copay of $10 (instead of $100), but BCBS seems to be very confused on their own issue. I’ve now got the pharmacy, doctor’s office, customer service reps and pharmacy help desk involved.
BCBS of NC has created a claim and will report back to me in 10 days. It will be interesting to see if they can figure out their own policy. I also have the FDA memo that states Actavis/Watson generic is still an AB rated generic and was not moved to the Orange Book. That really seems to confuse the reps who tell me “the FDA made us do this”. Nope, wrong answer!
Will keep you posted.
Samantha
Wow, good for you, Samantha. Good luck!
My boyfriend switched to Concerta in December after a year trial time with Adderall. It is definitely a different ball park than that journey, but something in us kept telling us that it could be better. Tonight we dropped a note to his doctor to write a prescription stating “Watson/Actavis brand only” but I will also be calling pharmacies tomorrow to see what manufacturer they get their meds from. Thank you so much for this Gina – this might be the last little bit he needs! Yayyy!
Hi Shanna,
Great! It might, in the end, be that Concerta isn’t the best fit for your boyfriend. Or maybe it would work better in combination with another medication, such as Strattera. But at least, if you get the real thing, you will eliminate several variables.
Good luck!
g
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I’m not sure if Walgreen’s was charging me more or not. I ended up paying the same amount because I have insurance and luckily my insurance company just recognized it as any other generic. And I didn’t think to look at the bag the pills come in to check what the retail price is.
I know it’s been said a million times before but I can’t say how thankful I am I found these articles on this site. I’d be lost without the info.
Yay! Thanks, Afton. Comments such as yours make it worth me devoting a big chunk of a beautiful Saturday to write this post. 😉
best,
g
I was so happy when I went to Walgreen’s to fill my Concerta prescription this month and realized they were still carrying the authorized generic. I had read that the deal between Ortho McNeil and Actavis was supposed to be over by the end of 2014. I was worried. I was wondering if you think the FDA might try to go after the generic Ritalin SR. According to an industry standard reference for pharmacists, that medication is supposed to be effective anywhere between 2 and 8 hours. Doesn’t inspire much confidence.
Hi Afton,
Hurrah for you!
Was the price higher on the authorized generic this time?
Yes, the deal was supposed to end in 2014, but as I wrote in the piece, they extended it to 2017.
re: Ritalin SR. If you’re talking about the brand, that’s a different matter. There will always be individual variability with the Rx. Some people are fast metabolizers, and some very slow.
best,
g
I have 2 kids on generic Concerta. I was shocked when it was no longer considered generic by BCBS of Alabama. I complained to customer service, that you can get either brand or generic version at the same pharmacy. this was their reply:
Our pharmacy area has reviewed the drug and responded that as of 11/20/2014, this drug’s classification changed from generic to branded generic per Medispan. Medispan is a drug database that keeps up with the market trends of all drugs and reports those changes and updates back to the healthcare providers so that they classify their drugs correctly to the consumers. Medispan provides comprehensive, reliable drug information to health care professionals worldwide. Medispan reports the current class of drugs as well as any updates on pricing or clinical classifications of drugs as stated by the manufacturer of the drugs.
I think that BCBS is full of BS. Generic is generic. My pharmacist said she’d never heard of Medispan. I opted to keep the kids on the “brand” that is really generic, meet my deductible, and get reimbursed 80%.
I thought I’d share my experience with getting a 90 day refill through Express Pharmacy. My son’s doctor has always written ‘to be filled with Watson generic’ on the prescription document. This time, Express called to say they couldn’t get Watson/Actavis due to the shortage and that they could fill it with one of the other generics or Concerta. I said Concerta of course. They made a big deal about documenting this and had two people on the line confirming what I’d said. (I thought that was strange.) They then told me the co-pay price which of course was much higher ($85) than generic Watson but I at first expected that. I then got a call a few days later saying the price was going to be $270. Didn’t get a good explanation for it. No matter how I asked (two different people), it just didn’t make sense. Finally, I figured they were charging me the price for choosing a name brand when I could have had a generic they had in stock — of course the available generics aren’t acceptable. Calling again and involving the insurance company itself, I ended up paying the non-formulary brand name co-pay which was still higher than if Concerta was considered a preferred Formulary drug ($50). It’s not preferred because Express had always viewed a generic as acceptable. Given the FDA ruling that the other available generics aren’t therapeutically equivalent, it’s not fair that a patient is penalized for having to have the name brand. To deal with this, I was told to ask my doctor to write a letter stating that while he originally wrote the prescription for Watson generic, now learning that it’s not available, he wants it filled with Concerta (which it is) but this very letter somehow is supposed to make Express justify classifying Concerta as ‘preferred’ in this interim period before Watson/Actavis supply comes on board. I share this in case this might be useful to someone else navigating their insurance during this time. I found the Pharmacy customer service reps to be very confused and give conflicting information about Concerta’s status, it’s generics, and pricing. Good luck to all! Whew!
Thank you, Amy, for that report from the front lines.
I imagine insurance companies and pharmacies are scrambling to figure out how to deal with all this. Let’s hope the dust settles soon.
g
I totally agree. I am disappointed in Watson/Actavis if they are using this opportunity to raise prices and the patients are the ones who lose. I fully understand they are in the business of making a profit, but the original investment in Concerta has been fully recouped at this point…..although that was with Janssen.
I look forward to your next post and thanks for all the hard work!
Samantha
Hi Samantha,
Thank you. It HAS been some hard work. 😉
Yep, companies answer to shareholders, not to morality. 😉
So, sometimes regulations are a good thing.
We want pharma to make a profit (at least I do), so it keeps producing good options for folks with ADHD and every other medical condition.
These generic manufacturers, though, they’re not developing new products; they’re just providing cheap knock-offs. I know that yes, sometimes a generic will do just fine, and it does create cost-savings for consumers. That’s a very good thing.
But I’ve never seen the wisdom in them for any condition that requires more precise dosaging, such as with psychiatric conditions. At least now, the FDA seems willing to re-assess its “bioequivalence” standard. That’s a win for everyone, I think.
best,
g
I spent most of today on the phone as well with Watson/Actavis, BCBS of NC and others. It sounds like the best option is to ask my Dr. to file an “exception” request so that it can be covered at the $10 level. The BCBS rep today did know what I was talking about, and told me many other families had been calling in very irate about this change.
I also read some articles that claim this is the FDA’s way of allowing Watson/Actavis to corner the market. Whatever the reality is, it’s the families who suffer and the children who get hurt. We are fortunate that we can afford the co-pay, but I think of all those families that cannot and it makes me angry.
I plan on making a whole bunch of noise with both Watson/Actavis and BCBS. I hope that it makes a small difference. Please keep us posted on what you find out, as this cannot be smart business for Watson/Actavis. Their sales will start to decline if the only option is brand name, right?
That’s good. If BCBS gets enough complaints, maybe it will re-consider. They should be reminded of the long-term healthcare costs of untreated ADHD.
And yes, if Actavis sees that it’s losing business to either the brand or methylphenidate alternatives, perhaps it will lower its price.
The thing is, companies have to defend their actions to stockholders. In other words, they have to aim for the most profit possible. So, by raising the price, Actavis is just being a …. company. 😉
As for the claim that “this is the FDA’s way of allowing Watson/Actavis to corner the market,” that sounds like propaganda from the generic makers. They are already whining about the FDA’s poor judgment, etc. They’ve lost money, and their stock has gone down. I didn’t expect them to take this lying down. But I’m very proud that we have an FDA that listens to consumers. We worked hard to get these generics downgraded, and I for one am not crying a river for the stockholders of Mallinckrodt and Kudco. I’m preparing a public shaming, actually. 😉 It’s one thing to maximize profits, but to palm off an inferior product as the same as original….sociopathy, imho.
Stay tuned.
Best,
g
What a great article, thank you! I had the unfortunate surprise of going to pick up my son’s Watson Generic Concerta yesterday and the co-pay is now $100!! It used to be $10. After hours on the phone with BCBS of NC, they have moved all 3 generics to their “non approved” list. I knew more than the rep I spoke with, so she wasn’t much help. They claimed the FDA forced them to do this. When I read the FDA memo to her that specifically excluded the Watson brand, she had no answers.
I need help/advice: Should I file a formal appeal? Run it up the chain? Have my son’s Dr. request an exception because his request will be heard better than mine? Any ideas would be so helpful. It’s infuriating that BCBS is taking this opportunity to deny paying for the Watson brand we’ve been using for 3 years. Argh!!
Thank you!
HI Samantha,
I know. It’s quite a shocker. You’ve gotten a very good deal for 3 years, at $10/Rx.
But now that those two “true” generics have been downgraded, Watson has no competition in the generics department. So, it can raise the price. At least, I’m assuming that’s what happened. Insurance companies have responded by not playing ball with Watson.
I encourage you to read the tips in the last part of the article.
Good luck!
g
Thank you so much for all this information.
I thought it was weird when my daughter’s Concerta generic looked different one month. I asked the pharmacist and he said it was just a different manufacturer. I didn’t think anything about it but over the next couple months realized it wasn’t as effective. I came across your site last year and realized it wasn’t just me! I didn’t know anything about generic prescriptions. We’ve been driving to a different pharmacy for six months or so to get the REAL generic.
Thank you!
Thanks for writing, JM, and for letting me know that this coverage has helped you.
Knowing that this tedious research and writing makes a difference in real people’s lives is why I do what I do!
tx
g
Thanks for putting this all together. I filled my concerta in December and was glad to see it was the same. I am glad to know that it will probably be until 2017 before it’s a concern again.
You’re welcome, Drew, and yahoo! I’m glad you didn’t have any problems.
best
g