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Is this post now completely outdated?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 I’ve noted in a few spots exactly why and how it’s outdated.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:
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:
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:
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.
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