by Dr. Axel Heinze, Dr. Katja Heinze-Kuhn and Prof. Dr. Hartmut Göbel
Patients who tried to fill their triptan prescriptions at a pharmacy as usual from September 1, 2010, onwards were in for a nasty surprise. For packs of 6 tablets, some pharmacies charged a co-payment of up to €33 for certain triptans. Even patients who were normally exempt from co-payments had to pay an additional amount of up to €28.
The reason for this significant and unannounced increase in the co-payment is the new fixed reimbursement regulation for triptans:
- The fixed amount refers to the maximum limit up to which statutory health insurance funds will cover the costs of certain medicines or aids.
- If the price of a drug exceeds the fixed amount, the patient must pay the difference out of their own pocket if they specifically want that drug.
- In addition, there is the usual 10% co-payment for the medication, whereby the 10% refers only to the lower fixed amount and not the actual price.
- Only this 10% co-payment can be exempted upon application.
The purpose of fixed reimbursement rates is to reduce costs in the healthcare system. The savings should by no means be passed on to the patient. Rather, the aim is to encourage patients to switch from expensive medications to more affordable alternatives. At the same time, manufacturers should be incentivized to lower their prices.
Fixed reimbursement amounts can only be introduced if there are at least three drugs in a drug class, none of which represents a therapeutic improvement or, for example, has reduced side effects. The fixed reimbursement amount is then always based on the least expensive drug in that drug class.
The first representative of the triptan class of drugs was sumatriptan. In the following years, six more triptans were approved (zolmitriptan, naratriptan, rizatriptan, almotriptan, eletriptan, and frovatriptan). In 2006, the patent protection for sumatriptan expired, and it was subsequently offered by numerous manufacturers as a generic drug. The resulting price reduction for sumatriptan led to a significant price difference between sumatriptan and the other triptans. This price difference within a drug class is a prerequisite for a fixed reimbursement rate to be financially viable for statutory health insurance funds.
The next step was the finding that all other triptans offer no therapeutic advantage over sumatriptan. The healthcare system refers to these as "me too" drugs
This determination involved, among others, the Federal Joint Committee (G-BA), the Drug Commission of the German Medical Association, and the Institute for Quality and Efficiency in Health Care (IQWiG). This fulfilled the conditions for the leading associations of health insurance funds to introduce a fixed reimbursement amount for all triptans in tablet or orally disintegrating tablet form, effective from September 1, 2010. The fixed reimbursement amount is based on the cost of inexpensive sumatriptan generics.
From a scientific perspective, the individual triptans share a similar mechanism of action. However, they differ significantly in clinical application with regard to potency, speed of action, duration of action, and/or tolerability. The latter is particularly evident in the fact that only one triptan (naratriptan) is currently available without a prescription in Germany. A current literature review comparing the individual active ingredients of the triptan drug class can be found in the comprehensive review . This review clearly shows that there are significant differences in clinical application between the individual active ingredients. Furthermore, for a considerable number of active ingredients, no direct scientific comparison between the different forms of administration has been conducted, thus questioning the existence of a basis for establishing a fixed reimbursement group.
It can be assumed that the majority of patients currently using other triptans have at least some experience with sumatriptan. Due to drug budget constraints, prescribing physicians have long been in the interest of primarily using the inexpensive sumatriptan; the lack of co-payment was attractive to patients. Patients who nevertheless took other triptans did so because of a doctor's prescription, greater efficacy, or better tolerability. For these individual patients, "their" triptan was and is therefore not a "me too" drug.
Of the triptan manufacturers, only the manufacturer of Maxalt has reacted to the changed fixed reimbursement amount regulations so far. The price of the Maxalt tablet has been reduced to the current fixed reimbursement amount, meaning there are no additional costs beyond the 10% co-payment. The price of the Maxalt Lingua pain tablet has also been reduced, but remains above the fixed reimbursement amount.
In the initial weeks of the new fixed reimbursement system, patients with the help of accommodating pharmacists were able to switch to inexpensive parallel imports for all other triptans. In particular, the two companies EMRA-MED and EURIM Pharm offered triptans imported from other European countries at prices more than half those of the corresponding German preparations (and those of other parallel importers). These parallel imports are identical products, though some differ in name (AscoTop = Zomig; Allegro = Tigreat). During these weeks in September, and in some cases until the beginning of October, virtually all triptans were available without markups, and the 10% co-payment was correspondingly significantly reduced (by up to €5 per pack). Unfortunately, these parallel imports were largely sold out at pharmaceutical wholesalers by October at the latest, and it is unclear when and at what price they will be available again.
What specific steps can individually affected patients consider?
The situation is fluid, and constant changes are to be expected. This is precisely the intention of the law. The fixed reimbursement amounts are meant to exploit potential efficiency gains and trigger effective price competition. The main point of criticism is whether triptans can actually be grouped together under a fixed reimbursement amount, i.e., whether they are pharmacologically and therapeutically comparable active ingredients. Theoretically, this could be the case. However, in practice, it has become clear that the individual efficacy and tolerability of one triptan can vary considerably, and clinical comparability is lacking. Patients can consider the following steps (as of November 15, 2010):
- Try again and test the two inexpensive triptans, sumatriptan and rizatriptan (Maxalt tablets). Rizatriptan has a slightly stronger and faster effect in comparison. Most generic sumatriptans don't even cost the 10% co-payment.
- If the effect is insufficient, ensure correct dosage; if necessary, increase the dose (Sumatriptan 100 mg instead of 50 mg, Rizatriptan 10 mg instead of 5 mg).
- Aim to take it as early as possible during a migraine attack.
- Such a triptan rotation would encourage the existing provider to compete on price.
- If a different triptan didn't help in the past (or was poorly tolerated), it may well work at a later time, so don't rely on past experiences.
- Absorption can be improved by adding an anti-nausea agent such as MCP or domperidone.
- For zolmitriptan, the nasal spray can be used instead of the tablet and orally disintegrating tablet, and this is not affected by the fixed reimbursement amount regulation.
- Test for improved efficacy and, above all, a reduction in recurring headaches by adding a long-acting NSAID such as Naproxen 500 mg.
- Adjust preventative medication regimen.
- Pay close attention to prevention through behavior.
- After all these measures, we can assume that even the last manufacturer has come close to agreeing to fixed amounts.
The exact pricing policy and the development of the fixed reimbursement amounts can be found here . The new fixed reimbursement amounts will be updated shortly. The legal background can be found here . It is hoped that in the future, patients will not be surprised and affected by new adjustments to the regulations without prior notice.
More discussions on this topic can be found in Headbook: The Migraine and Headache Network
This is a very positive development and shows us that the strategy was indeed correct. In the long run, this is probably the only solution to counteract the financial disaster in healthcare policy.
Kind regards,
Bettina Frank
The wait is over: Naratriptan HEXAL® and Zolmitriptan HEXAL® are now available as a no-cost alternative
HEXAL is introducing two new medications for the treatment of migraine headaches: Naratriptan HEXAL® and Zolmitriptan HEXAL®. These second-generation triptans have been further developed with regard to their pharmacokinetic profile. Naratriptan is characterized by its sustained effect, good tolerability, and low headache recurrence rate. Zolmitriptan focuses on a balanced profile of efficacy, tolerability, speed of action, and duration of effect.
Naratriptan HEXAL® is bioequivalent and has the same indication as Naramig®. Naratriptan HEXAL® 2.5 mg film-coated tablets are available in pack sizes of 4 (N1), 6 (N2), and 12 (N3). While the original brand-name drug is priced above the fixed reimbursement amount, Naratriptan HEXAL® is available to patients without any additional payment.
Zolmitriptan HEXAL® is available in 2.5 mg and 5 mg strengths in two dosage forms: film-coated tablets and orodispersible tablets. Orodispersible tablets are suitable when nausea or vomiting needs to be avoided, or when no liquid is available for swallowing.
Zolmitriptan HEXAL® is bioequivalent and has the same indications as AscoTop®. HEXAL offers additional pack sizes: a 12-tablet pack (N3) is available for both strengths and dosage forms. With Zolmitriptan HEXAL®, patients also have a non-reimbursable alternative, whereas the original brand-name product is subject to a fixed reimbursement amount. HEXAL already offers Sumatriptan-HEXAL®, another product in the triptan class.
I think the grouping of triptans into a fixed reimbursement category is a blatant misjudgment by the “Joint Federal Committee”.
This fixed reimbursement group contradicts the recommendations of the World Health Organization, those of national and international professional societies, and the patient information of the Institute for Quality and Efficiency in Health Care (IQWiG).
Quote from IQWiG: “So if a triptan cannot relieve the migraine as hoped, it might be worth trying another one.”
But that would have to be at my own expense or only with an additional payment?
Sources and further information can be found here:
http://www.ck-wissen.de/ckwiki/index.php?title=Triptane_-_Festbetragsregelung
Short address: http://tinyurl.com/CKWFBTT
The people who made these laws and regulations have surely never experienced the pain and associated symptoms (such as light sensitivity, nausea, etc.) of a migraine. They, too, should learn how to use the available funds wisely.
I've suffered from migraines for over 40 years. Lately, I was thankfully only getting them every two to three months. A necessary opiate treatment changed that drastically. Over the years, I'd been getting migraines once or twice a week. If I was aware of the onset of a migraine attack (usually at night), Almogran helped, which I was very grateful for. After four years, my opiate was changed, and the migraines became SOMEWHAT less frequent, but unfortunately, still too often.
Last week, I went to the pharmacy to get Almogran again and was confronted with co-payments I can't afford. My doctor at the pain clinic, with some reservations, prescribed Sumatriptan. As feared, it didn't help. On the contrary, since Monday (today is Friday), I've had migraines of varying severity. I've never experienced anything like this before. I'm afraid I didn't tolerate Sumatriptan.
What now? Suffering again in the future? Suffering even more because the necessary opiate treatment causes migraines to occur more frequently? A nightmare!
For cluster headache patients, I would like to offer a little reassurance here.
The article above by Dr. Heinze et al. focuses primarily on the current problems affecting migraine patients.
The cluster headache patient needs "their" triptan in a fast-acting form, i.e., as an injection or nasal spray. Since these take effect significantly faster than orally administered triptans, they also have a different "bioavailability"—and this bioavailability is precisely what is included as a decisive criterion in Section 35 of the German Social Code, Book V (SGB V)—nevertheless, some patients have experienced the aforementioned co-payment problems: they were expected to pay €35.00 out of pocket for a double pack of injections.
The CSG e. V. has taken up this issue – for the benefit of cluster headache patients – and has, among other things, requested a statement from the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds).
This fully agrees with the patient's opinion and states that the fixed reimbursement rate for triptans is NOT applicable to nasal sprays and injections.
Furthermore, the CSG e. V. has also received a “Notification of a Resolution of the Federal Joint Committee on an Amendment to the Drug Directive” from January 2010 (Federal Gazette No. 44, p. 1069; dated March 19, 2010), which addresses “Selective Serotonin 5HT1 Agonists, Group 1” under point 3. The following groups and dosage forms are listed there among those affected by the fixed reimbursement regulation:
Group: – oral, divided dosage forms
Dosage form: – Film-coated tablets, orodispersible tablets, sublingual tablets, tablets, coated tablets
but NO nasal sprays or injections (and no suppositories either).
Where does our federal government get the right to set drug prices at which no manufacturer or re-importer is willing to supply? There is clearly no legal basis for grouping certain medications into specific categories due to ineffectiveness or side effects, particularly with triptans.
According to the ruling S 13 KR 170 10, it is evident that the legislature is deliberately and shockingly negligent in its handling of patients' health. Asthma and migraines are chronic and sometimes incurable illnesses with severe physical suffering. It
is obvious that the legislature is once again establishing a bill contrary to the democratic principles of our society, which can only be countered by legal action and the associated postponement, after a long wait, of any potential repeal or amendment of Section 35 of the German Social Code, Book V (SGB V), in favor of pain patients.
Happy Holidays
The high co-payment has now hit me hard. Even the Almogran re-import, which was previously exempt from co-payments, has been discontinued by EMRA, and for other medications, I would have to pay around €50. Since I don't have that kind of money, I have no other option but to look for a different medication. I was still able to get it in October. Now I have to start all over again choosing a triptan. The problem is that I often experience severe side effects, or the medications simply don't work. Pharmaceutical policy only benefits the rich. If someone receives a full disability pension and has multiple illnesses, the healthcare system and politicians take away their last bit of money to live on.
Despite all that, Merry Christmas.
I followed the program with great interest. This high co-payment hit me hard a few weeks ago. My pharmacist went to great lengths to obtain a parallel import from EMRA. After several phone calls with the importer, we discovered that EMRA no longer produces this cheaper version of the migraine medication Zomig.
Where does the government get this fixed price for the drug if it's not even available? Are we being taken for a ride by the pharmaceutical industry? I depend on my migraine medication, have no other option, and now face a co-payment of over €50.
EMRA couldn't provide me with a source, so we'll just have to accept these high co-payments. I'd like to complain more loudly, but a regular patient can't do anything about this pharmaceutical policy. And unfortunately, you can't expect anything from the government either.
I then contacted my health insurance company. The health insurance company offers a patient hotline to address the concerns of its members. My request was received, acknowledged, and forwarded, but I haven't received a result yet.
Thank you for the clarification. I would have expected this from my health insurance company, as I've had to use Imigran for many years. It was
only with the last reimbursement that I was shocked to discover that, once again, not everything had been paid. So, thank you again and have a wonderful Advent season.
Walter