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

[engl.]= me too, or freely translated: “I also have the same substance”).

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):

  1. 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.
  2. 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).
  3. Aim to take it as early as possible during a migraine attack.
  4. Such a triptan rotation would encourage the existing provider to compete on price.
  5. 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.
  6. Absorption can be improved by adding an anti-nausea agent such as MCP or domperidone.
  7. 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.
  8. Test for improved efficacy and, above all, a reduction in recurring headaches by adding a long-acting NSAID such as Naproxen 500 mg.
  9. Adjust preventative medication regimen.
  10. Pay close attention to prevention through behavior.
  11. 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