Key ideas for specialized migraine care with CGRP monoclonal antibodies

Migraine is a very common, severely disabling primary headache disorder. With its over 48 subtypes, it is one of the particularly complex neurological diseases. Epidemiological studies demonstrate its high prevalence and immense socio-economic and individual impacts. In recent years, numerous diagnostic and therapeutic innovations have been added to care (Fig. 1). Further forms of therapy that specifically and precisely intervene in the pathomechanisms of migraine are expected in the near future. Severely affected people therefore need a high level of expertise, up-to-date knowledge and special experience from the medical practitioner. This is particularly true for the use of monoclonal antibodies against the CGRP receptor and the CGRP ligand. Gepante and Ditane are further active ingredient groups that will soon expand migraine therapy.

The new drugs require a targeted indication. Contemporary precision medicine with innovative active ingredients requires focused and specialized care. The approval studies are based on the exact application of the International Headache Society ICHD-3 diagnostic criteria. Patient selection. The progress and success monitoring of care must be carried out with appropriate expertise in order to achieve effectiveness and reliability in scientific studies in the real world of treatment. This requires experienced centers and qualified practitioners.

At the same time, the new active ingredients require economic regulation. In addition to the approved indication, there are requirements of the Federal Joint Committee (G-BA) as well as special guidelines from the specialist societies. This results in constant changes in supply. These must be known and continually taken into account. There are no clear operationalized instructions on how these requirements should be implemented in practice. The result is uncertainty on the part of the prescribers.

However, a defined procedure for appropriate care and structured documentation of progress and success monitoring provide payers and prescribers with security for appropriate use and freedom from recourse. On the other hand, the special effort involved in this specialized care process also requires an adjusted remuneration. Potential savings through targeted treatment and discount contracts enable economic implementation for the insured community and prescribers. CGRP antibodies and other innovative substances can be used in a targeted and specialized manner in the treatment of migraines and can be prescribed economically.

Monoclonal antibodies against CGRP in migraine prevention

Development of the nationwide migraine special care contract

These guiding ideas and goals led to the development of an innovative contract with the title “Contract for special care in accordance with Section 140a SGB V for the indication migraine – migraine special care contract (Migraine SV contract)”. The contract has been in force since January 1, 2022. The aim is to provide insured persons with special medical services, to avoid medically unnecessary services and to ensure that treatment processes are optimized. For patients participating in this care offer, personal responsibility and self-management should be strengthened and care should be improved in a tangible way.

The Migraine SV contract was concluded between the Techniker Krankenkasse (TK) and the Kiel Pain Clinic. The two contractual partners organize special care as part of specialized migraine therapy. All doctors nationwide who are approved to provide statutory health care can take part. You must hold a recognized specialist title. Furthermore, they must offer the additional qualification “Special Pain Therapy” or a designated migraine care focus in their practice.

If these requirements are met, contracted doctors can take part in this contract. Interest can be expressed by sending an e-mail to the Migraine SV contract administration office The relevant requirements (specialist title, additional qualification in “special pain therapy” or focus on migraine care in the practice) and interest in participation should be declared. The contract documents will then be sent. After reviewing the documents, the future participating practice can send the completed, signed declaration of participation with the practice stamp to the administrative office of the Migraine SV contract (Fax: 0431-20099-159 or E-Mail: ) . If several doctors from a group practice want to take part, each participant must send their own declaration of participation.

Indications and care phases

As part of the Migraine SV contract, all forms of migraine can be treated in accordance with ICD G43.x. The contract is aimed at TK insured persons who must fulfill the following two points:

  • There are at least four migraine days per month over a period of six
  • There were at least two documented previous treatments with approved active ingredients for migraine prophylaxis that were not effective, not tolerated, or for which there were contraindications.

The contract is open for additional health insurance companies to join. In this respect, it is possible to expand the participation of those insured by other health insurance companies.

As part of CGRP antibody therapy, patients must be in one of the following phases so that they can be treated under the migraine SV contract:

  • You need to be readjusted to a CGRP antibody.
  • They are switched from one CGRP antibody to another CGRP antibody. The reasons for this are either the insufficient effectiveness of the previous antibody or its intolerance.
  • The patients are in a phase of therapy escalation with dose adjustment.
  • If remission persists, therapy with a CGRP antibody is reduced or stopped.

The participating doctors are not bound to the use of a specific drug. There is complete preservation of freedom from medical therapy. However, the TK provides information about particularly economical medicines. These are labeled as so-called focus medicines.

According to Section 130a Paragraph 8 SGB V, the Migraine SV contract also aims to increase the proportion of prescriptions for discounted medicines and thus improve the cost-effectiveness of care (Section 12 SGB V). When selecting medicines and changing medicines, intensive support to monitor progress and success is a prerequisite with regard to innovative medicines. Treatment with CGRP antibodies therefore particularly requires the specialist competence and experience of a care concept that specializes in the indication and therapy support.

If new therapy principles emerge in the future in addition to the CGRP antibody group of drugs (see Fig. 1), an agreement will be reached regarding their inclusion in the migraine SV contract. The selection of medicines in the specific care process should be carried out in close coordination and intensive support between the prescribers and the patients (so-called “shared decision”). The general state of medical knowledge applies.

Standardized progress documentation offers recourse security

A documentation form is provided for standardized documentation. This can record previous drug therapies for migraine prevention using approved active ingredients. The structured documentation of the prescribed CGRP antibodies and the previous therapies offers the participating doctors security of recourse. The consultation checklist from the migraine app can be used to easily digitize progress and success monitoring (free download from the app stores for iOS and Android). The participating patients enter the frequency of headache days in the migraine app, differentiated by frequency of aura, migraine days, days with tension-type headaches and other headache days per month. Furthermore, the severity and duration of the headaches that occur are documented by the migraine app. The acute medication taken is also recorded in terms of its frequency and effectiveness. In addition, the impact of the headache on work, household and leisure activities is continuously documented. The days with a at least 50 percent or complete reduction in performance are continuously recorded. The consultation hour checklist can be sent to the prescribers as a PDF by email or as a printout (see Fig. 2). Documenting the historical data with the migraine app is optional. If the patient being treated does not have this data available from the app, it can also be recorded conventionally in paper form.

Specialized quality-assured and economical supply

The participating doctors are committed to providing quality-assured, effective, sufficient, appropriate and economical care when prescribing medication for patients with migraines. This also includes compliance with the respective guidelines of the specialist societies relevant to this disease. As far as medically justifiable and economical, classic preventative medications are initially used in accordance with the guidelines, as long as they are medically indicated. Doctors’ freedom of treatment remains fully intact. When medically indicated and justifiable, when selecting medicines, prescribers take into account focus medicines for which special discount agreements with the manufacturers apply. The TK offers the participating doctors a pharmaceutical consultation and/or individual case conference in order to inform them about economical and evidence-based pharmacotherapy as well as questions about drug therapy safety or about pharmaceutical and pharmacological questions that are related to the contents of the contract , to answer.

Bonus for the special effort of specialized care

A care bonus rewards medical advice and support for patients during specialized migraine therapy. This amount also covers the special documentation of previous therapies and treatment progress.

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