Guiding principles of specialized migraine care with CGRP monoclonal antibodies

Migraine is a very common and highly debilitating primary headache disorder. With its more than 48 subtypes, it is one of the most complex neurological conditions. Epidemiological studies confirm its high prevalence and immense socioeconomic and individual impact. In recent years, numerous diagnostic and therapeutic innovations have been introduced into care (Fig. 1). Further therapies that specifically and precisely target the pathomechanisms of migraine are expected in the near future. Severely affected individuals therefore require a high level of expertise, up-to-date knowledge, and specialized experience from their physicians. This is particularly true for the use of monoclonal antibodies against the CGRP receptor and the CGRP ligand. Gepants and ditans are further classes of drugs that will soon expand migraine therapy.

The new drugs require targeted indication. Modern precision medicine with innovative active ingredients demands focused and specialized care. The approval studies are based on the exact application of the diagnostic criteria of the International Headache Society ICHD-3. Patient selection is crucial. Monitoring of treatment progress and success must be conducted with appropriate expertise to ensure that the efficacy and reliability demonstrated in scientific studies translate to real-world clinical practice. This requires experienced centers and qualified practitioners.

At the same time, the new active ingredients require cost-effective prescribing. In addition to the approved indication, there are requirements from the Federal Joint Committee (G-BA) as well as specific guidelines from professional societies. This results in constant changes in healthcare provision. These changes must be known and continuously taken into account. Clear, operationalized instructions on how to implement these requirements in practice are lacking. Consequently, prescribers experience uncertainty.

A defined procedure for appropriate care and structured documentation of progress and outcome monitoring provide insurers and prescribers with assurance of appropriate use and avoidance of recourse claims. The particular effort involved in this specialized care setting, however, also necessitates adjusted reimbursement. Potential savings through targeted treatment and discount agreements enable cost-effective 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 prescribed economically.

Monoclonal antibodies against CGRP in migraine prevention

Development of the nationwide migraine specialist care contract

These guiding principles and objectives led to the development of an innovative contract entitled "Special Care Contract pursuant to Section 140a of the German Social Code, Book V (SGB V) for the indication of migraine – Migraine Special Care Contract (Migraine SV Contract)." The contract has been in effect since January 1, 2022. Its aim is to provide insured individuals with specialized medical services, avoid medically unnecessary procedures, and ensure optimized treatment processes. For patients participating in this care program, the contract seeks to strengthen their self-responsibility and self-management skills and to tangibly improve their care.

The migraine care contract was concluded between Techniker Krankenkasse (TK) and the Kiel Pain Clinic. The two contracting parties organize specialized care within the framework of migraine therapy. All physicians nationwide who are authorized to provide services under the statutory health insurance system are eligible to participate. They must hold a recognized specialist title. Furthermore, they must offer the additional qualification "Special Pain Therapy" or a designated focus on migraine care in their practice.

If these requirements are met, contracted physicians can participate in this contract. Interest can be expressed by sending an email to the administration office of the Migraine Social Security Contract at msvv@schmerzklinik.de. The email should state the relevant qualifications (specialist title, additional qualification "Special Pain Therapy," or a focus on migraine care in the practice) and the interest in participating. The contract documents will then be sent. After reviewing the documents, the prospective participating practice can send the completed, signed, and practice-stamped declaration of participation to the administration office of the Migraine Social Security Contract (fax: +49 431 20099-159 or email: msvv@schmerzklinik.de ). If several physicians from a group practice wish to participate, each participant must submit their own declaration of participation.

Indications and phases of care

Under the migraine insurance contract, all forms of migraine according to ICD G43.x can be treated. The contract is aimed at TK-insured individuals who must meet the following two requirements:

  • There are at least four migraine days per month over a period of six
  • two were carried out, which were ineffective, not tolerated, or for which contraindications exist.

The agreement is open to the participation of other health insurance funds. Therefore, expanding participation to include insured members of other health insurance funds is possible.

As part of CGRP antibody therapy, patients must be in one of the following phases in order to be treated under the migraine SV contract:

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

Participating physicians are not obligated to use a specific medication. They retain complete freedom to choose their treatment. However, TK provides information on particularly cost-effective medications. These are designated as so-called focus medications.

The migraine insurance contract, in accordance with Section 130a Paragraph 8 of the German Social Code, Book V (SGB V), also aims to increase the proportion of prescriptions for discounted medications and thus improve the cost-effectiveness of care (Section 12 SGB V). With regard to innovative medications, intensive monitoring of progress and success is essential when selecting or switching medications. Treatment with CGRP antibodies therefore requires, to a particularly high degree, the specialized expertise and experience of a care concept focused on the indication and therapy support.

Should new therapeutic principles emerge in the future in addition to the CGRP antibody drug class (see Fig. 1), an agreement will be reached regarding their inclusion in the migraine care contract. Drug selection in specific care settings should be made in close consultation and with intensive monitoring between prescribers and patients (so-called "shared decision"). The current state of medical knowledge applies in this process.

Standardized documentation of the process offers protection against recourse claims

A standardized documentation form is provided. This form allows for the recording of previous migraine prophylaxis therapies using approved active ingredients. The structured documentation of prescribed CGRP antibodies and prior therapies provides participating physicians with security against reimbursement claims. For easy, digital monitoring of progress, the consultation checklist from the migraine app can be used (free download in the app stores for iOS and Android). Participating patients enter the frequency of headache days into the migraine app, differentiated by the frequency of aura, migraine days, days with tension-type headaches, and other headache days per month. The app also documents the severity and duration of headaches. The frequency and effectiveness of acute medications taken are also recorded. Furthermore, the impact of headaches on work, household chores, and leisure activities is continuously documented. Days with at least a 50% or complete reduction in the corresponding functional capacity are continuously recorded. The consultation checklist clearly documents the progress (see Fig. 2). Documenting the progress data with the migraine app is optional. If the patient does not have access to this data from the app, it can also be recorded conventionally on paper.

Specialized, quality-assured and economical supply

Participating physicians commit to providing quality-assured, effective, sufficient, appropriate, and economical care when prescribing medications for patients with migraines. This includes adherence to the relevant guidelines of the professional societies responsible for this condition. Where medically justifiable and economical, standard preventive medications will be used first, in accordance with guidelines, as long as they are medically indicated. Physicians retain full therapeutic freedom. When medically indicated and justifiable, prescribers will consider targeted medications for which special discount agreements with manufacturers apply. TK offers participating physicians pharmaceutical consultations and/or individual case conferences to inform them about economical and evidence-based pharmacotherapy, medication safety, and to answer pharmaceutical and pharmacological questions related to the contract.

Bonus for the special effort involved in specialized care

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

contacted by email at msvv@schmerzklinik.de

You can send an email directly using the QR code below: