Teclistamab in Germany: When Will It Be Available and All Your Options in the Meantime

Tecvayli (teclistamab-cqyv), an innovative immunotherapy for multiple myeloma, gained the FDA's accelerated approval in 2022 as the first bispecific antibody for myeloma[1].

In the EU, Tecvayli has conditional marketing authorization [3]. The medicine's manufacturer, Janssen, is aiming for full authorization.

Yet, even with EU approval, teclistamab may not be available everywhere. Especially in Germany, where Janssen doesn't intend to launch its therapy any time soon [4].

If you're a multiple myeloma patient in Germany, you have options. This article explores the legal ways to access Tecvayli before it's available in Germany.

Is Tecvayli (teclistamab) approved in Europe?

Tecvayli received conditional marketing authorization by the EMA in 2022 [3]. This authorization addressed the shortage of treatment choices for certain multiple myeloma patients.

In August 2023, the European Commission(EC) additionally granted approval for a type 2 variation application for Tecvayli. This made it possible to reduce the dosing frequency in patients who have achieved a complete response to the treatment for at least 6 months [2].

It's unclear when Tecvayli (teclistamab) might gain full marketing authorization from the EMA. The current conditional authorization is due to be reevaluated annually.

Why is Tecvayli (teclistamab) not available in Germany?

Janssen, the manufacturer of Tecvayli, says that the German Medicines Market Reorganization Act (AMNOG) does not recognize the clinical phase 1/2 evidence that allowed the European Commission to approve Tecvayli [4].

According to the company, Germany’s healthcare reimbursement system design is “anti-innovation” and “outdated” [4]. As a result, Janssen has decided not to launch Tecvayli (teclistamab) on the German market soon.

What does that mean for patients trying to access Tecvayli (teclistamab) in Germany?

Ways to safely access Tecvayli (teclistamab) in Germany

Are you a German patient with multiple myeloma? If your doctor is of the opinion that you might benefit from treatment with Tecvayli (teclistamab), you might not have to wait.

Your doctor and you could consider joining a Tecvayli clinical trial or applying for a Compassionate Use programme. You could also buy and access the medicine on an Individual Named-Patient basis.

Here's how all these options work.

Access Tecvayli via a clinical trial

Joining a clinical trial might allow you to use teclistamab or other drugs not yet approved in Germany. However, it requires effort. You and your healthcare provider must locate an active trial accepting participants from your region, and you must fit the set requirements. Your doctor's support is essential in this journey.

To explore ongoing clinical trials for Tecvayli (teclistamab), consider these resources:

• ClinicalTrials.gov: A comprehensive US clinical trial database. Some trials, like NCT04557098 involving teclistamab, accept international participants, including patients based in Germany [5].
• EUClinicaltrials.eu: Lists clinical trials within the European Union. It has some restrictions on data from trials started before 31 January 2022. For those, see the EU Clinical Trials Register.
• myTomorrows: This organization aids patients in discovering clinical trial treatment opportunities.

Access Tecvayli (teclistamab) via a Compassionate Use Programme

In Germany, there is a Compassionate Use programme available for teclistamab via the Paul-Ehrlich-Institut [6]. Participants in this programme receive the treatment free of charge.

Please note that this program is only available for patient groups, and not for individual patients [7]. In order to qualify for it, you need to meet the programme's criteria.

Buy Tecvayli (teclistamab) on an Individual Named-Patient basis

In many countries, the law allows for patients to buy and import medicines for life-threatening or debilitating diseases, when these medicines are not approved or available in their country. This regulation is known as the Individual Named-Patient Import.

If you're looking to get Tecvayli (teclistamab) before it's available on the German market, this could be a path for you. Here, again, your doctor's support is crucial.

The Individual Named-Patient Import regulation applies when:

• the medicine in question is approved somewhere else but not in the patient's country;
• there is no alternative on the local market;
• the medicine is for personal use;
• the patient has a prescription from their treating doctor. The treating doctor takes responsibility for the treatment. This may require different documentation from country to country.

Are you considering using the Individual Named-Patient Import regulation to get Tecvayli (teclistamab) before it's available in Germany? Discuss it with your treating doctor, as the first step is having a prescription.

If you already have a prescription, our team can help you access Tecvayli (teclistamab). We specialize in sourcing and delivering medicines not yet approved or available where you are. Get in touch with us for more information.

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Final thoughts on accessing teclistamab before it's available in Germany

Market accessibility for new medicines in Europe is traditionally a slow process. Speeding up your access to the medicine might seem attractive. However, there are also serious side effects for Tecvayli you need to know about from your doctor. If, after being well-informed, you and your doctor decide to try and access the medicine, there are always options.

Whether you want to explore a clinical trial or buy Tecvayli on a Named-Patient basis, having your doctor on board is very important.

For resources to help you in conversations with your treating doctor, check out more of our articles.

References:

1. Staff, Post. FDA Grants Accelerated Approval to Teclistamab-cqyv for Resistant Myeloma. The ASCO Post, 25 November 2022.
2. European Commission Approves Reduced Dosing Frequency for Janssen's Bispecific Antibody TECVAYLI® (teclistamab).  Johnson & Johnson, 18 August 2023. 
3. Tecvayli | European Medicines Agency. European Medicines Agency, Accessed 25 September 2023.
4. Janssen to Postpone Launch of Tecvayli in Germany Citing “Outdated” System. NAVLIN DAILY, 5 September 2022.
5. A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-1). ClinicalTrials.gov, Accessed 25 September 2023.
6. List of the Compassionate Use programs of the Paul-Ehrlich-Institut. Paul-Ehrlich-Institut, 30 March 2021.