GVS advice RZV (Shingrix®) for the prevention of herpes zoster and related post-herpetic neuralgia
Zorginstituut Nederland has completed its assessment whether the recombinant herpes zoster vaccine with adjuvant (RZV, Shingrix®) is interchangeable with a product that is included in the Medicine Reimbursement System (GVS). RZV (Shingrix®) is indicated for the prevention of herpes zoster and related post-herpetic neuralgia. The Zorginstituut recommends including the recombinant herpes zoster vaccine with adjuvant (Shingrix®) in List 1B and List 2 of the Health Insurance Regulation.
Registered indication
RZV (Shingrix®) is indicated for the prevention of herpes zoster (shingles) and related post-herpetic neuralgia (secondary prevention of Varicella zoster infection) in:
- adults ≥ 50 years old;
- adult ≥ 18 years old with increased risk of herpes zoster.
The marketing authorisation holder (MAH) requests inclusion in List 1B of the Health Insurance Regulation for the vaccination of part of the group of adults with an increased risk of herpes zoster.
Assessment of interchangeability
None of the medicinal products included in the Medicine Reimbursement System are interchangeable with RZV (Shingrix®). Based on this, RZV (Shingrix®) cannot be placed on List 1A. Next, the Zorginstituut assessed whether RZV (Shingrix®) is eligible for inclusion on List 1B. In this matter, it was advised by the Scientific Advisory Board (WAR).
The Zorginstituut has concluded that for the vaccination of adults aged 18 years or over with an increased risk of herpes zoster and belonging to the following medical risk groups:
- persons who have recently undergone a stem cell transplant (allogenic or autologous); or a stem cell transplant is planned;
- persons with a solid tumour or haematological cancer who are treated with an immune suppressive treatment, in which vaccination must be administered before, during or after treatment;
- persons who have recently undergone an organ transplant or for whom an organ transplant is planned;
- persons infected with the Human Immune-deficiency Virus (HIV);
the recombinant herpes zoster vaccine (with adjuvant) has added value compared to no vaccination.
Zorginstiuut's advice
The Zorginstituut advises the minister to include the recombinant herpes zoster vaccine with adjuvant (Shingrix®) in List 1B and List 2 of the Health Insurance Regulation, and imposing the conditions stated below. Inclusion in List 1B will lead to additional costs.
Conditions for the recombinant herpes zoster vaccine with adjuvant
Only for insured persons aged 18 years or older:
- who have recently undergone a stem cell transplant (allogenic or autologous), or for whom a stem cell transplant is planned;
- with a solid tumour or haematological cancer, who are being treated with an immunosuppressive treatment;
- who have recently undergone an organ transplant; or for whom an organ transplant is planned;
- who are infected with the Human Immunodeficiency Virus (HIV).