Select a Region North America

Netherlands’ Parallel Procedures Pilot Expedites Registration, Reimbursement of New Medicines

Date: June 22, 2021 | Country: NETHERLANDS | Region: EUROPE | Type: Drug ApprovalPricing & ReimbursementRegulation | Keywords: #astellas #avacopan #bayer #ciltacabtageneautoleucel 
#finerone #gvs #insmed #janssen #meb #novonordisk #parallelproceduresmebzin #pilot #vig #zin

PRICENTRIC BRIEF:

  • After coming into fruition in May 2019, the Netherlands’ Parallel Procedures MEB-ZIN pilot has allowed for concurrent drug registration review by the Medicines Evaluation Board (MEB) and reimbursement review by the Zorginstituut (ZIN), whereas typically a drug must first pass quality, safety, and efficacy assessment by MEB before ZIN can decide on its eligibility for inclusion in the Medicines Reimbursement System (GVS)
  • So far, Novo Nordisk’s Rybelsus (semaglutide) for insufficiently controlled type 2 diabetes mellitus (T2D) and Insmed’s Arikayce (amikacin liposomal suspension for inhalation) for non-tuberculosis mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC) have successfully completed the pilot, each receiving an expeditious recommendation for inclusion in the GVS by ZIN—according to the Dutch Association of Innovative Medicines (VIG), Rybelsus and Arikayce partaking in the Parallel Procedure “resulted in an average time saving of three months”
  • Following these two medicines are Astellas’ Evrenzo (roxadustat) for anemia due to chronic kidney disease (CKD), Bayer’s finerenone for chronic kidney damage and T2D, Vifor Pharma’s avacopan for ANCA-associated vasculitis (AAV), and Janssen’s ciltacabtagene autoleucel (cilta-cel) for multiple myeloma (MM), with Janssen’s CAR-T therapy as the first inpatient medicine to partake in the Parallel Procedure Pilot

THE DETAILS

AMSTERDAM, Netherlands – After coming into fruition in May 2019, the Netherlands’ Parallel Procedures MEB-ZIN pilot has allowed for concurrent drug registration review by the Medicines Evaluation Board (MEB) and reimbursement review by the Zorginstituut (ZIN), whereas typically a drug must first pass quality, safety, and efficacy assessment by MEB before ZIN can decide on its eligibility for inclusion in the Medicines Reimbursement System (GVS).

So far, Novo Nordisk’s Rybelsus (semaglutide) for insufficiently controlled type 2 diabetes mellitus (T2D) and Insmed’s Arikayce (amikacin liposomal suspension for inhalation) for non-tuberculosis mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC) have successfully completed the pilot, each receiving a recommendation for inclusion in the GVS by ZIN.

According to Dineke Amsing, Access and Good Use of Medicines Manager, the Dutch Association of Innovative Medicines (VIG), Rybelsus and Arikayce partaking in the Parallel Procedure “resulted in an average time saving of three months,” expediting the entire process from registration to reimbursement.

Following these two medicines are Astellas’ Evrenzo (roxadustat) for anemia due to chronic kidney disease (CKD), Bayer’s finerenone for chronic kidney damage and T2D, Vifor Pharma’s avacopan for ANCA-associated vasculitis (AAV), and Janssen’s CAR-T therapy, ciltacabtagene autoleucel (cilta-cel) for multiple myeloma (MM). Notably, Janssen’s CAR-T therapy is the first inpatient medicine to partake in the Parallel Procedure Pilot.

Both procedures (registration and reimbursement) for avacopan and cilta-cel will commence in the second half of 2021.

For Amsing, the entry of Janssen’s inpatient therapy offers experience “we can use to further streamline the procedures for registration and reimbursement,” a major win, as VIG has backed embedding this pilot as an option for reimbursement applications. 

Parallel Procedure Eligibility 

Besides specific timestamps, the main criteria to be eligible in the pilot include: reimbursement on Appendix 1B of the GVS must be requested for the drug, the drug will most likely be placed in the “lock for expensive medicines,” and the responsible company must participate actively during the pilot procedure to further shape the methodology.

If a drug has been simultaneously entered into the BeNeLuxA or EUnetHTA Project, among other schemes, there’s a high chance marketing authorization will not be granted, or two similar medicines meet the criteria for inclusion in the pilot, then a drug is not eligible for the Parallel Procedure.

Learn more about Pricentric ONE and our Global Pricing Solutions!

Contact us with your questions and global pricing needs, and an expert will follow up shortly.