On the basis of the evaluation conducted by the Scientific Advisory Board, the Dutch National Health Care Institute (ZIN) has provided the Dutch Ministry of Health, Welfare and Sport with positive opinions for recommendation of three originator medicines.
IHS Life Sciences perspective | |
Significance | The Dutch National Health Care Institute (ZIN) has included three drugs in the national reimbursement list. |
Implications | The ZIN has recommended the Dutch Ministry of Health, Welfare and Sport includes Janssen-Cilag (subsidiary of Johnson & Johnson, US)'s hepatitis C virus (HCV) drug Olysio (simeprevir) and chronic obstructive pulmonary disease (COPD) treatment Anoro (umeclidinium + vilanterol; GlaxoSmithKline, GSK, UK) for Schedule 1A of the Dutch Medicines Reimbursement System. Adenuric (febuxostat; Menarini, Italy) was listed on Schedule 1B as it is not substitutable with other drugs. |
Outlook | Inclusion in Schedule 1A means that the medicine is therapeutically comparable to products included in the reference price system and is subject to this therapeutic reference pricing for out-patient reimbursement. Conversely, products in Schedule 1B bring a unique therapeutic value and cannot be referenced with other products. |
The Dutch National Health Care Institute (ZIN) has published positive recommendations for inclusion of three drugs under the Dutch reimbursement system. In particular, a positive opinion was granted to Janssen-Cilag (subsidiary of Johnson & Johnson, US)'s hepatitis C virus (HCV) drug Olysio (simeprevir), chronic obstructive pulmonary disease (COPD) treatment Anoro (umeclidinium + vilanterol; GlaxoSmithKline, GSK, UK), and Adenuric (febuxostat; Menarini, Italy) was approved for the treatment of hyperuricaemia.
Olysio considered interchangeable with Sovaldi
On the basis of the analysis of data from indirect comparison between use of Olysio and Gilead Sciences (US)' Sovaldi (sofosbuvir) in HCV patients with genotype 1 and 4 (without the presence of Q10K polymorphism genotype 1a), the Scientific Advisory Board (WAR) of the ZIN observed that there are no clinically meaningful differences in properties between the treatments. However, there are clinically relevant differences in characteristics between Olysio and older boceprevir + telaprevir treatments. Therefore, the WAR concluded that Olysio is interchangeable with Sovaldi, but is not substitutable with boceprevir + telaprevir, and accepted Janssen-Cilag's request to include Olysio in Schedule 1A of the reimbursement system and proposed a new reimbursement cluster with Olysio and Sovaldi. Schedule 1A includes medicines that are subject to this therapeutic reference pricing scheme for out-patient reimbursement. The full evaluation is available, in Dutch, here.
GSK's Anoro included in Schedule 1A
The WAR has evaluated that Anoro is interchangeable with Novartis (Switzerland)'s Ultibro Breezhaler (indacaterol + glycopyrronium), which is also a beta-agonist already included in the Dutch reimbursement system. Due to the substitutability of the two products, the ZIN has rejected the manufacturer's request to include Anoro in Schedule 1B and to form a new cluster. Conversely, the ZIN recommended inclusion of Anoro in Ultibro Breezhaler's reimbursement cluster (YR03ALAIDCV). The full assessment is accessible, in Dutch, here.
Adenuric listed in Schedule 1B
Menarini filed a dossier with a request for evaluation of Adenuric for a segment of the approved patient population on the basis of the consideration that patient's access to Adenuric is essential for the treatment of chronic hyperuricaemia in patients with gout, for whom no treatment options are available. The WAR has evaluated that in the treatment of chronic hyperuricaemia, Adenuric's therapeutic value is equivalent to allopurinol in the treatment of adult patients, in conditions where urate deposition has already occurred and there are symptoms of gout.
However, in patients who cannot be treated with, or do not respond to treatment with allopurinol, Adenuric has an added therapeutic value in comparison to benzbromarone. In terms of economic cost for the health insurance, if the reimbursement of Adenuric is limited to that group of patients that cannot be treated, or do not respond to treatment, with allopurinol, the additional costs for the pharmacy budget is estimated to reach between EUR1 million (USD1.25 million) and EUR1.6 million. If the use of Adenuric is not limited to the requested reimbursement indication, the total cost could reach EUR 25 million.
Furthermore, Adenuric has been deemed not substitutable with any other product listed in the Dutch Medicines Reimbursement System (GVS); therefore, it is eligible for inclusion in Schedule 1B only for patients who cannot be treated, or do not respond to treatment, with allopurinol, and which there is also evidence of urate deposition. The ZIN also recommends monitoring use of Adenuric. The full reimbursement decision is available, in Dutch, here.
Outlook and implications
The positive opinion granted to Olysio follows the listing of Sovaldi in the national reimbursement list. The latter, in fact, became available for reimbursement in the Netherlands on 1 November. Inclusion of the two drugs in the same cluster is likely to trigger price competition between the two medicines. In particular, drugs included within the same cluster are subject to the therapeutic reference pricing scheme. In particular, the Dutch Ministry of Health announced that further to negotiations with the manufacturer, the price was discounted by 14.6% on the list price; in addition, the ministry agreed a confidential cost reduction.
Furthermore, the opinion for inclusion of Anoro in Schedule 1A is mixed news for the manufacturer. In fact, although the drug has secured reimbursement under the Dutch GVS, the therapeutic reference pricing is likely to affect price levels of the medicine. Meanwhile, the decision of the ZIN to approve Menarini's request will pave the way for patient access to Adenuric for treatment of chronic hyperuricaemia when other treatment options are not available. The positive opinion, although limited to a smaller population of patients compared to the indication approved by the European Medicines Agency, will allow Menarini to expand its sales in the Dutch market.