Searching for "pricing" found 88

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Ministry of Health, Welfare and Sport (Ministerie van Volksgezondheid, Welzijn en Sport) The policy and regulation of drugs (‘medicinal products’), biologicals and medical devices falls under the jurisdiction of the Ministry of Health,…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal.  1. Price 1.1. How does price control at ex-factory prices work in your country? Ex-factory prices (PVA) are relevant to determine the retail price (PVP) of medicinal products and their maximum legal margins, as below.…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. Price Control 1.1. How does price control at ex-factory prices work in your country? Price control is regulated in Art. 65d HIO. Triennially, the FOPH reviews whether the medicinal products included in the LS…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.  1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? The Danish Medicines Council New medicines (or product with new indications) that are intended for the Danish hospital market,…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Romania.  1. Price Control 1.1. How does price control at ex-factory prices work in your country? In order to obtain the maximum manufacturer price approval, the medicine’s marketing authorization holder should submit an application dossier to…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Price Control 1.1. How does price control at ex-factory prices work in your country? The Ex-Factory Price (“PF”) is defined by CMED upon application by the company requesting drug marketing authorization, in accordance with…

USA In late 2023, The Wall Street Journal published the article Generic Drugs Should Be Cheap, but Insurers Are Charging Thousands of Dollars for Them. This article examined interactions between patient health insurance prescription benefits, pharmacies, and pharmacy benefit managers (PBMs), and their collective impact on the prices that patients pay for their prescription…

Global Merck’s Kaushal Kishore attempts to illustrate why pharma companies have struggled to crack what he calls “the Gross to Net (GtN) code.” He outlines the maturity journey for a pharma commercial and pricing organisation which can lead to maturity on the GtN topic, and highlights a successful example that can…

Pharma Legal Handbook 1. Price Control 1. How does price control at ex-factory prices work in your country? This question may be broken down in two parts: (i) situations in which a medicinal product may be in connection with its reimbursement status/price; and (ii) criteria to determine PVL.   Situations in which a…

USA The subject of intense industry criticism from the likes of lobby groups, Big Pharma, and biotech alike, the Inflation Reduction Act (IRA) subjects certain drugs to price negotiations directly with industry sponsors in the US for the first time. Ten initial drugs – which accounted for over USD 45 billion…

Global Merck KGaA’s Marco Rauland and Kaushal Kishore examine how artificial intelligence and machine learning can best be applied in pharmaceutical pricing and market access. Noting the significant uptake of such tools in other aspects of the pharma value chain, Rauland and Kishore speculate how they might come to revolutionise pricing…

USA After considerable government pressure to reduce insulin costs in the US, Eli Lilly recently slashed its prices by as much as 70 percent, followed by competitors Novo Nordisk and Sanofi. While these steps to make insulin more affordable, together with the US Medicare insulin price cap that came into effect…