Policy

Yesterday, 4 senators introduced a bill on the Senate floor that would allow HHS to block drug price increases that it deems as “excessive.”
In its annual preview of the landscape for pharmaceuticals, Vantage predicted that 2019 will be a year of shakeups for the industry, with biosimilars potentially playing a substantial role.
Pfizer disclosed that it would increase the price of 41 drugs; 37 drugs will see price increases of 5%, 1 drug by 9%, and 3 drugs by 3% on January 15, 2019. The announcement was met with pushback from politicians who have been vocal about drug pricing concerns.
Yesterday, 339 patient, provider, and caregiver groups, on behalf of the Part B Access for Seniors and Physicians Coalition, sent a letter to Congress encouraging lawmakers to block the implementation of the International Pricing Index (IPI) model that was announced last month.
Since the advent of biosimilar filgrastim, patient access to the prophylaxis of chemotherapy-induced febrile neutropenia has improved in many regulatory territories, yet concerns remain about whether the United States is keeping pace with the rest of the world in biosimilar uptake and associated patient access.
 
With the likelihood increasing that the United Kingdom will leave the European Union without a trade agreement in early 2019, the UK Health Secretary, Matt Hancock, has issued new advice to the pharmaceutical industry in which he warned that there could be long border delays that seriously impact the flow of pharmaceuticals in Europe.
In the United States, Amgen has 57 patents on Enbrel, whereas in Europe it has 20, and in Japan it has 18.
Last month, the European Parliament’s Health Committee introduced amendments to Supplementary Protection Certificate (SPC) manufacturing waivers. On December 4, 2018, the committee voted in favor of the amendments.
In revised draft guidance published in October 2018, the FDA announced its intention to crack down on citizen petitions that seek to delay competition from generic or biosimilar drugs. Now, in a comment letter, the Federal Trade Commission (FTC) has said that it stands ready to work with the FDA on curtailing abusive petitions.
After increased pressure on pharmacy benefit managers to remake their approaches to rebates, CVS Health has announced that it will offer a new prescription benefit option in 2019 that will pass all drug makers' rebates back to its plan clients.
 

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