| Canadian Biosimilar Stakeholder Consultation Survey Open Until January 13
The Canadian Agency for Drugs and Technologies and Health (CADTH), in conjunction with the pan-Canadian Pharmaceutical Alliance (pCPA) – is leading a consultation on the use and implementation of biosimilars. ASBM encourages Canadian stakeholders- particularly those in the patient and physician communities who are concerned with biosimilar policy- to participate and make their voices heard.
The first phase of the consultation included interviews with stakeholders; the second phase was an in-person consultation on November 18, 2019, and the third and final phase is an online survey.
The survey is online until January 13, 2020 at 9am Eastern. It may be accessed at www.biosimilarsconsultation.ca (click on “how can my organization participate” in the middle of bottom of the home page).
The summary from the November 18 in-person consultation may be read here: https://www.biosimilarsconsultation.ca/the-process.
|
ASBM Releases Statement on Alberta Forced-Switching Policy
On December 13th, ASBM released a statement regarding the announcement by Alberta Health Minister Tyler Shandro of a new policy under which more than 26,000 patients would be forced to switch to biosimilars beginning in July 2020.
Affected patients include 22,000 Albertans with diabetes, 2,000 with Crohn’s disease or ulcerative colitis, 1,400 with rheumatic diseases, 750 with multiple sclerosis, 450 with low white-blood cell counts and 35 with plaque psoriasis.
Only half of Albertan patients- those on public pharmacare plans- will be subject to the forced-switching policy. Patients on private health plans, including Ministry of Health officials, will not be forced to switch. Children and pregnant women are also exempted. “For the affected patients, Health Minister Tyler Shandro is supplanting the role traditionally played by their physician’s medical judgment,” says ASBM executive director Michael Reilly. “In effect this creates two groups of Albertans- one who get medicine prescribed by their physician, and another who get medicine prescribed by politicians.’
The decision follows a similar announcement from British Columbia last May which has drawn sharp criticism from physician and patient advocacy organizations, who object to the switching of stable patients for non-medical reasons.
Representatives from the gastroenterology specialty and main GI patient groups were notably absent at the scheduled announcement. According to Crohn’s and Colitis Canada, which held a rally December 1st to raise awareness of the impending policy announcement, patients have sent in more than 11,000 letters urging the Alberta government to reconsider its position.
Read ASBM’s full statment on the policy here.
|
| Senate Confirms Hahn as New FDA Commissioner
On December 12th, the US Senate confirmed Dr. Stephen Hahn to be the the 24th commissioner of the US Food and Drug Administration. The Senate vote was 72 to 18.
Dr. Hahn is an oncologist and chief medical executive of the University of Texas MD Anderson Cancer Center in Houston, where has been a professor of radiation oncology since January 2015.
In his prepared statement, Dr. Hahn expressed his respect for the FDA’s role and emphasized the importance of its science and data-driven policymaking:
The FDA represents the gold standard for protecting the public health, is trusted by Americans and admired around the world for its mission ensuring the safety, efficacy, and security of medical products and the safety of the nation’s food supply… I believe strongly in the importance of science, data, and the law that have guided and should continue to guide the decision-making at the FDA.
Read more about Dr. Hahn’s confirmation here.
|
| House Passes Lower Drug Costs Now Act
On December 12th, the House of Representatives voted 230-192 to pass HR 3, the Elijah E. Cummings Lower Drug Costs Now Act, although the White House has already said it will veto the measure were it to be passed by the Senate.
In a letter to House leadership dated December 4th, ASBM expressed its opposition to an amendment in the bill which would financially incentivize physicians to prescribe biosimilars:
If implemented, this plan will give physicans a 33% bonus for using a biosimilar instead of an originator product. This provision will introduce financial incentives into the treatment decision-making process where patient interests should prevail.
Treatment decisions can and should take into consideration a number of factors, including economic factors such as the affordability of the drug for the patient, but these should not include additional or exceptional or extended profit for the physician. Every patient should be confident that their physician will prescribe the product that is in their best interest, not the one that is the most profitable to the physician personally. This proposed scheme fundamentally undermines the patient-physician relationship of trust.
Read more about HR 3 here.
Read ASBM’s letter to House leadership here.
|
| FDA Approves 26th Biosimilar, Fourth for Remicade
On December 6th, the FDA announced that it has approved Amgen’s infliximab biosimilar, Avsola (infliximab-axxq). It is the fourth biosimilar approved which references Remicade (infliximab), manufactured by Janssen Biotech. It is the 26th biosimilar approved by the FDA since March 2015.
Avsola (infliximab-azzq) was approved to treat Crohn disease (CD), pediatric CD, ulcerative colitis (UC), pediatric UC, rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
Read more about the approval here.
|
| UPCOMING EVENTS
Festival of Biologics USA
San Diego, CA – March 2-4, 2020
DIA European Meeting 2020
Brussels, Belgium – March 17-19, 2020
American Society of Clincial Oncology (ASCO) Annual Meeting
Chicago – May 29 -June 2, 2020
EULAR European Congress of Rheumatology 2020
Frankfurt, Germany – June 3-6, 2020
|
|
|
|
|
|
