7 minute read
Will Restrictions at the Border Lead to IG Shortages?
BY GINA SHAW
For well over a year, pharmacists, physicians and patients have been dealing with sporadic shortages of immune globulin (IG) products, as the COVID-19 pandemic led to a significant decline in donations of the blood plasma that is the primary component of these therapies.
According to the Plasma Protein Therapeutics Association (PPTA), plasma donations fell by 20% in 2020. Because the fractionation process that turns donated plasma into IG can take nine to 12 months from “needle to needle,” they expected the shortages to be much worse, but the IG supply in the United States remained relatively robust compared with other countries.
A lack of cross-border plasma donations is not helping. Because Mexico does not allow monetary compensation for plasma donations, many Mexican citizens cross the border regularly to donate plasma in the United States. On June 15, the U.S. Customs and Border Patrol (CBP) agency announced that it was stopping that practice and would no longer permit Mexican citizens to cross the border on temporary visas to sell blood plasma.
“Selling plasma constitutes labor for hire in violation of B-1 nonimmigrant status, as both the labor (the taking of the plasma) and accrual of profits would occur in the U.S. with no principal place of business in the foreign country,” the agency said in a statement.
The U.S.–Mexico border was closed to nonessential travel through much of the pandemic, so plasma donation centers at the border already experienced significant declines in donations, said Matthew Hotchko, PhD, the president of the Marketing Research Bureau, which supplies market data and intelligence on the global blood and plasma industry. “There had already been a steep dropoff. I don’t have exact figures, but I believe somewhere between 70% to 80% of plasma donors coming from Mexico had already dropped out of the regular donor pool because of the challenge of getting across the border.”
Before the pandemic, the approximately 40 border centers contributed about 10% to 12% of total U.S. plasma collections, with most coming from those living in Mexico, Dr. Hotchko said. He estimated that between the border closures and the new CBP ruling, plasma donations at border centers have been reduced by more than half. “I would say that probably about 3% to 4% of total plasma collections in the U.S. are now coming from those border centers after the recent CBP policy change.”
Organizations that advocate for patients with primary immunodeficiencies (PIs), such as the Immune Deficiency Foundation, have urged the Biden administration to rethink this policy change. “This action could reduce the plasma supply used to make lifesaving therapies by 5% to 10%,” said IDF vice president of public policy Lynn H. Albizo, JD, in a letter sent in June, to Health and Human Services Secretary Alejandro Mayorkas. “If these changes are implemented, we will see further pressure on the supply of plasma that will jeopardize the health of Americans with PI and other conditions.”
The PPTA, which represents manufacturers of IG and other plasma products such as CSL Behring, Grifols and Takeda, also issued a statement. “The change by U.S. Customs and Border Protection to limit the ability of people to cross the border to donate plasma is bad policy that risks American lives. Nearly 125,000 people in the U.S. with rare diseases, as well as countless others facing trauma and emergency medical needs every day, rely on medicines that are only available because of the commitment of dedicated plasma donors, and this new policy risks hindering the availability of these lifesaving medicines.” As of Dec.15, the policy was still in place. “PPTA continues to be actively engaged with policymakers and the administration to reverse CBP's policy change, as do several national and international patient advocacy groups and PPTA member companies. PPTA feels strongly that this restriction risks patients' lives by stopping dedicated
—Matthew Hotchko, PhD
individuals from Mexico from donating plasma, which is the unique starting material for lifesaving plasma-derived therapies. The longer this policy change remains in effect, the greater the likelihood that more than 125,000 U.S. patients (and countless others who rely on these therapies every day via emergency medical needs) will experience challenges accessing the treatments that enable them to live full, healthy lives,” PPTA told Infectious Disease Special Edition in an email.
The Gorilla in the Field
The United States is the 1,000 lb gorilla of the plasma therapeutics field, so supplies affect it less than other countries. “The reimbursement for a gram of plasma in the United States is so much more than in any other country, the manufacturers moved all that they possibly could from the rest of the world into the U.S. to meet that demand, because economically that just makes the most sense for them,” said Stacey Ness, PharmD, the vice president of clinical services at Managed Health Care Associates, and president of the Immunoglobulin National Society (IgNS).
Not only does the United States pay more for plasma products than other countries, but it supplies most of it as well. “The U.S. supplies approximately 70% of the source plasma used to manufacture plasma therapies for the entire world,” said Peter Jawoski, PhD, an associate teaching professor in strategy, ethics, economics and public policy at Georgetown University’s McDonough School of Business, in Washington, D.C., and an advocate of compensation for plasma donors. “Virtually the entire world is dependent on the U.S.”
There are U.S. shortages of certain products. (A complete list is regularly updated at the ASHP [https://bit.ly/33lVHtkIDSE]), but many foreign supply issues are dire. “The reduction in plasma collections has resulted in countries with lower prices for plasma products not getting enough supply, including many European countries and many other countries around the world,” Dr. Hotchko said.
Spain, which began reporting shortages of IG products in early July in local and regional news outlets, may be the “canary in the coal mine” for other countries, Dr. Jaworski suggested. The newspaper La Razon reported on July 5, 2021, that hospitals were significantly lowering doses of IG products given to patients with chronic neuropathies to preserve supplies for those with PIs. In an opinion piece published
in Redaccion Medica on July 12, Teresa Lluch, the vice president of GBS/CIDP Espana, reported that La Paz Hospital, in Madrid, had to suspend all IG treatments, while La Fe Hospital, in Valencia, was receiving 30% of its normal IG supply. The National Health Service in the United Kingdom, which reinstated plasma donations in April 2021 after banning them in 1998 due to fears of Creutzfeldt-Jakob disease, initiated its first national campaign calling for plasma donations. “They are perilously short of supply,” Dr. Jaworski said. The CBP order just makes the current trend even more negative, Dr. Hotchko said. “Countries that are struggling now will struggle even more, but the U.S. will still have a prioritized supply because of our pricing and because we are the location of most of the source plasma. We still may Before the pandemic, about 10% to 12% of total U.S. plasma collections see lowered supplies in the U.S. if the suppliers cannot redirect enough came from border collection supply to the United States for various reasons, but I centers—and most of the donors were from Mexico. don’t see that, yet.” Although this country has avoided severe shortages so far, Sohail Masood, PharmD, the founder and CEO of KabaFusion, which specializes in IV and subcutaneous IG therapies and operates 28 accredited home infusion specialty pharmacies nationally, thinks that is likely to change. “We do still have ample supplies of IG now, but if the border restrictions continue, I think it’s unavoidable that shortages will hit us in the U.S., as well. It will tend to impact companies that are more dependent on the border centers first.” Dr. Hotchko predicted that collections will rebound with time, however. “I would have said by the end of this year but the delta variant has thrown a monkey wrench into that, and it might be mid-2022 before we see supply growing again,” he said. “There are now more places to donate and a lot more marketing with higher donor compensation offered. There were about 100 new centers added nationwide last year, and there will be about the same number added by the end of this year.” Because the cost of collecting plasma is also going up, including increased remuneration to donors, Dr. Hotchko also predicted rising prices for IG therapies. “They are likely to rise faster than inflation, probably around the 3% to 5% per year range in the U.S., and faster in other markets.” ■ The sources reported no relevant financial disclosures beyond their stated employment/affiliation.
