The Trump administration commits to importing drugs, patients with chronic lymphocytic leukemia (CLL) may have a potential new standard of care, and 3 insulin makers receive subpoenas over their pricing practices.
Welcome to This Week in Managed Care, I’m Laura Joszt.
HHS Lays Foundation for Importing Certain Prescription Drugs
HHS Secretary Alex Azar outlined the Trump administration’s dedication to lowering drug prices through drug importation. The Safe Importation Action Plan offers 2 avenues for importing drugs originally intended for foreign markets.
Said Azar: “Access to affordable prescription drugs can be a matter of life or death for American patients. The president has heard how much this matters to Americans, and we at HHS have heard the same. We all know how unfair it is that other countries are paying lower prices for the same drugs, and we’re taking action.”
The first pathway would allow states, wholesalers, or pharmacists to submit demonstration projects to HHS that outline how they would import certain drugs from Canada. These drugs would have to be versions of FDA-approved drugs and the pathway would not allow for importation of biologics, intravenous drugs, or controlled medicines. The second could potentially allow for importation of a much broader class of drugs, including insulins, and from all countries. FDA would offer recommendations to manufacturers who want to import US versions of drugs they sell in other countries.
CMS Testing Pilot to Give Medicare Providers Historical Claims Data
CMS Administration Seema Verma this week also announced a new pilot program that would integrate Medicare historical claims data into electronic health records. The program will give physicians more information about their patients at the time of an office visit.
The initiative, Data at the Point of Care, is part of the administration’s MyHealthEData initiative. According to Verma, consumers and beneficiaries would use apps so their information is portable and available at every doctor’s visit.
Verma also explained:
Claims information will only be available to providers who have already seen the patient
Patients have the right to opt out if they do not want to share claims data with their doctors
CMS will deploy the project to the first few providers with test data in August with plans to test with production data in September and October.
Drug Combination Shows Promise in CLL
Patients with CLL will likely see a new standard of care based on results of a phase 3 trial. Results published in New England Journal of Medicine showed that patients treated with the combination of ibrutinib and rituximab were alive and disease free longer than patients on the current treatment regimen.
According to the study authors, the current standard of care for CLL works but is terribly toxic. However, patients taking the ibrutinib–rituximab combination reported less fatigue and fewer serious infections. In addition, they had improved rates of progression-free survival and overall survival. The study compared 354 patients on the new combination with 175 on the standard chemoimmunotherapy regimen. Even patients who historically did not respond as well to the standard regimen received benefits from the new combination.
Said Dr Tait Shanafelt, MD, professor of Medicine at Stanford and lead author: “These results will fully usher the treatment of chronic lymphocytic leukemia into a new era. We’ve found that this combination of targeted treatments is both more effective and less toxic than the previous standard of care for these patients. It seems likely that, in the future, these patients will be able to forego chemotherapy altogether.”
Attorney General Subpoenas 3 Insulin Makers Over Pricing
Sanofi, Eli Lilly, and Novo Nordisk have all received subpoenas from the New York attorney general regarding their pricing practices for insulin. STAT reported that the subpoena seeks documents regarding pricing, discount programs, sales and expenses, contracting, marketing materials, and legal proceedings. The subpoenas follow months of increased scrutiny on insulin prices including hearings in the House and Senate at the beginning of the year on rising insulin prices and a bill announced just last week that would seek to roll back insulin price hikes.
More than 29 million Americans have some form of diabetes and about 7.4% use insulin. However, over the past few decades, the cost of insulin has skyrocketed. For instance, a 1-month supply of Eli Lilly’s Humalog only cost $21 in 1996, but it is now around $275: a 1200% increase. In March, Eli Lilly announced it was rolling out a generic version of Humalog and in April Sanofi began offering a program that set the monthly price of insulin at $99.
At the time of the announcement, Michelle Carnahan, North America Head of Primary Care, Sanofi, said: “It is unacceptable to Sanofi that some people living with diabetes are struggling to pay for their insulin, so we have moved to act creatively and aggressively to help address affordability and access needs.”
Advancing Oncology Quality Through Value-Based Care
Finally, the next installment of The American Journal of Managed Care®'s Institute for Value-Based Medicine® dinner series will be September 19 in September. Lawrence Shulman, MD, FACP, FASCO, deputy director for Clinical Services, Abramson Cancer Center, University of Pennsylvania, will moderate a panel discussion on advancing oncology quality through value-based care.
Attendees will hear about lessons learned through the Oncology Care Model and a payer perspective on advancing value-based care agreements.