Radar on Specialty Pharmacy

Women diagnosed with multiple sclerosis (MS) and being treated with disease-modifying therapies (DMTs) who become pregnant often discontinue those agents, as none are approved for use during pregnancy. But a recent study by AllianceRx Walgreens Prime, in conjunction with parent company Walgreens, demonstrates that when these women remain adherent to DMTs, this may reduce their nonmaternity inpatient and outpatient costs.

The findings were presented at the virtual Americas Committee for Treatment and Research in Multiple Sclerosis Forum 2021, which was held at the end of February.

The renal cell carcinoma (RCC) therapeutic class boasts multiple agents, but a recent entrant is offering a new tool for certain patients. A Zitter Insights survey shows that the majority of oncologist respondents are likely to prescribe Aveo Oncology’s Fotivda (tivozanib) for advanced RCC.

On March 10, the FDA approved Fotivda for the treatment of adults with relapsed or refractory advanced RCC who have received at least two prior systemic therapies. It is the first FDA-approved therapy for this use.

Many people taking specialty medications, such as people with cancer, are immunocompromised, and specialty drugs themselves can cause drug-induced immunosuppression. As COVID-19 vaccines roll out, it may be unclear how those products could impact people taking specialty therapies. At least one medical society, however, has released a guidance summary, and industry experts say that all stakeholders, including specialty pharmacies, have a role to play in making sure people getting vaccinated do so in the most effective, safest way possible.

In February, the American College of Rheumatology (ACR) released its COVID-19 Vaccine Clinical Guidance Summary, which provides recommendations on vaccinating people with musculoskeletal, inflammatory and autoimmune diseases. A panel of nine rheumatologists, two infectious disease specialists and two public health experts developed the guidance through multiple meetings in December and January. The guidance was updated on March 4.

The FDA is conducting an industrywide evaluation of drugs with indications given accelerated approval in an effort to determine whether confirmatory clinical trials verified the therapies’ clinical benefits. Manufacturers already have withdrawn indications approved in the U.S. for four drugs, and an upcoming meeting will scrutinize six additional indications. It’s important that the agency speed approvals of cancer drug indications if they look promising, contend experts, but it’s equally important that the FDA confirms their efficacy.

“The FDA has a large toolbox of options for getting important products to the market,” says Nancy Dreyer, Ph.D., chief scientific officer at IQVIA Real World Solutions. These include priority review, accelerated approval, fast track and breakthrough therapy designations, as well as emergency use authorizations (EUAs), which are used in emergency situations, such as the COVID-19 pandemic. “It appears that we are well covered in terms of having EUA for emergencies and other fast-track options that assure that the risks are not likely to outweigh the benefits of a new treatment and that the new treatment offers meaningful therapeutic benefit.”

✦ AstraZeneca said Feb. 22 that it would voluntarily withdraw the Imfinzi (durvalumab) indication in the U.S. for previously treated adults with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The FDA gave the indication accelerated approval on May 1, 2017 (RSP 5/17, p. 10). A confirmatory trial did not meet post-marketing requirements. View the statement at https://bit.ly/3kF92RO.

✦ Merck & Co., Inc. said March 1 that it was voluntarily withdrawing the U.S. indication for Keytruda (pembrolizumab) for the treatment of patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other line of therapy. The FDA gave the drug accelerated approval on June 18, 2019, for the indication (RSP 7/19, p. 8). The company was required to conduct a post-marketing study to establish superiority of the drug as determined by overall survival. The confirmatory Phase III trial had two primary endpoints; the drug met the progression-free survival endpoint but did not reach statistical significance for the overall survival endpoint. The move comes just a few months after Bristol Myers Squibb said on Dec. 29, 2020, that it was withdrawing the exact same indication for Opdivo (nivolumab) following accelerated approval on Aug. 17, 2018 (RSP 1/21, p. 12). View Merck’s statement at https://bit.ly/2NKEe6t.