Radar on Specialty Pharmacy

As the new coronavirus continues its spread, pharma companies are finding themselves facing a spate of challenges. And although they’ll need to find ways to counter those setbacks, they also can help address issues facing other health care industry stakeholders.

“This is an unprecedented time and one that is full of challenges for companies of all sizes and in all sectors,” observes Mike DeLone, principal at Deloitte Consulting and U.S. life sciences sector leader. “We believe there are five fundamental qualities of resilient leadership that should serve as guiding principles now more than ever: Be genuinely, sincerely empathetic while maintaining a hard, rational line to protect financial performance; put the mission first; aim for speed over elegance; own the narrative; and embrace the long view. While it will take time and effort, this crisis can become an opportunity to move forward and create even more value and positive societal impact.”

As the COVID-19 pandemic continues its assault on the globe and the U.S. passes 12,000 deaths from it, all eyes are on the health care industry. While the public looks to pharma manufacturers for potential treatments and vaccines, labs for testing to detect the virus, and providers and others in their realm for being on the front line of the defense against it, specialty pharmacies still have a vital role to play.

“During this unprecedented time, specialty pharmacies need to be nimble and possess the flexibility necessary to continue serving patients while keeping team members safe,” says John Stephens, vice president, transformation and growth at AllianceRx Walgreens Prime. At that specialty pharmacy, 75% of employees are working from home, with the rest “still working on site to dispense and ship lifesaving medications. Ship-to-home is the basic skill or capability keeping people out of pharmacies and hospitals, especially since specialty patients are more at risk due to the pandemic.”

Responding to the two-part Advance Notice proposing rate and risk adjustment changes for Medicare Advantage plans in 2021, insurers and other stakeholders expressed concern that payment rates for serving members with end-stage renal disease (ESRD) who will newly enter the MA program will not suffice.

The 21st Century Cures Act, signed into law in 2016, lifted a ban on ESRD patients enrolling in MA plans, which currently only serve those patients when they are diagnosed during the year. Part II of the Advance Notice stated that CMS will use fee-for-service Medicare reimbursement and enrollment data for beneficiaries in dialysis status from 2014 to 2018 to develop state-based ESRD MA benchmarks for 2021 (RMA 2/20/20, p. 1).

✦Walgreen Co. and Kroger Co. can continue to pursue a lawsuit (No. 19-1730) over Remicade (infliximab) against Janssen Biotech Inc. and its parent company, Johnson & Johnson, according to a decision by the U.S. Court of Appeals. The lawsuit claims that Janssen “used its size and bargaining power in the broader pharmaceutical market to enter into exclusive contracts and anticompetitive bundling agreements with health insurers that suppressed generic competition to Remicade, which in turn allowed Janssen to sell Remicade at supracompetitive prices.” The decision overturns a ruling by the U.S. District Court for the Eastern District of Pennsylvania (D.C. No. 2-18-cv-02357), which ruled in Janssen’s favor in March 2019. View the decision at https://bit.ly/2Tx21pa.

✦The U.S. Preventive Services Task Force (USPSTF) gave a B grade to screening for hepatitis C infection in people between the ages of 18 and 79. The Affordable Care Act mandates that private insurers cover preventive services with a USPSTF grade of A or B. View the recommendation at https://bit.ly/38kjMxx.

✦ Feb. 10: The FDA granted final approval to Eagle Pharmaceuticals, Inc.’s Pemfexy (pemetrexed) for the treatment of people with locally advanced or metastatic nonsquamous non-small cell lung cancer in combination with cisplatin; locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as maintenance treatment; locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy; and malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery in combination with cisplatin. The drug, to which the FDA granted tentative approval in 2017, is a branded alternative to Eli Lilly and Company’s Alimta (pemetrexed). The two drugmakers reached a settlement in patent litigation on Dec. 13, 2019, that will allow Pemfexy to launch with a three-week supply on Feb. 1, 2022, then an uncapped entry on April 1, 2022. Dosing for the intravenous injection depends on the indication. For more information, visit https://bit.ly/2vkZBSi.

✦ Feb. 18: The FDA approved a new dosage form for Procysbi (cysteamine bitartrate) for the treatment of people at least one year old with nephropathic cystinosis. The Horizon Pharma plc drug is now available in delayed-release oral granules, as well as capsules. The granules, also known as microbeads, will be available in packets of 75 mg and 300 mg strengths in the first half of 2020. The agency initially approved the capsule in 1994. Dosing is weight-based. Website Drugs.com lists the price of 250 75 mg delayed-release capsules as $26,454. Visit www.procysbi.com.