Radar on Specialty Pharmacy

One common characteristic of specialty medications is that they require special handling. Quite often that means they need to remain refrigerated or frozen, which is critical while drugs are being transported to patients and providers. To help ensure these products’ integrity — and, in turn, improve patient outcomes and reduce pharmaceutical waste — AllianceRx Walgreens Prime has begun using a new patented process when shipping specialty products.

When a drug needs to remain at a cool temperature and it isn’t, that results in drug waste and reshipment. But that assumes that the person receiving the drug knows it’s been compromised. If that’s not the case, and the product has lost its potency, that puts people’s health at risk if they are taking an ineffective drug. It also means that a payer is reimbursing for an inadequate drug.

The spinal muscular atrophy (SMA) therapeutic category continues to expand with the Aug. 7 FDA approval of Evrysdi (risdiplam) from Roche Group member Genentech, Inc. Industry experts maintain that the drug has the potential to significantly impact the class for a variety of reasons, including its route of administration and price.

People with SMA cannot produce enough SMN protein, leading to the loss of motor neurons, which results in problems breathing, swallowing, speaking and walking. Before a therapy was available to treat SMA, the condition was the No. 1 genetic cause of infant death.

With the COVID-19 pandemic affecting a variety of health care stakeholders, the cost of these services is becoming even more important. Payers tightening their budgets are trying to make sure that they are truly paying for value. But that’s easier said than done. All industry stakeholders, including pharma companies, should work to make changes in the health care system to bring value to the forefront of decision making, maintain industry experts.

Pointing out that people may never agree on the issue of whether prices for innovative drugs are too high, Kate Dion, value communications lead at 3D Communications, a company that provides strategic regulatory and value communications services to pharmaceutical, device and biologic companies, maintained that “what’s really at stake, and COVID-19 is pushing this into sharp focus, is how urgently we need to get medicines to patients. And not just medicines for the pandemic. The challenge is formidable. All at the same time, we need to make medicines more accessible to patients, incentivize scientific innovation and keep investors happy.”

President Donald Trump has issued another executive order focused on the pharmaceutical industry: a so-called “Buy American” order. While the approach presents some benefits, industry experts maintain that several challenges exist to its implementation, not the least of which is that it’s coming in the middle of a pandemic. And multiple specialty therapies may be impacted by it.

The order, signed Aug. 6, comes only a couple of weeks after the president signed a handful of executive orders focused on drug pricing. One of them, a most-favored nation order, was criticized by industry experts as a last-ditch effort before the Nov. 3 election to show the country that the administration is doing something about drug prices (RSP 8/20, p. 1). At the same time, critics argued that it’s taking away from efforts to develop therapeutics and vaccines for the COVID-19 pandemic. The president held off on publicizing that order with the other three on July 24, saying that he was giving pharma one month to come up with alternatives. As of RSP press time on Sept. 9, that order had not been made public.

✦ July 7: The FDA approved Astex Pharmaceuticals, Inc., Taiho Oncology, Inc. and Otsuka Pharmaceutical Co., Ltd.’s Inqovi (decitabine and cedazuridine) for the treatment of adults with intermediate and high-risk myelodysplastic syndromes. The agency gave the application priority review and orphan drug designation. Review of the application was done in collaboration with agency counterparts in Canada and Australia through Project Orbis (RSP 10/19, p. 12). Dosing is one tablet once daily on days one through five of each 28-day cycle. Taiho Oncology will commercialize the drug in the U.S. Its launch is pending. Visit www.inqovi.com.

✦ July 9: The FDA approved Mylan N.V. and Fujifilm Kyowa Kirin Biologics Co., Ltd.’s Hulio (adalimumab-fkjp) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. The agency approved the biosimilar of AbbVie Inc.’s Humira (adalimumab) — the sixth one that the agency has approved — in both prefilled syringe and auto-injector presentations. Dosing varies depending on the indication. A patent license agreement with AbbVie will allow the drug to launch in the U.S. in 2023. Visit https://bit.ly/2DnyjOZ.