Among the top drugs under development is a new treatment for type 2 diabetes and a novel acute migraine drug, according to OptumRx’s “Drug Pipeline Insight Report” for the third quarter of 2019.
The top 5 drugs under development, according to OptumRx, include:
1. Oral semaglutide (Novo Nordisk) to treat type 2 diabetes mellitus (T2DM) and reduce major cardiovascular (CV) events. FDA previously approved the pharma maker’s once-a-week injectable form of semaglutide (Ozempic) in December 2017. “If approved, oral semaglutide would be the first GLP-1 receptor agonist in a pill form,” OptumRx says.
“With type 2 diabetes affecting over 28 million Americans, oral semaglutide’s market impact could be significant. The currently available GLP-1 agonists work well, but an oral form eliminates barriers caused by the route of administration (subcutaneous injection),” Sumit Dutta, MD, chief medical officer at OptumRx, told FormularyWatch.
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While Novo Nordisk has not revealed pricing plans, one analyst firm projects oral semaglutide will realize sales of more than $2 billion by 2024, Dutta said.
Spending for diabetes medications consistently ranks first among all classes, outpacing even oncology, Dutta noted. “GLP-1 agonists are priced significantly greater than other branded diabetes drugs and if oral semaglutide enters at a similar price point, then overall costs of treating diabetes could increase,” he said.
2. Ubrogepant (Allergan), a new oral migraine treatment based on the calcitonin gene-related peptide (CGRP) mechanism of action—the first oral medication in its class. Ubrogepant has been accepted for FDA review, and is expected to reach market in late 2019.
Currently, 3 injectable CGRP inhibitors are available for patients to take preventatively, while new oral CGRP inhibitors such as ubrogepant treat the acute migraine’s symptoms of a migraine and are not preventative, Dutta said. “The difference in indication and administration are important distinctions. Pricing is also a concern since most triptans are available generically and cost as low as $20 to $30 per month or prescription,” Dutta said. Meanwhile, the injectable CGRPs have a list price at around $6,900 a year (or $575 monthly).
3. Cabotegravir and rilpivirine (Cabenuva, Viiv Healthcare), a 2-drug regimen for treating HIV-1 in adults. If approved, Cabenuva would be the first long-acting, injectable treatment for adults living with HIV, potentially changing the way many patients living with HIV are managed and treated, OptumRx said.
In 2016, it was estimated that 1.1 million individuals aged 13 years and older are positive for HIV infection, with an additional 162,000 whose infections are not diagnosed.
The current standard of care for HIV is a daily, oral, three-drug regimen of antiretroviral therapy (ART). However, 2 global phase 3 studies have shown that once per month injections of cabotegravir/rilpivirine are as effective as a standard ART, OptumRx said. “With dosing frequencies reduced from 365 times per year with ART to potentially less than 12 times a year with cabotegravir/rilpivirine, we see prospect for both improved patient satisfaction and medication adherence,” Dutta said.
4. Luspatercept (Acceleron Pharma and Celgene), an investigational agent to treat anemia in adult patients with very low to intermediate-risk myelodysplastic syndromes (MDS) and beta-thalassemia. Both conditions often require regular blood transfusions, which are costly, and associated with their own set of side effects, including risk of infection and iron overload toxicity. The only curative treatment is stem cell transplantation, OptumRx said.
“It is estimated that MDS is diagnosed in at least 10,000 people each year in the United States, with more than 60,000 people living with the disease in the US today,” Dutta said. Industry analysts are projecting that luspatercept will reach sales in excess of $2 billion, based on its ability to treat MDS and beta thalassemia.
FDA has set target action dates of December 4, 2019, for the beta-thalassemia indication (priority review) and April 4, 2020, for the MDS indication.
5. Brolucizumab (Novartis) to treat wet age-related macular degeneration (AMD), also known as neovascular AMD, or nAMD. Wet AMD is a leading cause of blindness, estimated to affect up to 1.75 million people in the US by 2020, according to OptumRx.
Analysts predict that brolucizumab will reach annual sales over $1 billion globally by 2021, and that it will become the most profitable AMD drug by 2026. “However, the US patents on both Lucentis and Eylea will expire in 2020, and biosimilars for both are in development. These forecasts depend on the biosimilar drugs that are currently in various stages of development for the existing AMD drugs. If these should come to market, there could be additional price competition in the class,” OptumRx said.