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Officials with OptumRx predict four new therapies that are expected to an impact on patients and on the market.
The top medications in the pipeline include a first-in-class treatment for chronic kidney disease (CKD) associated with type 2 diabetes, along with a new oral treatment for migraine headaches and specialty medications for rare liver diseases, according to PBM OptumRx.
Here are the top four drugs in the pipeline in the third quarter, according to OptumRx’s Drug Pipeline Insights Report.
1. Bayer’s Kerendia (finerenone) treats patients with chronic kidney disease (CKD) and type 2 diabetes.Diabetes is one of the leading causes of CKD, said OptumRx, noting that there are 26.8 million people diagnosed with diabetes in the United States and about 1 in 3 of them develop some degree of CKD.
“Kerendia is unique in that it was the first drug in the class to be studied in such a robust randomized trial, and there may be some safety benefits versus the older drugs,” Arash Sadeghi, clinical pharmacist of Pipeline and Drug Surveillance at OptumRx, told FormularyWatch®.
In addition, sodium-glucose cotransporter-2 (SGLT2) inhibitors such as AstraZeneca’s Farxiga (dapagliflozin) are already approved to treat CKD. “So, while Kerendia is unique in mechanism, it will also be competing with drugs such as Farxiga in the CKD population. Compared indirectly, SGLT2 inhibitors such as Farxiga do appear to have more robust data and they are also approved for diabetes, which a major risk factor for CKD,” Sadeghi said.
A barrier to adoption of Kerendia is that other drugs used to treat CKD such as ACE inhibitors are available in generic form and are very inexpensive, OptumRx said, while the wholesale acquisition cost (WAC) for Farxiga is around $6,500 per year.
2. AbbVie’s ategoepant is expected to garner FDA approval in the third quarter. It offers an additional oral treatment option for preventing migraine attacks but enters a competitive market, Sadeghi said.
Current oral preventive treatments include beta blockers, antidepressants and anticonvulsants —many of which are available as generic products. In addition, another oral calcitonin gene-related peptide (CGRP) receptor antagonist, Biohaven Pharmaceuticals’ Nurtec ODT (rimegepant), is now approved for migraine treatment and prophylaxis.
“Atogepant is entering a crowded market and will compete with not only Nurtec ODT but with the other current treatment options for migraine prevention,” Sadeghi said. “We lack data comparing atogepant versus historical migraine prophylaxis agents. While it is difficult to compare across clinical trials, atogepant does appear to have similar or incrementally better efficacy than the injectable CGRP antagonists and Nurtec ODT.”
Investigators presented data from the phase 3 ADVANCE trial evaluating the long-term safety and tolerability of atogepant in several posters at the International Headache Society and the European Headache Federation, on September 8, 2021. The study enrolled 910 patients who completed a 12-week treatment period. Patients were randomized to either placebo or one of three different doses of atogepant.
Investigators found that in all doses, atogepant demonstrated improvements for the primary end point of reduction in mean monthly migraine days. Atogepant was also associated with improvements in migraine-specific quality of life, with improvements seen in the fourth week.
3. In late July, the FDA approved Albireo Pharma’s Bylvay (odevixibat), the first drug approved for the treatment of pruritus in all subtypes of progressive familial intrahepatic cholestasis (PFIC). PFIC is a rare and devastating disorder affecting young children that causes progressive, life-threatening liver disease, according to OptumRx.
While there is a small treatable population of about 600 people with PFIC, there is a high unmet need for effective treatments for the disease, Savitha Vivian, senior vice president of Clinical and Formulary Services at OptumRx, told FormularyWatch®.
“PFIC is typically unresponsive to conventional treatments that are used off-label, such as ursodeoxycholic acid, antihistamines, or rifampicin. The only proven effective treatments are surgical interventions and transplantation,” Vivian said.
The estimated average cost for Bylvay is $385,000 annually, according to Vivian.
4. Mirum Pharmaceuticals’ maralixibat, an oral apical sodium dependent bile acid transporter (ASBT) inhibitor to treat cholestatic pruritus in patients with Alagille syndrome (ALGS) one year of age and older, garnered FDA priority review in March 2021.
The agency expects to make a formal decision on maralixibat by late September, and it would be the first treatment for the rare liver disease, OptumRx reported. Vivian expects a similar WAC for maralixibat as Bylvay.
“There are high unmet needs for effective treatments for both PFIC and Alagille Syndrome,” OptumRx said. “Bylvay is the first FDA approved treatment for PFIC. Similarly, if approved, maralixibat would be the first approved treatment for Alagille Syndrome. It’s expected that the cost for these drugs will be high given the rarity of the diseases.”