A review of market access for treatments for people with anemia due to chronic kidney disease shows that under the pharmacy benefit, about 20% of the lives under commercial formularies are covered with utilization management restrictions. Around 40% of the lives under health exchange formularies are not covered for at least one of the drugs.
Under the medical benefit, about 46% of the lives under commercial policies are covered with utilization management restrictions. About 57% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.
For about 81% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, almost 72% of the lives require a single step. Around 38% of payer-controlled pharmacy benefit covered lives require prior authorization, with 60% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.
In February 2023, the FDA approved GSK’s Jesduvroq (daprodustat) for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least four months. The company says that the drug is the first innovative medication for anemia in more than 30 years, and it is the only hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) approved in the U.S. The starting dose for the tablet, which is available in five strengths, varies depending on hemoglobin level, liver function and concomitant medications.
In March 2022, the FDA issued a complete response letter (CRL) to Akebia Therapeutics, Inc. and Otsuka Pharmaceutical Co., Ltd.’s New Drug Application (NDA) for anemia drug vadadustat for use in patients with chronic kidney disease, citing concerns about vascular access complications and liver toxicity. The agency concluded that the data in the NDA do not support a favorable benefit-risk assessment of the oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for dialysis and nondialysis patients. In November 2022, Akebia submitted a Formal Dispute Resolution Request focused on the favorable balance of the benefits and risks of the drug.
In April 2021, the FDA issued a complete response letter (CRL) to FibroGen and AstraZeneca’s New Drug Application (NDA) for roxadustat for the treatment of anemia associated with chronic kidney disease. The agency requested an additional clinical study of the oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor before resubmission of the NDA.
Market Events Drive Changes
In February 2023, the FDA approved GSK’s Jesduvroq (daprodustat) for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months. In January 2020, the FDA approved Pharmacosmos Therapeutics Inc.’s Monoferric (ferric derisomaltose) injection 100 mg/mL to treat iron deficiency anemia in adult patients who have an intolerance to oral iron, have had an unsatisfactory response to oral iron or have nonhemodialysis-dependent CKD.
Competitive Market Landscape
New-to-market products will have to compete with well-established erythropoiesis-stimulating agents (ESAs) and a biosimilar, as well as an IV iron replacement product for people not on dialysis. Products with improved side-effect profiles compared with ESAs will have an advantage.
Pharmacy, Medical Benefit Implications
Most products in this indication are provider administered intravenously and primarily covered under the medical benefit. Products with self-administered formulations have coverage under both the pharmacy and the medical benefits. Many polices have documented diagnosis requirements and specify hemoglobin levels for initial and reauthorization coverage. Policies also contain iron store criteria and dose adjustment provisions. Some payers require a step through the preferred product and limit dispensing to specialty pharmacies.
Key Players in Market: