A review of market access for treatments for adults with anemia due to chronic kidney disease shows that under the pharmacy benefit, about 37% of the lives under commercial formularies are covered with utilization management restrictions. Around 41% of the lives under Medicare formularies are not covered for at least one of the drugs.
Under the medical benefit, about 54% of the lives under commercial policies are covered with utilization management restrictions. Only 72% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.
For about 92% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, almost all of the lives require a single step. Around 66% of payer-controlled pharmacy benefit covered lives require prior authorization, with 14% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.
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 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.
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 chronic kidney disease.
Market Events Drive Changes
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 chronic kidney disease (CKD). In June 2018, the agency expanded the label for Mircera (methoxy polyethylene glycol-epoetin beta), a Roche drug that is commercialized in the U.S. and Puerto Rico by Vifor Pharma Inc., to include the treatment of pediatric patients 5 to 17 years old with CKD-related anemia who are on hemodialysis and are switching from another erythropoiesis-stimulating agent (ESA) after stabilization of their hemoglobin level. In May 2018, the FDA approved the first biosimilar to Amgen Inc.’s Epogen (epoetin alfa), Pfizer Inc. unit Hospira Inc.’s Retacrit (epoetin alfa-epbx).
Competitive Market Landscape
Most payers cover the drugs under both the pharmacy and 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.
Pharmacy Benefit Implications
New-to-market products will have to compete with well-established 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.
Key Players in Market: