Orphan Drug Coverage In Exchange Plans Explored In Study
This article was originally published in The Pink Sheet Daily
Executive Summary
Researchers from Avalere and the National Organization for Rare Disorders find orphan drugs that are the only products in their class, such as Amgen’s Sensipar, have “relatively robust” coverage in a selection of popular health plans sold through exchanges in 15 states.
Orphan drugs that are the only products in their class are getting “relatively robust” coverage in popular insurance plans being offered through state-based exchanges in 2014, according to a study by researchers at Avalere Health and the National Organization for Rare Disorders.
Such drugs includeAmgen Inc.’s Sensipar (cinacalcet), Lundbeck Inc.’s Xenazine (tetrabenazine), Amedra Pharmaceuticals’ Albenza (albendazole) and Bristol-Myers Squibb Co’s.Droxia (hydroxyurea); each is covered by more than 65% of 84 plans evaluated across 15 states, the researchers reported.
The researchers found similar levels of coverage for GlaxoSmithKline PLC’s Votrient (pazopanib), which differs from the other drugs in that it is approved for both orphan and non-orphan indications. The drugs in the analysis were selected to ensure a varied sample, based in part on the characteristics and prevalence of the conditions the drugs are used to treat. They were also chosen to represent different marketing situations.
The researchers focused on bronze and silver level plans, which are the most popular type in the exchange marketplace. Data were drawn from the pharmacy benefit information offered to the public by plan sponsors. The study was published in the Journal of Managed Care and Specialty Pharmacy Sept. 22.
Sensipar has the broadest coverage among the drugs studied, with on-formulary status in 95% of plans. It is indicated for hypercalcimia and also appears to be the largest of the five drugs in terms of annual sales: $757 million in the U.S. in 2013, according to Amgen.
Percent Of Bronze/Silver Plans Covering Select Orphan Drugs
Amgen’s Sensipar: 95%
GlaxoSmithKline’s Votrient: 82%
Lundbeck’s Xenazine: 80%
Amedra’s Albenza: 76%
Bristol-Myers Squibb’s Droxia: 67%
Source: Avelere/NORD study
Votrient and Xenazine are each covered in about 80% of plans. Votrient has an orphan designation for advanced soft tissue sarcoma and a non-orphan indication for advanced kidney cancer. Xenazine is a treatment for Huntington Disease. The drugs had U.S. sales of roughly $235 million and $241 million in 2013, respectively.
Albenza is covered on 76% of formularies. The drug is indicated for Hydatid disease and neurocysticercosis. A treatment for sickle cell anemia, Droxia is covered by about 67% of plans. Sales figures for the two drugs are not readily available from their marketers: Amedra is privately held and BMS reports revenues for Droxia only in combination with its other “mature” brands.
Usage rates of formulary management tools for the drugs, such as prior authorization, ranged widely, from 6% of plans for Albenza to nearly 75% of plans for Xenazine, according to the analysis.
In general, the researchers found better access to the orphan drugs in silver plans compared with the less expensive bronze plans. For example, although Votrient had the highest level of coverage among bronze plans in the analysis, only six of 15 bronze plans covered the drug, compared with 53 of 69 silver plans.
The drugs in the analysis were typically covered on the formularies’ highest cost sharing tier and most often with coinsurance ranging from 10% to 50% of the cost of the drug. Average coinsurance rates were in the 27% to 38% range.
The researchers suggest that results show patients may find more favorable coverage and costs for rare disease drugs in higher premium gold and platinum plans than in the less expensive plans. “A gold or platinum plan may prove to be more cost-effective in the long term for patients than a bronze plan, with higher premiums potentially being offset by reduced out-of-pocket maximums and better coverage,” they say. A recent analysis for exchange plan coverage for specialty drugs by the research firm HealthPocket reached a similar conclusion (Also see "Specialty Drug Out-Of-Pocket Costs Compared Among 2015 ACA Plans" - Pink Sheet, 5 Sep, 2014.).
Coverage Under The Medical Benefit
The Avalere study also tried to evaluate coverage of a number of drugs for Gaucher disease. However, the analysis was complicated by the fact that because most of the drugs are injectables, they are likely to be reimbursed under the plans’ medical benefit and not their pharmacy benefit, which was the focus of the study.
The drugs include Genzyme Corp.’s Ceredase (aglucerase), Sanofi’s Cerezyme (imiglucerase), Pfizer Inc. and Protalix BioTherapeutics Inc.’s Elelyso(tagliglucerase), Shire PLC’s Vpriv (velaglucerase alfa) and Actelion Pharmaceuticals Ltd.’s Zavesca (miglustat).
Zavesca is the only oral medication in the group and is covered by 52% of the plans, the researchers found. Ceredase, Cerezyme, Vpriv, and Elelyso – all intravenous drugs – are covered (under the pharmacy benefit) by only 2% to 26% of plans. However, this is likely an incomplete picture because it does not take into account coverage under the medical benefit, the researchers point out. Information on drug coverage under the medical benefit is not very transparent, which adds to the challenges faced by rare disease patients when choosing a plan, they add.