Medicare coverage and cost-sharing for abiraterone following generic entry.
Notice bibliographique
Résumé
13 Background: Generic competition lowers drug prices, but may not reduce out-of-pocket costs for patients. Abiraterone, first approved by the United States Food and Drug Administration in 2011, has two commonly used dosage units (250mg and 500mg) with multiple generic market entrants over the last 5 years. This makes it ideal to evaluate the association between generic competition and changes in product coverage and cost-sharing. Methods: We studied 4 abiraterone products (tablets): generic 250mg, generic 500mg, brand-name 250mg, and brand-name 500mg. We used the FDA’s Orange Book to identify market entry of generic products until May 2022. We used Part D formulary data from 2018 to 2022 to identify changes in product coverage and expected annual out-of-pocket costs for the average Part D beneficiary (daily dose of 1000mg). We also calculated “best-case” cost-sharing in 2022, using the Part D Plan Finder. Results: During 2018-2022, 12 generic 250mg and 4 generic 500mg abiraterone formulations came to market. The first 250mg generic came to market in October 2018, and 10 of the 12 formulations came to market by 2019. The first 500mg generic formulation came to market in December 2020. The proportion of Part D plans that covered generic products increased from 0% in 2018, to 100% for 250mg and 79% for 500mg in 2022. Expected annual out-of-pocket costs for a Part D beneficiary ranged from $7,491 to $10,148 across products and years. In 2022, the average out-of-pocket costs for generic 500mg tablets was $10,148, greater than that for brand-name 500mg tablets, which was $9,298. The same was true when using the Part D plan finder (generic, $11,093, brand-name, $9,476). For the 250mg product, however, out-of-pocket costs were much higher for the brand-name versus generic product (> $150,000 versus $1,139). Conclusions: During 2018-2022, market entry of generic abiraterone products led to their preferential coverage over brand-name products on Part D formularies, but this was associated with only modest savings for beneficiaries. In fact, in 2022 for the 500mg product, average out-of-pocket costs were higher for generic, versus brand-name products. For the 250mg generic product, a patient able to price-shop could pay approximately $1,100, 1/7th of what the average beneficiary spent. These data indicate that Part D beneficiaries do not immediately benefit from price reductions associated with generic entry of specialty drugs. Part D beneficiaries’ out-of-pocket costs with generics can be higher despite lower list prices (vs. brand-name). Proposals to redesign Part D correct this fundamental flaw that makes high-cost generic drugs more expensive to patients than brands. Affordable medications should be available to all patients, not just the most resourced and able to price-shop. Limitations include that formulary files capture data from the prior 3 months, and expected out-of-pocket costs are averaged across beneficiaries and plans.
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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,012 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,001 |
| Bibliométrie | 0,002 | 0,003 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,006 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».